Item 1A Risk Factors 46

Item 1B Unresolved Staff Comments 87

Item 1C Cybersecurity 88

Item 2 Properties 88

Item 3 Legal Proceedings 88

Item 4 Mine Safety Disclosures 88

PART II

Item 6 [Reserved]

Item 7A Quantitative and Qualitative Disclosures about Market Risk 104

Item 8 Financial Statements and Supplementary Data 104

Item 9A Controls and Procedures 104

Item 9B Other Information 105

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 105

PART III

Item 10 Directors, Executive Officers and Corporate Governance 106

Item 11 Executive Compensation 106

Item 14 Principal Accountant Fees and Services 106

PART IV

Item 15 Exhibits and Financial Statement Schedules 106

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Cautionary Note Regarding Forward-Looking Statements

This Annual Report on Form 10-K (this “Annual Report”)

contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning the Company and

other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as

assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,”

“will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs

and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including,

without limitation.

● the Company’s ability to protect its intellectual property rights;

Any forward-looking statements in this Annual Report

reflect the Company’s current views with respect to future events or to our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be

materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as

required by law, the Company assumes no obligation to update or revise these forward-looking statements for any reason, whether as a result of new information, future events or otherwise.

In this Annual Report, unless otherwise stated or the context otherwise indicates, references to “PDS Biotech,” “the Company,” “we,”

“us,” “our” and similar references refer to PDS Biotechnology Corporation, a Delaware corporation.

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PART I

Unless the context requires otherwise, references in this report to “PDS Biotech,” “Company,” “we,” “us,” and “our”

and similar designations refer to PDS Biotechnology Corporation and our subsidiary.

ITEM 1. Business

Company Overview

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies

based on our Versamune® T cell activator and Versamune® in combination with our interleukin 12 (IL-12) fused anti-body drug conjugate (ADC), PDS01ADC. In addition, we are developing the Infectimune® T cell-activator in infectious diseases.

We believe our investigational targeted immunotherapies

have the potential to overcome limitations of current immunotherapy approaches through effective conversion of the immune suppressive tumor to an immunogenic microenvironment in addition to the induction of the right type, potency and quantity of

tumor-targeting killer (CD8) T cells. Our Versamune® immunotherapies and Versamune® in combination with PDS01ADC, are being developed for treatments in oncology, and Infectimune® is being developed for preventive vaccines against infectious

agents. 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 disease-specific CD4 helper and CD8 killer T cells, a

specific sub-type of T cell that has shown potential to be 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 and reduces the prevalence of immune suppressive cells and components within the tumor.

We believe our proprietary combinations of Versamune® and PDS01ADC together with immune checkpoint inhibitors or other standards of

care, may enhance the proliferation, potency and longevity of antigen specific multifunctional CD8 T cells in the tumor microenvironment and work synergistically to inhibit or treat cancer.

In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the

European Society for Medical Oncology (ESMO) Congress 2024.

In October 2024, we announced updated data from the IMMUNOCERV Phase 2 clinical trial evaluating PDS0101 with chemoradiation to treat

locally advanced cervical cancer presented at the American Society for Radiation Oncology (ASTRO) annual meeting 2024.

In March 2025, we announced the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating PDS0101 (PDS0101) in HPV16-positive

first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.

In July 2025, we announced that the colorectal cancer cohort of a phase 2 clinical trial with PDS01ADC met the pre-defined criteria

for expansion to stage 2 following positive stage 1 results.

In August 2025, we announced final topline survival data from our VERSATILE-002 Phase 2 trial evaluating PDS0101 in HPV16-positive

first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.

In September 2025, we announced final topline survival data for the low-CPS patient population from our VERSATILE-002 Phase 2 trial

evaluating PDS0101 in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma.

In October 2025, we announced our request for a Type C meeting with the FDA to discuss a proposed expedited pathway for our

VERSATILE-003 Phase 3 clinical trial, based on a proposed amendment to the trial’s design to include progression-free survival as an interim primary endpoint, in addition to median overall survival.

The challenges to effective immunotherapy

The clinical effectiveness of immunotherapy has been limited by two main challenges: (i) inability to access and convert the tumor to an

immunogenic microenvironment, and (ii) inability to generate adequate quantities of high-quality killer CD8 T cells. Effective treatments should also minimize systemic toxicities and generate immunological memory. On a fundamental biological or

immunological level, one of the most significant challenges facing clinicians is the availability of simple and easy to administer therapies that can effectively treat cancer with minimal side effects.

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Cancer Immunotherapy

Cancer immunotherapy is a form of cancer treatment that utilizes the ability of the body’s own immune system to recognize, attack and

eliminate cancer. The ultimate goal of cancer immunotherapy is to improve patient quality of life and to extend patient life by slowing down progression of the cancer, causing shrinkage of the tumors and in some cases eradication of the cancer. The

body’s immune system is a complex, biological network designed to defend against germs, other microscopic invaders, and cancer cells. Once the immune system recognizes an organism or cell as foreign or dangerous, it begins a series of complex

reactions to identify, target and eliminate them. This process of events is referred to as mounting an immune response. Cancer immunotherapy takes advantage of the fact that most cancer cells express unique proteins, also called tumor antigens, not

normally expressed by healthy cells that can be recognized by the immune system as abnormal. Because the immune system is precise, for the most part, a resulting immune response can target these dangerous cancer cells exclusively while sparing

healthy cells. However, the challenge remains that cancer cells are able by various mechanisms to evade the immune system’s surveillance, so the body becomes tolerant to them.

We believe cancer immunotherapy should have the following attributes to maximize the opportunity for clinical effectiveness in patients:

● Stimulate both tumor-specific killer and helper T cells within the body

As stated in the June 2019 issue of The Journal of

Immunology, a leading peer-reviewed journal in the field of immunology, our Versamune® platform possesses each of these attributes, inducing potent anti-tumor responses in preclinical studies. (Gandhapudi, et al., J. Immunology, June 2019;

Rumfield et al, J. Journal for ImmunoTherapy of Cancer, May 2020). We believe our Versamune® technology platform, potentially in combination with our IL-12 antibody drug conjugate, PDS01ADC, is unique in its ability to successfully encompass the mechanistic attributes required to induce a safe and

effective anti-cancer immune response in preclinical data.

How does cancer immunotherapy work?

An important function of the body’s immune system is to identify and respond to proteins not normally expressed in healthy tissue

(antigens). Once an antigen has been identified as foreign, abnormal or dangerous, the antigen is presented to T cells, a type of white blood cell effective at eliminating cancer cells and infectious agents (e.g. bacteria and viruses). The

presentation of an antigen to T cells is implemented primarily in the lymph nodes by specialized antigen presenting cells known as dendritic cells which are programmed specially to identify foreign antigens, process them and to present them to T

cells. Unique proteins on the surface of dendritic cells, known as major histocompatibility complex (MHC) molecules, bind to the foreign antigen and display them on the cell surface for recognition by the appropriate T cells. Then, once presented,

a sub-population of T cells known as the CD8 or killer T cells, are primed and respond to the specific foreign antigen by attacking and killing the cells containing the abnormal protein. Other T cell sub-populations, such as CD4 or helper T cells,

are also critical in regulating immune responses.

Cells communicate via chemical signaling. For an immune response to be triggered and to be effective, important immune signaling

pathways must be activated to enable the body to induce messenger proteins known as cytokines and chemokines. Some of these cytokines and chemokines serve both to activate and expand T cells and to arm the T cells with the appropriate

cancer-killing function.

An effective cancer immunotherapy must modulate these complex processes, enhancing activation and producing robust expansion of the

critically important high-quality, tumor-specific T cell populations, most notably CD8 killer cells. As will be reviewed in more detail in the section below, the ability to promote the induction of therapeutic quantities of high-quality

tumor-targeting CD8 killer T cells within a patient’s own body has been a major limitation of cancer immunotherapy.

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Production of adequate numbers of high-quality CD8 killer T cells alone, however, is insufficient to eradicate all cancer cells. One of

the difficulties in treating cancer stems from the fact that cancer cells have the unique ability to evade the immune system; they camouflage themselves or suppress T cell attack by activating immune mechanisms that suppress the ability of T cells to

detect or attack them. They accomplish this in part by increasing the population of immune suppressive cells, including cells known as regulatory T cells (Treg) as well as other cell types, within the tumor microenvironment. An effective

immunotherapy must overcome the tumor’s immune suppressive mechanisms in order to successfully locate and attack the cancer cells.

Finally, cancers can be difficult to cure because they may recur even after successful initial treatment due to micro-metastatic

(hidden) tumors that are not completely eradicated after treatment and that eventually expand. It is yet another task of the immune system to remain vigilant over a sustained period to mitigate the risk of recurrence. Such vigilance may be

mediated by memory T cells which serve as the immune system’s long-term memory. To be durable and effective over an extended period after treatment, and to minimize the likelihood of cancer recurrence, immunotherapy should enhance this immune

function as well.

Versamune®Platform

Versamune® has the potential to stimulate the body’s immune system

Versamune® is a proprietary lipid nanoparticle and T cell stimulating platform designed to overcome the challenges of current

immunotherapy and improve the treatment outcomes of patients with cancer. Versamune® derived products are based on positively charged (cationic) and immune activating lipids that form spherical nanoparticles in aqueous media. These lipids include the

R-enantiomer of 1,2-dioleoyl-e-trimethyl-ammonium-propane (R-DOTAP). Cationic lipids are positively charged molecules that have a water-soluble portion (head group) attached to a water insoluble tail. The water-soluble portion of the molecule has a

positive charge, and the water-insoluble portion is made up of hydrocarbon (also called fatty acid) chains. The nanoparticles, which are coated with a positive charge, are deliberately sized to mimic viruses, facilitating detection by the body’s

immune system and uptake by dendritic cells.

To treat a specific cancer, the unique or overexpressed antigen found on the surface of the cancer cells is manufactured, then mixed with the Versamune®

nanoparticles to create a pharmaceutical product for simple subcutaneous injection.

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Versamune® has the potential to promote dendritic cell update of antigens

One of the biggest challenges in developing a potent immunotherapy is the uptake of the immunotherapy by dendritic cells. Versamune® is

designed specifically to be taken up by dendritic cells in the skin. As noted above, Versamune® nanoparticles are sized comparably to viruses normally taken up as part of the natural function of the dendritic cells, facilitating efficient uptake of

the Versamune® based immunotherapy. Studies evaluating the uptake of Versamune® nanoparticles by dendritic cells and epithelial cells, found almost exclusive uptake by the dendritic cells. Four hours following a single subcutaneous injection, studies

have shown that about 80% of the dendritic cells in the draining lymph node were found to have taken up the Versamune® based immunotherapy.

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Versamune® has the potential to promote efficient antigen processing and T cell presentation

When dendritic cells take up Versamune® nanoparticles they become activated, mature and begin recruiting additional dendritic cells.

Once inside the dendritic cell, the tumor-associated antigen is released and processed into the requisite small peptides (pieces of protein) in the cell compartment known as the cytoplasm. An important potential advantage of Versamune® is its ability

to fuse with and destabilize endosomes in the cell, promoting efficient entry of the antigen into the cell compartment where processing can take place. Processed antigen is turned into peptides that go on to present in both the MHC class I and class

II pathways. The MHC class I pathway is critical to programming CD8 killer T cells and the MHC class II pathway to programming CD4 helper T cells to recognize tumor antigens. When Versamune® - induced maturation occurs, the dendritic cells express

costimulatory molecules on their surface, which facilitate the highly efficient uptake and presentation of antigens to the T cells. We believe this activity overcomes one of the most significant limitations of current immunotherapy development – the

efficient priming of critical CD8 killer T cells against tumor antigens. Versamune® has been demonstrated to promote presentation of antigens to CD4 helper T cells as well.

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Versamune® has the potential to promote efficient activation and robust expansion of high quality polyfunctional

CD8 killer T cells and CD4 helper in Lymph Nodes

Ultimately mature dendritic cells migrate into lymph nodes, small glands located throughout the body containing white blood cells

including T cells, where much of the key immunological activity pertaining to the priming and expansion of T cells takes place. In the lymph nodes, the dendritic cells present the tumor antigens to T cells resulting in activation or priming of the

T cells to recognize the particular antigen expressed by the cancer. Importantly, Versamune® has also demonstrated the potential to upregulate type I interferon genes (type I IFN), which are responsible for critical immunological processes.

Upregulation of type I IFN induces an important immunological protein called CD69 that facilitates interactions between the dendritic cell and T cells in the lymph nodes.

Upregulation of type I IFN signaling also induces

multiple immune messenger proteins called cytokines and chemokines that further signal T cells to infiltrate into the lymph nodes. Powerful activators of CD8 killer T cells, such as CCL2 and CXCL10 are documented to be induced by Versamune® as

well. As the Versamune® induced production of chemokines appears to be restricted to the lymph nodes, the site of T cell activation, it provides for both superior activation and expansion of CD8 killer T cells. Localization of these immune

messengers within the lymph nodes and their limited presence in the blood circulation enhances the safety of the Versamune® based immunotherapies. Thus, through the versatility of its mechanisms of action, as understood to date, we believe that

Versamune® may safely promote the efficient and robust expansion in-vivo of large numbers of highly potent (polyfunctional) CD8 killer T cells, both critical factors in developing a successful immunotherapy.

Versamune® has the potential to overcome immune suppression

Regulatory T cells (Treg) are a sub-population of white blood cells normally responsible for recognizing normal healthy cells and for

preventing autoimmune disease. In cancer however, they are utilized by the cancer cells to suppress immune detection. Versamune® may contribute to significant alteration of the tumor microenvironment by dramatically reducing the Treg to killer CD8

T cell ratio thus making the tumors more susceptible to destruction by killer T cells. Preclinical studies have demonstrated that lowering the Treg to CD8 killer T cell ratio with polyfunctional CD8 killer and CD4 helper T cells promotes effective

tumor lysis and regression. Overcoming a tumor’s immune tolerance and minimizing its ability to evade detection is a significant goal of successful cancer immunotherapy that together with potent T cell induction may translate to enhanced tumor

elimination.

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In preclinical studies, Versamune® (R-DOTAP) nanoparticles demonstrated a reduction in the Treg/CD8 T cell ratio

Results of Comparative Preclinical Testing of Versamune® and other Immunotherapies for the eradication of a Tumor

Using the tumor model, the Versamune® based therapy was unique in its ability to reduce the tumor size and eventually completely regress

the tumors. The results from the Versamune® based treatment are attributed to its ability to induce: (i) powerful activation of the critical immunological signaling pathways, (ii) robust production of both CD8 killer and CD4 helper T cells, and (iii)

the degradation of the tumor’s protective immune suppression mechanism.

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Versamune® has the potential to induce Immune Memory

Memory T cells allow the body to maintain tumor-recognizing and attacking T cells for an extended period after treatment, with the

ideal outcome of reducing cancer recurrence. Preliminary studies demonstrated that Versamune® protected mice that had experienced tumor regression against tumor reestablishment even when the mice were reinjected with the same tumor cells. This

sustained protection was evidence of immune memory: persistence of antigen-specific T cells to recognize tumor proteins associated with a particular cancer, as the animals were not protected against establishment of different tumors. Evidence of

the potential for Versamune® based immunotherapies to induce immune memory was also demonstrated in a Phase 1 clinical trial in humans.

Enhancing tumor-specific memory responses to monitor for tumor antigens and eradicate cancer cells well after initial treatment we

believe provides potential for significant durable clinical benefit by possibly reducing the incidence of tumor recurrence and improving survival of patients.

Many cancer immunotherapies produce serious systemic autoimmune effects due to blockage of existing regulatory mechanisms such as the

immune checkpoints as well as inflammatory toxicities due to the increased presence and spikes of cytokines in the blood circulation. We believe the mechanism of action of Versamune® as well as its design have the potential to contribute to the

localization of cytokines in the lymph nodes and specific targeting of CD8 killer T cells to antigens in tumor tissue. Therefore, our hypothesis is that Versamune® based therapies may exhibit an improved and favorable safety profile compared to

currently available treatments.

As noted, Versamune® is injected subcutaneously, and its mechanisms of action are localized primarily in the lymph nodes. Further

supporting these observations are data demonstrating that negligible levels of Versamune® induced cytokines were detected in the blood of mice. Very low quantities of Versamune® were detected in the blood or in any organ outside of the lymph nodes.

Additionally, Versamune® is broken down (hydrolyzed) in the body into fatty acids and excreted, showing in these preliminary studies

that it could mitigate the potential for short- or long-term accumulation of the nanoparticles. These preclinical observations have been confirmed by early clinical data documenting that this localized, and highly specific cascade of immune

activity was associated with an absence of significant systemic toxicity at all doses tested. In a Phase 1 clinical trial designed to evaluate safety, all patients had transient swelling and redness at the injection site due to initiation of the

immunological cascade at the injection site which cleared completely within 3-7 days and no dose-limiting toxicities or long-term safety concerns were observed. Similarly, in our ongoing Phase 2 trials in combination with other treatments, no

dose-limiting toxicities or long-term safety concerns were attributed to PDS0101 since the studies were initiated in 2020.

In choosing and designing a Versamune® based therapy for development, careful attention is paid to selecting specific, appropriate

antigens because, as described above, Versamune® induces a strong T cell response to the antigen. All the antigens currently being evaluated in combination with Versamune®, such as antigens specific to Human Papilloma Virus, are present primarily

in cancer cells which should therefore result in tumor-specific T cell attack, thereby minimizing off-target toxicity and potential destruction of healthy cells and tissue.

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Versamune® has the potential to minimize circulating tumor DNA (ctDNA)

ctDNA is tumor-derived fragmented DNA that is released

into a person’s blood stream by cancerous cells and tumors. It can come from primary or metastatic cancer sites. We believe that the reduction of ctDNA, as a biomarker, has the potential to signify a potential reduction or elimination of cancer.

As noted, we believe Versamune® may safely promote the efficient and robust expansion in-vivo of large numbers of highly potent (polyfunctional) CD8 killer T cells. In a Phase 2 clinical trial lead by MD Anderson, IMMUNOCERV, the ctHPV 16 DNA biomarker measured in certain patients decreased

in the blood by Day 170 (T5) as HPV16-specific killer T cells proliferated in the tumor microenvironment as seen in a representative patient in the chart below.

Versamune®’s potential as a cancer immunotherapy platform

The potential ability of Versamune® to modulate and enhance numerous critical steps required for an effective immune response may

provide additional opportunities to treat a variety of cancers. Further, its diverse mechanisms of action together with its favorable safety profile suggest therapeutic promise when used in combination with other treatment modalities or

immunotherapies such as immune checkpoint inhibitors as well as in the single-agent monotherapy setting.

PDS0101: Human Papilloma Virus (HPV)-Related Cancers

Despite the successful introduction of HPV preventive vaccines, HPV-related cancers remain a significant component of the global

cancer burden. HPV infection occurs in both men and women and is associated with head and neck (oropharyngeal), cervical, anal, vaginal, vulvar and penile cancers.

PDS0101 is our lead Versamune® based immunotherapy.

PDS0101 combines Versamune® with a mixture of short proteins (peptides) derived from the carcinogenic HPV16 viral protein. HPV16 is the most pervasive and difficult to treat HPV amongst the 13 different high-risk, cancer-causing HPV types. In a

preclinical study in the most widely utilized animal HPV-cancer tumor model, PDS0101 uniquely induced complete regression of the tumors after a single sub-cutaneous injection. As a result of this data, we conducted a Phase 1 open-label,

dose-escalation, proof of concept study of PDS0101 in women with cervical intraepithelial neoplasia (CIN) infected with high-risk HPV types. The data demonstrated that PDS0101 was immunologically active at all three doses studied, confirmed

induction of high levels of active HPV-specific CD8 killer T cells, and was associated with clinical regression of the cervical lesions that often occurred rapidly. These results suggest that PDS0101 activated the critical mechanisms in humans

resulting in potent T cells which target and effectively kill human HPV-positive cancer cells. All patients who experienced regression remained disease-free over the 2-year retrospective evaluation period, suggesting potential durability or

memory of the immune response. The clinical data was presented at the 34th Annual Society for the Immunotherapy of Cancer Conference in November 2019

(Wood, et al., 2019). Based on this encouraging preclinical and human data, PDS0101 has been studied in multiple Phase 2 clinical trials in various HPV-related cancers; one sponsored by the Company in collaboration with Merck (VERSATILE-002) and

three investigator-initiated trials being conducted by the National Cancer Institute (NCI), MD Anderson Cancer Center and Mayo Clinic. We believe the data presented from these Phase 2 clinical trials in 2022, 2023, 2024 and 2025 demonstrated

favorable results.

In 2025, we completed our VERSATILE-002 trial in head and neck cancer. The topline survival results of the trial appear to confirm the

potential efficacy of PDS0101 in HPV16-positive head and neck cancer treatment, and publication of the full results of the trial are expected in 2026.

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PDS0102: T cell receptor gamma Alternate Reading frame Protein (TARP)-Related Cancers

The TARP antigen is strongly associated with prostate and breast cancers. In the U.S. 450,000 patients are projected to be diagnosed

with prostate or breast cancer this year. Approximately 90% of prostate cancers and 50% of breast cancers overexpress the TARP tumor antigen. In a human clinical trial, the NCI demonstrated that its proprietary TARP antigens were effectively

recognized by the immune system in prostate cancer patients with PSA biochemical recurrence leading to a notable reduction in tumor growth rate. In preclinical studies, a dramatically enhanced TARP-specific killer T cell response was observed when

our designed TARP antigens were combined with Versamune®. As discussed further below, in November 2021, we entered into the NCI Patent License Agreement with the U.S. Department of Health and Human Services, as represented by the NCI of the

National Institutes of Health (NIH). We obtained a nonexclusive worldwide license to the patent rights for NCI’s TARP to develop and commercialize TARP peptide-based therapies in combination with our Versamune® technology for the treatment of

acute myeloid leukemia, prostate and breast cancers. We are not currently pursuing development of PDS0102.

PDS0103:Mucin-1 (MUC1)-Related Cancers

MUC1 is highly expressed in multiple solid tumor types and has been shown to be associated with drug resistance and poor disease

prognosis. We are developing PDS0103, a Versamune® based therapy in combination with novel, highly immunogenic, agonist epitopes of the MUC1 oncogenic C-terminal region to treat ovarian, breast, colorectal and lung cancers. In preclinical studies,

a dramatically enhanced MUC1-specific killer T cell response was observed when the novel antigens were combined with Versamune®.

Versamune® has demonstrated immunological compatibility with a wide array of tumor and pathogenic antigens. While our current oncology

pipeline pairs Versamune® with 4 different tumor antigens, to address over 10 cancer types, more than 75 tumor antigens have been identified and reported. We believe that Versamune® has the potential to work well with a wide range of identified tumor

antigens and neoantigens, and we are exploring the expansion of our Versamune® based pipeline by pairing the technology with multiple tumor antigens to potentially develop additional product candidates.

Versamune® based immunotherapies plus PDS01ADC as a cancer immunotherapy platform

PDS01ADC is a novel investigational antibody conjugated

(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 immune suppression and simultaneously promote a targeted T cell attack against cancer. As with Versamune®, PDS01ADC is administered by subcutaneous injection. Clinical data suggests the addition of PDS01ADC to Versamune® based

immunotherapies may demonstrate significant disease control by shrinking tumors and/or prolonging life. In a completed Phase 2 clinical trial conducted by NCI, evaluating PDS0101 and PDS01ADC in combination with M7824 (Bintrafusp alfa),

survival data for ICI naïve patients from the trial indicated that 75% (6/8) of these patients were still alive at 36 months, and the median overall survival (OS) has not

yet been reached. Published data on standard-of-care ICIs report 30-50% of these patients typically remain alive at 12 months, and less than 30% of the patients remain alive at 24 months. In the ICI-resistant group, the 12-month OS rate was 72%

and the triple combination achieved a median OS of approximately 20 months.

PDS01ADC monotherapy has shown activation of an immune response and correlation with clinical

benefit in metastatic solid tumors

We believe PDS01ADC monotherapy promotes therapeutically

relevant immune responses, and stronger immune activation has been observed at higher doses. An analysis of patients at baseline and after PDS01ADC monotherapy treatment is displayed in the graphs below. Interferon-gamma is associated with the

induction of natural killer (NK) cells and T cells. Granzyme B is associated with the induction of active killer CD8 T cells. Importantly, higher levels of these CD8 T cells were associated with improved clinical outcomes. (Toney NJ et al. International Immunopharmacology 116 (2023) 109736).

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PDS01ADC is differentiated from other IL-12 treatments

PDS01ADC is a novel investigational immune-cytokine fusion protein composed of two molecules of IL-12 fused to each of the two

heavy-chains of a human IGg1 antibody. The IGg1 antibody targets the DNA/histones exposed in necrotic areas of solid tumors, thus delivering the IL-12 into the tumor and limiting its systemic accumulation. As seen in the chart below, PDS01ADC shows

low accumulation in blood circulation potentially promoting safety.

Oncology Development Strategy

The unique combination of high potency and favorable

safety profile of the Versamune® platform observed in preclinical studies was corroborated in the successfully completed 12-patient PDS0101 monotherapy Phase 1/2a clinical trial. All patients were infected with cancer causing (high risk) strains

of HPV, which are less likely to spontaneously regress. In September 2019, we reported retrospective clinical outcome data from this trial. Despite most of the patients being infected with multiple HPV strains including or excluding HPV16,

regression was seen in 8 out of 10 patients, with complete regression of pre-cancerous lesions documented in 6 out of 10 patients at their first post-treatment evaluation, which occurred within 1-3 months of completing treatment. In addition,

the fact that no disease recurrence occurred over the two-year evaluation period strongly suggested a robust and durable therapeutic immune response due to the induction of T cells by PDS0101 administration that were clinically active. As a

result of this information and the documentation in the trial of PDS0101’s ability to generate potent and biologically active CD8 T cells in-vivo, we focused our clinical strategy on areas of more severe unmet medical need in which PDS0101 is combined with other immune-modulating agents, including immune checkpoint

inhibitors and standard of care e.g., chemoradiotherapy, to provide improved clinical benefit to patients.

We believe that rational design of combination immunotherapies using complementary agents that promote synergy with each other and

reduce the potential for compounded toxicity will substantially enhance the potential for combination therapies to deliver improved clinical benefit for cancer patients. Based on our data, Versamune® appears to activate an appropriate combination

of immunological pathways to promote strong CD8 T cell induction while also altering the tumor microenvironment to make tumors more susceptible to T cell attack, which we believe makes it an ideal complement to immune checkpoint inhibitors and

other immune-modulating agents by enhancing their potency as part of combination therapies. In addition, the differences in mechanism of action between Versamune® and checkpoint inhibitors, as well as the initial demonstrated safety profile of

Versamune®, suggests that these combinations may be potentially much better tolerated by patients than other combination therapies involving immune checkpoint inhibitors and other cancer treatments such as immune-cytokines and chemotherapy.

Clinical Candidate Pipeline

VERSATILE-003: PDS0101 + pembrolizumab vs pembrolizumab

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.

In this trial, which is 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. 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.

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VERSATILE-002: PDS0101 + Keytruda®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1

therapy, Keytruda® (pembrolizumab) which is the FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer commenced. Enrollment in stage 2 of 2 for the ICI naïve arm and the ICI resistant arms are complete.

The clinical trial evaluated the efficacy and safety of this therapeutic combination as a first and second line treatment in patients with recurrent or metastatic head and neck cancer and high-risk human papillomavirus-16 (HPV16) infection.

In this trial sponsored by PDS Biotech, patients whose cancer has returned following initial treatment or spread were treated with the

combination of PDS0101and 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 two cohorts

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 have failed immune checkpoint inhibitor therapy (ICI resistant).

In June 2023, an abstract was presented at the

2023 American Society of Clinical Oncology: Abstract number 6012, Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC). The

abstract was also selected as one of the featured posters to be reviewed by an expert panel in the Head and Neck Cancer discussion session. Data on 34 patients was presented. The data from the abstract is as follows:

● 15/34 patients (44.1%) had stable disease.

● 9/34 patients (26.5%) had progressive disease.

In October 2023, at a key opinion roundtable updated interim data was presented based on an August 2, 2023 cut-off from our

VERSATILE-002 Phase 2 clinical trial evaluating the combination of PDS0101 in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) which is an FDA-approved standard of care for first-line treatment of recurrent/metastatic head and

neck cancer. Data on 52 patients was presented. The data from the roundtable based on investigator assessment was as follows:

Highlights from the ICI naïve cohort included:

● 12-month OS rate of 80%; published results of 30-50% with approved ICIs.

● Tumor shrinkage seen in 60% (31/52) of patients.

● Confirmed overall response rate ORR of 27% (14/52) to date.

In May 2024, at a virtual key opinion leader event, updated interim data was presented based on a November 30, 2023 cut-off from our

neck cancer. Data from 53 patients was presented. The data from the event based on investigator assessment was as follows:

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Highlights from the ICI naïve cohort with CPS > 1 included:

In June 2024, we provided a data update from our VERSATILE-002 clinical trial. Interim data was presented based on a May 17, 2024

cut-off. The data update was as follows:

In August 2024, we provided an update to our clinical strategy following discussions with the FDA. During the August 2024 update, we

announced our intent to initiate a registrational study in first line treatment in HPV16-positive recurrent/metastatic HNSCC with the double combination of PDS0101 + pembrolizumab.

In September 2024, we announced updated data from our VERSATILE-002 Phase 2 clinical trial presented during a poster session at the

European Society for Medical Oncology (ESMO) Congress 2024. The data presented was based on a May 17, 2024 data cut-off. The main elements of the update were as follows:

● Disease Control Rate (DCR) is 77% (41/53)

● 21% (11/53) of patients had deep tumor responses and shrinkage of 90-100%

● 9% (5/53) of patients had a complete response

In June 2025, we announced publication of an abstract at the American Society of Clinical Oncology (ASCO) Annual Meeting with updated

data from VERSATILE-002. Main elements of the update were as follows:

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In August 2025, we announced final topline survival data from VERSATILE-002. Main element of the update was as follows:

In September 2025, we announced final topline survival data for the low-CPS patient population from VERSATILE-002. Main element of the

update was as follows:

National Cancer Institute: PDS0101 + PDS01ADC +Bintrafusp Alfa

In June 2020, the first patient was dosed under a Cooperative Research and Development Agreement (CRADA), in the NCI led Phase 2

investigator-initiated trial evaluating PDS0101 with PDS01ADC, and M7824 (Bintrafusp alfa), which is owned by EMD Serono (Merck KGaA) in patients with advanced HPV-positive cancers who have failed prior treatment. In February 2021, the NCI’s Phase 2

clinical trial of PDS0101 for the treatment of advanced HPV-positive cancers had achieved its preliminary objective response target in patients naïve to check point inhibitors which allowed for full enrollment of approximately 20 patients in this

group. In addition, based on promising results in the ICI naïve arm, the trial was amended to allow enrollment of a separate cohort of ICI -resistant patients for assessment of safety and activity of the triple combination. The trial has been closed

for enrollment. Preliminary efficacy assessment of the triple combination in this added group of 29 ICI resistant patients has been completed and evaluation of long-term patient survival is ongoing.

Preclinical study results arising from this CRADA were published in the Journal for ImmunoTherapy of Cancer, Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine (Journal for ImmunoTherapy of Cancer2020;8:e000612. Doi:10.1136/ jitc-2020-000612), and indicate

that PDS0101 generated both HPV-specific T cells and anassociatedantitumor

response when used as a monotherapy. When PDS0101 was combined with the two other novel clinical-stage anti-canceragents, Bintrafusp Alfa and M9241 (which is now

owned by us and referred to as PDS01ADC), the preclinical data suggested that all three therapeutic agents workedsynergistically to provide superior tumor T cell

responses and subsequent tumor regression when compared to any of the agents alone or the 2-component combinations. The published preclinical data demonstrating powerful activity of the triplecombination appears to be corroborated in the Phase 2 trial, and this triple combination could form the basis of a unique platform providing improved cancer treatments across multiple cancers.

In November 2023, we released updated interim survival data as follows:

● 12-month survival rate in (ICI) resistant patients of 72%

In February 2025, we announced the publication of clinical results in the Journal of the American Medical Association (JAMA) Oncology:

MD Anderson Cancer Center (IMMUNOCERV): PDS0101

+ Chemoradiotherapy

In October 2020, a Phase 2 Investigator Initiated Trial (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.

The trial enrolled 17 newly diagnosed high-risk patients with large tumors of at least 5 cm in size.

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In October 2023, data demonstrating PDS0101 combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid

decline in human papillomavirus circulating cell-free DNA (ctHPV-DNA), a potential predictive biomarker of treatment response. The data from the IMMUNOCERV Phase 2 clinical trial was featured in an oral presentation at the American Society for

Radiation Oncology Annual Meeting which included the following:

In October 2024, final data from the IMMUNOCERV trial were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting

2024. Highlights from the presentation include:

● All patients received at least 2 doses of PDS0101

● Median follow-up was 19 months

● Complete metabolic response (CMR) was achieved in 15/17 (88%) patients.

Mayo Clinic: PDS0101 Monotherapy and in combination with pembrolizumab

In February 2022, we initiated an IIT, 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 was conducted by the Mayo Clinic, a nationally and internationally recognized center of excellence for the treatment of head and

neck cancers. We believe that this trial allows us to better understand the activity of PDS0101 alone or in combination with pembrolizumab in earlier stages of disease.

In this trial, treatment was 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. The 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).

PDS0103 (Versamune® MUC1)

In April 2020, the above-mentioned CRADA between PDS Biotech and the NCI was expanded beyond PDS0101 to include clinical and preclinical

development of PDS0103. PDS0103 is an investigational immune therapy owned by PDS Biotech and designed to treat cancers associated with the mucin-1, or MUC1, oncogenic protein. These include cancers such as ovarian, breast, colorectal and lung

cancers. PDS0103 combines Versamune® with novel highly immunogenic agonist epitopes of MUC1 developed by the NCI and licensed by us.

MUC1 is highly expressed in several types of cancer and has been shown to be associated with drug resistance and poor disease prognosis

in breast, colorectal, lung and ovarian cancers, for which PDS0103 is being developed. Expression of MUC1 is often associated with poor disease prognosis, due in part to drug resistance. In preclinical studies, and similarly to PDS0101, PDS0103

demonstrated the ability to generate powerful MUC1-specific CD8 killer T cells.

In March 2025, we announced FDA clearance of our IND application for the combination of PDS0103 and PDS01ADC in treatment of metastatic

colorectal cancer.

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IL-12 Oncology Immunocytokine Pipeline

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 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.

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, several IIT Phase 2 trials are currently in progress at the NCI, some of which are outlined

below:

In October 2023, interim safety and immune response data was presented for the first-in-human Phase 1/2 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 11th Annual Meeting of the

International Cytokine & Interferon Society. The data presented included the following:

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.

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Current Clinical Pipeline of Versamune®, and PDS01ADC Based Therapies

Infectimune® Development Strategy

Infectimune® has potential as an infectious disease vaccine platform

We have developed a second cationic platform that is being applied to the development of infectious disease vaccines and this specific

formulation has been trademarked Infectimune®. It has been formulated to activate the immune system to induce rapid and longer-lasting neutralizing antibody responses for improved protection against infectious pathogens. Preclinical studies

suggest that it has the potential to induce T cell responses including memory T cell responses to provide the immune system with long-term memory and potential sustained protection against infectious pathogens over an extended period of time that

may exceed traditional antibody-based protection. We believe it could provide safe and effective vaccines that are well tolerated by healthy individuals.

PDS0202: Universal influenza vaccine

We believe 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.

Based on the preclinical data with the universal seasonal flu vaccine and the current focus of the NIAID in developing more effective

flu vaccines, we have decided to focus our near-term infectious disease activities to align with the interests of the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) program. This will involve development of a universal seasonal flu

vaccine and the potential development of a universal pandemic influenza vaccine based on similar computationally designed antigens as have shown promise with Infectimune®.

The preclinical results for Infectimune® based vaccines were published in two separate articles in the peer reviewed journal Viruses in

February 2023: 1. preclinical studies demonstrating complete protection against sickness after lethal challenge with live SARS-CoV-2 or influenza viruses (Gandhapudi SK et al. Viruses 2023, 15, 432) and 2. Dramatically enhanced CD4 T cell responses

to recombinant influenza proteins compared to leading commercial vaccine adjuvants (Henson TR et al. Viruses 2023, 15, 538).

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In September 2023, preclinical data on our investigational universal flu vaccine, PDS0202, was presented at the 9th European Scientific

Working Group on Influenza (ESWI) conference. This data demonstrated active neutralization across multiple influenza viruses in animals and provided protection against infection and weight loss after challenging with high doses of H1N1 viruses when

they were not previously exposed to flu.

Clinical Development Strategy

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. We have never been profitable and have incurred net losses each year since our inception.

Our net losses were $34.5 million, and $37.6 million for the twelve months ended December 31, 2025 and 2024, respectively. As of

December 31, 2025, we had an accumulated deficit of $216.6 million. Substantially all 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.

As of December 31, 2025, we had $26.7 million in cash and cash equivalents.

Our future funding requirements will depend on many factors, including the following:

● the outcome, timing and costs of seeking regulatory approvals;

● the ability to repay debt financings including interest payments;

● the extent to which we license or acquire other products and technologies.

Leadership

We are led by a team of executives and directors with

significant experience in drug discovery, development and commercialization. The following table sets forth certain information about our executive officers as of the date of the filing of this Annual Report:

Name Age Position

Gregory L. Conn, Ph.D. 71 Chief Scientific Officer

Kirk V. Shepard, M.D. 74 Chief Medical Officer

Stephan Toutain 60 Chief Operating Officer

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Frank Bedu-Addo, Ph.D.

Dr. Bedu-Addo has served as director, President and Chief Executive Officer of PDS Biotech since March 2019. Dr. Bedu-Addo is a

veteran biotech executive with experience in successfully starting and growing biotechnology organizations. He has been responsible for the oversight, development and implementation of operational and drug development strategies in both large

organizations and emerging biotechnology companies. Dr. Bedu-Addo was a member of the senior executive team at KBI BioPharma, Inc. As Vice President of Drug Development, he oversaw all operations including business development, drug

development/manufacturing and profit and loss. Before his tenure at KBI, he successfully started and managed Cardinal Health’s East Coast biotechnology drug development and manufacturing operations. Prior to Cardinal Health, Dr. Bedu-Addo was an

Associate Director at Akzo-Nobel, Senior Scientist at Elan (The Liposome Co.), and Principal Scientist at Schering-Plough. In these positions, he contributed to the development of numerous drugs, including antiviral and anticancer products. Dr.

Bedu-Addo obtained both his M.S. in Chemical Engineering and Ph.D. in Pharmaceutics from the University of Pittsburgh.

Gregory L. Conn, Ph.D.

Dr. Conn was a founding member of the PDS Biotech team in 2005 as Chief Scientific Officer and continues to serve PDS Biotech in that

role. He has more than 35 years of drug-development expertise, including development of antiviral and anticancer drugs through to commercialization. He is a graduate of the Albert Einstein College of Medicine, where he obtained both his M.S. and

Ph.D., discovering novel angiogenic molecules in the human brain. Dr. Conn started his pharmaceutical career at Merck, Sharpe, and Dohme, where he continued his work on novel angiogenic factors, discovering and characterizing the VEGF family of

growth factors, work which led to the development and commercialization of the anti-cancer drug Avastin. He was later a leading scientist at Regeneron Pharmaceuticals, where he established and headed various groups in the Cell and Molecular Biology

and Drug Discovery departments. Dr. Conn subsequently became a Director in the Process Development department at Covance Biotechnology Services Inc., a contract research and development and drug manufacturing organization, where he supervised the

analytical development teams responsible for drug characterization, method development and drug stability studies, and program teams responsible for developing drug manufacturing processes. Dr. Conn has expertise across all phases of the drug

development process, including FDA and regulatory requirements, and is the co-inventor of eight drug patents.

Kirk V. Shepard, M.D.

Dr. Shephard has served as Chief Medical Officer of PDS Biotech since January 2024. Dr. Shepard is a board-certified medical oncologist

and hematologist with more than 30 years of experience in the pharmaceutical industry. His experience spans multiple therapeutic areas and includes operational and strategic product development from Phases 1 through 4 and diverse disciplines of

medical affairs and product commercialization. Prior to joining PDS Biotech, Dr. Shepard was Chief Medical Officer, Senior Vice President and Head of the Global Medical Affairs Oncology Business Group at Eisai Pharmaceutical Company from March 2017

to August 2023. Dr. Shepard previously held leadership roles including Senior Vice President & Head, Global Medical Affairs at Baxter International Inc., Senior Vice President, Global Medical Affairs at Takeda Pharmaceuticals International and

Vice President, Clinical and Scientific Affairs at Boehringer Ingelheim Pharmaceuticals, Inc. Before his pharmaceutical industry career, Dr. Shepard served as a staff physician in the Department of Hematology and Medical Oncology at the Cleveland

Clinic Foundation, where he supervised numerous studies in oncology and symptom control. He has been published in more than 50 medical publications. Dr. Shepard holds a bachelor’s degree from Cornell University and earned his medical degree from the

University of Cincinnati Medical School. He completed his internship and internal medicine residency at Case Western Reserve University and fellowships in hematology and oncology at the University of Chicago Hospitals and Clinics.

Lars Boesgaard

Mr. Boesgaard has served as Chief Financial Officer of PDS Biotech since December 2023. Mr. Boesgaard has had a career spanning more

than 25 years in healthcare and has deep capital markets and investor relations experience with global clinical and commercial-stage pharmaceutical and biotechnology companies. He has prepared and executed corporate transactions and built financial

frameworks for rapidly growing organizations. Mr. Boesgaard served as CFO of AM-Pharma B.V. from September 2021 to August 2023. Mr. Boesgaard also served as CFO of Columbia Care from August 2018 to August 2021, where he completed key transactions

including an IPO/reverse merger resulting in a $120 million capital infusion and raising $200 million in public equity and debt offerings. Mr. Boesgaard was also previously the Vice President, CFO of Roka Bioscience from November 2015 to July 2018

and held several other senior finance positions with publicly traded companies including Insulet Corporation, Alexion Pharmaceuticals and Novo Nordisk A/S. Mr. Boesgaard holds a Bachelor of Science in Business Administration from the Copenhagen

Business School and a Master of Business Administration from the Richard Ivey School of Business, Western University, Ontario, Canada.

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Stephan Toutain

Mr. Toutain has served as Chief Operating Officer of PDS Biotech since May 2024. Mr. Toutain brings more than 30 years of operational

experience in the pharmaceutical industry from drug development, general management, operations, commercial development, market access and sales and marketing leadership with prior global expertise in the oncology and orphan drugs markets. Before

joining the Company, Mr. Toutain served as COO at Anavex Life Sciences from May 2018 to April 2024 and Chief Commercial Officer at Interleukin Genetics (OTCQB: ILIU) from July 2016 to August 2017. Mr. Toutain also worked with Alnylam

Pharmaceuticals to build its early access program. In addition, Mr. Toutain led Global Commercial Development for Sarepta Therapeutics and served as General Manager for Alexion Pharmaceuticals in Europe. Mr. Toutain has also held various U.S.

commercial, marketing and product management positions with Celgene Corporation and Johnson & Johnson. Mr. Toutain received a Master of Business Administration from the University of North Carolina Kenan-Flagler Business School and a Master of

Engineering in Biotechnology from the University of Nancy II in France.

Spencer Brown

Mr. Brown has served as Senior Vice President, General Counsel of PDS Biotech since June 2022. He was appointed as Compliance Officer

in October 2023. Mr. Brown previously served as Vice President, Legal Affairs from January 2018 to January 2022 and as Senior Vice President, Legal Affairs and Compliance Officer from January 2022 to May 2022, for Aclaris Therapeutics, Inc.

(Nasdaq: ACRS). Prior to joining Aclaris Therapeutics, Inc., Mr. Brown worked nearly eight years at GE Healthcare as Senior Commercial Counsel for the Life Sciences Core Imaging business in Princeton, New Jersey. Prior to that, Mr. Brown spent

almost ten years at AstraZeneca Pharmaceuticals in Wilmington, Delaware where he provided legal support for most of the company’s therapeutic areas at some point during his tenure. Mr. Brown has over two decades of in-house experience in the

pharmaceutical industry. Mr. Brown began his legal career as an associate at Skadden, Arps, Slate, Meagher & Flom. Mr. Brown earned his bachelor’s degree at Princeton University and obtained his juris doctorate degree from the University of

Pennsylvania Carey School of Law.

Facilities & Manufacturing and Commercial Scale Up

Product candidates using our Versamune®, Versamune® in combination with PDS01ADC and Infectimune® development platforms are

manufactured using a readily scalable, fill-finish process with well-defined and reproducible operations. We do not own or operate cGMP compliant manufacturing facilities to produce any of our product candidates and we do not have plans to develop

our own manufacturing operations in the foreseeable future. We currently rely on third-party contract manufacturing organizations to produce the amounts of our product candidates necessary for our preclinical research and clinical studies. As part

of the manufacture and design process for our product candidates, we rely on internal, scientific and manufacturing know-how and trade secrets and the know-how and trade secrets of third-party manufacturers. We currently employ internal resources

to manage our manufacturing contractors.

Our research and development activities are located at the Princeton Innovation Center BioLabs, 303A College Road East, Princeton, NJ

08540, which provides first-rate development facilities for biotech companies. All animal toxicology and efficacy testing are done via third-party contracts and collaborations to provide maximum flexibility and to minimize operational costs and

overhead. This approach allows for independent validation of our data, and we believe it has historically been a cost-efficient way to progress our development programs.

We do not intend to incur the costs of building, staffing and maintaining manufacturing facilities in the near term. Our management team

has formulation, manufacturing and operations expertise, including past senior executive management roles in contract drug development and manufacturing. Our management team plans to utilize its expertise and knowledge to identify suitable

alternative contract manufacturers who will be capable of efficiently manufacturing our products.

For our PDS0101 and PDS01ADC product candidates, we continue to progress our ongoing Phase 3 and Phase 2 clinical trials. The final

protocols for all clinical trials were submitted to the FDA prior to trial initiation and information for all trials is available on www.clinicaltrials.gov.

We anticipate that we will seek marketing authorization from the FDA for our product candidates through the Biologics License

Application pathway, under Section 351(a) of the Public Health Service Act. This process and the requirements are described further under “U.S. Product Development Process.”

For our earlier stage, preclinical product candidate PDS0103, we submitted an IND for a Phase 1 trial in colorectal cancer in January

2025.

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Intellectual Property

Patents

We seek to maintain high barriers to entry around our clinical and product candidates and the markets in which they are utilized by

using a multiple layered approach to our patents, patent applications, substantial know-how and trade secrets related to our platforms. We strive to protect and enhance our proprietary technology, inventions and improvements that are commercially

important to our business, including seeking, maintaining, and defending patent rights. We also rely on trade secrets relating to our platforms and on know-how, continuing technological innovation to develop, strengthen and maintain its proprietary

position in the vaccine field. In addition, we rely on regulatory protection afforded through data exclusivity, market exclusivity and patent term extensions where available. We also utilize trademark protection for our company name and we expect

to do so for products and/or services as they are marketed.

We have developed numerous patents and patent applications

and own substantial know-how and trade secrets related to our Versamune® platform. As of March 9, 2026, we hold fourteen (14) U.S. patents with granted claims directed to its platform technology and seven (7) pending U.S. patent applications. These

issued patents will expire in 2026 through 2037. Should the more recently submitted patent applications currently in prosecution be issued, these will expire in 2033 through 2043 assuming no patent term extensions are granted. As of March 9, 2026,

we hold seventy-nine (79) issued foreign patents and thirty-five (35) pending or published foreign patent applications. Most of our international issued patents are issued in multiple countries including Europe, Japan and Australia, and all of

which cover compositions of matter and methods of use related to its platform technology. These issued patents will expire in 2028 through 2038, or later if patent term extension applies. Included in the patents above is a patent protecting the

use of Versamune® in combination with IL-12.

Licensed Patents

We have licensed patented antigens from the US government for use worldwide in our cationic lipid immunotherapies. We have licensed T

cell receptor gamma alternate reading frame protein (“TARP”) from the National Cancer Institute (“NCI”) to develop and commercialize TARP peptide-based therapies in combination with our Versamune® technology and any other of our proprietary

technologies for prostate and breast cancers and Acute Myeloid Leukemia. These patents are directed to immunogenic peptides and peptide derivatives for the treatment of prostate and breast cancer treatment and multi-epitope TARP peptide vaccines

and uses thereof. These antigens are incorporated in PDS0102 with Versamune®. We have licensed novel and highly immunogenic agonist epitopes of mucin-1 (“MUC1”) developed by the National Cancer Institute. MUC1 is highly expressed in multiple solid

tumors and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which PDS0103 is being developed. We have granted patents and are pursuing additional patents that

cover compositions and methods of use of cationic lipid immunotherapies with each of the licensed technologies.

We entered into a non-exclusive agreement to license COBRA universal influenza antigens with the University of Georgia Research

Foundation to develop, manufacture and use COBRA antigens in a clinical trial for a universal influenza vaccine worldwide. These antigens are developed by Dr. Ted Ross at the University of Georgia. We believe that the combination of these

antigens with our proprietary Infectimune® technology, represented by PDS0202, has the potential to induce a broad immune response as a universal flu vaccine, based on preclinical development studies performed to date.

Exclusive License Agreements

On December 30, 2022, we entered into a License Agreement (the “Merck KGaA License”), with Merck KGaA, Darmstadt, Germany, pursuant to

which Merck KGaA, Darmstadt, Germany granted us an exclusive (even as to Merck KGaA), worldwide, sublicensable, milestone and royalty-bearing right and license to certain patent rights and certain related data (the “Licensed Technology”) to

develop, manufacture, use, commercialize and otherwise exploit any product containing NHS-IL12 fusion protein formerly known as M9241, now PDS01ADC (the “Compound”). Merck KGaA, Darmstadt, Germany retains the right under the Licensed Technology in

connection with certain existing collaborations between Merck KGaA, Darmstadt, Germany and academic institutions to allow such academic institutions to exercise their rights granted under such collaborations. We agreed to use commercially

reasonable efforts to develop, manufacture and commercialize at least one pharmaceutical preparation, substance, or formulation, comprising or employing, the Compound (the “Product”).

In consideration for the rights granted by Merck KGaA, Darmstadt, Germany, we (i) made a one-time up-front cash payment of $5.0

million to Merck KGaA, Darmstadt, Germany, and (ii) entered into a Share Transfer Agreement dated December 30, 2022 (the “Share Transfer Agreement”), pursuant to which we issued 378,787 shares of our common stock (the “Shares”) to Merck KGaA,

Darmstadt, Germany in a private placement for an aggregate value of $5.0 million, as measured by the closing price of our common stock on the Nasdaq Capital Market as of December 30, 2022.

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Pursuant to the Merck KGaA License Agreement, we agreed to make (i) development and first commercial sale 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 Product 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.

We 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 (collectively, the “Royalty Term”). The royalty rate is subject to reduction in that event that (i) a Product is not covered by a valid patent claim, (ii) a biosimilar to the Compound or the Product comes on the

market in a particular country, or (iii) we obtain a license to any intellectual property owned or controlled by a third-party in order to ensure that we are not infringing intellectual property owned or controlled by such third-party by making,

using or selling the Compound.

The Merck KGaA License Agreement will expire on a product-by-product and country-by-country basis upon expiration of the

last-to-expire Royalty Term for such Product. On expiration (but not earlier termination), we will have a fully paid-up, royalty-free, non-exclusive, transferable, perpetual and irrevocable license under the licensed patent rights and related data

to develop, manufacture, use, commercialize and otherwise exploit the Compound. Either party may terminate the Merck KGaA License Agreement for the other party’s material breach following a cure period. The Merck KGaA License Agreement may not be

terminated upon certain insolvency events relating to us. We may terminate the License Agreement for any reason upon ninety days written notice to Merck KGaA, Darmstadt, Germany. The Merck KGaA License Agreement also includes indemnification

obligations of each party.

Trade Secrets and Other Proprietary Information

In contrast to patent protection or regulatory

exclusivities, trade secret protection is a form of intellectual property that does not require disclosure of the subject information as part of the process, but instead depends on maintaining the subject information as strictly confidential.

Companies may in some circumstances rely on trade secrets to protect certain aspects of their proprietary know-how and technological advances, especially where they do not believe patent protection is appropriate or obtainable. Trade secret

protection depends in part on confidentiality agreements with employees, consultants, outside scientific collaborators, sponsored researchers and other advisors that prohibit disclosure of designated proprietary information. Trade secrets can be

difficult to protect. Confidentiality agreements may not succeed in preventing a person or parties from disclosing confidential information, and in that event the rights of the trade secret holder are subject to the viability of an adequate remedy

at law, typically under state law modeled on the Uniform Trade Secrets Protection Act, to stop, mitigate or compensate for the unauthorized disclosure of confidential information. Costly and time-consuming litigation could be necessary to enforce

and determine the scope of our proprietary rights. Finally, there is always at least some risk that others may independently discover the trade secrets and proprietary information.

Material License Agreements and Research and Development Agreements

Patent License Agreements with National Institutes of Health.

Effective January 5, 2015, we entered into a Patent License Agreement (the “Patent License Agreement”) as Amended by the First

Amendment to Patent License Agreement (“First Amendment”) of August 5, 2015, with an agency within the Department of Health and Human Services (“HHS”), pursuant to which NIH granted us a nonexclusive license to certain patent rights for the

development of a therapeutic cancer vaccine specifically in combination with our proprietary Versamune® technology for ovarian, breast, colon and lung cancers. The Patent License Agreement expires when the last licensed patent expires if the Patent

License Agreement is not terminated prior to that date. NIH may terminate the Patent License Agreement if we are in default in the performance of any material obligation under the Patent License Agreement. We may unilaterally terminate the Patent

License Agreement in any country or territory upon sixty (60) days’ written notice.

Under the Patent License Agreement and First Amendment we agreed to pay NIH: (a) a non-creditable, non-refundable royalty in the amount

of $30,000 upon execution of the Patent License Agreement; (b) a non-creditable, non-refundable royalty in the amount of $60,000 upon execution of the First Amendment to Patent License Agreement (c) a non-refundable minimum annual royalty of $5,000;

(d) earned royalties of two percent (2%) on net sales, reducible by a half percent (0.5%) for any earned royalties we must pay to third parties; (e) benchmark royalties as follows: (i) $25,000 upon successful completion of each Phase 2 Clinical

Studies of a licensed product for breast, colon, lung or ovarian cancer within each licensed territory; (ii) $50,000 upon initiation of the first Phase 3 Clinical Trial of a licensed product for breast, colon, lung or ovarian cancer within each

licensed territory; (iii) $750,000 upon the first commercial sale in the licensed territory utilizing and/or directed to licensed product(s) and/or licensed process(es) within the licensed patent rights for breast, colon, lung or ovarian cancer; and

(f) additional sublicensing royalties for each sublicense required to be approved by NIH of four percent (4%) on the fair market value of any consideration received for granting such sublicense.

Index

Effective as November 5, 2021, we entered into a Patent License Agreement (the “NCI Patent License Agreement”) with the U.S. Department

of Health and Human Services, as represented by NCI of NIH. Pursuant to the NCI Patent License Agreement, we obtained a nonexclusive, worldwide license to the patent rights for TARP to develop and commercialize TARP peptide-based therapies in

combination with our Versamune® technology and any other of our proprietary technologies for prostate and breast cancers and Acute Myeloid Leukemia. The NCI Patent License Agreement expires when the last licensed patent expires if the Patent License

Agreement is not terminated prior to that date. NCI may terminate the Patent License Agreement if we are in default in the performance of any material obligation under the Patent License Agreement. We may unilaterally terminate the NCI Patent License

Agreement in any country or territory upon sixty (60) days written notice. Under the NCI Patent License Agreement, we agreed to pay NCI certain non-creditable, nonrefundable license issue royalties, unreimbursed patent expenses for the licensed

patent rights, a nonrefundable minimum annual royalty, earned royalties as a percentage of net sales and benchmark royalties.

DOTAP Chloride Enantiomer License Agreement with Merck Eprova AG.

Effective November 1, 2008, we entered into a DOTAP Chloride Enantiomer License (the “DOTAP License Agreement”) with Merck Eprova AG

(“EPRO”), pursuant to which we obtained an exclusive license from EPRO technology to undertake development of products relating to the R-enantiomer and S-enantiomer of DOTAP Chloride for worldwide commercialization in a composition and method of

inducing an immune response in a subject by administering at least one cationic lipid with or without an antigen. The DOTAP License Agreement expires on a licensed product-by-licensed product and country-by-country basis until the expiration of the

obligation to pay royalties applicable to such licensed product in such country. We have the right to unilaterally terminate the DOTAP License Agreement (in its entirety or on a licensed product-by-licensed product or country-by-country basis) at any

time for any reason upon prior written notice.

Cooperative Research and Development Agreement for Intramural-PHS Clinical Research with The U.S. Department of

Health and Human Services.

Effective February 2, 2016, we entered into a Cooperative

Research and Development Agreement (the “CRADA”) with the

U.S. Department of Health and Human Services, as represented by the National Cancer Institute (“NCI”), pursuant to which the parties agreed to perform certain research and development activities as defined by the exhibited Research Plan. The principal goal of the CRADA is to determine whether our

Versamune® immunotherapeutic technology will be effective for enhancing delivery of cancer vaccines or viral vaccines or other immunotherapies developed by the Vaccine Branch, Center for Cancer Research, NCI, in mouse models and in human clinical

studies. The CRADA provides for development, testing and studies to be conducted in conjunction with the Vaccine Branch involving Versamune® and Multi-epitope (ME) T cell receptor gamma alternate reading frame protein peptide (TARP) to develop a

treatment for prostate cancer using autologous dendritic cells and co- administered locally with ME TARP peptides co-formulated with Versamune® immunotherapeutic technology in a non-cellular vaccine platform.

Cost Reimbursement Agreement with University of Kentucky Research Foundation

Effective November 1, 2015, we entered into an annual

Research Agreement (the “Cost Reimbursement Agreement”) with the University of Kentucky Research Foundation (“UKRF”), pursuant to which UKRF agreed to test our preclinical and clinical-stage formulations based on HPV, TARP, MUC1 and Melanoma

antigens as specified more fully in the statement of work. The agreement was terminated on November 11, 2025.

Cost Reimbursement and Sponsored Agreement with University of Kentucky Research Foundation - II.

Effective November 1, 2015, we entered into an annual

Research Agreement (the “Cost Reimbursement Agreement”) with UKRF, pursuant to which UKRF agreed to test our preclinical and clinical-stage formulations based on HPV, TARP, MUC1, Melanoma antigens as specified more fully in the statement of work.

The agreement was terminated on November 11, 2025.

Index

Clinical Trial Collaboration and Supply Agreement with MSD International GmbH.

Effective May 19, 2017, we entered into a Clinical Trial Collaboration and Supply Agreement (the “CTCSA”) with MSD International GmbH

(“Merck”) pursuant to which we and Merck agreed to collaborate in a Phase 2 clinical trial to evaluate the safety, and preliminary efficacy of the concomitant and/or sequenced administration of the combination of a Merck compound (i.e.,

pembrolizumab, a humanized anti-human PD-1 monoclonal antibody) and our compound (i.e., PDS0101, a cationic lipid-based therapeutic vaccine combining HPV peptides) in treatment of patients with recurrent or metastatic head and neck cancer and

high-risk human papillomavirus-16 (HPV 16) infection. The term of the CTCSA commenced on May 19, 2017 and will continue until the earlier of (i) delivery of the final trial report and (ii) study completion (i.e., upon database lock of the trial

results), or until terminated by either party. In the event the CTCSA is terminated by Merck upon a material breach by us, we must reimburse Merck for its direct manufacturing costs, such as manufacturing fees, raw materials, direct labor, freight

and duty, factory overhead costs and its indirect manufacturing costs, such as allocations of indirect factory overhead and site support costs. This agreement was amended on October 28, 2019 to reflect that the trial will be for first in line

treatment of disease.

On October 28, 2019, we entered into an amendment to the clinical trial collaboration agreement with Merck to evaluate the combination

of our lead Versamune® based immunotherapy, PDS0101, with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab), in a Phase 2 clinical trial. The modification to the clinical trial design to evaluate PDS0101 in combination with Keytruda® as first-line

treatment comes as a result of Merck’s approval by the FDA on June 10, 2019 for first line treatment of patients with metastatic or unresectable recurrent HNSCC using Keytruda® in combination with platinum and fluorouracil (FU) for all patients and

as a single agent for patients whose tumors express PD-L1 as determined by an FDA-approved test. The trial (VERSATILE-002) was initiated in November of 2020 to evaluate the efficacy and safety of the combination as a first-line treatment in patients

PDSB US Equity

PDSB · 10-K · period ended 2025-12-31

Item 1A Risk Factors 46

Item 1B Unresolved Staff Comments 87

Item 1C Cybersecurity 88

Item 2 Properties 88

Item 3 Legal Proceedings 88

Item 4 Mine Safety Disclosures 88

Item 6 [Reserved]

PDSB US Equity☆

PDSB · 10-K · period ended 2025-12-31

Item 1A Risk Factors 46

Item 1B Unresolved Staff Comments 87

Item 1C Cybersecurity 88

Item 2 Properties 88

Item 3 Legal Proceedings 88

Item 4 Mine Safety Disclosures 88

Item 6 [Reserved]

PDSB US Equity