As filed with the Securitiesand Exchange Commission on August 20, 2025

Registration No. 333-          

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

iSpecimen, Inc.

(Exact name of registrant as specified in its charter)

8 Cabot Road, Suite 1800

Woburn, MA 08101

Telephone: (781) 301-6700

(Address, including zip code, and telephone number,including area code, of registrant’s principal executive offices)

Katharyn Field

President

8 Cabot Road, Suite 1800

Woburn, MA 01801

(781) 301-6700

(Name, address, including zip code, and telephonenumber, including area code, of agent for service)

Copies to:

Ross D. Carmel, Esq.

Barry P. Biggar, Esq.

Benjamin E. Sklar, Esq.

Sichenzia Ross Ference Carmel LLP

1185 Avenue of the Americas

New York, New York 10036

Phone: (212) 930-9700

Approximate date of commencement of proposed sale to the public:As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this Form are to be offeredon a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. ☒

If this Form is filed to register additional securities for an offeringpursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement numberof the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c)under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registrationstatement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d)under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registrationstatement for the same offering. ☐

If delivery of the Prospectus is expected to be made pursuant to Rule434, check the following box. ☐

Indicate by check mark whether the registrant is a large acceleratedfiler, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitionsof “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerginggrowth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registranthas elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuantto Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this Registration Statement on suchdate or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically statesthat this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act or until thisRegistration Statement shall become effective on such date as the Securities and Exchange Commission acting pursuant to said Section 8(a)may determine.

The information in this preliminary prospectus is not complete andmay be changed. These securities may not be sold until the registration statement filed with the Securities and Exchange Commission iseffective. This preliminary prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securitiesin any state where the offer or sale is not permitted.

1,559,828 Shares of Common Stock

This prospectus relates to the offer and resaleof up to an aggregate of 1,559,828 shares of common stock, par value $0.0001 per share, of iSpecimen, Inc., held by selling stockholders,consisting of the following: (i) 267,379 shares of common stock (the “Shares”) and (ii) 1,292,449 shares of common stock (the“Warrant Shares”) issuable upon exercise of pre-funded warrants (the “Warrants”), each exercisable into one shareof common stock at a nominal exercise price per share of $0.0001, without expiration, all of which were issued by us in connection witha private placement transaction (the “August 2025 Private Placement”) pursuant to a securities purchase agreement, dated asof July 31, 2025 (the “Purchase Agreement”). The holders of the Shares and the Warrant Shares and the Warrants are each referredto herein as a “Selling Stockholder” and collectively as the “Selling Stockholders.”

This prospectus also covers any additional shares of common stock thatmay become issuable upon any anti-dilution adjustment pursuant to the terms of the Warrants issued to the Selling Stockholders by reasonof stock splits, stock dividends, and other events described therein.

The Selling Stockholders, or their respective transferees, pledgees,donees or other successors-in-interest, may sell the Shares or the Warrant Shares through public or private transactions at prevailingmarket prices, at prices related to prevailing market prices or at privately negotiated prices. The Selling Stockholders may sell any,all or none of the securities offered by this prospectus, and we do not know when or in what amount the Selling Stockholders may selltheir Shares or Warrant Shares hereunder following the effective date of this registration statement. We provide more information abouthow a Selling Stockholder may sell its Shares or Warrant Shares in the section titled “Plan of Distribution” on page 79.

We are registering the Shares and Warrant Shareson behalf of the Selling Stockholders, to be offered and sold by them from time to time. While we will not receive any proceeds from thesale of our common stock by the Selling Stockholders in the offering described in this prospectus, we may receive up to $0.0001 per shareupon the cash exercise of each of the Warrants. We cannot predict when and in what amounts or if the Warrants will be exercised. We haveagreed to bear all of the expenses incurred in connection with the registration of the Shares and the Warrant Shares. The Selling Stockholderswill pay or assume discounts, commissions, fees of underwriters, selling brokers or dealer managers and similar expenses, if any, incurredfor the sale of the Shares and the Warrant Shares.

Our common stock is currently listed on the NasdaqCapital Market under the symbol “ISPC.” On August 19, 2025, the last reported sale price for our common stock was $1.11 pershare.

We are an “emerging growth company” as the term is usedin the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) and, as such, have elected to comply with certain reducedpublic company reporting requirements for this and future filings. This prospectus describes the general manner in which the Shares andthe Warrant Shares may be offered and sold. If necessary, the specific manner in which the Shares and the Warrant Shares may be offeredand sold will be described in a supplement to this prospectus.

Investing in our Common Stock involves risks. You should carefullyreview the risks described under the heading “Risk Factors” beginning on page 9 before you invest in our common stock.

Neither the Securities and Exchange Commission nor any state securitiescommission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representationto the contrary is a criminal offense.

The date of this prospectus is [*].

Table of Contents

ABOUT THIS PROSPECTUS

This prospectus describes the general manner in which the Selling Stockholdersmay offer from time to time the Shares and Warrant Shares. You should rely only on the information contained in this prospectus and therelated exhibits, any prospectus supplement or amendment thereto and the documents incorporated by reference, or to which we have referredyou, before making your investment decision. Neither we nor the Selling Stockholders have authorized anyone to provide you with differentinformation. If anyone provides you with different or inconsistent information, you should not rely on it. This prospectus, any prospectussupplement or amendments thereto do not constitute an offer to sell, or a solicitation of an offer to purchase, the common stock offeredby this prospectus, any prospectus supplement or amendments thereto in any jurisdiction to or from any person to whom or from whom itis unlawful to make such offer or solicitation of an offer in such jurisdiction. You should not assume that the information containedin this prospectus, any prospectus supplement or amendments thereto, as well as information we have previously filed with the U.S. Securitiesand Exchange Commission (the “SEC”), is accurate as of any date other than the date on the front cover of the applicable document.

If necessary, the specific manner in which the shares of common stockmay be offered and sold will be described in a supplement to this prospectus, which supplement may also add, update or change any of theinformation contained in this prospectus. To the extent there is a conflict between the information contained in this prospectus and anyprospectus supplement, you should rely on the information in such prospectus supplement, provided that if any statement in one of thesedocuments is inconsistent with a statement in another document having a later date - for example, a document incorporatedby reference in this prospectus or any prospectus supplement - the statement in the document having the later date modifiesor supersedes the earlier statement.

Neither the delivery of this prospectus nor any distribution of commonstock pursuant to this prospectus shall, under any circumstances, create any implication that there has been no change in the informationset forth or incorporated by reference into this prospectus or in our affairs since the date of this prospectus. Our business, financialcondition, results of operations and prospects may have changed since such date.

When used herein, unless the context requires otherwise, referencesto the “iSpecimen” “Company,” “we,” “our” and “us” refer to iSpecimen, Inc.,a Delaware corporation.

Trademarks

This prospectus contains references to trademarks and service marksbelonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus may appear without the® or TM symbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to thefullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our use or display of other companies’trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus and the documents incorporated by reference hereincontains various forward-looking statements various forward-looking statements within the meaning of Section 27A of the Securities Actand Section 21E of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”) that reflect our current expectationsand views of future events. The forward-looking statements are contained principally in the sections included or incorporated by referenceherein entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results ofOperations.” Readers are cautioned that known and unknown risks, uncertainties and other factors, including those over which wemay have no control and others listed in the “Risk Factors” section of this prospectus, may cause our actual results, performanceor achievements to be materially different from those expressed or implied by the forward-looking statements.

You can identify some of these forward-looking statements by wordsor phrases such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,”“intend,” “plan,” “believe,” “is/are likely to,” “potential,” “continue”or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections aboutfuture events that we believe may affect our financial condition, results of operations, business strategy and financial needs. Theseforward-looking statements include statements relating to:

These forward-looking statements involvenumerous risks and uncertainties. Although we believe that our expectations expressed in these forward-looking statements arereasonable, our expectations may later be found to be incorrect. Our actual results of operations or the results of other mattersthat we anticipate could be materially different from our expectations. Important risks and factors that could cause our actualresults to be materially different from our expectations are generally set forth in “Risk Factors,”“Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Business,”“Regulation” and other sections included or incorporated by reference in this prospectus. You should thoroughly readthis prospectus and the documents incorporated herein by reference with the understanding that our actual future results may bematerially different from and worse than what we expect. We qualify all of our forward-looking statements by these cautionarystatements.

The forward-looking statements made in this prospectus relate onlyto events or information as of the date on which the statements are made in or incorporated by reference in this prospectus. Except asrequired by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information,future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. Youshould read this prospectus, the documents incorporated by reference into this prospectus and the documents we have filed as exhibitsto the registration statement, of which this prospectus forms a part, completely and with the understanding that our actual future resultsmay be materially different from what we expect.

RISK FACTORS

Risks Related to Our Business

We have incurredlosses since inception and anticipate that we will continue to incur losses for the foreseeable future. We are not currently profitable,and we may never achieve or sustain profitability.

We were founded in 2009and completed our first commercial sale in 2012. We did not start generating revenues until 2016. We are not profitable and have incurredlosses in each period since our inception in 2009. For the years ended December 31, 2024 and 2023, we reported net losses of $12,497,805and $11,099,488, respectively. As of June 30, 2025, the Company had negative working capital of $4,005,455, an accumulated deficitof $74,568,256, cash and cash equivalents of $588,775, and accounts payable and accrued expenses of $4,960,577.

We expect to continueto incur losses for the foreseeable future, and we expect these losses to increase as we continue to invest in the growth of our business.We may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.The magnitude of our future net losses will depend, in part, on the rate of future growth of our expenses and our ability to generateand grow revenue. Even if we achieve profitability in a future period, we may not be able to sustain profitability in subsequent periods.Our prior losses and expected future losses have had and will continue to have adverse effects on our stockholders’ equity (deficit)and working capital.

There is substantialdoubt about our ability to continue as a going concern.

Our audited financialstatements included in this Annual Report include an explanatory paragraph that indicates that they were prepared assuming that we wouldcontinue as a going concern. We have suffered recurring net losses and accumulated deficits as of June 30, 2025. These conditions raisesubstantial doubts about our ability to continue as a going concern. Our plan for continuing as a going concern includes improving ourprofitability and obtaining additional financing, including public and private placements of capital stock for additional funding to meetour operating needs. There can be no assurance that we will be successful in our plans described above or in attracting equity or alternativefinancing on acceptable terms, or if at all. These consolidated financial statements do not include any adjustments to the recoverabilityand classification of recorded asset amounts and classification of liabilities that might be necessary should we be unable to continueas a going concern.

During the yearended December 31, 2024, we identified a material weakness in our internal control over financial reporting that may cause us to failto meet our reporting obligations or result in material misstatements of our financial statements. If we fail to remediate this materialweakness or if we otherwise fail to establish and maintain effective control over financial reporting, our ability to accurately and timelyreport our financial results could be adversely affected.

We are required to complywith the SEC’s rules implementing Sections 302 and 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”),which requires management to certify financial and other information in our quarterly and annual reports and provide an annual managementreport on the effectiveness of our controls over financial reporting. We are also required to make assessment of our internal controlsover financial reporting pursuant to Section 404. We have included in this Annual Report management’s assessment disclosure of anymaterial weaknesses in our internal control over financial reporting. Our independent registered public accounting firm will not be requiredto attest to the effectiveness of our internal control over financial reporting until our first annual report required to be filed withthe SEC, following the later of the date we are deemed to be an “accelerated filer” or a “large accelerated filer,”each as defined in the Exchange Act. We could be an emerging growth company for up to five years after the date of our initial publicoffering (“IPO”).

A material weakness isa deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibilitythat a material misstatement of our financial statements will not be prevented or detected on a timely basis.

As described elsewherein this Annual Report, we identified a material weakness in our internal control over financial reporting related to a failure to designand maintain adequate controls to maintain appropriate documentation for the tax exempt status of its customers, calculate and collectsales tax at point of sale, and subsequently report and remit in a timely manner to the relevant tax jurisdictions sales tax obligations.

We initiated and implementedseveral remediation measures including, but not limited to, (i) engaging external tax advisors to complement internal resources and effortsand provide support in assessing the appropriate sales tax treatment associated with the Company’s products for all prior yearsin which the Company had generated revenue, (ii) obtaining sales tax exemption letters, representation letters or proof of payments ofcompensating use tax from our customers and we have started a collection effort of these sales taxes from certain customers who have notifiedthe Company that they do not have a sales tax exemption letter, (iii) implementing a sales tax software platform solution for the calculation,communication, collection, and remittance of sales tax for all non-exempt future sales, and assisting with the collection and trackingof Voluntary Disclosure Agreements received from states where a potential sales tax liability may exist, (iv) designing and implementingenhanced policies, procedures and controls related to the calculation, communication, collection, and remittance of sales tax to relevantjurisdictions, and (v) training appropriate personnel in the effective design and execution of our enhanced policies, procedures, andcontrols, including the importance of the ongoing, consistent effective execution of such procedures and controls.

We believe the measuresdescribed above should address the material weakness identified and strengthen our internal control over financial reporting. These measuresare expected to result in future costs for us. While we continue the process to implement our plan to remediate the material weakness,we cannot predict the success of such plan or the outcome of our assessment of this plan until the remediation initiatives have been completedand have been operating effectively for a sufficient period of time. We can give no assurance that these measures will remediate the deficienciesin internal control or that additional material weaknesses or significant deficiencies in our internal control over financial reportingwill not be identified in the future. Our failure to implement and maintain effective internal control over financial reporting couldresult in errors in our financial statements that may lead to a restatement of our financial statements or cause us to fail to meet ourreporting obligations for the year ended December 31, 2024, any of which could diminish investor confidence in us and cause a declinein our stock price.

We may identify futurematerial weaknesses in our internal controls over financial reporting or fail to meet the demands that will be placed upon us as a publiccompany, including the requirements of the Sarbanes-Oxley Act, and we may be unable to accurately report our financial results, or reportthem within the timeframes required by law or stock exchange regulations. We cannot assure that additional material weaknesses will notexist or otherwise be discovered, any of which could adversely affect our reputation, financial condition and results of operations.

We may likely requireadditional capital in the future and an inability to meet future capital needs could adversely impact our ability to operate.

We require substantialcapital to fund our business growth and we will likely need additional capital in the future to fund our operations. In addition to investingin personnel growth commensurate with business growth, we believe we must continue to invest in the development of our iSpecimen Marketplaceplatform to enhance and improve its performance, functionality, ease of use, and reliability to carry out our business strategies. Newindustry standards, the availability of alternative products, and evolving life science research needs could render our products and servicesobsolete and/or new third-party marketplace technology may be introduced that makes it easier for our competitors to create their ownmarketplace platforms. Our success will depend, in part, on our ability to develop new products and services and make corresponding technologyenhancements that address the increasingly sophisticated and varied needs of our suppliers and customers and respond to technologicaladvances and emerging industry standards and practices on a cost-effective and timely basis. We cannot be certain that additional financingwill be available to us if required on favorable terms or at all. To the extent that we cannot raise capital if needed, we may not beable to continue operations.

Our revenue trendis not predictive which can lead to difficulty in accurately forecasting future results.

Our revenue trend isnot predictive and our ability to accurately forecast future results is limited and is impacted by a number of factors, including:

Many of these are outsideof our control and all of which may change from time to time. Our historical revenue results should not be taken as predictive of futureperformance. There are many risks that could impact future performance resulting in variations in expected results which could lead toa negative business impact.

Our growth strategy may not prove viableand we may not realize expected results.

Our business strategyis to grow by improving and expanding iSpecimen’s Marketplace platform. This growth is expected to come through: (i) expansion ofour platform capabilities to drive increased acquisition of annotated biospecimens through the platform, (ii) further expansion of ourcustomer and supplier base in and outside the United States, and (iii) expansion into new lines of business such as patient recruitmentand data licensing. Expansion of our existing business and entry into new lines of business will require a significant investment in technologydevelopment, supply development, operations, and marketing and sales. We may not achieve market expansion and acceptance and we may incurproblems introducing new solutions and services. We may experience losses related to these investments, which could have a material adverseeffect on our results of operations.

Our growth strategy involves a number of risksand uncertainties, including:

If we fail to properlyevaluate and execute existing and new business opportunities properly, we may not achieve anticipated benefits and may incur increasedcosts. There can be no assurance that we will be able to successfully capitalize on growth opportunities, which may adversely impact ourbusiness model, revenues, results of operations, and financial condition.

International operationexpansion could expose us to additional risks which could harm our business, prospects, results of operation, and financial condition.

We operate internationally and expect to expand internationally. Forexample, we procure specimens from sites outside of the United States and we also distribute samples to organizations located around theworld. As of June 30, 2025, we had customers in 5 countries and supply sites in 5 countries, International expansion exposes us to additionalrisks, including:

The occurrence of anyone of these risks could harm our international business and, consequently, our results of operations. Additionally, operating in internationalmarkets requires significant management attention and financial resources. We cannot be certain that the investment and additional resourcesrequired to operate in other countries will produce desired levels of revenue or profitability.

We, or the thirdparties who provide services for us, may be adversely affected by external events for which our business continuity plans may not adequatelyprepare us.

The occurrence of severeweather, natural disasters, health epidemics, acts of war or terrorism, military conflicts such as the war between Russia and Ukraine,and other adverse external events or conditions that impact us or the operations of third parties who provide services for us have thepotential to significantly impact our ability to conduct business. Although we have business continuity plans in place, including an emergencysuccession plan, there is no guarantee that our plans can be successfully implemented. Even if we were to successfully implement our continuityplans, we may incur substantial expenses and there is no guarantee that our business, financial condition, and results of operations willnot be materially impacted.

We rely upon ourtechnology solution for the operation of our business and if our technology platform contains defects or fails to perform as expected,we may need to suspend its availability and divert development resources, and our business and reputation may be harmed.

Technology as complexas ours may contain unknown and undetected errors or performance problems. There could be numerous reasons for performance and qualityissues including new and updated features, defects in integrated commercial and open source technologies, outages and disruptions in thecloud infrastructure on which our platform relies, human error or malfeasance, scale constraints, design flaws, and bad actions by externalfactors including security and performance related incidents. Many serious defects are frequently found during the period immediatelyfollowing introduction and initial release of new capabilities or enhancements to existing platforms. Although we attempt to resolve errorsthat we believe would be considered serious by our users before making our platforms available to them, our products are not error-free.If a significant failure occurs that prevents our customers, suppliers, or our Company from using the iSpecimen Marketplace, our operationsmay be disrupted, and it may be difficult or, in certain cases, impossible for us to continue our business for a period of time untilthe failure is corrected. Any performance or quality problem could result in lost revenues or delays in user acceptance that would bedetrimental to our business and reputation. We may not be able to detect and correct errors before releasing our product commercially.Undetected errors or performance problems in our existing or future products may be discovered in the future and known errors, consideredminor by us, may be considered serious by our customers, resulting in a loss of customers and a decrease in our revenues.

Sustainable futurerevenue growth is dependent upon the development of technology solutions that enable scale and address new markets.

Our iSpecimen Marketplacetechnology consists of four major functional areas: data ingestion and harmonization, search, workflow management, and administration,compliance and reporting. Each of these functional areas need continual development to both enable our current business to scale and toenable us to enter new markets. As financial resources become available, our intention is to focus most of our engineering resources onthe development of the iSpecimen Marketplace platform for the foreseeable future. While we have spent a significant amount of time andresources on the development of this platform, we cannot provide any assurances of our iSpecimen Marketplace’s short or long-termsuccess or growth and there is no assurance that the resources being allocated for the platform will be sufficient to complete plannedadditional capabilities, or that such completion will result in significant revenues or profit for us. If our customers or suppliers donot perceive this platform to be of high value and quality, we may not be able to retain them or acquire new customers or suppliers.

Our platform maybecome technologically obsolete or commoditized.

We must continue to enhanceand improve the performance, functionality, ease of use, and reliability of our iSpecimen Marketplace platform or it may become obsoleteor commoditized. New industry standards, the availability of alternative products, and evolving life science research needs could renderour products and services obsolete and/or new third-party marketplace technology may be introduced that makes it easier for our competitorsto create their own marketplace platforms. Our success will depend, in part, on our ability to develop new products and services thataddress the increasingly sophisticated and varied needs of our suppliers and customers and respond to technological advances and emergingindustry standards and practices on a cost-effective and timely basis. The development of our technology involves significant technicaland business risks. We may fail to use new technologies effectively or to adapt our proprietary technology and systems to user requirementsor emerging industry standards. If we are unable to adapt to changing market conditions, user requirements, or emerging industry standards,we may not be able to increase our revenue and expand our business. Additionally, if existing or future competitors develop or offer productsor services that provide significant performance, price, creative or other advantages over this platform, demand for our services throughthe iSpecimen Marketplace may decrease and our business, prospects, results of operations and financial condition could be adversely affected.

If our securitymeasures are breached, or if our services are subject to attacks that degrade or deny the ability of users to access our platforms, ourplatforms and applications may be perceived as not being secure, customers and suppliers may curtail or stop using our services, and wemay incur significant legal and financial exposure.

Our platforms and thenetwork infrastructure that are hosted by third-party providers involve the storage and transmission of healthcare data as well as proprietaryinformation about organizations and programs, and security breaches could expose us to a risk of loss of this information, litigation,and potential liability. Our security measures may be breached due to the actions of outside parties, employee error, malfeasance, securityflaws in the third party hosting service that we rely upon, or any number of other reasons and, as a result, an unauthorized party mayobtain access to our suppliers’ or customers’ data. Although we have never had any breach of data in our third-party provider’senvironment, any future breach or unauthorized access could result in significant legal and financial exposure, damage to our reputation,and a loss of confidence in the security of our platforms and applications that could potentially have an adverse effect on our business.Because the techniques used to obtain unauthorized access, disable or degrade service, or sabotage systems change frequently and oftenare not recognized until launched against a target, we may be unable to anticipate these techniques or to implement adequate preventativemeasures on a timely basis. If an actual or perceived breach of our security occurs, the market perception of the effectiveness of oursecurity measures could be harmed and we could lose suppliers and customers and we may have difficulty obtaining merchant processors orinsurance coverage essential for our operations.

We, and the third-partyproviders upon which we rely, have experienced, and may in the future experience, cybersecurity threats, including threats or attemptsto disrupt our information technology infrastructure and unauthorized attempts to gain access to sensitive or confidential information.Our and our third-party vendors’ technology systems may be damaged or compromised by malicious events, such as cyberattacks (includingcomputer viruses, malicious and destructive code, phishing attacks, and denial of service attacks), physical or electronic security breaches,natural disasters, fire, power loss, telecommunications failures, personnel misconduct, and human error. Such attacks or security breachesmay be perpetrated by internal bad actors, such as employees or contractors, or by third parties (including traditional computer hackers,persons involved with organized crime, or foreign state or foreign state- supported actors). Cybersecurity threats can employ a wide varietyof methods and techniques, which may include the use of social engineering techniques, are constantly evolving, and have become increasinglycomplex and sophisticated; all of which increase the difficulty of detecting and successfully defending against them. Furthermore, becausethe techniques used to obtain unauthorized access or sabotage systems change frequently and generally are not identified until after theyare launched against a target, we and our third-party providers may be unable to anticipate these techniques or implement adequate preventativemeasures. Although prior cyberattacks directed at us have not had a material impact on our financial results, and we are continuing tobolster our threat detection and mitigation processes and procedures, we cannot guarantee that future cyberattacks, if successful, willnot have a material impact on our business or financial results. While we have security measures in place to protect our information andour customers’ and suppliers’ information and to prevent data loss and other security breaches, there can be no assurancethat in the future we will be able to anticipate or prevent security breaches or unauthorized access of our information technology systemsor the information technology systems of the third-party providers upon which we rely. Despite our implementation of network securitymeasures and internal information security policies, data stored on personnel computer systems is also vulnerable to similar securitybreaches, unauthorized tampering or human error.

Many governments andother regulatory bodies including the SEC have enacted laws requiring companies to provide notice of data security incidents involvingcertain types of data, including personal data. If an actual or perceived breach of security measures, unauthorized access to our systemor the systems of the third-party providers that we rely upon, or any other cybersecurity threat occurs, we may face direct or indirectliability, costs, or damages, contract termination, our reputation in the industry and with current and potential customers may be compromised,our ability to attract new customers could be negatively affected, and our business, financial condition, and results of operations couldbe materially and adversely affected.

We maintain cybersecurityinsurance and other types of insurance, subject to applicable deductibles and policy limits, but our insurance may not be sufficient tocover all costs associated with a potential data security incident. We also cannot be sure that our existing general liability insurancecoverage and coverage for cyber liability or errors or omissions will continue to be available on acceptable terms or will be availablein sufficient amounts to cover one or more large claims or that the insurer will not deny coverage as to any future claim. The successfulassertion of one or more large claims against us that exceed available insurance coverage, or the occurrence of changes in our insurancepolicies, including premium increases or the imposition of large deductible or co-insurance requirements, could harm our financial condition.

Changes in demandfor our products and services could affect profitability.

We are fundamentallya matchmaking service provider between researchers who have needs for access to subjects, samples, and data, and healthcare providersand other organizations that have them. Any change that either reduces the demand for our services or changes the composition of the demandcould adversely impact our financial results.

Overall customer demandcould change for many reasons outside of our control, reducing demand or making it more difficult to match up to our supply chain’scapabilities. These reasons include:

If we fail to addressthese factors in a timely manner or at all, our financial results could be adversely affected.

Additionally, overall customer demand coulddecrease if we fail to:

We incur creditrisk with our customers, and we may provide them with products and services for which we do not get paid.

Our customers generallyplace orders for our products and services using a purchase order and we invoice our customers after they have received the products orservices from us. During this procurement process, we become obligated to pay our suppliers for any products or services we procure fromthem on behalf of our customers regardless of whether our customers ultimately pay us for these products or services. Therefore, we bearthe responsibility for the credit risk of our customers. We mitigate this credit risk through procedures that evaluate the creditworthinessof customers prior to accepting a purchase order from them. However, our procedures may not successfully identify all those who ultimatelyfail to pay us for our products and services and any non-payments may negatively impact our revenues, results of operations, and financialcondition.

Our customer mixincreases the risk of customers not paying our invoices.

We derive, and believethat we may continue to derive, a significant portion of our revenues from privately held, investor-backed biopharma companies that arenot profitable and have little operating history. These organizations may be at a higher risk of not paying for provided products andservices on a timely basis or at all. If these companies fail to pay our invoices, our profitability will be adversely impacted.

We rely upon relativelyfew customers for a significant portion of revenue and do not have a recurring revenue business model. A loss of large customers couldaffect our ability to operate.

We have derived, andbelieve that we may continue to derive, a significant portion of our revenue from a limited number of customers that vary each year. Wedo not have a recurring revenue model and our customers may buy less of our products or services depending on their research and developmentcycles, internal budget cycles, product and service requirements, and competitive offerings. A major customer in one year may not purchaseany of our products or services in another year, which may adversely affect our financial performance.

Customers and customerprospects may be averse to using a self-service marketplace to procure specimens and may continue to require iSpecimen personnel in theprocurement process, impacting our scalability and profitability.

The iSpecimen Marketplacefunctions as a lead generation system to capture customer requests for specimens and as a workflow engine to allow customers, suppliers,and our Company to track and manage specimen requests. Currently, it does not fully support self-service eCommerce because key capabilitiesrequired to satisfy these transactions across all of our product lines, such as a pricing engine and patient-level search, have yet tobe incorporated. Therefore, currently all customer requests for specimens require assistance from iSpecimen sales personnel. At a minimum,our sales personnel are involved in the generation of customer quotes, but they often also act in a consulting role to help develop specimenrequest specifications on more complex projects or to perform searches on the customer or customer prospect’s behalf.

While we continue toinvest in capabilities to support customer self-service in the iSpecimen Marketplace, we do not know when we will consider these capabilitiesto be fully developed. Additionally, we do not know if researchers will utilize the iSpecimen Marketplace to transact without the interventionof iSpecimen personnel which could limit our scalability. We may continue to invest in software which may never provide a return on itsinvestment and diverts resources from the development of software that drives other parts of our procurement workflow.

Our business maybe materially and adversely impacted by the reduction, delay or cancellation of orders from our customers.

Our contracts with ourcustomers generally allow them to reduce, delay, or cancel the unfulfilled portion of their specimen order with a two-week notice. Customersmay reduce, delay, or cancel their unfulfilled orders due to a variety of reasons including they make changes to project requirementsand the open request no longer meets their needs; their budgets change or projects get cancelled; they place orders with multiple specimenproviders and cancel open orders when they have procured sufficient quantity of samples across all their sources; or we are unable tofulfill the entire order before the project deadline. These percentages do not take into consideration long term or open- ended projectsthat are not intended to be completely fulfilled at year end. Our business, financial condition, results of operations and cash flowsmay be materially and adversely impacted by the reduction, delay or cancellation of orders.

We have enteredinto contracts with U.S. government agencies and contractors which subjects us to federal contract and audit risks.

We entered into contractswith U.S. government agencies and contractors that may contain unfavorable termination provisions and are subject to audit and modificationby the government at its sole discretion, which subjects us to additional risks. These risks include the ability of the U.S. governmentto unilaterally:

The U.S. government mayterminate any of its contracts with us either for its convenience or if we default by failing to perform in accordance with the contractschedule and terms. Termination for convenience provisions may enable us to recover only our costs incurred or committed, and settlementexpenses and profit on the work completed prior to termination. Termination for default provisions may not permit these recoveries andmake us liable for excess costs incurred by the U.S. government in procuring undelivered items from another source.

As a U.S. governmentcontractor and subcontractor, we may become subject to periodic audits and reviews. Based on the results of these audits, the U.S. governmentmay adjust our contract-related costs and fees, including allocated indirect costs. As part of any such audit or review, the U.S. governmentmay review the adequacy of, and our compliance with, our internal control systems and policies, including those relating to our purchasing,property, compensation, and/or management information systems. In addition, if an audit or review uncovers any improper or illegal activity,we may be subject to civil and criminal penalties and administrative sanctions, including termination of our contracts, forfeiture ofprofits, suspension of payments, fines and suspension or prohibition from doing business with the U.S. government.

We could also sufferserious harm to our reputation if allegations of impropriety were made against us. Although we have not had any government audits andreviews to date, future audits and reviews could cause adverse effects.

Sustainable futurerevenue growth is dependent on growth in the capabilities of our supply network which we may not be able to achieve.

Our business is fundamentallya match-making business between healthcare providers who have access to subjects, samples, and data and life science researchers who needthem. Currently, we receive more requests for our products and services than we have access to in our supply network and we are thereforesupply constrained. Although we continue to allocate resources to supply development and commensurately grow our supply network capabilitiesto keep pace with demand, this supply-demand imbalance could increase in the future if we do not continue or increase our investment inthis area.

Additionally, demandfor specimens we receive is becoming more specific, requiring access to a greater population of subjects, samples, and data to find thosethat meet a researcher’s inclusion and exclusion criteria. It takes a larger network of subjects, samples, and data to access awide enough population of subjects to meet a growing number of requests with more stringent criteria. Delays, difficulties, or unanticipatedcosts in developing our supply network capabilities necessary to successfully procure products and services could adversely affect revenueand profitability.

Sustainable futurerevenue growth is dependent upon gaining access to more healthcare data from our supply network and a failure to obtain this data mayadversely affect our growth.

Key to our growth strategyis the accessibility and availability of deep medical record data from our healthcare provider supply sites. This data is used to automatethe process of matching researchers to subjects, samples, and data, and also used to automate the procurement workflow. Currently, wehave gained access to laboratory data to support the distribution of clinical lab specimens as well as biorepository data to support thedistribution of banked specimens. However, we have not gained access to deeper medical record data sets from a broad set of healthcareproviders to support custom specimen collections, clinical trial recruitment, or data licensing. Should we fail in our ability to accessdeeper healthcare data, we may not be able to effectively compete in our served markets or grow as anticipated and our business may suffer.

The adoption cycleof our supply network tends to be very lengthy, which may adversely affect our ability to scale rapidly and increase revenues.

The business developmentcycle for the adoption of our technology solution at healthcare provider supply partners can take up to 18 months or more from initialcontact with the prospect through execution of a contract. We may spend significant resources to attempt to secure a new supply partnerwithout successfully engaging the supply partner. Even if we are successful in securing a new supply partner, once a contract is executed,implementation of our technology in the supply partner’s environment can take another several months to a year or more. Becauseof the lengthy adoption cycle, we may fail to expand our supply network quickly enough to reach our revenue growth targets.

Potential adverseeffects from changes in the healthcare industry, including consolidations and regulatory changes, could affect access to subjects, samples,and data and affect our growth.

Changing healthcare-relatedlegislation and regulation may impact the fiscal stability and sustainability of our supply partners. Additionally, many healthcare providersare consolidating to create larger healthcare systems and/or integrated healthcare delivery systems. These changes can divert resourcesat our healthcare provider supply sites away from the evaluation or implementation of the iSpecimen solution to the adoption of new infrastructure,policies, and procedures to support the changes, thereby extending their timeline to adopt the iSpecimen solution. We cannot predict whetheror when future healthcare reform initiatives at the international, federal, or state level, consolidations, or other initiatives affectinghealthcare providers’ businesses will be proposed, enacted, or implemented or what impact those initiatives may have on our business,results of operations, and financial condition.

Our supply chainmay not provide adequate resources to quickly respond to requests for specimens and delays in the procurement process can affect our reputation,revenue, and profitability.

Many of the healthcareproviders in our supply network are not-for-profit organizations whose primary business is to provide clinical care to patients. Supportingbiospecimen research may be an adjunct activity for them. These organizations may lack adequate resources to quickly respond to our requestsfor specimens now and into the future. Should we and our customers experience slow turnaround times on specimen requests, our reputationmay be damaged and there may be an adverse impact on our revenue and profitability.

We do not controlthe end-to-end quality of specimens and data collected in our supply chain and quality issues can affect our reputation, revenue, andprofitability.

We rely upon our supplysites and their quality control processes to provide us with products and services that meet order specifications. In certain situations,products are shipped directly from the supply sites to our customers. When we receive products from our supply sites, we perform a visualinspection of the products, but we do not perform an in-depth quality control check to ensure that products meet all specifications.

Instead, we rely uponour customers to perform quality checks themselves and offer refunds or replacements for products that do not meet specification. Followingfeedback from our customers, we implemented a robust return and exchange program to better meet customer needs. iSpecimen is also terminatingcontracts with suppliers with lower quality specimens. Any issues with quality from our supply sites can adversely affect our reputation,revenue, and profitability.

Reliance on relativelyfew supply partners for significant supplies and services could affect our ability to operate and grow.

We have derived, andbelieve that we may continue to derive, a significant portion of our revenues from products we procure from a limited number of supplysites. Any change in the ability of a major supply site to provide us with products and services (such as financial health of the supplysite, key leadership, research focus, information technology, competitive demand for specimens from third-parties, pricing structures,contract status and changes in the general economy) may adversely affect our financial performance.

Specimen collectionfrom human subjects, including the possible occurrence of adverse events during or after tissue collection, could provide exposure toclaims and litigation.

There are inherent risksassociated with collecting specimens from human subjects. Although specimen collections are completed by certified staff according toestablished industry standards, specimen donors vary in their ability to tolerate specimen collection protocols and such donors may potentiallyhave an adverse health reaction either during or following a specimen collection. Research subjects or their legally authorized representativemay file claims related to a specimen collection and these claims could result in litigation that could be expensive, and time consumingto defend or result in judgements that exceed the resources of the Company and its insurance coverage.

We procure specimensand data from organizations outside of the U.S. and as such, we rely upon these organizations to collect and distribute specimens anddata in accordance with their local regulations as well as our contractual requirements. A failure by our sites to comply with both applicableregulations and our contractual requirements could introduce us to compliance risk.

Some of the organizationsfrom which we procure specimens and data reside outside of the U.S. in jurisdictions that may have data protection rules, human researchprotection rules, and other pertinent rules that relate to the collection and distribution of specimens and data that vary from U.S. regulations.We, as an organization are not knowledgeable about all the pertinent rules and regulations of all of the jurisdictions in which thesesites operate, and therefore we rely upon our contractual relationships with supply sites to ensure that they have legal responsibilityfor compliance with their own jurisdiction-specific regulations.

Should any site failto comply with the applicable regulations, we may suffer reputational risks if we have distributed specimens and data from that site.Additionally, any compliance failure on the part of our supply sites that impacts our research customers’ ability to utilize specimensand data they previously obtained from us, as well as utilize any research results, they derived from these specimens and data, may subjectus to claims by these customers. These claims could result in litigation that could be expensive to defend or result in judgements thatexceed our resources and our insurance coverage. Any such litigations and judgement could adversely affect our business, financial condition,and results of operations.

We may experiencedelays or interruption in the shipments of our specimens due to factors outside of our control, and such disruption could lead to lostrevenue and customer satisfaction issues.

We distribute biologicalspecimens to customers around the world. These specimens need to be delivered over a range of temperatures from ambient to cryogenic anddelivery timeframes that can be as quick as hours. We rely on third- party shipping materials (such as thermal containers) as well asshipping services (such as FedEx) to transport specimens to our customers. Shipping materials may be defective and third-party shippingservices, including international shipping services, could become disrupted by adverse weather conditions, natural disasters, militaryconflicts, flight cancellations, ground logistics issues, customs delays, and other service interruptions. Any defect in our shippingmaterials or delays in shipping service times could cause damage to these specimens and render them unusable by our customers. If we areunable to deliver our specimens in a timely matter and without damage, our revenue could be negatively impacted and our reputation withour customers could suffer, resulting in material harm to our business.

The Company’s businesswas negatively impacted during the first half of 2022 by the ongoing war between Russia and Ukraine. At the start of the war, the Companyhad approximately $1 million of purchase orders that were slated to be fulfilled by the Company’s supply network in Ukraine andRussia. This supply network shut down quickly at the start of the war. Ukrainian suppliers were disabled due to war conditions and evacuationsand some of the Company’s Russian suppliers were disabled by sanctions. While the Company mobilized to shift these purchase ordersto other suppliers in the network, the process of getting specimen collections from other supply sites took time, which caused a delayin the fulfillment of such purchase orders.

As of December 31, 2023and 2024, the Company’s supply sites in Russia that had not been under sanctions were now accessible and the Company’s supplysites in Ukraine had mostly reopened. However, due to the uncertainty caused by the ongoing war, Ukraine suppliers may again become inaccessibleto the Company. Therefore, as long as the uncertainty continues, the Company does not use them as sole specimen sources at a purchaseorder level. Alternate suppliers do not have the same favorable unit economics or specimen collection rates. The short and long-term implicationsof the war are difficult to predict at this time. The imposition of more sanctions and counter sanctions may have an adverse effect onthe economic markets generally and could impact the Company’s business and the businesses of the Company’s supply partners,especially those in Ukraine and Russia. Because of the highly uncertain and dynamic nature of these events, it is not currently possibleto estimate the impact of the war on the Company’s business and the companies from which the Company obtains supplies and distributesspecimens.

Our future successdepends on our ability to retain our key personnel and to attract, retain and motivate qualified personnel.

Our future success willdepend upon our ability to retain our key management and other personnel and will also depend in large part on our ability to attractand retain additional qualified software developers, bioinformaticists, operations personnel, sales and marketing personnel, and businessdevelopment personnel. Competition for these types of employees is intense due to the limited number of qualified professionals and thehigh demand for them, particularly in the Boston, Massachusetts area where our headquarters are located. We have in the past experienceddifficulty in recruiting qualified personnel, especially in the area of sales. Failure to attract, assimilate, and retain personnel wouldhave a material adverse effect on our business and potential growth.

Our senior managementteam has limited experience managing a public company.

Our senior managementteam has limited experience managing a public company, and regulatory compliance may divert its attention from the day-to-day managementof our business. Our management team may not successfully or efficiently manage our continued transition to a public company that willbe subject to significant regulatory oversight and reporting obligations under the federal securities laws. In particular, these obligationswill require substantial attention from our senior management and could divert their attention away from the day-to-day management ofour business, which could materially and adversely impact our business operations.

Our competitorsmay have greater resources than us and may outspend us to grow more quickly.

Our competitors are highlyfragmented and comprise of thousands of biobanks, healthcare providers, and commercial biospecimen organizations. We expect to continueto experience significant and increasing levels of competition in the future, especially from several larger biospecimen providers whohave consolidated via mergers and acquisitions and who are well-capitalized by private equity. These organizations are currently acquiringsmaller biospecimen businesses and have larger customer bases, their own collection centers, biospecimen inventories, larger marketingand sales budgets, and an international presence. They may also be developing their own technology solution that could be better or lesscostly to develop than our own iSpecimen Marketplace, thereby eliminating one of our key competitive advantages. They may continue tooutspend us to grow more quickly and we may not be able to successfully compete with a competitor that has greater resources; hence suchcompetition may adversely affect our business.

We may lose businessto competitors which have or develop their own biorepositories and/or collection centers that can meet customers’ needs.

Many of our competitorshave their own biorepository of specimens that they have collected or procured over time. These inventories, when they meet a customer’sneeds for product, almost always provide our competitors with a time-to-delivery advantage because they can directly fulfill requestsfrom their own inventories, whereas we must procure products through our supply network after an order has been received from our customers.Additionally, some competitors have their own collection facilities and direct access to eligible research subjects, which also providesa time-to-delivery advantage. We have lost and will continue to lose business to competitors when they can provide samples more quicklythan we can from our supply network.

We may face pricingpressure from competitors who may lower prices to reduce biorepository inventories or because they have more favorable specimen acquisitioncosts.

Many competitors investin biorepositories of specimens and data. These competitors may be incented to drop prices in order to more quickly recoup their inventorycarrying costs, especially when they have held inventory for longer periods of time. This may cause downward pricing pressure on us. Additionally,some competitors may have cost advantages on some types of collections either because of more favorable supply relationships or becausethey have their own collection centers, and they can likewise exert pricing pressure in the market. Lower prices will adversely impactour revenue and gross margins.

Our overall business results may sufferfrom an economic downturn.

We rely upon researchersfrom biopharma companies as the primary source of our revenue. During an economic downturn, the biopharma industry typically experiencesa drop in the annual growth rate of research and development spending and allocates fewer resources towards it. An economic downturn couldadversely affect the demand for our products and services and have a corresponding impact on our revenue and profitability. A prolongedeconomic downturn may cause us to reduce investment in the longer-term growth of our Company in order to reduce short term costs.

Our operations and performancedepend on economic conditions in the United States and other countries where we do business. Deterioration in general economic conditionscould negatively affect our and our customers’ purchasing power.

Our results of operations and financialcondition may be adversely impacted from high inflation rates.

We have experienced negativeeffects from inflation in certain areas of our business due to the recent high rates of inflation in the U.S. and around the world. Inflationis causing the cost of employee salaries to rise and our salaries account for a significant portion of our overall operating costs. Additionally,costs of supplies and other sales, marketing and general and administrative costs have increased due to inflation.

Inflation has not hada significant adverse impact on the cost of specimens due to our long-term contracts maintained with vendors, which include revenue sharingplans. However, if inflation continues, it may have an adverse impact on the costs of our samples in the future.

Our timely fulfillment of customer ordersmay be adversely impacted due to constraints in the supply chain.

Our operations are heavilyreliant on specimen availability and delays or shortages in obtaining specimens caused by constraints in the supply chain, may adverselyimpact the timing and extent of our ability to fulfill our customer orders which could adversely impact our results of operations andfinancial condition.

We may have difficultymanaging growth in our business, which could adversely affect our financial condition and results of operations.

Significant growth inthe size and scope of our operations could place a strain on our financial, technical, operational, and management resources. The failureto continue to upgrade our technical, administrative, operating and financial control systems, or the occurrences of unexpected expansiondifficulties, could have a material adverse effect on our financial condition and our ability to timely execute our business plans.

We have incurredlosses from sales tax obligations owed to various jurisdictions by us because we did not collect taxes on taxable sales in prior years,and we may never be able to recover the prior sales taxes from the customers.

States and other jurisdictionshave varying policies regarding when a company has a taxable presence in their locale. We are required to collect taxes on taxable salesin prior years but we failed to do so and thus have incurred losses from sales tax obligations owed to various jurisdictions. We are indiscussions with those tax jurisdictions to rectify and have made tax payments to some of those jurisdictions. We have also reached outto our customers who owe sales taxes and recovered partial tax payments from certain customers. However, we may never be able to recoverthe prior sales taxes from all the customers, which could have a material adverse effect on our financial condition.

We may acquireother businesses, products, or technologies that could disrupt our business, reduce our financial resources, or cause dilution to ourstockholders.

As part of our businessstrategy, we may, in the future, pursue acquisitions of businesses and assets or pursue strategic alliances and joint ventures that leverageour core technology and industry experience to expand our offerings, increase our customer base, or increase our supply base. We havelimited experience with acquiring other companies or assets, with forming strategic alliances and joint ventures. We may not be able tofind suitable partners or acquisition candidates, and we may not be able to complete such transactions on favorable terms, if at all.If we make any acquisitions, we may not be able to integrate these acquisitions successfully into our existing business, and we couldassume unknown or contingent liabilities. Any future acquisitions also could result in significant write-offs or the incurrence of debtand contingent liabilities, any of which could have a material adverse effect on our financial condition, results of operations, and cashflows. Integration of an acquired company also may disrupt ongoing operations and require management resources that would otherwise focuson developing our existing business. We may experience losses related to acquisitions of other companies, which could have a materialadverse effect on our results of operations. We may not identify or complete these transactions in a timely manner, on a cost-effectivebasis, or at all, and we may not realize the anticipated benefits of any acquisition, technology license, strategic alliance, or jointventure.

To finance any acquisitionsor joint ventures, we may choose to issue shares of our common stock as consideration, which would dilute the ownership of our stockholders.If the price of our common stock is low or volatile, we may not be able to acquire other companies or fund a joint venture project usingour stock as consideration. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or privatefinancings. Additional funds may not be available on terms that are favorable to us, or at all.

We may incur significantdebt, and our governing documents contain no limit on the amount of debt we may incur.

Subject to market conditionsand availability, we may incur significant debt through the Purchase Agreement or other repurchase or credit facilities (including termloans and revolving facilities), public and private debt issuances or otherwise. The amount of leverage we use will vary depending onour available capital, our ability to obtain and access financing arrangements with lenders and our estimate of the stability of our cashflow. Our governing documents contain no limit on the amount of debt we may incur, and we may significantly increase the amount of leveragewe utilize at any time without approval of our shareholders. The amount of leverage on individual assets may vary, with leverage on someassets substantially higher than others. Leverage can enhance our potential returns but can also exacerbate our losses.

Incurring substantialdebt could subject us to many risks that, if realized, would materially and adversely affect us, including the risk that:

We cannot be sure thatour leverage strategies will be successful.

A failure to complywith restrictive covenants in the Purchase Agreement or our other financing arrangements would have a material adverse effect on us, andany future financings may require us to provide additional collateral or pay down debt.

We are subject to variousrestrictive covenants contained in the Purchase Agreement and we may be subject to additional covenants in connection with future financingarrangements. Financing arrangements that we may enter into in the future may contain similar or more restrictive covenants. These covenantsmay limit our flexibility to pursue certain investments or incur additional debt. If we fail to meet or satisfy any of these covenants,we may be in default under the agreements governing the applicable arrangements, and our lenders could elect to accelerate our obligationto repurchase certain assets, declare outstanding amounts due and payable, terminate their commitments, require the posting of additionalcollateral or enforce their rights against existing collateral. We may also be subject to cross default and acceleration rights and, withrespect to collateralized debt, the posting of additional collateral or foreclosure upon default.

Risks Related to Intellectual Property

We use third-party technology licensesas part of our technology solution.

The iSpecimen Marketplaceuses third parties for certain technology to support development, delivery, and operations of the platform including product management,software development, cloud hosting, data processing, content mapping, and security services and may need to license additional technologyin the future for use in the ongoing operations as part of our technology solution. Most of the software (including source code) and othermaterials we use are distributed under a “free,” “open source,” or similar licensing model. We also use softwareand services from commercial providers. However, we believe all of them are generally commercially available to us from other parties.We continue to evaluate partners whose capabilities can help us deliver our iSpecimen Marketplace solution in areas such as functionality,efficiency, and security and expect to continue to leverage and consider additional third-party capabilities in our ongoing Marketplacedevelopment. However, there is no assurance that these third-party technology licenses will continue to be available to us on acceptablecommercial terms or at all, which could significantly harm our business, financial condition, and operating results.

We use open sourcelicenses as part of our technology solution, which may subject us to claims from third parties claiming ownership and unauthorized use.

We use open source softwarein our software solutions and technology-enabled services. We may encounter claims from third parties claiming ownership and unauthorizeduse of the software purported to be licensed under the open source terms, demanding release of derivative works of open source softwarethat could include our proprietary source code, or otherwise seeking to enforce the terms of the applicable open source licenses. Theseclaims could result in litigation that could be expensive to defend. If we become liable to third parties for such claims, we could berequired to make our software source code available under the applicable open source license, utilize or develop alternative technology,or cease using, selling, offering for sale, licensing, implementing or supporting the applicable solutions or technology-enabled services.In addition, use of certain open source software may pose greater risks than use of third-party commercial software, as most open sourcelicensors and distributors do not provide commercial warranties or indemnities or controls on the origin of the software.

We may become subjectto third parties’ claims alleging infringement of their patents and proprietary rights, which could be costly, time consuming, andprevent the use of our technology solution.

We cannot assure youthat third parties will not claim our current or future products or services infringe their intellectual property rights. Any such claims,with or without merit, could cause costly litigation that could consume significant management time. As the number of product and servicesofferings in our market increases and functionalities increasingly overlap, companies such as ours may become increasingly subject toinfringement claims. These claims also might require us to enter into royalty or license agreements. If required, we may not be able toobtain such royalty or license agreements or obtain them on terms acceptable to us.

We do not haveany patents protecting our intellectual property and if we are unable to protect the confidentiality of our trade secrets, know-how andother proprietary and internally developed technology, our business could be adversely affected.

Our success depends uponour proprietary technology. We do not have registered patents on any of our technology because we do not believe that we could obtainblocking patents and that the costs of patent monitoring and prosecution outweigh the benefits. Instead, we rely upon software copyrightlaws, service marks, trade secret laws, confidentiality procedures, and contractual provisions to establish and protect our proprietaryrights as well as the skills, knowledge and experience of our technical and operational personnel, our consultants and advisors, and contractors.Because we operate in a highly competitive industry, we rely in part on trade secrets to protect our proprietary technology and processes.However, trade secrets are difficult to protect.

We enter into confidentialityor non-disclosure agreements with our corporate partners, employees, consultants, collaborators, and other advisors. These agreementsgenerally require that the receiving party keep confidential and not disclose to third-parties confidential information developed by thereceiving party or made known to the receiving party by us during the course of the receiving party’s relationship with us. Theseagreements also generally provide that inventions conceived by the receiving party in the course of rendering services to us will be ourexclusive property, and we enter into assignment agreements to protect our rights. These confidentiality, inventions and assignment agreementsmay be breached and may not effectively assign intellectual property rights to us. Our trade secrets also could be independently discoveredby competitors, in which case we may not be able to prevent the use of such trade secrets by our competitors. The enforcement of a claimalleging that a party illegally obtained and was using our trade secrets could be difficult, expensive and time consuming and the outcomewould be unpredictable. In addition, effective protection of intellectual property rights is unavailable or limited in certain foreigncountries. The failure to obtain or maintain meaningful trade secret protection could adversely affect our competitive position.

Risks Related to RegulatoryEnvironment

Failure to complywith federal and state data protection regulations could result in fines, penalties, and litigation, and have a material adverse effectupon our business.

Because we may gain accessto protected healthcare or personal data, we must comply with various data protection regulations worldwide, including the Health InsurancePortability and Accountability Act of 1996, as amended by HITECH, and their implementing regulations at 45 CFR Parts 160-164 (collectively,“HIPAA”). As part of the operation of our business, we act in the capacity of a HIPAA business associate with respect to protectedhealth information (“PHI”), we receive from our healthcare provider partners. As a HIPAA business associate, we are requiredto protect the privacy and confidentiality of PHI, and we are required to comply with HIPAA security regulations requiring certain administrative,physical, and technical safeguards to ensure the confidentiality, integrity, and availability of electronic PHI (“ePHI”).To comply with our regulatory and contractual obligations, which may change over time, we may have to reorganize processes and investin new technologies. We are also required to train personnel regarding data protection requirements. If we, or any of our employees oragents, are unable to maintain the privacy, confidentiality, and security of the PHI that is entrusted to us, we could be subject to civiland criminal fines and sanctions imposed by the HHS or state regulatory authorities, and we could be found to have breached our HIPAAbusiness associate agreements with our healthcare provider suppliers. In addition to the HIPAA requirements that we are subject to, wemay be subject to similar state laws and regulations, which regulate the collection, handling, processing, and storage of sensitive personalinformation. While we have never had a data breach, we cannot guarantee that it will not happen in the future nor can we guarantee thatwe will always be in compliance with these regulations. Failure to comply with federal, state and local laws and regulations could subjectthe Company to denial of the right to conduct business, fines, criminal penalties, and/or other enforcement actions which would have amaterial adverse effect on its business. In addition, compliance with future legislation could impose additional requirements on the Company,which may be costly.

Failure to complywith international laws related to data protection, such as the General Data Protection Regulation (“GDPR”) could result infines, penalties, and litigation, and have a material adverse effect upon the Company’s business.

We may be required tocomply with international laws, such as the GDPR. The GDPR took effect in May 2018 and regulates the collection, storage, use, disclosure,transfer, and/or other processing of personal data of identified or identifiable individuals located in the European Economic Area (“EEA”),including the EU. This data specifically includes personal health data that generally is provided as part of biospecimen collection studies.The GDPR imposes numerous requirements on companies that process personal data, including requirements relating to processing health andother sensitive data, obtaining consent of the individuals to whom the personal data relates for processing (with some exceptions), allowingindividuals to revoke consents granted, enabling individuals the right to have their data erased (with some exceptions), amended, or transferredto another data controller (known as “data portability”), providing information to individuals regarding data processing activities,implementing safeguards to protect the security and confidentiality of personal data, limiting the transfer of data to countries outsideof the EU, providing notification of data breaches, and taking certain measures when engaging third-parties who may also use or processthe data. In addition, EU member states may make their own further laws and regulations limiting the processing of personal data, includingbiometric, genetic or health data.

The GDPR covers areaswhere we may not have expertise and the GDPR and the regulatory guidance enforcing GDPR may be actively evolving. We, or our other third-partycustomers, suppliers and/or distribution partners, may not be able to maintain regulatory compliance with the GDPR or may incur significantcosts in obtaining or maintaining regulatory compliance. Any action brought against us for violations of this law, even if successfullydefended, could cause us to incur significant legal expenses, reputational risks, and divert our management’s attention from theoperation of our business. In addition, compliance with future legislation could impose additional requirements on the Company, whichmay be costly.

Failure to complywith federal and state laws around environmental, health and safety, biohazards and dangerous goods, and imports/exports could resultin fines, penalties, and litigation, and have a material adverse effect upon our business.

Because we receive, store,and ship specimens, we are subject to regulation under federal, state, and local laws and regulations relating to the protection of theenvironment and human health and safety, including laws and regulations relating to the handling, transportation, and disposal of specimensand infectious and hazardous waste materials, as well as regulations relating to the safety and health of laboratory employees. Our laboratoryis subject to applicable federal and state laws and regulations relating to biohazard disposal of all laboratory specimens, and we utilizeoutside vendors for disposal of such specimens. In addition, the federal Occupational Safety and Health Administration has establishedextensive requirements relating to workplace safety for healthcare employers whose workers may be exposed to blood-borne pathogens suchas HIV, COVID-19, and the hepatitis B virus. These requirements, among other things, require work practice controls, protective clothingand equipment, training, medical follow-up, vaccinations, and other measures designed to minimize exposure to, and transmission of, blood-bornepathogens. There are also federal laws related to import and export of biospecimens and related data.

Failure to comply withfederal, state and local laws and regulations could subject us to denial of the right to conduct business, fines, criminal penalties,and/or other enforcement actions which would have a material adverse effect on our business. In addition, compliance with future legislationcould impose additional requirements on us which may be costly.

Failure to complywith other international laws around environmental, health and safety, biohazards and dangerous goods, imports/exports, and other regulationscould result in fines, penalties, and litigation, and have a material adverse effect upon our business.

Because we procure specimensfrom and distribute specimens to countries outside of the United States, we are subject to international and foreign rules similar toany of the aforementioned U.S. rules, including those related to environmental, health and safety, biohazards, and imports/exports. Wemay be unaware of those international and foreign rules.

These laws cover areaswhere we may not have expertise and, in many areas, these laws are actively evolving. We, or our other third-party customers, suppliersand/or distribution partners, may not be able to maintain regulatory compliance in such countries or may incur significant costs in obtainingor maintaining our foreign regulatory compliance. Any action brought against us for violations of these laws or regulations, even if successfullydefended, could cause us to incur significant legal expenses, reputational risks, and divert our management’s attention from theoperation of our business. In addition, compliance with future legislation could impose additional requirements on us which may be costly.

Failure to complywith laws and regulations related to the protection of research subjects could result in fines, penalties, and litigation, and have amaterial adverse effect upon our business.

We are subject to regulationunder international, federal, state, and local laws and regulations relating to the protection of research subjects. Federally-fundedhuman-subject research in the United States, including the collection of identifiable human biospecimens, is governed by 45 CFR Part 46,also known as the Health and Human Services Policy for Protection of Human Research Subjects or the “Common Rule.” Use ofbiospecimens in certain other research is subject to FDA regulations for the Protection of Human Subjects and Institutional Review Boardsat 21 CFR Parts 50 and 56. Research funded by the National Institutes of Health (“NIH”) may be subject to grant or contractrequirements, as well as NIH Certificates of Confidentiality. When collecting specimens for research in the United States, iSpecimen andits collection sites are responsible for ensuring that specimens are collected in accordance with these regulations. In addition, othercountries have their own regulations around the ethical collection of human specimens for research. While we believe that we are in compliancewith these laws, we may not be aware of all such laws or may fail to properly audit and identify gaps in compliance. Similarly, we mayfind errors in our technology and processes and may fail to properly match the compliance requirements of our researchers to the compliancerequirements of our suppliers. Failure of our Company or our suppliers to comply with international, federal, state, and local laws andregulations could subject us to denial of the right to conduct business, fines, criminal penalties, and/or other enforcement actions whichcould have a material adverse effect on our business.

Our failure tocomply with other laws and regulations related to our business operations also have a material adverse effect upon our business.

In addition to the above-describedlaws and regulations, there are many other federal, state and international laws and regulations applicable to iSpecimen. The followinglist contains some of the other laws and regulations that could directly or indirectly affect our ability to operate the business:

These laws cover severalareas of our business and are actively evolving. We, or our other third-party customers, suppliers and/or distribution partners, may notbe able to maintain regulatory compliance or may incur significant costs in obtaining or maintaining regulatory compliance. Any actionbrought against us for violations of these laws or regulations, even if successfully defended, could cause us to incur significant legalexpenses, reputational risks, and divert our management’s attention from the operation of our business. In addition, compliancewith future legislation could impose additional requirements on us which may be costly.

Failure to complywith governmental export and import regulations could result in fines, penalties, and litigation, and have a material adverse effect uponthe Company’s business.

Our products and servicesare subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations,and various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls.Exports of our products and services must be made in compliance with these laws and regulations. If we fail to comply with these lawsand regulations, we and certain of our employees could be subject to substantial civil or criminal penalties, including the possible lossof export or import privileges; fines, which may be imposed on us and responsible employees or managers; and, in extreme cases, the incarcerationof responsible employees or managers.

In addition, changesin our products and services or changes in applicable export or import laws and regulations may create delays in the introduction andsale of our products and services to international markets, prevent our customers from procuring our products and services or, in somecases, prevent the export or import of our products and services to certain countries, governments or persons altogether. Any change inexport or import laws and regulations, shift in the enforcement or scope of existing laws and regulations, or change in the countries,governments, persons or technologies targeted by such laws and regulations could also result in decreased use of our products and services,or in our decreased ability to export or sell our products and services to existing or potential customers. Any decreased use of our productsand services or limitation on our ability to export or sell our products and services could adversely affect our business, financial conditionand results of operations.

Product safetyand product liability, including bio-hazard risks, could provide exposure to claims and litigation.

Specimens may have hazardousproperties and may carry transmissible infectious agents. There are inherent risks in connection with the handling, storage, disposal,distribution, and/or use of the specimens.

Although we believe thatour safety procedures for handling and disposing of such materials comply with the standards prescribed by federal, state and local regulationand regulations of foreign jurisdictions, the risk of accidental contamination or injury from these materials cannot be completely eliminated.Individuals who use or come in contact with the specimens may file claims related to their use and these claims could result in litigationthat could be expensive to defend or result in judgements that exceed our resources and our insurance coverage. Any such litigations andjudgement could adversely affect our business, financial condition and results of operations.

Risks Related to OurSecurities

There can be noassurance that an active and liquid trading market for our common stock will continue or that we will be able to continue to comply withNasdaq’s continued listing standards.

Our common stock begantrading on Nasdaq in June 2021, as a result of our consummation of an initial public offering of our shares of common stock. Our commonstock is currently listed on Nasdaq under the symbol “ISPC”. There can be no assurance an active and liquid trading marketin our common stock will continue.

There is no guaranteethat we will be able to maintain such listing for any period of time by perpetually satisfying the Nasdaq’s continued listing requirements.Our failure to continue to meet these requirements may result in our common stock being delisted from Nasdaq.

If we are not ableto comply with the applicable continued listing requirements or standards of The Nasdaq Stock Market LLC, our common stock could be delistedfrom Nasdaq.

Our common stock is currentlylisted on Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards,including those regarding director independence and independent committee requirements, minimum stockholders’ equity, minimum shareprice, and certain corporate governance requirements. There can be no assurances that we will be able to comply with the applicable listingstandards of The Nasdaq Stock Market LLC.

In the event that ourcommon stock is delisted from Nasdaq and is not eligible for quotation on another market or exchange, trading of our common stock couldbe conducted in the over-the-counter market established for unlisted securities, such as the OTC Markets. In such event, it could becomemore difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely also be a reduction inour coverage by securities analysts and the news media, which could cause the price of our common stock to decline further. Also, it maybe difficult for us to raise additional capital if we are not listed on a major exchange.

In the event thatour common stock is delisted from Nasdaq, U.S. broker-dealers may be discouraged from effecting transactions in shares of our common stockbecause it may be considered a penny stock and thus be subject to the penny stock rules.

The SEC has adopted anumber of rules to regulate a “penny stock” that restricts transactions involving stock which is deemed to be a penny stock.Such rules include Rules 3a51-1, 15g-1, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7, and 15g-9 under the Exchange Act. These rules may havethe effect of reducing the liquidity of penny stocks. “Penny stocks” generally are equity securities with a price of lessthan $5.00 per share (other than securities registered on certain national securities exchanges or traded on Nasdaq if current price andvolume information with respect to transactions in such securities is provided by the exchange or system). Our shares of common stockmay, in the future constitute, a “penny stock” within the meaning of the rules. The additional sales practice and disclosurerequirements imposed upon U.S. broker-dealers may discourage such broker-dealers from effecting transactions in shares of our common stock,which could severely limit the market liquidity of such shares of common stock and impede their sale in the secondary market.

A U.S. broker-dealerselling a penny stock to anyone other than an established customer or “accredited investor” (generally, an individual witha net worth in excess of $1,000,000 or an annual income exceeding $200,000, or $300,000 together with his or her spouse) must make a specialsuitability determination for the purchaser and must receive the purchaser’s written consent to the transaction prior to sale, unlessthe broker-dealer or the transaction is otherwise exempt. In addition, the “penny stock” regulations require the U.S. broker-dealerto deliver, prior to any transaction involving a “penny stock”, a disclosure schedule prepared in accordance with SEC standardsrelating to the “penny stock” market, unless the broker-dealer or the transaction is otherwise exempt. A U.S. broker-dealeris also required to disclose commissions payable to the U.S. broker-dealer and the registered representative and current quotations forthe securities. Finally, a U.S. broker-dealer is required to submit monthly statements disclosing recent price information with respectto any “penny stock” held in a customer’s account and information with respect to the limited market in “pennystocks”.

You should be aware that,according to the SEC, the market for “penny stocks” has suffered in recent years from patterns of fraud and abuse. Such patternsinclude (i) control of the market for the security by one or a few broker- dealers that are often related to the promoter or issuer; (ii)manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; (iii) “boilerroom” practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; (iv) excessiveand undisclosed bid-ask differentials and markups by selling broker-dealers; and (v) the wholesale dumping of the same securities by promotersand broker-dealers after prices have been manipulated to a desired level, resulting in investor losses. Our management is aware of theabuses that have occurred historically in the penny stock market. Although we do not expect to be in a position to dictate the behaviorof the market or of broker-dealers who participate in the market, management will strive within the confines of practical limitationsto prevent the described patterns from being established with respect to our securities.

Certain provisionsof our certificate of incorporation, as amended, and our bylaws, as amended, may make it more difficult for a third party to affect achange-of-control.

Our certificate of incorporation,as amended, authorizes the board of directors (the “Board”) to issue up to 50,000,000 shares of preferred stock. The preferredstock may be issued in one or more series, the terms of which may be determined at the time of issuance by the Board without further actionby the stockholders.

These terms may includepreferences as to dividends and liquidation, conversion rights, redemption rights and sinking fund provisions. The issuance of any preferredstock could diminish the rights of holders of our common stock, and therefore could reduce the value of such common stock. In addition,specific rights granted to future holders of preferred stock could be used to restrict our ability to merge with, or sell assets to, athird party. The ability of the Board to issue preferred stock could make it more difficult, delay, discourage, prevent or make it morecostly to acquire or effect a change-in-control, which in turn could prevent our stockholders from recognizing a gain in the event thata favorable offer is extended and could materially and negatively affect the market price of our common stock. In addition, our certificateof incorporation, as amended, provides for a staggered Board. As a consequence, only a minority of the Board will be considered for electionat every annual meeting of stockholders, which may make the removal of management more difficult and may discourage transactions thatotherwise could involve payment of a premium over prevailing market prices for our securities. Additional provisions that may discourageunsolicited takeover proposals include (i) board vacancies may be filled by a majority of the remaining board members, (ii) the boardmay adopt, repeal, rescind, alter or amend our bylaws without stockholder approval, (iii) stockholders holding more than 15% of the outstandingshares may call a special meeting, (iv) a director may be removed from office only by the affirmative vote of a majority of the issuedand outstanding stock entitled to vote; and (v) no cumulative voting in the election of directors, which would allow holders of less thana majority of the stock to elect some directors.

Our bylaws, as amended, designate certaincourts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which couldlimit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.

Our bylaws, as amended,provide that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware (or, if the Court ofChancery does not have jurisdiction, the federal district court for the District of Delaware) will be the exclusive forum for: (i) anyderivative action or proceeding brought on behalf of the Company; (ii) any action asserting a claim for breach of a fiduciary duty owedby any director, officer, employee, or agent of ours to us or our stockholders; (iii) any action asserting a claim arising pursuant toany provision of the Delaware General Corporation Law, the certificate of incorporation, or the bylaws; and (iv) any action assertinga claim governed by the internal affairs doctrine (the “Delaware Forum Provision”). Our bylaws further provide that, unlesswe consent in writing to the selection of an alternative forum, the federal district courts of the United States of America shall be thesole and exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act (the “FederalForum Provision”). In addition, our bylaws provide that any person or entity purchasing or otherwise acquiring any interest in sharesof our common stock is deemed to have notice of and consented to the Delaware Forum Provision and the Federal Forum Provision.

Section 27 of the Exchangecreates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rulesand regulations thereunder. As a result, the Delaware Forum Provision will not apply to suits brought to enforce any duty or liabilitycreated by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction. We note, however, that thereis uncertainty as to whether a court would enforce this provision and that investors cannot waive compliance with the federal securitieslaws and the rules and regulations thereunder.

We recognize that theDelaware Forum Provision and the Federal Forum Provision in our bylaws may impose additional litigation costs on stockholders in pursuingany such claims, particularly if the stockholders do not reside in or near the State of Delaware. Additionally, the Delaware Forum Provisionand the Federal Forum Provision may limit our stockholders’ ability to bring a claim in a forum that they find favorable for disputeswith us or our directors, officers or employees, which may discourage such lawsuits against us and our directors, officers and employeeseven though an action, if successful, might benefit our stockholders. In addition, while the Delaware Supreme Court ruled in March 2020that federal forum selection provisions purporting to require claims under the Securities Act be brought in federal court were “faciallyvalid” under Delaware law, there is uncertainty as to whether other courts will enforce the Federal Forum Provision. If the FederalForum Provision is found to be unenforceable, we may incur additional costs associated with resolving such matters. The Federal ForumProvision may also impose additional litigation costs on stockholders who assert that the provision is not enforceable or invalid. TheCourt of Chancery of the State of Delaware and the United States District Court may also reach different judgments or results than wouldother courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the action,and such judgments may be more or less favorable to us than our stockholders.

Limitations ondirector and officer liability and indemnification of our officers and directors by us may discourage stockholders from bringing suitagainst an officer or director.

Our certificate of incorporation,as amended, and bylaws, as amended, provide that, to the fullest extent permitted by Delaware law, as it presently exists or may be amendedfrom time to time, a director shall not be personally liable to us or our stockholders for monetary damages for any breach of fiduciaryduty as a director. Under Delaware law, this limitation of liability does not extend to, among other things, acts or omissions which involveintentional misconduct, fraud or knowing violation of law, or unlawful payments of dividends. These provisions may discourage stockholdersfrom bringing suit against a director or officer for breach of fiduciary duty and may reduce the likelihood of derivative litigation broughtby stockholders on our behalf against a director or officer.

We are responsible for the indemnificationof our officers and directors.

Should our officers and/ordirectors require us to contribute to their defense, we may be required to spend significant amounts of our capital. Our certificate ofincorporation, as amended, and bylaws, as amended, also provide for the indemnification of our directors, officers, employees, and agents,under certain circumstances, against attorney’s fees and other expenses incurred by them in any litigation to which they becomea party arising from their association with or activities on behalf of our Company. This indemnification policy could result in substantialexpenditures, which we may be unable to recoup. If these expenditures are significant or involve issues which result in significant liabilityfor our key personnel, we may be unable to continue operating as a going concern.

We do not expectto pay dividends in the foreseeable future. Any return on investment may be limited to the value of our common stock.

We have never paid cashdividends on our common stock and do not anticipate doing so in the foreseeable future. The payment of dividends on our common stock willdepend on earnings, financial condition and other business and economic factors affecting us at such time as our Board may consider relevant.If we do not pay dividends, our common stock may be less valuable because a return on an investment will only occur if our stock priceappreciates.

We may need additionalcapital, and the sale of additional shares of common stock or other equity securities could result in additional dilution to our stockholders.

We may need to raiseadditional funds sooner than expected to fund our current operating plans. We may finance our cash needs through a combination of equityofferings, debt financings, collaborations, strategic alliances, licensing arrangements, or other sources. In addition, we may seek additionalcapital due to favorable market conditions or strategic considerations, even if we believe that we have sufficient funds for our currentor future operating plans.

To the extent that weraise additional capital through the sale of equity or convertible debt securities, ownership interest will be diluted, and the termsof these securities may include liquidation or other preferences that adversely affect rights as a common stockholder. Debt financingand preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to takespecific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional fundsthrough collaborations, strategic alliances, or licensing arrangements with third parties, we may be required to relinquish valuable rightsto our technologies or future revenue streams or grant licenses on terms that may not be favorable to us. If we are unable to raise additionalfunds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate technology development orfuture commercialization efforts.

Our quarterly revenue tends to fluctuate,making it harder to forecast and meet investor expectations.

Quarterlyrevenue has been difficult to predict, has historically fluctuated, and may vary from quarter to quarter due to a variety of factors,many of which are beyond our control. Accordingly, comparing our operating results on a period- to-period basis may not be meaningful.Factors that may affect our quarterly revenue and operating results may include: any material changes in demand for our products and services;changes in our supply sites’ ability to collect and ship specimens or our ability to retain them; changes in the number, availability,and quality of competing products; our ability to maintain a timely delivery of high quality products and services; the timing and amountof sales and marketing expenses incurred by us to attract new customers; changes in the economic or business prospects of our customersor the economy generally; changes in the pricing policies of our competitors; unforeseen defects in our technology; changes in the regulatoryenvironment; and unforeseen costs necessary to improve and maintain our technology.

These factors affectingour future earnings are difficult to forecast and could harm our quarterly and/or annual operating results. The change in our earningsor general economic conditions may cause the market price of our common stock to fluctuate.

Our stock price may be volatile.

Our share price has beenvolatile in the past and may continue to be so in the future. The stock market in general has experienced extreme volatility that hasoften been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able tosell their common stock at or above the price paid for such shares. The market price of our common stock is likely to be highly volatileand could fluctuate widely in price in response to various risk factors, including the following:

In addition, the securitiesmarkets have from time to time experienced significant price and volume fluctuations that are unrelated to the operating performance ofparticular companies. These market fluctuations may also materially and adversely affect the market price of our common stock.

General Risk Factors

Our status as an“emerging growth company” under the JOBS Act may make it more difficult to raise capital when we need to do it or make ourcommon stock less attractive to investors.

Because of the exemptionsfrom various reporting requirements provided to us as an “emerging growth company,” and because we will have an extended transitionperiod for complying with new or revised financial accounting standards, we may be less attractive to investors and it may be difficultfor us to raise additional capital as and when we need it. Investors may be unable to compare our business with other companies in ourindustry if they believe that our financial accounting is not as transparent as other companies in our industry. If we are unable to raiseadditional capital as and when we need it, our financial condition and results of operations may be materially and adversely affected.

We have limited insurance which maynot cover claims by third parties against us or our officers and directors.

We have limited directors’and officers’ liability insurance and commercial liability insurance policies, if any. Claims by third parties against us may exceedpolicy amounts and we may not have amounts to cover these claims. Also, due to high self-insured retention costs and deductibles, we mayincur significant costs from any claim made against us before insurance policies provide coverage. Any significant claims would have amaterial adverse effect on our business, financial condition, and results of operations. In addition, our limited directors’ andofficers’ liability insurance may affect our ability to attract and retain directors and officers.

The requirements of being a U.S. publiccompany may strain our resources and divert management’s attention.

As a public company,we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and ConsumerProtection Act of 2010 (the “Dodd-Frank Act”) and Nasdaq rules. The requirements of these rules and regulations result insignificant legal and financial compliance costs, including costs associated with the employment of personnel, making some activitiesmore difficult, time-consuming or costly, and may also place undue strain on our personnel, systems and resources and divert management’sattention.

The Exchange Act requires,among other things, that we file annual, quarterly, and current reports with respect to our business and financial condition. The Sarbanes-OxleyAct requires, among other things, that we maintain disclosure controls and procedures and internal control over financial reporting. Ensuringthat we have adequate internal financial and accounting controls and procedures in place, as well as maintaining these controls and procedures,is a costly and time-consuming effort that needs to be re-evaluated frequently.

Additionally, variousrules and regulations applicable to public companies make it more difficult and more expensive for us to maintain directors’ andofficers’ liability insurance, and we may be required to accept reduced coverage or higher deductibles or incur substantially highercosts to maintain coverage.

Evaluation of internalcontrol and remediation of potential problems will be costly and time consuming and could expose weaknesses in financial reporting.

Section 404 of the Sarbanes-OxleyAct (“Section 404”) requires that we evaluate our internal control over financial reporting to enable management to reporton the effectiveness of those controls annually. In connection with the Section 404 requirements, we could, as part of that documentation,identify material weaknesses, significant deficiencies, or other areas for further attention or improvement.

Implementing any appropriatechanges to our internal controls may require specific compliance training for our directors, officers, and employees, require the hiringof additional finance, accounting and other personnel, entail substantial costs to modify our existing accounting systems, and take asignificant period of time to complete. Such changes may not, however, be effective in maintaining the adequacy of our internal controls,and any failure to maintain that adequacy, or consequent inability to produce accurate financial statements on a timely basis, could increaseour operating costs and could materially impair our ability to operate our business. Moreover, adequate internal controls are necessaryfor us to produce reliable financial reports and are important to help prevent fraud. As a result, our failure to satisfy the requirementsof Section 404 on a timely basis could result in the loss of investor confidence in the reliability of our financial statements, whichin turn could cause the market value of our common stock to decline.

Public company compliance may make itmore difficult to attract and retain officers and directors.

The Sarbanes-Oxley Actand new rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies. As a publiccompany, we are expected to follow Sarbanes-Oxley Act regulations and other public company rules, and these rules and regulations willincrease our compliance costs and make certain activities more time consuming and costly. As a result, these rules and regulations maymake it more difficult and expensive for us to obtain director and officer liability insurance and we may be required to accept reducedpolicy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficultand costly for us to attract and retain qualified persons to serve on our Board or as executive officers.

Risks Related to ThisOffering

The sale of a substantial amount of ourcommon stock, including resale of the shares of common stock by the selling stockholders in the public market, could adversely affectthe market price of our common stock.

We are registering for resale 1,559,828 sharesof common stock, including 1,292,449 shares issuable upon the exercise of pre-funded warrants held by the selling stockholders. Salesof substantial amounts of our common stock in the public market, or the perception that such sales might occur, could adversely affectthe market price of our common stock. We cannot predict if and when the selling stockholders may sell such shares in the public market.

USE OF PROCEEDS

We will not receive any of the proceeds from the sale of the Sharesor the Warrant Shares by the Selling Stockholders pursuant to this prospectus. We may receive up to approximately $129 in aggregate grossproceeds from cash exercises of the Warrants, based on the per share exercise price of the Warrants. Any proceeds we receive from theexercise of the Warrants will be used for working capital and general corporate purposes. The Selling Stockholders will pay any agent’scommissions and expenses they incur for brokerage, accounting, tax or legal services or any other expenses that they incur in disposingof the shares of common stock. We will bear all other costs, fees and expenses incurred in effecting the registration of the shares ofcommon stock covered by this prospectus and any prospectus supplement. These may include, without limitation, all registration and filingfees, SEC filing fees and expenses of compliance with state securities or “blue sky” laws.

We cannot predict when or if the Warrants will be exercised. As a result,we may never receive meaningful, or any, cash proceeds from the exercise of the Warrants, and we cannot plan on any specific uses of anyproceeds we may receive beyond the purposes described herein.

DIVIDEND POLICY

We currently intend to retain all available funds and any future earningsto fund the development, commercialization, and growth of our business, and therefore we do not anticipate declaring or paying any cashdividends on any class of our common stock in the foreseeable future. Any future determination as to the declaration and payment of dividends,if any, will be at the discretion of our board of directors, subject to compliance with contractual restrictions and covenants in theagreements governing our current and future indebtedness. Any such determination will also depend upon our business prospects, resultsof operations, financial condition, cash requirements and availability, and other factors that our board of directors may deem relevant.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONAND RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financialcondition and plan of operations together with our selected financial data, financial statements and the related notes, and other financialinformation appearing elsewhere in this prospectus. In addition to historical information, this discussion and analysis contains forward-lookingstatements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those discussed below. Factorsthat could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in thesection titled “Risk Factors” included elsewhere in this prospectus.

Overview

We were incorporatedin 2009 under the laws of the state of Delaware. Our mission is to accelerate life science research and development via a single globalmarketplace platform, the iSpecimen Marketplace, which connects researchers to subjects, specimens, and associated data. We are headquarteredin Woburn, Massachusetts. We operate as one operating and reporting segment.

In addition to creatinga single global platform where both specimen providers and researchers can connect, the platform automates the process of searching forand selecting specimens for research. The platform taps into healthcare provider data to gain insights into the available samples in biobanksor laboratories, or to gain insights into the patient populations to support specimen collections directly from research subjects. Theplatform receives de-identified data from electronic medical records, laboratory information systems, and other healthcare data sourcesof available specimens and research subjects and harmonizes the data across all participating organizations.

Researchers can searchthis data using our intuitive, web-based user interface to obtain specimens more efficiently. They can instantly find the specific specimensthey need for their studies, request quotes for these specimens or for custom collections directly from research subjects, place orders,and track and manage their specimens and associated data across projects.

Biospecimen providersalso gain efficiencies using the iSpecimen Marketplace, not only because the platform provides instant access to a large researcher base,but because the technology orchestrates the bioprocurement workflow from specimen request to fulfillment. Specimen providers can accessintuitive dashboards to view requests, create proposals, and track and manage their orders.

Finally, the platformhelps with administrative and reporting functions for researchers, suppliers, and our internal personnel, including user and compliancemanagement.

The iSpecimen Marketplaceis composed of four major functional areas: search, workflow, data, and administration and reporting. As capital is made available todo so, we continue to invest in the evolution of these areas to improve engagement with the platform and liquidity across it. Our corebusiness objective is to retain and grow both researcher and supplier usage of our platform to support biospecimen procurement, as wellas to position our Company to explore other adjacent business opportunities that can benefit from the use of the iSpecimen Marketplace.

The iSpecimen Marketplacecurrently supports the supply chain management and bioprocurement process for specimens and associated data. We generate revenue by procuringvarious specimens from hospitals, laboratories, and other supply sites comprising our network, and delivering them to our medical researchcustomers using our proprietary software to identify and locate the required specimens. Costs paid to acquire specimens from hospitalsand laboratories generally vary depending upon the sample type, collection requirements, and data provided. We generally operate in a“just in time” fashion, meaning we procure specimens from our suppliers and distribute specimens to our customers after weobtain an order for specimens from a research client. Generally, we do not speculatively purchase and bank samples in anticipation offuture, unspecified needs. We believe our approach offers many advantages over a more traditional inventory-based supplier business modelwhere biorepositories take inventory risks, and where inventory turnover and cash conversion cycles can be lengthy.

Private PlacementOffering

On December 1, 2021,we closed on a private placement offering (“PIPE”) for gross proceeds of approximately $21 million, before deducting approximately$1.4 million for underwriting discounts and commissions and estimated offering expenses, for (i) an aggregate of 87,500 shares of commonstock and (ii) warrants, which are exercisable for an aggregate of up to 65,625 shares of common stock, all of which were repurchasedby us on February 13, 2024, and are no longer outstanding.

At the Market Offering

On March 5, 2024, weentered into an At the Market Offering Agreement (the “ATM Agreement”) with Rodman & Renshaw LLC as agent (the “SalesAgent”) pursuant to which we may issue and sell shares of our common stock, having an aggregate offering price of up to $1,500,000(the “ATM Shares”), from time to time through the Sales Agent. The ATM Shares when issued will be registered pursuant to ourshelf registration statement on Form S-3 (File No 333- 265976), which became effective on July 12, 2022. We sold the ATM Shares, fromtime to time, pursuant to the ATM Agreement, in transactions that are “at the market offerings” as defined in Rule 415(a)(4)promulgated under the Securities Act. During the year ended December 31, 2024, we issued 199,004 shares of common stock for gross proceedsof approximately $1,494,000 under the ATM Agreement. In connection with the ATM Offering, we incurred offering costs of approximately$255,000, resulting in net proceeds of approximately $1,239,000.

Reverse Stock Split

On October 9, 2023, wereceived a notification from Nasdaq that our Common Stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutivebusiness days as required by the Listing Rules of The Nasdaq Stock Market.

On July 19, 2024,our stockholders approved a proposal to amend our Fourth Amended and Restated Certificate of Incorporation to effect a reverse stock splitof our issued and outstanding shares of common stock, as well as any shares of common stock held by the Company in treasury, at a ratioin the range from 1-for-10 to 1-for-20.

On August 19, 2024, theBoard approved a one-for-twenty (1:20) reverse stock split of our issued and outstanding shares of common stock. On September 13, 2024,we filed with the Secretary of State of the State of Delaware a Certificate of Amendment to our Certificate of Incorporation to effectthe Reverse Stock Split. The Reverse Stock Split became effective on September 13, 2024, and our common stock began trading on a split-adjustedbasis on Nasdaq on September 16, 2024.

On October 1, 2024, wereceived a notification from Nasdaq that the Staff has determined that for the last 11 consecutive business days, from September 16, 2024to September 30, 2024, the closing bid price of our Common Stock was $1.00 per share or greater. Accordingly, we regained compliance withListing Rule 5559(a)(2).

Except as otherwise indicated,all references to our common stock, share data, per share data and related information have been adjusted for the Reverse Stock Splitratio of 1-for-20 as if they had occurred at the beginning of the earliest period presented. The Reverse Stock Split combined each 20shares of our outstanding common stock and treasury shares into one share of common stock without any change in the par value per share,and the Reverse Stock Split correspondingly adjusted, among other things, the exercise rate of our warrants and options into our commonstock. No fractional shares were issued in connection with the Reverse Stock Split, and any fractional shares resulting from the ReverseStock Split were rounded up to the nearest whole share.

Debt Financing

On September 19, 2024,we entered into the Purchase Agreement with the Lender. Pursuant to the provisions of the Purchase Agreement, the Lender agreed to providea loan to us in the amount of $1,000,000 and we agreed to issue to the Lender a promissory note in the principal amount of $1,000,000payable within 12 months after the date of issuance, with interest accruing and payable at a rate of 18% per annum. The Purchase Agreementcontains customary representations and warranties and obligates the Lender to provide an additional loan to us, in the form of a revolvingline of credit of up to $1,000,000, upon our initial filing of a Registration Statement for an underwritten or best-efforts public offeringfor gross proceeds of at least $5,000,000. On September 25, 2024, we and the Lender closed the transactions described in the PurchaseAgreement, the Lender provided funds to the Company in the net amount of $959,980 and we issued the Note to the Lender in the principalamount of $1,000,000. WestPark Capital, Inc. (“WestPark”) served as the placement agent in connection with the Loan and waspaid a placement agent fee in the amount of $40,020 for its services.

On October 31, 2024,we paid off the outstanding principal balance of $1,000,000 and accrued interest of $18,000 on the Note.

Securities Offeringon Form S-1

On October 29, 2024,we entered into a placement agency agreement (the “Placement Agency Agreement”) with WestPark. (the “Placement Agent”),and a securities purchase agreement (the “Securities Purchase Agreement”) with investors pursuant to which we agreed to issueand sell, in a “reasonable best efforts” public offering (the “Offering”) (i) 132,814 shares (the “Shares”)of our common stock, par value $0.0001 per share (the “Common Stock”) at an offering price of $2.999 per share, and (ii) pre-fundedwarrants to purchase up to 1,533,852 shares of Common Stock (the “Pre-Funded Warrants”) at an offering price of $3.00 perShare, less $0.0001 per Pre-Funded Warrant, for aggregate gross proceeds of $4,998,464 (or $4,999,998 assuming the full exercise of thePre-Funded Warrants), before deducting placement agent fees and other offering expenses. As part of its compensation for acting as PlacementAgent for the Offering, we paid the Placement Agent a cash fee of 4.0% of the aggregate gross proceeds plus reimbursement of certain expensesand legal fees. We intend to use the net proceeds of the offering for repayment of outstanding debt, potential acquisitions of assetsor investments in businesses, products and technologies, and for marketing and advertising services. The remainder of the net proceedswill be used for working capital purposes.

The Offering closed onOctober 31, 2024. The securities sold in the Offering were offered and sold pursuant to a registration statement on Form S-1 (FileNo. 333-282736), which was filed with the Securities and Exchange Commission (the “Commission”) on October 18, 2024, and subsequentlydeclared effective by the Commission on October 29, 2024.

Impact of the CurrentEconomy

The Company’s financialperformance is subject to global economic conditions and their impact on levels of spending by our customer research organizations, particularlydiscretionary spending for procurement of specimens used for research. Economic recessions may have adverse consequences across industries,including the health and biospecimen industries, which may adversely affect our business and financial condition. We increased our allowancefor doubtful accounts in accounts receivables by $17,579 as of June 30, 2025 due to certain customers either lack liquidity or have filedfor bankruptcy. We have enhanced procedures related to our credit check process for new and existing customers to mitigate the risk tofuture collectability of receivables.

Changes in general market,economic and political conditions in domestic and foreign economies or financial markets, including fluctuation in stock markets resultingfrom, among other things, trends in the economy and inflation, as are being currently experienced, may result in a reduction in researchers’demand for specimens due to the research organization’s inability to obtain funding.

To further address thecurrent market conditions, we have taken steps, which include but are not limited to, reevaluating our pricing in order to be more competitive,creating campaigns to highlight and fast-track high demand items, enhancing internal team communications to accelerate the sales cycle,moving to a new line of business structure organized by our internal categorization of biospecimen suppliers capabilities to increaseefficiency in operations, implementation of next day quotes to increase conversion ratios of quotes to purchase orders, and initiationof efforts to decrease expenditures through reductions in our workforce.

We believe that our businesswill continue to be resilient through a continued industry-wide economic slowdown in life science research, and that we will continueto work on improving our liquidity to address our financial obligations and alleviate possible adverse effects on our business, financialcondition, results of operations or prospects.

Impact of the Russian-UkrainianWar on Our Operations

Our business was negativelyimpacted during the first half of 2022 by the ongoing war between Russia and Ukraine. At the start of the war, we had approximately $1 millionof purchase orders that were slated to be fulfilled by our supply network in Ukraine and Russia. This supply network was shut down atthe start of the war. Ukrainian suppliers were disabled due to war conditions and evacuations and some of our Russian suppliers were disabledby sanctions. While we mobilized to shift these purchase orders to other suppliers in the network, the process of specimen collectionsfrom other supply sites took time, which caused a delay in the fulfillment of such purchase orders. Alternate suppliers do not have thesame favorable unit economics or specimen collection rates, and this also impacted our margins. Additionally, key resources werediverted from operations to resolving the re-fulfillment issues caused by the conflict.

As of June 30, 2025,our supply sites in Russia that had not been under sanctions were accessible and our supply sites in Ukraine were mostly reopened. However,logistics and transportation of specimens out of the country of Ukraine remains challenging and not as economically feasible as they wereprior to the beginning of the war. Due to the uncertainty caused by the ongoing war, Ukrainian and Russian suppliers may again becomeinaccessible to us. Therefore, as long as the uncertainty continues, our policy is to ensure at a purchase order level that an order isnot solely sourced from the two countries. The short and long-term implications of the war are difficult to predict as of the date ofthis Form 10-Q. The imposition of more sanctions and counter sanctions may have an adverse effect on the economic markets generally andcould impact our business and the businesses of our supply partners, especially those in Ukraine and Russia. Because of the highly uncertainand dynamic nature of these events, it is not currently possible to estimate the impact of the war on our business and the companies fromwhich we obtain supplies and distribute specimens.

Known Trends, Demands,Commitments, Events or Uncertainties Impacting Our Business

Chief Executive OfficerInitiatives

The Company’s missionremains to accelerate life sciences research and development, pursuant to a single global marketplace platform. Executive management ofthe Company continues to review the Company’s structure, processes, and resources to evaluate and identify areas for improvement,and has been focused on creating and ensuring a runway for growth and scale for the business.

Throughout the yearsended December 31, 2024 and 2023, we have initiated efforts to decrease our capital and operational expenditures by cutting costs andright sizing the Company through reductions in our workforce while streamlining operations and rationalizing our resources to focus onkey market opportunities. As a result, we began to experience significant decreases in expenditures starting in the second half of 2023.The reductions in workforce since January 1, 2023 through December 31, 2024, cumulatively resulted in an estimated reduction in monthlycompensation costs of approximately 146% and technology costs of approximately 64% during the year December 31, 2024 when compared tothe year ended December 31, 2023. During the second quarter of 2025, the reductions in workforce resulted in an estimated reduction inmonthly compensation costs of approximately 76% and technology costs of approximately 71% during the six months ended June 30, 2025, whencompared to the six months ended June 30, 2024.

During the year endedDecember 31, 2023, we performed operational process improvement activities to increase collaboration within and between departments. Wemoved to a line of business structure organized by our internal categorization of biospecimen suppliers’ capabilities, which hasincreased efficiency in our operations and throughout the Company. We continue to see benefits from this move.

We completed the implementationof a next day quote system in the third quarter of 2023 and we continue to see positive results in 2024 and up to the second quarter of2025, as evidenced by increased conversion ratios of quotes to purchase orders of 43%. Previously, it took an extended number of daysto complete a feasibility study in order to provide a customer quote, which negatively impacted the time to convert a quote to a purchaseorder.

While we are committedto developing our technology, we are investing at a significantly lower level in 2025 when compared to 2024 and prior years, while wefocus on growing our revenues through key market opportunities and assessing our capital raise prospects. During the six months endedJune 30, 2025 and 2024, we capitalized approximately $0 and $448,000, respectively, of internally developed software costs. Theseinvestments have resulted in multiple process improvements, streamlining workflows and providing deeper insights into orders for all usersof our marketplace.

We have shifted our focusfrom high volume to high value suppliers that meet our newly defined costs, quality and speed requirements. We established business criteriathat focus on supplier capabilities and revenue growth strategies as well as technology criteria for integrating onto our iSpecimen Marketplaceplatform and participating with us. During the year ended December 31, 2024, we terminated 180 supplier agreements and are in the finalstages of what we call our “supplier network refresh project”. This has resulted in fewer key suppliers, supported by ourlean workforce and processes more effectively. We have been reengaging our suppliers in a more meaningful manner which assisted us inthe implementation of our next day quote system. We now have a key supplier program whereby we proactively engage with the suppliers topromote our business through marketing campaigns and supplier organizations’ offerings.

Going forward, we willleverage the hard work detailed above to support a sales overhaul. As we wrap up several operationally focused projects, we will now bere-organizing the commercial end of the business. This starts with a new account-based sales approach and the introduction of an outboundsales team to ensure we are meeting our customers and prospects where they are. We are also bringing marketing and sales closer to enablethe same efficiencies within the commercial organization, the same way that our line of business realignment brought to the operationalside of the business this past year. This refined approach and tighter internal integration will continue to accelerate our next day quoteprogram and deepen customer relationships for increased predictability.

Our strategic businessintelligence initiatives have enabled us to understand our market and business better than ever before. We now have the capabilities touse data to know how and where to grow. We will continue adjusting the shape of the business toward our core competencies and the market.We can better use key insights from our sales data to understand market needs to assess areas where we lose deals today, through multiplelenses, in order to adjust our supplier network and marketing efforts accordingly. Conversely, this strategy will also allow us to assessareas where we win with an eye toward expanding deeper into those market niches or disease states.

Following the completionof our supplier network refresh efforts, we will have a better than ever understanding of our key supplier capabilities, specificallyfocused on their pricing, quality, and speed. Using this information and the outputs of our strategic business intelligence capabilities,we will continue to be able to increase the speed of an opportunity through our sales funnel and our conversion ratios, which we believewill continue to grow our revenue.

Components of Our Results of Operations

Revenue

We generate revenue byprocuring various specimens from hospitals, laboratories, and other supply sites, for our medical research customers using our proprietarysoftware, the iSpecimen Marketplace, to identify, locate, and ultimately validate the required specimens to our customers’ requestedspecifications. The Company’s performance obligation is to procure a specimen meeting the customer specification(s) from asupplier, on a “best efforts” basis, for our customer at the agreed price per specimen as indicated in the customer contractwith the Company. We do not currently charge suppliers or customers for the use of our proprietary software. Each customer will executea material and data use agreement with the Company or agree to online purchase terms, each of which includes terms such as specimen anddata use, shipment terms, payment and cancellation terms. These are then supplemented by purchase orders that specify specimen requirementsincluding detailed inclusion/exclusion criteria, quantities to be collected, and pricing. Collectively, these customer agreements representthe Company’s contracts with its customer. Generally, contracts have fixed unit pricing. For certain specimen orders, a refundablecustomer deposit may be required prior to order fulfillment depending on project set-up requirements, presented as deferred revenue. TheCompany expects to recognize the deferred revenue within the next twelve months.

We recognize revenueover time, as we have created an asset with no alternative use and we have an enforceable right to payment for performance completed todate. At contract inception, we review a contract and related order upon receipt to determine if the specimen ordered has an alternativeuse to us. Generally, specimens ordered do not have an alternative future use to us and our performance obligation is satisfied when therelated specimens are accessioned. We use an output method to recognize revenue for specimens with no alternative future use. The outputis measured based on the number of specimens accessioned.

Customers are typicallyinvoiced upon shipment. Depending on the quantity of specimens ordered, it may take several accounting periods to completely fulfill apurchase order. In other words, there can be multiple invoices issued for a single purchase order, reflecting the specimens being accessionedover time. However, specimens are generally shipped as soon as possible after they have been accessioned.

During 2024, the Companyrecognized its revenue when the related specimens are delivered.

Cost of Revenue

Cost of revenue primarilyconsists of the purchase price to acquire specimens from hospitals and laboratories, inbound and outbound shipping costs, supply costsrelated to samples, payment processing and related transaction costs, costs paid to the supply sites to support sample collections, amortizationof capitalized sequenced data costs and other assets related to sequenced data. Shipping costs upon receipt of products from suppliersare recognized in cost of revenue.

Technology

Technology costs includeconsulting fees, payroll and related expenses for employees involved in the development and implementation of our technology, softwarelicense and system maintenance fees, outsourced data center costs, data management costs, amortization of internally developed software,and other expenses necessary to support technology initiatives. Collectively, these costs reflect the efforts we make to offer a widevariety of products and services to our customers. Technology and data costs are generally expensed as incurred.

A portion of technologycosts are related to research and development. Costs incurred for research and development are expensed as incurred, except for softwaredevelopment costs that are eligible for capitalization. Research and development costs primarily include salaries and related expenses,in addition to the cost of external service providers.

Sales and Marketing

Sales and marketing costsprimarily consist of payroll and related expenses for personnel engaged in marketing and selling activities, including salaries and salescommissions, travel expenses, public relations and social media costs, ispecimen.com website development and maintenance costs, searchengine optimization fees, advertising costs; direct marketing costs, trade shows and events fees, marketing and customer relationshipmanagement software, and other marketing-related costs.

Supply Development

We have agreements withsupply partners that allow us to procure specimens from them and distribute these samples to customers. Supply development costs primarilyinclude payroll and related expenses for personnel engaged in the development and management of this supply network, related travel expenses,regulatory compliance costs to support the network, and other supply development and management costs.

Fulfillment

Fulfillment costs primarilyconsist of those costs incurred in operating and staffing operations and customer service teams, including costs attributable to assessthe feasibility of specimen requests, creating and managing orders, picking, packaging, and preparing customer orders for shipment, respondingto inquiries from customers, and laboratory equipment and supplies.

General and Administrative

General and administrativeexpenses primarily consist of costs for corporate functions, including payroll and related expenses for human resources, legal, finance,and executive teams, associated software licenses, facilities, and equipment expenses, such as depreciation and amortization expense andrent, outside legal expenses, insurance costs, and other general and administrative costs.

Financial OperationsOverview and Analysis for the Three and Six Months Ended June 30, 2025 and 2024 (Unaudited)

Comparison of the Three Months EndedJune 30, 2025 and 2024

Revenue

Revenue decreased byapproximately $2,151,000, or 75%, from approximately $2,864,000 for the three months ended June 30, 2024 to approximately $713,000 forthe three months ended June 30, 2025. This was primarily due to the decrease of 3,385, or approximately 57%, in specimen count from 5,918specimens in the three months ended June 30, 2024 to 2,533 specimens in the three months ended June 30, 2025. The significant decreasein specimen count was mainly due to the change in revenue recognition during the fourth quarter of 2024. The specimen counts during thesecond quarter of 2024 consists of accessioned specimens that were both delivered and not yet delivered specimens to customers, whilethe specimen counts during the second quarter of 2025 consists only of delivered specimens.

The effect of the decreasein specimen count have also caused a decrease to the average selling price by approximately $202, or 42%, from approximately $484 in thethree months ended June 30, 2024 to approximately $282 in the three months ended June 30, 2025.

Cost of Revenue

Cost of revenue decreasedby approximately $980,000, or 69%, from approximately $1,424,000 for the three months ended June 30, 2024 to approximately $444,000 forthe three months ended June 30, 2025, which was attributable to an approximately 57% decrease in the number of specimens delivered forthe current period as compared to the accessioned specimens in the same period in the prior year, and an approximately $65, or 27%, decreasein the average cost per specimen.

Technology

Technology expenses decreasedby approximately $376,000, or 41%, from approximately $912,000 for the three months ended June 30, 2024 to approximately $536,000 forthe three months ended June 30, 2025. The decrease was related to decrease in amortization expense of internally developed software ofapproximately $175,000 and payroll and related expenses of approximately $214,000, which was partially offset by the increase in professionalfees of approximately $13,000. 

Technology expenditurescapitalized as internally developed software costs decreased by approximately $172,000, or 100%, from approximately $172,000 forthe six months ended June 30, 2024 to $0 for the three months ended June 30, 2025 due to reductions in workforce stemming from our decisionto invest in the software at a significantly lower level in 2025 when compared to 2024 and prior years.

Sales and Marketing Expenses

Sales and marketing expensesdecreased by approximately $825,000, or 76%, from approximately $1,083,000 for the three months ended June 30, 2024 to approximately $258,000for the three months ended June 30, 2025. The decrease was primarily attributable to decrease in payroll and related expenses of approximately$668,000, advertising and promotions expense of approximately $97,000 and external marketing expense of approximately $62,000, which waspartially offset by the increase in general operating expenses related to sales and marketing of approximately $2,000.

Supply Development

Supply development expensesdecreased by approximately $38,000, or 28%, from approximately $138,000 for the three months ended June 30, 2024 to approximately $99,000for the three months ended June 30, 2025. The decrease was primarily attributable to a decrease in payroll and related expenses of approximately$48,000, offset by the increase in professional fees of approximately $10,000.

Fulfillment

Fulfillment costs decreasedby approximately $185,000, or 43%, from approximately $433,000 for the three months ended June 30, 2024 to approximately $248,000 forthe three months ended June 30, 2025. The decrease was primarily attributable to a decrease in professional fees of approximately $4,000,payroll and related expenses of approximately $179,000 for personnel engaged in pre-sales feasibility assessments and order fulfillmentand general operating expenses related to fulfillment of approximately $2,000.

General and Administrative Expenses

General and administrativeexpenses decreased by approximately $107,000, or 10%, from approximately $1,055,000 for the three months ended June 30, 2024 to approximately$948,000 for the three months ended June 30, 2025. The decrease was attributable to a decrease in general operating expenses of approximately$38,000, utilities and facilities expenses of approximately $33,000, doubtful account expense of approximately $100,000 and taxes andinsurance of approximately $169,000, which were partially offset by increases in compensation costs of approximately $84,000, professionalfees of approximately $68,000, depreciation and amortization of approximately $1,000 and franchise tax of $80,000.

Other Income, net

Other income, net, increasedby approximately $702,000, or 966%, from an income of approximately $73,000 for the three months ended June 30, 2024 to approximately$774,000 for the three months ended June 30, 2025. The increase in other income, net, was attributable to an increase of other incomeof approximately $696,000 and increase in recovery of interest and penalties on sales tax liability of approximately $10,000, which waspartially offset by a decrease in interest income of approximately $9,000 and decrease in interest expense of approximately $4,000.

Comparison of the Six Months Ended June30, 2025 and 2024

Revenue

Revenue decreased byapproximately $3,383,000, or 66%, from approximately $5,154,000 for the six months ended June 30, 2024 to approximately $1,771,000 forthe six months ended June 30, 2025. This was primarily due to the decrease of 6,317, or approximately 57%, in specimen count from 11,159specimens in the six months ended June 30, 2024 to 4,842 specimens in the six months ended June 30, 2025. The significant decrease inspecimen count was mainly due to the change in revenue recognition during the fourth quarter of 2024. The specimen counts during the secondquarter of 2024 consists of accessioned specimens that were both delivered and not yet delivered specimens to customers, while the specimencounts during the second quarter of 2025 consists only of delivered specimens.

The effect of the decreasein specimen count have also caused a decrease to the average selling price by approximately $96, or 21%, from approximately $462 in thesix months ended June 30, 2024 to approximately $366 in the six months ended June 30, 2025.

Cost of Revenue

Cost of revenue decreasedby approximately $1,323,000, or 55%, from approximately $2,424,000 for the six months ended June 30, 2024 to approximately $1,101,000for the six months ended June 30, 2025, which was attributable to an approximately 57% decrease in the number of specimens delivered forthe current period as compared to the accessioned specimens in the same period in the prior year, offset by an approximately $10, or 5%,increase in the average cost per specimen.

Technology

Technology expenses decreasedby approximately $742,000, or 41%, from approximately $1,824,000 for the six months ended June 30, 2024 to approximately $1,082,000 forthe six months ended June 30, 2025. The decrease was related to professional fees of approximately $17,000, amortization expense of internallydeveloped software of approximately $340,000 and payroll and related expenses of approximately $384,000 and general operating expensesrelated to technology expenses of approximately $1,000. 

Technology expenditurescapitalized as internally developed software costs decreased by approximately $448,000, or 100%, from approximately $448,000 forthe six months ended June 30, 2024 to $0 for the six months ended June 30, 2025 due to reductions in workforce stemming from our decisionto invest in the software at a significantly lower level in 2025 when compared to 2024 and prior years.

Sales and Marketing Expenses

Sales and marketing expensesdecreased by approximately $1,143,000, or 65%, from approximately $1,749,000 for the six months ended June 30, 2024 to approximately $606,000for the six months ended June 30, 2025. The decrease was primarily attributable to decrease in payroll and related expenses of approximately$937,000, advertising and promotions expense of approximately $176,000 and external marketing expense of approximately $34,000, whichwas partially offset by the general operating expenses related to sales and marketing of approximately $4,000.

Supply Development

Supply development expensesdecreased by approximately $143,000, or 43%, from approximately $335,000 for the six months ended June 30, 2024 to approximately $193,000for the six months ended June 30, 2025. The decrease was primarily attributable to a decrease in professional fees of approximately $76,000and payroll and related expenses of approximately $67,000.

Fulfillment

Fulfillment costs decreasedby approximately $302,000, or 36%, from approximately $844,000 for the six months ended June 30, 2024 to approximately $542,000 for thesix months ended June 30, 2025. The decrease was primarily attributable to a decrease in professional fees of approximately $7,000 andpayroll and related expenses of approximately $296,000 for personnel engaged in pre-sales feasibility assessments and order fulfillment,which was partially offset by the general operating expenses related to fulfillment of approximately $1,000.

General and Administrative Expenses

General and administrativeexpenses decreased by approximately $1,452,000, or 46%, from approximately $3,159,000 for the six months ended June 30, 2024 to approximately$1,707,000 for the six months ended June 30, 2025. The decrease was attributable to a decrease in compensation costs of approximately$503,000, general operating expenses of approximately $73,000, professional fees of approximately $145,000, utilities and facilities expensesof approximately $65,000, doubtful account expense of approximately $187,000, taxes and insurance of approximately $259,000 and franchisetax of approximately $222,000, which was partially offset by the increase in depreciation and amortization of approximately $2,000.

Other Income, net

Other income, net, increasedby approximately $583,000, or 341%, from an income of approximately $171,000 for the six months ended June 30, 2024 to approximately $754,000for the six months ended June 30, 2025. The increase in other income, net, was attributable to an increase of other income of approximately$622,000, partially offset by increase in interest and penalties on sales tax liability of approximately $9,000, a decrease in interestincome of approximately $36,000, and decrease in interest expense of approximately $7,000.

Liquidity and Capital Resources

Capital Resources

We have recurring lossessince inception. As of June 30, 2025, our available cash and cash equivalents totaled approximately $589,000, which represented a decreaseof approximately $1,290,000 from approximately $1,878,000, as of December 31, 2024. We had working capital deficit of approximately $4,005,000,an accumulated deficit of approximately $74,568,000, cash and cash equivalents of approximately $589,000 and accounts payable and accruedexpenses of approximately $4,961,000. Our continued viability is dependent on the ability to successfully obtain additional working capitaland/or ultimately attain profitable operations. During the six months ended June 30, 2025, the Company continued its efforts, which hadbegun in 2023, to decrease its capital and operational expenditures by cutting costs and right sizing the Company through a reductionin workforce while streamlining operations and rationalizing resources to focus on key market opportunities. The reductions in workforcesince January 1, 2023 through December 31, 2024, cumulatively resulted in an estimated reduction in monthly compensation costs of approximately146% and technology costs of approximately 64% during the year December 31, 2024 when compared to the year ended December 31, 2023. Duringthe second quarter of 2025, the reductions in workforce resulted in an estimated reduction in monthly compensation costs of approximately76% and technology costs of approximately 71% during the six months ended June 30, 2025, when compared to the six months ended June 30,2024. While we plan to improve our sales and revenues, we are taking steps to significantly reduce and manage expenditures to improveour financial position and ensure continued funding of operations. However, as certain elements of our operating plan are not within ourcontrol, we are unable to assess their probability. During the year ended December 31, 2024, we engaged in raising capital through debtfinancing as discussed in Note 7 and through public equity as discussed in Note 10.

We may be unsuccessfulin increasing our revenues or contain our operating expenses, or we may be unable to raise additional capital on commercially favorableterms. Our failure to generate additional revenues or contain operating costs would have a negative impact on our business, results ofoperations and financial condition and our ability to continue as a going concern. If we do not generate enough revenue to provide anadequate level of working capital, our business plan will be scaled down further.

These conditions raisesubstantial doubt regarding our ability to continue as a going concern for a period of one year after the date of this Quarterly Report.Management’s plan to mitigate the conditions that raise substantial doubt includes generating additional revenues, deferring certainprojects and capital expenditures and eliminating certain future operating expenses for us to continue as a going concern. However, therecan be no assurance that we will be successful in completing any of these options. As a result, management’s plans cannot be consideredprobable and thus do not alleviate substantial doubt about our ability to continue as a going concern.

Cash Flows

Operating Activities

For the six months endedJune 30, 2025, net cash used in operating activities was approximately $1,288,000, which consisted of a net loss of approximately $2,706,000offset by non-cash charges of approximately $901,000, which included approximately of $735,000 related to amortization of internally developedsoftware, approximately $18,000 in stock-based compensation, approximately $18,000 in bad debt expense, approximately $34,000 relatedto depreciation of property and equipment, and approximately $96,000 related to amortization of other intangible assets.

Total changes in assetsand liabilities of approximately $517,000 were attributable to an approximately $1,055,000 decrease in accounts receivable, an approximately$60,000 decrease in prepaid expenses, an approximately $29,000 decrease in operating lease right-of-use asset, and an approximately $197,000decrease in deferred revenue, offset by an approximately $117,000, increase in accounts payable, an approximately $523,000 decrease inaccrued expenses and an approximately $24,000 decrease in operating lease liability.

For the six months endedJune 30, 2024, net cash used in operating activities was approximately $3,612,000, which consisted of a net loss of approximately $5,011,000offset by non-cash charges of approximately $1,553,000, which included approximately $1,076,000 related to amortization of internallydeveloped software, approximately $205,000 in bad debt expense, approximately $174,000 in stock-based compensation, approximately $96,000related to amortization of other intangible assets, approximately $32,000 related to depreciation of property and equipment, and approximately$1,000 of losses from sales of available-for-sale securities, which were offset by approximately $29,000 of accretion of discount on available-for-salesecurities.

Total changes in assetsand liabilities of approximately $154,000 were attributable to an approximately $369,000 increase in accounts receivable, an approximately$221,000 decrease in accrued expense, an approximately $157,000 decrease in deferred revenue, and an approximately $81,000 decrease inlease liability, offset by an approximately $280,000 increase in accounts payable, an approximately $259,000 decrease in accounts receivable-unbilled,an approximately $82,000 decrease in operating lease right-of-use asset, and an approximately $55,000 decrease in prepaid expenses andother current assets.

Investing Activities

Net cash used in investingactivities was less than $1,000 for the six months ended June 30, 2025, which consisted of approximately $400 of purchase of propertyand equipment.

Net cash provided byinvesting activities was approximately $2,233,000 for the six months ended June 30, 2024, which consisted of approximately $3,150,000of proceeds from sales and maturities of available-for-sale securities, which were offset by approximately $461,000 of purchases of available-for-salesecurities, approximately $448,000 of capitalization of internally developed software, and approximately $9,000 of purchase of propertyand equipment.

Financing Activities

Net cash used in financingactivities was approximately $1,000 for the six months ended June 30, 2025, which consisted of approximately $1,000 for the payment ofoffering costs in connection with the on-going Public Offering.

Net cash provided byfinancing activities was approximately $1,187,000 for the six months ended June 30, 2024, which consisted of approximately $1,494,000of proceeds received from the issuance of common stock in connection with the ATM Offering, offset by approximately $255,000 for the paymentof offering costs in connection with the issuance of common stock in connection with the ATM Offering and approximately $53,000 for therepurchase of common stock exercisable under PIPE Warrants.

Effects of Inflation and Supply Chain Shortages

Our operations are heavilyreliant on specimen availability, and as a result, we often receive more requests than we can fulfill. While the Company is subject tothese types of supply chain constraints that are specific to the specimen industry, we have not been materially affected by the more commonsupply chain issues currently affecting the economy, specifically surrounding transportation. Due to the small size of the packages thatwe ship, our carriers were able to continue making timely deliveries during the six months ended June 30, 2025. However, there had beenan increase in our shipping costs period over period during the six months ended June 30, 2025.

We have experienced negativeeffects of inflation in certain areas of our business due to the high rates of inflation in the world’s current economy. This inflationis affecting employee salaries, which account for a significant portion of our operating costs. Additionally, the costs of supplies havebeen affected by inflation; however, these costs are not significant to the Company’s results.

Inflation has not hada significant impact on the cost of specimens due to our long-term contracts maintained with vendors, which include revenue sharing plans.

Critical Accounting Policies and Estimates

We have chosen accountingpolicies that we believe are appropriate to accurately and fairly report our operating results and financial condition in conformity withGAAP. We apply these accounting policies in a consistent manner. Our significant accounting policies are discussed in Note 2, “Summaryof Significant Accounting Policies,” in our financial statements included in our Annual Report on Form 10-K for the year ended December31, 2024.

The application of criticalaccounting policies requires that we make estimates and assumptions that affect the reported amounts of assets, liabilities, revenuesand expenses and related disclosures. These estimates and assumptions are based on historical experience and other market-specific orother relevant assumptions that we believe to be reasonable under the circumstances. We evaluate these estimates and assumptions on anongoing basis. If actual results ultimately differ from previous estimates, the revisions are included in results of operations in theperiod in which the actual amounts become known. The critical accounting policies that involve the most significant management judgmentsand estimates used in preparation of our unaudited condensed financial statements or are the most sensitive to change from outside factors,are discussed in “Part II. Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations”contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024. There have been no material changesin our critical accounting policies and procedures during the six months ended June 30, 2025.

JOBS Act Transition Period

On April 5, 2012,the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”) was enacted. Section 107 of the JOBS Act provides thatan “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) ofthe Securities Act for complying with new or revised accounting standards. In other words, an “emerging growth company” candelay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We have elected not to“opt out” of such extended transition period, which means that when a standard is issued or revised and it has different applicationdates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revisedstandard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transitionperiod or (ii) no longer qualify as an emerging growth company.

We are in the processof evaluating the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certainconditions set forth in the JOBS Act, as an “emerging growth company,” we intend to rely on certain of these exemptions, includingwithout limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuantto Section 404(b) of the Sarbanes-Oxley Act of 2002 and (ii) complying with any requirement that may be adopted by thePCAOB regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about theaudit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth company”until the earliest of (i) the last day of the fiscal year in which we have total annual gross revenues of $1.235 billion ormore; (ii) December 31, 2026; (iii) the date on which we have issued more than $1 billion in nonconvertible debt during theprevious three years; or (iv) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

BUSINESS

Our Mission, Vision, and Core Values

iSpecimen’s mission is to accelerate life science research, discoveryand development with a global marketplace platform that connects researchers to subjects, specimens, and associated data. Our vision isto create an “Amazon-like” global Marketplace of patients, biospecimens, and data for research to improve the quality of humanlife. We implement employee programs that foster a company culture predicated on the core values of corporate and individual growth, resultsand accountability, team before self; a can-do positive attitude, and the perseverance to succeed.

Overview

iSpecimen is technology-driven company founded to address a criticalchallenge: how to connect life science researchers who need human biofluids, tissues, and living cells (“biospecimens”) fortheir research, with the billions of biospecimens available (but not easily accessible) in healthcare provider organizations worldwide.Our ground-breaking iSpecimen Marketplace platform was designed to solve this problem and transform the biospecimen procurement processto accelerate medical discovery.

The iSpecimen Marketplace brings new capabilities to a highly fragmentedand inefficient biospecimen procurement market. Our technology consolidates the biospecimen buying experience in a single, online marketplacethat brings together healthcare providers who have biospecimens and researchers across industry, academia, and government institutionswho need them. We are seeking to transform the world of biospecimen procurement much like the way travel websites changed the consumerbuying process for flights, hotels, and rental cars.

The iSpecimen Marketplace Solution

The iSpecimen Marketplace offers single-source access to millions ofhuman biospecimens and patients across a diverse network of specimen providers quickly and compliantly, saving researchers time and moneyin their specimen procurement process while making it easier and more efficient for providers to get their specimens in the hands of researcherswho need them. Our iSpecimen Marketplace technology makes it as easy to find specimens for research as it is to find flights on a travelwebsite. We have adopted many of the same ease-of-use characteristics of these business-to-consumer, or B2C marketplaces, from simpleguided searches, to the ability to refine search criteria with sliders and checkboxes, to the ability to add chosen items to a cart inorder to purchase them, to online order management. Our two-sided marketplace platform makes it easy for researchers and healthcare providersto connect and transact, introducing efficiencies into what is otherwise a very time-consuming and manual process.

The platform is built upon a robust healthcare data set comprised ofinformation about available specimens and research subjects, which then enables the search and matchmaking process. It receives de-identifiedspecimen and patient data from electronic medical records, laboratory information systems, biobank inventory systems, and other healthcaredata sources (either in real time via data feeds or regularly via file extracts) and harmonizes this “big data” across allparticipating organizations into a common dataset, which now incorporates external clinical content to further optimize and standardizethe biospecimen data on iSpecimen’s proprietary Marketplace platform. The data is then easily searchable by researchers using ourintuitive, web-based user interface. Researchers can use their unique study inclusion and exclusion criteria as selection filters to searchthe de-identified healthcare data to find matching specimens currently available in laboratories and biobanks in our network. Researcherscan then select the specific specimens they need for their studies, add them to a cart, request quotes, place orders, and track and managetheir specimen requests and associated data across projects. When specimens are not available that meet their research criteria, researcherscan, with a click of a button, request a quote for a custom specimen collection and this custom specimen request will be distributed acrossour network of biospecimen providers.

Biospecimen providers also gain efficiencies using the iSpecimen Marketplace,not only by giving providers instant access to a large researcher base, but because the technology orchestrates the bioprocurement workflowfrom specimen request to fulfilment. Specimen providers gain access to intuitive dashboards to view requests, create proposals, and trackand manage their orders.

In addition to providing the technology platform to connect researchersand healthcare providers, iSpecimen handles all marketing, sales, contracting, and compliance functions across both sides of the marketplace.

We market to and develop relationships with researchers and specimenproviders alike to bring them together into a single platform. We contract once with each participating customer and with each supplierorganization and a single agreement then enables all users in that organization to instantly connect and work with all other organizationsin the iSpecimen network. We also audit our suppliers to confirm they have proper Institutional Review Board (“IRB”) (or equivalent)protocols in place where required by law.

As of December 31, 2024, we had more than 7,925 external registeredusers on the iSpecimen Marketplace platform, representing more than 3,006 unique internet domains. Collectively, these users logged intothe iSpecimen Marketplace more than 162,252 times and performed nearly 19,295 specimen searches yielding more than 3,098 quote requestssince its launch.

Our iSpecimen Marketplace platform has compiled de-identified healthcaredata provided by our healthcare supply partners’ approximately 19 million patient records, 105 million clinical specimen records,1.4 million banked specimen records, and 1.2 million medical conditions as of December 31, 2024 — to allow researchers to easilysearch for and select research subjects, specimens, and associated data they need to drive their research programs. It then orchestratesand manages the biospecimen procurement workflows of both researchers and suppliers to bring efficiency to the entire buying process.Through the iSpecimen Marketplace, researchers gain instant access to millions of specimens anytime, anywhere, while participating supplyorganizations gain an opportunity to contribute compliantly to medical research while increasing their revenue and sustainability.

Planned Developments of our Marketplace

While the iSpecimen Marketplace currently supports our business modelof providing access to search, find, and acquire human biospecimens and associated data from “inquiry to invoice” and positionsus for future expanded business model exploration, there are a number of areas in which the iSpecimen Marketplace functionality couldbe enhanced to better support our stakeholders, including our prospects and customers, iSpecimen sales and operations staff, and our supplypartners. We believe with additional investment in technology development resources, we could make significant progress in scaling ouriSpecimen Marketplace and, in addition to increased patient and specimen data integration, we expect to continue to improve the matchmakingacross the platform and have capabilities such as more direct support for our prospective collections, deeper search and workflow capabilities,increased automation, and direct pricing availability in the platform.

As investment allows, we plan to continue to better connect healthcareresearchers with our network of suppliers to enable the acquisition of human biospecimens and data to help accelerate research and expandthe impact of our iSpecimen Marketplace platform from “inquiry to invoice” through the following key approaches:

We continue to prioritize and release updated versions of the iSpecimenMarketplace platform in alignment with these areas and believe that continuing to focus on these approaches will enable us to scale ourbusiness model more effectively. As part of this continued platform evolution, iSpecimen continues to explore adjacencies that leveragethe platform including a data as a product model.

Our Technology

Technology Components

The iSpecimen Marketplace technology is comprised of four major functionalareas: search, workflow, data and administrative, compliance and reporting. We continue to invest in the evolution of these areas to improvecustomer and supplier engagement with the platform; provide operational efficiencies for our suppliers, our customers, and our internaloperations; and increase the liquidity of products and services obtained through the platform. Our core business objective is to retainand grow both researcher and supplier usage of our platform to support biospecimen procurement, as well as to position our Company toexplore other adjacent business opportunities that can benefit from the use of the iSpecimen Marketplace.

By entering subject and sample selection requests through the iSpecimenMarketplace, researchers can instantly search across the available medical records of large populations within iSpecimen’s healthcareprovider network to create customized patient and specimen cohorts. Researchers can specify their criteria and either refine and reviewresults to select specific specimens instantly, or they can request that iSpecimen find patients, specimens, and associated data to satisfytheir needs when specimens do not currently exist in our network. Using our own proprietary algorithms, we enable researchers to exploreboth biospecimens that are currently available and view projections of those that are likely to become available in the future based onhistoric statistical analysis of data. This allows researchers to quickly and easily determine how we can fulfill their requirements,which is especially useful for project planning and budgeting.

Our search capabilities are what most notably distinguishes the iSpecimenMarketplace from other business-to- business, or B2B bioprocurement marketplaces. Whereas some other bioprocurement marketplaces supporta search that generates a list of service providers that the researcher must then contact to inquire about specimen availability, theiSpecimen Marketplace goes a step further and returns a list of available specimens and data that actually meet the researcher’sspecific requirements. Researchers can then select the individual specimens, add them to a cart, and request a quote for these exact specimens.By incorporating user experiences that researchers are accustomed to from their online consumer shopping experiences, such as facetedsearches and the ability to add items to a cart, the iSpecimen Marketplace brings B2C ease of use to the B2B space.

In addition to supporting our suppliers’ workflow requirements,our workflow engine orchestrates customers’ bioprocurement workflows from specimen requests through fulfillment. Customers can notonly search for and select specimens, but they can track and manage their specimen quote requests, place orders, track the progress oforders as they are fulfilled and shipped, and download packing lists, data sheets, and other accompanying data.

Finally, the Marketplace technology acts as the command and controlcenter for internal iSpecimen operations users and allows them to easily federate and manage the sourcing of specimens and data for allrequested projects across a large and growing supply chain. The technology tracks and manages requests for specimens from inquiry-to-invoiceand provides a single place for internal users to manage all specimen requests, orders, shipments, and data. Additionally, because ourtechnology easily scales to support a growing supply network and customer base, we have satisfied projects of all types and sizes —from small specimen requests to projects with more than a thousand samples from specific patient cohorts.

In addition, our platform gathers usage data that enables us to granularlyunderstand supply and demand as well as provide value-added insights to our business partners. For example, our biobanking partners oftenhave access to more samples than they can economically store.

Understanding which samples are likely to be the most useful to researchershelps guide the biobanks’ operational practices to optimize their supply chain (for example, providing them with information onthe medical conditions and specimen types that are in highest demand can help guide their collection practices). Our ability to deliverrelevant insights further increases the engagement with our platform and positions us as a valuable partner.

As we continue to ingest and generate more data, there are additionalbusiness opportunities to leverage our platform and continue to evolve the iSpecimen Marketplace using modern approaches such as roboticprocess automation and artificial intelligence/machine learning techniques to further improve the efficiency and effectiveness of theplatform and enhance the value of the data. Our ability to leverage network effects will enable us to realize increasing returns fromour investments and expand into adjacent markets such as clinical trial patient recruitment, data as a product, software-as-a-service(“SaaS”), and Next Generation Sequencing (an initiative launched in late 2023). With additional data comes additional securityrisks we worked to mitigate through shoring up existing security processes and protocols and the addition of a 24x7 managed risk vendor.

Our Products and Services

The iSpecimen Marketplace currently supports the supply chain managementand bioprocurement process for specimens and associated data. We derive our revenue by procuring specimens from our healthcare providernetwork and then distributing these annotated biospecimens to our research client base. Revenue flows from the researchers who pay ourCompany to provide the specimens and we share that revenue back with the healthcare providers who supplied them. Revenue share back tothe supplying organization is generally 20% to 50%, depending upon the sample type, collection requirements, and data provided. We areflexible and allow our suppliers to work with us using a number of revenue share constructs, including a fixed percent revenue share arrangement(whereby we share a fixed percentage of the revenue back with them), a fixed pricing schedule (whereby they set their pricing per specimentype), or on a project-based pricing (whereby the supply site sets fees on a per project basis). We have derived substantially all ofour revenue from annotated biospecimen procurement and to date, have not charged our customers or suppliers fees for the use of the iSpecimenMarketplace platform, or for marketing, sales, contracting, or compliance functions that we provide as part of the specimen procurementprocess.

We generally operate in a “just in time” fashion, meaningwe procure specimens from our suppliers and distribute specimens to our customers after we obtain an order for specimens from a researchclient. Generally, we do not speculatively purchase and bank samples in anticipation of future, unspecified needs. We believe our approachoffers many advantages over a more traditional inventory-based supplier business model where biorepositories take inventory risks, andwhere turnover and cash conversion cycles can be lengthy, depending on market demand for certain specimen types.

Currently, we provide access to the following types of human biospecimensfrom healthy and diseased-state subjects:

For each of the biospecimen types, we offer:

The cross product of all these categories (i.e. remnant or researchuse only and biofluids, tissues, or hematopoietic stem or immune cells) describes the product types we use to track and manage the business.These groupings include:

For each of these product types, biospecimens may already exist inlaboratory archives or banked in our network of biorepositories (“banked”) or may be collected in the future from our networkof healthcare providers and commercial specimen providers (“prospectively-collected” or “custom collections”).

Our Supply Partners

Critical to the success of the iSpecimen Marketplace is the networkof healthcare providers who make their patients, samples, and data available to researchers. This supply network was built over a ten-yearperiod and as of December 31, 2024, our supply network consisted of approximately 76 unique healthcare organizations and biospecimen providersunder agreement, including healthcare systems, community hospitals, clinics, private practice groups, commercial laboratories, blood centers,commercial biobanks, clinical research sites, and cadaveric donation centers.

Our suppliers are located in eleven (11) countries across the Americas,Europe, and Asia and our cost of revenue for the years ended December 31, 2024 and 2023, break out as follows geographically:

Each supplier organization may give us access to one or more of thefollowing environments within their organization where specimens may be obtained:

Supply sites may provide specimens from one or all these environments,depending on their practices and capabilities. Each supply site can select how it will work with our Company.

In addition to obtaining specimens and data directly from healthcareorganizations, we work with several commercial biobanks and biospecimen brokers who have their own network of healthcare provider supplypartners and wish to make their samples available to our research clients as well. While these organizations are generally consideredour competitors, they are willing to work with us because we provide value by acting as both a distribution channel for them and a supplypartner to them to increase their revenues. Moreover, the inclusion of competitors’ specimens in our iSpecimen Marketplace platformfurther strengthens our competitive position and value to our customers by further de- fragmenting our customers’ buying experience.

Our Customers

Our customer base is primarily comprised of three main segments: biopharmaceuticalcompanies, in vitro diagnostic companies, and government/academic institutions. As of December 31, 2024, we had distributed our specimensto approximately 765 customers, such as the Centers for Disease Control and Prevention. Since entering the regenerative medicine marketlate 2019, we have acquired 33 customers representing 0.7% of our total revenue both in 2023 and in 2024.

From our inception through December 31, 2024, we had distributed morethan 240,000 specimens to 23 countries and our geographical revenues distribution for the years ended December 31, 2024 and 2023 wereas follows:

During the year ended December 31, 2024, there was one customer thataccounted for approximately 29% of our total revenue generated. During the year ended December 31, 2023, there were one customer thataccounted for approximately 25% of our total revenue generated. We continuously engage with all customers when we receive inbound requestsfrom them, whether they are within or outside of the Americas. Year-over-year, our top customers have been different because their specimenneeds tend to be project-based and depending upon where they are in their research and development cycle, they may not need large numbersof specimens each year. During the year, our customer retention rates are moderate, with 16 of our top 25 customers (64%) in the yearended December 31, 2023 also procuring specimens in the year ended December 31, 2024.

Biospecimens have broad utility within the healthcare and life scienceindustries, as they are collected and used throughout nearly every stage of diagnostic and therapeutic product discovery and development.For diagnostic products, they are used consistently for preclinical discovery, clinical validation, and post-market validation, as wellas surveillance. For therapeutic products, these samples are most often used during preclinical research involving drug target identificationand validation, compound screening, lead optimization, predictive toxicology, and pharmacokinetic studies. They are also used for biomarkercompanion diagnostic discovery and development, which has been shown to reduce the costs of drug clinical trials by 30 to 60% accordingto Ark Research. In the case of regenerative medicine applications, hematologic samples are used for research and development of engineeredcell therapies (e.g. CAR-T, CAR-NK), stem cell therapies (e.g. hematopoietic stem cells, mesenchymal stem cells), exosome therapies, identificationof cell immunophenotypes for allogeneic therapies, and for developing and scaling-up cell therapy manufacturing processes.

Given recent advances in technology that now allow for the identificationof molecular determinants of disease, the role of the patient’s biospecimen has become even more important in all these endeavorsand is essential to the development of precision medicine. This pursuit of precision medicine by the healthcare and life science industrieshas further increased the already high demand for human biospecimens and the clinical data that describe them.

Our Competitors

We compete with a highly fragmented landscape of organizations whohave access to human biospecimens. The competitive organizations, including:

In each of these cases, the landscape is extraordinarily fragmented,and our management estimates that most biospecimen providers have less than 5% market share each, and no single biospecimen provider hasmore than a 20% market share. Most competitors are smaller organizations with limited specimen procurement abilities. However, there areseveral larger biospecimen providers who are consolidating the industry by acquiring smaller specimen providers to enable them to providebroader access to specimens and research subjects. These organizations are well-capitalized by private equity and while they still lacka technology-based approach that enables them to search the inventories across their biospecimen provider network, because of their broadspecimen access, banked inventory, and available cash, they currently represent our biggest competitive threat.

Specimen providers (e.g. Discovery Life Sciences and StemExpress) maintaininternal biobanks and enable researchers to search online for specimens that reside within their own biobanks. Other research servicesmarketplaces (e.g. Science Exchange) allow researchers to describe a specimen request which then gets broadcast to a network of specimenproviders (i.e. no searching for specimens, but rather the identification of specimen providers who may or may not have matching specimensand the distribution of the specimen request to them). As such, we believe that there are no other online human biospecimen marketplacesthat operate in a manner similar to our business. In addition, we believe that over the long term, the iSpecimen technology-based approachwill allow us to scale faster than our competitors who rely upon manual efforts to procure specimens. Nonetheless, we believe we willcontinue to face competition from: healthcare providers that have their own inventory of biospecimens and thus offer lower prices by eliminatingus and others as middlemen; commercial biobanks that have their own inventory of biospecimens and thus may deliver samples more quicklywhen a researcher’s needs align with their existing inventory; specimen brokers with a specific niche (e.g. infectious disease);and commercial specimen providers with their own donor centers who may more predictably collect and deliver specimens.

Our Intellectual Property

Intellectual property rights are an important component of our business.While we currently do not have any patents protecting our intellectual property, we rely on a combination of copyright, trademark, andtrade secret laws in the United States and other jurisdictions, as well as confidentiality and non-disclosure agreements and other contractualprotections with employees and third parties to protect our intellectual property rights, including our proprietary technology, brand,and know-how. We believe factors such as the technological and creative skills of our people; our existing and evolving partnerships;the creation of new features, functionality, and services; and the frequent enhancements to our platform have helped us to establish andwill help us maintain our technology leadership position.

Regulations

iSpecimen works with the healthcare industry and with clinical researchers,both highly regulated environments in the United States and other countries. Government departments and agencies, at the federal, state,and local levels have regulations related to research activities that involve human subject research as well as regulations about thecollection, storage, and dissemination of personal and healthcare data related to individuals. To support compliance with regulations,we have both internal personnel and external resources who provide us with expertise in various areas of compliance including a ChiefInformation Security Officer, Chief Privacy Officer, contracts manager, biospecimen and data privacy counsel (external), general counsel(external), IRB (external), and other employees with expertise and oversight of site compliance, lab compliance, and operational compliance.

The following is a general overview of the major laws and regulationspertaining to our business in the United States:

Most countries have their own corresponding rules that we are alsorequired to follow.

45 CFR Part 46 — Federal Policy for the Protection of HumanSubjects — “The Common Rule”

The Common Rule refers to regulations issued by the U.S. Departmentof Health and Human Services (“HHS”) and other federal agencies that fund or participate in research, which regulations protectindividuals participating in research. The Common Rule defines “Human Subjects Research” as research involving a living individualabout whom an investigator is conducting research when information or biospecimens are obtained through intervention or interaction withthe individual, or where the research uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.For this type of research, the Common Rule stipulates: (i) when this research must be reviewed and approved by an IRB (as well as whenit may be exempt from IRB review and approval); (ii) the requirements for an IRB’s membership, authority, review procedures, recordkeeping, and approval criteria; (iii) when informed consent must be obtained from a research subject for participation in research andthe elements that must be communicated in an informed consent form (as well as when consent may be waived by an IRB); and (iv) rules relatedto special requirements for vulnerable populations (such as prisoners and pregnant women).

iSpecimen is involved with both Human Subject Research and non-HumanSubject Research. The collection of Research Use Only (“RUO”) specimens (i.e., samples collected specifically for researchvia a direct intervention with the research subject and not collected as part of routine clinical care) is considered Human Subject Research.In those cases, iSpecimen and our suppliers are subject to the Common Rule. Therefore, all research use only specimens collected in theUnited States need to be collected under an IRB-approved protocol, with informed consent (unless an IRB waives consent under appropriateregulatory standards).

When iSpecimen is the study sponsor (i.e. specimens are collected underour IRB protocol), we work with a commercial IRB (currently Advarra) to approve our protocol, informed consent forms, subject recruitmentmaterial, and collection sites. These protocols and associated material are reviewed regularly by our IRB in accordance with the CommonRule. When iSpecimen is not the study sponsor (i.e., when research use only specimens are collected at participating healthcare providersunder their own IRB-approved protocols), we audit the site before we start procuring specimens to ensure that appropriate IRB approvalsare in place.

For international specimen collection sites, we rely on those sitesto ensure they are collecting specimens in accordance with the laws in their own jurisdictions, in addition to following basic U.S. rulesrelated to Human Subjects Research.

Finally, iSpecimen participates in Non-Human Subject Research, specificallywhen we collect clinical remnant samples (i.e., those specimens that were collected originally as part of clinical care). According tothe Common Rule, as long as the physical sample and any associated dataset is de-identified before being used for research, the use ofclinical remnant samples is not considered Human Subject Research and therefore does not need IRB review and approval, nor does it requirepatient consent. For these samples, iSpecimen leaves it up to each supplier to determine whether the supplier seeks patients’ consentor whether the supplier will inform its patients about the supplier’s use of remnant samples, or allows its patients to opt-outof their use. In all cases, we track any use limitations that attached to a particular specimen. For researchers who only want samplesfrom patients who have consented to allow use in research, we only distribute specimens meeting that criteria to those researchers.

Health Insurance Portability and Accountability Act, as amended bythe Health Information Technology for Economic and Clinical Health ( “HITECH”) Act, all as implemented by 45 CFR Part 160,162 and 164 (collectively, “HIPAA”).

HIPAA includes several applicable rules, including the Standardsfor Privacy of Individually Identifiable Health Information (“Privacy Rule”), the Security Standards forthe Protection of Electronic Protected Health Information (“Security Rule”), and the Breach NotificationRule (“Breach Notification Rule”).

The Privacy Rule addresses the allowable uses and disclosures of anindividual’s PHI by Covered Entities, defined by HHS as (1) health plans, (2) healthcare clearinghouses, and (3) healthcare providerswho electronically transmit any health information in connection with transactions for which HHS has adopted standards (such as electronicbilling). The Privacy Rule also applies to Business Associates, which include persons or entities that performs certain functions or activitiesthat involve the use or disclosure of PHI on behalf of, or provide certain services to, a Covered Entity. HIPAA requires Covered Entitiesto obtain HIPAA Business Associate Agreements with their Business Associates.

The Security Rule establishes a national security standard for protectingePHI. The Security Rule requires Covered Entities and Business Associates to implement physical, administrative, and technical safeguardsto protect ePHI.

The Breach Notification Rule pertains to Covered Entities and BusinessAssociates that have access to PHI and requires them to provide notification following a use or disclosure of PHI that does not complywith the Privacy Rule that compromises the security or privacy of the PHI (a “Breach”).

Covered Entities and Business Associates that fail to comply with theHIPAA standards may be subject to civil money penalties or criminal prosecution.

iSpecimen has implemented many protocols and processes to comply withHIPAA and other data privacy and related laws and regulations. First, to reduce the likelihood of any Breach, iSpecimen removes all ePHIprior to storing information in our datacenter so that we do not possess PHI that is subject to HIPAA. Secondly, to the extent any PHIinadvertently remains in our datacenter, we have implemented physical, administrative, and technical safeguards to comply with the HIPAASecurity Rule. We have implemented more than eighty HIPAA privacy and security policies at the Company to help ensure compliance withHIPAA Privacy, Security and Breach Notice rules. Thirdly, we regularly undergo HIPAA gap analyses and security testing using external,independent firms to find weaknesses and vulnerabilities in our technology and our data protection policies and procedures and remediateas needed. Finally, iSpecimen executes Business Associate Agreements or Data Use Agreements with our healthcare provider partners if theymight share ePHI with us. To date, iSpecimen has never had a Breach of PHI and has never been investigated by HHS nor found to be outof compliance with HIPAA.

21 CFR — FDA Regulations

The Food and Drug Administration (“FDA”) is an HHS agencythat regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices. TheFDA has its own set of rules related to the protection of human subjects in research which may differ from the Common Rule. However, FDAdoes harmonize its regulations with the Common Rule whenever permitted by law (see section 1002 of the 21st Century Cures Act, PublicLaw 114-255). iSpecimen follows the FDA regulations related to the protection of research subjects, so that its customers may submit datato the FDA resulting from research performed using data and specimens provided to the researcher by iSpecimen.

21 CFR Part 11 Electronic Records; Electronic Signatures

21 CFR Part 11 is relevant when submissions to the FDA include recordsin electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forthin FDA regulations. At a high level, Part 11 requires organizations to implement good business practices by defining the criteria underwhich electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and generally equivalentto paper records and handwritten signatures on paper. These rules stipulate a range of features that must be in place in computer systemsthat handle electronic data; standard operating procedures relating to information technology systems and processes; system validationprocesses and procedures to ensure that electronic systems operate as intended.

Although iSpecimen defines and implements many relevant policies, processes,and technical controls, the iSpecimen Marketplace has not been certified or audited for 21 CFR Part 11 compliance. In addition, we donot require the originating systems from whom we receive data to be 21 CFR Part 11 compliant. While we do not represent to customers orsuppliers that our systems are 21 CFR Part 11 compliant, our clients may still submit data to the FDA that was received, stored, and transmittedin our systems.

The vast majority of the specimens used by our customers are for projectsthat do not require 21 CFR Part 11 compliance, and our customers are responsible for determining whether they require Part 11-compliantdata for the particular use. For specimens that are collected with informed consent, we audit informed consent differently for supplysites that use their own IRB or ethics committee and those supply sites that use the IRB we contract. In the event we are required tocontact a client about a shipped specimen that is not supported by informed consent, which had not happened as of December 31, 2024, theclient would then determine whether it could use the specimen without informed consent. In addition, we contract with an outside IRB forIRB services, which agrees to perform the services in accordance with all applicable laws and regulations governing independent institutionalreview boards, and to indemnify us for its failure to comply with applicable laws, rules, and regulations. The failure of our Companyor our supply sites to comply with international, federal, state, and local laws and regulations could subject us to denial of the rightto conduct business, fines, criminal penalties, and/or other enforcement actions which could have a material adverse effect on our business.

21 CFR Part 50 — Protection of Human Subjects

21 CFR Part 50 contains the general standards for obtaining informedconsent and for human participation in clinical investigations as well as additional safeguards for children involved in clinical investigations,when the investigations are regulated by the FDA. The regulations specify the requirements for informed consent, exceptions to these requirements,elements of informed consent, and documentation of informed consent. Additionally, the requirements detail additional regulations forinvestigations involving children. Informed consent is not required to use de-identified specimens and data for certain FDA-regulatedresearch, as set forth in guidance documents issued by the FDA.

To the extent our suppliers seek informed consent from individualsto use specimens and data for research, we will provide our clients, upon request, with copies of our or our suppliers’ templateinformed consent forms and IRB approval prior to obtaining samples from us. However, gaps may exist in our or our suppliers’ protocolsand informed consent forms that make them incompatible with this regulation and we may fail to properly audit and identify these gaps.

21 CFR 56 Institutional Review Boards

21 CFR Part 56 contains the general standards for the composition,operation, and responsibility of an IRB that reviews clinical investigations regulated by the FDA. These regulations are intended to protectthe rights and welfare of human subjects involved in such investigations and indicate the required organization and membership of an IRB;the IRB’s function and operations; record-keeping and reporting; and administrative actions for non-compliance.

iSpecimen utilizes an outside IRB to review the iSpecimen specimencollection protocol. While we believe the IRB composition and operations to be 21 CFR Part 56 compliant, there may be gaps that make themincompatible with this regulation.

Other Information Laws and Regulations

Other information laws and regulations include all applicable lawsconcerning the privacy and/or security of personal information including, but not limited to, state data breach notification laws; personaldata protection laws such as the California Consumer Privacy

Act of 2018, Nevada Senate Bill 220 (an amendment to the state’sexisting online privacy policy statute) and Maine’s Act to Protect the Privacy of Online Consumer Information; and all applicablePayment Card Industry Security Standards with respect to account data protection.

Currently, iSpecimen collects personal data on customers, suppliers,investors, employees, research subjects, Marketplace registrants, and other individuals who interact with iSpecimen personnel or our websites.We believe we are in compliance with these data protection rules but there remains inherent risk of a data breach of iSpecimen’ssystems or any of our technology service and SaaS providers (such as those organizations who provide us with customer relationship managementsoftware, marketing automation software, online file storage, web services, email systems, accounting systems, and data aggregation andvisualization services).

Other Applicable Laws

In addition to the above-described regulation by United States federaland state government related to Human Subject Research and data privacy and security, there are many other U.S. and international rulesthat are applicable to iSpecimen. The following list contains some of the other federal and state laws and regulations that could directlyor indirectly affect our ability to operate the business:

These laws cover areas where we may not have expertise and, in manyareas, these laws are actively evolving. We, or our other third-party customers, suppliers and/or distribution partners, may not be ableto maintain regulatory compliance in such countries or may incur significant costs in obtaining or maintaining our foreign regulatorycompliance.

International Regulatory Environment

Because iSpecimen procures specimens from and distributes specimensto countries outside of the United States, we are subject to international rules related to the protection of human subjects in research,data privacy and security, import and export regulations, tariffs, and foreign rules similar to any of the aforementioned U.S. rules,as well as those of which we are unaware.

One of the more prominent international regulations is the GeneralData Protection Regulation (“GDPR’) which took effect in May 2018. The GDPR regulates the collection, use, disclosure, transfer,and/or other processing of personal data of identified or identifiable individuals located in the European Economic Areas, including theEuropean Union (“EU”). This data specifically includes personal health data that generally is provided as part of biospecimencollection studies. The GDPR imposes numerous requirements on companies that process personal data, including requirements relating toprocessing health and other sensitive data, obtaining consent of the individuals to whom the personal data relates for processing (withsome exceptions), allowing individuals to revoke consents granted, enabling individuals the right to have their data erased (with someexceptions), amended, or transferred to another data controller (known as “data portability”), providing information to individualsregarding data processing activities, implementing safeguards to protect the security and confidentiality of personal data, limiting thetransfer of data to countries outside of the EU, providing notification of data breaches, and taking certain measures when engaging third-partieswho may also use or process the data.

In addition, EU member states may make their own further laws and regulationslimiting the processing of personal data, including biometric, genetic, or health data.

The GDPR increases our obligations with respect to data collected byour EU suppliers. We generally rely upon our contractual terms with these organizations as a means for obligating them to provide us datain accordance with the GDPR regulations. In addition to utilizing contractual terms to obligate specimen suppliers to conform with GDPR,we generally request the international supplier fills out a pre-contract questionnaire to understand their GDPR compliance before engagingin the contracting process and then perform a post-contract audit that also asks about GDPR applicability and the site’s conformanceto the GDPR. Audit questionnaires are distributed every two years after the initial site audit.

Employees

As of June 30, 2025, we had twenty-four (24) employees, one (1) ofwhom was engaged in research and development activities, nine (9) of whom were engaged in sales and marketing activities, eleven (11)of whom were engaged in operations and fulfillment activities, and three (3) of whom were engaged in supply development and managementactivities. Our employees are primarily located in Woburn, Massachusetts with fifteen (15) remote sales, marketing, and supply developmentpersonnel located elsewhere in the U.S.

MANAGEMENT

Officers and Directors

The following is a list of our directors and executive officers asof August 18, 2025, along with the specific information required by Rule 14a-3 of the Exchange Act:

Robert Bradley Lim has been serving as our Chief ExecutiveOfficer and director since December 2024. Mr. Lim also serves as a Treasurer and Secretary of the Company. Mr. Lim is the Principal andCo-founder of De Novo Law Corporation, a Vancouver-based law firm specializing in corporate/commercial law and civil litigation. Mr. Limcurrently serves as a director of Qualigen Therapeutics Inc. (Nasdaq: QLGN) since July 2024 and has served as a director of Aerwins TechnologyLtd. from July 2023 – July 2024. Mr. Lim holds a Bachelor of Commerce from the University of British Columbia and a Juris Doctorfrom Thompson Rivers University.

Yuying Liang has been serving as our Chief Financial Officersince December 2024. Ms. Liang is the Principal and Director of Canmore Financial Services Inc. and Yuying Liang Professional Corp. withsignificant experience in corporate accounting, financial reporting, and CFO services. Ms. Liang has worked extensively with public andprivate companies across multiple sectors, providing financial leadership and strategic guidance. Ms. Liang holds a Bachelor of BusinessAdministration from Simon Fraser University and holds the professional designation of chartered professional accountant (CPA). Ms. Liangis CFO and Director of Modern Plant Based Foods Inc., Montego Resources Inc. and Ultra Brands Ltd.; the CFO of BlockchainK2 Corp, GoldhillsHolding Ltd., Intact Gold Corp., Kincora Copper Limited and Transatlantic Mining Corp.

Katharyn (Katie) Field been serving as our President sinceFebruary 2025 and was previously a director from September 2024 until her appointment as President. Ms. Field has a background which includespositions spanning both the private and public sectors and brings a wealth of experience and expertise in strategy consulting and executiveleadership. Ms. Field is currently the chief executive officer and Chairman of Halo Collective Inc., a cannabis company, where she hasserved since May 2019, an Executive Director at Akanda Corporation (Nasdaq: AKAN), a medical cannabis company, where she has served sinceJune 2022, and a director and Vice President of Virpax Pharmaceuticals, Inc., a preclinical-stage pharmaceutical company, where she hasserved as director since July 2024. Previously, she served as a director of Elegance Brands from March 2021 until March 2022. She hasheld prominent positions at renowned organizations such as The White House in the office of the public liaison, The Brookings Institutionas a manager of operations, and Bain & Company as a consultant. In 2014, Ms. Field entered the cannabis industry and played a pivotalrole in the procurement, build-out, and sale of one of the original vertically integrated licensed medical marijuana treatment centersin Florida. Subsequently, she operated a strategy consulting practice focused on cannabis and served as Executive Vice President of CorporateDevelopment at MariMed from 2018 to 2019. Ms. Field holds an MBA in Economics from Columbia Business School and a BA in Public Policywith honors from Stanford University. Ms. Field is well-qualified to serve as President of the Company due to her experience and expertisein strategy consulting and executive leadership.

Siyun Yang has been serving as an independent directorof the Company since February 2025. She also serves on the Audit Committee and Nominating and Corporate Governance Committee of the Board.Ms. Yang is an Associate Attorney at Quill & Arrow LLP, specializing in consumer protection and product liability litigation. Previously,she served as In-House Counsel at Halo Collective Inc., overseeing regulatory compliance, corporate transactions, and litigation mattersrelated to cannabis operations and intellectual property. Prior to that, she was a Provisional Licensed Lawyer at Di Li Law, PC, whereshe focused on trademark filings, oppositions, and intellectual property matters. Ms. Yang holds an LL.M. in International ComparativeLaw from UCLA School of Law and an LL.B. in International Economic Law from East China University of Political Science and Law. Her expertisein litigation, corporate governance, and data analytics enhances the Board’s oversight capabilities.

Anthony Lau has been serving as a director of the Company since June 2025. He also serves on the AuditCommittee and the Nominating and Corporate Governance Committee of the Board. Mr. Lau currently serves as Director, Chief Executive Officer,and Chief Financial Officer of Remington Resources, Inc., a Canadian resource company, a position he has held since 2021. He brings tothe Board significant leadership and financial management experience, having overseen corporate strategy, operations, and capital marketsactivities in his executive role. Mr. Lau received his undergraduate degree from the British Columbia Institute of Technology. Mr. Lauis well-qualified to serve on the Board due to his extensive experience as a senior executive and director of a public company, with expertisein corporate governance, finance, and executive management.

Avtar Dhaliwal has been serving as our director since September2024. Mr. Dhaliwal has served as a director and a member of the compensation committee of the board of Halo Collective Inc. since March2022, which is a cannabis extraction company that develops and manufactures quality cannabis oils and concentrates, and he has been amember of its audit committee of the board in August 2024. Since August 2024, Mr. Dhaliwal has been a director of Advent TechnologiesHoldings Inc., a US corporation that develops, manufactures, and assembles complete fuel cell systems as well as supplying customers withcritical components for fuel cells in the renewable energy sector. Since December 2021, Mr. Dhaliwal has been the Chief Executive Officerof Modern Plant Based Foods, a Canadian food company that offers a portfolio of plant-based products. Previously, Mr. Dhaliwal workedin operations and logistics with Modern Plant Based Foods Inc. beginning in October 2019, and has also been the Chief Executive Officerof Pontus Protein Ltd., an agricultural food and technology company focused on creating and acquiring the best technology, since March2022. From January 2024 until May 2024, Mr. Dhaliwal was the Chief Executive Officer and a director of Trilogy AI, a company committedto transforming the beauty industry through its artificial intelligence technology. Mr. Dhaliwal holds a Bachelor of Science in Biologyfrom the University of British Columbia Okanagan. Mr. Dhaliwal is well-qualified to serve on the Board due to his management experienceacross multiple industries.

Family Relationships

There are no family relationships among any of our executive officersor directors.

Composition of our Board of Directors

Our Board currently consists of five (5)directors. Our certificate of incorporation, as amended, and bylaws, as amended, provide that our Board can consist of any number ofdirectors as voted on and approved by the Board. Our Board is divided into three classes, designated as Class I, Class II and ClassIII directors, with only one class of directors being elected in each year and each class serving a three-year term. The term ofoffice of the Class I directors, consisting of Ms. Yang and Mr. Lim will expire at our 2025 annual meeting ofstockholders. The term of office of the Class II directors, consisting of Mr. Dhaliwal, will expire at our 2026 annual meeting ofstockholders. When considering whether directors have the experience, qualifications, attributes or skills, taken as a whole, toenable our Board to satisfy its oversight responsibilities effectively in light of our business and structure, the Board focusesprimarily on each person’s background and experience as reflected in the information discussed in each of the directors’individual biographies set forth above. We believe that our directors provide an appropriate mix of experience and skills relevantto the size and nature of our business.

Director Independence

As our common stock is listed on the Nasdaq Capital Market, our determinationof the independence of directors is made using the definition of “independent director” contained in Nasdaq Listing Rule 5605(a)(2).Our Board has affirmatively determined that each of Mr. Lau, Mr. Dhaliwal and Ms. Yang are “independent directors,” as thatterm is defined in the Nasdaq rules. Under the Nasdaq rules, our Board must be composed of a majority of “independent directors.”Additionally, subject to certain limited exceptions, our Board’s audit, compensation, and nominating and corporate governance committeesalso must be composed of all independent directors.

Audit committee members must also satisfy the independence criteriaset forth in Rule 10A-3 under the Exchange Act. Under the rules of Nasdaq, a director will only qualify as an “independent director”if, in the opinion of that company’s board of directors, that person does not have a relationship that would interfere with theexercise of independent judgment in carrying out the responsibilities of a director.

To be considered to be independent for purposes of Rule 10A-3 of theExchange Act, a member of an audit committee of a listed company may not, other than in his capacity as a member of our audit committee,our Board, or any other committee of our Board: (1) accept, directly or indirectly, any consulting, advisory, or other compensatory feefrom the listed company or any of its subsidiaries; or (2) be an affiliated person of the listed company or any of its subsidiaries.

Committees of Our Board of Directors

Our Board directs the management of our business and affairs, as providedby Delaware law, and conducts its business through meetings of the Board and standing committees. We have a standing audit committee,compensation committee, and nominating and corporate governance committee. In addition, from time to time, special committees may be establishedunder the direction of the Board when necessary to address specific issues.

Audit Committee

We have established an audit committee of the Board. Mr. Lau, Mr. Paoloneand Ms. Yang serve as members of our audit committee, and Mr. Lau chairs the audit committee. Each member of the audit committee is financiallyliterate, and our Board has determined that Mr. Lau qualifies as an “audit committee financial expert” as defined in applicableSEC rules and has accounting or related financial management expertise.

We have adopted an audit committee charter that is available to stockholderson the Company’s website, which details the principal functions of the auditcommittee, including:

The Board reviews the Nasdaq listing standards definition of independencefor audit committee members on an annual basis and has determined that all current members of our audit committee are independent (asindependence is currently defined in Rule 5605(c)(2)(A)(i) and (ii) of the Nasdaq listing standards).

Compensation Committee

We have established a compensation committee of the Board. Mr. Lau,Ms. Yang and Mr. Dhaliwal serve as members of our compensation committee. Ms. Yang chairs the compensation committee.

We have adopted a compensation committee charter that is available to stockholders on the Company’s website at https://investors.ispecimen.com/governance-documents, which details the principal functions of the compensation committee, including:

Notwithstanding the foregoing, no compensation of any kind, includingfinders, consulting or other similar fees, will be paid to any of our existing stockholders, officers, directors or any of their respectiveaffiliates, prior to, or for any services they render in order to effectuate the consummation of an initial business combination. Accordingly,it is likely that prior to the consummation of an initial business combination, the compensation committee will only be responsible forthe review and recommendation of any compensation arrangements to be entered into in connection with such initial business combination.

The charter also provides that the compensation committee may, in itssole discretion, retain or obtain the advice of a compensation consultant, independent legal counsel or other adviser and will be directlyresponsible for the appointment, compensation and oversight of the work of any such adviser. However, before engaging or receiving advicefrom a compensation consultant, external legal counsel or any other adviser, the compensation committee will consider the independenceof each such adviser, including the factors required by Nasdaq and the SEC.

Nominating and Corporate Governance Committee

We have established a nominating and corporate governance committeeof the Board. Mr. Dhaliwal, Mr. Lau and Ms. Yang serve as members of our nominating and corporate governance committee. Mr. Dhaliwal chairsthe nominating and corporate governance committee.

We have adopted a nominating and corporate governance committee charterthat is available to stockholders on the Company’s website at https://investors.ispecimen.com/governance-documents, which detailsthe principal functions of the nominating and corporate governance committee, and which provides that persons to be nominated to serveas directors:

The nominating and corporate governance committee will consider severalqualifications relating to management and leadership experience, background and integrity and professionalism in evaluating a person’scandidacy for membership on the Board. The nominating committee may require certain skills or attributes, such as financial or accountingexperience, to meet specific Board needs that arise from time to time and will also consider the overall experience and makeup of itsmembers to obtain a broad and diverse mix of Board members. The nominating committee does not distinguish among nominees recommended bystockholders and other persons.

Compensation Committee Interlocks and Insider Participation

None of the members of our compensation committee is or has been anofficer or employee of our company. None of our executive officers currently serves, or in the past year has served, as a member of theBoard’s compensation committee (or other board committee performing equivalent functions) of any entity that has one or more ofits executive officers serving on our Board or compensation committee.

Code of Conduct and Ethics

We have adopted a written code of business conduct and ethics thatapplies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal accountingofficer or controller, or persons performing similar functions. A copy of the code of business conduct and ethics has been posted on ourwebsite, www.ispecimen.com. In addition, we post on our website all disclosures that are required by law or the Nasdaq listing standardsconcerning any amendments to, or waivers from, any provision of the code.

EXECUTIVE COMPENSATION

The following discussionof compensation arrangements should be read with the compensation tables and related disclosures set forth below. This discussion containsforward-looking statements that are based on our current plans and expectations regarding future compensation programs, see “SpecialNote Regarding Forward-Looking Statements.” Actual compensation programs that we adopt may differ materially from the programs summarizedin this discussion.

The discussion belowincludes a review of our compensation decisions with respect to fiscal years 2024 and 2023 for our “named executive officers,”or NEOs, namely our principal executive officer, our two other most highly compensated executive officers and two additional persons forwhom disclosure would have been provided but for the fact that they were not serving as our executive officers as of December 31, 2024.

In 2024 and 2023, wecompensated our NEOs through base salary, as described below. Our officers are also eligible for the standard benefits programs we offerall employees.

Summary Compensation Table

The following table setsforth information regarding compensation awarded to, earned by or paid to each of our named executive officers for fiscal years 2024 and2023.

Employment Agreements

We have entered intoindependent consulting agreements with each of our Chief Executive Officer and Chief Financial Officer. and have also entered into anemployment agreement with our President.

Katharyn Field

We entered into an employmentagreement with Ms. Field, effective as of February 28, 2025, appointing her as President of the Company. The agreement provides for anannual base salary of $240,000, payable in accordance with the Company’s standard payroll schedule. Ms. Field is also eligible toparticipate in the Company’s Stock Incentive Plan and receive standard fringe benefits available to full-time employees. Under theterms of the agreement, Ms. Field’s employment is at-will and may be terminated by either party with thirty (30) days’ notice.

Robert Bradley Lim

We entered into an independentcontractor agreement with Mr. Lim, effective as of December 9, 2024, through his personal corporation, 1513932 B.C. Ltd., a company incorporatedunder the laws of the Province of British Columbia, Canada appointing him as Chief Executive Officer of the Company and a member of theBoard of Directors, which, by its terms, will remain in effect from year to year and may be terminated by the Board of Directors of theCompany at any time with or without notice, and with or without cause.

Under the terms of theAgreement, the Company will pay 1513932 B.C. Ltd. an annual fee of $270,000, payable in equal monthly installments of $22,500.

This Agreement does notcreate an employer-employee, partnership, or joint venture relationship between the parties. Mr. Lim will be entitled to severance payments.If the Mr. Lim is to be terminated by the Company without Cause, or in the event that the Mr. Lim terminates this Agreement for Good Reason,the Company agrees to provide the Contractor with severance payment equivalent of $67,500.

On December 27, 2024,by written consent, the Board of Directors appointed Mr. Lim to the additional roles of Treasurer and Secretary of the Company in accordancewith the Company’s Second Amended and Restated Bylaws. There were no changes to Mr. Lim’s compensation or other terms of employmentin connection with this appointment.

Yuying Liang

We entered into an engagementagreement with Ms. Liang, effective as of December 13, 2024, appointing her as Chief Financial Officer, which, by its terms, will remainin effect from year to year unless amended in writing by both parties or terminated by 60 days written notice from either party.

If there should be aChange of Control, Ms. Liang may terminate its obligations under this engagement within 90 days following the Change of Control by giving30 days-notice in writing to the Company.

For the purposes of thisengagement, a “Change of Control” shall be deemed to have occurred when: a person becomes a “control person” (asdefined in the Securities Act); a majority of the directors are not individuals nominated by the Company’s then incumbent Boardof Directors; or any person or group of persons acquires the ability, directly or indirectly to direct the management and policies ofthe Company through: the legal or beneficial ownership of voting securities; the right to appoint managers, directors or corporate management;contract; operating agreement; voting trust.

Under the terms of thisagreement, Ms. Liang is paid an approximate annual base salary of $300,000, which is to be paid on a monthly basis of $25,000 plus applicabletaxes. Should any circumstances cause fees to exceed the proposed amount Ms. Liang will inform the Company in advance to obtain the approvalof such additional fees. If such approval is not obtained, the Company will not be billed outside the proposed amount.

Separation Agreements

Tracy Curley

On November 8, 2024,the Company and Tracy Curley mutually agreed to end her employment. The parties dispute whether she resigned or was terminated. Additionally,on the same date, Curley resigned from the Board due to differences regarding the Company’s future direction. The Company has sincetaken steps to ensure a smooth leadership transition.

Non-Employee DirectorCompensation

The following table setsforth information regarding the total compensation paid to our current non-employee directors during 2024 for their service on our Board.Our directors who are employed by us do not receive any additional compensation for serving on our Board.