PDS Biotechnology Corp

Current report

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Current report

We are required to meet the Nasdaq Capital Market’s continued listing requirements and other Nasdaq rules, and if we fail to meet such rules and requirements, we may be subject to delisting. Delisting could negatively affect the price of our common stock, which could make it more difficult for us to sell securities in a future financing or for you to sell our common stock.

Current report

We are required to meet the continued listing requirements of the Nasdaq Capital Market and other Nasdaq rules, including those regarding director independence and independent committee requirements, minimum stockholders’ equity, minimum share price and certain other corporate governance requirements. The continued listing standards of Nasdaq applicable to the Nasdaq Capital Market require, among other things, that the minimum price of a listed company’s stock be at or above $1.00. If the minimum bid price is below $1.00 for a period of more than 30 consecutive trading days, the listed company will fail to be in compliance with Nasdaq’s listing rules and, if the listed company does not regain compliance within an 180-day grace period, it may be subject to delisting. In order to regain compliance, the bid price of the listed company’s common stock must close at a price of at least $1.00 per share for a minimum of 10 consecutive trading days within an 180-day grace period. In addition, in July 2026 Nasdaq approved a new rule requiring listed companies to maintain a minimum market value of listed securities (MVLS) of $5 million. If our MVLS falls below this threshold for 30 consecutive business days, we may be subject to delisting proceedings. On July 30, 2026, we received a deficiency letter from Nasdaq notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). The letter also indicated that, pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we would be afforded 180 calendar days to regain compliance with the bid price requirement. There can be no assurance that we will regain compliance with the minimum bid price requirement or, if we do so, that we will maintain compliance with the minimum bid price requirement or any other Nasdaq listing standards.

Current report

Pursuant to the Promissory Note (as defined below), if we fail to cure the minimum bid price requirement within seventy-five (75) calendar days of receipt of the deficiency letter, or the Special Amortization Event, then commencing with the next installment date and each successive installment date for so long as any Special Amortization Event is continuing, we will be required to pay to the Investor (as defined below) (i) the principal amount of $2,000,000 (or the outstanding principal if less than such amount), and such increased amount shall be (x) payable in lieu of, and not in addition to, the installment principal amount that would otherwise be payable on such installment date and (y) applied against future installment principal amounts in reverse chronological order), (ii) the payment premium in respect of such increased installment principal amount, and (iii) accrued and unpaid interest hereunder as of such installment date.

Current report

If we fail to regain compliance with the minimum bid price requirement or other Nasdaq listing standards, our common stock will be subject to delisting. Delisting from Nasdaq could adversely affect our ability to raise additional financing through the public or private sale of equity securities, would significantly affect the ability of investors to trade our securities and would negatively affect the value and liquidity of our common stock. Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional investor interest and fewer business development opportunities. Delisting from the Nasdaq Capital Market could also cause us to pursue eligibility for trading of these securities on other markets or exchanges, including the over-the-counter (OTC) BB or QB markets, or on the OTC “pink sheets.” In such case, our stockholders’ ability to trade, or obtain quotations of the market value of our common stock would be severely limited because of lower trading volumes and transaction delays. These factors could contribute to lower prices and larger spreads in the bid and ask prices of our securities. There can be no assurance that our securities, if delisted from the Nasdaq Capital Market in the future, would be listed on a national securities exchange, a national quotation service, the OTC markets or the pink sheets. Delisting from the Nasdaq Capital Market would also result in negative publicity, make it more difficult for us to raise additional capital, cause us to lose eligibility to register the sale or resale of our shares on Form S-3 and the automatic exemption from registration under state securities laws for exchange-listed securities, adversely affect the market liquidity of our securities, decrease securities analysts’ coverage of us or diminish investor, supplier and employee confidence.

Current report

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Current report

Our recent strategic refocus to prioritize the development of PDS0301, to cease further internal investments in PDS0101 and to discontinue the VERSATILE-003 Phase 3 clinical trial may not achieve the anticipated benefits and involves significant risks and uncertainties.

Current report

In August 2026, we announced a strategic refocus to prioritize PDS0301, our tumor-targeted IL-12 immunocytokine, as our lead development program. As part of this refocus, weceased further internal investments in PDS0101 anddiscontinued the VERSATILE-003 Phase 3 clinical trial evaluating PDS0101 in combination with pembrolizumab in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma, and we announced our intention to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. This strategic refocus involves significant risks, including but not limited to the following:

Current report

We have become substantially more dependent on the success of PDS0301 and the failure of PDS0301 could disproportionately impact the success of our business. If the anticipated benefits of this strategic refocus are not realized, our business, financial condition, results of operations, and prospects could be materially and adversely affected.

Current report

We may not be able to identify, negotiate, or consummate strategic partnerships or other externally funded opportunities for the continued development of PDS0101, and any such partnerships may not be on favorable terms.

Current report

As part of our strategic refocus, we intend to pursue strategic partnership or other externally funded opportunities for PDS0101. Establishing strategic partnerships is difficult and time-consuming. Our discussions with potential partners may not lead to the establishment of partnerships on favorable terms, if at all. We face significant competition in seeking appropriate partners, and potential partners may evaluate alternative immunotherapies for similar indications that may be available or more attractive than PDS0101. In addition, a potential partner’s evaluation of PDS0101 may be adversely affected by our decision to discontinue the VERSATILE-003 trial.

Current report

Whether we reach a definitive agreement for a partnership will depend, among other things, upon the potential partner’s assessment of the Versatile-002 Phase 2 clinical data generated to date, the design and results of any further clinical trials necessary for approval, the potential market for PDS0101, the costs and complexities of completing development and commercialization, the competitive landscape, and the existence of alternative product candidates. If we are unable to establish a strategic partnership for PDS0101 on acceptable terms, or at all, the potential value of the PDS0101 program may diminish, and we may not recoup the significant investment we have made in the program. To the extent that we enter into partnership, licensing, or other arrangements, we may have to relinquish valuable rights to PDS0101, including future revenue streams, or grant licenses on terms that may not be favorable to us.

Current report

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Current report

We may expend our limited resources to pursue PDS0301 and fail to capitalize on other product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Current report

Because we have limited financial and managerial resources, our decision to prioritize PDS0301 as our lead development program means that we will allocate substantially all of our development resources toward the advancement of PDS0301 in metastatic colorectal cancer and other solid tumors. As a result, we may forego or delay pursuit of opportunities with PDS0101 or other product candidates that later prove to have greater commercial potential or a greater likelihood of success. Our resource allocation decisions may cause us to fail to timely capitalize on viable commercial products or profitable market opportunities. If we do not accurately evaluate the commercial potential or target market for PDS0301, or if PDS0301 does not demonstrate the safety and efficacy we expect in future clinical trials, we will have further narrowed our development pipeline without achieving meaningful clinical or commercial progress. Our spending on the PDS0301 development program may not yield any commercially viable products.

Current report

The discontinuation of the VERSATILE-003 Phase 3 trial and our limited cash resources may further impact our ability to continue as a going concern.

Current report

As of June 30, 2026, we had $5.6 million in cash and cash equivalents, and we have concluded that substantial doubt exists about our ability to continue as a going concern. The discontinuation of the VERSATILE-003 trial, combined with our strategic refocus on PDS0301, may increase investor uncertainty regarding our prospects and make it more difficult to obtain financing on acceptable terms, or at all. Our ability to advance PDS0301 through its planned Phase 2b clinical trial and to maintain operations is dependent upon our ability to raise additional capital. If we are unable to raise capital or secure a strategic partnership for PDS0101 that provides non-dilutive funding, we may be required to delay, reduce, or terminate our PDS0301 development program or potentially cease operations. Any inability to continue as a going concern would have a material adverse effect on our stockholders, and you could lose all or part of your investment in the Company.

Current report

We have a limited operating history and have never generated any product revenue.

Current report

We have no products approved for sale. We are a clinical-stage biopharmaceutical company with a limited operating history. Our operations to date have been limited to organizing our company and developing the Versamune® platform and related immunotherapy product candidates that incorporate the technology of our Versamune® platform. We have not yet successfully completed a large-scale, pivotal clinical trial, obtained marketing approval, manufactured Versamune® at commercial scale, or conducted sales and marketing activities that will be necessary to successfully commercialize our Versamune®product candidates. Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing immunotherapies.

Current report

Our product candidates will require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, marketing approval in multiple jurisdictions, substantial investment and significant marketing efforts before we generate any revenues from product sales. We are not permitted to market or promote any of our product candidates before we receive marketing approval from the FDA and comparable foreign regulatory authorities, and we may never receive such marketing approvals.

Current report

Our ability to generate revenue and achieve and maintain profitability will depend upon our ability to successfully complete the development of ouroncology products and to obtain the necessary regulatory approvals. We have never generated any product revenue and have no immunotherapy candidate in late-stage clinical development or approved for commercial sale.

Current report

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Current report

Even if we receive regulatory approval for sale of PDS0301, our Versamune® products or Infectimune®products, we do not know when we will begin to generate revenue from PDS0301 or other products, if at all. Our ability to generate revenue depends on a number of factors, including our ability to:

Current report

Because of the numerous risks and uncertainties associated with immunotherapy development and manufacturing, we are unable to predict the timing or amount of increased development expenses, or when we will be able to achieve or maintain profitability, if at all. Our expenses could increase beyond expectations if we are required by the U.S. Food and Drug Administration, or FDA, or comparable non-U.S. regulatory authorities, to perform studies or clinical trials in addition to those we currently anticipate. Even if PDS0301 is approved for commercial sale, we anticipate incurring significant costs associated with the commercial launch of and the related commercial-scale manufacturing requirements for PDS0301, Versamune®or Infectimune® products. If we cannot successfully execute on any of the factors listed above, our business may not succeed, and your investment will be adversely affected.

Current report

We have incurred significant losses since our inception and expect to continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability.

Current report

We have never generated any product revenues and expect to continue to incur substantial and increasing losses as we continue to develop PDS0301, Versamune® products, Versamune® in combination with PDS0301 and Infectimune® products. None of our products have been approved for marketing in the United States and may never receive such approval. As a result, we are uncertain when or if we will achieve profitability and, if so, whether we will be able to sustain it. Our ability to generate revenue and achieve profitability is dependent on our ability to complete development, obtain necessary regulatory approvals, and have our products manufactured and successfully marketed. We cannot assure you that we will be profitable even if we successfully commercialize PDS0301, Versamune®or Infectimune® based products. If we successfully obtain regulatory approval to marketany product, our revenues will be dependent, in part, upon the size of the markets in the territories for which regulatory approval is received, the number of competitors in such markets for the approved indication, and the price at which we can offer our products. If the indication approved by regulatory authorities is narrower than we expect, or the treatment population is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of our products, even if approved. Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If we fail to become and remain profitable the market price of our common stock and our ability to raise capital and continue operations will be adversely affected.

Current report

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Current report

We expect research and development expenses to increase significantly for PDS0301 if we initiate the planned Phase 2b trial. In addition, even if we obtain regulatory approval, significant sales and marketing expenses will be required to commercialize our products. As a result, we expect to continue to incur significant and increasing operating losses and negative cash flows for the foreseeable future. These losses have had and will continue to have an adverse effect on our financial position and working capital. As of December 31, 2025 and 2024, we had an accumulated deficit of $216.6 and $182.1 million, respectively.

Current report

We are dependent on the success of our PDS0301, Versamune® and Infectimune® products, which are still in clinical development, and if our PDS0301, Versamune® and Infectimune® products do not receive regulatory approval or are not successfully commercialized, our business may be harmed.

Current report

PDS0301 is in mid clinical development, and as a consequence, it is too early to determine whether our products will ever be approved for commercial sale or be marketable. We expect that a substantial portion of our efforts and expenditures over the next few years will be devoted to PDS0301. Accordingly, our business currently depends heavily on the successful development, regulatory approval and commercialization of PDS0301. PDS0301 may not receive regulatory approval or be successfully commercialized even if regulatory approval is received. The research, testing, manufacturing, labeling, approval, sale, marketing and distribution of PDS0301 is and will remain subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries that each have differing regulations. We are not permitted to market PDS0301 in the United States until it receives approval of a biologics license application, or BLA, from the FDA, or in any foreign countries until it receives the requisite approval from such countries. To date, we have only completed Phase 2 clinical trials for certain applications of PDS0301. As a result, we have not submitted a BLA to the FDA or comparable applications to other regulatory authorities and do not expect to be in a position to do so for the foreseeable future. Obtaining approval of a BLA is an extensive, lengthy, expensive and inherently uncertain process, and the FDA may delay, limit or deny approval of PDS0301 for many reasons, including:

Current report

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Current report

We will require additional capital to fund our operations, and if we fail to obtain necessary financing, we may not be able to complete the development and commercialization of PDS0301, Versamune® and Infectimune® based products.

Current report

We expect to spend substantial amounts to complete the development of, seek regulatory approvals for and commercialize PDS0301. Even with our current cash reserves, we will require substantial additional capital to complete the development and potential commercialization of PDS0301 and the development of other Versamune® and Infectimune® based products. If we are unable to raise capital or find appropriate partnering or licensing collaborations or other nondilutive financing, when needed or on acceptable terms, if at all, we could be forced to delay, reduce or eliminate one or more of our development programs or any future commercialization efforts. In addition, attempting to secure additional financing may divert the time and attention of our management from day-to-day activities and harm our development efforts.

Current report

Our estimate as to what we will be able to accomplish is based on assumptions that may prove to be inaccurate, and we could exhaust our available capital resources sooner than is currently expected. Because the length of time and activities associated with successful development of PDS0301 is highly uncertain, we are unable to estimate the actual funds we will require for development and any approved marketing and commercialization activities. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

Current report

Additional funding may not be available on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of PDS0301 or potentially discontinue operations.

Current report

Raising additional funds by issuing securities may cause dilution to existing stockholders and raising funds through lending and licensing arrangements may restrict our operations or require us to relinquish proprietary rights.

Current report

We expect our expenses to increase in connection with our planned operations. Although we believe we will reduce expenses in the near term from historical levels, such expenses will begin to increase as the planned Phase 2 PDS0301 clinical trial is initiated. Until such time, if ever, as we can generate substantial revenues from the sale of drugs, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and/or licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interests in our securities may be diluted, and the terms of these securities could include liquidation or other preferences and anti-dilution protections that could adversely affect the rights of our common stockholders. In addition, debt financing, if available, would result in fixed payment obligations and may involve agreements that include restrictive covenants that limit our ability to take specific actions, such as incurring additional debt, making capital expenditures, creating liens, redeeming stock or declaring dividends, that could adversely impact our ability to conduct our business. In addition, securing financing could require a substantial amount of time and attention from our management and may divert a disproportionate amount of their attention away from day-to-day activities, which may adversely affect our management’s ability to oversee the development of our product candidates.

Current report

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Current report

If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or Versamune® products or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, or through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties on acceptable terms, we may be required to delay, limit, reduce or terminate our PDS0301 development or future commercialization efforts or grant rights to develop and market Versamune® and Infectimune® products that we would otherwise develop and market.

Current report

Our operating activities may be restricted as a result of covenants related to the outstanding indebtedness issued pursuant to the transactions contemplated by that certain securities purchase agreement with YA II PN, LTD, and we may be required to repay the outstanding indebtedness in an event of default, which could have a materially adverse effect on our business.

Previous report

There were no unregistered sales of the Company’s equity securities during the three months ended March 31, 2026.