iSpecimen Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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Sep 30, 2024 · Filed Nov 7, 2024
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Notes to Unaudited Condensed Financial Statements
**1.**NATURE OF BUSINESS AND BASIS OF PRESENTATION
Business
iSpecimen Inc. (“iSpecimen” or the “Company”) was incorporated in 2009 under the laws of the state of Delaware. The Company has developed and launched a proprietary online marketplace platform that connects medical researchers who need access to subjects, samples, and data, with hospitals, laboratories, and other organizations who have access to them. iSpecimen is a technology-driven company founded to address a critical challenge: how to connect life science researchers who need human biofluids, tissues, and living cells (“biospecimens”) for their research, with biospecimens available (but not easily accessible) in healthcare provider organizations worldwide. The Company’s proprietary platform, the iSpecimen Marketplace platform, was designed to solve this problem and transform the biospecimen procurement process to accelerate medical discovery. The Company is headquartered in Woburn, Massachusetts and its principal market is North America. The Company operates asone operating and reporting segment.
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information, and, pursuant to the rules and regulations of Article 10 of Regulation S-X of the Securities Act of 1933, as amended (the “Securities Act”), published by the Securities and Exchange Commission (“SEC”) for interim financial statements. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
Reclassifications
Certain reclassifications have been made to the Company’s prior year amounts to conform to the current year presentation.
Reverse Stock Split
On October 9, 2023, the Company received a notification from Nasdaq that its Common Stock failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days as required by the Listing Rules of The Nasdaq Stock Market.
On July 19, 2024, the Company’s stockholders approved a proposal to amend the Company’s Fourth Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”) to effect a reverse stock split of the Company’s issued and outstanding shares of common stock, as well as any shares of common stock held by the Company in treasury, at a ratio in the range from 1-for-10 to 1-for-20.
On August 19, 2024, the Company’s board of directors approved a one-for-twenty (1:20) reverse stock split of the Company’s issued and outstanding shares of common stock (the “Reverse Stock Split”). On September 13, 2024, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment to the Company’s Certificate of Incorporation to effect the Reverse Stock Split. The Reverse Stock Split became effective on September 13, 2024, and the Company’s common stock began trading on a split-adjusted basis on Nasdaq on September 16, 2024.
On October 1, 2024, the Company received a notification from Nasdaq that the Staff has determined that for the last 11 consecutive business days, from September 16, 2024 to September 30, 2024, the closing bid price of the Company’s Common Stock was $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5559(a)(2).
Except as otherwise indicated, all references to the Company’s common stock, share data, per share data and related information has been adjusted for the Reverse Stock Split ratio of 1-for-20 as if they had occurred at the beginning of the earliest period presented. The Reverse Stock Split combined each 20 shares 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 the Company’s common stock. No fractional shares were issued in connection with the Reverse Stock Split, and any fractional shares resulting from the Reverse Stock Split were rounded up to the nearest whole share.
Going Concern Uncertainty and Management’s Plan
The Company has recognized recurring losses since inception. As of September 30, 2024, the Company had negative working capital of$1,610,379, an accumulated deficit of$65,815,806, cash and cash equivalents and short-term investments of$1,751,854, and accounts payable and accrued expenses of$5,077,705. Since inception, the Company has relied upon raising capital and its revenues to finance operations.
The future success of the Company is dependent on its ability to successfully obtain additional working capital and/or to ultimately attain profitable operations. During the year ended December 31, 2023, the Company began initiating efforts to decrease its capital and operational expenditures by cutting costs and right sizing the Company through reductions in workforce while streamlining operations and rationalizing resources to focus on key market opportunities. The reductions in workforce since January 1, 2023 through September 30, 2024, cumulatively resulted in an estimated reduction in monthly compensation costs of approximately 70% and technology costs of approximately 70% by the end of September 30, 2024 when compared to January 1, 2023. While the Company plans to improve its sales and revenues, the Company is taking steps to significantly reduce and manage expenditures to improve its financial position and ensure continued funding of operations. However, as certain elements of the Company’s operating plan are not within the Company’s control, the Company is unable to assess their probability of success. In the nine months ended September 30, 2024, the Company engaged in raising capital through debt financing as discussed in Note 7 and subsequently, through public equity as discussed in Note 13.
The Company may be unsuccessful in increasing its revenues or contain its operating expenses, or it may be unable to raise additional capital on commercially favorable terms. The Company’s failure to generate additional revenues or contain operating costs would have a negative impact on the Company’s business, results of operations and financial condition and the Company’s ability to continue as a going concern. If the Company does not generate enough revenue to provide an adequate level of working capital, its business plan will be scaled down further.
These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year from the date these unaudited condensed financial statements are issued. Management’s plan to mitigate the conditions that raise substantial doubt includes generating additional revenues, deferring certain projects and capital expenditures and eliminating certain future operating expenses for the Company to continue as a going concern. However, there can be no assurance that the Company will be successful in completing any of these options. As a result, management’s plans cannot be considered probable and thus do not alleviate substantial doubt about the Company’s ability to continue as a going concern.
The accompanying unaudited condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the ordinary course of business. The unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the uncertainties described above.
**2.**SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company’s significant accounting policies and recent accounting standards are summarized in Note 2 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2023. There were no significant changes to these accounting policies during the nine months ended September 30, 2024.
Use of Estimates
The preparation of the Company’s unaudited condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company utilizes certain estimates in the determination of the deferred tax valuation allowances, revenue recognition, stock-based compensation, allowance for doubtful accounts, accrued expenses, and the useful lives of internally developed software and sequenced data. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results could differ from such estimates.
Investments
The Company’s investments are considered to be available-for-sale and are recorded at fair value. Unrealized gains and losses are included in accumulated other comprehensive income. Purchases and sales of securities are reflected on a trade-date basis. Realized gains or losses are released from accumulated other comprehensive income and into earnings on the statement of operations, and amortization of premiums and accretion of discounts on the U.S treasury bills are recorded in interest expense or income, respectively.
The Company continually monitors the difference between its cost basis and the estimated fair value of its investments. The Company’s accounting policy for impairment recognition requires other-than-temporary impairment charges to be recorded when it determines that it is more likely than not that it will be unable to collect all amounts due according to the contractual terms of the fixed maturity security or that the anticipated recovery in fair value of the equity security will not occur in a reasonable amount of time. Impairment charges on investments are recorded based on the fair value of the investments at the measurement date or based on the value calculated using a discounted cash flow model. Credit-related impairments on fixed maturity securities that the Company does not plan to sell, and for which it is not more likely than not to be required to sell, are recognized in net income. Any non-credit related impairment is recognized as a component of other comprehensive income. Factors considered in evaluating whether there is a decline in value include: the length of time and the extent to which the fair value has been less than cost; the financial condition and near-term prospects of the issuer; and the likelihood that it will be required to sell the investment.
Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:
| ● | Level 1 — Valuations based on quoted prices for identical assets and liabilities in active markets. |
| ● | Level 2 — Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. |
| ● | Level 3 — Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment. |
For certain financial instruments, including cash and cash equivalents, accounts receivable, and accounts payable, the carrying amounts approximate their fair values as of September 30, 2024 and December 31, 2023, respectively, because of their short-term nature. Available-for-sale securities are recorded at fair value and as level 1 investments.
Revenue Recognition and Accounts Receivable
The Company recognizes revenue using the five-step approach as follows: (1) identify the contract with the customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the Company satisfies the performance obligations.
The Company generates revenue by procuring various specimens from hospitals, laboratories, and other supply sites, for the Company’s customers using the Company’s proprietary software, the iSpecimen Marketplace, to identify, locate, and ultimately validate the required specimens to the Company’s customers’ requested specifications. The Company’s performance obligation is to procure a specimen meeting the customer’s specification(s) from a supplier, on a “best efforts” basis, for the Company’s customer at the agreed price per specimen as indicated in the customer’s contract with the Company. The Company does not currently charge suppliers or customers for the use of the Company’s proprietary software. Each customer will execute a material and data use agreement with the Company or agree to online purchase terms, each of which includes terms such as specimen and data use, shipment terms, payment, and cancellation terms. These are then supplemented by purchase orders that specify specimen requirements including detailed inclusion/exclusion criteria, quantities to be collected, and pricing. Collectively, these customer agreements represent the Company’s contracts with its customers. Generally, contracts have fixed unit pricing. For certain specimen orders, a refundable customer deposit may be required prior to order fulfillment depending on project set-up requirements, which is presented as deferred revenue. The Company expects to recognize the deferred revenue as revenue within the next twelve months.
Specimen collections occur at supply sites within the Company’s network. “Collection” is when the specimen has been removed, or “collected” from the patient or donor. A specimen is often collected specifically for a particular Company order. Once collected, the specimen is assigned by the supplier to the Company and control of the specimen passes to the Company. “Accession” is the process whereby a collected specimen and associated data are registered and assigned in the iSpecimen Marketplace to a particular customer order, which can occur while a specimen is at the supplier site or while at the Company site and it is when control of the specimen passes to the customer. Suppliers may ship specimens to the Company or directly to the customer if specimens must be delivered within a short time period (less than 24 hours after collection) or shipping to the Company is not practical.
The Company has evaluated principal versus agent considerations as part of the Company’s revenue recognition policy. The Company has concluded that it acts as principal in the arrangement as it manages the procurement process from beginning to end and determines which suppliers will be used to fulfill an order, usually takes physical possession of the specimens, sets prices for the specimens, and bears the responsibility for customer credit risk.
The Company recognizes revenue over time, as the Company has created an asset with no alternative use to the Company, which has an enforceable right to payment for performance completed to date. At contract inception, the Company reviews a contract and related order upon receipt to determine if the specimen ordered has an alternative use by the Company. Generally, specimens ordered do not have an alternative future use to the Company and the performance obligation is satisfied when the related specimens are accessioned. The Company uses an output method to recognize revenue for specimens with no alternative future use. The output is measured based on the number of specimens accessioned. In the rare circumstances where specimens do have an alternative future use, the Company's performance obligation is satisfied at the time of shipment.
Customers are generally invoiced upon shipment. Depending on the quantity of specimens ordered, it may take several accounting periods to completely fulfill a purchase order. In other words, there can be multiple invoices issued for a single purchase order, reflecting the specimens being accessioned over time. However, specimens are generally shipped as soon as possible after they have been accessioned.
Once a specimen that has no alternative future use and for which the Company has an enforceable right to payment has been accessioned, the Company records the offset to revenue in accounts receivable – unbilled. Once the specimen has been shipped and invoiced, a reclassification is made from accounts receivable - unbilled to accounts receivable.
Customers are generally given fourteen days from the receipt of specimens to inspect the specimens to ensure compliance with specifications set forth in the purchase order documentation. Customers are entitled to either receive replacement specimens or receive reimbursement of payments made for such specimens. The Company has a nominal history of returns for nonacceptance of specimens delivered. When this occurs, the Company gives the customer a credit for the returns. The Company has not recorded a returns allowance.
The following table summarizes the Company’s revenue for the three and nine months ended September 30:
| · · · · · · · · · · · · | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| · · Three months ended September 30, · · Nine months ended September 30, | ||||||||||
| · 2024 · 2023 · 2024 · 2023 | ||||||||||
| Specimens - contracts with customers | | $2,626,907 | | $2,640,301 | | $7,754,338 | | $6,874,786 | ||
| Shipping and other | | 35,029 | | 137,450 | | | 61,270 | | | 478,304 |
| Revenue | | $2,661,936 | | $2,777,751 | | $7,815,608 | | $7,353,090 | ||
The Company carries its accounts receivable at the invoiced amount less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its accounts receivable to determine if an allowance for doubtful accounts is necessary based on the current expected credit loss model. Receivables are written off when deemed uncollectible, with any future recoveries recorded as income when received. As of September 30, 2024 and December 31, 2023, the Company had an allowance for doubtful accounts of $639,116 and $520,897, respectively.
The Company applies the practical expedient to account for shipping and handling activities as fulfillment cost rather than as a separate performance obligation. Shipping and handling costs incurred are included in cost of revenue.
Internally Developed Software, Net
The Company capitalizes certain internal and external costs incurred during the application development stage of internal-use software projects until the software is ready for its intended use. Amortization of the asset commences when the software is complete and placed into service and is recorded in operating expenses. The Company amortizes completed internal-use software over its estimated useful life offive years on a straight-line basis. Costs incurred during the planning, training and post-implementation stages of the software development life cycle are classified as technology costs and are expensed to operations as incurred.
Other Intangible Assets, Net
The Company procures data generated from sequencing of Formalin-Fixed Paraffin-Embedded (“FFPE”) blocks from a third-party sequencer which the Company licenses to its customers with the sale of FFPE blocks at an additional cost. The sequenced data is also organized to form a database of research content that is available for sale through a subscription model. The Company has determined that the sequenced data is an intangible asset and capitalizes the cost to procure the sequenced data. The sequenced data is amortized to cost of revenue over an estimated useful life offive years on a straight-line basis. The costs paid to the third-party sequencer are the only costs capitalized and all other related costs are expensed to operations as incurred.
Impairment of Long-Lived Assets
Management reviews long-lived assets for impairment when circumstances indicate the carrying amount of an asset may not be recoverable. An impairment loss is recognized when expected cash flows are less than the asset’s carrying value. Long-lived assets consist of property and equipment, internal-use software and other intangible assets. No impairment charges were recorded for the nine months ended September 30, 2024 and 2023.
Debt Issuance Costs
Debt issuance costs are recorded net against the related debt and amortized to interest expense over the life of the related debt.
Stock-Based Compensation
The Company records stock-based compensation for options granted to employees, non-employees, and to members of the board of directors for their services to the Company based on the grant date fair value of awards issued, and the expense is recorded on a straight-line basis over the requisite service period. Forfeitures are recognized when they occur.
The Company uses the Black-Scholes-Merton option pricing model to determine the fair value of stock options. The use of the Black-Scholes-Merton option pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. The Company has concluded that its historical share option exercise experience does not provide a reasonable basis upon which to estimate expected term. Therefore, the expected term was determined according to the simplified method, which is the average of the vesting tranche dates and the contractual term. Due to the lack of Company-specific historical and implied volatility data, the estimate of expected volatility is primarily based on the historical volatility of a group of similar companies that are publicly traded. For these analyses, companies with comparable characteristics are selected, including enterprise value and position within the industry, and with historical share price information sufficient to meet the expected life of the stock-based awards. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of its stock-based awards.
The risk-free interest rate is determined by reference to U.S. Treasury zero-coupon issues with remaining maturities similar to the expected term of the options. The Company has not paid, and does not anticipate paying, cash dividends on shares of its common stock.
The fair value of the Company’s common stock is equal to the closing price on the specified grant date.
Restricted Stock Units (“RSUs”)
The Company recognizes stock-based compensation expense from RSUs ratably over the specified vesting period. The fair value of RSUs is determined to be the closing share price of the Company’s common stock on the grant date.
Common Stock Warrants
The Company accounts for common stock warrants as either equity instruments or liabilities, depending on the specific terms of the warrant agreement. The warrants shall be classified as a liability if 1) the underlying shares are classified as liabilities or 2) the entity can be required under any circumstances to settle the warrant by transferring cash or other assets. The measurement of equity-classified non-employee stock-based payments is generally fixed on the grant date and are considered compensatory.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss applicable to common stockholders by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted-average number of shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method. Therefore, basic and diluted net loss per share applicable to common stockholders were the same for all periods presented.
The table below provides information on shares of the Company’s common stock issuable upon vesting and exercise, as of September 30:
| | | | | |
|---|---|---|---|---|
| · · 2024 · 2023 | ||||
| Shares issuable upon vesting of RSUs | | 1,921 | | 6,490 |
| Shares issuable upon exercise of stock options | | 17,206 | | 15,075 |
| Shares issuable upon exercise of PIPE Warrant (defined below) to purchase common stock | | — | | 65,625 |
| Shares issuable upon exercise of Lender Warrant (defined below) to purchase common stock | | 625 | | 625 |
| Shares issuable upon exercise of Underwriter Warrant (defined below) to purchase common stock | | 4,500 | | 4,500 |
Recently Adopted Accounting Standards
In August 2020, the FASB issued ASU No. 2020-06,Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity(“ASU 2020-06”), which simplifies an issuer’s accounting for convertible instruments by reducing the number of accounting models that require separate accounting for embedded conversion features. ASU 2020-06 also simplifies the settlement assessment that entities are required to perform to determine whether a contract qualifies for equity classification and makes targeted improvements to the disclosures for convertible instruments and earnings-per-share (EPS) guidance. This update will be effective for the Company’s fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, and interim periods within those fiscal years. Entities can elect to adopt the new guidance through either a modified retrospective method of transition or a fully retrospective method of transition. The Company adopted this new standard as of January 1, 2024. ASU 2020-06 did not have a material impact on the Company’s unaudited condensed financial statements.
**3.**AVAILABLE-FOR-SALE SECURITIES
The Company’s U.S. Treasury bills that were classified as available-for-sale securities fully matured during the nine months ended September 30, 2024. There wereno available-for-sale securities as of September 30, 2024. The balance of amortized cost, gross unrealized gains and losses, and fair value for available-for-sale securities as of December 31, 2023 is as follows:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · December 31, 2023 | ||||||||
| · · · · · Gross · · Gross · · · | ||||||||
| · · Amortized · · unrealized · · unrealized · · · | ||||||||
| · cost · gains · · losses · · Fair value | ||||||||
| Available-for-sale securities: · · · · · · · · · · · · | ||||||||
| U.S. Treasury Bills | | $2,661,092 | | $36,138 | | $(35,298) | | $2,661,932 |
| Total Available-for-sale securities | | $2,661,092 | | $36,138 | | $(35,298) | | $2,661,932 |
The Company recorded $680 of realized losses in the nine months ended September 30, 2024. The Company didnot have any realized gains or losses in the nine months ended September 30, 2023.
**4.**PROPERTY AND EQUIPMENT, NET
Property and equipment, net consisted of the following at the dates indicated:
| · · · · · · | ||||
|---|---|---|---|---|
| | | September 30, | | December 31, |
| · 2024 · 2023 | ||||
| Website | | $285,377 | | $285,377 |
| Computer equipment and purchased software | | 91,332 | | 96,037 |
| Equipment | | 19,291 | | 35,449 |
| Furniture and fixtures | | 26,982 | | 87,184 |
| Leasehold improvements | | 4,781 | | 68,471 |
| Total property and equipment | | 427,763 | | 572,518 |
| Accumulated depreciation | | (324,960) | | (444,731) |
| Total property and equipment, net | | $102,803 | | $127,787 |
Depreciation expense for property and equipment was$16,506 and$23,399 for the three months ended September 30, 2024 and 2023, respectively, and$48,607 and$99,125 for the nine months ended September 30, 2024 and 2023, respectively.
**5.**INTERNALLY DEVELOPED SOFTWARE, NET
During the nine months ended September 30, 2024 and 2023, the Company capitalized $588,093 and $3,501,206, respectively, of internally developed software costs in connection with the development and continued enhancement of the technology platform and web interfaces. Capitalized costs primarily consist of payroll and payroll-related costs for the Company’s employees. The Company recognized $478,384 and $494,353 of amortization expense associated with capitalized internally developed software costs during the three months ended September 30, 2024 and 2023, respectively. The Company recognized $1,553,939 and $1,429,182 of amortization expense associated with capitalized internally developed software costs during the nine months ended September 30, 2024 and 2023, respectively. Accumulated amortization associated with capitalized internally developed software costs as of September 30, 2024 and December 31, 2023 was $8,518,694 and $6,964,755, respectively.
**6.**OTHER INTANGIBLE ASSETS, NET
During the nine months ended September 30, 2024, the Company did not sequence any FFPE blocks and therefore did not capitalize any sequenced data as other intangible assets. The Company licenses to its customers, at an additional cost, the sequenced data associated with the sequenced FFPE blocks with the sale of said FFPE blocks. The sequenced data is also organized to form a database of research content that is available for sale to the Company’s customers through a subscription model. Amortization expense associated with the capitalized sequenced data was $47,889 for the three months ended September 30, 2024 and $143,666 for the nine months ended September 30, 2024. Amortization expense associated with the capitalized sequenced data was $6,383 for the three and nine months ended September 30, 2023.
**7.**DEBT FINANCING
On September 19, 2024, the Company entered into a Note Purchase Agreement (the “Purchase Agreement”) with a lender (the “Lender”). Pursuant to the provisions of the Purchase Agreement, the Lender agreed to provide a loan to the Company in the amount of $1,000,000 (the “Loan”) and the Company agreed to issue to the Lender a promissory note in the principal amount of $1,000,000 payable within 12 months after the date of issuance, with interest accruing and payable at a rate of 18% per annum (the “Note”). The Purchase Agreement contains customary representations and warranties and obligates the Lender to provide an additional loan to the Company,
in the form of a revolving line of credit of up to $1,000,000, upon our initial filing of a Registration Statement for an underwritten or best-efforts public offering for gross proceeds of at least $5,000,000. On September 25, 2024, the Company and the Lender closed the transactions (“Closing”) described in the Purchase Agreement, the Lender provided funds to the Company in the net amount of $959,980 and the Company issued the Note to the Lender in the principal amount of $1,000,000. WestPark served as the placement agent in connection with the Loan and was paid a placement agent fee in the amount of $40,020 for its services.
The outstanding principal balance on the Note was$1,000,000 as of September 30, 2024.
Interest expense on the Note totaled$2,500 for the three month period ended September 30, 2024.
Debt issuance costs related to the Note totaled$140,020 which comprised of placement agent fee of$40,020 and legal costs of$100,000. The debt issuance cost will be amortized over the loan term of 12 months. The amortization expense which is included in interest expense on the statement of operations, totaled$1,945 for the three months ended September 30, 2024. Unamortized debt issuance costs on the Note totaled$138,075 at September 30, 2024.
On October 31, 2024, the Company paid off the outstanding principal balance of$1,000,000 and accrued interest of$18,000 on the Note.
**8.**FAIR VALUE MEASUREMENTS
As of September 30, 2024, the Company did not have any assets or liabilities measured at fair value on a recurring basis. The following table sets forth the Company’s assets to be measured at fair value on a recurring basis and their respective classification within the fair value hierarchy as of December 31, 2023:
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Fair Value at December 31, 2023 | ||||||||
| | | Total | | Level 1 | | Level 2 | | Level 3 |
| Assets: · · · · · · · · · · · · | ||||||||
| Available-for-sale securities | | $2,661,932 | | $2,661,932 | | $— | | $— |
| Total Assets | | $2,661,932 | | $2,661,932 | | $— | | $— |
**9.**COMMITMENTS AND CONTINGENCIES
Leases
On July 2, 2024, the Company entered into a new operating lease (the “Woburn Lease”) of office space in Woburn, Massachusetts (the “Woburn Premises”) for a term offive years and two months, commencing on September 1, 2024, and terminating on October 30, 2029. The Company has a one-time option to extend the term of the Woburn Lease for one additional term offive years, provided that the Company is not in arrears in any payment of rent, the payment of any outstanding invoice, or otherwise in default. On June 28, 2024, the Company exercised a termination option included in the lease agreement of its former office space in Lexington, Massachusetts, and terminated the lease effective August 31, 2024.
Right-of-use assets and liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. The Company used the interest rate of 8% stated in the lease agreement to discount its real estate lease liabilities.
There are no material residual guarantees associated with any of the Company’s leases, and there are no significant restrictions or covenants included in the Company’s lease agreements. There wasno sublease rental income for the three and nine months ended September 30, 2024, and the Company is not the lessor in any lease arrangement, and there wereno related-party lease agreements.
Lease Costs
The table below presents certain information related to the lease costs for the Company’s operating lease for the nine months ended September 30, 2024:
| · · · | ||
|---|---|---|
| Operating lease expense | | $120,099 |
| Short-term lease expense | | — |
| Total lease cost | | $120,099 |
Lease Position as of September 30, 2024
Right-of-use lease assets and lease liabilities for the Company’s operating lease as of September 30, 2024 were recorded in the balance sheet as follows:
| | | | |
|---|---|---|---|
| Assets | | | |
| Operating lease right-of-use assets | | $342,107 | |
| Total lease assets | | $342,107 | |
| | | | |
| Liabilities | | | |
| Current liabilities: | | | |
| Operating lease liability – current portion | | $42,513 | |
| Non-current liabilities: | | | |
| Operating lease liability – net of current portion | | | 281,437 |
| Total lease liability | | $323,950 |
Lease Terms and Discount Rate
The table below presents certain information related to the weighted average remaining lease term and the weighted average discount rate for the Company’s operating lease as of September 30, 2024:
| | | | |
|---|---|---|---|
| Weighted average remaining lease term (in years) – operating lease | | | 5.08 |
| Weighted average discount rate – operating lease | | 8.00% |
Undiscounted Cash Flows
Future lease payments included in the measurement of lease liabilities on the balance sheet are as follows:
| | | | |
|---|---|---|---|
| 2024 (excluding the nine months ended September 30, 2024) | | $18,184 | |
| 2025 | | | 66,674 |
| 2026 | | | 76,372 |
| 2027 | | | 80,190 |
| 2028 | | | 84,200 |
| Thereafter | | | 73,675 |
| Total future minimum lease payments | | | 399,295 |
| Less effect of discounting | | | (75,345) |
| Present value of future minimum lease payments | | $323,950 |
Rent expense for the three months ended September 30, 2024 and 2023 amounted to $28,467 and $41,078, respectively. Rent expense for the nine months ended September 30, 2024 and 2023 amounted to $120,099 and $125,735, respectively.
Cash Flows
Supplemental cash flow information related to the operating lease for the nine months ended September 30, 2024 was as follows:
| · · · | ||
|---|---|---|
| Non-cash operating lease expense (operating cash flow) | | $112,876 |
| Change in operating lease liabilities (operating cash flow) | | $(108,420) |
Sales Tax Payable
The majority of the Company’s customers are researchers, universities, hospitals, and not-for-profit entities that were believed by the Company to have a sales and use tax exemption that generally excludes them from paying sales taxes. The main types of specimens the Company sells are blood, blood plasma, human tissue, human parts, and human bodily fluids and only a few of these products are typically not taxable in some states regardless of the buyer’s tax exemption status. The Company historically has not collected sales tax in states where it had sales. Had the Company contemporaneously collected and remitted sales tax for all customers and in all jurisdictions where it would have been required, there would have been no material impact on the Company’s unaudited condensed financial statements.
As a result of an entity-wide risk assessment process that commenced in the second quarter of 2023, the Company engaged external tax consultant advisors to complement internal resources and efforts to provide support in assessing the appropriate sales tax treatment associated with the Company’s products for all prior years in which the Company had generated revenue, to assist with the facilitation and tracking of Voluntary Disclosure Agreements (“VDAs”) in jurisdictions where a potential tax liability may exist and to assist with
the implementation of a sales tax software platform solution for the calculation, communication, collection, and remittance of sales tax for all non-exempt future sales.
From the Company’s inception through the filing date of this Quarterly Report, the Company now believes that an obligation to collect and remit sales tax existed for certain of its sales of products to certain of its customers. The Company has analyzed its product sales, on an invoice-by-invoice and customer-by-customer basis, to determine which products are subject to sales tax in each jurisdiction, and determining which of its customers are exempt from sales tax, and which customers who were not exempt from sales tax have already paid compensating use tax to the appropriate jurisdiction. Part of this process includes requesting and obtaining exemption letters or representations from its customers or proof of payment of their compensating use tax. As the Company continues to make progress on this project, certain customers have notified the Company that they are not exempt from the payment of sales tax and have not remitted use tax and the Company has started to invoice such customers for past sales tax due.
As of December 31, 2023, the Company had established and accrued a reliable point estimate with a maximum potential of the sales tax liability of approximately $707,000 and the related interests and penalties of approximately $215,000 in accrued expenses on the balance sheet. The estimated liability represents the estimated tax liability for sales made to customers who have notified the Company that they are not exempt from sales taxes and customers who have not responded to Company’s request to provide a sales exemption letter. As of December 31, 2023, the Company had also recovered approximately$359,000 of prior taxes from certain customers who do not have a sales tax exemption. During the year ended December 31, 2023, the Company recognized a loss of approximately $564,000 in its statement of operations and comprehensive loss related to the sales tax liability. The Company continued to pursue nonresponsive customers with the expectation that over time, further exemption letters or representations will be received that will reduce the liability.
In the nine months ended September 30, 2024, the Company received additional sales tax exemption letters or representations from customers. In addition to this, the Company received confirmation from certain tax jurisdictions in which it had previously accrued a potential tax liability that its specimens are exempt from tax in those jurisdictions, therefore, the Company reversed the accrued liability associated with those jurisdictions. The Company also registered in certain states and commenced the filing and remittance of sales taxes. These factors contributed to the reduction of the sales tax liability to approximately $407,000 and the related interests and penalties to approximately $144,000 as of September 30, 2024.
As of September 30, 2024, the Company had recovered approximately$491,000 of prior taxes from certain customers who do not have a sales tax exemption. The Company didnot recognize any additional loss in its statement of operations and comprehensive loss related to the sales tax liability during the nine months ended September 30, 2024. The Company commenced VDA filings with certain tax jurisdictions in the third quarter of 2024, during which it started remitting its sales tax obligations.
Legal Proceedings
From time to time the Company is involved in litigation, claims, and other proceedings arising in the ordinary course of business. Such litigation and other proceedings may include, but are not limited to, actions relating to employment law and misclassification, intellectual property, commercial or contractual claims, or other consumer protection statutes. Litigation and other disputes are inherently unpredictable and subject to substantial uncertainties and unfavorable resolutions could occur. As of September 30, 2024, there was a legal dispute filed against the Company.
Resignation* of Chief Information Officer and Filing of Demand for *Arbitration
On July 25, 2024, Benjamin Bielak, the Company’s Chief Information Officer, until his resignation on July 14, 2024, initiated a Demand for Arbitration against the Company with the American Arbitration Association, pursuant to the dispute resolution provisions contained
in Mr. Bielak’s employment agreement. The terms and conditions of Mr. Bielak’s employment with the Company were governed by his employment agreement.
In his Demand for Arbitration Mr. Bielak claims that the Company failed to provide him with certain bonus payments allegedly due to him for work performed in 2023 and 2024. Mr. Bielak also claims that the Company failed to provide him with severance payments allegedly due pursuant to the provisions of his employment agreement. The total amount of Mr. Bielak’s claim for alleged damages is $586,800 plus attorneys’ fees and interest.
The Company believes that Mr. Bielak’s claims are without legal or factual basis, and intends to vigorously defend these claims. An arbitrator has been selected, however, a schedule for the arbitration is yet to be set as of November 7, 2024.
**10.**STOCKHOLDERS’ EQUITY
The Company’s authorized capital is 250,000,000 shares, of which (1)200,000,000 shares are common stock, par value $0.0001 per share and (2)50,000,000 shares are preferred stock, par value $0.0001 per share, which may, at the sole discretion of the Company’s board of directors, be issued in one or more series.
At the Market Offering
On March 5, 2024, the Company put in place an At the Market Offering Agreement (the “ATM Agreement”) which allowed the Company to issue and sell shares of its common stock, having an aggregate offering price of up to$1,500,000 (the “ATM Shares”), from time to time through the Sales Agent. During the nine months ended September 30, 2024, the Company sold 199,004 ATM Shares for gross proceeds of approximately$1,494,000 under the ATM Agreement. The Company incurred offering costs of approximately$255,000, resulting in net proceeds of approximately$1,239,000.
Stock Options
During the nine months ended September 30, 2023, the Company issued 3,545 shares of common stock for cash exercises of options of $70,889. There wereno options exercises during the nine months ended September 30, 2024.
Warrants
Underwriter Warrants
In connection with the Company's underwriting agreement with ThinkEquity, a division of Fordham Financial Management, Inc. (“ThinkEquity”) and the representative of the Company’s IPO underwriters, the Company entered into a warrant agreement to purchase up to 4,500 shares of common stock to several affiliates of ThinkEquity (the “Underwriter Warrants”). The Underwriter Warrants are exercisable at a per share exercise price of $200.00 and are exercisable at any time and from time to time, in whole or in part, during thefour- and one-half year period commencing 180 days from the effective date of the IPO registration statement. The Underwriter Warrants became exercisable on or after December 16, 2021 (six months from the effective date of the offering) and expire on June 15, 2026. Upon issuance of the Underwriter Warrants, as partial compensation for its services as an underwriter, the fair value of approximately $0.4 million was recorded as equity issuance costs in the year ended December 31, 2021. As of September 30, 2024, the Underwriter Warrants had not been exercised, and had a weighted average exercise price of $200 per share and a remaining weighted average time to expiration of 1.71 years.
Lender Warrant
In connection with the loan agreement entered into with Western Alliance Bank (the “Lender”) on August 13, 2021, the Company issued a warrant (the “Lender Warrant”) to the Lender to purchase 625 shares of common stock of the Company. The Lender Warrant is exercisable at a per share exercise price of $160.00 and is exercisable at any time on or after August 13, 2021 through August 12, 2031. The Company determined that the Lender Warrant was equity-classified. As of September 30, 2024, the Lender Warrant had not been exercised, and had a weighted average exercise price of $160 per share and a remaining weighted average time to expiration of 6.87 years.
PIPE Warrants
On December 1, 2021, the Company completed a private placement (the “PIPE”) in which the Company issued warrants (the “PIPE Warrants”) to purchase up to an aggregate of 65,625 shares of common stock. These PIPE Warrants have an exercise price of $260.00 per share and are immediately exercisable upon issuance and will expire on thefive and one-half-year anniversary of the issuance date.
On February 13, 2024, the Company entered into certain warrant repurchase and termination agreements with the holders of the PIPE Warrants to repurchase the PIPE Warrants for a purchase price equal to$0.04 multiplied by the number of shares of common stock issuable pursuant to such PIPE Warrants. In connection with such repurchases, all past, current and future obligations of the Company relating to the PIPE Warrants were released, discharged and are of no further force or effect.
A summary of total warrant activity during the nine months ended September 30, 2024 is as follows:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · · · · · · · Weighted | |||||
| · · · · · · · Average | |||||
| · · · · Weighted · · Remaining | |||||
| · · Warrants · · Average · · Contractual Term | |||||
| · Outstanding · Exercise Price · in Years | |||||
| Balance at December 31, 2023 | 70,750 | | $255.30 | 3.47 | |
| Granted | — | | | — | — |
| Exercised | — | | | — | — |
| Repurchased | (65,625) | | | — | — |
| Balance at September 30, 2024 | 5,125 | | $195.12 | 2.34 | |
**11.**STOCK-BASED COMPENSATION
Stock Incentive Plans
2021 Plan
In March 2021, the Company adopted the iSpecimen Inc. 2021 Stock Incentive Plan, which was subsequently amended in June 2021 and then on May 25, 2022 (the “2021 Plan”). The 2021 Plan was adopted to enhance the Company’s ability to attract, retain and motivate employees, officers, directors, consultants, and advisors by providing such persons with equity ownership opportunities and performance-based incentives. The 2021 Plan authorizes options, restricted stock, RSUs and other stock-based awards. The Company's board of directors, or any committee to which the board of directors delegates such authority, has the sole discretion in administering, interpreting, amending, or accelerating the 2021 Plan. Awards may be made under the 2021 Plan for up to 30,400 shares of the Company's common stock, and the 2021 Plan was made effective with the completion of the IPO.
On May 24, 2023, at the Company’s annual meeting of stockholders, the stockholders approved an amendment to the 2021 Plan to increase the number of shares under the 2021 Plan from 30,400 shares of common stock to 93,475 shares of common stock.
During the nine months ended September 30, 2024 and 2023,5,521 and 9,157 equity awards were granted under the 2021 Plan, respectively. During the three months ended September 30, 2024 and 2023,754 and 977 equity awards were granted under the 2021 Plan, respectively. As of September 30, 2024, there were 67,224 shares of common stock available for future grants under the 2021 Plan.
2013 Plan
The iSpecimen Inc. 2013 Stock Incentive Plan (the “2013 Plan”) was adopted on April 12, 2013 and subsequently amended on July 29, 2015. The aggregate number of shares of common stock that may be issued pursuant to the 2013 Plan was 85,679.
No equity awards were granted under the 2013 Plan during the nine months ended September 30, 2024 and 2023. According to the 2013 Plan, which was adopted by the Company’s board of directors on April 12, 2013, no awards shall be granted under the 2013 Plan after the completion often years from the date on which the 2013 Plan was adopted by the Company’s board of directors. Therefore, as of April 13, 2023, no further shares had been granted under the 2013 Plan.
Stock Options
During the nine months ended September 30, 2024 and 2023, the Company granted 5,521 and 9,115 stock options, respectively. The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes-Merton option pricing model during the nine months ended September 30:
| · · · · · | ||||
|---|---|---|---|---|
| · · 2024 · · 2023 · | ||||
| Assumptions: · | ||||
| Risk-free interest rate | 3.49% – 4.56% | | 3.75% – 4.52% | |
| Expected term (in years) | 0.27 – 4.00 | | 0.61 – 4.00 | |
| Expected volatility | 57.28% –58.71% | | 59.17% – 59.95% | |
| Expected dividend yield | — | | — | |
A summary of stock option activity under the 2021 Plan and 2013 Plan is as follows:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · Weighted · · | ||||||||||
| | | | | | | | Average | | | |
| · · · · Weighted · · Remaining · | ||||||||||
| · · Options · · Average · · Contractual Term · Aggregate | ||||||||||
| · Outstanding · Exercise Price · in Years · Intrinsic Value | ||||||||||
| Balance at December 31, 2023 | 14,830 | | $43.47 | 8.53 | | $— | ||||
| Granted | 5,521 | | | 7.30 | | — | | | — | |
| Exercised | — | | | — | | — | | | — | |
| Cancelled/forfeited | (3,145) | | | 24.70 | | — | | | — | |
| Balance at September 30, 2024 | 17,206 | | $35.30 | 6.41 | | $— | ||||
| | | | | | | | | | | |
| Options exercisable at September 30, 2024 | 10,591 | | $46.05 | 5.43 | | $— | ||||
The aggregate intrinsic value in the table above represents the difference between the Company's stock price as of the balance sheet date and the exercise price of each in-the-money option on the last day of the period. No stock options were exercised during the nine months ended September 30, 2024. The aggregate intrinsic value of stock options exercised was $48,494 during the nine months ended September 30, 2023.
The weighted average grant date fair value of stock options issued in the nine months ended September 30, 2024 and 2023 was $2.15 and $10.68, respectively. The following table sets forth the recorded stock options compensation expense of the Company during the three and nine months ended September 30:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| Operating expenses: · · 2024 · · 2023 · · 2024 · 2023 | ||||||||||||
| Technology | | $160 | | $— | | $3,363 | | $5,106 | ||||
| Sales and marketing | | | 524 | | | 509 | | | 1,355 | | | 2,007 |
| Supply development | | 265 | | — | | 696 | | 820 | ||||
| Fulfillment | | | 943 | | | 1,037 | | | 1,812 | | | 2,362 |
| General and administrative | | | 7,748 | | | 23,797 | | | 39,949 | | | 78,680 |
| Total stock options expense | | $9,640 | | $25,343 | | $47,175 | | $88,975 | ||||
As of September 30, 2024 and 2023, a total of $51,788 and $139,090 of unamortized compensation expense is being recognized over the remaining requisite service period of 2.15 and 2.72 years, respectively.
There wereno stock options exercises during the nine months ended September 30, 2024. During the nine months ended September 30, 2023, the Company received proceeds of $70,889 from the exercise of stock options.
Restricted Stock Units
A summary of RSUs activity under the 2021 Plan and 2013 Plan is as follows:
| · · · · · | ||||
|---|---|---|---|---|
| | | | | Weighted |
| | | RSUs | | Average Grant |
| · Outstanding · · Date Fair Value | ||||
| Unvested Balance at December 31, 2023 | 5,630 | | $113.09 | |
| Granted | — | | | — |
| Vested | (1,743) | | | 117.80 |
| Forfeited | (1,966) | | | 110.04 |
| Unvested Balance at September 30, 2024 | 1,921 | | $111.14 | |
The Company recorded RSUs compensation expense during the three and nine months ended September 30 as follows:
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||||||
| Operating expenses: · · 2024 · · 2023 · · 2024 · 2023 | ||||||||||||
| Technology | | $7,575 | | $27,152 | | $57,351 | | $94,805 | ||||
| Sales and marketing | | | 11,657 | | | 16,763 | | | 37,074 | | | 47,577 |
| Supply development | | — | | 356 | | 277 | | 3,180 | ||||
| Fulfillment | | | 15,440 | | | 12,092 | | | 33,168 | | | 51,144 |
| General and administrative | | | 20,829 | | | 24,587 | | | 63,658 | | | 65,866 |
| Total RSU expense | | $55,501 | | $80,950 | | $191,528 | | $262,572 | ||||
As of September 30, 2024 and 2023, the total unrecognized stock-based compensation expense related to unvested RSUs was $191,528 and $688,510, and it is expected to be recognized on a straight-line basis over a weighted average period of approximately 1.18 and 2.11 years, respectively.
**12.**INCOME TAXES
As of September 30, 2024 and December 31, 2023, the Company had federal net operating loss carryforwards of approximately $56,500,000 and $50,800,000, respectively, of which approximately $13,000,000 expires at various periods through 2037 and approximately $43,500,000 and $37,800,000, respectively, can be carried forward indefinitely. As of September 30, 2024 and December 31, 2023, the Company had state net operating loss carryforwards of approximately $33,300,000 and $31,100,000, respectively, that expire at various periods through 2044, respectively. As of September 30, 2024 and December 31, 2023, the Company had federal and state tax credits of approximately $2,142,000 and $2,058,300, respectively, available for future periods that expire at various periods through 2044. The Company has recorded a full valuation allowance against net deferred income tax assets due to a history of losses generated since inception.
Due to changes in ownership provisions of the Internal Revenue Code of 1986 (the “IRC”), the availability of the Company's net operating loss carryforwards may be subject to annual limitations under Section 382 of the IRC against taxable income in the future period, which could substantially limit the eventual utilization of such carryforwards.
13. SUBSEQUENT EVENT
Securities Offering on Form S-1 and Material Definitive Agreement
On October 29, 2024, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with WestPark Capital, Inc. (the “Placement Agent”), and a securities purchase agreement (the “Purchase Agreement”) with investors pursuant to which the Company agreed to issue and sell, in a “reasonable best efforts” public offering (the “Offering”) (i)132,814 shares (the “Shares”) of the Company’s common stock, par value $0.0001 per share (the “Common Stock”) at an offering price of $2.999 per share, and (ii) pre-funded warrants to purchase up to 1,533,852 shares of Common Stock (the “Pre-Funded Warrants”) at an offering price of $3.00 per Share, less $0.0001 per Pre-Funded Warrant, for aggregate gross proceeds of $4,998,464 (or $4,999,998 assuming the full exercise of the Pre-Funded Warrants), before deducting placement agent fees and other offering expenses. As part of its compensation for acting as Placement Agent for the Offering, the Company paid the Placement Agent a cash fee of 4.0% of the aggregate gross proceeds plus reimbursement of certain expenses and legal fees. The Company intends to use the net proceeds of the offering for repayment of outstanding debt, potential acquisitions of assets or investments in businesses, products and technologies, and for marketing and advertising services. The remainder of the net proceeds will be used for working capital purposes.
The Offering closed on October 31, 2024. The securities sold in the Offering were offered and sold pursuant to a registration statement on Form S-1 (File No. 333-282736), which was filed with the Securities and Exchange Commission (the “Commission”) on October 18, 2024, and subsequently declared effective by the Commission on October 29, 2024.
On October 31, 2024, the Company entered into an Investor Relations Agreement (the “IR Agreement”) with IR Agency LLC (the “Consultant”). Under the IR Agreement, the Consultant will provide marketing and advertising services to promote the Company to the financial community. In consideration for these services, the Company paid the Consultant a fee, for an initial term of one month, after which it may be extended by mutual agreement, of Two Million U.S. Dollars ($2,000,000), paid in cash via bank wire transfer. Either party may terminate the IR Agreement at any time by providing written notice. The IR Agreement is governed by New Jersey law, with jurisdiction in federal and state courts located in New Jersey. A copy of the IR Agreement was filed as Exhibit 10.3 to the Current Report on Form 8-K on October 31, 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.