PDS Biotechnology Corp
For the period ended Jun 30, 2025. Filed Aug 13, 2025.
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Jun 30, 2025 · Filed Aug 13, 2025
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Notes to Condensed Consolidated Financial Statements
Notes to Condensed Consolidated Financial Statements (Unaudited)
Note 1–Nature of Operations
PDS Biotechnology Corporation, a Delaware corporation (the “Company” or “PDS Biotech”), is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted immunotherapies designed to overcome the limitations of current immunotherapy and vaccine technologies. The Company develops proprietary platforms designed to train and enable the immune system to attack and destroy disease; Versamune®, and Versamune® in combination with PDS01ADC for treatments in oncology and Infectimune® for treatments in infectious diseases. When paired with an antigen, which is a disease-related protein that is recognizable by the immune system, Versamune® and Infectimune® have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional CD4 helper and CD8 killer T cells, a specific sub-type of T cell that is more effective at killing infected or target cells. PDS01ADC is a novel investigational tumor-targeting fusion protein of Interleukin 12 that enhances the proliferation, potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome the limitations of cytokine therapy which today has resulted in high toxicity and limited therapeutic potential. Infectimune® is also designed to promote the induction of disease-specific neutralizing antibodies. The Company’s immuno-oncology product candidates are of potential interest for use as a component of combination product candidates (for example, in combination with other therapies such as immune checkpoint inhibitors) to provide more effective treatments across a range of advanced and/or refractory cancers. The Company is also evaluating its immunotherapies as monotherapies in early-stage disease. The Company is developing targeted product candidates to treat several cancers, including Human Papillomavirus (HPV) associated cancers, melanoma, colorectal, lung, breast and prostate cancers. The Company’s infectious disease candidate is of potential interest for use in universal influenza vaccines.
Note 2 – Summary of Significant Accounting Policies
| (A) | Unaudited interim financial statements: |
|---|
The unaudited financial statements for all periods presented are referred to as “Condensed Consolidated Financial Statements”, and have been prepared by the Company in United States (“U.S.”) dollars and in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial reporting and pursuant to the rules and regulations for reporting on Form 10-Q, which do not conform in all respects to the requirements of U.S. GAAP for annual financial statements. Accordingly, certain information and disclosures required by U.S. GAAP for complete Consolidated Financial Statements are not included herein. Accordingly, these notes to the unaudited Condensed Consolidated Financial Statements should be read in conjunction with the audited consolidated financial statements prepared in accordance with U.S. GAAP that are contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 27, 2025. The unaudited Condensed Consolidated Financial Statements have been prepared using accounting policies that are consistent with the policies used in preparing the Company’s audited consolidated financial statements for the year ended December 31, 2024. The unaudited Condensed Consolidated Financial Statements reflect all normal and recurring adjustments necessary for a fair statement of the Company’s financial position and results of operations for the interim periods. The operating results for the interim periods presented are not necessarily indicative of the results expected for the full year or for any other subsequent interim period.
| (B) | Use of estimates: |
|---|
The preparation of the Condensed Consolidated Financial Statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of expenses at the date of the Condensed Consolidated Financial Statements and during the reporting periods, and to disclose contingent assets and liabilities at the date of the Condensed Consolidated Financial Statements. Actual results could differ from those estimates. Significant estimates relate to the fair value of securities underlying stock-based compensation, and the fair value of the Company’s common stock, warrants and debt issued in its financing transactions.
| (C) | Significant risks and uncertainties: |
|---|
The Company’s operations are subject to a number of factors that may affect its operating results and financial condition. Such factors include, but are not limited to: the Company’s ability to complete clinical trials necessary to obtain regulatory product licenses, the regulatory approvals needed to pursue development of its clinical and product candidates, the Company’s adherence to covenants under its debt agreement, the Company’s ability to preserve its cash resources, the Company’s ability to add clinical and product candidates to its pipeline, the Company’s ability to protect its intellectual property, competition from products manufactured and sold or being developed by other companies, the price of, and demand for, Company products if approved for sale, the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products, and the Company’s ability to raise capital.
Index
The Company currently has no commercially approved products. As such, there can be no assurance that the Company’s future research and development programs will be successfully commercialized. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees, consultants and key vendors, and obtaining and protecting its intellectual property.
| (D) | Cash equivalents and concentration of cash balance: |
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The Company considers all highly liquid securities with a maturity of less than three months to be cash equivalents. The Company’s cash and cash equivalents in bank deposit accounts, at times, may exceed federally insured limits.
| (E) | Research and development: |
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Costs incurred in connection with research and development activities are expensed as incurred. These costs include licensing fees to use certain technology in the Company’s research and development projects as well as fees paid to consultants and vendors that perform certain research activities and testing on behalf of the Company.
Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data, such as patient enrollment, clinical site activations or information provided by vendors about their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the timing and pattern of costs incurred.
| (F) | Patent costs: |
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The Company expenses patent costs as incurred and classifies such costs as general and administrative expenses in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss.
| (G) | Stock-based compensation: |
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The Company accounts for its stock-based compensation in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, directors and non-employees to be recognized as expense in the Condensed Consolidated Statements of Operations and Comprehensive Loss based on their grant date fair values. In order to determine the fair value of stock options on the date of grant, the Company uses the Black-Scholes option-pricing model. Inherent in this model are assumptions related to expected stock-price volatility, option term, risk-free interest rate and dividend yield. While the risk-free interest rate and dividend yield are less subjective assumptions that are based on factual data derived from public sources, the expected stock-price volatility and option term assumptions require a greater level of judgment. The Company expenses the fair value of its stock-based compensation awards to employees and directors on a straight-line basis over the requisite service period, which is generally thevesting period, or when it is considered probable that performance conditions will be achieved. The Company recognizes stock-based compensation award forfeitures as they occur.
| (H) | Net loss per common share: |
|---|
Basic and diluted net loss per common share is determined by dividing net loss attributable to common stockholders by the weighted average common shares outstanding during the period. For all periods presented, the common shares underlying the stock options and warrants have been excluded from the calculation because their effect would be antidilutive. Therefore, the weighted average shares outstanding used to calculate both basic and diluted loss per common share is the same.
The potentially dilutive securities excluded from the determination of diluted loss per share as their effect is antidilutive, are as follows:
| As of June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Stock options to purchase Common Stock | 7,394,404 | 5,563,211 |
| Warrants to purchase Common Stock | 8,757,034 | 466,112 |
| Total | 16,151,438 | 6,029,323 |
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| (I) | Income taxes: |
|---|
The Company makes provision for deferred income taxes under the asset and liability method, which requires deferred tax assets and liabilities to be recognized for the future tax consequences attributable to net operating loss carryforwards and for differences between the financial statement carrying amounts and the respective tax bases of assets and liabilities. Deferred tax assets are reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax assets will not be realized.
| (J) | Fair value of financial instruments: |
|---|
FASB ASC 820, Fair Value Measurement, specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).
The three levels of the fair value hierarchy are as follows:
| ● | Level 1 — Unadjusted quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities. |
| ● | Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly (e.g., quoted prices of similar assets or liabilities in active markets, or quoted prices for identical or similar assets or liabilities in markets that are not active). Level 2 includes financial instruments that are valued using models or other valuation methodologies. |
| ● | Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable. |
| (K) | Leases: |
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The Company determines if an arrangement is a lease at inception and recognizes the lease in accordance with ASC 842, Leases (“ASC 842”). Both financing and operating leases are included in right-of-use (“ROU”) assets, lease obligation-short term and lease obligation-long term in the Company’s Condensed Consolidated Balance Sheets. ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. The ROU assets and lease liabilities are recognized at the lease commencement date based on the present value of the lease payments over the lease term. The Company determines the portion of the lease liability that is current as the difference between the calculated lease liability at the end of the current period and the lease liability that is projected 12 months from the current period.
| (L) | New accounting standards: |
|---|
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which improves the disclosures required for reportable segments in the Company’s annual and interim financial statements, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for annual periods beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024. The Company adopted this ASU for the annual period ended December 31, 2024 and the amendments have been applied retrospectively to all prior periods presented in these Condensed Consolidated Financial Statements by expanding the disclosure of expenses included in segment measures of profitability. Refer to the Company’s segment disclosure in Note 13 – Segment Reporting for more information.
Index
Recent Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosures of specific categories in the rate reconciliation, additional information for reconciling items that meet a quantitative threshold and income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual periods beginning after December 15, 2024. The Company has evaluated the impact of adopting this standard and does not believe it will have a material impact on the consolidated financial statements and disclosures.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures(Subtopic 220-40): Disaggregation of Income Statement Expenses. The new guidance requires a public business entity to provide disaggregated disclosures, in the notes to the financial statements, of certain categories of expenses that are included in expense line items on the face of the Statement of Operations and Comprehensive Loss. The amendments in this Update are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impact that the new guidance will have on its consolidated financial statements.
Note 3 – Liquidityand Capital Resources
As of June 30, 2025, the Company had $31.9 million in cash and cash equivalents. The Company’s primary use of cash is to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted bythe level of activities undertaken, as well as the timing of when the Company pays these expenses, as reflected in the change to the Company’s outstanding accounts payable and accrued expenses. Since inception, the Company has experienced net losses and negative cash flows from operations each fiscal year. The Company has no revenues and expects to continue to incur operating losses for the foreseeable future and may never become profitable.
The Company funds its operations through equity and/or debt financings such as the following:
In August 2022, the Company filed a shelf registration statement, or the 2022 Shelf Registration Statement, with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities, and units, up to an aggregate amount of $150 million, approximately $97 million of which covers the offer, issuance and sale by the Company of its common stock under the Sales Agreement and the New Sales Agreement (as discussed below). The 2022 Shelf Registration Statement was declared effective on September 2, 2022.
In August 2022, the Company entered into an At Market Issuance Sales Agreement, or the Sales Agreement, with B. Riley Securities, Inc. and BTIG, LLC, each an Agent and collectively the Agents, with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $50 million, or the Placement Shares, through or to the Agents, as sales agents or principals. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agents may sell the Placement Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act of 1933, as amended, including, without limitation, sales made through The Nasdaq Capital Market or on any other existing trading market for the Company’s common stock. The Agents will use commercially reasonable efforts to sell the Placement Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay the Agents a commission equal to three percent (3%) of the gross sales proceeds of any Placement Shares sold through the Agents under the Sales Agreement, and the Company has also provided the Agents with customary indemnification and contribution rights. The Company is not obligated to make any sales of its common stock under the Sales Agreement. The offering of Placement Shares pursuant to the Sales Agreement will terminate upon the earlier of (i) the sale of all Placement Shares subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms. In August 2024, the Company entered into an Amended and Restated At Market Issuance Sales Agreement, or the New Sales Agreement, with B. Riley Securities, Inc. and H.C. Wainwright & Co., LLC, with terms that are substantially consistent with those included in the original Sales Agreement. The New Sales Agreement superseded and replaced the Sales Agreement. For the year ended December 31, 2024, the Company sold 3,428,681 shares of common stock for a net value of $19.5 million pursuant to the Sales Agreement and 1,108,105 shares of common stock for a net value of $3.2 million pursuant to the New Sales Agreement. During the three and six months ended June 30, 2025, the Company sold 960,511 and 1,165,861 shares, respectively, of its common stock with a net value of $1.5 million and $1.8 million, respectively, pursuant to the New Sales Agreement. During the three and six months ended June 30, 2024, the Company sold 0 and 3,428,681 shares, respectively, of its common stock with a net value of $0 and $19.5 million, respectively, pursuant to the Sales Agreement.
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In August 2022, the Company entered into a venture loan and security agreement, or the Loan and Security Agreement, with Horizon Technology Finance Corporation, as lender and collateral agent for itself and the other lenders. In total, the Company received $24.6 million in net proceeds under the Loan and Security Agreement. The Company’s indebtedness under the Loan and Security Agreement was satisfied in full and retired in full with a portion of the proceeds received from the Securities Purchase Agreement, as discussed below.
In April 2024, the Company received approximately $0.9 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to its participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2022.
In January and February 2025, the Company received approximately $1.2 million from the net sale of tax benefits totwo unrelated, profitable New Jersey corporations pursuant to its participation in the New Jersey Technology Business Tax Certificate Transfer NOL program for tax year 2023.
In February 2025, the Company entered into a securities purchase agreement with certain purchasers, pursuant to which the Company agreed to sell an aggregate of 6,396,787 shares of common stock, pre-funded warrants to purchase up to an aggregate of 933,334 shares of common stock, and common stock warrants to purchase up to an aggregate of 7,330,121 shares of common stock at a combined purchase price of $1.50 per share and warrant (the “February 2025 Offering”). Two of the Company’s directors participated in the February 2025 Offering and purchased 30,121 shares of common stock in the aggregate at an offering price per share of $1.66 and common stock warrants to purchase 30,121 shares of common stock. The common stock warrants issued to the Company’s directors have an exercise price per share of $1.53, but are otherwise identical to the common stock warrants issued to all other participants in the February 2025 Offering. Aggregate gross proceeds from the February 2025 Offering were approximately $11 million. Net proceeds to the Company from the February 2025 Offering, after deducting the placement agent fees and other estimated offering expenses payable by the Company, were approximately $10.05 million. The placement agent fees and offering expenses were accounted for as a reduction of additional paid in capital. The February 2025 Offering closed on February 28, 2025.
On April 30, 2025, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain third party lenders and JGB Collateral LLC, as collateral agent. Pursuant to the Securities Purchase Agreement, the Company agreed to sell (i) senior secured convertible debentures (the “Debentures”), in an aggregate principal amount of $22,222,222 and (ii) warrants to purchase up to 1,000,000 shares of common stock, for an exercise price of $2.52 per share (collectively, the “Warrants”), subject to adjustments as set forth in the Warrants, for a total purchase price of $20,000,000. Approximately $19 million of the proceeds from the transactions contemplated by the Securities Purchase Agreement were used to satisfy in full and retire the Company’s indebtedness under the Loan and Security Agreement. The remaining proceeds from the transactions contemplated by the Securities Purchase Agreement will be used for general corporate purposes and transaction expenses. Pursuant to the Debentures, the Company must at all times maintain a cash balance equal to the lesser of (a) $15.0 million and (b) the then-outstanding principal balance of the Debentures plus $3.0 million, in a deposit account subject to an account control agreement. In addition, for as long as any portion of the Debentures remain outstanding, the Company is generally restricted from: incurring indebtedness; granting or suffering liens on any of its property or assets; amending its organizational documents; repurchasing any of its securities; paying dividends; selling, disposing, licensing or leasing our assets other than in the ordinary course; and other customary restrictive covenants. Beginning on August 28, 2025, the holders of the Debentures may require the Company to redeem a portion of the Debentures in an amount up to $500,000 per calendar month in the aggregate by providing written notice to the Company. In connection with the Securities Purchase Agreement, on April 30, 2025, the Company also entered into a Security Agreement (the “Security Agreement”), pursuant to which the Company and its subsidiary granted, for the benefit of the investors, to secure the Company’s obligations under the Securities Purchase Agreement and the Debentures, (i) first priority liens on certain assets, in each case subject to permitted liens described in the Security Agreement. In addition, on April 30, 2025, the Company and its subsidiary under the Security Agreement entered into a Subsidiary Guarantee, pursuant to which the Company and its subsidiary guaranteed all of our obligations under the JGB Purchase Agreement and the Debentures.
Going Concern
The Company evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the filing of this Quarterly Report on Form 10-Q in accordance with ASC Subtopic 205-40, Going Concern. Since inception, the Company has experienced net losses and negative cash flows from operations each fiscal year. The Company has no revenues and expects to continue to incur operating losses for the foreseeable future and may never become profitable. In addition, the Debentures allow for the lenders to call the outstanding balance of the Debentures if the Company fails to maintain minimum cash balances outlined in the Debentures.
Index
The Company’s estimated cash requirements in 2025 and beyond include expenses related to continuing development and clinical trials as well as payments on its debt. The Company plans to execute its operating plan by obtaining additional capital, principally through issuance of equity through separate offerings or an at-the-market facility, issuance of debt, or by entering into collaborations, strategic alliances, or license agreements with third parties. However, there is no assurance that sufficient additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or its existing shareholders. The Company may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in dilution to the Company’s stockholders. Incurring debt financing would result in debt service obligations, and the instruments governing such debt could provide for operating and financing covenants that would restrict its operations. If the Company is unsuccessful in securing sufficient financing, it may need to delay, reduce, or eliminate its research and development programs, which could adversely affect its business prospects, grant rights to third parties to develop and market immunotherapies that the Company would otherwise prefer to develop and market itself, or cease operations entirely. In addition, the Debentures allow for the lenders to call the outstanding balance of the Debentures if the Company fails to maintain minimum cash balances outlined in the Debentures. Any of these actions could harm its business, results of operations and prospects. Failure to obtain adequate financing may also adversely affect the Company’s ability to operate as a going concern.
As a result of these uncertainties, the Company has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for a period of at least 12 months from the date of the issuance of these unaudited Condensed Consolidated Financial Statements on Form 10-Q. The unaudited Condensed Consolidated Financial Statements do not include any adjustments to the carrying amounts and classifications of assets and liabilities that would result if the Company was unable to continue as a going concern.
Note 4 – Fair Value of Financial Instruments
There were no transfers among Levels 1, 2, or 3 during the three and six months ended June 30, 2025 or 2024.
| Fair Value Measurements at Reporting Date Using | ||||||
|---|---|---|---|---|---|---|
| Total · Quoted Prices in Active Markets (Level 1) · Quoted Prices in Inactive Markets (Level 2) · Significant Unobservable Inputs (Level 3) | ||||||
| As of June 30, 2025: (unaudited) | ||||||
| Cash and cash equivalents | $31,873,495 | $31,873,495 | $ | - | $ | - |
| Cash and cash equivalents | $41,689,591 | $41,689,591 | $ | - | $ | - |
The carrying value of the Debentures approximated its fair value as of June 30, 2025 due to the variable interest rate applicable.
Note 5 – Leases
Operating Lease:
The Company maintains a month-to-month lease for its research facilities at the Princeton Innovation Center BioLabs located at 303A College Road E, Princeton NJ, 08540.
Financing Lease:
The Company has financed certain laboratory equipment as follows:
| As of June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Cash paid for finance lease liabilities | $34,925 | $34,925 |
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Maturity of the Company’s financing lease liabilities is as follows:
| Year ended December 31, | |
|---|---|
| 2025 | $34,925 |
| 2026 | 40,108 |
| 2027 and after | 26,724 |
| Total future minimum lease payments | 101,757 |
| Less imputed interest | (8,647) |
| Remaining lease liability | $93,110 |
The Company entered into four financing leases for laboratory equipment with a total cost of $251,959 with four tofive-year terms and a capitalized interest rate of 9.15%. Each of the lease agreements include a bargain purchase option to acquire the equipment at the end of the lease term. The aggregate monthly payments are approximately $6,000.
Note 6 – Accrued Expenses
Accrued expenses consist of the following:
| As of June 30, 2025 | As of December 31, 2024 | |
|---|---|---|
| Accrued research and development | $178,192 | $1,267,627 |
| Accrued professional fees | 315,420 | 657,498 |
| Accrued compensation | 988,101 | 663,399 |
| Accrued interest on debt | - | 252,322 |
| Accrued rent | 368 | 368 |
| Total | $1,482,081 | $2,841,214 |
Note 7 – Stock-Based Compensation
In 2014, the Company’s stockholders approved the 2014 Equity Incentive Plan (the “Original Plan”) pursuant to which the Company may grant up to 91,367 shares as ISOs, NQs and restricted stock units (“RSUs”), subject to increases as hereafter described (the “Plan Limit”). In addition, on January 1, 2015, and each January 1 thereafter and prior to the termination of the 2014 Equity Incentive Plan, pursuant to the terms of the Original Plan, the Plan Limit was and shall be increased by the lesser of (x)4% of the number of shares of Common Stock outstanding as of the immediately preceding December 31 and (y) such lesser number as the Board of Directors (“Board”) may determine in its discretion. In March 2019, the Company’s Board adopted and the Company’s stockholders approved the Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Prior Plan”) which amended and restated the Original Plan in order to remove the annual increase component and was limited to 826,292 shares.
On December 8, 2020, the Company’s Board adopted and on June 17, 2021, the stockholders approved, the Second Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Restated Plan”), which amended and restated the Prior Plan. The Restated Plan is identical to the Prior Plan in all material respects, except (a) the number of shares of Common Stock authorized for issuance under the Restated Plan was increased from 826,292 shares to 4,165,535 shares, plus the total number of shares that remained available for issuance, that were not covered by outstanding awards issued under the Prior Plan, immediately prior to December 8, 2020; and (b) the Prior Plan was amended to terminate on December 7, 2030, unless earlier terminated.
On May 19, 2023, the Company’s Board adopted and on July 14, 2023, the stockholders approved, the Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan (the “Third Restated Plan”), which amended and restated the Restated Plan to increase the total amount of shares authorized for issuance thereunder. The Third Restated Plan was identical to the Restated Plan in all material respects, except, the number of shares of Common Stock authorized for issuance under the Third Restated Plan increased from 4,165,535 to 6,565,535.
Index
On April 28, 2025, the Company’s Board adopted and on June 11, 2025, the stockholders approved, an amendment to the Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan, which amendment increased the total amount of shares authorized for issuance under the Third Restated Plan to the sum of (i)4,165,535 shares of Common Stock, which was the total number of shares of Common Stock authorized for issuance under the Restated Plan, plus (ii)2,400,000 shares of Common Stock, which reflects the additional shares of Common Stock authorized by the Board under the Third Restated Plan as of its effective date, plus (iii)3,144,049 shares of Common Stock that were approved at the Company’s 2025 Annual Meeting of Stockholders. As of June 30, 2025 there were 3,409,087 shares available for grant under the Third Restated Plan, as amended.
Pursuant to the terms of the Third Restated Plan, as amended, stock options have a term often years from the date of grant or such shorter term as may be provided in the option agreement. Unless specified otherwise in an individual option agreement, ISOs generally vest over afour-year period.
On June 17, 2019, the Board adopted the 2019 Inducement Plan (the “Inducement Plan”). On December 8, 2020, the Company amended the Inducement Plan solely to increase the total number of shares of common stock reserved for issuance under the Inducement Plan from 200,000 shares to 500,000 shares. On May 17, 2022, the Company further amended the Inducement Plan solely to increase the total number of shares of Common Stock reserved for issuance under the Inducement Plan from 500,000 shares to 1,100,000 shares. On January 22, 2024, the Company further amended the Inducement Plan solely to increase the total number of shares of Common Stock reserved for issuance under the Inducement Plan from 1,100,000 shares to 2,100,000 shares. The Inducement Plan provides for the grant of non-qualified stock options. The Inducement Plan, and each amendment thereto, was recommended for approval by the Compensation Committee of the Board and subsequently approved and adopted by the Board without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.
The Inducement Plan is administered by the Compensation Committee of the Board. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, non-qualified stock options under the Inducement Plan may only be made to an employee who has not previously been an employee of the Company or member of the Board of Directors of the Company (or any parent or subsidiary of the Company), if he or she is granted such non-qualified stock options in connection with his or her commencement of employment with the Company or a subsidiary and such grant is an inducement material to his or her entering into employment with the Company or such subsidiary. As of June 30, 2025, there were 957,407 shares available for grant under the Inducement Plan.
The following table summarizes the components of stock-based compensation expense in the Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2025 and 2024:
| Three Months Ended June 30, | Six Months ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| (unaudited) · (unaudited) | ||||
| Stock-Based Compensation | ||||
| Research and development | $(316,466) | $609,828 | $204,061 | $1,161,746 |
| General and administrative | 764,495 | 1,185,894 | 1,497,850 | 2,263,987 |
| Total | $448,029 | $1,795,722 | $1,701,911 | $3,425,733 |
Index
The following table summarizes stock option activity for the six months ended June 30, 2025:
| Number of Shares | |
|---|---|
| Options outstanding at December 31, 2024 | 5,373,063 |
| Granted options | 1,246,500 |
| Exercised | - |
| Forfeited and expired | (222,379) |
| Options outstanding at June 30, 2025 | 6,397,184 |
| Vested and expected to vest at June 30, 2025 | 6,397,184 |
| Exercisable at June 30, 2025 | 3,796,123 |
The weighted average exercise price of all outstanding options as of June 30, 2025 was $5.88.
The Company granted 800,000 performance-based restricted stock units during the three and six months ended June 30, 2025. All performance-based restricted stock units were unvested as of June 30, 2025. No performance-based restricted stock units were granted in 2024. The fair value of performance-based restricted stock units was determined as the closing price of the Company’s stock on the grant date.
Note 8 – Income Taxes
The Company records a valuation allowance against its deferred tax assets to reduce the net carrying value to an amount that it believes is more likely than not to be realized. In assessing the realizability of the net deferred tax assets, the Company considers all relevant positive and negative evidence to determine whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss carryforwards. The Company expects to have a loss for 2025 and therefore there will beno current income tax expense. The Company recorded a full valuation allowance against the net deferred tax assets as of June 30, 2025 and December 31,2024. Consequently, the Company recordedno income tax benefit due to realization uncertainties.
The Company is subject to a U.S. federal statutory income tax rate of 21%. The primary factor impacting the effective tax rate for the three and six months ended June 30, 2025 is the anticipated full year operating loss which will require a full valuation allowance against any associated net deferred tax assets.
Entities are required to evaluate, measure, recognize and disclose any uncertain income tax positions taken on their income tax returns. The Company has analyzed its tax positions and has concluded that as of June 30, 2025, there wereno uncertain positions. The Company’s U.S. federal and state net operating losses have occurred since its inception and as such, tax years subject to potential tax examination could apply from that date because the utilization of net operating losses from prior years opens the relevant year to audit by the IRS and/or state taxing authorities. The Company didnot have any unrecognized tax benefits and hasnot accrued any interest or penalties for the three and six months ended June 30, 2025 or for the year ended December 31,2024.
In accordance with the State of New Jersey’s Technology Business Tax Certificate Program, which allows certain high technology and biotechnology companies to sell unused NOL carryforwards to other New Jersey-based corporate taxpayers, the Company sold New Jersey NOL carryforwards, resulting in the recognition of $1.2 million and $0.9 million of income tax benefit, net of transaction costs in the six months ended June 30, 2025 and 2024, respectively.
Note 9 – Commitments and Contingencies
Rent
For month-to-month arrangements not impacted by the adoption of ASC 842, rent for the three and six months ended June 30, 2025 was $64,200 and $129,900 respectively, compared to the three and six months ended June 30, 2024 of $66,000 and $132,000, respectively.
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Exclusive License Agreement
In December 2022, the Company entered into an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting IL 12 fused antibody drug conjugate, M9241 (the “Merck KGaA License Agreement”). Pursuant to the Merck KGaA License Agreement, the Company agreed to make (i) development and first commercial sales milestone payments totaling up to $11 million upon the achievement of certain milestones, including the dosing of the fifth patient in a Phase 3 trial of the clinical candidate and first commercial sale of the product for a first and second indication in a major market, and (ii) up to $105 million upon achieving certain aggregate sales levels of the product.
The Company also agreed to pay Merck KGaA, Darmstadt, Germany a royalty of 10% on aggregate net sales of product as specified in the Merck KGaA License Agreement on a product-by-product and country-by-country basis until the later of: (i)ten years after the first commercial sale of a product in a given country; and (ii) the expiration or invalidation of the licensed patents covering the compound or product in such country. The royalty rate is subject to reduction in the event that a product is not covered by a valid patent claim, a biosimilar to the compound or the product comes on the market in a particular country, or if the Company obtains a license to any intellectual property owned or controlled by a third-party which, but for such license would be infringed by making, using or selling the compound.
Legal Proceedings
The Company is currently not a party to, and the Company’s property is not currently the subject of anymaterial pending legal proceedings. The Company may be involved, from time to time, in legal proceedings and claims arising in the ordinary course of business. Such matters are subject to many uncertainties and outcomes that may not be predictable with assurance.
Note 10 – Venture Loan and Security Agreement
In August 2022, the Company entered into a Venture Loan and Security Agreement (the “Loan and Security Agreement”) with Horizon Technology Finance Corporation, as a lender and collateral agent for itself and the other Lenders, and the other persons party thereto from time to time as lenders. The Company’s indebtedness under the Loan and Security Agreement was retired and satisfied in full with a portion of the proceeds received from the Securities Purchase Agreement, as discussed above.
The Company recognized interest expense of $277,859 and $1,206,035, and $1,184,294 and $2,355,053 for the three and six months ended June 30, 2025 and 2024, respectively and $82,329 and $354,907, and $283,774 and $554,010 was related to the amortization of the debt discount for the three and six months ended June 30, 2025 and 2024, respectively.
During the three months ended June 30, 2025, the Company recognized $1,107,005 of interest expense associated with extinguishment of debt recorded under the Loan and Security Agreement.
Note 11 – Securities Purchase Agreement
On April 30, 2025, the Company entered into a Securities Purchase Agreement with certain third-party lenders and JGB Collateral LLC, as collateral agent. Pursuant to the Securities Purchase Agreement, the Company agreed to issue and sell (i) senior secured convertible debentures (“Debentures”) in an aggregate principal amount of $22,222,222 which is convertible into shares of the Company’s common stock, according to the terms, conditions, and limitations outlined in the Securities Purchase Agreement and (ii) warrants to purchase up to 1,000,000 shares of the Company’s common stock, for an exercise price of $2.52 per share, subject to adjustments as set forth in the warrants, for a total purchase price of $20,000,000. The maturity date of the Debentures is April 30, 2028 unless earlier redeemed, repurchased, or converted. Partial repayment at $500,000 per month may commence at the option of the lenders beginning August 28, 2025.
The Debentures are convertible, at the option of the lenders, into the Company’s shares of common stock, if fully converted at the initial principal amount, at a conversion price of $2.52 per share, to 8,818,340 shares of common stock.
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Warrants issued under the Securities Purchase Agreement and common shares issuable upon conversion are subject to customary adjustments for stock splits. No anti-dilution provisions apply. The warrants are equity classified in accordance with ASC 815-40.
Approximately $19 million of the proceeds from the transactions contemplated by the Securities Purchase Agreement were used to satisfy in full and retire the Company’s indebtedness under the Loan and Security Agreement.
The coupon rate of the Debentures is theprime rate plus 5.0%, provided that if the prime rate would be less than 6.0%, the coupon rate under the Debentures will be deemed to be 6.0% +5.0%.
Issuance costs for the Debentures of $762,116 were recorded as a debt discount. As of June 30, 2025, the effective annual interest rate of the Debentures was approximately 24.1%.
For the three and six months ended June 30, 2025, the Company recognized interest expense of $757,257. For the three and six months ended June 30, 2025, the Company amortized $278,862 of the debt discount, and as of June 30, 2025, had a remaining debt discount balance of $3,778,566.
Note 12 – Retirement Plan
The Company has a 401(k) defined contribution plan for the benefit of all employees and permits voluntary contributions by employees subject to IRS-imposed limitations. The 401(k) employer contributions were $51,293 and $116,833 for the three and six months ended June 30, 2025, respectively, compared to the three and six months ended June 30, 2024 of $46,995 and $113,483, respectively.
Note 13 – Segment Reporting
In accordance with FASB ASC Topic 280, Segment Reporting, the Company has determined that it operates as asingle reportable segment, developing a growing pipeline of targeted immunotherapies designed to overcome the limitations of current immunotherapy. The financial results of the Company’s operations are managed and reported to the Chief Executive Officer who is considered the Company’s chief operating decision maker (CODM), on a consolidated basis.
The CODM assesses performance and allocates resources based on the Company’s consolidated statements of operations and key components and processes of the Company’s operations are managed centrally. Segment asset information is not used by the CODM to allocate resources.
As asingle reportable segment entity, the Company’s segment performance measure is net income / (loss) attributable to shareholders. Significant segment expenses, as provided to the CODM, are presented below:
| Three Months Ended June 30, | Six Months Ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Segment expenses | ||||
| Salaries and Benefits | $2,857,617 | $4,124,151 | $6,686,838 | $8,307,421 |
| Professional fees | 1,278,581 | 1,688,412 | 2,405,627 | 2,765,678 |
| General administrative expenses | 387,897 | 378,905 | 732,251 | 743,567 |
| Clinical development expenses | 2,017,145 | 1,004,848 | 2,455,049 | 2,846,909 |
| Other development expenses | 1,082,111 | 1,487,988 | 4,449,344 | 4,118,356 |
| Total operating and segment expenses | $7,623,351 | $8,684,304 | $16,729,109 | $18,781,931 |
| Interest income | 333,624 | 675,209 | 711,473 | 1,344,104 |
| Interest expense | (2,144,481) | (1,187,971) | (3,075,359) | (2,362,716) |
| Benefit from income taxes | - | 869,169 | 1,169,820 | 869,169 |
| Segment and consolidated net loss | $(9,434,208) | $(8,327,897) | $(17,923,175) | $(18,931,374) |
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.