As filed with theSecurities and Exchange Commission on June 26, 2025
Registration No. 333-
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-1
REGISTRATION STATEMENT UNDER THE SECURITIESACT OF 1933
CELLECTAR BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 2834 | 04-3321804 | ||
| (State or other jurisdiction of incorporation or organization) | (Primary Standard Industrial Classification Code Number) | (I.R.S. Employer Identification No.) |
100 Campus Drive, Florham Park, New Jersey07932
Telephone (608) 441-8120
(Address, including zip code and telephone number,including area code, of registrant’s principal executive offices)
JamesV. Caruso
President and Chief Executive Officer
Cellectar Biosciences, Inc.
100 Campus Drive, Florham Park, New Jersey07932
Telephone (608) 441-8120
(Name, address, including zip code and telephonenumber, including area code, of agent for service)
With copies to:
| Asher M. Rubin, Esq. Istvan Hajdu, Esq. Kostian Ciko, Esq. Sidley Austin LLP 787 Seventh Avenue New York, New York 10019 Telephone (212) 839-5300 | Michael F. Nertney, Esq. Ellenoff Grossman & Schole LLP 1345 Avenue of the Americas 11th Floor New York, New York 10105 Telephone (212) 370-1300 |
Approximate date of commencement of proposedsale to the public:
As soon as practicable after this RegistrationStatement becomes effective.
If any of the securities being registered on thisForm are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the followingbox. x
If this Form is filed to register additionalsecurities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the SecuritiesAct registration statement number of the earlier effective registration statement for the same offering. ¨
If this Form is a post-effective amendmentfiled pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statementnumber of the earlier effective registration statement for the same offering. ¨
If this Form is a post-effective amendmentfiled pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statementnumber of the earlier effective registration statement for the same offering. ¨
Indicate by check mark whether the registrantis a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ¨ | Accelerated filer ¨ | Non-accelerated filer x | Smallerreporting company x | Emerging growth company ¨ |
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accountingstandards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ¨
The registrant hereby amends this RegistrationStatement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment whichspecifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of theSecurities Act of 1933, as amended, or until the Registration Statement shall become effective on such date as the Securities and ExchangeCommission, acting pursuant to said Section 8(a), may determine.
The information inthis preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filedwith the Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and isnot soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
Subject to Completion
Dated June 26, 2025
Preliminary Prospectus
Up to 755,667 Class A Units with eachClass A Unit consisting of (i) one (1) Share of Common Stock and (ii) one (1)
Common Warrant to purchase one (1) Share of Common Stock
Or
Up to 755,667 Class B Units with eachClass B Unit consisting of (i) one (1) Pre-Funded Warrant to Purchase one (1)
Share of Common Stock and (ii) one (1) Common Warrant to purchase one (1) Share of Common Stock
Up to 45,340 Representative Warrants toPurchase up to 45,340 Shares of Common Stock
Up to 1,556,674 Shares of Common Stock IssuableUpon Exercise of up to (i) 755,667 Pre-Funded Warrants, (ii) up to 755,667
Common Warrants and (iii) up to 45,340 Representative Warrants
We are offering up to 755,667 Class AUnits (the “Class A Units”) with each Class A Unit consisting of (i) one (1) share of our common stock,par value $0.00001 per share (the “common stock”) and (ii) one (1) warrant to purchase one (1) share of commonstock (each, a “Common Warrant”) at an assumed public offering price of $7.94 per Class A Unit (which is the last reportedsale price of our common stock on The Nasdaq Capital Market on June 25, 2025).
We are also offering to certain purchaserswhose purchase of Class A Units in this offering would otherwise result in the purchaser, together with its affiliates and certainrelated parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediatelyfollowing the consummation of this offering, the opportunity to purchase, if any such purchaser so chooses, up to 755,667 Class BUnits (the “Class B Units”), with each Class B Unit consisting of (i) one (1) pre-funded warrant (each,a “Pre-Funded Warrant”) to purchase one (1) share of common stock, in lieu of shares of common stock and (ii) one(1) Common Warrant. The purchase price of each Class B Unit will be equal to the public offering price for Class A Unitsin this offering, minus $0.00001. Each Pre-Funded Warrant is exercisable for one (1) share of our common stock and has an exerciseprice of $0.00001 per share, and a perpetual term. For each Class B Unit that we sell, the number of Class A Units we are offeringwill be reduced on a one-for-one basis. This prospectus also relates to the offering of common stock issuable upon exercise of the Pre-FundedWarrants and Common Warrants. We collectively refer to the Class A Units, Class B Units, the shares of common stock, Pre-FundedWarrants, Common Warrants and the shares of common stock underlying the Pre-Funded Warrants and Common Warrants as the “securities.”
The Class A Units and Class B Unitswill not be certificated and the shares of common stock, Pre-Funded Warrants, and Common Warrants are immediately separable and will beissued separately in this offering. Each Common Warrant will be exercisable immediately upon issuance, have a term of five (5) yearsfrom the date of issuance and an exercise price equal to $ .
The underwriters have the option to purchaseup to 113,350 additional shares of common stock and/or additional Common Warrants to purchase up to an additional 113,350 shares of commonstock solely to cover over-allotments, if any, at the public offering price, less the underwriting discounts and commissions. The over-allotmentoption may be used to purchase shares of common stock and/or Common Warrants, or any combination thereof, as determined by the underwriters.The overallotment option is exercisable for forty-five days from the date of this prospectus.
Our common stock is listed on The Nasdaq CapitalMarket under the symbol “CLRB”. On June 25, 2025, the last reported sale price of our common stock was $7.94 per share. Theassumed public offering price may not be indicative of the final public offering price. The final public offering price will be determinedthrough negotiation between us and the underwriters based upon a number of factors, including our history and our prospects, the industryin which we operate, our past and present operating results and the general condition of the securities markets at the time of this offeringand may be at a discount to the current market price.
On June 24, 2025, a reverse stock split of our outstanding sharesof common stock took effect at a ratio of one-for-thirty (the “Reverse Stock Split”), which was approved by our Board ofDirectors and majority of stockholders, and consummated pursuant to a Certificate of Amendment filed with the Secretary of State of Delawareon June 23, 2025. There will be no change to the number of authorized shares or the par value per share. Unless the context expresslydictates otherwise, all references to share and per share amounts referred to in this prospectus give effect to the Reverse Stock Split.However, our periodic and current reports that are incorporated by reference, and all other documents that were filed prior to June 24,2025, do not give effect to the Reverse Stock Split.
Investing in our securities involves ahigh degree of risk. Before making an investment decision, please read the information under “Risk Factors” beginningon page 17 of this prospectus and under similar headings in any amendment or supplement to this prospectus or in any filing withthe Securities and Exchange Commission that is incorporated by reference herein.
| Class A Unit | Class B Unit | Total | ||||||
| Public offering price (1) | $ | $ | $ | |||||
| Underwriting discounts and commissions (2) | $ | $ | $ | |||||
| Proceeds to us, before expenses (3) | $ | $ | $ |
(1) The public offering priceand underwriting discount corresponds to (i) a public offering price per Class A Unit of $ ($ net of the underwriting discount)and (ii) a public offering price per Class B Unit of $ ($ net of the underwriting discount).
(2) We have agreed to reimbursethe representative of the underwriters for certain expenses and issue the representative, or its designees, warrants to purchase up to6.0% of the number of Class A Units and Class B Units sold in this offering, including shares of common stock sold pursuantto the over-allotment option, if any. See “Underwriting” on page 56 for additional information regarding underwritingcompensation.
(3) The above summary of offeringproceeds does not give effect to any proceeds from the cash exercise of any Pre-Funded Warrants, Common Warrants, or representative warrantsbeing issued in this offering.
The underwriters expect todeliver the securities to purchasers in the offering on or about , 2025.
NEITHER THE SECURITIESAND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUSIS TRUTHFUL OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
Ladenburg Thalmann
The date of this prospectus is ,2025.
Tableof Contents
The registration statementwe filed with the Securities and Exchange Commission, or the SEC, includes exhibits that provide more detail of the matters discussedin this prospectus. You should read this prospectus, the related exhibits filed with the SEC, and the documents incorporated by referenceherein before making your investment decision. You should rely only on the information provided in this prospectus and the documents incorporatedby reference herein or any amendment thereto. In addition, this prospectus contains summaries of certain provisions contained in someof the documents described herein, but reference is made to the actual documents for complete information. All of the summaries are qualifiedin their entirety by the actual documents. Copies of some of the documents referred to herein have been filed, will be filed or will beincorporated by reference as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies of thosedocuments as described below under the heading “Where You Can Find Additional Information.” Information contained in later-dateddocuments incorporated by reference will automatically supplement, modify or supersede, as applicable, the information contained in thisprospectus or in earlier-dated documents incorporated by reference.
We have not authorized anyoneto provide any information or to make any representations other than those contained in this prospectus, the documents incorporated byreference herein or in any free writing prospectuses prepared by or on behalf of us or to which we have referred you. We take no responsibilityfor, and can provide no assurance as to the reliability of, any other information that others may give you. The information containedin this prospectus, the documents incorporated by reference herein or in any applicable free writing prospectus is current only as ofits date, regardless of its time of delivery or any sale of our securities. Our business, financial condition, results of operations andprospects may have changed since that date.
This prospectus is an offerto sell only the securities offered hereby, and only under circumstances and in jurisdictions where it is lawful to do so. We are not,and the underwriters are not, making an offer to sell these securities in any state or jurisdiction where the offer or sale is not permitted.
The terms “CellectarBiosciences,” “Cellectar,” the “Company,” “our,” “us” and “we,” as usedin this prospectus, refer to Cellectar Biosciences, Inc., a Delaware corporation, and its subsidiaries unless we state otherwiseor the context indicates otherwise.
This summary highlightsinformation contained elsewhere in this prospectus. Because it is a summary, it may not contain all of the information that is importantto you. Accordingly, you are urged to carefully read the entire prospectus, any applicable prospectus supplement and any related freewriting prospectus, including the risks of investing in our securities discussed under the heading “Risk Factors” containedin any applicable prospectus supplement and any related free writing prospectus, and under similar headings in the other documents thatare incorporated by reference into this prospectus. You should also carefully read the information incorporated by reference into thisprospectus, including our financial statements, and the exhibits to the registration statement of which this prospectus is a part.
Company Overview
We are a late-stage clinical biopharmaceuticalcompany focused on the discovery, development and commercialization of drugs for the treatment of cancer. Our core objective is to leverageour proprietary phospholipid ether drug conjugate™ (PDC™) delivery platform to develop PDCs that are designed to specificallytarget cancer cells and deliver improved efficacy and better safety as a result of fewer off-target effects. We believe that our PDC platformpossesses the potential for the discovery and development of the next generation of cancer-targeting treatments, and we plan to developPDCs both independently and through research and development collaborations. On April 30, 2025, we announced that we will explorea full range of strategic alternatives to advance our platform and radiopharmaceutical drug development pipeline. Strategic alternativesunder consideration may include, but are not limited to mergers, acquisitions, partnerships, joint ventures, licensing arrangements orother strategic transactions.
The Company is primarilyfocused on the development of its radioconjugate PDC programs, also known as phospholipid radioconjugates or PRCs, designed to providetargeted delivery of a radioisotope directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiatesour PRCs from many traditional on-market treatments and radiotherapeutics. Our three lead programs are: CLR 121125 (CLR 125), an iodine-125Auger-emitting program, prepared to enter a clinical trial in 2025; CLR 121225 (CLR 225), an actinium-225 based program; and iopofosineI 131 (iopofosine I 131, or simply iopofosine), a beta-emitting iodine-131 based program which has been studied extensively, as describedbelow. On June 4, 2025, the Company announced that the U.S Food and Drug Administration (the “FDA”) has granted BreakthroughTherapy Designation for iopofosine I 131, as a radioconjugate monotherapy for the treatment of relapsed/refractory Waldenstrom macroglobulinemia(r/r WM).
| · | CLR 125, the Auger-emitting PRC, utilizes iodine-125 and has been observed to show tolerability with minimal toxicities in animalmodels. Additionally, the Company observed CLR 125 to have good activity in multiple solid tumor models, especially in triple negativebreast cancer. Auger emitters provide the greatest precision in targeted radiotherapy as the emission can only travel a few nanometers.The Company believes that this means that to cause the necessary breakage of the tumor cell DNA, the isotope most get inside the celland near the cell nucleus to be effective. The Company believes that CLR 125 achieves this due to the Company’s novel phospholipidether drug conjugate platform. CLR 125 is prepared to be the subject of a Phase 1b dose finding study in the second half of 2025 as describedbelow, subject to our ability to obtain additional financing. |
| · | CLR 225, the alpha-emitting, actinium-225 based PRC has been observed to show activity in multiple solid tumor animal models, includingpancreatic, colorectal, and breast cancer. The Company observed CLR 121225 to be well tolerated in these models with the animals showingno adverse events at the highest doses tested. The Company also observed that the compound has excellent biodistribution and uptake bythe tumor. Furthermore, in multiple models of pancreatic adenocarcinoma, including highly refractory pancreatic cancer, we have observedthe compound’s proportional dose response with a single dose providing either tumor stasis at the lowest dose tested or tumor volumereduction at the higher doses. The Company is currently prepared to initiate a Phase 1 imaging and dose escalation safety study in thesecond half of 2025, subject to our ability to obtain additional financing. |
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| · | Iopofosine, the beta-emitting PRC, utilizes iodine-131 and was studied in our CLOVER-WaM Phase 2 study of iopofosine in patients withrelapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM) where it was observed to result in statistically significant outcomeson both primary and secondary endpoints, and our Phase 2b studies in r/r multiple myeloma (MM) patients and r/r central nervous systemlymphoma (CNSL) are ongoing. The CLOVER-2 Phase 1a study for a variety of pediatric cancers has concluded and a Phase 1b study in pediatricpatients with high grade glioma is enrolling. Additionally, a Phase 1 Investigator-initiated study conducted by the University of WisconsinMadison of iopofosine in combination with external beam radiation in patients with recurrent head and neck cancer has also been completed.As with all clinical trials, adverse events, serious adverse events or fatalities may arise during a clinical trial resulting from medicalproblems that may not be related to clinical trial treatments. Furthermore, due to recent communications with the FDA regarding a confirmatorystudy to support accelerated approval and the regulatory submission for iopofosine, the Company is, in addition to determining the availabilityof funding for such a study, pursuing strategic options for the further development and commercialization of this product candidate. Aspart of our previous announcement to seek a full range of strategic alternatives, we have initiated a process that includes identifyinga strategic partner with the resources to develop iopofosine I 131. |
Clinical and Preclinical Pipeline
Preclinical Evaluations of CLR 125
In preclinical, in vivo evaluations of CLR125, utilizing triple-negative breast cancer (TNBC) models, the compound was observed to have tumor uptake at a substantially higher ratethan that of healthy tissue. Additionally, no signs of end-organ toxicity were observed, including hematological toxicity.
CLR 125 Proposed Study
The anticipated use of funds generated from thisoffering is to provide necessary capital for operating expenses and to initiate a Phase 1b clinical study in TNBC with CLR 125, whichis chemically and structurally the same as iopofosine, with the only difference being the iodine isotope with which it is radiolabeled.The clinical experience of iopofosine informs the biodistribution of the compound and may instruct the potential potency and side effectsof CLR 125, although given the different physical properties of the emissions from CLR 125, the Company believes that side effects couldbe less.
We expect the study to be a Phase 1b, randomized,open-label, multi-center study comparing the safety and efficacy of CLR 125 in patients with advanced TNBC who are relapsed/refractory(r/r) to at least one prior therapy. Three dose levels will be assessed in parallel, with enrollment of patients in a 1:1:1 manner. Weexpect that each arm will have a minimum of 15 evaluable patients. CLR 125 will be administered as a fractionated dose on Day 1and Day 3 for cycle 1 and repeat approximately every 8-week for subsequent cycles. Depending on arm assignments, patients will receivebetween two and four cycles. An expansion arm may be evaluated of at least 15 patients following evaluation of the three dose levels bythe data monitoring committee (DMC).
We anticipate a maximum of 75 patients to be enrolledin the trial. Safety and tolerability of CLR 125 will be assessed by physical examination, Eastern Cooperative Oncology Group (ECOG) performancestatus, vital signs, laboratory changes over time, ECGs, and adverse events of special interest. Efficacy of CLR 125 will be assessedby CT (or MRI if needed) examinations obtained at six-week intervals following the initial dose of CLR 125.
The study objective is to determine the Phase 2dosing level with secondary endpoints including safety, tolerability, initial response assessment and distribution.
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Preclinical Evaluations of CLR 225
In preclinical, in vivo evaluations of CLR225, utilizing a pancreatic cancer model, the compound was observed to reduce tumor volume and improved survival benefit at four differentdosing levels. Observed biodistribution exhibited substantial uptake in the tumor while remaining low in healthy tissue.
Clinical Studies in Iopofosine
The CLOVER-1 Phase 2 studyof iopofosine, conducted in r/r B-cell malignancies, met the primary efficacy endpoints from the Part A dose-finding portion. TheCLOVER-1 Phase 2b study, where iopofosine remains under further evaluation in highly refractory MM and CNSL patients, is closed to enrollmentbut ongoing with patients in follow-up. Fatalities have occurred in patients post-treatment with iopofosine.
The CLOVER-WaM study wasdesigned as a pivotal registration study evaluating iopofosine in WM patients that were r/r to at least two prior lines of therapy includinghaving failed or had a suboptimal response to a Bruton tyrosine kinase inhibitor (BTKi). The study completed enrollment in the fourthquarter of 2023, and initial top line data from the study was reported in January 2024. CLOVER-WaM was a single-arm study with atarget enrollment of 50 patients. Based upon the data from September 2024, the CLOVER-WaM study enrolled a total of 55 patientsin the modified Intent to Treat (mITT) population and met its primary endpoint with a major response rate (MRR) of 58.2% (95% confidenceinterval [44.50%, 75.80%, two-sided p value < 0.0001]) exceeding the FDA agreed-upon statistical hurdle of 20%. The overall responserate (ORR) in evaluable patients was 83.6%, and 98.2% of patients experienced disease control. Responses were durable, with median durationof response not reached with 11.4 months of follow-up and 76% of patients remaining progression free at a median follow-up of eight months.These outcomes exceed real world data, which demonstrate a 4-12% MRR and a duration of response of approximately six months or less despitecontinuous treatment in a patient population that is less pretreated and not refractory to multiple classes of drugs. Notably, iopofosineI 131 monotherapy achieved a 7.3% complete remission (CR) rate in this highly refractory WM population. Overall, 45 (69.2%) patientshad prior exposure to at least 3 drug classes and 19 (29.2%) patients had prior exposure to at least 4 drug classes of anti-cancer therapies.Forty-eight (73.8%) patients had prior exposure to a BTKi of which 37 (77.1%) were deemed to be refractory to BTKis. Forty-three (66.2%)patients were exposed to BTKi and anti-CD20 antibody with 25 (58.1%) being refractory to both BTKi and anti-CD-20 antibodies. Thirty-seven(56.9%) patients had prior exposure to BTKi, anti-CD20 antibody, and chemotherapy and 18 (48.6%) patients were refractory to all threeclasses of drugs, BTKi, anti-CD20 antibody, and chemotherapy. Iopofosine I 131 was well tolerated and its toxicity profile was consistentwith the Company’s previously reported safety data. The safety population was 65 patients which was composed of patients that receivedat least a single dose of iopofosine I 131 but did not receive enough drug to be assessed for efficacy. There were 3 (4.6%) patientsthat experienced treatment-related adverse events (TRAEs) leading to discontinuation. The rates of greater TRAEs observed in more than10% of patients included thrombocytopenia (56 [86.2%] patients), neutropenia (52 [80.0%] patients), anemia (42 [64.6%] patients) anddecreased white blood cell count (21 [32.3%] patients) among hematologic toxicities and fatigue (22 [33.8%] patients), nausea (19 [29.2%]patients and diarrhea (13 [20.0%] patients) among non-hematologic toxicities. The rates of Grade 3 or greater TRAEs observed in morethan 10% of patients included thrombocytopenia (53 [81.5%] patients), neutropenia (43 [66.2%] patients), anemia (31 [47.7%] patients),decreased white blood cell count (18 [27.7%]), decreased lymphocyte count 8 (12.3%). All patients recovered from cytopenias with no reportedaplastic sequalae. Importantly, there were no clinically significant bleeding events, and the rate of febrile neutropenia was 10.8%.There were no treatment-related deaths in the study.
The CLOVER-1 Phase 2 study met the primary efficacyendpoints from the Part A dose-finding portion, conducted in r/r B-cell malignancies, and is now enrolling an MM and CNSL expansioncohort (Phase 2b). The Phase 2b study will evaluate highly refractory MM patients in triple class, quad- and penta-drug refractory patients,including post-BCMA immunotherapy patients and r/r CNSL patients. The initial Investigational New Drug (IND) application was acceptedby the FDA in March 2014 with multiple INDs submitted since that time. The Phase 1 study was designed to assess the compound’ssafety and tolerability in patients with r/r MM and to determine maximum tolerated dose (MTD) and was initiated in April 2015. Thestudy completed enrollment, and the final clinical study report is expected in the first half of 2025. Initiated in March 2017, theprimary goal of the Phase 2a study was to assess the compound’s efficacy in a broad range of hematologic cancers.
The CLOVER-2 Phase 1a pediatric study an open-label,sequential-group, dose-escalation study was conducted internationally at seven leading pediatric cancer centers. The study was an open-label,sequential-group, dose-escalation study to evaluate the safety and tolerability of iopofosine in children and adolescents with relapsedor refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin’s lymphoma).The maximum tolerated dose was determined to be greater than 60mCi/m2 administered as a fractionated dose. CLOVER-2 Phase 1b study isan open-label, international dose-finding study evaluating two different doses and dosing regiments of iopofosine in r/r pediatric patientswith high grade gliomas. These cancer types were selected for clinical, regulatory and commercial rationales, including the radiosensitivenature and continued unmet medical need in the r/r setting, and the rare disease determinations made by the FDA based upon the currentdefinition within the Orphan Drug Act. This study is partially funded (~$2M) by a National Institutes of Health SBIR grant from the NationalCancer Institute.
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The U.S. Food and Drug Administration (FDA) grantediopofosine Fast Track Designation for lymphoplasmacytic lymphoma (LPL) and WM patients having received two or more prior treatment regimens,as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for LPL/WM, MM, neuroblastoma,soft tissue sarcomas including rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric DiseaseDesignation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commissiongranted ODD to iopofosine for treatment of r/r MM and WM, as well as PRIME designation for WM.
Additionally, in June 2020, the European MedicinesAgency (EMA) granted us Small and Medium-Sized Enterprise (SME) status by the EMA’s Micro, Small and Medium-sized Enterprise office.SME status allows us to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice,clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities and fee waivers for selectiveEMA pre-and post-authorization regulatory filings, including orphan drug and PRIME designations. We are also eligible to obtain EMA certificationof quality and manufacturing data prior to a review of clinical data. Other financial incentives include EMA-provided translational servicesof all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process.
Phase 3 Study in Patients with r/r Waldenstrom’s macroglobulinemia
On March 6, 2025 the Company conducted itsEnd-of-Phase-2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA). As a result of the meeting, the Company believes thatit understands the path forward for a one trial design for potential accelerated and full approval based upon a randomized Phase 3 trialassessing major response rate and progression free survival, respectively, as the primary endpoints in WM patients previously treatedwith a BTKi. The FDA and Cellectar agreed to utilize an Investigator Choice comparator approach, where investigators can select betweenone of two fixed duration treatments currently recommended by the NCCN guidelines. The initiation of this study is dependent on funding.
This meeting followed a November 2024 meetingwhere the FDA informed the Company that while the data from the CLOVER WaM study was meaningful, the FDA’s preferred route to acceleratedapproval of iopofosine in WM was via a one trial design approach which would be in alignment with the recently issued accelerated approvalguidance.
PDC Platform
We have leveraged our PDC platform to establishthree ongoing collaborations featuring four unique payloads and mechanisms of action. Through research and development collaborations,our strategy is to generate near-term capital, supplement internal resources, gain access to novel molecules or payloads, accelerate productcandidate development, and broaden our proprietary and partnered product pipelines.
Our PDC platform is designed to provide selectivedelivery of a diverse range of oncologic payloads to cancerous cells, whether a hematologic cancer or solid tumor; a primary tumor, ora metastatic tumor; and cancer stem cells. The PDC platform’s mechanism of entry is designed not to rely upon a specific cell surfaceepitope or antigen as are required by other targeted delivery platforms but rather a unique change in the tumor cell membrane. Our PDCplatform takes advantage of a metabolic pathway (beta oxidation) utilized by nearly all tumor cell types in all stages of the tumor cycle.Tumor cells modify the cell membrane to create specific, highly organized microdomains by which to transport lipids and long chain fattyacids into the cytoplasm, as a result of the utilization of this metabolic pathway. Our PDCs are designed to bind to these regions anddirectly enter the intracellular compartment. This mechanism allows the PDC molecules to accumulate in tumor cells over time, which webelieve can enhance drug efficacy. The direct intracellular delivery allows our molecules to avoid the specialized, highly acidic cellularcompartment known as lysosomes, which allows a PDC to deliver payloads that previously could not be delivered in this targeted manner.Additionally, molecules targeting specific cell surface epitopes face challenges in completely eliminating a tumor because the targetedantigens are limited in the total number presented on the cell surface, limiting total potential uptake and resulting in heterogenousuptake across the tumor, have longer cycling time from internalization to relocation on the cell surface, again diminishing their availabilityfor binding, and are not present on all of the tumor cells because of the heterogenous nature of cancer cells, further increasing theunequal distribution of the drug across the tumor. This means a subpopulation of tumor cells always exists that cannot be addressed bytherapies targeting specific surface epitopes. Additionally, the epitope utilized is also present on other normal tissue, resulting inoff-target toxicities.
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Beyond the benefits provided by the mechanism ofentry, the PDC platform features include the capacity to link with almost any molecule, provide a significant increase in targeted oncologicpayload delivery, a more uniform delivery, and the ability to target all types of tumor cells. As a result, we believe that we can createPDCs to treat a broad range of cancers with the potential to improve the therapeutic index of oncologic drug payloads, enhance or maintainefficacy while also reducing adverse events by minimizing drug delivery to healthy cells, and increasing delivery to cancerous cells andcancer stem cells.
We employ a drug discovery and development approachthat allows us to efficiently design, research and advance drug candidates. Our iterative process allows us to rapidly and systematicallyproduce multiple generations of incrementally improved targeted drug candidates without the expense of having to generate significantcompound libraries.
CLOVER-1: Phase 2 Study in Select B-Cell Malignancies
The Phase 2 CLOVER-1 study was an open-label studydesigned to determine the efficacy and safety of CLR 131 in select B-cell malignancies (multiple myeloma (MM), indolent chronic lymphocyticleukemia (CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom’s macroglobulinemia (WM), marginalzone lymphoma (MZL), mantle cell lymphoma (MCL), DLBCL, and central nervous system lymphoma (CNSL) who have been previously treated withstandard therapy for their underlying malignancy. As of March 2022, the study arms for CLL/SLL, LPL/WM, MZL, MCL, and DLBCL wereclosed. Dosing of patients varied by disease state cohort and was measured in terms of TBD.
In July 2016, we were awarded a $2,000,000National Cancer Institute (NCI) Fast-Track Small Business Innovation Research grant to further advance the clinical development of iopofosine.The funds supported the Phase 2 study initiated in March 2017 to define the clinical benefits of iopofosine in r/r MM and other nichehematologic malignancies with unmet clinical need. These niche hematologic malignancies include CLL, SLL, MZL, LPL/WM and DLBCL. The studywas conducted in approximately 10 U.S. cancer centers in patients with orphan-designated relapse or refractory hematologic cancers. Theplanned study enrollment was up to 80 patients.
The study’s primary endpoint was clinicalbenefit response (CBR), with secondary endpoints of ORR, PFS, time to next treatment (TtNT), median Overall Survival (mOS), DOR and othermarkers of efficacy following patients receiving one of three TBDs of iopofosine (<50mCi, ~50mCi and >60mCi), with the option fora second cycle approximately 75-180 days later. Dosages were provided either as a single bolus or fractionated (the assigned dose levelsplit into two doses) given day 1 and day 15. Over the course of the study the dosing regimen of iopofosine advanced from a single bolusdose to two cycles of fractionated administrations of 15 mCi/m2 per dose on days 1, 15 (cycle 1), and days 57, 71 (cycle 2). Adverse eventsoccurring in at least 25% of subjects were fatigue (39%) and cytopenias, specifically, thrombocytopenia (75%), anemia (61%), neutropenia(54%), leukopenia (51%), and lymphopenia (25%). Serious adverse events occurring in greater than 5% of subjects were restricted to thrombocytopenia(9%) and febrile neutropenia (7.5%).
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Phase 2a Study: Patients with r/r Waldenstrom’s MacroglobulinemiaCohort
Patients in the r/r WM cohort all received TBDof ≥ 60 mCi (25 mCi/m2 single bolus, 31.25 mCi/m2 fractionated, 37.5 mCi/m2 fractionated, or two cycles of mCi/m2 fractionated) eitheras a bolus dose or fractionated. Current data from our Phase 2a CLOVER-1 clinical study show a 100% ORR in six WM patients and an 83.3%major response rate with one patient achieving a complete response (CR), which reached 39 months post-last treatment. While median treatmentfree survival (TFS), also known as treatment free remission (TFR), and DOR have not been reached, the average treatment TFS/TFR is currentlyat 330 days. We believe this may represent an important improvement in the treatment of r/r WM as we believe no approved or late-stagedevelopment treatments for second- and third-line patients have reported a CR to date. Based on study results, iopofosine was well tolerated,with the most common adverse events being cytopenias and fatigue.
Phase 2a Study: Patients with r/r Multiple Myeloma Cohort
In September 2020, we announced that a 40%ORR was observed in the subset of refractory MM patients deemed triple class refractory who received 60 mCi or greater TBD. Triple classrefractory is defined as patients that are refractory to immunomodulatory, proteasome inhibitors and anti-CD38 antibody drug classes.The 40% ORR (6/15 patients) represents triple class refractory patients enrolled in Part A of Cellectar’s CLOVER-1 study andadditional patients enrolled in Part B from March through May 2020 and received >60mCi TBD (25 mCi/m2 single bolus,31.25 mCi/m2 fractionated, 37.5 mCi/m2 fractionated, or two cycles of mCi/m2 fractionated) either as a bolus dose or fractionated. Patientswith MM received 40 mg of dexamethasone concurrently beginning within 24 hours of the first CLR 131 infusion. All MM patients enrolledin the expansion cohort are required to be triple class refractory. The additional six patients enrolled in 2020 were heavily pre-treatedwith an average of nine prior multi-drug regimens. Three patients received a TBD of > 60 mCi and three received less than 60 mCi. Consistentwith the data released in February 2020, patients receiving > 60 mCi typically exhibit greater responses. Based on study resultsto date, patients continue to tolerate iopofosine well, with the most common and almost exclusive treatment-emergent adverse events arecytopenias, such as thrombocytopenia, neutropenia, and anemia.
In December 2021, we presented data from 11MM patients from our Phase 2 CLOVER-1 study in a poster at the American Society of Hematology (ASH) Annual Meeting and Exposition. TheMM patients were at least triple class refractory (defined as refractory to an immunomodulatory agent, proteasome inhibitor and monoclonalantibody) with data current as of May 2021. Patients had a median of greater than 7 prior therapies with 50% classified as high risk.Initial results in these patients showed an ORR of 45.5%, a CBR of 72.7%, and a disease control rate (DCR) of 100%. Median PFS was 3.4months. In a subset of five quad/penta drug refractory patients, efficacy increased, demonstrating an ORR of 80% and CBR of 100% in thishighly treatment refractory group. The most commonly observed treatment emergent adverse events were cytopenias that included Grade 3or 4 thrombocytopenia (62.5%), anemia (62.5%), neutropenia (62.5%) and decreased white blood cell count (50%). Treatment emergent adverseevents were mostly limited to bone marrow suppression in line with prior observations. No patients experienced treatment emergent adverseevents of neuropathy, arrhythmia, cardiovascular event, bleeding, ocular toxicities, renal function, alterations in liver enzymes, orinfusion-site reactions or adverse events. We continue to enrich the r/r MM patient cohort with patients that are even more refractory,specifically enrolling patients that are quad-class refractory (triple class plus refractory to any of the recent approved product classes)and have relapsed post-BCMA immunotherapy. We reported in the Blood Cancer Journal in August 2022 that we observed iopofosine hada 50% ORR in patients receiving >60mCi total administered dose (3/6 patients).
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Phase 2a: Patients with r/r non-Hodgkin’s Lymphoma Cohort
In February 2020, we announced positive datafrom our Phase 2a CLOVER-1 study in patients with NHL patients were treated with three different doses (<50mCi, ~50mCi and >60mCiTBD. Patients in the r/r NHL cohort received TBD of either ≥ 60 mCi or < 60 mCi (25 mCi/m2 single bolus, 31.25 mCi/m2 fractionated,37.5 mCi/m2 fractionated, or two cycles of mCi/m2 fractionated) either as a bolus dose or fractionated. Patients with r/r NHL who received <60mCi TBD and the >60mCi TBD had a 42% and 43% ORR, respectively and a combined rate of 42%. These patients were also heavily pre-treated,having a median of three prior lines of treatment (range, 1 to 9) with the majority of patients being refractory to rituximab and/or ibrutinib.The patients had a median age of 70 with a range of 51 to 86. All patients had bone marrow involvement with an average of 23%. In additionto these findings, subtype assessments were completed in the r/r B-cell NHL patients. We observed a 30% ORR in patients with DLBCL, withone patient achieving a CR, which continues at nearly 24 months post-treatment. The ORR for CLL/SLL and MZL patients was 33%.
Based upon the dose response observed in the Phase2a study for patients receiving TBDs of 60mCi or greater, we determined that patient dosing of iopofosine in the pivotal study would be >60mCi TBD. Therefore, patients are now grouped as receiving <60mCi or >60mCi TBD.
The most frequently reported adverse events inall patients were cytopenias, which followed a predictable course and timeline. The frequency of adverse events did not increase as doseswere increased and the profile of cytopenias remained consistent. Importantly, our assessment is that these cytopenias have had a predictablepattern to initiation, nadir and recovery and are treatable. The most common grade ≥3 events at the highest dose (75mCi TBD) were hematologictoxicities including thrombocytopenia (65%), neutropenia (41%), leukopenia (30%), anemia (24%) and lymphopenia (35%). No patients experiencedcardiotoxicities, neurological toxicities, infusion site reactions, peripheral neuropathy, allergic reactions, cytokine release syndrome,keratopathy, renal toxicities, or changes in liver enzymes. The safety and tolerability profile in patients with r/r NHL was similar tor/r MM patients except for fewer cytopenias of any grade. Based upon iopofosine being well tolerated across all dose groups, the observedresponse rate, and especially in difficult to treat patients such as high risk and triple class refractory or penta-refractory, and corroboratingdata showing the potential to further improve upon current ORRs and durability of those responses, the study has been expanded to testa two-cycle dosing optimization regimen with a target TBD >60 mCi/m2 of iopofosine.
In May 2020, we announced that the FDA grantedFast Track Designation for iopofosine in WM in patients having received two or more prior treatment regimens.
Phase 1 Study in Patients with r/r Multiple Myeloma
In February 2020, final results from a multicenter,Phase 1 dose escalation clinical trial of iopofosine in r/r MM were presented. The trial was designed to evaluate the safety and potentialinitial efficacy of iopofosine administered in an up to 30-minute I.V. infusion either as a single bolus dose or as a fractionated dosein heavily pretreated MM patients. The study enrolled a total of 26 evaluable patients at three trial sites. For the trial, which useda modified three-plus-three dose escalation design, 15 evaluable patients were dosed in single bolus doses from 12.5mCi/m2 up to 31.25mCi/m2(TBD 20.35-59.17 mCi) and 11 evaluable patients were dosed in fractionated dosing cohorts of 31.25mCi/m2 to 40mCi/m2 (TBD 54.915-89.107mCi). An iDMC did not identify dose-limiting toxicities in any cohort. Of the 26 evaluable patients in the trial, a partial response wasobserved in 4 of 26 patients (15.4%) and stable disease or minimal response in 22 of 26 patients (84.6%), for a disease control rate of100%. A significant decrease in M-protein and free light chain (FLC) was also observed.
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Iopofosine in combination with dexamethasone wasunder investigation in adult patients with r/r MM. MM is an incurable cancer of the plasma cells and is the second most common form ofhematologic cancer. Patients had to be refractory to or relapsed from at least one proteasome inhibitor and at least one immunomodulatoryagent. The clinical study was a standard three-plus-three dose escalation safety study to determine the maximum tolerable dose. We usethe International Myeloma Working Group (IMWG) definitions of response, which involve monitoring the surrogate markers of efficacy, Mprotein and FLC. The IMWG defines a PR as a 50% or greater decrease in M protein or to 50% or greater decrease in FLC levels (for patientsin whom M protein is unmeasurable). Secondary objectives included the evaluation of therapeutic activity by assessing surrogate efficacymarkers, which include M protein, FLC, PFS and OS. All patients were heavily pretreated with an average of five prior lines of therapy.An iDMC assessed the safety of iopofosine up to its planned maximum single, bolus dose of 31.25 mCi/m2 or a TBD of ~63 mCi. The four singledose cohorts examined were: 12.5 mCi/m2 (~25mCi TBD), 18.75 mCi/m2 (~37.5mCi TBD), 25 mCi/m2(~50mCi TBD), and 31.25 mCi/m2(~62.5mCi TBD),all in combination with low dose dexamethasone (40 mg weekly). Of the five patients in the first cohort, four were assessed as achievingstable disease and one patient progressed at Day 15 after administration and was taken off the study. Of the five patients admitted tothe second cohort, all five were assessed as achieving stable disease; however, one patient progressed at Day 41 after administrationand was taken off the study. Four patients were enrolled to the third cohort, and all were assessed as achieving stable disease. In September 2017,we announced safety and tolerability data for cohort 4, in which patients were treated with a single infusion up to 30-minutes of 31.25mCi/m2of iopofosine, which was tolerated by the three patients in the cohort. Additionally, all three patients experienced CBR with one patientachieving a partial response (PR). The patient experiencing a PR had an 82% reduction in FLC. This patient did not produce M protein,had received seven prior lines of treatment including radiation, stem cell transplantation and multiple triple combination treatmentsincluding one with daratumumab that was not tolerated. One patient experiencing stable disease attained a 44% reduction in M protein.In January 2019, we announced that the pooled mOS data from the first four cohorts was 22.0 months. In late 2018, we modified thisstudy to evaluate a fractionated dosing strategy to potentially increase efficacy and decrease adverse events.
Cohorts five and six received fractionated dosingof 31.25 mCi/m2(~62.5mCi TBD) and 37.5 mCi/m2 (~75mCi TBD), each administered on day 1 and day 8. Following the determination that allprior dosing cohorts were tolerated, we initiated a cohort seven utilizing a 40mCi/m2 (~95mCi TBD) fractionated dose administered 20mCi/m2(~40mCi TBD) on days 1 and day 8. Cohort seven was the highest pre-planned dose cohort and subjects have completed the evaluation period.Adverse events occurring in at least 25% of subjects were fatigue (26%) and cytopenias, specifically, thrombocytopenia (90%), anemia (65%),neutropenia (55%), leukopenia (61%), and lymphopenia (58%). Serious adverse events occurring in greater than two subjects were restrictedto febrile neutropenia n=3 (9.7%).
In May 2019, we announced that the FDA grantedFast Track Designation for iopofosine in fourth line or later r/r MM. Iopofosine is currently being evaluated in our ongoing CLOVER-1Phase 2 clinical study in patients with r/r MM and other select B-cell lymphomas. Patients in the study received up to four, approximately20-minute, IV infusions of iopofosine over 3 months, with doses given 14 days apart in each cycle and a maximum of two cycles. Lowdose dexamethasone 40 mg weekly (20mg in patients ≥ 75), was provided for up to 12 weeks. The planned study enrollment was up to 80patients. Its primary endpoint was clinical benefit rate (CBR), with additional endpoints of ORR, PFS, median overall survival (OS) andother markers of efficacy. Over the course of the study the dosing regimen of iopofosine advanced from a single bolus dose to two cyclesof fractionated administrations of 15 mCi/m2 per dose on days 1, 15 (cycle 1), and days 57, 71 (cycle 2). Following treatment with iopofosine,approximately 91% of patients experience a reduction in tumor marker with approximately 73% experiencing greater than 37% reduction.
CLOVER 2: Phase 1 Study in r/r Pediatric Patients with selectSolid tumors, Lymphomas and Malignant Brain Tumors
In December 2017, the Division of Oncologyat the FDA accepted our IND and study design for the Phase 1 study of iopofosine in children and adolescents with select rare and orphandesignated cancers. This study was initiated during the first quarter of 2019. In December 2017, we submitted an IND applicationfor r/r pediatric patients with select solid tumors, lymphomas and malignant brain tumors. The Phase 1 clinical study of iopofosine isan open-label, sequential-group, dose-escalation study evaluating the safety and tolerability of intravenous administration of iopofosinein children and adolescents with relapsed or refractory malignant solid tumors (neuroblastoma, Ewing’s sarcoma, osteosarcoma, rhabdomyosarcoma)and lymphoma or recurrent or refractory malignant brain tumors for which there are no standard treatments. Secondary objectives of thestudy are to identify the recommended efficacious dose of iopofosine and to determine preliminary antitumor activity (treatment response)of iopofosine in children and adolescents. In 2018, the FDA granted ODD and RPDD for iopofosine for the treatment of neuroblastoma, rhabdomyosarcoma,Ewing’s sarcoma and osteosarcoma.
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In August 2020, based on data on four doselevels from 15mCi/m2 up to 60mCi/m2, the iDMC permitted the beginning of the evaluation of the next higher dose cohort, at 75mCi/m2. TheiDMC advised, based upon the initial data, to enrich the 60 mCi/m2 dose level for patients over the age of 10 with HGG and Ewing sarcoma.Changes in various tumor parameters appeared to demonstrate initial response and tumor uptake. This includes patients with relapsed HGGswith over five months of PFS. In November 2020, we announced clinical data providing that iopofosine had been measured in pediatricbrain tumors, confirming that systemic administration of iopofosine crosses the blood brain barrier and is delivered into tumors and thatthe data show disease control in heavily pretreated patients with ependymomas. In November 2021, we announced favorable data on changesin various tumor parameters in a Phase 1 study in children and adolescents with relapsed and refractory high-grade gliomas (HGGs) andsoft tissue sarcomas. Pediatric HGGs are a collection of aggressive brain and central nervous system tumor subtypes (i.e. diffuse intrinsicpontine gliomas, glioblastomas, astrocytomas, ependymomas, etc.) with about 400 new pediatric cases diagnosed annually in the U.S.Children with these tumors have a poor prognosis and limited 5-year survival. Adverse events occurring in at least 25% of subjects werefatigue, headache, nausea and vomiting (28% respectively), and cytopenias, specifically, thrombocytopenia (67%), anemia (67%), neutropenia(61%), leukopenia (56%), and lymphopenia (33%). There were no serious adverse events occurring in more than 2 subjects. The part A portionof this Phase 1 study has concluded, and part B has initiated to determine the appropriate dosing regimen in pediatric patients with r/rHGG. In 2022, the NCI awarded Cellectar a $1,900,000 SBIR Phase 2 grant to explore iopofosine in pediatric HGG.
Phase 1 Study in r/r Head and Neck Cancer
In August 2016, theUniversity of Wisconsin Carbone Cancer Center (UWCCC) was awarded a five-year Specialized Programs of Research Excellence (SPORE) grantof $12,000,000 from the NCI and the National Institute of Dental and Craniofacial Research to improve treatments and outcomes for headand neck cancer (HNC) patients. HNC is the sixth most common cancer across the world with approximately 56,000 new patients diagnosedevery year in the U.S. As a key component of this grant, the UWCCC researchers completed testing of iopofosine in various animal HNCmodels and initiated the first human clinical study enrolling up to 30 patients combining iopofosine and external beam radiation treatment(EBRT) with recurrent HNC in the fourth quarter of 2019. UWCCC has completed the part A portion of a safety and tolerability study ofiopofosine in combination with EBRT and preliminary data suggest safety and tolerability in relapsed or refractory HNC. The reductionin the amount or fractions (doses) of EBRT has the potential to diminish the (number and severity of) adverse events associated withEBRT. Patients with HNC typically receive approximately 60-70 Grays (Gy) of EBRT given as 2 – 3 Gy daily doses over a six-weektimeframe. Patients can experience long-term tumor control following re-irradiation in this setting; however, this approach can causesevere injury to normal tissue structures, significant adverse events and diminished quality of life. Part B of the study was toassess the safety and potential benefits of iopofosine in combination with EBRT in a cohort of up to 24 patients. This portion of thestudy has fully enrolled, and data were reported at the ASTRO 2024 conference on March 2, 2024. Complete remission was achievedin 64% of patients, with an ORR of 73% (n=11). Prior to treatment with iopofosine I 131, six patients had multiple recurrences, and onehad metastatic disease, both of which are indicative of poor outcomes. Additionally, in the study we observed durability of tumor controlwith an overall survival of 73% and progression free survival of 36% at 12 months. Eleven patients (92%) experienced a treatment-relatedadverse event. Treatment-related adverse events of grade 3 or higher occurring in 20% or more patients were thrombocytopenia (75%), lymphopenia(75%), leukopenia (75%), neutropenia (67%), and anemia (42%). Observed adverse events were consistent with the known toxicity profileof iopofosine I 131, with cytopenias being the most common. All patients recovered. We believe that these data support the notion ofenhanced patient outcomes when combining the use of iopofosine I 131 in combination with external beam radiation for a treatment of solidtumors.
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Additional Pipeline Candidates
We believe our PDC platform has potential to providetargeted delivery of a diverse range of oncologic payloads, as exemplified by our lead product candidates discussed above. Additionalpipeline product candidates, listed below, may also result in improvements to the current standard of care (SOC) for the treatment ofa broad range of human cancers:
| · | The company has developed a series of proprietary small molecule phospholipid drug conjugates. These programs employ either novelpayload or novel linkers. Many of these molecules have demonstrated efficacy and tolerability in preclinical mouse models. The collaborationwith IntoCell Inc. successfully met its agreed upon endpoint. The collaboration provided significant data which has led Cellectar to selecta series of highly potent cytotoxic small molecule payloads for further development. |
| · | In collaboration with other parties, Cellectar has also validated that the PLE is capable of delivering peptide payloads and oligonucleotide(siRNA, mRNA, etc.) payloads to the tumors when delivered systemically. These molecules have also been shown to demonstrate activityand safety in multiple preclinical mouse models. Based upon these collaborations and the data, the company has initiated internal proprietaryprograms with each of these treatment modalities. We are also evaluating other alpha-emitting isotopes such as astatine-211 and lead-212in preclinical studies. |
Recent Developments
Breakthrough Designation
OnJune 4, 2025, we announced that the FDA has granted Breakthrough Therapy Designation for iopofosine I 131, as a radioconjugate monotherapyfor the treatment of relapsed/refractory Waldenstrom macroglobulinemia (r/r WM).
Warrant Inducement
On June 5, 2025, we enteredinto inducement offer letter agreements with certain holders (the “Holders”) of certain of our (i) Common Stock PurchaseWarrants to purchase shares of Common Stock, issued on June 5, 2020 (the “2020 Warrants”), (ii) Common Stock Purchase Warrantsto purchase shares of Common Stock, issued on October 25, 2022 (the “2022 Warrants”), and (iii) Common Stock Purchase Warrantsto purchase shares of Common Stock, issued on July 21, 2024 (the “2024 Warrants” and together with the 2020 Warrants andthe 2022 Warrants, the “Existing Warrant(s)”) (the “Warrant Inducement”). Pursuant to the Warrant Inducement,the Holders agreed to exercise the Existing Warrants for cash at a reduced exercise price of $0.3041 per share (on a pre-Reverse StockSplit basis) in consideration for exercising in full for cash all of the Existing Warrants held by the Holders at the reduced exerciseprice on or before 9:00 a.m. Eastern Time on June 5, 2025. The Warrant Inducement provided for the immediate exercise of certain outstandingExisting Warrants to purchase an aggregate of 8,281,322 shares of common stock (on a pre-Reverse Stock Split basis).
The shares of common stockunderlying the Existing Warrants have either been registered pursuant to the registration statement on Form S-1 filed with the SEC onMay 8, 2020, as amended (File No, 333-238132), or registered for resale pursuant to either the registration statement on Form S-1 filedwith the SEC on November 23, 2022 (File No. 333-268544) or the registration statement on Form S-1 filed with the SEC on January 29, 2025(File No. 333-284580).
Reverse Stock Split
At 12:01 a.m. EasternTime on Tuesday, June 24, 2025 (the “Effective Time”), our Reverse Stock Split became effective.
In connection with theReverse Stock Split, every 30 shares of our common stock issued and outstanding as of the Effective Time was automatically convertedinto one share of our common stock. Stockholders who otherwise held a fractional share of common stock will receive a cash payment inlieu of such fractional share. On the Effective Time, our shares of common stock issued and outstanding were reduced from 54,361,197to approximately 1,812,039 shares of common stock issued and outstanding. Our shares of common stock commenced trading on a split-adjustedbasis when the Nasdaq Capital Market opened on June 24, 2025, and will continue to trade under its existing symbol “CLRB.”The new CUSIP number for the common stock following the Reverse Stock Split is 15117F880.
As a result of the ReverseStock Split, the number of shares of common stock available for issuance under our equity incentive plans were proportionately affected.Additionally, under the terms of our outstanding stock options and warrants, when the Reverse Stock Split became effective, the numberof shares of our common stock covered by each of them were divided by the number of shares being combined into one share of our commonstock in the Reverse Stock Split and the exercise or conversion price per share was increased to a dollar amount equal to the currentexercise or conversion price, multiplied by the number of shares being combined into one share of our common stock in the Reverse StockSplit. This resulted in the same aggregate price being required to be paid upon exercise as was required immediately preceding the ReverseStock Split. Furthermore, the conversion ratio of our outstanding preferred stock was also adjusted proportionately.
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Our periodic and current reports that areincorporated by reference, and all other documents that were filed prior to June 24, 2025, do not give effect to the Reverse Stock Split.The following selected “previously reported” information has been derived from our audited financial statements includedin our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025, and our unaudited financialstatements included in our Quarterly Report on Form 10-Q for the period ended March 31, 2025, filed with the SEC on May 13, 2025. The “post Reverse Split” information below recasts the “previously reported” share and per share information to reflectthe June 24, 2025 one-for-thirty Reverse Stock Split, discussed elsewhere in the registration statement.
| Twelve Months Ended December 31, | Three Months Ended March 31, | |||||||||||||||
| 2024 | 2023 | 2025 | 2024 | |||||||||||||
| Weighted-average common shares outstanding, basic - previously reported | 36,622,474 | 12,221,571 | 46,079,875 | 29,346,679 | ||||||||||||
| Weighted-average common shares outstanding, diluted - previously reported | 37,143,769 | 12,221,571 | 46,079,875 | 29,346,679 | ||||||||||||
| Weighted-average common shares outstanding, basic - post-Reverse Split | 1,220,749 | 407,386 | 1,535,996 | 978,223 | ||||||||||||
| Weighted-average common shares outstanding, diluted - post-Reverse Split | 1,238,126 | 407,386 | 1,535,996 | 978,223 | ||||||||||||
| Net loss per share, basic - previously reported | $ | (1.22 | ) | $ | (3.50 | ) | $ | (0.14 | ) | $ | (0.91 | ) | ||||
| Net loss per share, diluted - previously reported | $ | (1.40 | ) | $ | (3.50 | ) | $ | (0.14 | ) | $ | (0.91 | ) | ||||
| Net loss per share, basic - post-Reverse Split | $ | (36.52 | ) | $ | (104.99 | ) | $ | (4.20 | ) | $ | (27.30 | ) | ||||
| Net loss per share, diluted - post-Reverse Split | $ | (41.89 | ) | $ | (104.99 | ) | $ | (4.20 | ) | $ | (27.30 | ) | ||||
| As of | As of | As of | ||||||||||
| Dec 31, 2024 | Dec 31, 2023 | Mar 31, 2025 | ||||||||||
| Common stock - previously reported | $ | 461 | $ | 207 | $ | 461 | ||||||
| Additional paid-in capital - previously reported | $ | 261,115,905 | $ | 182,924,210 | $ | 261,678,642 | ||||||
| Common stock issued and outstanding - previously reported | 46,079,875 | 20,744,110 | 46,079,875 | |||||||||
| Common stock - post-Reverse Split | $ | 15 | $ | 7 | $ | 15 | ||||||
| Additional paid-in capital - post-Reverse Split | $ | 261,116,351 | $ | 182,924,410 | $ | 261,679,088 | ||||||
| Common stock issued and outstanding - post-Reverse Split | 1,535,996 | 691,470 | 1,535,996 | |||||||||
Submission of First-in-Humans Phase 1 ClinicalTrial Protocol to US Food and Drug Administration for CLR 125 to Treat Triple-Negative Breast Cancer
On June 24, 2025, we submitteda protocol with the U.S. Food and Drug Administration (FDA) for a Phase 1 study of our Auger emitting radiopharmaceutical, CLR 125, forthe treatment of relapsed triple-negative breast cancer (TNBC).
Implications of Being a Smaller Reporting Company
We are a “smaller reportingcompany” and accordingly have elected to take advance of certain of the reduced disclosure obligations in the registration statementof which this prospectus is a part and may elect to take advantage of other reduced reporting requirements in future filings. As a result,the information that we provide to our stockholders may be different than you might receive from other public reporting companies in whichyou hold equity interests.
Corporate Information
Our principal executive officesare located at 100 Campus Drive, Florham Park, New Jersey 07932 and the telephone number of our principal executive offices is (608) 441-8120.We maintain a website at www.cellectar.com. The information included or referred to on, or accessible through, our website does not constitutepart of, and is not incorporated by reference into, this prospectus.
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| Class A Units we are offering | Up to 755,667 Class A Units with each Class A Unit consisting of (i) one (1) share of our common stock and (ii) one (1) Common Warrant. | |
| Class B Units we are offering | Up to 755,667 Class B Units with each Class B Unit consisting of (i) one (1) Pre-Funded Warrant and (ii) one (1) Common Warrant. In the event that certain purchasers whose purchase of shares of common stock in the Class A Units in this offering would otherwise result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock immediately following the closing of this offering, such purchasers will have the opportunity to purchase, if such purchasers so choose, Class B Units, in lieu of the Class A Units that would otherwise result in any such purchaser’s beneficial ownership exceeding 4.99% (or, at the election of the purchaser, 9.99%) of our outstanding common stock. Each Pre-Funded Warrant is exercisable for one share of our common stock. The exercise price of each Pre-Funded Warrant is $0.00001 per share. The Pre-Funded Warrants are exercisable immediately and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. This offering also relates to the shares of common stock issuable upon exercise of any Pre-Funded Warrants sold in this offering. For each Class B Unit that we sell, the number of Class A Units that we are offering will be reduced on a one-for-one basis.
To better understand the terms of the Pre-Funded Warrants, you should carefully read the “Description of Securities We Are Offering” section of this prospectus. You should also read the form of Pre-Funded Warrant, which is filed as an exhibit to the registration statement that includes this prospectus. | |
| Public offering price | We have assumed a public offering price of $7.94 per Class A Unit, which represents the last reported sale price of our common stock as reported on the Nasdaq Capital Market on June 25, 2025. The Class B Units will be sold at the same price as the Class A Units minus $0.00001 per Class B Unit (which is the exercise price of the Pre-Funded Warrant contained in the Class B Unit). The final public offering price will be determined through negotiation between us and the underwriters in the offering and may be at a discount to the current market price. Therefore, the assumed public offering price used throughout this prospectus may not be indicative of the final public offering price. | |
| Common Warrants | Each Class A Unit and Class B Unit purchased in this offering, as the case may be, will include one (1) Common Warrant to purchase one (1) share of common stock at an exercise price of $ per share, subject to adjustment in the event of stock dividends, stock splits, stock combinations, reclassifications, reorganizations, or similar events affecting our common stock, will be immediately exercisable upon issuance and will expire five (5) years from the date of issuance. The shares of common stock in the Class A Units or the Pre-Funded Warrants in the Class B Units, as applicable, and the accompanying Common Warrants, can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. This offering also relates to the offering of the shares of common stock issuable upon exercise of the Common Warrants. Each Common Warrant is exercisable for one (1) share of common stock.
To better understand the terms of the Common Warrants, you should carefully read the “Description of Securities We Are Offering” section of this prospectus. You should also read the form of Common Warrant, which is filed as an exhibit to the registration statement that includes this prospectus. | |
| Over-allotment option | The underwriters have the option to purchase an aggregate of 113,350 additional shares of common stock and/or additional Common Warrants to purchase up to 113,350 shares of common stock solely to cover over-allotments, if any, at the price to the public less the underwriting discounts and commissions. The over-allotment option may be used to purchase shares of common stock and/or Common Warrants in any combination as determined by the underwriters. The over-allotment option is exercisable for forty-five (45) days from the date of this prospectus. |
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| Common stock outstanding immediately before this offering | 1,812,039 shares of common stock. | |
| Common stock outstanding immediately after this offering | 2,567,706 shares of common stock, or 2,681,056 shares if the underwriters exercise the over-allotment option in full, and assuming no sale of any Class B Units and assuming none of the Common Warrants or representative warrants issued in this offering are exercised. | |
| Use of proceeds | We estimate that we will receive net proceeds of approximately $5.0 million from the sale of the securities offered by us in this offering, based on the assumed public offering price of $7.94 per Class A Unit (the last reported sale price of our common stock on the Nasdaq Capital Market on June 25, 2025), assuming no sales of Class B Units, which, if sold, would reduce the number of Class A Units that we are offering on a one-for-one basis, and after deducting the underwriting commission and estimated offering expenses payable by us. We intend to use the net proceeds from this offering for general corporate purposes, including working capital and operating expenses, and to initiate a Phase 1b clinical study of our compound CLR 121125 (CLR 125) in triple-negative breast cancer. See “Use of Proceeds” for additional information. | |
| Lock-Up Agreements | We, and each of our officers and directors are subject to certain lock-up restrictions as set forth in more detail in the “Underwriting” section. | |
| Nasdaq Symbol | Our common stock is listed on The Nasdaq Capital Market under the symbol “CLRB.” There is no established trading market for the Pre-Funded Warrants or the Common Warrants and we do not expect such markets to develop. In addition, we do not intend to apply for the listing of the Pre-Funded Warrants or Common Warrants on any national securities exchange or other trading market. Without an active trading market, the liquidity of the Pre-Funded Warrants and Common Warrants will be limited. | |
| Risk Factors | An investment in our securities involves a high degree of risk. See “Risk Factors” beginning on page 17 of this prospectus and the other information included and incorporated by reference in this prospectus for a discussion of the risk factors you should carefully consider before deciding to invest in our securities. |
Unless otherwise indicated, all information inthis prospectus assumes no exercise of outstanding options or warrants.
Unless otherwise indicated, all information containedin this prospectus assumes no sale of Pre-Funded Warrants, which, if sold, would reduce the number of shares of common stock that we areoffering on a one-for-one basis and no exercise of any Common Warrants or representative warrants issued in this offering.
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Unless otherwise indicated, the number ofshares of common stock to be outstanding immediately after this offering is based on 1,535,996 shares of common stock outstanding asof March 31, 2025, which is adjusted to 1,812,039 to give effect to 276,043 shares that were issued pursuant to the Warrant Inducement,and which excludes:
| · | any shares of common stock issuable upon the exercise of the Underwriters’ over-allotment option; | |
| · | any shares of common stock issuable upon the exercise of Pre-Funded Warrants issued in this offering; | |
| · | any shares of common stock issuable upon the exercise of Common Warrants issued in this offering; | |
| · | any shares of common stock issuable upon the exercise of the representative warrants issued as compensation to the representative of the underwriters in this offering; | |
| · | an aggregate of 211,816 shares of common stock issuable upon the exercise of outstanding stock options issued to employees, directors and consultants; | |
| · | an aggregate of 13,040 shares of common stock issuable upon the conversion of outstanding shares of Series E-2 preferred stock; | |
| · | an aggregate of 3,704 shares of common stock issuable upon the conversion of outstanding shares of Series D preferred stock; and | |
| · | an aggregate of 522,011 additional shares of common stock reserved for issuance under outstanding warrants having expiration dates between June 2025 and July 2029, and exercise prices ranging from $58.80 to $362.250 per share. |
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Summary Risk Factors
Investing in our securitiesinvolves a high degree of risk. You should carefully consider all of the risks discussed in the section entitled “Risk Factors,”not just those discussed under this “Summary of Risk Factors” before making a decision to invest in our securities. The followingis a list of some of these risks:
Risks Related to This Offering
| · | The net proceeds from this offering, together with our existing cash and cash equivalents, will not besufficient to progress CLR 125 through a Phase 1b dose finding study data readout and we will require additional funding to do so. Ifno additional sources of funding materialize, the Company may be required to seek other alternatives which may include, among others,the sale of assets, discontinuance of certain operations, a wind-down of operations and/or filing for bankruptcy protection. | |
| · | Management will have broad discretion as to the use of the proceeds from this offering, if any, and maynot use the proceeds effectively. | |
| · | If we do not maintain a current and effective prospectus relating to the common stock issuable upon exerciseof the Common Warrants, public holders will only be able to exercise such Common Warrants on a “cashless basis.” | |
| · | If you purchase our common stock, Pre-Funded Warrants and Common Warrants in this offering, you will incurimmediate and substantial dilution in the book value of your shares. | |
| · | Significant holders or beneficial holders of our common stock may not be permitted to exercise Pre-FundedWarrants or Common Warrants that they hold. | |
| · | The Common Warrants are speculative in nature. | |
| · | We may be required to repurchase the Common Warrants, which may prevent or deter a third party from acquiringus. | |
| · | An investment in the Pre-Funded Warrants, Common Warrants and our common stock has numerous tax consequences. | |
| · | Our stock price has experienced, and may continue to experience, price fluctuations. | |
| · | Future sales of a significant number of our shares of common stock in the public markets, or the perceptionthat such sales could occur, could depress the market price of our shares of common stock. | |
| · | There is no public market for the Common Warrants or Pre-Funded Warrants being offered in this offering. | |
| · | Holders of our Common Warrants and Pre-Funded Warrants will have no rights as a common stockholder untilthey acquire our common stock. | |
| · | We have never paid dividends and we do not anticipate paying dividends in the future. | |
| · | A significant number of shares of our common stock are issuable pursuant to outstanding stock awards,and we expect to issue additional stock awards and shares of common stock in the future. Exercise of these awards and sales of shareswill dilute the interests of existing security holders and may depress the price of our common stock. | |
| · | You may experience future dilution as a result of future equity offerings. | |
| · | Failure to meet Nasdaq’s continued listing requirements could result in the delisting of our commonstock, negatively impact the price of our common stock and negatively impact our ability to raise additional capital. | |
| · | If our business plans are not successful, we may not be able to continue operations as a going concernand investors in this offering may lose their entire investment in us. |
Risks Related to Capital and Our Operations
| · | If the Company’s exploration of strategic alternatives is unsuccessful, its financial conditionand results of operations may be materially adversely affected. | |
| · | We will require additional capital in order to continue our operations and may have difficulty raisingadditional capital. | |
| · | Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited. |
Risks Related to Manufacturing and Supply
| · | We rely on a collaborative outsourced business model, and disruptions with our third-party collaboratorsmay impede our ability to gain FDA approval and delay or impair commercialization of any products. |
Risks Related to Research and Developmentand the FDA
| · | We cannot assure the successful development and commercialization of our compounds in development. | |
| · | Failure to complete the development of our technologies, obtain government approvals, including requiredFDA approvals, or comply with ongoing governmental regulations could prevent, delay or limit introduction or sale of proposed productsand result in failure to achieve revenues or maintain our ongoing business. | |
| · | Fast track designation by the FDA may not actually lead to a faster development or regulatory review orapproval process and does not assure FDA approval of our product candidates. | |
| · | The FDA has granted rare pediatric disease designation, RPDD, to iopofosine for treatment of neuroblastoma,rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma; however, we may not be able to realize any value from such designation. | |
| · | Clinical studies involve a lengthy and expensive process with an uncertain outcome, and results of earlierstudies may not be predictive of future study results. | |
| · | We may be required to suspend or discontinue clinical studies because of unexpected side effects or othersafety risks that could preclude approval of our product candidates. | |
| · | The biopharmaceutical industry is subject to extensive regulatory obligations and policies that are subjectto change, including due to judicial challenges. |
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Risks Related to Legal Compliance and Litigation
| · | Controls we or our third-party collaborators have in place to ensure compliance with all applicable lawsand regulations may not be effective. | |
| · | We are exposed to product, clinical and preclinical liability risks that could create a substantial financialburden should we be sued. |
Risks Related to Intellectual Property
| · | We expect to rely on our patents as well as specialized regulatory designations such as orphan drug classificationfor our product candidates, but regulatory drug designations may not confer marketing exclusivity or other expected commercial benefits. | |
| · | If we are unable to adequately protect or enforce our rights to intellectual property or to secure rightsto third-party patents, we may lose valuable rights, experience reduced market share, assuming any, or incur costly litigation to protectour intellectual property rights. |
Risks Related to Our Employees
| · | We rely on a small number of key personnel who may terminate their employment with us at any time, andour success will depend on our ability to hire additional qualified personnel. | |
| · | Confidentiality agreements with employees and others may not adequately prevent disclosure of our tradesecrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete. |
Risks Related to Commercialization of ourProducts
| · | Acceptance of our products in the marketplace is uncertain and failure to achieve market acceptance willprevent or delay our ability to generate revenues. | |
| · | Regulatory approval for any approved product is limited by the FDA, the European Commission, and otherregulators, to those specific indications and conditions for which clinical safety and efficacy have been demonstrated, and we may incursignificant liability if it is determined that we are promoting the “off-label” use of any of our future product candidatesif approved. |
Risks Related to Internal Controls
| · | We identified certain misstatements to our previously issued financial statements and have restated thefinancial statements described below, which has exposed us to additional risks and uncertainties. | |
| · | We identified material weaknesses in our internal control over financial reporting. If we are unable toremediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain effectiveinternal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations,which may adversely affect our business and share price. |
Risks Related to Our Equity Securities
| · | Our common stock could be further diluted as the result of the issuance of additional shares of commonstock, convertible securities, warrants or options. | |
| · | Provisions of our certificate of incorporation, by-laws, and Delaware law may make an acquisition of usor a change in our management more difficult. |
General Risk Factors
| · | Our business and operations may be materially adversely affected in the event of computer system failuresor security breaches. |
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An investment in our securitiesinvolves a high degree of risk. Prior to making a decision about investing in our securities, prospective investors should consider carefullyall of the information included and incorporated by reference or deemed to be incorporated by reference in this prospectus, includingthe risk factors incorporated by reference herein from our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, as updated by annual, quarterly andother reports and documents we file with the SEC after the date of this prospectus and that are incorporated by reference herein. Eachof these risk factors could have a material adverse effect on our business, results of operations, financial position or cash flows, whichmay result in the loss of all or part of your investment. For more information, see “Where You Can Find Additional Information”and “Incorporation of Documents by Reference.”
The risks described in thesedocuments are not the only ones we face. There may be other unknown or unpredictable economic, business, competitive, regulatory or otherfactors that could have material adverse effects on our future results. Further, past financial performance may not be a reliable indicatorof future performance, and historical trends should not be used to anticipate results or trends in future periods. Please also read carefullythe section below entitled “Forward-Looking Statements.”
Risks Related to This Offering
The net proceeds from this offering, togetherwith our existing cash and cash equivalents, will not be sufficient to progress CLR 125 through a Phase 1b dose finding study data readoutand we will require additional funding to do so. If no additional sources of funding materialize, the Company may be required to seekother alternatives which may include, among others, the sale of assets, discontinuance of certain operations, a wind-down of operationsand/or filing for bankruptcy protection.
Our intended use of net proceedsfrom this offering will be for general corporate purposes, including working capital and operating expenses and to initiate a Phase 1bdose finding study for CLR 121125 in triple-negative breast cancer. However, we do not expect that our net use of proceeds from this offering,together with our existing cash and cash equivalents, will be sufficient to progress this study through a preliminary data readout. Assuch, our ability to progress through a preliminary data readout and our current operating plan will continue to depend on our abilityto obtain additional funding from the sale of equity and/or debt securities, strategic transaction or other sources of capital.
Our ability to obtain additionalfunding on acceptable terms or at all is subject to a variety of risks and uncertainties outside of our control. Those risks and uncertaintiesare further exacerbated since the Company is not expected to have any readouts of its data from the Phase 1b dose finding study of CLR121125 in close proximity to the time when it may need to seek additional funding.
The Company plans to continueactively pursuing additional funding, however, there can be no assurance that such additional funding will materialize. If no additionalsources of funding materialize, the Company may be required to seek other alternatives which may include, among others, the sale of assets,discontinuance of certain operations, a wind-down of operations and/or filing for bankruptcy protection.
Management will have broad discretion asto the use of the proceeds from this offering, if any, and may not use the proceeds effectively.
We currently anticipate thatany net proceeds from this offering will be used for general corporate purposes, including working capital and operating expenses, andto initiate a Phase 1b clinical study of our compound CLR 125 in triple-negative breast cancer. However, we have not determined the specificallocation of the net proceeds from this offering, if any, among these potential uses. Our management will have broad discretion as tothe application of the net proceeds from this offering, if any, and could use them for purposes other than those contemplated at the timeof the offering. Our management may use the net proceeds for corporate purposes that may not improve our financial condition or marketvalue.
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If we do not maintain a current and effectiveprospectus relating to the common stock issuable upon exercise of the Common Warrants, public holders will only be able to exercise such CommonWarrants on a “cashless basis.”
If we do not maintain a currentand effective prospectus relating to the shares of common stock issuable upon exercise of the Common Warrants at the time that holderswish to exercise such respective warrants, they will only be able to exercise them on a “cashless basis,” and under no circumstanceswould we be required to make any cash payments or net cash settle such warrants to the holders. As a result, the number of shares of commonstock that holders will receive upon exercise of the Common Warrants will be fewer than it would have been had such holders exercisedtheir Common Warrants for cash. We will use our best efforts to maintain a current and effective prospectus relating to the shares ofcommon stock issuable upon exercise of such Common Warrants until the expiration of such Common Warrants or until all Common Warrantshave been exercised in full. However, we cannot assure you that we will be able to do so. If we are unable to do so, the potential “upside”of the holder’s investment in our Company may be reduced.
If you purchase our common stock, Pre-FundedWarrants and Common Warrants in this offering, you will incur immediate and substantial dilution in the book value of your shares.
The public offering pricein this offering is substantially higher than the net tangible book value per share of our common stock. Investors purchasing commonstock and Common Warrants in this offering will pay a price per share that substantially exceeds the book value of our tangible assetsafter subtracting our liabilities. As a result, investors purchasing common stock and Common Warrants in this offering will incur immediatedilution of $2.10 per share, based on the assumed public offering price of $7.94 per Class A Unit.
As a result of the dilutionto investors purchasing securities in this offering, investors may receive significantly less than the purchase price paid in this offering,if anything, in the event of our liquidation. For a further description of the dilution that you will incur as a result of purchasingsecurities in this offering, see “Dilution.”
Significant holders or beneficial holdersof our common stock may not be permitted to exercise Pre-Funded Warrants or Common Warrants that they hold.
The Pre-Funded Warrants andCommon Warrants being offered hereby will prohibit a holder from exercising its Pre-Funded Warrants or Common Warrants if doing so wouldresult in such holder (together with such holder’s affiliates and any other persons acting as a group together with such holderor any of such holder’s affiliates) beneficially owning more than 4.99% of our common stock outstanding immediately after givingeffect to the exercise, provided that, at the election of a holder and notice to us, such beneficial ownership limitation as to such holdershall be 9.99% of our common stock outstanding immediately after giving effect to the exercise. As a result, if you hold a significantamount of our securities, you may not be able to exercise your Pre-Funded Warrants or Common Warrants for shares of our common stock,in whole or in part, at a time when it would be financially beneficial for you to do so.
The Common Warrants are speculativein nature.
The Common Warrants offeredhereby do not confer any rights of common stock ownership on their holders, such as voting rights or the right to receive dividends, butrather merely represent the right to acquire shares of common stock at a fixed price. Specifically, commencing on the date of issuance,holders of the Common Warrants may acquire the common stock issuable upon exercise of such Common Warrants at an exercise price of $ pershare of common stock. Moreover, following this offering, the market value of the Common Warrants will be uncertain and there can be noassurance that the market value of the Common Warrants will equal or exceed the exercise price of the Common Warrants, and consequently,whether it will ever be profitable for holders of the Common Warrants to exercise the Common Warrants.
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An investment in the Pre-Funded Warrants,Common Warrants and our common stock has numerous tax consequences.
There are numerous tax consequencesto investors as a result of their investment in the Company. We encourage investors to seek advice from competent tax advisors as to theconsequences of an investment in our Pre-Funded Warrants, Common Warrants and common stock. See “Material U.S. Federal Income TaxConsiderations.”
Our stock price has experienced, and maycontinue to experience, price fluctuations.
Our stock price has been andcontinues to be highly volatile. There can be no assurance that the market price for our common stock will remain at its current level,and a decrease in the market price could result in substantial losses for investors. The market price of our common stock may be significantlyaffected by one or more of the following factors:
| · | announcements or press releases relating to the biopharmaceutical sector or to our own business or prospects; |
| · | regulatory, legislative or other developments affecting us or the healthcare industry generally; |
| · | sales by holders of restricted securities pursuant to effective registration statements or exemptionsfrom registration; |
| · | market conditions specific to biopharmaceutical companies, the healthcare industry and the stock marketgenerally; and |
| · | our ability to meet the continued listing standards of the Nasdaq Capital Market (“Nasdaq”)exchange. |
Future sales of a significant number ofour shares of common stock in the public markets, or the perception that such sales could occur, could depress the market price of ourshares of common stock.
Sales of a substantial numberof our shares of common stock in the public markets, or the perception that such sales could occur, including from the exercise of outstandingwarrants or sales of common stock issuable thereunder, could depress the market price of our shares of common stock and impair our abilityto raise capital through the sale of additional equity securities. A substantial number of shares of common stock are being offered bythis prospectus. We cannot predict the number of these shares that might be sold nor the effect that future sales of our shares of commonstock, including shares issuable upon the exercise of outstanding warrants, would have on the market price of our shares of common stock.
There is no public market for the CommonWarrants or Pre-Funded Warrants being offered in this offering.
There is no established publictrading market for the Common Warrants or Pre-Funded Warrants being offered in this offering, and we do not expect such markets to develop.In addition, we do not intend to apply to list the Common Warrants or Pre-Funded Warrants on any securities exchange or nationally recognizedtrading system, including The Nasdaq Stock Market. Without an active market, the liquidity of the Common Warrants and Pre-Funded Warrantswill be limited.
Holders of our Common Warrants and Pre-FundedWarrants will have no rights as a common stockholder until they acquire our common stock.
Until holders of our CommonWarrants and Pre-Funded Warrants acquire shares of our common stock upon exercise of the Common Warrants and Pre-Funded Warrants, theholders will have no rights with respect to shares of our common stock issuable upon exercise of the Common Warrants and Pre-Funded Warrants.Upon exercise of the Common Warrants and Pre-Funded Warrants, holders will be entitled to exercise the rights of a common stockholderonly as to matters for which the record date occurs after the exercise date.
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We have never paid dividends and we do notanticipate paying dividends in the future.
We have never paid dividendson our capital stock and do not anticipate paying any dividends for the foreseeable future. We anticipate that the Company will retainits earnings, if any, for future growth. Investors seeking cash dividends should not invest in the Company’s common stock for thatpurpose.
A significant number of shares of our commonstock are issuable pursuant to outstanding stock awards, and we expect to issue additional stock awards and shares of common stock inthe future. Exercise of these awards and sales of shares will dilute the interests of existing security holders and may depress the priceof our common stock.
As of June 24, 2025, therewere approximately 1,812,039 shares of common stock outstanding, as well as outstanding awards to purchase approximately 211,816 sharesof common stock under various incentive stock plans of the Company. Additionally, as of June 24, 2025, there were approximately 98,909shares of common stock available for future issuance under various incentive plans. We may issue additional common stock, warrants andother convertible securities from time to time to finance our operations. We may also issue additional shares to fund potential acquisitionsor in connection with additional stock options or other equity awards granted to our employees, officers, directors and consultants underour various incentive plans. The issuance of additional shares of common stock, warrants or other convertible securities and the perceptionthat such issuances may occur or exercise of outstanding warrants or options may have a dilutive impact on other stockholders and couldhave a material negative effect on the market price of our common stock.
You may experience future dilution as aresult of future equity offerings.
In order to raise additionalcapital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for ourcommon stock at prices that may not be the same as the price per share paid by any investor in this offering. We may sell shares or othersecurities in any other offering at a price per share that is less than the price per share paid by any investor in this offering, andinvestors purchasing shares or other securities in the future could have rights superior to you. The price per share at which we selladditional shares of our common stock, or securities convertible or exchangeable into common stock, in future transactions may be higheror lower than the price per share paid by any investor in this offering.
Failure to meet Nasdaq’s continuedlisting requirements could result in the delisting of our common stock, negatively impact the price of our common stock and negativelyimpact our ability to raise additional capital.
We must continue to satisfyNasdaq continued listing requirements, including, among other things, certain corporate governance requirements, minimum stockholders’equity of $2.5 million, and a minimum closing bid price requirement of $1.00 per share. If a company fails for 30 consecutive businessdays to meet the $1.00 minimum closing bid price requirement, Nasdaq will send a deficiency notice to the company, advising that it hasbeen afforded a “compliance period” of 180 calendar days to regain compliance with the applicable requirements.
On January 30, 2025,we received a deficiency letter from Nasdaq notifying us that, for the last 30 consecutive business days, the closing bid price for ourcommon stock was below the minimum $1.00 per share required for continued listing on Nasdaq pursuant to the minimum closing bid pricerequirement. The Nasdaq deficiency letter had no immediate effect on the listing of our common stock. In accordance with Nasdaq ListingRule 5810(c)(3)(A), we have been given 180 calendar days, or until July 29, 2025, to regain compliance with the minimum closingbid price requirement by causing our stock to close above $1.00 for a minimum of 10 consecutive trading days. If we do not regain compliancewith the minimum closing bid price requirement by July 29, 2025, we may be afforded a second 180 calendar day period to regain compliance.To qualify, we would be required to meet the continued listing requirement for market value of publicly held shares and all other initiallisting standards for Nasdaq, except for the minimum bid price requirement. In addition, we would be required to notify Nasdaq of ourintent to cure the deficiency during the second compliance period.
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On June 24, 2025, we effectedthe 1-for-30 Reverse Stock Split to regain compliance with the bid price requirement prior to the July 29, 2025 compliance deadline.There is no assurance we will regain and maintain compliance with Nasdaq continued listing requirements.
If our common stock becomessubject to delisting, it would be subject to rules that impose additional sales practice requirements on broker-dealers who sellour securities. The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effectingtransactions in our common stock. This would adversely affect the ability of investors to trade our common stock and would adverselyaffect the value of our common stock. These factors could contribute to lower prices and larger spreads in the bid and ask prices forour common stock.
If our business plans are not successful,we may not be able to continue operations as a going concern and investors in this offering may lose their entire investment in us.
We have historically incurredsubstantial losses to fund our business operations including our research and development activities. We will, in all likelihood, sustainoperating expenses without corresponding revenues for the foreseeable future. This may result in our incurring net operating losses thatwill increase continuously until we are able to obtain regulatory approval for, and commercialize, our product candidates, the occurrenceof which cannot be assured. If we cannot continue as a going concern, investors in this offering may lose their entire investment in us.
Risks Related to Capital and Our Operations
If the Company’s exploration of strategicalternatives is unsuccessful, its financial condition and results of operations may be materially adversely affected.
As previously announced, theCompany has engaged a financial advisor to assist it in evaluating potential strategic alternatives to enhance stockholder value. Strategicalternatives under consideration may include, but are not limited to mergers, acquisitions, business combinations, partnerships, jointventures, licensing arrangements or other strategic transactions. The Company and its financial advisor have engaged in preliminary discussionswith potential counterparties but there is no assurance that the potential strategic alternatives will lead to a definitive agreement.If the Company is unable to consummate a strategic transaction, or if there is any significant delay in closing such a transaction, theCompany’s financial condition and results of operations may be materially adversely affected. In addition, the Company may be requiredto seek other alternatives which may include, among others, the sale of the Company or its assets, discontinuance of certain operations,a wind-down of operations and/or filing for bankruptcy protection.
We will require additional capital in orderto continue our operations and may have difficulty raising additional capital.
We expect that we will continueto generate operating losses for the foreseeable future. As of March 31, 2025, our consolidated cash balance was approximately $13.9million. We believe our cash balance as of March 31, 2025, excluding the proceeds from this offering, is adequate to fund our basicbudgeted operations into the fourth quarter of 2025.
The Company’s abilityto execute its current operating plan depends on its ability to obtain additional funding via the sale of equity and/or debt securities,a strategic transaction or other source of capital. The Company plans to continue actively pursuing financing alternatives, however, therecan be no assurance that it will obtain the necessary funding, raising substantial doubt about the Company’s ability to continueas a going concern within one year of the date these financial statements are issued. The accompanying financial statements do not includeany adjustments that might result from the outcome of this uncertainty.
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Our capital requirements andour ability to meet them depend on many factors, including:
| · | the number of potential products and technologies in development; | |
| · | continued progress and cost of our research and development programs; | |
| · | progress with preclinical studies and clinical studies; | |
| · | the time and costs involved in obtaining regulatory clearance; | |
| · | costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; | |
| · | costs of developing sales, marketing and distribution channels and our ability to sell our drugs; | |
| · | costs involved in establishing manufacturing capabilities for clinical study and commercial quantitiesof our drugs; | |
| · | competing technological and market developments; | |
| · | claims or enforcement actions with respect to our products or operations; | |
| · | market acceptance of our products; | |
| · | costs for recruiting and retaining management, employees and consultants; | |
| · | our ability to manage computer system failures or security breaches; | |
| · | costs for educating physicians regarding the application and use of our products; | |
| · | whether we are able to maintain our listing on a national exchange; | |
| · | uncertainty and economic instability resulting from conflicts, military actions, terrorist attacks, naturaldisasters, public health crises, including the occurrence of a contagious disease or illness, cyber-attacks and general instability; and | |
| · | the condition of capital markets and the economy generally, both in the U.S. and globally. |
We may consume available resourcesmore rapidly than currently anticipated, resulting in the need for additional funding sooner than expected. We may seek to raise any additionalfunds through the issuance of any combination of common stock, preferred stock, warrants and debt financings or by executing collaborativearrangements with corporate partners or other sources, any of which may be dilutive to existing stockholders or have a material effecton our current or future business prospects. If we cannot secure adequate financing when needed, we may be required to delay, scale backor eliminate one or more of our research and development programs or to enter into license or other arrangements with third parties tocommercialize products or technologies that we would otherwise seek to develop and commercialize ourselves. In the event that additionalfunds are obtained through arrangements with collaborative partners or other sources, we may have to relinquish economic and/or proprietaryrights to some of our technologies or products under development that we would otherwise seek to develop or commercialize by ourselves.In such an event, our business, prospects, financial condition and results of operations may be adversely affected.
Our ability to utilize our net operatingloss carryforwards and certain other tax attributes may be limited.
Our ability to utilize ourfederal net operating loss and tax credit carryforwards may be limited under Sections 382 and 383 of the Internal Revenue Code of 1986,as amended (the Code). The limitations apply if we experience an “ownership change”, generally defined as a greater than 50percentage point change in the ownership of our equity by certain stockholders over a rolling three-year period. Similar provisions ofstate tax law may also apply. We have not evaluated whether such an ownership change has occurred previously. If we have experienced anownership change at any time since our formation, we may already be subject to limitations on our ability to utilize our existing netoperating losses and other tax attributes to offset taxable income. In addition, future changes in our stock ownership, which may be outsideof our control, may trigger an ownership change and, consequently, the limitations under Sections 382 and 383 of the Code. As a result,if or when we earn net taxable income, our ability to use our net operating loss carryforwards and other tax attributes to offset suchtaxable income may be subject to limitations, which could adversely affect our future cash flows.
Risks Related to Manufacturing and Supply
We rely on a collaborative outsourced businessmodel, and disruptions with our third-party collaborators may impede our ability to gain FDA approval and delay or impair commercializationof any products.
We are in the preclinicaland clinical study phases of product development and commercialization. We have closed manufacturing operations located at our formercorporate headquarters in Wisconsin and have implemented a collaboration outsourcing model to more efficiently manage costs. We rely significantlyon contracts with third parties to use their facilities to conduct our research, development and manufacturing.
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We have engaged AtomVie andSpectronRx as sources to supply drug product for our ongoing research and clinical studies.
In addition, we rely exclusivelyon contract research organizations to conduct research and development. Any inability of these organizations to fulfill the requirementsof their agreements with us may delay or impair our ability to gain FDA approval and commercialization of our drug delivery technologyand products.
Our reliance on third-partycollaborators exposes us to risks related to not being able to directly oversee the activities of these parties. Furthermore, these collaborators,whether foreign or domestic, may experience regulatory compliance difficulties, mechanical shutdowns, employee strikes, or other unforeseeableacts that may delay fulfillment of their agreements with us. This may lead to the stopping or delay of our clinical trials or commercialmanufacturing activity. Failure of any of these collaborators to provide the required services in a timely manner or on commercially reasonableterms could materially delay the development and approval of our products, increase our expenses, and materially harm our business, prospects,financial condition and results of operations.
Our current and anticipatedfuture dependence upon these third-party manufacturers may adversely affect our ability to develop and commercialize product candidateson a timely and competitive basis, which could have an adverse effect on sales, results of operations and financial condition. If we wererequired to transfer manufacturing processes to other third-party manufacturers and we were able to identify an alternative manufacturer,we would still need to satisfy various regulatory requirements. Satisfaction of these requirements could cause us to experience significantdelays in receiving an adequate supply of our products and products in development and could be costly. Moreover, we may not be able totransfer processes that are proprietary to the manufacturer, if any. These manufacturers may not be able to produce material on a timelybasis or manufacture material at the quality level or in the quantity required to meet our development timelines and applicable regulatoryrequirements and may also experience a shortage in qualified personnel. We may not be able to maintain or renew our existing third-partymanufacturing arrangements, or enter into new arrangements, on acceptable terms, or at all. Our third-party manufacturers could terminateor decline to renew our manufacturing arrangements based on their own business priorities, at a time that is costly or inconvenient forus. If we are unable to contract for the production of materials in sufficient quantity and of sufficient quality on acceptable terms,our planned clinical trials may be significantly delayed. Manufacturing delays could postpone the filing of our IND applications and/orthe initiation or completion of clinical trials that we have currently planned or may plan in the future.
Drug manufacturers are subjectto ongoing periodic unannounced inspection by the FDA, the Drug Enforcement Administration, the EMA, national competent authorities inthe EU and UK and other federal and state government and regulatory agencies to ensure strict compliance with cGMP and other governmentregulations and corresponding foreign standards. We do not have control over third-party manufacturers’ compliance with these regulationsand standards and they may not be able to comply. Switching manufacturers may be difficult because the number of potential manufacturersis limited. It may be difficult or impossible for us to find a replacement manufacturer quickly on acceptable terms, or at all. Additionally,if we are required to enter into new supply arrangements, we may not be able to obtain approval from the FDA of any alternate supplierin a timely manner, or at all, which could delay or prevent the clinical development and commercialization of any related product candidates.Failure of our third-party manufacturers or us to comply with applicable regulations could result in sanctions being imposed on us, includingfines, civil penalties, delays in or failure to grant marketing approval of our product candidates, injunctions, delays, suspension orwithdrawal of approvals, license revocation, seizures or recalls of products and compounds, operating restrictions and criminal prosecutions,warning or similar letters or civil, criminal or administrative sanctions against the company, any of which could adversely affect ourbusiness.
We believe that we have agood working relationship with our third-party collaborators. However, should the situation change, we may be required to relocate theseactivities on short notice, and we do not currently have access to alternate facilities to which we could relocate our research, developmentand/or manufacturing activities. The cost and time to establish or locate an alternate research, development and/or manufacturing facilityto develop our technology would be substantial and would delay obtaining FDA approval and commercializing our products.
Furthermore, if our productsare approved for commercial sale, we will need to work with our existing third-party collaborators to ensure sufficient capacity, or engageadditional parties with the capacity, to commercially manufacture our products in accordance with FDA and other regulatory requirements.There can be no assurance that we would be able to successfully establish any such capacity or identify suitable manufacturing partnerson acceptable terms.
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Risks Related to Research and Development andthe FDA
We cannot assure the successful developmentand commercialization of our compounds in development.
At present, our success isdependent on one or more of the following to occur: the successful development of iopofosine for the treatment of a hematologic or solidtumor cancer including Waldenstrom’s macroglobulinemia, multiple myeloma and B-Cell lymphomas or the treatment of pediatric solidtumors and lymphomas; the development of new PDCs, specifically new products developed from our PDC program, and the advancement of ourPDC agents through research and development; and/or commercialization partnerships.
We are a late-stage clinicalbiopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer. We leverageour PDC platform to specifically target cancer cells. The PDC platform possesses the potential for the discovery and development of thenext generation of cancer-targeting agents. The PDC platform features include the capacity to link with almost any molecule, the deliveryof a significant increase in targeted oncologic payload, and the ability to target nearly all tumor cells. As a result, we believe thatwe can generate PDCs to treat a broad range of cancers with the potential to improve the therapeutic index of oncologic drug payloads,enhance or maintain efficacy while reducing adverse events by minimizing drug delivery to healthy cells, and increase delivery to cancerouscells and cancer stem cells.
Our proposed products andtheir potential applications are in clinical and manufacturing/process development and face a variety of risks and uncertainties inherentin the development of pharmaceutical products, including the following:
| · | The inherent difficulty in selecting the right drug and drug target and avoiding unwanted side effects,as well as unanticipated problems relating to product development, testing, enrollment, obtaining regulatory approvals, maintaining regulatorycompliance, manufacturing, competition and costs and expenses that may exceed current estimates; | |
| · | Future clinical study results may show that our cancer-targeting and delivery technologies are not well-toleratedby patients at their effective doses or are not efficacious. In future clinical trials, we or our partners may discover additional sideeffects and/or a higher frequency of side effects than those observed in previously completed clinical trials. | |
| · | Future clinical study results may be inconsistent with testing results obtained to-date. The results ofpreliminary and mid-stage clinical trials do not necessarily predict clinical or commercial success, and larger later-stage clinical trialsmay fail to confirm the results observed in the previous clinical trials. | |
| · | A clinical trial may show that a product candidate is safe and effective for certain patient populationsin a particular indication, but other clinical trials may fail to confirm those results in a subset of that population or in a differentpatient population, which may limit the potential market for that product candidate. | |
| · | Even if our cancer-targeting and delivery technologies are shown to be safe and effective for their intendedpurposes, we may face significant or unforeseen difficulties in obtaining or manufacturing sufficient quantities at reasonable pricesor at all. | |
| · | Our ability to complete the development and commercialization of our cancer-targeting and delivery technologiesfor their intended use is substantially dependent upon our ability to raise sufficient capital or to obtain and maintain experienced andcommitted partners to assist us with obtaining clinical and regulatory approvals for, clinical trial patient enrollment in, and the manufacturing,marketing and distribution of, our products. | |
| · | Even if our cancer-targeting and delivery technologies are successfully developed, approved by all necessaryregulatory authorities, and commercially produced, there is no guarantee that there will be market acceptance of our products. | |
| · | Our competitors may develop therapeutics or other treatments that are superior or less costly than ourown with the result that our product candidates, even if they are successfully developed, manufactured and approved, may not generatesufficient revenues to offset the development and manufacturing costs of our product candidates. |
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If we are unsuccessful indealing with any of these risks, or if we are unable to successfully advance the development of our cancer-targeting and delivery technologiesfor some other reason, our business, prospects, financial condition and results of operations may be adversely affected.
With respect to our own compoundsin development, we have established anticipated timelines with respect to the initiation of clinical trials based on existing knowledgeof the compounds. However, we cannot provide assurance that we will meet any of these timelines for clinical development. Additionally,the initial results of a completed earlier clinical trial of a product candidate do not necessarily predict final results and the resultsmay not be repeated in later clinical trials.
Because of the uncertaintyof whether the accumulated preclinical evidence (PK, pharmacodynamic, safety and/or other factors) or early clinical results will be observedin later clinical trials, we can make no assurances regarding the likely results from our future clinical trials or the impact of thoseresults on our business.
Failure to complete the development of ourtechnologies, obtain government approvals, including required FDA approvals, or comply with ongoing governmental regulations could prevent,delay or limit introduction or sale of proposed products and result in failure to achieve revenues or maintain our ongoing business.
Our research and developmentactivities and the manufacture and marketing of our intended products are subject to extensive regulation for safety, efficacy and qualityby numerous government authorities in the U.S. and abroad. Before receiving approval to market our proposed products by the FDA, we willhave to demonstrate that our products are safe and effective for the patient population for the diseases that are to be treated. Clinicalstudies, manufacturing and marketing of drugs are subject to the rigorous testing and approval process of the FDA and equivalent foreignregulatory authorities. The Federal Food, Drug, and Cosmetic Act and other federal, state and foreign statutes and regulations governand influence the testing, manufacturing, labeling, advertising, distribution and promotion of drugs and medical devices. As a result,clinical studies and regulatory approval can take many years to accomplish and require the expenditure of substantial financial, managerialand other resources.
We cannot predict whetherregulatory clearance or approval will be obtained for any product that we hope to develop. Of particular significance to us are the requirementsrelating to research and development and testing. The activities associated with the research, development and commercialization of CLR121225, CLR 121125, iopofosine and other future candidates in our pipeline must undergo extensive clinical trials, which can take manyyears and require substantial expenditures, subject to extensive regulation by the FDA and other regulatory agencies in the U.S. and bycomparable authorities in other countries. The process of obtaining regulatory approvals in the U.S. and other foreign jurisdictions isexpensive, and lengthy, if approval is obtained at all.
Before commencing clinicaltrials in humans, we, or our collaborative partners, will need to submit and receive approval from the FDA of an IND application. Clinicaltrials are subject to oversight by institutional review boards and the FDA and:
| · | must be conducted in conformance with the FDA’s good clinical practices and other applicable regulations; | |
| · | must meet requirements for institutional review board oversight; | |
| · | must meet requirements for informed consent; | |
| · | are subject to continuing FDA and regulatory oversight; | |
| · | may require large numbers of test subjects; and | |
| · | may be suspended by us, our collaborators or the FDA at any time if it is believed that the subjects participatingin these trials are being exposed to unacceptable health risks or if the FDA finds deficiencies in the IND or the conduct of these trials. |
We do not know whether wewill be permitted to undertake clinical trials of potential products beyond the trials already concluded and the trials currently in process.It will take us or our collaborative partners several years to complete any such testing, and failure can occur at any stage of testing.Interim results of trials do not necessarily predict final results, and acceptable results in early trials may not be repeated in latertrials. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks inadvanced clinical trials, even after achieving promising results in earlier trials.
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Before receiving FDA approvalor similar approval in the European Union or other jurisdiction to market a product, we must demonstrate with substantial clinical evidencethat the product is safe and effective in the patient population and the indication that will be treated. Data obtained from preclinicaland clinical activities are susceptible to varying interpretations that could delay, limit or prevent regulatory approvals. Our clinicaltrials may fail to produce results satisfactory to the FDA or regulatory authorities in other jurisdictions. The regulatory process alsorequires preclinical testing, and data obtained from preclinical and clinical activities are susceptible to varying interpretations. Inconnection with clinical trials of our product candidates, we may face the following risks among others:
| · | the product candidate may not prove to be effective; | |
| · | the product candidate may cause harmful side effects; | |
| · | the clinical results may not replicate the results of earlier, smaller trials; | |
| · | we, or the FDA or similar foreign regulatory authorities, may delay, terminate or suspend the trials; | |
| · | our results may not be statistically significant; | |
| · | patient recruitment and enrollment may be slower than expected; | |
| · | patients may drop out of the trials or otherwise not enroll; and | |
| · | regulatory and clinical trial requirements, interpretations or guidance may change. |
The FDA has substantial discretionin the approval process and may refuse to approve any NDA or sNDA and decide that our data is insufficient for approval and require additionalpreclinical, clinical or other studies. Varying interpretations of the data obtained from preclinical and clinical testing could delay,limit or prevent regulatory approval of our products for any individual, additional indications.
To be commercially viable,we must successfully research, develop, manufacture, introduce, and obtain the required regulatory approval described above for our productcandidates, in order to market and distribute our product candidates. This includes meeting a number of critical developmental milestones,including:
| · | demonstrating benefit from delivery of each specific drug for specific medical indications; | |
| · | demonstrating through preclinical and clinical studies that each drug is safe and effective; and | |
| · | demonstrating that we have established viable FDA cGMPs capable of potential scale-up. |
The timeframe necessary toachieve these developmental milestones may be long and uncertain, and we may not successfully complete these milestones for any of ourintended products in development.
In addition to the risks previouslydiscussed, our technology is subject to developmental risks that include the following:
| · | uncertainties arising from the rapidly growing scientific aspects of drug therapies and potential treatments; | |
| · | uncertainties arising as a result of the broad array of alternative potential treatments related to cancerand other diseases; and | |
| · | expense and time associated with the development and regulatory approval of treatments for cancer andother diseases. |
In addition, delays or rejectionsmay be encountered based upon additional government regulation from future legislation or administrative action or changes in FDA policyduring the period of product development, clinical trials and FDA regulatory review. Failure to comply with applicable FDA or other applicableregulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products, total or partial suspensionof production or injunction, adverse publicity, as well as other regulatory action against our potential products or us.
To conduct the clinical studiesthat are necessary to obtain approval by the FDA to market a product, it is necessary to receive clearance from the FDA to conduct suchclinical studies. The FDA can halt clinical studies at any time for safety reasons or because we or our clinical investigators do notfollow the FDA’s requirements for conducting clinical studies. If any of our studies are halted, we will not be able to obtain FDAapproval until and unless we can address the FDA’s concerns. If we are unable to receive clearance to conduct clinical studies fora product, we will not be able to achieve any revenue from that product in the U.S., as it is illegal to sell any drug for use in humansin the U.S. without FDA approval.
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If regulatory approval ofa product is granted, this approval will be limited to those indications or disease states and conditions for which the product is demonstratedthrough clinical trials to be safe and efficacious. We cannot assure you that any compound developed by us, alone or with others, willprove to be safe and efficacious in clinical trials and will meet all of the applicable regulatory requirements needed to receive marketingapproval.
Even if we do ultimately receiveFDA approval for any of our products, these products will be subject to extensive ongoing regulation, including regulations governingmanufacturing, labeling, packaging, testing, dispensing, prescription and procurement quotas, record keeping, reporting, handling, shipmentand disposal of any such drug. Failure to obtain and maintain required registrations or to comply with any applicable regulations couldfurther delay or preclude development and commercialization of our drugs and subject us to enforcement action.
Outside the US, our ability,or that of our collaborative partners, to market a product is contingent upon receiving a marketing authorization from the appropriateregulatory authorities. This foreign regulatory approval process typically includes all of the risks and costs associated with FDA approvaldescribed above and may also include additional risks and costs, such as the risk that such foreign regulatory authorities, which oftenhave different regulatory and clinical trial requirements, interpretations and guidance from the FDA, may require additional clinicaltrials or results for approval of a product candidate, any of which could result in delays, significant additional costs or failure toobtain such regulatory approval. There can be no assurance, however, that we or our collaborative partners will not have to provide additionalinformation or analysis, or conduct additional clinical trials, before receiving approval to market product candidates.
Fast track designation by the FDA may notactually lead to a faster development or regulatory review or approval process and does not assure FDA approval of our product candidates.
If a product candidate isintended for the treatment of a serious or life-threatening condition and the product candidate demonstrates the potential to addressunmet medical need for this condition, the sponsor may apply for FDA fast track designation. Fast track designation applies to the combinationof the product and the specific indication for which it is being studied. The sponsor of a fast track product has opportunities for morefrequent interactions with the review team during product development, and the FDA may consider for review sections of the NDA on a rollingbasis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA,the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user feesupon submission of the first section of the NDA.
However, fast track designationdoes not change the standards for approval and does not ensure that the product candidate will receive marketing approval or that approvalwill be granted within any particular timeframe. As a result, while the FDA has granted fast track designation to iopofosine for WM patientshaving received two or more prior treatment regimens and/or we may seek and receive fast track designation for our future product candidates,we may not experience a faster development process, review or approval compared to conventional FDA procedures. In addition, the FDA maywithdraw fast track designation if it believes that the designation is no longer supported by data from our clinical development program.Fast track designation alone does not guarantee qualification for the FDA’s priority review procedures.
The FDA has granted rare pediatric diseasedesignation, RPDD, to iopofosine for treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma; however, wemay not be able to realize any value from such designation.
Iopofosine has received RPDDdesignation from the FDA for the treatment of neuroblastoma, rhabdomyosarcoma, osteosarcoma and Ewing’s sarcoma. The FDA definesa “rare pediatric disease” as a disease that affects fewer than 200,000 individuals in the U.S. primarily under the age of18 years old, or a patient population greater than 200,000 in the U.S. when there is no reasonable expectation that the cost of developingand making available the drug in the U.S. will be recovered from sales in the U.S. for that drug or biological product. Under the FDA’sRare Pediatric Disease Priority Review Voucher Program, upon the approval of an NDA or a BLA for the treatment of a rare pediatric disease,the sponsor of such application could be eligible for a Rare Pediatric Disease Priority Review Voucher that can be redeemed to obtainpriority review for a subsequent NDA or BLA. The sponsor of a rare pediatric disease drug product receiving a priority review vouchermay transfer (including by sale) the voucher to another sponsor. The voucher may be further transferred any number of times before thevoucher is used, as long as the sponsor making the transfer has not yet submitted the application.
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The FDA may also revoke anypriority review voucher if the rare pediatric disease drug for which the voucher was awarded is not marketed in the U.S. within one yearfollowing the date of approval. In addition, the priority review voucher is only awarded to an NCE. Thus, if iopofosine is approved firstfor an indication that is not a rare pediatric disease, our application may not be eligible to receive the voucher. There is no assurancewe will receive a Rare Pediatric Disease Priority Review Voucher or that it will result in a faster development process, review or approvalfor a subsequent marketing application. Also, although Priority Review Vouchers may be sold or transferred to third parties, there isno guaranty that we will be able to realize any value if we were to sell a Priority Review Voucher. In December 2020, the PriorityReview Voucher Program was extended by the FDA permitting additional grants through September 2026 for rare pediatric diseases. Itis possible that even if we obtain approval for iopofosine and qualify for a priority review voucher, the program may no longer be ineffect at the time of such approval.
Furthermore, due to recentcommunications with the FDA regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine,the Company is, in addition to determining the availability of funding for such a study, pursuing strategic options for the further developmentand commercialization of this product candidate.
Clinical studies involve a lengthy and expensiveprocess with an uncertain outcome, and results of earlier studies may not be predictive of future study results.
To obtain regulatory approvalfor the commercialization of our product candidates, we must conduct, at our own expense, extensive clinical studies to demonstrate safetyand efficacy of these product candidates. Clinical testing is expensive, it can take many years to complete, and its outcome is uncertain.Failure can occur at any time during the clinical study process.
We may experience delays inclinical testing of our product candidates. We do not know whether planned clinical studies will begin on time, need to be redesigned,or be completed on schedule, if at all. Clinical studies can be delayed for a variety of reasons, including delays in obtaining regulatoryapproval to commence a study, reaching agreement on acceptable clinical study terms with prospective sites, obtaining institutional reviewboard approval to conduct a study at a prospective site, recruiting patients to participate in a study, or obtaining sufficient suppliesof clinical study materials. Many factors affect patient enrollment, including the size of the patient population, the proximity of patientsto clinical sites, the eligibility criteria for the study, competing clinical studies, and new drugs approved for the conditions we areinvestigating. Prescribing physicians will also have to decide to use our product candidates over existing drugs that have establishedsafety and efficacy profiles or other drugs undergoing development in clinical studies. Any delays in completing our clinical studieswill increase our costs, slow down our product development and approval process, and delay our ability to generate revenue.
Additionally, the resultsof preclinical studies and early clinical studies of our product candidates do not necessarily predict the results of later-stage clinicalstudies. Product candidates in later stages of clinical studies may fail to show the desired safety and efficacy traits despite havingprogressed through initial clinical testing. The data collected from clinical studies of our product candidates may not be sufficientto support the submission of an NDA or to obtain regulatory approval in the U.S. or elsewhere. Because of the uncertainties associatedwith drug development and regulatory approval, we cannot determine if or when we will have an approved product for commercialization orwill achieve sales or profits.
Furthermore, we typicallyrely on third-party clinical investigators to conduct our clinical trials and other third-party organizations to oversee the operationsof such trials and to perform data collection and analysis. The clinical investigators are not our employees, and we cannot control theamount or timing of resources that they devote to our programs. Failure of the third-party organizations to meet their obligations couldadversely affect clinical development of our products. As a result, we may face additional delaying factors outside our control if theseparties do not perform their obligations in a timely fashion. For example, any number of those issues could arise with our clinical trialscausing a delay. Delays of this sort could occur for the reasons identified above or other reasons. If we have delays in conducting theclinical trials or obtaining regulatory approvals, our product development costs will increase. For example, we may need to make additionalpayments to third-party investigators and organizations to retain their services or we may need to pay recruitment incentives. If thedelays are significant, our financial results and the commercial prospects for our product candidates will be harmed, and our abilityto become profitable will be delayed. Moreover, these third-party investigators and organizations may also have relationships with othercommercial entities, some of which may compete with us. If these third-party investigators and organizations assist our competitors atour expense, it could harm our competitive position.
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Our clinical studies may notdemonstrate sufficient levels of efficacy necessary to obtain the requisite regulatory approvals for our drugs, and our proposed drugsmay not be approved for marketing.
We may not be able to initiateor continue clinical studies or trials for our product candidates if we are unable to locate and enroll a sufficient number of eligiblepatients to participate in these clinical trials as required by the FDA or other regulatory authorities. Even if we are able to enrolla sufficient number of patients in our clinical trials, if the pace of enrollment is slower than we expect, the development costs forour product candidates may increase and the completion of our clinical trials may be delayed, or our clinical trials could become tooexpensive to complete. Significant delays in clinical testing could negatively impact our product development costs and timing. Our estimatesregarding timing are based on a number of assumptions, including assumptions based on past experience with our other clinical programs.If we are unable to enroll the patients in these trials at the projected rate, the completion of the clinical program could be delayedand the costs of conducting the program could increase, either of which could harm our business.
We may be required to suspend or discontinueclinical studies because of unexpected side effects or other safety risks that could preclude approval of our product candidates.
Our clinical studies may besuspended at any time for a number of reasons. For example, we may voluntarily suspend or terminate our clinical studies if at any timewe believe that they present an unacceptable risk to the clinical study patients. In addition, regulatory agencies may order the temporaryor permanent discontinuation of our clinical studies at any time if they believe that the clinical studies are not being conducted inaccordance with applicable regulatory requirements or that they present an unacceptable safety risk to the clinical study patients.
Administering any productcandidates to humans may produce undesirable side effects. These side effects could interrupt, delay or halt clinical studies of our productcandidates and could result in the FDA or other regulatory authorities denying further development or approval of our product candidatesfor any or all targeted indications. Ultimately, some or all of our product candidates may prove to be unsafe for human use. Moreover,we could be subject to significant liability if any volunteer or patient suffers, or appears to suffer, adverse health effects as a resultof participating in our clinical studies.
The biopharmaceutical industry is subject to extensive regulatoryobligations and policies that are subject to change, including due to judicial challenges.
On June 28, 2024, theU.S. Supreme Court issued an opinion holding that courts reviewing agency action pursuant to the Administrative Procedure Act (APA) “mustexercise their independent judgment” and “may not defer to an agency interpretation of the law simply because a statute isambiguous.” The decision will have a significant impact on how lower courts evaluate challenges to agency interpretations of law,including those by the FDA and other agencies with significant oversight of the biopharmaceutical industry. The new framework is likelyto increase both the frequency of such challenges and their odds of success by eliminating one way in which the government previouslyprevailed in such cases. As a result, significant regulatory policies will be subject to increased litigation judicial scrutiny. Any resultingchanges in regulation may result in unexpected delays, increased costs, or other negative impacts on our business that are difficult topredict.
Risks Related to Legal Compliance and Litigation
Controls we or our third-party collaboratorshave in place to ensure compliance with all applicable laws and regulations may not be effective.
We and our third-party collaboratorsare subject to federal, state and local laws and regulations governing the storage, use and disposal of hazardous materials and wasteproducts. Current or future regulations may impair our research, development, manufacturing and commercialization efforts. The inabilityof our third-party collaborators to maintain the required licenses and permits for any reason will negatively impact our manufacturing,and research and development activities. In addition, we may be required to indemnify third-party collaborators against certain liabilitiesarising out of any failure by them to comply with such regulations and/or laws. If we or our third-party collaborators fail to complywith any of these regulations and/or laws, a range of consequences could result, including the suspension or termination of clinical studies,failure to obtain approval of a product candidate, restrictions on our products or manufacturing processes, withdrawal of our productsfrom the market, significant fines, exclusion from government healthcare programs, or other sanctions or litigation.
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We are exposed to product, clinical andpreclinical liability risks that could create a substantial financial burden should we be sued.
Our business exposes us topotential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of pharmaceuticalproducts. In addition, the use in our clinical studies of pharmaceutical products that we, or our current or potential collaborators,may develop and then subsequently sell, may cause us to bear a portion of, or all, product liability risks. While we carry an insurancepolicy covering up to $5,000,000 per occurrence and $5,000,000 in the aggregate for liability incurred in connection with such claimsshould they arise, there can be no assurance that our insurance will be adequate to cover all situations. Moreover, there can be no assurancethat such insurance, or additional insurance if required, will be available or, if available, will be available on commercially reasonableterms. Furthermore, our current and potential partners with whom we have collaborative agreements, or our future licensees, may not bewilling to indemnify us against these types of liabilities and may not themselves be sufficiently insured or have a net worth sufficientto satisfy any product liability claims. A successful product liability claim or series of claims brought against us could have a materialadverse effect on our business, prospects, financial condition and results of operations.
Risks Related to Intellectual Property
We expect to rely on our patents as wellas specialized regulatory designations such as orphan drug classification for our product candidates, but regulatory drug designationsmay not confer marketing exclusivity or other expected commercial benefits.
We expect to file for ODDor other regulatory designations (fast track, break-through, priority review, etc.) as appropriate for our product candidates. Wehave been granted ODD in the U.S. for iopofosine as a therapeutic for the treatment of multiple myeloma, neuroblastoma, osteosarcoma,rhabdomyosarcoma, Ewing’s sarcoma and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia. Additionally, we have beengranted ODD in Europe for iopofosine as a therapeutic for the treatment of multiple myeloma and Waldenstrom’s macroglobulinemia.
Under the Orphan Drug Act,the FDA may grant orphan drug designation to a drug or biologic intended to treat a rare disease or condition, which is defined as oneoccurring in a patient population of fewer than 200,000 in the US, or a patient population greater than 200,000 in the US where thereis no reasonable expectation that the cost of developing the drug will be recovered from sales in the US. In the US, orphan drug designationentitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-feewaivers. In addition, if a product that has orphan drug designation subsequently receives the first FDA approval for the disease for whichit has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications,including a full NDA, to market the same drug for the same indication for seven years, except in limited circumstances, such as a showingof clinical superiority to the product with orphan drug exclusivity or where the manufacturer is unable to assure sufficient product quantity.
Even though we have receivedODD as described above, we may not be the first to obtain marketing approval for the orphan-designated indication because of the uncertaintiesassociated with developing pharmaceutical products. For any product candidate for which we have been or will be granted ODD in a particularindication, it is possible that another company also holding ODD for the same product candidate will receive marketing approval for thesame indication before we do. If that were to happen, our applications for that indication may not be approved until the competing company’speriod of exclusivity expires. In addition, exclusive marketing rights in the US for iopofosine for an orphan-designated indication orany future product candidate may be limited if we seek approval for an indication broader than the orphan-designated indication or maybe lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assuresufficient quantities of the product to meet the needs of patients with the rare disease or condition. We will not be able to rely onit to exclude other companies from manufacturing or selling products using the same principal molecular structural features for the sameindication beyond these timeframes without our patent portfolio. Even if we were the first to obtain marketing authorization for an orphandrug indication, there are circumstances under which a competing product may be approved for the same indication during the seven-yearperiod of marketing exclusivity, such as if the later product is shown to be clinically superior to the product with orphan exclusivity.Even after an orphan product is approved, the FDA can subsequently approve the same drug with the same active moiety for the same conditionif the FDA concludes that the later drug is safer, more effective, or makes a major contribution to patient care. In addition, exclusivemarketing rights in the US for iopofosine or any future product candidate may be limited if we seek approval for an indication broaderthan the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defectiveor if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease orcondition.
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Further, even if we obtainorphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugswith different active moieties can be approved for the same condition. Further, the seven-year marketing exclusivity, if granted, wouldnot prevent competitors from obtaining approval of the same product candidate as ours for indications other than those in which we havebeen granted ODD, or for other indications if not for our patent portfolio, or for the use of other types of products in the same indicationsas our orphan product. Furthermore, although the ODD and exclusivity are in effect right now, the FDA has the authority to modify thisassessment at any time. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives thedrug any advantage in the regulatory review or approval process.
In addition, Congress is consideringupdates to the orphan drug provisions of the FDCA in response to a recent decision by the U.S. Court of Appeals for the Eleventh Circuit.Any changes to the orphan drug provisions could change our opportunities for, or likelihood of success in obtaining, orphan drug exclusivityand would materially adversely affect our business, results of operations, financial condition and prospects.
We may face litigation from third partiesclaiming our products infringe on their intellectual property rights, particularly because there is often substantial uncertainty aboutthe validity and breadth of medical patents.
We may be exposed to futurelitigation by third parties based on claims that our technologies, products or activities infringe on the intellectual property rightsof others or that we have misappropriated the trade secrets of others. This risk is exacerbated by the fact that the validity and breadthof claims covered in medical technology patents, and the breadth and scope of trade-secret protection, involve complex legal and factualquestions for which important legal principles are unresolved. Any litigation or claims against us, whether valid or not, could resultin substantial costs, place a significant strain on our financial and managerial resources, and harm our reputation. License agreementsthat we may enter into in the future would likely require that we pay the costs associated with defending this type of litigation. Inaddition, intellectual property litigation or claims could force us to do one or more of the following:
| · | cease selling, incorporating or using any of our technologies and/or products that incorporate the challengedintellectual property, which would adversely affect our ability to generate revenue; | |
| · | obtain a license from the holder of the infringed intellectual property right, which license may be costlyor may not be available on reasonable terms, if at all; or | |
| · | redesign our products, which would be costly and time-consuming. |
If we are unable to adequately protect orenforce our rights to intellectual property or to secure rights to third-party patents, we may lose valuable rights, experience reducedmarket share, assuming any, or incur costly litigation to protect our intellectual property rights.
Our ability to obtain licensesto patents, maintain trade-secret protection, and operate without infringing the proprietary rights of others will be important to commercializingany products under development. Therefore, any disruption in access to the technology could substantially delay the development of ourtechnology.
The patent positions of biotechnologyand pharmaceutical companies, such as ours, for products that involve licensing agreements are frequently uncertain and involve complexlegal and factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patentis issued or in subsequent legal proceedings. Consequently, our patent applications and any issued and licensed patents may not provideprotection against competitive technologies or may be held invalid if challenged or circumvented. To the extent we license patents fromthird parties, the early termination of any such license agreement would result in the loss of our rights to use the covered patents,which could severely delay, inhibit or eliminate our ability to develop and commercialize compounds based on the licensed patents. Ourcompetitors may also independently develop products similar to ours or design around or otherwise circumvent patents issued or licensedto us. In addition, the laws of some foreign countries may not protect our proprietary rights to the same extent as U.S. law.
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We also rely on trade secrets,technical know-how and continuing technological innovation to develop and maintain our competitive position. Although we generally requireour employees, consultants, advisors, and collaborators to execute appropriate confidentiality and assignment-of-inventions agreements,our competitors may independently develop substantially equivalent proprietary information and techniques, reverse engineer our informationand techniques, or otherwise gain access to our proprietary technology. We may be unable to meaningfully protect our rights in trade secrets,technical know-how and other non-patented technology.
We may have to resort to litigationto protect our rights for certain intellectual property or to determine the scope, validity or enforceability of our intellectual propertyrights. Enforcing or defending our rights would be expensive, could cause diversion of our resources, and may not prove successful. Anyfailure to enforce or protect our rights could cause us to lose the ability to exclude others from using our technology to develop orsell competing products.
Risks Related to Our Employees
We rely on a small number of key personnelwho may terminate their employment with us at any time, and our success will depend on our ability to hire additional qualified personnel.
Our success depends to a significantdegree on the continued services of our executive officers, including our Chief Executive Officer, James V. Caruso. Our management andother employees may voluntarily terminate their employment with us at any time, and there can be no assurance that these individuals willcontinue to provide services to us. Our success will depend on our ability to attract and retain highly skilled personnel. We may be unableto recruit such personnel on a timely basis, if at all. The loss of services of key personnel, or the inability to attract and retainadditional qualified personnel, could result in delays in development or approval of our products, loss of sales and diversion of managementresources.
Confidentiality agreements with employeesand others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protectour intellectual property, which could limit our ability to compete.
We operate in the highly technicalfield of research and development of small-molecule drugs and rely, in part, on trade-secret protection in order to protect our proprietarytrade secrets and unpatented know-how. However, trade secrets are difficult to protect, and we cannot be certain that our competitorswill not develop the same or similar technologies on their own. We have taken steps, including entering into confidentiality agreementswith our employees, consultants, outside scientific collaborators, sponsored researchers and other advisors, to protect our trade secretsand unpatented know-how. These agreements generally require that the other party keep confidential and not disclose to third parties allconfidential information developed by the party or made known to the party by us during the course of the party’s relationship withus. Also, we typically obtain agreements from these parties that inventions conceived by them in the course of rendering services to uswill be our exclusive property. However, these agreements may not be honored and may not effectively assign intellectual property rightsto us. Enforcing a claim that a party has illegally obtained, and is using our trade secrets or know-how, is difficult, expensive, andtime-consuming, and the outcome is unpredictable. In addition, courts outside the U.S. may be less willing to protect trade secrets orknow-how. The failure to obtain or maintain trade-secret protection could adversely affect our competitive position.
We may be subject to claims that our employeeshave wrongfully used or disclosed alleged trade secrets of their current or former employers.
As is common in the biotechnologyand pharmaceutical industry, we engage individuals who were previously employed at other biotechnology or pharmaceutical companies, includingour competitors or potential competitors or who are employed by academic research institutions. Although no claims against us are currentlypending, we may be subject to claims that we, or these employees, have used or disclosed trade secrets or other proprietary informationof their current or former employers, either inadvertently or otherwise. Litigation may be necessary to defend against these claims. Evenif we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
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Risks Related to Commercialization of our Products
Acceptance of our products in the marketplaceis uncertain and failure to achieve market acceptance will prevent or delay our ability to generate revenues.
Our future financial performancewill depend, at least in part, on the introduction and customer acceptance of our proposed products. Even if approved for marketing bythe necessary regulatory authorities, our products may not achieve market acceptance. The degree of market acceptance will depend on severalfactors, including:
| · | receiving regulatory clearance of marketing claims for the uses that we are developing; | |
| · | the timing of market introduction of the product as well as competitive products; | |
| · | the clinical indications for which the product is approved; | |
| · | establishing and demonstrating the advantages, safety and efficacy of our technologies; | |
| · | relative convenience and ease of administration, and the convenience of prescribing, administrating andinitiating patients on the product and the length of time the patient is on the product; | |
| · | the willingness of the target patient population to try new therapies and of physicians to prescribe thesetherapies; | |
| · | the willingness of physicians to change their current treatment practices; | |
| · | the willingness of hospitals and hospital systems to include our product candidates as treatment options; | |
| · | demonstration of efficacy and safety in clinical trials; | |
| · | the prevalence and severity of any side effects; | |
| · | the ability to offer product candidates for sale at competitive prices; | |
| · | the price we charge for our product candidates; | |
| · | the strength of marketing and distribution support; | |
| · | the ability to distinguish safety and efficacy from existing, less expensive generic alternative therapies,if any; | |
| · | the potential and perceived value and advantages of the product over alternative treatments; | |
| · | the cost of treatment in relation to alternative treatments, including any similar generic treatments; | |
| · | pricing and reimbursement policies of government and third-party payors such as insurance companies, healthmaintenance organizations and other health plan administrators; | |
| · | attracting corporate partners, including pharmaceutical companies, to assist in commercializing our intendedproducts; and | |
| · | marketing our products. |
Physicians, patients, payors,or the medical community in general, may be unwilling to accept, use, or recommend any of our products. If we are unable to obtain regulatoryapproval or commercialize and market our proposed products as planned, we may not achieve any market acceptance or generate revenue. Ifwe are unable to sustain anticipated levels of sales growth from our products, if approved, we may need to reduce our operating expenses,access other sources of cash or otherwise modify our business plans, which could have a negative impact on our business, financial conditionand results of operations.
Regulatory approval for any approved productis limited by the FDA, the European Commission, and other regulators, to those specific indications and conditions for which clinicalsafety and efficacy have been demonstrated, and we may incur significant liability if it is determined that we are promoting the “off-label”use of any of our future product candidates if approved.
Any regulatory approval islimited to those specific diseases, indications and patient populations for which a product is deemed to be safe and effective by theFDA, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency and other regulators. In addition to theFDA approval required for new formulations, any new indication for an approved product also requires FDA approval. If we are not ableto obtain FDA approval for any desired future indications for our products and product candidates, our ability to effectively market andsell our products may be reduced and our business may be adversely affected.
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While physicians may chooseto prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinicalstudies and approved by the regulatory authorities, our ability to promote the products is limited to those indications and patient populationsthat are specifically approved by the FDA or similar regulatory authorities in jurisdictions outside the U.S. These “off-label”uses are common across medical specialties and may constitute an appropriate treatment for some patients in varied circumstances. We haveimplemented compliance and monitoring policies and procedures, including a process for internal review of promotional materials, to deterthe promotion for off-label uses. We cannot guarantee that these compliance activities will prevent or timely detect off-label promotionby sales representatives or other personnel in their communications with health care professionals, patients and others, particularlyif these activities are concealed from the Company. Regulatory authorities in the US generally do not regulate the behavior of physiciansin their choice of treatments. Regulatory authorities do, however, restrict communications by pharmaceutical companies on the subjectof off-label use. If our promotional activities fail to comply with the FDA’s or other competent national authority’s regulationsor guidelines, we may be subject to warnings from, or enforcement action by, these regulatory authorities. In addition, our failure tofollow FDA rules and guidelines relating to promotion and advertising may cause the FDA to issue warning letters or untitled letters,suspend or withdraw an approved product from the market, require a recall or institute fines, which could result in the disgorgement ofmoney, operating restrictions, injunctions or civil or criminal enforcement, and other consequences, any of which could harm our business.
Notwithstanding the regulatoryrestrictions on off-label promotion, the FDA and other regulatory authorities allow companies to engage in truthful, non-misleading andnon-promotional scientific exchange concerning their products. We engage in medical education activities and communicate with investigatorsand potential investigators regarding our clinical trials. If the FDA or other regulatory or enforcement authorities determine that ourcommunications regarding our marketed product are not in compliance with the relevant regulatory requirements and that we have improperlypromoted off-label uses, or that our communications regarding our investigational products are not in compliance with the relevant regulatoryrequirements and that we have improperly engaged in pre-approval promotion, we may be subject to significant liability, including civiland administrative remedies as well as criminal sanctions.
Any product for which we have obtained regulatoryapproval, or for which we obtain approval in the future, is subject to, or will be subject to, extensive ongoing regulatory requirementsby the FDA, EMA and other comparable regulatory authorities, and if we fail to comply with regulatory requirements or if we experienceunanticipated problems with our products, we may be subject to penalties, we may be unable to generate revenue from the sale of such products,our potential for generating positive cash flow may be diminished, and the capital necessary to fund our operations may be increased.
Any product for which we haveobtain regulatory approval in the future, along with the manufacturing processes and practices, post-approval clinical research, productlabeling, advertising and promotional activities for such product, are subject to continual requirements of, and review by, the FDA, theEMA and other comparable international regulatory authorities. These requirements include submissions of safety and other post-marketinginformation and reports, registration and listing requirements, current good manufacturing practices (cGMP) requirements relating to manufacturing,quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution ofsamples to physicians, import and export requirements and recordkeeping. If we or our suppliers encounter manufacturing, quality or compliancedifficulties with respect to any of our product candidates, when and if approved, we may be unable to obtain or maintain regulatory approvalor meet commercial demand for such products, which could adversely affect our business, financial conditions, results of operations andgrowth prospects.
In addition, the FDA oftenrequires post-marketing testing and surveillance to monitor the effects of products. The FDA, the EMA and other comparable internationalregulatory agencies may condition approval of our product candidates on the completion of such post-marketing clinical studies. Thesepost-marketing studies may suggest that a product causes undesirable side effects or may present a risk to the patient. Additionally,the FDA may require a REMS to help ensure that the benefits of the drug outweigh its risks. A REMS may be required to include variouselements, such as a medication guide or patient package insert, a communication plan to educate healthcare providers of the drug’srisks, limitations on who may prescribe or dispense the drug, requirements that patients enroll in a registry or undergo certain healthevaluations or other measures that the FDA deems necessary to ensure the safe use of the drug.
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Discovery after approval ofpreviously unknown problems with any of our products, manufacturers or manufacturing processes, or failure to comply with regulatory requirements,may result in actions such as:
| · | restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoingor planned trials; | |
| · | restrictions on product manufacturing processes; | |
| · | restrictions on the marketing of a product; | |
| · | restrictions on product distribution; | |
| · | requirements to conduct post-marketing clinical trials; | |
| · | untitled or warning letters or other adverse publicity; | |
| · | withdrawal of products from the market; | |
| · | refusal to approve pending applications or supplements to approved applications that we submit; | |
| · | recall of products; | |
| · | refusal to permit the import or export of our products; | |
| · | product seizure; | |
| · | fines, restitution or disgorgement of profits or revenue; | |
| · | refusal to allow us to enter into supply contracts, including government contracts; | |
| · | injunctions; or | |
| · | imposition of civil or criminal penalties. |
If such regulatory actionsare taken, the value of our company and our operating results will be adversely affected. Additionally, if the FDA, the EMA or any othercomparable international regulatory agency withdraws its approval of a product that is or may be approved, we will be unable to generaterevenue from the sale of that product in the relevant jurisdiction, our potential for generating positive cash flow will be diminishedand the capital necessary to fund our operations will be increased. Accordingly, we continue to expend significant time, money and effortin all areas of regulatory compliance, including manufacturing, production, product surveillance, post-marketing studies and quality control.
If any of our third-party contractors failto perform their responsibilities to comply with FDA rules and regulations, the marketing and sales of our products could be delayedand we may be subject to enforcement action, which could decrease our revenues.
Conducting our business requiresus to manage relationships with third-party contractors. As a result, our success depends partially on the success of these third partiesin performing their responsibilities to comply with FDA rules and regulations. Although we pre-qualify our contractors and we believethat they are fully capable of performing their contractual obligations, we cannot directly control the adequacy and timeliness of theresources and expertise that they apply to these activities.
If any of our partners orcontractors fail to fulfil their obligations in an adequate and timely manner or fail to comply with the FDA’s rules and regulations,then the marketing and sales of our products could be delayed. The FDA may also take enforcement actions against us based on complianceissues identified with our contractors. If any of these events occur, we may incur significant liabilities, which could decrease our revenues.For example, sales and medical science liaison or MSL personnel, including contractors, must comply with FDA requirements for the advertisementand promotion of products.
If manufacturers obtain approval for genericversions of our products, once approved, or of products with which we compete, our business may be harmed.
Under the FDCA, the FDA canapprove an abbreviated new drug application (ANDA) for a generic version of a branded drug without the ANDA applicant undertaking theclinical testing necessary to obtain approval to market a new drug. Generally, in place of such clinical studies, an ANDA applicant usuallyneeds only to submit data demonstrating that its product has the same active ingredient(s), strength, dosage form and route of administrationand that it is bioequivalent to the branded product.
The FDCA requires that anapplicant for approval of a generic form of a branded drug certify either that its generic product does not infringe any of the patentslisted by the owner of the branded drug in the Orange Book or that those patents are not enforceable. This process is known as a paragraphIV challenge. Upon notice of a paragraph IV challenge, a patent owner has 45 days to bring a patent infringement suit in federal districtcourt against the company seeking ANDA approval of a product covered by one of the owner’s patents. If this type of suit is commenced,the FDCA provides a 30-month stay on the FDA’s approval of the competitor’s application. If the litigation is resolved infavor of the ANDA applicant or the challenged patent expires during the 30-month stay period, the stay is lifted, and the FDA may thereafterapprove the application based on the standards for approval of ANDAs. Once an ANDA is approved by the FDA, the generic manufacturer maymarket and sell the generic form of the branded drug in competition with the branded medicine.
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The ANDA process can resultin generic competition if the patents at issue are not upheld or if the generic competitor is found not to infringe the owner’spatents. If this were to occur with respect to iopofosine or any future products, once approved, with which our products compete, ourbusiness would be harmed.
Unforeseen safety issues could emerge withour products, once approved, that could require us to change the prescribing information to add warnings, limit use of the product, and/orresult in litigation. Any of these events could have a negative impact on our business.
Discovery of unforeseen safetyproblems or increased focus on a known problem with respect to our products, once approved, could impact our ability to commercializeour products and could result in restrictions on its permissible uses, including withdrawal of the medicine from the market.
If we or others identify additionalundesirable side effects caused by our products after approval:
| · | regulatory authorities may require the addition of labeling statements, specific warnings, contraindications,or field alerts to physicians and pharmacies; | |
| · | regulatory authorities may withdraw their approval of the product and require us to take our approveddrugs off the market; | |
| · | we may be required to change the way the product is administered, conduct additional clinical trials,change the labeling of the product, or implement a Risk Evaluation and Mitigation Strategy, or REMS; | |
| · | we may have limitations on how we promote our drugs; | |
| · | third-party payers may limit coverage or reimbursement for our products; | |
| · | sales of our approved products may decrease significantly; | |
| · | we may be subject to litigation or product liability claims; and | |
| · | our reputation may suffer. |
Any of these events couldprevent us from achieving or maintaining market acceptance of our products, once approved and could substantially increase our operatingcosts and expenses, which in turn could delay or prevent us from generating significant revenue from sale of any products for which weobtain approval.
If a safety issue emergespost-approval, we may become subject to costly product liability litigation by our customers, their patients or payers. Product liabilityclaims could divert management’s attention from our core business, be expensive to defend, and result in sizable damage awards againstus that may not be covered by insurance. If we cannot successfully defend ourselves against claims that our approved products caused injuries,we will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:
| · | decreased demand for any product candidates or products that we may develop; | |
| · | the inability to commercialize any products that we may develop; | |
| · | injury to our reputation and significant negative media attention; | |
| · | withdrawal of patients from clinical studies or cancellation of studies; | |
| · | significant costs to defend the related litigation; | |
| · | substantial monetary awards to patients; and | |
| · | loss of revenue. |
The market for our proposed products israpidly changing and competitive, and new therapeutics, drugs and treatments that may be developed by others could impair our abilityto develop our business or become competitive.
The pharmaceutical and biotechnologyindustries are subject to rapid and substantial technological change. Developments by others may render our technologies and proposedproducts noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors. Technologicalcompetition from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the fieldis intense and expected to increase. Most of these entities have significantly greater research and development capabilities and budgetsthan we do, as well as substantially more marketing, manufacturing, financial and managerial resources. These entities represent significantcompetition for us. Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies by large corporations couldincrease our competitors’ financial, marketing, manufacturing and other resources.
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Our resources are limited,and we may experience management, operational or technical challenges inherent in our activities and novel technologies. Competitors havedeveloped, or are in the process of developing, technologies that are, or in the future may be, the basis for competition. Some of thesetechnologies may accomplish therapeutic effects similar to those of our technology, but through different means. Our competitors may developdrugs and drug delivery technologies that are more effective than our intended products and, therefore, present a serious competitivethreat to us.
The potential widespread acceptanceof therapies that are alternatives to ours may limit market acceptance of our products even if they are commercialized. Many of our targeteddiseases and conditions can also be treated by other medication or drug delivery technologies. These treatments may be widely acceptedin medical communities and have a longer history of use. The established use of these competitive drugs may limit the potential for widespreadacceptance of our technologies and products if commercialized.
As a result of continued changes in marketing,sales and distribution, we may be unsuccessful in our efforts to sell our proposed products, develop a direct sales organization, or enterinto relationships with third parties.
We have not established marketing,sales or distribution capabilities for our proposed products. Until such time as our proposed products are further along in the developmentprocess, we will not devote any meaningful time and resources to this effort. At the appropriate time, we will determine whether we willdevelop our own sales and marketing capabilities or enter into agreements with third parties to sell our products.
We have limited experiencein developing, training or managing a sales force. If we choose to establish a direct sales force, we may incur substantial additionalexpenses in developing, training and managing such an organization. We may be unable to build a sales force on a cost-effective basisor at all. In addition, we will compete with many other companies that currently have extensive marketing and sales operations. Our marketingand sales efforts may be unable to compete against these other companies. We may be unable to establish a sufficient sales and marketingorganization on a cost-effective or timely basis, if at all.
If we choose to enter intoagreements with third parties to sell our proposed products, we may be unable to establish or maintain third-party relationships on acommercially reasonable basis, if at all. In addition, these third parties may have similar or more established relationships with ourcompetitors.
We may be unable to engagequalified distributors. Even if engaged, these distributors may:
| · | fail to adequately market our products; | |
| · | fail to satisfy financial or contractual obligations to us; | |
| · | offer, design, manufacture or promote competing products; or | |
| · | cease operations with little or no notice. |
If we fail to develop sales,marketing and distribution channels, we would experience delays in product sales and incur increased costs, which would have a materialadverse effect on our business, prospects, financial condition and results of operation.
If we are unable to convince physiciansof the benefits of our intended products, we may incur delays or additional expense in our attempt to establish market acceptance.
Achieving use of our productsin the target market of cancer diagnosis and treatment may require physicians to be informed regarding these products and their intendedbenefits. The time and cost of such an educational process may be substantial. Inability to successfully carry out this physician educationprocess may adversely affect market acceptance of our proposed products. We may be unable to educate physicians, in sufficient numbers,in a timely manner regarding our intended proposed products to achieve our marketing plans and product acceptance. Any delay in physicianeducation may materially delay or reduce demand for our proposed products. In addition, we may expend significant funds towards physicianeducation before any acceptance or demand for our proposed products is created, if at all.
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Efforts to educate the physicians,patients, healthcare payors and others in the medical community on the benefits of our product candidates may require significant resourcesand may not be successful. If any of our product candidates are approved, if at all, but do not achieve an adequate level of acceptance,we may not generate significant product revenue and we may not become profitable on a sustained basis.
If our products are unable to obtain adequatereimbursement from third-party payors, or if additional healthcare reform measures are adopted, it could hinder or prevent the commercialsuccess of our product candidates.
The commercial success ofany product for which we obtain regulatory approval in the future will depend substantially on the extent to which the costs of our productor product candidates are or will be paid by third-party payors, including government health care programs and private health insurers.There is a significant trend in the health care industry by public and private payers to contain or reduce their costs, including by takingthe following steps, among others: decreasing the portion of costs payers will cover, ceasing to provide full payment for certain productsdepending on outcomes or not covering certain products at all. If payers implement any of the foregoing with respect to our products,it would have an adverse impact on our revenue and results of operations. If coverage is not available, or reimbursement is limited, we,or any of our collaborative partners, may not be able to successfully commercialize our product candidates in some jurisdictions. Evenif coverage is provided, the approved reimbursement amount may not be at a rate that covers our costs, including research, development,manufacture, sale and distribution. In the U.S., no uniform policy of coverage and reimbursement for products exists among third-partypayors; therefore, coverage and reimbursement levels for products can differ significantly from payor to payor. As a result, the coveragedetermination process is often a time consuming and costly process that may require us to provide scientific, clinical or other supportfor the use of our products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistentlyor obtained in the first instance.
In both the U.S. and someforeign jurisdictions, there have been a number of legislative and regulatory proposals to change the healthcare system in ways that couldaffect our ability to sell our products profitably. For example, the Affordable Care Act which was passed in March 2010 and substantiallychanged the way healthcare is financed by both governmental and private insurers, has been subject to judicial, legislative, and regulatoryefforts to replace it or to alter its interpretation or implementation. Congress has considered legislation that would repeal or repealand replace all or part of the Affordable Care Act. While Congress has not passed comprehensive repeal legislation, several bills affectingthe implementation of certain taxes under the Affordable Care Act have been enacted. The Tax Cuts and Jobs Act of 2017 included a provisionthat repealed the tax-based shared responsibility payment imposed by the Affordable Care Act on certain individuals who fail to maintainqualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. In addition,the Consolidated Appropriations Act of 2020 fully repealed the Affordable Care Act’s mandated “Cadillac” tax on high-costemployer-sponsored health coverage and medical device tax and also eliminated the health insurer tax. On June 17, 2021, the U.S.Supreme Court dismissed the most recent judicial challenge to the Affordable Care Act brought by several states without specifically rulingon the constitutionality of the law. It is unclear how future actions before the Supreme Court, other such litigation, and any healthcarereform measures of the Trump administration will impact the Affordable Care Act.
Other legislative changeshave been proposed and adopted in the U.S. since the Affordable Care Act was enacted. In August 2011, the Budget Control Act of 2011,among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommendinga targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggeringthe legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments toproviders of 2% per fiscal year, which went into effect in April 2013, and, a result of subsequent legislative amendments, will remainin effect into 2031, unless additional Congressional action is taken. However, COVID-19 relief support legislation suspended the 2% Medicaresequester from May 1, 2020 through March 31, 2022 with a subsequent reduction to 1% implemented from April 1, 2022 untilJune 30, 2022. To offset the temporary suspension during the COVID-19 pandemic, in 2030, reductions in Medicare payments will be2.25% for the first half of the year, and 3% in the second half of the year. In January 2013, President Obama signed into law theAmerican Taxpayer Relief Act of 2012 (ATRA), which, among other things, further reduced Medicare payments to several providers, includinghospitals and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments toproviders from three to five years.
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There have been, and likelywill continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availabilityof healthcare and containing or lowering the cost of healthcare. We cannot predict the initiatives that may be adopted in the future.If we or any third parties we may engage are slow or unable to adapt to changes in existing requirements or the adoption of new requirementsor policies, or if we or such third parties are not able to maintain regulatory compliance, our product candidates may lose any regulatoryapproval that may have been obtained and we may not achieve or sustain profitability.
Enacted and future legislation may increasethe difficulty and cost for us to commercialize our product candidates and may affect the prices we may set.
In the U.S., there have beenseveral recent Congressional inquiries and federal legislation designed to, among other things, bring more transparency to drug pricing,review the relationship between pricing and manufacturer-sponsored patient assistance programs, and reform government program reimbursementmethodologies for drugs. See Part I, Item 1, Business-Regulation-Reimbursement and Pricing Controls in our Annual Report onForm 10-K for the year ended December 31, 2024 for more information on recent healthcare reform measures that may affect ourability to operate.
We cannot predict the likelihood,nature, or extent of health reform initiatives that may arise from future legislation or administrative action. However, we expect theseinitiatives to increase pressure on drug pricing. Further, certain broader legislation that is not targeted to the health care industrymay nonetheless adversely affect our profitability. Any additional healthcare reform measures could limit the amounts that the U.S. federalgovernment will pay for healthcare products and services, which could result in reduced demand for our product candidates or additionalpricing pressures.
We may be subject, directly or indirectly,to federal and state healthcare fraud and abuse laws, false claims laws and other federal and state healthcare laws, and the failure tocomply with such laws could result in substantial penalties. Our employees, independent contractors, consultants, principal investigators,CROs, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standardsand requirements.
Our business operations andcurrent and future arrangements with investigators, healthcare professionals, consultants, third-party payers and customers, may exposeus to broadly applicable federal, state and foreign fraud and abuse and other healthcare laws and regulations including anti-kickbackand false claims laws, data privacy and security laws, and transparency reporting laws. These laws may constrain the business or financialarrangements and relationships through which we conduct our operations, including how we research, market, sell and distribute any productfor which we have obtained regulatory approval, or for which we obtain regulatory approval in the future. In particular, the promotion,sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subjectto extensive laws and regulations intended to prevent fraud, misconduct, bribery kickbacks, self-dealing and other abusive or inappropriatepractices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, includingpromoting off-label uses of our products, commission compensation, certain customer incentive programs, certain patient support offerings,and other business arrangements generally. Activities subject to these laws also involve the improper use or misrepresentation of informationobtained in the course of patient recruitment for clinical trials, creating fraudulent data in our preclinical studies or clinical trialsor illegal misappropriation of drug product, which could result in regulatory sanctions and cause serious harm to our reputation. See “Part I, Item 1, Business - Regulation - Other U.S. Regulatory Requirements” of our Annual Report on Form 10-Kfor more information on the healthcare laws and regulations that may affect our ability to operate.
We are also exposed to therisk of fraud, misconduct or other illegal activity by our employees, independent contractors, consultants, principal investigators, CROs,commercial partners and vendors. Misconduct by these parties could include intentional, reckless and/or negligent conduct that fails to:comply with the laws of the FDA and other similar foreign regulatory bodies; provide true, complete and accurate information to the FDAand other similar foreign regulatory bodies; comply with manufacturing standards we have established; comply with federal and state dataprivacy, security, fraud and abuse and other healthcare laws and regulations in the US and similar foreign fraudulent misconduct laws;or report financial information or data accurately or to disclose unauthorized activities to us. It is not always possible to identifyand deter employee misconduct, and the precautions we take to detect and prevent inappropriate conduct may not be effective in controllingunknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from afailure to be in compliance with such laws or regulations.
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We are also subject to therisk that a person or government could allege such fraud or other misconduct, even if none occurred. Efforts to ensure that our businessarrangements will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmentaland enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or caselaw interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, andwe are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, includingthe imposition of significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, imprisonment, additionalreporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegationsof non-compliance with these laws, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs,contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, anyof which could adversely affect our ability to operate our business and our results of operations.
Risks Related to Internal Controls
We identified certain misstatements to ourpreviously issued financial statements and have restated the financial statements described below, which has exposed us to additionalrisks and uncertainties.
We have restated our previouslyissued audited financial statements as of and for the years ended December 31, 2022 and 2023 and our interim financial statementsas of and for the quarterly periods ended March 31, 2024, March 31, 2023 through September 30, 2023 and March 31,2022 through September 30, 2022.
As a result of the misstatementsdiscussed and the Restatement, we have become subject to a number of additional risks and uncertainties and unanticipated costs for accounting,legal and other fees and expenses, including risks of lawsuits relating to securities offered by us in public and private offerings aswell as claims by purchasers of our shares of common stock in the public market. Any actions, lawsuit or other legal proceedings relatedto the misstatements or the Restatement could result in liabilities, reputational harm and defense and other costs, regardless of theoutcome of the lawsuit or proceeding.
We cannot ensure that litigationor other claims by stockholders will not be brought in the future arising out of the Restatement. We may also be subject to further examinations,investigations, proceedings and orders by regulatory authorities as a result of the Restatement. Any such further actions could be expensiveand damaging to our business, results of operations and financial condition.
We identified material weaknesses in ourinternal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional materialweaknesses in the future or otherwise fail to maintain effective internal control over financial reporting, we may not be able to accuratelyor timely report our financial condition or results of operations, which may adversely affect our business and share price.
We are required to establishand maintain appropriate internal controls over financial reporting. Rules adopted by the SEC pursuant to Section 404 of theSarbanes-Oxley Act of 2002 require an annual assessment of internal controls over financial reporting and for certain issuers an attestationof this assessment by the issuer’s independent registered public accounting firm. The standards to assess that our internal controlsover financial reporting are effective are evolving and complex, require significant documentation and testing, and may require remediationif they are not met. We expect to incur significant expenses and to devote resources to Section 404 compliance on an ongoing basis.It is difficult for us to predict how long it will take or costly it will be to complete the assessment of the effectiveness of our internalcontrol over financial reporting for each year and to remediate any deficiencies in our internal control over financial reporting. Asa result, we may not be able to complete the assessment and remediation process on a timely basis. In addition, although attestation requirementsby our independent registered public accounting firm are not presently applicable to us, we could become subject to these requirementsin the future, and we may encounter problems or delays in completing the implementation of any resulting changes to internal controlsover financial reporting.
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Effective internal controlsare necessary for us to provide reasonable assurance with respect to our financial reports and to effectively prevent fraud. Failure tomaintain effective internal controls could adversely affect our public disclosures regarding our business, prospects, financial condition,or results of operations. In addition, management’s assessment of internal controls over financial reporting may identify weaknessesand conditions that need to be addressed in our internal controls over financial reporting or other matters that may raise concerns forinvestors. Any actual or perceived weaknesses and conditions that need to be addressed in our internal control over financial reportingor disclosure of management’s assessment of our internal controls over financial reporting our business and results of operationscould be harmed, we could fail to meet our reporting obligations, and there could be a material adverse effect on our common stock price.There are identified material weaknesses that are described further in Item 9A. of our Annual Report on Form 10-K for the year endedDecember 31, 2024. These material weaknesses resulted in our historical financial statements requiring restatement, as is noted above,and delayed our required filings with the SEC, a situation that could recur in the event that we do not effectively remediate the existingmaterial weaknesses and/or experience additional material weaknesses.
Risks Related to Our Equity Securities
Our common stock could be further dilutedas the result of the issuance of additional shares of common stock, convertible securities, warrants or options.
In the past, we have issuedcommon stock, convertible securities (such as convertible preferred stock and notes payable) and warrants to raise capital. We have alsoissued equity as compensation for services and incentive compensation for our employees and directors. We have shares of common stockreserved for issuance upon the exercise of certain of these securities and may increase the shares reserved for these purposes in thefuture. Our issuance of additional common stock, convertible securities, options and warrants could dilute our common stock, affect therights of our stockholders, reduce the market price of our common stock, result in adjustments to exercise prices of outstanding warrants(resulting in these securities becoming exercisable for, as the case may be, a greater number of shares of our common stock), or obligateus to issue additional shares of common stock to certain of our stockholders.
Provisions of our certificate of incorporation,by-laws, and Delaware law may make an acquisition of us or a change in our management more difficult.
Certain provisions of ourcertificate of incorporation and by-laws could discourage, delay or prevent a merger, acquisition or other change in control that stockholdersmay consider favorable, including transactions in which an investor might otherwise receive a premium for its shares. These provisionsalso could limit the price that investors might be willing to pay in the future for shares of our common stock or warrants, thereby depressingthe market price of our common stock. Stockholders who wish to participate in these transactions may not have the opportunity to do so.
Furthermore, these provisionscould prevent or frustrate attempts by our stockholders to replace or remove our management. These provisions:
| · | provide for the division of the Board into three classes as nearly equal in size as possible with staggeredthree-year terms and further limit the removal of directors and the filling of vacancies; | |
| · | authorize our Board to issue without stockholder approval blank-check preferred stock that, if issued,could operate as a “poison pill” to dilute the stock ownership of a potential hostile acquirer to prevent an acquisition thatis not approved by our Board; | |
| · | require that stockholder actions must be effected at a duly called stockholder meeting and prohibit stockholderaction by written consent; | |
| · | establish advance notice requirements for stockholder nominations to our Board or for stockholder proposalsthat can be acted on at stockholder meetings; | |
| · | limit who may call stockholder meetings; and | |
| · | require the approval of the holders of 75% of the outstanding shares of our capital stock entitled tovote in order to amend certain provisions of our certificate of incorporation. |
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In addition, because we areincorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which may, unlesscertain criteria are met, prohibit large stockholders, in particular those owning 15% or more of our outstanding voting stock, from mergingor combining with us for a prescribed period of time.
General Risk Factors
Conflicts, military actions, terrorist attacks, natural disasters.public health crises, including the occurrence of a contagious disease or illness, cyber-attacks and general instability could adverselyaffect our business.
Conflicts, military actions,terrorist attacks, natural disasters, public health crises and cyber-attacks have precipitated economic instability and turmoil in financialmarkets. Instability and turmoil may result in raw material cost increases. In addition, the long-term effects of climate change on generaleconomic conditions and the pharmaceutical manufacturing and distribution industry in particular are unclear, and changes in the supply,demand or available sources of energy and the regulatory and other costs associated with energy production and delivery may affect theavailability or cost of goods and services, including raw materials and other natural resources, necessary to run our businesses. Theuncertainty and economic disruption resulting from hostilities, military action, acts of terrorism, natural disasters, public health crisesor cyber-attacks may impact our operations or those of our suppliers. Accordingly, any conflict, military action, terrorist attack, naturaldisasters, public health crises or cyber-attack that impacts us or any of our suppliers, could have a material adverse effect on our business,liquidity, prospects, financial condition and results of operations.
War, terrorism, other acts of violence, or natural or manmadedisasters may affect the markets in which we operate, our patients and resources required in our research and development activities.
Our business may be adverselyaffected by political instability, disruption or destruction in a geographic region in which we operate, regardless of cause, includingwar, terrorism, riot, civil insurrection or social unrest, and natural or manmade disasters, including famine, flood, fire, earthquake,storm or pandemic events and spread of disease and the significant military action against Ukraine by Russia. Such events may affect ourbusiness by increasing prices for resources required in our research and development activities or limiting our access to patients forour clinical trials which may delay our progress on one or more of our clinical or preclinical drug product candidates.
Our business and operations may be materially adversely affectedin the event of computer system failures or security breaches.
Despite the implementationof security measures, our internal computer systems, and those of our third-party manufacturers, contract research organizations and otherthird parties on which we rely, are vulnerable to damage from computer viruses, unauthorized access, cyber-attacks, phishing attempts,natural disasters, fire, terrorism, war and telecommunication and electrical failures. If such an event were to occur and interrupt ouroperations, it could result in a material disruption in our business. For example, the loss of clinical study data from ongoing or plannedclinical studies could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproducethe data. To the extent that any disruption or security breach results in a loss of or damage to our data or applications, loss of tradesecrets, inappropriate disclosure of confidential or proprietary information, including protected health information or personal dataof employees or former employees, lack of access to our clinical data, or disruption of the manufacturing process, we could incur liabilityand the further development of our drug candidates could be delayed. We may also be vulnerable to cyber-attacks or other malfeasance byhackers. This type of breach of our cybersecurity may compromise our confidential and financial information, adversely affect our business,or result in legal proceedings. Further, these cybersecurity breaches may inflict reputational harm upon us that may result in decreasedmarket value and erode public trust.
Failure to meet investor and stakeholder expectations regardingenvironmental, social and corporate governance, or “ESG” matters may damage our reputation.
There is an increasing focusfrom certain investors, employees and other stakeholders concerning ESG matters. Additionally, public interest and legislative pressurerelated to public companies’ ESG practices continue to grow. If our ESG practices fail to meet investor, employee or other stakeholders’evolving expectations and standards for responsible corporate citizenship in areas including environmental stewardship, Board of Directorsand employee diversity, human capital management, corporate governance and transparency, our reputation, brand, appeal to investors andemployee retention may be negatively impacted, which could have a material adverse effect on our business or financial condition.
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This prospectus, togetherwith any accompanying prospectus supplement, includes and incorporates by reference forward-looking statements within the meaning of Section 21Eof the Securities Exchange Act of 1934, as amended, which we refer to as the Exchange Act. Examples of our forward-looking statementsinclude:
| · | our current views with respect to our business strategy, business plan and research and development activities; |
| · | the progress of our product development programs, including clinical testing and the timing of commencementand results thereof; |
| · | our projected operating results, including research and development expenses; |
| · | our ability to identify a strategic partner with the resources to develop iopofosine I 131 (also knownas iopofosine or CLR 131) or otherwise continue the development or pursue other strategic options in connection with iopofosine; |
| · | our ability to obtain additional funding via the sale of equity and/or debt securities, a strategic transactionor otherwise; |
| · | our ability to initiate a Phase 1b dose finding study for CLR 121125 and obtain the necessary additionalfunding for such study; |
| · | our ability to initiate a Phase 1 imaging and dose escalation safety study for CLR 121225 and obtain thenecessary additional funding for such study; |
| · | our ability to continue development plans for our clinical and preclinical assets; |
| · | our ability to continue development plans for our Phospholipid Drug Conjugates (PDC)™; |
| · | our ability to advance our technologies into product candidates; |
| · | our ability to maintain orphan drug designation in the U.S. for iopofosine as a therapeutic for the treatmentof multiple myeloma, neuroblastoma, osteosarcoma, rhabdomyosarcoma, Ewing’s sarcoma and lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia,and the expected benefits of orphan drug status; |
| · | any disruptions to our suppliers; |
| · | our current view regarding general economic and market conditions, including our competitive strengths; |
| · | uncertainty and economic instability resulting from conflicts, military actions, terrorist attacks, naturaldisasters, public health crises, including the occurrence of a contagious disease or illness, cyber-attacks and general instability; |
| · | the future impacts of legislative and regulatory developments in the United States on the pricing andreimbursement of our product candidates; |
| · | our ability to meet the continued listing standards of Nasdaq; |
| · | assumptions underlying any of the foregoing; and |
| · | any other statements that address events or developments that we intend or believe will or may occur inthe future. |
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In some cases, you can identifyforward-looking statements by terminology, such as “expects,” “anticipates,” “intends,” “estimates,” “plans,” “believes,” “seeks,” “may,” “should,” “could,” “would”or the negative of such terms or other similar expressions. Accordingly, these statements involve estimates, assumptions and uncertaintiesthat could cause actual results to differ materially from those expressed in them. Forward-looking statements also involve risks and uncertainties,many of which are beyond our control. Any forward-looking statements are qualified in their entirety by reference to the factors discussedthroughout this prospectus.
You should read this prospectusand the documents that we reference herein and therein and have filed as exhibits to the registration statement, of which this prospectusis part, completely and with the understanding that our actual future results may be materially different from what we expect. You shouldassume that the information appearing in this prospectus is accurate only as of the date on the front cover of this prospectus or suchprospectus. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressedin any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements.Further, any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update any forward-lookingstatement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipatedevents. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannotassess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual resultsto differ materially from those contained in any forward-looking statements. We qualify all of the information presented in this prospectusand any accompanying prospectus supplement, and particularly our forward-looking statements, by these cautionary statements.
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We estimate that we willreceive net proceeds of approximately $5.0 million from the sale of the securities offered by us in this offering, based on theassumed public offering price of $7.94 per Class A Unit (the last reported sale price of our common stock on the Nasdaq CapitalMarket on June 25 , 2025), assuming no sales of Class B Units, which, if sold, would reduce the number of Class AUnits that we are offering on a one-for-one basis, and after deducting the underwriting commission and estimated offering expenses payableby us. If a holder of Common Warrants elects to exercise the Common Warrants issued in this offering in cash, we may receive additionalproceeds from the exercise of the Common Warrants. We cannot predict when or if the Common Warrants will be exercised. It is possiblethat the Common Warrants may expire and may never be exercised.
A $1.00 increase (decrease)in the assumed public offering price of $7.94 per Class A Unit would increase (decrease) the net proceeds to us from this offeringby approximately $0.75 million, assuming that the number of Class A Units offered by us, as set forth on the cover page ofthis prospectus, remains the same and after deducting the underwriting commission and estimated offering expenses payable by us and excludingthe proceeds, if any, from the cash exercise of the Common Warrants issued pursuant to this offering.
Similarly, a one hundredthousand share increase (decrease) in the number of Class A Units offered by us, as set forth on the cover page of this prospectus,would increase (decrease) the net proceeds to us by approximately $0.79 million, assuming the assumed public offering price of $7.94per Class A Unit remains the same, and after deducting underwriting commission and estimated offering expenses payable by us andexcluding the proceeds, if any, from the cash exercise of the Common Warrants issued pursuant to this offering.
We intend to use the net proceedsfrom this offering for general corporate purposes, including working capital and operating expenses, and to initiate a Phase 1b clinicalstudy of our compound CLR 121125 (CLR 125) in triple-negative breast cancer. Our expected use of net proceeds from this offering representsour current intentions based upon our present plans and business condition. As of the date of this prospectus, we cannot currently allocatespecific percentages of the net proceeds that we may use for the purposes specified above, and we cannot predict with certainty all ofthe particular uses for the net proceeds to be received upon the completion of this offering, or the amounts that we will actually spendon the uses set forth above. The amounts and timing of our actual use of the net proceeds will vary depending on numerous factors, includingour ability to obtain additional financing, the progress, cost and results of our preclinical and clinical development programs, and whetherwe are able to enter into future licensing or collaboration arrangements. We may find it necessary or advisable to use the net proceedsfor other purposes, and our management will have broad discretion in the application of the net proceeds, and investors will be relyingon our judgment regarding the application of the net proceeds from this offering.
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We have never declared norpaid cash dividends on our common stock. We currently intend to retain all of our future earnings, if any, to finance the growth and developmentof our business. We do not intend to pay cash dividends in respect of our common stock in the foreseeable future.
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The following table sets forth cash and capitalizationas of March 31, 2025:
| · | on an actual basis; |
| · | on pro forma as adjusted basis after adjusting for the Reverse Stock Split and the Warrant Inducement; | |
| · | on a pro forma as further adjusted basis to give effect to the assumed issuance and sale of shares of Class A Units in this offering at the assumed public offering price of $7.94 per Class A Unit (but excluding shares of common stock to be issued and any proceeds received upon cash exercise of the Common Warrants) (the last reported sale price of our common stock on the Nasdaq Capital Market on June 25, 2025), assuming (i) no sales of Class B Units, which, if sold, would reduce the number of Class A Units that we are offering on a one-for-one basis, after deducting underwriting commission and estimated offering expenses payable by us and (ii) no exercise of the representative warrants. |
The pro forma information set forth in the tablebelow is illustrative only and will be adjusted based on the actual public offering price and other terms of this offering determinedat pricing.
| (unaudited) | Actual as of March 31, 2025 | Pro Forma as Adjusted as of March 31, 2025 | Pro Forma as Further Adjusted as of March 31, 2025 | |||||||||
| Cash and cash equivalents | $ | 13,905,173 | $ | 16,155,173 | $ | 21,155,173 | ||||||
| Stockholders’ equity: | ||||||||||||
| Series E-2 preferred stock | $ | 520,778 | $ | 520,778 | $ | 520,778 | ||||||
| Common stock, $0.00001 par value; 170,000,000 shares authorized; 46,079,875 shares issued and outstanding actual, 1,812,039 shares issued and outstanding pro forma, 2,567,706 shares issued and outstanding pro forma as adjusted | $ | 461 | 18 | $ | 25 | |||||||
| Additional paid-in capital | $ | 261,678,642 | $ | 263,929,088 | $ | 268,929,082 | ||||||
| Accumulated deficit | $ | (253,946,492 | ) | (253,946,492 | ) | $ | (253,946,492 | ) | ||||
| Total stockholders’ equity | $ | 8,253,389 | $ | 10,503,392 | $ | 15,503,393 | ||||||
| Total capitalization | $ | 22,158,562 | $ | 26,658,565 | $ | 36,658,566 | ||||||
Unless otherwise indicated,the number of shares of common stock to be outstanding immediately after this offering is based on 1,535,996 shares of common stock outstandingas of March 31, 2025, which is adjusted to 1,812,039 to give effect to 276,043 shares that were issued pursuant to the Warrant Inducement,and which excludes:
| · | any shares of common stock issuable upon the exercise of the Underwriters’ over-allotment option; | |
| · | any shares of common stock issuable upon the exercise of Pre-Funded Warrants issued in this offering; | |
| · | any shares of common stock issuable upon the exercise of Common Warrants issued in this offering; | |
| · | any shares of common stock issuable upon the exercise of the representative warrants issued as compensation to the representative of the underwriters in this offering; | |
| · | an aggregate of 211,816 shares of common stock issuable upon the exercise of outstanding stock options issued to employees, directors and consultants; | |
| · | an aggregate of 13,040 shares of common stock issuable upon the conversion of outstanding shares of Series E-2 preferred stock; | |
| · | an aggregate of 3,704 shares of common stock issuable upon the conversion of outstanding shares of Series D preferred stock; and | |
| · | an aggregate of 522,011 additional shares of common stock reserved for issuance under outstanding warrants having expiration dates between June 2025 and July 2029, and exercise prices ranging from $58.80 to $362.250 per share. |
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If you invest in our commonstock in this offering, your interest will be diluted to the extent of the difference between the public offering price per Class AUnit and the net tangible book value per share of our common stock upon consummation of this offering. Dilution results from the factthat the public offering price is substantially in excess of the book value per share attributable to the existing stockholders for thepresently outstanding stock.
Thehistorical net tangible book value of our common stock, as adjusted for the Reverse Stock Split, as of March 31, 2025 was approximately$7.7 million, or approximately $5.03 per share of common stock. Historical net tangible book value (deficit) per share is determinedby dividing the number of outstanding shares of common stock into its total tangible assets (total assets less intangible assets) lesstotal liabilities and preferred shares, if any.
Subsequentto March 31, 2025, among other things, we entered into the Warrant Inducement where we issued an aggregate of 8,281,322 shares of commonstock (on a pre-Reverse Stock Split basis).
Ona pro forma as adjusted basis after giving effect to the Warrant Inducement and the Reverse Stock Split, our pro forma net tangible bookvalue would have been $10.0 million, or approximately $5.51 per share of common stock
Investorspurchasing securities in this offering will incur immediate and substantial dilution. After giving effect to the sale of securities offeredin this offering assuming a public offering price of $7.94 per Class A Unit, the closing price of our common stock on the NasdaqCapital Market on June 25, 2025) (but excluding any shares of common stock to be issued and any proceeds to be received upon cash exerciseof the Common Warrants, if any), and after deducting the underwriting commission and estimated offering costs payable by us, our proforma as further adjusted net tangible book value as of March 31, 2025 would have been approximately $15.0 million, or approximately$6.17 per share of common stock. This represents an immediate increase in net tangible book value of $0.33 per share to existing stockholders,and an immediate dilution in the as adjusted net tangible book value of $2.10 per share to investors purchasing shares of our commonstock and Common Warrants in this offering.
The following table illustratesthis per share dilution:
| Assumed public offering price per Class A Unit | $ | 7.94 | |||||
| Pro forma as adjusted net tangible book value per share as of March 31, 2025 | $ | 5.51 | |||||
| Increase in pro forma as adjusted net tangible book value per share attributable to this offering | 0.33 | ||||||
| Pro forma as further adjusted net tangible book value as of March 31, 2025 (giving effect to this offering) | 5.84 | ||||||
| Dilution per share to investors | $ | 2.10 |
Thedilution information discussed above is illustrative only and will change based on the actual public offering price and other terms ofthis offering determined at pricing. A $1.00 increase or decrease in the assumed public offering price of $7.94 per Class A Unitwould increase or decrease the as adjusted net tangible book value per share by approximately $0.20 and $0.23 per share, respectively,and the dilution per share to investors participating in this offering by approximately $2.90 and $1.33 per share, respectively, assumingthe number of securities offered by us, as set forth on the cover page of this prospectus, remains the same and after deductingthe underwriting commission and estimated offering expenses payable by us.
The discussion and table aboveassume (i) no sales of Class B Units, which, if sold, would reduce the number of Class A Units that we are offering ona one-for-one basis, (ii) no exercise of Common Warrants sold in this offering, and (iii) no exercise of the representativewarrants.
To the extent that stock optionsare exercised or new stock options are issued under our equity incentive plans, there will be further dilution to investors purchasingsecurities in this offering. In addition, we will need to raise additional capital because of market conditions and strategic considerations.If we raise additional capital through the sale of equity or convertible debt securities, the issuance of these securities could resultin further dilution to our stockholders.
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Descriptionof Securities WE ARE OFFERING
The following summary of certain terms andprovisions of the securities that are being offered hereby is not complete and is subject to, and qualified in its entirety by, the provisionsof the underlying securities, the forms of which are filed as exhibits to the registration statement of which this prospectus forms apart. Prospective investors should carefully review the terms and provisions of the forms of securities for a complete description ofthe terms and conditions.
Units
Class A Units -We are offering up to 755,667 Class A Units with each Class AUnit consisting of (i) one (1) share of our common stock and (ii) one (1) Common Warrant to purchase one (1) shareof our common stock.
Class B Units -We are also offering to each purchaser whose purchase of Class A Units in this offering would otherwise result in the purchaser,together with its affiliates and certain related parties, beneficially owning more than 4.99% (or, at the election of the purchaser,9.99%) of our outstanding common stock immediately following the consummation of this offering, the opportunity to purchase, if the purchaserso chooses, up to 755,667 Class B Units in lieu of Class A Units. Each Class B Unit consists of: (i) one (1) Pre-FundedWarrant and (ii) one (1) Common Warrant to purchase one (1) share of our common stock.
The Common Warrants includedin the Class A Units and Class B Units are identical.
The shares of common stockin the Class A Units or the Pre-Funded Warrants in the Class B Units, as applicable, and the accompanying Common Warrants, canonly be purchased together in this offering but will be issued separately and will be immediately separable upon issuance.
Common Stock
Voting.Holders of our common stock are entitled to one vote per share held of record on all matters to be voted upon by our stockholders.Our common stock does not have cumulative voting rights. Persons who hold a majority of the outstanding common stock entitled to voteon the election of directors can elect all of the directors who are eligible for election.
Dividends.Subject to preferences that may be applicable to the holders of any outstanding shares of our preferred stock, the holders of our commonstock are entitled to receive such lawful dividends as may be declared by our Board of Directors.
Liquidationand Dissolution. In the event of our liquidation, dissolution or winding up, and subject to the rights of the holders of anyoutstanding shares of our preferred stock, the holders of shares of our common stock will be entitled to receive pro rata all of our remainingassets available for distribution to our stockholders.
OtherRights and Restrictions. Our Certificate of Incorporation prohibits us from granting preemptive rights to any of our stockholders.
Description of Common Warrants
Form. Pursuant toa warrant agency agreement between us and Equiniti Trust Company, LLC, as warrant agent, the Common Warrants will be issued in book-entryform and shall initially be represented only by one or more global Common Warrants deposited with the warrant agent, as custodian on behalfof The Depository Trust Company, or DTC, and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directed by DTC.
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Exercisability.The Common Warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercisenotice accompanied by payment in full in immediately available funds for the number of shares of our common stock purchased upon suchexercise (except in the case of a cashless exercise as described below). A holder (together with its affiliates) may not exercise anyportion of the Common Warrant to the extent that the holder would own more than 4.99% (or, at the election of the holder, 9.99%) of theoutstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us, theholder may increase the amount of ownership of outstanding stock after exercising the holder’s Common Warrants up to 9.99% of thenumber of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determinedin accordance with the terms of the Common Warrants. Holders of the Common Warrants may also elect prior to the issuance of the CommonWarrants to have the initial exercise limitation set at 9.99% of our outstanding common stock. No fractional shares of common stock willbe issued in connection with the exercise of a Common Warrant. In lieu of fractional shares, we will either pay the holder an amount incash equal to the fractional amount multiplied by the exercise price or round up to the nearest whole share.
Durationand Exercise Price. The exercise price per whole share of our common stock purchasable upon the exercise of the Common Warrantsis $ per share. The Common Warrantswill be immediately exercisable upon issuance and may be exercised until the five (5) year anniversary from the date of issuance.The exercise price of the Common Warrants is subject to appropriate adjustment in the event of certain stock dividends and distributions,stock splits, stock combinations, reclassifications or similar events affecting our common stock and upon any distributions of assets,including cash, stock or other property to our stockholders.
CashlessExercise. If, at any time after the issuance of the Common Warrants, such holder exercises its Common Warrants and a registrationstatement registering the issuance of the shares of common stock underlying the Common Warrants under the Securities Act is not then effectiveor available (or a prospectus is not available for the resale of shares of common stock underlying the Common Warrants), then in lieuof making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, theholder shall instead receive upon such exercise (either in whole or in part) only the net number of shares of common stock determinedaccording to a formula set forth in the Common Warrants. Notwithstanding anything to the contrary, in the event we do not have or maintainan effective registration statement, there are no circumstances that would require us to make any cash payments or net cash settle theCommon Warrants to the holders.
Transferability.Subject to applicable laws, the Common Warrants may be offered for sale, sold, transferred or assigned at the option of the holder uponsurrender of the Common Warrant to us together with the appropriate instruments of transfer.
ExchangeListing. We do not plan on applying to list the Common Warrants on the Nasdaq Capital Market, any other national securitiesexchange or any other nationally recognized trading system. Without an active trading market, the liquidity of the Common Warrants willbe limited.
Fundamental Transactions.In the event of a fundamental transaction, as described in the Common Warrants and generally including any reorganization, recapitalizationor reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets,our consolidation or merger with or into another person, the acquisition of more than 50% of the voting power represented by our outstandingsecurities with voting rights, on an as converted basis, the holders of the Common Warrants will be entitled to receive upon exerciseof the Common Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercisedCommon Warrants immediately prior to such fundamental transaction. Any successor to us or surviving entity shall assume the obligationsunder the Common Warrants. Additionally, as more fully described in the Common Warrant, in the event of certain fundamental transactions,the holders of the Common Warrants may be entitled to receive consideration in an amount equal to the Black Scholes value of the CommonWarrants.
Rightsas a Stockholder. Except by virtue of such holder’s ownership of shares of our common stock, the holder of a Common Warrantdoes not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercises the CommonWarrant.
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Description of Pre-Funded Warrants
Form. Pursuantto a warrant agency agreement between us and Equiniti Trust Company, LLC, as warrant agent, the Pre-Funded Warrants will be issued inbook-entry form and shall initially be represented only by one or more global warrants deposited with the warrant agent, as custodianon behalf of The Depository Trust Company, or DTC, and registered in the name of Cede & Co., a nominee of DTC, or as otherwise directedby DTC.
Exercisability.The Pre-Funded Warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executed exercisenotice accompanied by payment in full in immediately available funds for the number of shares of our common stock purchased upon suchexercise (except in the case of a cashless exercise as described below). A holder (together with its affiliates) may not exercise anyportion of the Pre-Funded Warrant to the extent that the holder would own more than 4.99% (or, at the election of the holder, 9.99%) ofthe outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to us,the holder may increase the amount of ownership of outstanding stock after exercising the holder’s Pre-Funded Warrants up to 9.99%of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentage ownershipis determined in accordance with the terms of the Pre-Funded Warrants. Purchasers of Pre-Funded Warrants in this offering may also electprior to the issuance of the Pre-Funded Warrants to have the initial exercise limitation set at 9.99% of our outstanding common stock.No fractional shares of common stock will be issued in connection with the exercise of a Pre-Funded Warrant. In lieu of fractional shares,we will either pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price or round up to the nearestwhole share.
Durationand Exercise Price. The exercise price per whole share of our common stock purchasable upon the exercise of the Pre-FundedWarrants is $0.00001 per share of common stock. The Pre-Funded Warrants will be immediately exercisable and may be exercised at any timeuntil the Pre-Funded Warrants are exercised in full. The exercise price of the Pre-Funded Warrants is subject to appropriate adjustmentin the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affectingour common stock and upon any distributions of assets, including cash, stock or other property to our stockholders.
CashlessExercise. If, at any time after the holder’s purchase of Pre-Funded Warrants, such holder exercises its Pre-Funded Warrants,then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exerciseprice, the holder shall instead receive upon such exercise (either in whole or in part) only the net number of shares of common stockdetermined according to a formula set forth in the Pre-Funded Warrants.
Transferability.Subject to applicable laws, the Pre-Funded Warrants may be offered for sale, sold, transferred or assigned at the option of the holderupon surrender of the Pre-Funded Warrant to us together with the appropriate instruments of transfer.
ExchangeListing. We do not plan on applying to list the Pre-Funded Warrants on the Nasdaq Capital Market, any other national securitiesexchange or any other nationally recognized trading system. Without an active trading market, the liquidity of the Pre-Funded Warrantswill be limited.
Fundamental Transactions.In the event of a fundamental transaction, as described in the Pre-Funded Warrants and generally including any reorganization, recapitalizationor reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets,our consolidation or merger with or into another person, the acquisition of more than 50% of the voting power represented by our outstandingsecurities with voting rights, on an as converted basis, the holders of the Pre-Funded Warrants will be entitled to receive upon exerciseof the Pre-Funded Warrants the kind and amount of securities, cash or other property that the holders would have received had they exercisedthe Pre-Funded Warrants immediately prior to such fundamental transaction.
Rightsas a Stockholder. Except by virtue of such holder’s ownership of shares of our common stock, the holder of a Pre-FundedWarrant does not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercisesthe Pre-Funded Warrant.
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Description of Representative Warrants
Form.The representative warrants will be issued in certificated form by the Company.
Exercisability.The representative warrants will be exercisable, at the option of each holder, in whole or in part, by delivering to us a duly executedexercise notice accompanied by payment in full in immediately available funds for the number of shares of our common stock purchased uponsuch exercise (except in the case of a cashless exercise as described below). A holder (together with its affiliates) may not exerciseany portion of the representative warrant to the extent that the holder would own more than 4.99% (or, at the election of the holder,9.99%) of the outstanding common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holderto us, the holder may increase the amount of ownership of outstanding stock after exercising the holder’s representative warrantsup to 9.99% of the number of shares of our common stock outstanding immediately after giving effect to the exercise, as such percentageownership is determined in accordance with the terms of the representative warrants. Holders of the representative warrants may also electprior to the issuance of the representative warrants to have the initial exercise limitation set at 9.99% of our outstanding common stock.No fractional shares of common stock will be issued in connection with the exercise of a representative warrant. In lieu of fractionalshares, we will either pay the holder an amount in cash equal to the fractional amount multiplied by the exercise price or round up tothe nearest whole share.
Durationand Exercise Price. The exercise price per whole share of our common stock purchasable upon the exercise of the representativewarrants is 155% of the public offering price per Class A Unit sold in this offering. The representative warrants will be immediatelyexercisable upon issuance and may be exercised until the five (5) year anniversary from the commencement of sales of this offering.The exercise price of the representative warrants is subject to appropriate adjustment in the event of certain stock dividends and distributions,stock splits, stock combinations, reclassifications or similar events affecting our common stock and upon any distributions of assets,including stock or other property to our stockholders.
CashlessExercise. If, at any time after the issuance of the representative warrants, such holder exercises its representative warrantsand a registration statement registering the issuance of the shares of common stock underlying the representative warrants under the SecuritiesAct is not then effective or available (or a prospectus is not available for the resale of shares of common stock underlying the representativewarrants), then in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregateexercise price, the holder shall instead receive upon such exercise (either in whole or in part) only the net number of shares of commonstock determined according to a formula set forth in the representative warrants. Notwithstanding anything to the contrary, in the eventwe do not have or maintain an effective registration statement, there are no circumstances that would require us to make any cash paymentsor net cash settle the representative warrants to the holders.
Transferability.The representative warrants will be subject to FINRA Rule 5110(e)(1) in that, except as otherwise permitted by FINRA rules, for a periodof 180 days from the commencement of sales of this offering, the representative warrants shall not be sold, transferred, assigned, pledged,or hypothecated, or be the subject of any hedging, short sale, derivative, put, or call transaction that would result in the effectiveeconomic disposition of the securities by any person except as permitted by FINRA Rule 5110(e)(2). In addition, subject to applicablelaws, the representative warrants may be offered for sale, sold, transferred or assigned at the option of the holder upon surrender ofthe representative warrant to us together with the appropriate instruments of transfer after the initial 180 day period from the commencementof sales of the offering.
ExchangeListing. We do not plan on applying to list the representative warrants on the Nasdaq Capital Market, any other national securitiesexchange or any other nationally recognized trading system. Without an active trading market, the liquidity of the representative warrantswill be limited.
Fundamental Transactions.In the event of a fundamental transaction, as described in the representative warrants and generally including any reorganization, recapitalizationor reclassification of our common stock, the sale, transfer or other disposition of all or substantially all of our properties or assets,our consolidation or merger with or into another person, the acquisition of more than 50% of the voting power represented by our outstandingsecurities with voting rights, on an as converted basis, the holders of the representative warrants will be entitled to receive uponexercise of the representative warrants the kind and amount of securities, cash or other property that the holders would have receivedhad they exercised the representative warrants immediately prior to such fundamental transaction. Any successor to us or survivingentity shall assume the obligations under the representative warrants. Additionally, as more fully described in the representative warrant,in the event of certain fundamental transactions, the holders of the representative warrants will be entitled to receive considerationin an amount equal to the Black Scholes value of the representative warrants on the date of consummation of such transaction.
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Rightsas a Stockholder. Except by virtue of such holder’s ownership of shares of our common stock, the holder of a representativewarrant does not have the rights or privileges of a holder of our common stock, including any voting rights, until the holder exercisesthe representative warrant.
Anti-Takeover Effect of Certain Certificateof Incorporation and By-Law Provisions
Provisions of our Certificateof Incorporation and our amended and restated by-laws (our “By-Laws”) could make it more difficult to acquire us by meansof a merger, tender offer, proxy contest, open market purchases, removal of incumbent directors and otherwise. These provisions, whichare summarized below, are expected to discourage types of coercive takeover practices and inadequate takeover bids and to encourage personsseeking to acquire control of us to first negotiate with us. We believe that the benefits of increased protection of our potential abilityto negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouragingtakeover or acquisition proposals because negotiation of these proposals could result in an improvement of their terms.
Authorizedbut Unissued Stock. We have shares of common stock and preferred stock available for future issuance, in some cases, withoutstockholder approval. We may issue these additional shares for a variety of corporate purposes, including public offerings to raise additionalcapital, corporate acquisitions, stock dividends on our capital stock or equity compensation plans. The existence of unissued and unreservedcommon stock and preferred stock may enable our Board of Directors to issue shares to persons friendly to current management or to issuepreferred stock with terms that could render more difficult or discourage a third-party attempt to obtain control of us, thereby protectingthe continuity of our management. In addition, if we issue preferred stock, the issuance could adversely affect the voting power of holdersof common stock and the likelihood that such holders will receive dividend payments and payments upon liquidation.
Amendmentsto By-Laws. Our By-Laws are subject to alternation or repeal, and new by-laws may be made, by a majority of the voting powerof all then outstanding shares of capital stock entitled to vote generally in the election of directors, voting together a single class.Additionally, our By-Laws provide the Board of Directors with the power to make, adopt, alter, amend and repeal, from time to time, ourBy-Laws, provided, however, that the stockholders entitled to vote with respect to amendments to our By-Laws may alter, amend or repealBy-Laws made by the Board of Directors.
Classificationof Board of Directors; Removal of Directors; Vacancies. Our Certificate of Incorporation provide for the divisionof the Board of Directors into three classes as nearly equal in size as possible with staggered three-year terms; that directorsmay be removed only for cause by the affirmative vote of the holders of two-thirds of our shares of capital stock entitled to vote;and that any vacancy on the Board of Directors, however occurring, including a vacancy resulting from an enlargement of the Board of Directors,may be filled only by the vote of a majority of the directors then in office. The limitations on the removal of directors and the fillingof vacancies could have the effect of making it more difficult for a third party to acquire, or of discouraging a third party from acquiring,control of us. Our Certificate of Incorporation requires the affirmative vote of the holders of at least 75% of our shares of capitalstock issued and outstanding and entitled to vote to amend or repeal any of these provisions.
NoticePeriods for Stockholder Meetings. Our By-Laws provide that for business to be brought by a stockholder before an annual meetingof stockholders, the stockholder must give written notice to the corporation not later than the close of business on the 90th day, orearlier than the 120th day prior to the one year anniversary of the date of the annual meeting of stockholders of the previous year;provided, however, that in the event that the annual meeting of stockholders is called for a date that is not within 30 days prior to,or more than 60 days after, such anniversary date, notice by the stockholder must be received not later than 120 days prior to such annualmeeting and not later than the close of business on the 90th day prior to such annual meeting and the 10th day following the day on whichthe corporation's notice of the date of the meeting is first given or made to the stockholders or disclosed to the general public. OurBy-Laws also provide that the Board of Directors or the chair of such meeting may postpone, reschedule or cancel any annual meeting ofstockholders previously scheduled by the Board of Directors and in no event shall the adjournment, recess, postponement, judicial stayor rescheduling of an annual meeting commence a new time period, or extend any time period, for the giving of notice.
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StockholderAction; Special Meetings. Our Certificate of Incorporation provides that stockholder action may not be taken by writtenaction in lieu of a meeting and provides special meetings of the stockholders may only be called by the chair of the Board of Directors,the president or by our Board of Directors. These provisions could have the effect of delaying until the next stockholders' meeting stockholderactions that are favored by the holders of a majority of our outstanding voting securities. These provisions may also discourage anotherperson or entity from making a tender offer for our common stock, because that person or entity, even if it acquired a majority of ouroutstanding voting securities, would be able to take action as a stockholder only at a duly called stockholders' meeting, and not by writtenconsent. Our Certificate of Incorporation requires the affirmative vote of the holders of at least 75% of our shares of capital stockissued and outstanding and entitled to vote to amend or repeal the provisions relating to prohibition on action by written consent andthe calling of a special meeting of stockholders.
Nominations.Our By-Laws provide that nominations for election of directors may be made only by (i) the Board of Directors or a committee appointedby the Board of Directors; or (ii) a stockholder entitled to vote on director election, if the stockholder provides notice tothe Secretary of the Company presented not less than 90 days nor more than 120 days prior to the anniversary of the last annual meeting(subject to the limited exceptions set forth in the bylaws). These provisions may deter takeovers by requiring that any stockholder wishingto conduct a proxy contest have its position solidified well in advance of the meeting at which directors are to be elected and by providingthe incumbent Board of Directors with sufficient notice to allow them to put an election strategy in place. Our bylaws also provide thatstockholders seeking to present proposals before a meeting of stockholders to nominate candidates for election as directors at a meetingof stockholders must provide timely advance notice in writing, and specifies requirements as to the form and content of a stockholder’snotice.
Choiceof Forum. Our bylaws provides that the Court of Chancery of the state of Delaware shall be the exclusive forum for the followingtypes of actions or proceedings under Delaware statutory or common law:
| · | any derivative action or proceeding brought on our behalf; |
| · | any action asserting a breach of fiduciary duty; |
| · | any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, ourrestated certificate, or our amended and restated bylaws; or |
| · | any action asserting a claim against us that is governed by the internal affairs doctrine. |
The provision does not applyto suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act createsconcurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courtshave jurisdiction to entertain such claims.
To prevent having to litigateclaims in multiple jurisdictions and the threat of inconsistent or contrary rulings by different courts, among other considerations, ourbylaws provide that unless we consent in writing to the selection of an alternative forum, the federal district courts of the United Statesshall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.
While the Delaware courtshave determined that such choice of forum provisions are facially valid, a stockholder may nevertheless seek to bring a claim in a venueother than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity andenforceability of the exclusive forum provisions of our Certificate of Incorporation. This may require significant additional costs associatedwith resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in thoseother jurisdictions.
These exclusive forum provisionsmay limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors,officers, or other employees, which may discourage lawsuits against us and our directors, officers and other employees. If a court wereto find either exclusive-forum provision in our bylaws to be inapplicable or unenforceable in an action, we may incur further significantadditional costs associated with resolving the dispute in other jurisdictions, all of which could seriously harm our business.
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Our bylaws further providesthat the federal district courts of the United States of America shall be the exclusive forum for resolving any complaint asserting acause of action arising under the Securities Act.
NoCumulative Voting. Delaware General Corporation Law provides that stockholders are not entitled to the right to cumulate votesin the election of directors unless a corporation’s certificate of incorporation provides otherwise. Our Certificate of Incorporationand bylaws do not provide for cumulative voting.
Concentration of Ownership
Our executive officers, directorsand holders of five percent or more of our outstanding common stock, together with their respective affiliates, beneficially own or controla significant portion of the outstanding shares of the Company. Accordingly, these stockholders will have substantial influence over theoutcome of a corporate action of the Company requiring stockholder approval, including the election of directors, any merger, consolidationor sale of all or substantially all of the Company’s assets or any other significant corporate transaction. These stockholders mayalso exert influence in delaying or preventing a change in control of the Company, even if such change in control would benefit the otherstockholders of the Company.
Listing
Our common stock is currentlytraded on the Nasdaq Capital Market under the symbol “CLRB.”
Transfer Agent and Registrar
The transfer agent and registrarfor our common stock is Equiniti Trust Company, LLC.
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We are offering the securitiesdescribed in this prospectus through the underwriters named below. We have entered into an underwriting agreement dated ,2025 with Ladenburg Thalmann & Co. Inc., as the representative of the underwriters in this offering. Subject to the terms andconditions of the underwriting agreement, the underwriters have agreed to purchase the number of our securities set forth opposite itsname below.
| Underwriters | Number of Class A Units | Number of Class B Units | |||
| Ladenburg Thalmann & Co. Inc. | |||||
| Totals |
A copy of the underwritingagreement has been filed as an exhibit to the registration statement of which this prospectus is part.
We have been advised bythe underwriters that they propose to offer the Class A Units and Class B Units, if any, directly to the public at the publicoffering prices set forth on the cover page of this prospectus. Any securities sold by the underwriters to securities dealers willbe sold at the public offering price less a selling concession not in excess of $ per Class A Unit.
The underwriting agreementprovides that the underwriters’ obligation to purchase the securities we are offering is subject to conditions contained in theunderwriting agreement.
No action has been taken byus or the underwriters that would permit a public offering of the securities in any jurisdiction outside the United States where actionfor that purpose is required. None of our securities included in this offering may be offered or sold, directly or indirectly, nor maythis prospectus or any other offering material or advertisements in connection with the offer and sales of any of the securities offeringhereby be distributed or published in any jurisdiction except under circumstances that will result in compliance with the applicable rules andregulations of that jurisdiction. Persons who receive this prospectus are advised to inform themselves about and to observe any restrictionsrelating to this offering of securities and the distribution of this prospectus. This prospectus is neither an offer to sell nor a solicitationof any offer to buy the securities in any jurisdiction where that would not be permitted or legal.
The underwriters have advisedus that they do not intend to confirm sales to any account over which they exercise discretionary authority.
Underwriting Discount and Expenses
The following table summarizesthe underwriting discount and commission to be paid to the underwriters by us.
| Per Class A Unit | Per Class B Unit | Total Without Over- Allotment | Total With Full Over- Allotment | |||||||||||||
| Public offering price (1) | $ | $ | $ | $ | ||||||||||||
| Underwriting discounts and commissions (2)(3) | $ | $ | $ | $ | ||||||||||||
| Proceeds to us, before expenses | $ | $ | $ | $ |
| (1) | The public offering price and underwriting discount corresponds, in respect of the securities of (i) a public offering price per Class A Unit of $ ($ net of the underwriting discount) and (ii) a public offering price per Class B Unit of $ ($ net of the underwriting discount). | |
| (2) | We have also agreed to reimburse the accountable expenses of the representative, including a pre-closing expense allowance of up to a maximum of $50,000 and an additional closing expense allowance up to a maximum of $110,000. We paid an advance expense deposit of $25,000 to the representative for the representative’s anticipated accountable expenses. Any expense deposits will be returned to us to the extent the representative’s accountable expenses are not actually incurred in accordance with FINRA Rule 5110(g)(4)(A). | |
| (3) | We have granted a forty-five day over-allotment option to the underwriters to purchase up to an aggregate of 113,350 additional shares of common stock and/or additional Common Warrants to purchase up to 113,350 additional shares of common stock at the assumed public offering prices per security set forth above less the underwriting discounts and commissions solely to cover over-allotments, if any. |
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We estimate the totalexpenses payable by us for this offering to be approximately $1,000,000, which amount includes (i) the underwriting discount ofapproximately $480,000, (ii) reimbursement of the accountable expenses of the underwriters, including the legal fees of the representativeof the underwriters, in an amount not to exceed $160,000 and (iii) other estimated company expenses of approximately $360,000, whichincludes legal, accounting, printing costs and various fees associated with the registration and listing of our securities.
The securities we are offeringare being offered by the underwriters subject to certain conditions specified in the underwriting agreement.
Over-allotment Option
We have granted to theunderwriters an option exercisable not later than forty-five days after the date of this prospectus to purchase up to an aggregate ofan additional 113,350 shares of common stock and/or additional Common Warrants to purchase up to an additional 113,350 shares of commonstock, or any combination thereof, as determined by the underwriters, at the public offering price per security set forth on the coverpage hereto less the underwriting discounts and commissions. The underwriters may exercise the option solely to cover overallotments,if any, made in connection with this offering. If any additional shares of common stock and/or Common Warrants are sold, the underwriterswill offer such securities on the same terms as those on which the other securities are being offered.
Representative Warrants
We have agreed to issuecertain common stock purchase warrants (“representative warrants”) to the representative, or its designees, of the underwriters,upon the closing of this offering, which entitle it to purchase up to 45,340 shares of common stock, or 52,141 shares of common stockassuming the exercise of the over-allotment option in full. The representative warrants will have an exercise price equal to $ per shareof common stock, will be exercisable immediately upon issuance, at any time and from time to time, in whole or in part, during the five-yearperiod commencing from the commencement of sales of this offering. The representative warrants and the shares of common stock underlyingthe representative warrants are being registered on the registration statement of which this prospectus is a part. See the form of representativewarrant for a more complete description of the terms of such representative warrants which has been filed as an exhibit to the registrationstatement of which this prospectus is part.
Listing
Our shares of common stockare listed on The Nasdaq Capital Market under the symbol “CLRB.”
The last reported saleprice of our shares of common stock on June 25, 2025, was $7.94 per share. The final public offering price will be determined betweenus, the underwriters and the investors in the offering, and may be at a discount to the current market price of our common stock. Therefore,the assumed public offering price used throughout this prospectus may not be indicative of the final public offering price. There isno established public trading market for the Common Warrants or Pre-Funded Warrants, and we do not expect such markets to develop. Inaddition, we do not intend to apply for a listing of the Common Warrants or Pre-Funded Warrants on any national securities exchange orother nationally recognized trading system. Without an active trading market, the liquidity of the Common Warrants and Pre-Funded Warrantswill be limited.
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Lock-up Agreements
Each of our officers,directors and each of their respective affiliates and associated partners, and certain affiliated stockholders have agreed with the underwritersto be subject to a lock-up period of sixty (60) days following the closing of this offering, subject to certain exceptions. This meansthat, during the applicable lock-up period, such persons may not offer for sale, contract to sell, sell, distribute, grant any option,right or warrant to purchase, pledge, hypothecate or otherwise dispose of, directly or indirectly, any shares of our common stock orany securities convertible into, or exercisable or exchangeable for, shares of our common stock. Certain limited transfers are permittedduring the lock-up period if the transferee agrees to these lock-up restrictions. We have also agreed, in the underwriting agreement,to similar lock-up restrictions on the (i) issuance and sale of our equity securities from the date of this prospectus for a period ofsixty (60) days following the closing of this offering and (ii) entry into certain “variable rate transactions” from thedate of this prospectus for a period of one hundred and eighty (180) days following the closing of this offering , in each case subjectto certain exceptions. The representative may, in its sole discretion and without notice, waive the terms of any of these lock-up agreements.
Right of First Refusal
Pursuant to our investmentbanking agreement with the representative, from the twelve (12) months following the date of such closing and expiration of the term,should we propose to effect an additional financing, we have agreed to offer the representative the opportunity to participate as solebookrunner, exclusive placement agent or exclusive sales agent or financial advisor in respect of such financing.
Transfer Agent and Registrar
The transfer agent and registrarfor our common stock is Equiniti Trust Company, LLC.
Determination of Offering Price
Our common stock is currentlytraded on The Nasdaq Capital Market under the symbol “CLRB.” On June 25, 2025, the closing price of our common stock was$7.94 per share. We do not intend to apply for listing of the Common Warrants or Pre-Funded Warrants on any securities exchange or othertrading system.
The public offering priceof the securities offered by this prospectus will be determined by negotiation between us and the underwriters. Among the factors thatwill be considered in determining the public offering price:
| · | our history and our prospects; | |
| · | the industry in which we operate; | |
| · | our past and present operating results; | |
| · | the previous experience of our executive officers; and | |
| · | the general condition of the securities markets at the time of this offering. |
The public offering pricestated on the cover page of this prospectus should not be considered an indication of the actual value of the securities sold inthis offering. That price is subject to change as a result of market conditions and other factors, and we cannot assure you that the sharesof common stock underlying the Class A Units, Pre-Funded Warrants (contained in the Class B Units) and Common Warrants soldin this offering can be resold at or above the public offering price.
Stabilization, Short Positions and PenaltyBids
The underwriters may engagein syndicate covering transactions stabilizing transactions and penalty bids or purchases for the purpose of pegging, fixing or maintainingthe price of our common stock:
· Syndicatecovering transactions involve purchases of securities in the open market after the distribution has been completed in order to coversyndicate short positions. Such a naked short position would be closed out by buying securities in the open market. A naked short positionis more likely to be created if the underwriters are concerned that there could be downward pressure on the price of the securities inthe open market after pricing that could adversely affect investors who purchase in the offering.
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· Stabilizingtransactions permit bids to purchase the underlying security so long as the stabilizing bids do not exceed a specific maximum.
· Penaltybids permit the underwriters to reclaim a selling concession from a syndicate member when the securities originally sold by the syndicatemember are purchased in a stabilizing or syndicate covering transaction to cover syndicate short positions.
These syndicate covering transactions,stabilizing transactions, and penalty bids may have the effect of raising or maintaining the market prices of our securities or preventingor retarding a decline in the market prices of our securities. As a result, the price of our common stock may be higher than the pricethat might otherwise exist in the open market. Neither we nor the underwriters make any representation or prediction as to the effectthat the transactions described above may have on the price of our common stock. These transactions may be effected on The Nasdaq CapitalMarket, in the over-the-counter market or on any other trading market and, if commenced, may be discontinued at any time.
In connection with this offering,the underwriters also may engage in passive market making transactions in our common stock in accordance with Regulation M during a periodbefore the commencement of offers or sales of shares of our common stock in this offering and extending through the completion of thedistribution. In general, a passive market maker must display its bid at a price not in excess of the highest independent bid for thatsecurity. However, if all independent bids are lowered below the passive market maker’s bid that bid must then be lowered when specificpurchase limits are exceeded. Passive market making may stabilize the market price of the securities at a level above that which mightotherwise prevail in the open market and, if commenced, may be discontinued at any time.
Neither we nor the underwritersmake any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have onthe prices of our securities. In addition, neither we nor the underwriters make any representation that the underwriters will engage inthese transactions or that any transactions, once commenced will not be discontinued without notice.
Other Relationships
From time to time, certainof the underwriters and their affiliates may provide in the future, various advisory, investment and commercial banking and other servicesto us in the ordinary course of business, for which they will receive customary fees and commissions. In addition, Ladenburg Thalmann & Co. Inc. acted as the exclusive placement agent in connection with the Warrant Inducement.
Indemnification
We have agreed to indemnifythe underwriters against certain liabilities, including certain liabilities arising under the Securities Act, or to contribute to paymentsthat the underwriters may be required to make for these liabilities.
Electronic Distribution
A prospectus in electronicformat may be made available on the websites maintained by the underwriters, if any, participating in this offering and the underwritersmay distribute prospectuses electronically. Other than the prospectus in electronic format, the information on these websites is not partof this prospectus or the registration statement of which this prospectus forms a part, has not been approved or endorsed by us or theunderwriters, and should not be relied upon by investors.
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MaterialU.S. Federal Income Tax Considerations
The following is a generaldiscussion of the material U.S. federal income considerations applicable to the ownership and disposition of shares of our common stock,Common Warrants and Pre-Funded Warrants acquired in this offering. This discussion is for general information only and is not tax advice.Accordingly, all prospective holders of our common stock, Common Warrants and Pre-Funded Warrants should consult their own tax advisorswith respect to the U.S. federal, state, local and non-U.S. tax consequences of the purchase, ownership and disposition of our commonstock, Common Warrants and Pre-Funded Warrants. This discussion is based on current provisions of the U.S. Internal Revenue Code of 1986,as amended (the “Code”), existing and proposed U.S. Treasury Regulations promulgated thereunder, current administrative rulingsand judicial decisions, all as in effect as of the date of this prospectus, all of which are subject to change or to differing interpretation,possibly with retroactive effect. Any change could alter the tax consequences described in this prospectus. We assume in this discussionthat each holder holds shares of our common stock, Common Warrants and Pre-Funded Warrants as capital assets within the meaning of Section 1221of the Code (generally property held for investment).
This discussion does not addressall aspects of U.S. federal income taxation that may be relevant to a particular holder in light of that holder’s individual circumstances,does not address the alternative minimum or Medicare contribution taxes, and does not address any aspects of U.S. state, local or non-U.S.taxes or any U.S. federal taxes other than income tax. This discussion also does not consider any specific facts or circumstances thatmay apply to a holder and does not address aspects of U.S. federal income taxation that may be applicable to holders that are subjectto special tax rules, including without limitation:
| · | insurance companies; |
| · | tax-exempt organizations; |
| · | financial institutions; |
| · | brokers or dealers in securities; |
| · | regulated investment companies; |
| · | real estate investment trusts; |
| · | pension plans, individual retirement accounts and other tax deferred accounts; |
| · | persons that mark their securities to market; |
| · | controlled foreign corporations; |
| · | passive foreign investment companies; |
| · | “dual resident” corporations; |
| · | persons that receive our common stock, Common Warrants or Pre-Funded Warrants as compensation for theperformance of services; |
| · | owners that hold our common stock, Common Warrants or Pre-Funded Warrants as part of a straddle, hedge,conversion transaction, synthetic security or other integrated investment; |
| · | owners that own, or are deemed to own, more than 5% of our capital stock (except to the extent specificallyset forth below); |
| · | persons that have a functional currency other than the U.S. dollar; and |
| · | certain U.S. expatriates. |
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In addition, this discussiondoes not address the tax treatment of partnerships or other pass-through entities for U.S. federal income tax purposes, or persons whohold our common stock, Common Warrants or Pre-Funded Warrants through partnerships or other pass-through entities for U.S. federal incometax purposes. A partner in a partnership or other pass-through entity that will hold our common stock, Common Warrants or Pre-Funded Warrantsshould consult his, her or its own tax advisor regarding the tax consequences of acquiring, holding and disposing of our common stock,Common Warrants or Pre-Funded Warrants through a partnership or other pass-through entity, as applicable.
As used in this prospectus,the term “U.S. holder” means a beneficial owner of common stock, Common Warrants or Pre-Funded Warrants that is for U.S.federal income tax purposes:
| · | a citizen or individual resident of the United States; |
| · | a corporation (or other entity properly classified as a corporation for U.S. federal income tax purposes)created or organized in or under the laws of the United States, any state within the United States, or the District of Columbia; |
| · | an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or |
| · | a trust, if (i) a U.S. court is able to exercise primary supervision over the trust’s administrationand one or more “United States persons” (as defined in the Code) have the authority to control all substantial decisions ofthe trust, or (ii) in the case of a trust that was treated as a domestic trust under the laws in effect before 1997, a valid electionis in place under applicable U.S. Treasury regulations to treat such trust as a domestic trust. |
The term “non-U.S.holder” means any beneficial owner of common stock, Common Warrants or Pre-Funded Warrants that is not a U.S. holder and is nota partnership or other entity properly classified as a partnership for U.S. federal income tax purposes. For the purposes of this prospectus,U.S. holders and non-U.S. holders are referred to collectively as “holders.”
There can be no assurancethat the Internal Revenue Service (the “IRS”) will not challenge one or more of the tax consequences described herein. Wehave not obtained, nor do we intend to obtain, a ruling from the IRS with respect to the U.S. federal income tax consequences of the purchase,ownership or disposition of our common stock, Common Warrants or Pre-Funded Warrants.
Allocation of Purchase Price of the Class AUnits and Class B Units
Each Class A Unit shouldbe treated for U.S. federal income tax purposes as an “investment unit” consisting of one share of our common stock andone Common Warrant. Each Class B Unit should be treated for U.S. federal income tax purposes as an investment unit consistingof one Pre-Funded Warrant and one Common Warrant. The purchase price for each investment unit will be allocated between these componentsin proportion to their relative fair market values at the time the investment unit is purchased by the holder. This allocation will establisha holder’s initial tax basis for U.S. federal income tax purposes in his, her or its share of common stock (or, in lieu of commonstock, Pre-Funded Warrant) and Common Warrant included in each investment unit. We will not be providing holders with such allocation,and it is possible that different holders will reach different determinations regarding such allocation. A holder’s allocation ofpurchase price between each share of common stock (or, in lieu of common stock, each Pre-Funded Warrant) and the accompanying Common Warrantis not binding on the IRS or the courts, and no assurance can be given that the IRS or the courts will agree with a holder’s allocation.
Accordingly, each prospectiveholder should consult his, her or its own tax advisor with respect to the allocation, and the risks associated with such allocation, ofthe holder’s purchase price for the investment unit between our shares of common stock (or, in lieu of common stock, Pre-FundedWarrants) and Common Warrants.
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Treatment of Pre-Funded Warrants
Although it is not entirelyfree from doubt, a Pre-Funded Warrant should be treated as a share of our common stock for U.S. federal income tax purposes and a holderof Pre-Funded Warrants should generally be taxed in the same manner as a holder of common stock, as described below. Accordingly, no gainor loss should be recognized upon the exercise of a Pre-Funded Warrant and, upon exercise, the holding period of a Pre-Funded Warrantshould carry over to the share of common stock received. Similarly, the tax basis of the Pre-Funded Warrant should carry over to the shareof common stock received upon exercise, increased by the exercise price of $0.00001 per share. Each holder should consult his, her orits own tax advisor regarding the risks associated with the acquisition of Pre-Funded Warrants pursuant to this offering (including potentialalternative characterizations). The balance of this discussion generally assumes that the characterization described above will be respectedfor U.S. federal income tax purposes.
Tax Consequences to U.S. Holders
Exercise or Expiration of Common Warrants
Subject to the discussionbelow with respect to the cashless exercise of a Common Warrant, a U.S. holder will not recognize income, gain or loss on the exerciseof a Common Warrant. A U.S. holder’s tax basis in the common stock received upon the exercise of a Common Warrant will equal thesum of (i) the initial tax basis of the Common Warrant exercised (as determined pursuant to the rules discussed above under “Allocation of Purchase Price of the Class A Units and Class B Units”) and (ii) the exercise price of the CommonWarrant. The U.S. holder’s holding period for the common stock received upon exercise of a Common Warrant will begin on the dayafter such exercise (or possibly on the date of exercise) and will not include the period during which the U.S. holder held the CommonWarrant.
The tax consequences of acashless exercise of a Common Warrant are not clear under current U.S. tax law. A cashless exercise may be tax-free, either because theexercise is not a realization event or because the exercise is treated as a recapitalization for U.S. federal income tax purposes. Ineither case, a U.S. holder’s basis in the common stock received in connection with the cashless exercise would equal the U.S. holder’sbasis in the Common Warrants surrendered in connection with the cashless exercise. If the cashless exercise was not a realization event,it is unclear whether a U.S. holder’s holding period for the common stock would be treated as commencing on the date of exerciseor on the day following the date of exercise. If the cashless exercise were treated as a recapitalization, the holding period of the commonstock would include the holding period of the Common Warrants surrendered in connection with the cashless exercise.
It is possible that a cashlessexercise could be treated in part as a taxable exchange in which gain or loss would be recognized. In such event, a U.S. holder couldbe deemed to have surrendered Common Warrants having an aggregate fair market value equal to the exercise price for the total number ofCommon Warrants to be exercised. The U.S. holder would recognize capital gain or loss in an amount equal to the difference between theamount deemed realized (i.e., the exercise price for the Common Warrants exercised) and the U.S. holder’s tax basis in theCommon Warrants deemed surrendered to pay the exercise price. In this case, a U.S. holder’s tax basis in the common stock receivedwould equal the sum of the U.S. holder’s initial investment in the exercised Common Warrants and the exercise price for such CommonWarrants. It is unclear whether a U.S. holder’s holding period for the common stock would commence on the date of exercise of theCommon Warrants or the day following the date of exercise of the Common Warrants.
Due to the absence of authorityon the U.S. federal income tax treatment of a cashless exercise, there can be no assurance which, if any, of the alternative approachesdescribed above would be adopted by the IRS or a court of law. Accordingly, U.S. holders should consult their own tax advisors regardingthe tax consequences of a cashless exercise.
If a Common Warrant is allowedto lapse unexercised, a U.S. holder generally will recognize a capital loss equal to such holder’s tax basis in the Common Warrant.The deductibility of capital losses is subject to significant limitations.
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Distributions on Our Common Stock
As discussed above under “DividendPolicy,” we do not currently expect to make distributions on our common stock. In the event that we do make distributions on ourcommon stock to a U.S. holder, those distributions generally will constitute dividends for U.S. federal income tax purposes to the extentpaid from our current or accumulated earnings and profits as determined under U.S. federal income tax principles. If a distribution exceedsour current and accumulated earnings and profits, the excess will be treated as a tax-free return of the U.S. holder’s investment,up to such U.S. holder’s tax basis in the common stock. Any remaining excess will be treated as capital gain, subject to the taxtreatment described below in “—Sale, Exchange or Other Taxable Disposition of Our Common Stock or Warrants.” Dividendspaid by us generally will be eligible for the reduced rates of tax for qualified dividend income allowed to individual U.S. holders andfor the dividends received deduction allowed to corporate U.S. holders, in each case assuming that certain holding period and other requirementsare satisfied.
ConstructiveDistributions on Our Warrants
Under Section 305 ofthe Code, an adjustment to the number of shares of common stock that will be issued on the exercise of our warrants (whether Pre-FundedWarrants or Common Warrants), or an adjustment to the exercise price of such warrants, may be treated as a constructive distribution toa U.S. holder of the warrants if, and to the extent that, such adjustment has the effect of increasing such U.S. holder’s proportionateinterest in our “earnings and profits” or assets, depending on the circumstances of such adjustment (for example, if suchadjustment is to compensate for a distribution of cash or other property to holders of our common stock). Adjustments to the exerciseprice of a warrant made pursuant to a bona fide reasonable adjustment formula that has the effect of preventing dilution of the interestof the holder of the warrant should generally not result in a constructive distribution. Any constructive distributions generally wouldbe subject to the tax treatment described above under “—Distributions on Our Common Stock.”
Sale, Exchange or Other Taxable Dispositionof Our Common Stock or Warrants
Upon the sale, exchange, orother taxable disposition of our common stock or warrants (whether Pre-Funded Warrants or Common Warrants), a U.S. holder will recognizegain or loss equal to the difference between the amount realized upon the disposition and the U.S. holder’s tax basis in the commonstock or warrants sold or exchanged. Any gain or loss generally will be capital gain or loss, and will be long-term capital gain or lossif the U.S. holder’s holding period for the common stock or Common Warrants exceeded one year at the time of the disposition. CertainU.S. holders (including individuals) are currently eligible for preferential rates of U.S. federal income taxation in respect of long-termcapital gains. The deductibility of capital losses is subject to significant limitations.
Information Reporting and Backup Withholding
In general, information reportingrequirements may apply to distributions (whether actual or constructive) paid to a U.S. holder on our common stock or warrants, and tothe proceeds of the sale, exchange or other disposition of our common stock and warrants, unless the U.S. holder is an exempt recipient.Backup withholding will apply to such payments if the U.S. holder fails to provide a taxpayer identification number, a certification ofexempt status or has been notified by the IRS that it is subject to backup withholding (and such notification has not been withdrawn).Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules will be allowed as a refundor a credit against a U.S. holder’s U.S. federal income tax liability provided the required information is timely furnished to theIRS.
Tax Consequencesto Non-U.S. Holders
Exerciseor Expiration of Common Warrants
In general, a non-U.S. holderwill not be required to recognize income, gain or loss upon the exercise of a Common Warrant by payment of the exercise price. To theextent that a cashless exercise results in a taxable exchange, the consequences would be similar to those described below under “—Sale,Exchange or Other Taxable Disposition of Our Common Stock or Warrants.”
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The expiration of a CommonWarrant will be treated as if the non-U.S. holder sold or exchanged the Common Warrant and recognized a capital loss equal to the non-U.S.holder’s basis in the Common Warrant. A non-U.S. holder will not be able to utilize a loss recognized upon expiration of a CommonWarrant against the Non-U.S. holder’s U.S. federal income tax liability, however, unless the loss (i) is effectively connectedwith the non-U.S. holder’s conduct of a trade or business within the United States (and, if an income tax treaty applies, is attributableto a “permanent establishment” or “fixed base” in the United States) or (ii) is treated as a U.S. sourceloss and the non-U.S. holder is present in the United States 183 days or more in the taxable year of disposition and certain other conditionsare met.
Distributionson Our Common Stock
As discussed above under “DividendPolicy,” we do not currently expect to make distributions on our common stock. In the event that we do make distributions to holdersof our common stock or if we are treated as making a constructive distribution to holders of our Common Warrants or Pre-Funded Warrants,those distributions generally will constitute dividends for U.S. federal income tax purposes to the extent paid from our current or accumulatedearnings and profits, as determined under U.S. federal income tax principles. If a distribution exceeds our current and accumulated earningsand profits, the excess will be treated as a tax-free return of the non-U.S. holder’s investment, up to such non-U.S. holder’stax basis in the common stock. Any remaining excess will be treated as capital gain, subject to the tax treatment described below in “—Sale,Exchange or Other Taxable Disposition of Our Common Stock or Warrants.”
Distributions (including constructivedistributions) made to a non-U.S. holder that are treated as dividends generally will be subject to withholding of U.S. federal incometax at a rate of 30% of the gross amount or such lower rate as may be specified by an applicable income tax treaty between the UnitedStates and such holder’s country of residence, unless such dividends are effectively connected with a trade or business conductedby a non U.S. holder within the U.S. (as discussed below). A non-U.S. holder of our common stock who claims the benefit of an applicableincome tax treaty between the United States and such holder’s country of residence generally will be required to provide a properlyexecuted IRS Form W-8BEN or W-8BEN-E (or successor form), as applicable, and satisfy applicable certification and other requirements.Non-U.S. holders are urged to consult their own tax advisors regarding their entitlement to benefits under a relevant income tax treaty.A non-U.S. holder that is eligible for a reduced rate of U.S. withholding tax under an income tax treaty may be able to obtain a refundor credit of any excess amounts withheld by timely filing the required information with the IRS.
Dividends that are treatedas effectively connected with a trade or business conducted by a non-U.S. holder within the United States and, if an applicable incometax treaty so provides, that are attributable to a “permanent establishment” or a “fixed base” maintained by thenon-U.S. holder within the United States, generally are exempt from the 30% withholding tax if the non-U.S. holder satisfies applicablecertification and disclosure requirements. U.S. effectively connected income, net of specified deductions and credits, is generally taxedat the same graduated U.S. federal income tax rates applicable to United States persons (as defined in the Code). Any U.S. effectivelyconnected income received by a non-U.S. holder that is a corporation may also be subject to an additional “branch profits tax”at a 30% rate or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’scountry of residence.
Constructive Distributions on Our Warrants
As described above under “—TaxConsequences to U.S. Holders—Constructive Distributions on Our Warrants,” an adjustment to the Common Warrants or Pre-FundedWarrants could result in a constructive distribution to a non-U.S. holder, which would be treated as described under “—Distributionson Our Common Stock” above. Any resulting withholding tax attributable to deemed dividends would be collected from other amountspayable or distributable to the non-U.S. holder. Non U.S. holders should consult their tax advisors regarding the proper treatment ofany adjustments to the Common Warrants and Pre-Funded Warrants.
In addition, regulations governing “dividend equivalents” under Section 871(m) of the Code may apply to the Pre-Funded Warrants. Under those regulations,an implicit or explicit payment made to the holder of Pre-Funded Warrants that references a distribution on our common stock would generallybe taxable to a non-U.S. holder in the manner described under “—Distributions on our Common Stock” below. Such dividendequivalent amount would be taxable and subject to withholding whether or not there is actual payment of cash or other property, and wemay satisfy any withholding obligations by withholding from other amounts due to the non-U.S. holder. Non-U.S. holders are encouragedto consult their own tax advisors regarding the application of Section 871(m) of the Code to the Pre-Funded Warrants.
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Sale, Exchangeor Other Taxable Disposition of Our Common Stock or Warrants
In general, a non-U.S. holderwill not be subject to any U.S. federal income tax on any gain realized upon such holder’s sale, exchange or other taxable dispositionof shares of our common stock, Common Warrants or Pre-Funded Warrants unless:
| · | the gain is effectively connected with the non-U.S. holder’s conduct of a U.S. trade or businessand, if an applicable income tax treaty so provides, is attributable to a “permanent establishment” or a “fixed base”maintained by such non-U.S. holder in the United States, in which case the non-U.S. holder generally will be taxed on such gain at thegraduated U.S. federal income tax rates applicable to United States persons (as defined in the Code) and, if the non-U.S. holder is aforeign corporation, the branch profits tax described above in “—Tax Consequences to Non-U.S. Holders—Distributionson Our Common Stock” also may apply to such gain; |
| · | the non-U.S. holder is a nonresident alien individual who is present in the United States for 183 daysor more in the taxable year of the taxable disposition and certain other conditions are met, in which case the non-U.S. holder will besubject to a 30% tax (or such lower rate as may be specified by an applicable income tax treaty between the United States and such holder’scountry of residence) on the net gain derived from the taxable disposition, which may be offset by certain U.S. source capital lossesof the non-U.S. holder, if any; or |
| · | we are, or have been, at any time during the five-year period preceding such taxable disposition (or thenon-U.S. holder’s holding period, if shorter) a “U.S. real property holding corporation,” unless our common stock isregularly traded on an established securities market and the non-U.S. holder holds no more than 5% of our outstanding common stock, directlyor indirectly, during the shorter of the 5-year period ending on the date of the taxable disposition or the period that the non-U.S. holderheld our common stock. If we are determined to be a U.S. real property holding corporation and the foregoing exception does not apply,then a purchaser may withhold 15% of the proceeds payable to a non-U.S. holder from a sale of our common stock, Common Warrants or Pre-FundedWarrants, and the non-U.S. holder generally will be taxed on its net gain derived from the disposition at the graduated U.S. federal incometax rates applicable to United States persons (as defined in the Code). Generally, a corporation is a U.S. real property holding corporationonly if the fair market value of its U.S. real property interests equals or exceeds 50% of the sum of the fair market value of its worldwidereal property interests plus its other assets used or held for use in a trade or business. Although there can be no assurance, we do notbelieve that we are, or have been, a U.S. real property holding corporation, or that we are likely to become one in the future. No assurancecan be provided that our common stock will be regularly traded on an established securities market for purposes of the rules describedabove. |
InformationReporting and Backup Withholding
We must report annually tothe IRS and to each non-U.S. holder the gross amount of the distributions paid on our common stock (and constructive distributions onour Common Warrants and Pre-Funded Warrants) to such holder and the tax withheld, if any, with respect to such distributions. Non-U.S.holders may have to comply with specific certification procedures to establish that the holder is not a United States person (as definedin the Code) in order to avoid backup withholding at the applicable rate with respect to dividends on our common stock, Common Warrantsor Pre-Funded Warrants. Dividends paid to non-U.S. holders subject to the U.S. withholding tax, as described above in “Tax Consequencesto Non-U.S. Holders—Distributions on Our Common Stock,” generally will be exempt from U.S. backup withholding.
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Information reporting andbackup withholding generally will apply to the proceeds of a disposition of our common stock, Common Warrants and Pre-Funded Warrantsby a non-U.S. holder effected by or through the U.S. office of any broker, U.S. or foreign, unless the holder certifies its status asa non-U.S. holder and satisfies certain other requirements, or otherwise establishes an exemption. Generally, information reporting andbackup withholding will not apply to a payment of disposition proceeds to a non-U.S. holder where the transaction is effected outsidethe United States through a non-U.S. office of a broker. However, for information reporting purposes, dispositions effected through anon-U.S. office of a broker with substantial U.S. ownership or operations generally will be treated in a manner similar to dispositionseffected through a U.S. office of a broker. Non-U.S. holders should consult their own tax advisors regarding the application of the informationreporting and backup withholding rules to them.
Copies of information returnsmay be made available to the tax authorities of the country in which the non-U.S. holder resides or is incorporated under the provisionsof a specific treaty or agreement.
Backup withholding is notan additional tax. Any amounts withheld under the backup withholding rules from a payment to a non-U.S. holder can be refunded orcredited against the non-U.S. holder’s U.S. federal income tax liability, if any, provided that an appropriate claim is filed withthe IRS.
Foreign Accounts
The Foreign Account Tax ComplianceAct, or FATCA, generally imposes a 30% withholding tax on dividends (including constructive dividends) on, and gross proceeds from thesale or other disposition of, our common stock and Warrants if paid to a non-U.S. entity unless (i) if the non-U.S. entity is a “foreignfinancial institution,” the non-U.S. entity undertakes certain due diligence, reporting, withholding, and certification obligations,(ii) if the non-U.S. entity is not a “foreign financial institution,” the non-U.S. entity identifies certain of its U.S.investors, if any, or (iii) the non-U.S. entity is otherwise exempt under FATCA.
While withholding under FATCAmay apply to payments of gross proceeds from a sale or other disposition of our common stock, Common Warrants or Pre-Funded Warrants,under proposed U.S. Treasury Regulations withholding on payments of gross proceeds is not required. Although such regulations are notfinal, applicable withholding agents may rely on the proposed regulations until final regulations are issued.
An intergovernmental agreementbetween the United States and an applicable foreign country may modify the requirements described in this section. Under certain circumstances,a holder may be eligible for refunds or credits of the tax. Non-U.S. holders should consult their own tax advisors regarding the possibleimplications of FATCA on their investment in our common stock, Common Warrants or Pre-Funded Warrants.
The preceding discussionof material U.S. federal income tax considerations is for informational purposes only. It is not tax advice. Prospective investors shouldconsult their own tax advisors regarding the particular U.S. federal, state, local and non-U.S. tax consequences of purchasing, holdingand disposing of our common stock, Common Warrants or Pre-Funded Warrants, including the consequences of any proposed changes in applicablelaws.
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Unless otherwise indicatedin the applicable prospectus supplement, Sidley Austin LLP, New York, New York, will pass upon the validity of the securities offeredby this prospectus and any supplement hereto. The underwriters are being represented by Ellenoff Grossman & Schole LLP, New York,New York.
The financial statements ofCellectar Biosciences, Inc. as of December 31, 2024 and 2023, and for each of the two years in the period ended December 31,2024, incorporated by reference in this prospectus, have been audited by Deloitte & Touche LLP, an independent registered publicaccounting firm, as stated in their report. Such financial statements are incorporated by reference in reliance upon the report of suchfirm given their authority as experts in accounting and auditing.
WhereYou Can Find Additional Information
Weare a reporting company and file annual, quarterly and current reports, proxy statements and other information with the SEC. We have filedwith the SEC a registration statement under the Securities Act with respect to the securities being offered under this prospectus. Thisprospectus does not contain all of the information set forth in the registration statement and the exhibits to the registration statement.For further information with respect to us and the securities being offered under this prospectus, we refer you to the registration statementand the exhibits and schedules filed as a part of the registration statement. You may obtain copies of the registration statement andits exhibits via the SEC’s website at http://www.sec.gov.
You can also read our Securitiesand Exchange Commission filings, including the registration statement, over the Internet at the SEC’s website at www.sec.gov. Youmay also request a copy of these filings, at no cost, by writing us at 100 Campus Drive, Florham Park, New Jersey 07932 or telephoningus at (608) 441-8120.
We are subject to the informationaland reporting requirements of the Securities Exchange Act of 1934, as amended, and have filed and will file annual, quarterly and currentreports, proxy statements and other information with the SEC. These periodic reports, proxy statements and other information will be availablefor inspection and copying at the SEC’s public reference facilities and the website of the SEC referred to above. We maintain awebsite at https://www.cellectar.com. You may access these materials free of charge as soon as reasonably practicable after they are electronicallyfiled with, or furnished to, the SEC. Information contained on our website is not a part of this prospectus and the inclusion of our websiteaddress in this prospectus is an inactive textual reference only.
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Incorporationof Documents by Reference
The SEC allows us to “incorporateby reference” information into this prospectus. This means that we can disclose important information to you by referring you toanother document filed separately with the SEC. The information incorporated by reference is considered to be a part of this prospectus,except for any information that is superseded by other information that is included in this prospectus. The information we incorporateby reference is an important part of this prospectus and information that we subsequently file with the SEC will automatically updateand supersede information in this prospectus and in our other filings with the SEC.
We incorporate by referencethe documents listed below, which we have already filed with the SEC, and any filings we make with the SEC under Section 13(a), 13(c),14 or 15(d) of the Exchange Act (1) on or after the date of filing of the registration statement of which this prospectus formsa part and (2) on or after the date of this prospectus until the earlier of the date on which all of the securities registered hereunderhave been sold or the registration statement of which this prospectus is a part has been withdrawn (in each case, other than informationthat is deemed, under SEC rules, not to have been filed):
| · | our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 13, 2025; |
| · | our Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025, filed with the SEC on May 13, 2025; |
| · | the portions of our Definitive Proxy Statement on Schedule 14A, filed with the SEC on April 28, 2025,that are incorporated by reference in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024; |
| · | our Current Reports on Form 8-K, filed with the SEC on January 31, 2025, March 17, 2025, May 1, 2025, June 5, 2025 (excluding Item 7.01 and the related exhibit 99.1), June 13, 2025, June 18, 2025 and June 25, 2025 and |
| · | the description of our common stock and warrants to purchase common stock included in our registrationstatement on Form 8-A filed on August 14, 2014, as the same may be updated by Exhibit 4.3 to Amendment No. 1 to our Annual Report on Form 10-K filed on April 1, 2024, including all other amendments and reports filed for the purpose of updatingsuch description. |
We also incorporate by referenceany future filings (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed on such formthat are related to such items unless such Form 8-K expressly provides to the contrary) made with the SEC pursuant to Sections 13(a),13(c), 14 or 15(d) of the Exchange Act, including those made after the date of the initial filing of the registration statement ofwhich this prospectus is a part and those made after the effectiveness of such registration statement, until the termination of the offeringof the common stock made by this prospectus, and such filings will become a part of this prospectus from the respective dates that suchdocuments are filed with the SEC. Information in such future filings updates and supplements the information provided in this prospectus.Any statements in any such future filings will automatically be deemed to modify and supersede any information herein or in any documentwe previously filed with the SEC that is incorporated or deemed to be incorporated herein by reference to the extent that statements inthe later filed document modify or replace such earlier statements.
You may request and obtaina copy of any of the filings incorporated herein by reference, at no cost, by writing or telephoning us at the following address or phonenumber:
Cellectar Biosciences, Inc.
100 Campus Drive
Florham Park, New Jersey 07932
Attention: Chief Financial Officer
(608) 441-8120
68
Up to 755,667 Class A Units with eachClass A Unit consisting of (i) one (1) Share of Common Stock and (ii) one (1)
Common Warrant to purchase one (1) Share of Common Stock
Or
Up to 755,667 Class B Units with eachClass B Unit consisting of (i) one (1) Pre-Funded Warrant to Purchase one (1)
Share of Common Stock and (ii) one (1) Common Warrant to purchase one (1) Share of Common Stock
Up to 45,340 Representative Warrants toPurchase up to 45,340 Shares of Common Stock
Up to 1,556,674 Shares of Common Stock IssuableUpon Exercise of (i) up to 755,667 Pre-Funded Warrants, (ii) up to
755,667 Common Warrants and (iii) up to 45,340 Representative Warrants
PROSPECTUS
Ladenburg Thalmann
, 2025
We have not authorized anydealer, salesperson or other person to give any information or represent anything not contained in this prospectus. You must not relyon any unauthorized information. If anyone provides you with different or inconsistent information, you should not rely on it. This prospectusdoes not offer to sell any securities in any jurisdiction where it is unlawful. Neither the delivery of this prospectus, nor any salemade hereunder, shall create any implication that the information in this prospectus is correct after the date hereof.
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 13. Other Expenses of Issuance and Distribution
The following table sets forthall expenses to be paid by Cellectar Biosciences, Inc. (the Registrant), in connection with the offering. All amounts shown are estimatesexcept for the SEC registration fee and the FINRA filing fee.
| SEC Registration Fee | $ | 2,317 | ||
| FINRA Filing Fee | 2,800 | |||
| Accounting Fees and Expenses | 75,000 | |||
| Legal Fees and Expenses | 250,000 | |||
| Miscellaneous Fees and Expenses | 29,883 | |||
| Total | $ | 360,000 |
Item 14. Indemnification of Directors andOfficers
Section 102 of the DelawareGeneral Corporation Law (the “DGCL”) permits a corporation to eliminate the personal liability of its directors for monetarydamages for a breach of fiduciary duty as a director, except where the director breached his or her duty of loyalty, failed to act ingood faith, engaged in intentional misconduct or knowingly violated a law, authorized the payment of a dividend or approved a stock repurchasein violation of Delaware corporate law or obtained an improper personal benefit. Our second amended and restated certificate of incorporation(our “Certificate of Incorporation”) provides that none of our directors shall be personally liable to us or our stockholdersfor monetary damages for any breach of fiduciary duty as a director, notwithstanding any provision of law imposing such liability, exceptto the extent that the DGCL prohibits the elimination or limitation of liability of directors for breaches of fiduciary duty.
Section 145 of the DGCLprovides that a corporation has the power to indemnify a director, officer, employee, or agent of the corporation and certain other personsserving at the request of the corporation in related capacities against expenses (including attorneys’ fees), judgments, fines andamounts paid in settlements actually and reasonably incurred by the person in connection with an action, suit or proceeding to which heor she is or is threatened to be made a party by reason of such position, if such person acted in good faith and in a manner he or shereasonably believed to be in or not opposed to the best interests of the corporation, and, in any criminal action or proceeding, had noreasonable cause to believe his or her conduct was unlawful, except that, in the case of actions brought by or in the right of the corporation,no indemnification shall be made with respect to any claim, issue or matter as to which such person shall have been adjudged to be liableto the corporation unless and only to the extent that the Court of Chancery or other adjudicating court determines that, despite the adjudicationof liability but in view of all of the circumstances of the case, such person is fairly and reasonably entitled to indemnity for suchexpenses which the Court of Chancery or such other court shall deem proper.
Our Certificate of Incorporationcontains provisions that limit the liability of our directors for monetary damages to the fullest extent permitted by the DGCL. Consequently,our directors are not personally liable to us or our stockholders for monetary damages for any breach of fiduciary duties as directors,except liability for:
| · | any breach of the director’s duty of loyalty to us or our stockholders; |
| · | any act or omission not in good faith or that involves intentional misconduct or a knowing violation oflaw; |
| · | unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174of the DGCL; or |
| · | any transaction from which the director derived an improper personal benefit. |
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Our Certificate of Incorporationprovides that we shall indemnify any and all persons whom we shall have power to indemnify under Section 145 from and against anyand all of the expenses, liabilities or other matters referred to in or covered by Section 145. Our Certificate of Incorporationprovides for the advancement of expenses to each of our directors, officers, employees or agents for the defense of any action for whichindemnification is required or permitted.
We have entered into indemnificationagreements with certain of our directors and our executive officers. These agreements will provide that we will indemnify such directorsand officers to the fullest extent permitted by law and our Certificate of Incorporation.
We also maintain a generalliability insurance policy that covers certain liabilities of our directors and officers arising out of claims based on acts or omissionsin their capacities as directors or officers.
Item 15. Recent Sales of Unregistered Securities
Share and price per amountbelow are not adjusted to reflect the reverse stock split effectuated on June 24, 2025.
2024 Private Placements
On July 21, 2024, weentered into warrant exercise inducement letters with certain institutional investors holding Tranche B warrants, pursuant to which suchholders agreed to exercise for cash such Tranche B warrants to purchase an amount of shares of Series E-4 preferred stock which isconvertible to 6,739,918 shares of common stock, in the aggregate, at a reduced, as-converted common stock exercise price of $2.52 pershare, in exchange for our agreement to issue new inducement warrants. We received aggregate gross proceeds of approximately $19.4 millionfrom the exercise of the Tranche B warrants and the sale of the inducement warrants. We issued the inducement warrants in three differenttranches: Tranche A inducement warrants to purchase 6,739,918 shares of common stock, immediately exercisable at an exercise price of$2.52 per share; Tranche B inducement warrants to purchase 8,214,278 shares of common stock, immediately exercisable at an exercise priceof $4.00 per share; and Tranche C inducement warrants to purchase 4,267,152 shares of common stock, immediately exercisable at an exerciseprice of $5.50 per share. In each case, the exercise price and number of shares of common stock issuable upon exercise is subject to appropriateadjustment in the event of stock dividends, stock splits, reorganizations or similar events affecting our common stock and the exerciseprice. These securities were offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgatedthereunder, and we intend to issue shares of common stock upon exercise of the inducement warrants pursuant to the same exemption or pursuantto the exemption provided in Section 3(a)(9) under the Securities Act.
2023 Private Placements
On September 8, 2023,in a private placement with certain institutional investors, we issued 1,225 shares of Series E-1 preferred stock, along with TrancheA warrants to purchase 2,205 shares of Series E-3 preferred stock and Tranche B warrants to purchase 1,715 shares of Series E-4preferred stock. Shares of Series E preferred stock were issued at a fixed price of $20,000 per share, resulting in gross proceedsof $24.5 million and net proceeds of approximately $22.2 million after placement agent fees and other customary expenses. The conversionprices for the preferred stock are as follows: for the Series E-1 or E-2 preferred stock, $1.82 per share of common stock, or a totalof 13,461,538 shares of common stock; for the Series E-3 preferred stock, $3.185 per share of common stock, or a total of 13,846,154shares of common stock; and for the Series E-4 preferred stock, $4.7775 per share of common stock, or a total of 7,179,487 sharesof common stock, in each case subject to appropriate adjustment in the event of any stock dividend, stock split, combination or othersimilar recapitalization. These securities were offered pursuant to the exemption provided in Section 4(a)(2) under the SecuritiesAct and Rule 506(b) promulgated thereunder.
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2022 Private Placements
On October 20, 2022,we entered into a securities purchase agreement with certain purchasers named therein, pursuant to which we agreed to issue, in a privateplacement transaction, common warrants to purchase an aggregate of 3,275,153 shares of common stock at an exercise price of $1.96 pershare. In a separate concurrent private placement transaction, we entered into a private placement securities purchase agreement withcertain purchasers named therein, pursuant to which we agreed to issue pre-funded warrants to purchase an aggregate of up to 1,875,945shares of common stock, and common warrants to purchase an aggregate of 1,875,945 shares of common stock at an exercise price of $1.96per share. The purchase price of each pre-funded warrant was $2.08499 and they are exercisable at an exercise price of $0.00001 per share.The proceeds to us in connection with sale of the warrants and pre-funded warrants were approximately $3.9 million and we will receivean additional $10.1 million if the warrants and the pre-funded warrants are exercised in full. The common warrants, pre-funded warrantsand the shares of common stock issuable upon the exercise of the common warrants and the pre-funded warrants were offered pursuant tothe exemption provided in Section 4(a)(2) under the Securities Act and Rule 506(b) promulgated thereunder.
Item 16. Exhibits and Financial StatementSchedules
Item 16 Exhibits.
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* Filed herewith.
** Management contract or compensatoryplan or arrangement.
*** To be filed by amendment.
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Item 17. Undertakings
| (a) | The undersigned registrant hereby undertakes: |
| 1. | To file, during any period in which offers or sales are being made, a post-effective amendment to thisregistration statement: |
| (i) | To include any prospectus required by section 10(a)(3) of the Securities Act of 1933, as amended(the “Securities Act”); |
| (ii) | To reflect in the prospectus any facts or events arising after the effective date of the registrationstatement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental changein the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securitiesoffered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low orhigh end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if,in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forthin the “Calculation of Registration Fee” table in the effective registration statement. |
| (iii) | To include any material information with respect to the plan of distribution not previously disclosedin the registration statement or any material change to such information in the registration statement; provided, however, that the undertakingsset forth in paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) above do not apply if the information required to be includedin a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the Commission by the registrantpursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),that are incorporated by reference in this registration statement or are contained in a form of prospectus filed pursuant to Rule 424(b) thatis part of this registration statement. |
| 2. | That, for the purpose of determining any liability under the Securities Act, each such post-effectiveamendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securitiesat that time shall be deemed to be the initial bona fide offering thereof. |
| 3. | To remove from registration by means of a post-effective amendment any of the securities being registeredwhich remain unsold at the termination of the offering. |
| 4. | That, for the purpose of determining liability under the Securities Act to any purchaser, each prospectusfiled pursuant to Rule 424(b) as part of a registration statement relating to the offering, other than registration statementsrelying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be part of and included inthe registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registrationstatement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by referenceinto the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contractof sale prior to such first use, supersede or modify any statement that was made in the registration statement or prospectus that waspart of the registration statement or made in any such document immediately prior to such date of first use. |
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| (b) | The undersigned registrant hereby undertakes that, for purposes of determining any liability under theSecurities Act, each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the ExchangeAct (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the ExchangeAct) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to thesecurities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. |
| (c) | Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors,officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advisedthat in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurredor paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) isasserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unlessin the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction thequestion whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the finaladjudication of such issue. |
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Pursuant to the requirementsof the Securities Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirementsfor filing on Form S-1 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereuntoduly authorized, in the City of Florham Park, State of New Jersey on June 26, 2025.
| CELLECTAR BIOSCIENCES, INC. |
| By: | /s/ James V. Caruso | ||
| Name: | James V. Caruso | ||
| Title: | Chief Executive Officer | ||
POWER OF ATTORNEY
We, the undersigned directorsand officers of Cellectar Biosciences, Inc. (the Company), hereby severally constitute and appoint James V. Caruso and Chad J. Kolean,and each of them singly, our true and lawful attorneys, with full power to them, and to each of them singly, to sign for us and in ournames in the capacities indicated below, the registration statement on Form S-1 filed herewith, and any and all pre-effective andpost-effective amendments to said registration statement, and any registration statement filed pursuant to Rule 462(b) underthe Securities Act of 1933, as amended, in connection with the registration under the Securities Act of 1933, as amended, of equity securitiesof the Company, and to file or cause to be filed the same, with all exhibits thereto and other documents in connection therewith, withthe Securities and Exchange Commission, granting unto said attorneys, and each of them, full power and authority to do and perform eachand every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as each of themmight or could do in person, and hereby ratifying and confirming all that said attorneys, and each of them, or their substitute or substitutes,shall do or cause to be done by virtue of this Power of Attorney. This Power of Attorney does not revoke any power of attorney previouslygranted by the undersigned, or any of them.
Pursuant to the requirementsof the Securities Act of 1933, as amended, this registration statement has been signed by the following persons in the capacities indicatedon the date indicated:
| Signature | Title | Date | ||
| /s/ James V. Caruso | ||||
| James V. Caruso | President, Chief Executive Officer and Director (principal executive officer) | June 26, 2025 | ||
| /s/ Chad J. Kolean | ||||
| Chad J. Kolean | Chief Financial Officer (principal financial officer and principal accounting officer) | June 26, 2025 | ||
| /s/ Douglas J. Swirsky | ||||
| Douglas J. Swirsky | Chairman of the Board | June 26, 2025 | ||
| /s/ Asher Alban Chanan-Khan | ||||
| Asher Alban Chanan-Khan | Director | June 26, 2025 | ||
| /s/ Frederick W. Driscoll | ||||
| Frederick W. Driscoll | Director | June 26, 2025 | ||
| /s/ Stefan D. Loren, Ph.D. | ||||
| Stefan D. Loren, Ph.D. | Director | June 26, 2025 | ||
| /s/ John Neis | ||||
| John Neis | Director | June 26, 2025 |
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