PDS Biotechnology Corp

Previous wording

We believe our investigational targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. Versamune®, and Versamune® in combination with PDS01ADC are being developed for treatments in oncology and Infectimune® is being developed for treatments in infectious disease. 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. Infectimune® is also designed to promote the induction of disease-specific neutralizing antibodies. PDS01ADC is an investigational tumor targeting IL-12 that we believe may enhance the proliferation, potency and longevity of T cells in the tumor microenvironment. Based on preclinical studies and recent investigational clinical data, we believe that Versamune® in combination with PDS01ADC may enhance the proliferation, potency and longevity of antigen specific multifunctional CD8 T cells in the tumor microenvironment and work synergistically to overcome tumor immune suppression.

Current wording

We believe our investigational targeted immunotherapies have the potential to overcome the limitations of current immunotherapy approaches through the activation of the right type, quantity and potency of T cells. PDS0301, Versamune®, and Versamune® in combination with PDS0301 are being developed for treatments in oncology and Infectimune® is being developed for treatments in infectious disease. PDS0301 is an investigational tumor targeting IL-12 that we believe may enhance the proliferation, potency and longevity of T cells in the tumor microenvironment.

Previous wording

In July 2025, we announced that the colorectal cancer cohort of a Phase 2 clinical trial with PDS01ADC in combination with Hepatic Artery Infusion Pump (HAIP) and systemic therapy met the pre-defined criteria for expansion to stage 2 following positive stage 1 results.

Current wording

In July 2025, we announced that the colorectal cancer cohort of a Phase 2 clinical trial with PDS0301 in combination with Hepatic Artery Infusion Pump (HAIP) and systemic therapy met the pre-defined criteria for expansion to stage 2 following positive stage 1 results.

Previous wording

PDS01ADC is a novel investigational IL-12 fused antibody drug conjugate (IgG1), tumor-targeting interleukin 12 (IL-12) immune-cytokine that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune® based immunotherapies PDS01ADC works synergistically to overcome tumor immune suppression and to promote a targeted T cell attack against cancers. As with Versamune®, PDS01ADC is given by a simple subcutaneous injection. Clinical data suggests the addition of PDS01ADC to Versamune® based immunotherapies may demonstrate significant disease control in advanced cancer patients by shrinking tumors and/or prolonging life.

Current wording

PDS0301 is a novel investigational IL-12 fused antibody drug conjugate (IgG1), tumor-targeting interleukin 12 (IL-12) immune-cytokine that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment. Together with Versamune® based immunotherapies PDS0301 works synergistically to overcome tumor immune suppression and to promote a targeted T cell attack against cancers. As with Versamune®, PDS0301 is given by a simple subcutaneous injection. Clinical data suggests the addition of PDS0301 to Versamune® based immunotherapies may demonstrate significant disease control in advanced cancer patients by shrinking tumors and/or prolonging life.

Previous wording

With the exclusive global license agreement with Merck KGaA, Darmstadt, Germany for PDS01ADC, we believe we have simplified our registrational pathway for the NCI-led triple combination by owning both PDS0101 and PDS01ADC and combining these agents with an FDA approved ICI. PDS01ADC has been designed to overcome the limitations of cytokine therapy as explained above, and based on extensive preclinical studies performed at the NCI evaluating PDS01ADC as a monotherapy and also in combinations with established standard of care treatments for cancer, we believe that PDS01ADC has significant potential as a cytokine therapy independent of Versamune®. Based on the informative preclinical studies, a number of ITT Phase 2 trials are currently in progress at the NCI, some of which are outlined below:

Current wording

PDS0301 has been designed to overcome the limitations of cytokine therapy as explained above, and based on extensive preclinical studies performed at the NCI evaluating PDS0301 as a monotherapy and also in combinations with established standard of care treatments for cancer, we believe that PDS0301 has significant potential as a cytokine therapy. Based on the informative preclinical studies, a number of ITT Phase 2 trials are currently in progress at the NCI, some of which are outlined below:

Previous wording

In October 2023, interim safety and immune response data was presented for the first-in-human Phase1/2 clinical trial evaluating PDS01ADC in combination with current SOC chemotherapy, docetaxel, to treat metastatic castration sensitive and castration resistant prostate cancer. The data was featured in an oral presentation at the 11 th Annual Meeting of the International Cytokine & Interferon Society. The data presented included the following:

Current wording

In October 2023, interim safety and immune response data was presented for the first-in-human Phase1/2 clinical trial evaluating PDS0301 in combination with current SOC chemotherapy, docetaxel, to treat metastatic castration sensitive and castration resistant prostate cancer. The data was featured in an oral presentation at the 11 th Annual Meeting of the International Cytokine & Interferon Society. The data presented included the following:

Previous wording

In April 2026, we announced the publication of clinical and immunological biomarker data from Stage 1 of a Phase 2 trial evaluating PDS01ADC in the March 10, 2026 issue of Journal of Clinical Oncology (JCO) Oncology Advances. Key findings from stage 1 of the Phase 2 trial are outlined below:

Current wording

In April 2026, we announced the publication of clinical and immunological biomarker data from Stage 1 of a Phase 2 trial evaluating PDS0301 in the March 10, 2026 issue of Journal of Clinical Oncology (JCO) Oncology Advances. Key findings from stage 1 of the Phase 2 trial are outlined below:

Previous wording

We are working closely with the NCI to determine the best pathway forward for the prioritized PDS01ADC studies, as well as evaluating the use of PDS01ADC in combination with other Versamune® based clinical candidates. In January 2025, we submitted an investigational new drug application to the FDA for a Phase 1 trial with PDS0103 and PDS01ADC in colorectal cancer. At the time of this report, we have not initiated this trial.

Current wording

We are working closely with the NCI to determine the best pathway forward for the prioritized PDS0301 studies. In January 2025, we submitted an investigational new drug application to the FDA for a Phase 1 trial with PDS0301 and PDS0103 in colorectal cancer. At the time of this Quarterly Report, we have not initiated this trial.

Previous wording

In March 2025, we initiated our VERSATILE-003 Phase 3 clinical trial evaluating the combination of PDS0101 in combination with the anti-PD-1 therapy pembrolizumab versus pembrolizumab as a monotherapy. The clinical trial will evaluate the efficacy and safety of this therapeutic combination as a first line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.

Current wording

In March 2025, we initiated our VERSATILE-003 Phase 3 clinical trial evaluating the combination of PDS0101 in combination with the anti-PD-1 therapy pembrolizumab versus pembrolizumab as a monotherapy. The clinical trialwas designed to evaluate the efficacy and safety of this therapeutic combination as a first line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.

Previous wording

In this trial, sponsored by us, patients whose cancer has returned following initial treatment or spread (metastasized) will be treated with either the combination of PDS0101and pembrolizumab or with pembrolizumab alone, to evaluate if the addition of PDS0101 might improve the efficacy of pembrolizumab alone. Patients in the trial will receive a total of 5 cycles of combination therapy in the context of standard of care pembrolizumab therapy administered every three weeks until disease progression. The primary endpoint of VERSATILE-003 is median overall survival, or mOS, at six months following initiation of treatment. Following discussions with the FDA in December 2025, we amended the trial’s protocol, among other modifications, to include progression-free survival (PFS) as an interim primary endpoint of the trial. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment.

Current wording

In this trial, sponsored by us, patients whose cancer has returned following initial treatment or spread (metastasized)were treated with either the combination of PDS0101and pembrolizumab or with pembrolizumab alone, to evaluate if the addition of PDS0101 might improve the efficacy of pembrolizumab alone. Patients in the trial received a total of 5 cycles of combination therapy in the context of standard of care pembrolizumab therapy administered every three weeks until disease progression. The primary endpoint of VERSATILE-003 was median overall survival, or mOS, at six months following initiation of treatment. Following discussions with the FDA in December 2025, we amended the trial’s protocol, among other modifications, to include progression-free survival (PFS) as an interim primary endpoint of the trial. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment.

Previous wording

In this trial sponsored by us, patients whose cancer had returned following initial treatment or spread were treated with the combination of PDS0101 and Keytruda® to evaluate if the addition of PDS0101 might improve the efficacy reported in published studies of Keytruda® alone. Patients in the trial received a total of 5 cycles of combination therapy in the context of standard of care Keytruda® therapy administered every three weeks until disease progression. The primary endpoint of VERSATILE-002 is the objective response rate, or ORR, at six months following initiation of treatment. There are twocohorts in the trial. Cohort 1 is for patients who have yet to be treated with an immune checkpoint inhibitor (ICI naïve) and cohort 2 which consists of patients who have failed immune checkpoint inhibitor therapy (ICI resistant).

Current wording

In this trial sponsored by us, patients whose cancer had returned following initial treatment or spread were treated with the combination of PDS0101 and Keytruda® to evaluate if the addition of PDS0101 might improve the efficacy reported in published studies of Keytruda® alone. Patients in the trial received a total of 5 cycles of combination therapy in the context of standard of care Keytruda® therapy administered every three weeks until disease progression. The primary endpoint of VERSATILE-002 was the objective response rate, or ORR, at six months following initiation of treatment. There were twocohorts in the trial. Cohort 1 was for patients who have yet to be treated with an immune checkpoint inhibitor (ICI naïve) and cohort 2 which consisted of patients who had failed immune checkpoint inhibitor therapy (ICI resistant).

Previous wording

In August 2025, we announced final topline survival data from our VERSATILE-002 Phase 2 trial in head and neck cancer. 53 patients were enrolled in the 1L R/M HNSCC arm of the trial:

Current wording

In August 2025, we announced final topline survival data from our VERSATILE-002 Phase 2 trial in head and neck cancer.

Previous wording

In October 2020, a Phase 2 IIT was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting patients. This clinical trial investigated the safety and anti-tumor efficacy of PDS0101 in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers in patients with locally advanced cervical cancer. We believe that Versamune® has strong T cell induction with the potential to enhance efficacy of the current standard of care CRT treatment in this indication with the FDA at this meeting.

Current wording

In October 2020, a Phase 2 IIT was initiated with The University of Texas MD Anderson Cancer Center. This clinical trial investigated the safety and anti-tumor efficacy of PDS0101 in combination with standard-of-care chemo-radiotherapy, or CRT, and their correlation with critical immunological biomarkers in patients with locally advanced cervical cancer. We believe that Versamune® has strong T cell induction with the potential to enhance efficacy of the current standard of care CRT treatment in this indication.

Previous wording

In February 2022, we initiated an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the immune checkpoint inhibitor, pembrolizumab, in patients with HPV-positive oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The trial is being led by Drs. David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar at Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers. We believe that this trial not only broadens our addressable patient population of those affected by the increasing incidence of HPV(+)OPSCC, but also allows us to better understand the activity of PDS0101 alone or in combination with Keytruda® in earlier stages of disease. This trial is currently open for enrollment.

Current wording

In February 2022, we initiated an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the immune checkpoint inhibitor, pembrolizumab, in patients with HPV-positive oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence. The trialwas led by Drs. David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar at Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers.

Previous wording

In this trial, treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as neoadjuvant treatment. PDS0101 has been shown to induce killer T cells that target and kill HPV-positive cancers, either alone or in combination with ICIs in preclinical studies, and in combination in clinical studies of patients with advanced recurrent/metastatic HPV-positive cancers. This trial will explore whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA).

Current wording

In this trial, treatmentwas administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as neoadjuvant treatment. PDS0101 has been shown to induce killer T cells that target and kill HPV-positive cancers, either alone or in combination with ICIs in preclinical studies, and in combination in clinical studies of patients with advanced recurrent/metastatic HPV-positive cancers. This trial explored whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA).

Previous wording

National Cancer Institute: PDS0101 + PDS01ADC + Bintrafusp Alfa

Current wording

National Cancer Institute: PDS0101 + PDS0301 + Bintrafusp Alfa

Previous wording

In January 2025, we submitted an investigational new drug application to the FDA for a Phase 1 trial with PDS0103 and PDS01ADC in colorectal cancer.

Current wording

In January 2025, we submitted an investigational new drug application to the FDA for a Phase 1 trial with PDS0301 and PDS0103 in colorectal cancer. At the time of this Quarterly Report, we have not initiated this trial.

Previous wording

Our current clinical pipeline of Versamune® and PDS01ADC based therapies is as follows:

Current wording

Our current clinical pipeline of PDS0301 and Versamune® based therapies:

Previous wording

We believe that the key differentiating attributes of the Infectimune® platform technology are strong induction of CD8 and CD4 T cells as well as antibodies which can be leveraged to improve treatment and preventive options in several infectious disease indications. In January 2022, we presented preclinical data on our universal flu program sponsored by the National Institute of Allergy and Infectious Disease (NIAID) demonstrating the potential of the Infectimune® technology with computationally designed influenza proteins developed by the laboratory of Dr. Ted Ross at the University of Georgia to generate broadly protective anti-influenza immune responses across multiple strains of influenza. This data has provided a unique opportunity to highlight Infectimune®’s potentially transformative utility in the development of more broadly effective and longer lasting protective vaccines. Current preventive and prophylactic vaccine approaches and technologies predominantly focus on creating strong induction of antibody responses. However, the induction of T cell responses, in addition to antibody responses, provides more durable and broad protection against infectious diseases.

Current wording

We believe that the key differentiating attributes of the Infectimune® platform technology are strong induction of CD8 and CD4 T cells as well as antibodies which can be leveraged to improve treatment and preventive options in several infectious disease indications. In January 2022, we presented preclinical data on our universal flu program sponsored by the National Institute of Allergy and Infectious Disease (NIAID) demonstrating the potential of the Infectimune® technology with computationally designed influenza proteins developed by the laboratory of Dr. Ted Ross at the University of Georgia to generate broadly protective anti-influenza immune responses across multiple strains of influenza. This data has provided a unique opportunity to highlightthe potentially transformative utilityof Infectimune®in the development of more broadly effective and longer lasting protective vaccines. Current preventive and prophylactic vaccine approaches and technologies predominantly focus on creating strong induction of antibody responses. However, the induction of T cell responses, in addition to antibody responses, provides more durable and broad protection against infectious diseases.

Previous wording

Since our inception we have devoted substantially all our resources to developing our Versamune® and Infectimune® platforms, and products derived thereof, as well as PDS01ADC. This includes advancing preclinical programs, conducting clinical trials, manufacturing PDS0101 and PDS01ADC for clinical trials, and providing general and administrative support. We have funded our operations primarily from the issuance of common stock and issuance of debt. We have not generated any product revenue to date.

Current wording

Since our inception we have devoted substantially all our resources to developing our Versamune® and Infectimune® platforms, and products derived thereof, as well as PDS0301. This includes advancing preclinical programs, conducting clinical trials, manufacturing PDS0101 and PDS0301 for clinical trials, and providing general and administrative support. We have funded our operations primarily from the issuance of common stock and issuance of debt. We have not generated any product revenue to date.

Previous wording

We have never been profitable and have incurred net losses in each year since inception. Our net losses were $7.3 million, and $8.5 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $224.0 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with these operations.

Current wording

We have never been profitable and have incurred net losses in each year since inception. Our net losses were $17.1 million, and $17.9 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $233.7 million. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with these operations.

Previous wording

As of March 31, 2026, we had $21.7 million in cash and cash equivalents.

Current wording

As of June 30, 2026, we had $5.6 million in cash and cash equivalents.

Previous wording

We expect that our research and development expenses will increase significantly over the next several years as we advance our Versamune® and PDS01ADC clinical and product candidates into and through clinical trials, pursue regulatory approval of our Versamune® and PDS01ADC product candidates and prepare for a possible commercial launch, all of which will also require a significant investment in contract research services, manufacturing process validation and inventory related costs.

Current wording

We expect that our research and development expenses will increase significantly over the next several years as we advance our PDS0301 product candidate into and through clinical trials, pursue regulatory approval of our Versamune® and PDS0301 product candidates and prepare for a possible commercial launch, all of which will also require a significant investment in contract research services, manufacturing process validation and inventory related costs.

Previous wording

Research and development (R&D) expenses decreased to $3.5 million for the three months ended March 31, 2026 from $5.8 million for the three months ended March 31, 2025. The decrease of $2.3 million was primarily attributable to a decrease of $1.2 million in clinical trial costs, a decrease of $0.7 million in manufacturing costs, and a decrease of $0.4 million in personnel costs.

Current wording

Research and development (R&D) expenses decreased to $3.3 million for the three months ended June 30, 2026 from $4.2 million for the three months ended June 30, 2025. The decrease of $0.9 million was primarily attributable to a decrease of $1.0 million in clinical trial costs, a decrease of $0.4 million in manufacturing costs, and a decrease of $0.2 million in personnel costs, partially offset by an increase of $0.7 million in stock-based compensation expense.

Previous wording

General and administrative expenses decreased to $3.1 million for the three months ended March 31, 2026 from $3.3 million for the three months ended March 31, 2025. The decrease of $0.2 million was primarily attributable to a decrease in professional fees.

Current wording

General and administrative expenses decreased to $3.2 million for the three months ended June 30, 2026 from $3.4 million for the three months ended June 30, 2025. The decrease of $0.2 million was primarily attributable to a decrease in professional fees.

Previous wording

Income tax benefit was $0 for the three months ended March 31, 2026 and $1.2 million for the three months ended March 31, 2025. The decrease of $1.2 million was due to us having met the statutory $20 million lifetime cap on total cumulative value of NOLs sold, which makes us ineligible to participate in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program.

Current wording

Income tax benefit was zero for the six months ended June 30, 2026 and $1.2 million for the six months ended June 30, 2025. The decrease of $1.2 million was due to us having met the statutory $20 million lifetime cap on total cumulative value of NOLs sold, which makes us ineligible to continue participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program.

Previous wording

In August 2024, we 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. During the three months ended March 31, 2026 and 2025, the Company sold 937,420 shares of common stock and 205,250 shares of common stock for a net value of $0.85 million and $0.3 million, respectively, pursuant to the New Sales Agreement. The New Sales Agreement was terminated on May 1, 2026.

Current wording

In August 2024, we 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. During the three and six months ended June 30, 2026, we sold 0 sharesand 937,420 shares, respectively, of common stock with a net value of $0 million and $0.8 million, respectively, pursuant to the New Sales Agreement. During the three and six months ended June 30, 2025, we sold 960,511 and 1,165,861 shares, respectively, of common stock with a net value of $1.5 and $1.8 million, respectively, pursuant to the New Sales Agreement. The New Sales Agreement was terminated on May 1, 2026.

Previous wording

On April 30, 2025, we entered into a securities purchase agreement, or the “Securities Purchase Agreement” with certain third party lenders and JGB Collateral LLC, as collateral agent. Pursuant to the Securities Purchase Agreement, we agreed to sell (i) senior secured convertible debentures in an aggregate principal amount of $22,222,222 (collectively, the “Debentures”) 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 our indebtedness under the Loan and Security Agreement. The remaining proceeds from the transactions contemplated by the Securities Purchase Agreement were used for general corporate purposes and transaction expenses. Pursuant to the Debentures, we 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, we are generally restricted from: incurring indebtedness; granting or suffering liens on any of our property or assets; amending our organizational documents; repurchasing any of our securities; paying dividends; selling, disposing, licensing or leasing our assets other than in the ordinary course; and other customary restrictive covenants. Effective as of August 28, 2025, the holders of the Debentures may require us to redeem a portion of the Debentures in an amount up to $500,000 per calendar month in the aggregate. During the year ended December 31, 2025 and the three months ended March 31, 2026, the Company redeemed an aggregate of $2.5 million and $1.5 million of the principal amount of the Debentures, respectively. In connection with the Securities Purchase Agreement, on April 30, 2025, we also entered into a Security Agreement (the “Security Agreement”), pursuant to which we and our subsidiary granted, for the benefit of the investors, to secure our 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, we and our subsidiary entered into a Subsidiary Guarantee, pursuant to which we and our subsidiary guaranteed all of our obligations under the Securities Purchase Agreement and the Debentures.

Current wording

On April 30, 2025, we entered into a securities purchase agreement, or the “Securities Purchase Agreement” with certain third party lenders and JGB Collateral LLC, as collateral agent. Pursuant to the Securities Purchase Agreement, we agreed to sell (i) senior secured convertible debentures in an aggregate principal amount of $22,222,222 (collectively, the “Debentures”) 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 our indebtedness under the Loan and Security Agreement. On April 30, 2026, the Company delivered a redemption notice pursuant to which it irrevocably elected to prepay, for cash, all of the outstanding principal amount under each of the Debentures issued pursuant to the Securities Purchase Agreement. On June 15, 2026, the Company paid the applicable redemption amount, equal to 103% of the principal amount outstanding plus all accrued and unpaid interest and all other amounts payable thereunder, and, upon such payment, each Debenture was redeemed in full and is of no further force or effect.

Previous wording

As of March 31, 2026, we had $21.7 million in cash and cash equivalents. Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Current wording

As of June 30, 2026, we had $5.6 million in cash and cash equivalents. Our primary uses of cash are to fund operating expenses, primarily research and development expenditures. Cash used to fund operating expenses is impacted by the timing of when we pay these expenses, as reflected in the change in our outstanding accounts payable and accrued expenses.

Previous wording

We plan to continue to fund our operations and capital funding needs through existing cash and additional equity and/or debt financing. However, we cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our existing stockholders. We may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to our 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 our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves. In addition, the Debentures require us to maintain minimum cash balances in a deposit account subject to an account control agreement and impose restrictive covenants, as described above. Any of these actions could harm our business, results of operations and prospects.

Current wording

We plan to continue to fund our operations and capital funding needs through existing cash and additional equity and/or debt financing. However, we cannot be certain that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or our existing stockholders. We may also enter into government funding programs and consider selectively partnering for clinical development and commercialization. The sale of additional equity would result in additional dilution to our 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 our operations. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we may be required to delay, limit, reduce, or terminate our product development or future commercialization efforts or grant rights to develop and market immunotherapies that we would otherwise prefer to develop and market ourselves. Any of these actions could harm our business, results of operations and prospects.

Previous wording

Net cash used in operating activities was $4.3 million and $9.0 million for the three months ended March 31, 2026 and 2025, respectively. The decrease in net cash used in operating activities of $4.7 million was primarilydue to a decrease in the non-cash stock-based compensation expense of $0.1 million and a decrease in issuance of shares in consulting agreements of $0.2 million, offset by a decrease in net loss of $1.1 million, an increase in the amortization of debt discount of $0.2 million and changes in the timing of working capital requirements, including an increase in prepaid expenses and other assets, offset by decreases in accrued expenses and accounts payable.

Current wording

Net cash used in operating activities was $7.2 million and $18.1 million for the six months ended June 30, 2026 and 2025, respectively. The decrease in net cash used in operating activities of $10.9 million was primarilydue to a net increase of $2.0 million in the amortization of debt discount and loss on retirement of debt, an increase in stock-based compensation expense of $0.6 million, and changes in the timing of working capital. These changes were partially offset by a decrease in net loss of $0.8 million and a decrease in the issuance of shares in consulting agreement of $0.2 million.

Previous wording

Net cash provided by financing activities for the three months ended March 31, 2026 and 2025 decreased by $8.0 million primarily due to a $7.0 million decrease in proceeds from the issuance of common stock, a decrease in proceeds from the issuance warrants and pre-funded warrants of $3.2 million, offset by a decrease of $1.6 million in loan repayments and $0.5 million in proceeds from issuance of common stock through our at-the-market program.

Current wording

Net cash used in financing activities was $13.9 million for the six months ended June 30, 2026, compared to net cash provided by financing activities of $8.3 million for the six months ended June 30, 2025. The $22.2 million change was primarily due to a decrease in proceeds from the issuance of common stock of $7.0 million, a decrease in proceeds from the issuance of warrants and pre-funded warrants of $2.1 million, and a decrease in proceeds from the issuance of debt of $14.9 million, partially offset by a decrease in loan principal payments and loan repayments of $2.6 million and a decrease in net proceeds from the issuance of common stock under the at-the-market offering program of $0.8 million.

Previous wording

We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the filing of this Quarterly Report. Our budgeted cash requirements in 2026 and beyond include expenses related to continuing development and clinical studies as well as payments on our debt. Until we can generate significant cash from our operations, we expect to continue to fund our operations with available financial resources. These financial resources may not be adequate to sustain our operations. While we intend to finance our cash needs principally through equity or debt financings, collaborations, strategic alliances, or license agreements with third parties, there is no assurance that new financing will be available to us on commercially acceptable terms or in the amounts required, if at all. In addition, the terms of the Debentures allow for the holders to call the outstanding balance of the Debentures if we fail to maintain the minimum cash balances required by the Debentures.

Current wording

We evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the filing of this Quarterly Report. Our budgeted cash requirements in 2026 and beyond include expenses related to continuing development and clinical studies as well as payments on our debt. Until we can generate significant cash from our operations, we expect to continue to fund our operations with available financial resources. These financial resources may not be adequate to sustain our operations. While we intend to finance our cash needs principally through equity or debt financings, collaborations, strategic alliances, or license agreements with third parties, there is no assurance that new financing will be available to us on commercially acceptable terms or in the amounts required, if at all.

Previous wording

There have been no material changes to our critical accounting policies and estimates during the three months ended March 31, 2026 from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.

Current wording

There have been no material changes to our critical accounting policies and estimates during the six months ended June 30, 2026 from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025.