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Item 1. Business

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We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer immunotherapies based on our Versamune® T cell activator and Versamune® in

combination with our interleukin 12 (IL-12) fused antibody drug conjugate (ADC), PDS01ADC, a tumor targeting immunocytokine.

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 the 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 utilized for treatments in oncology, and Infectimune® is utilized for preventive vaccines against infectious agents.

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.

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 that our

proprietary combination of Versamune® and PDS01ADC 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 November 2022, we announced the presentation of data from two Phase 2 clinical trials at the 37 th

Annual Meeting for the Society of Immunotherapy of Cancer (SITC):

Abstract number 674, IMMUNOCERV, an ongoing Phase 2 trial combining PDS0101, an HPV-specific T cell immunotherapy, with chemotherapy and radiation for treatment of locally

advanced cervical cancers and Abstract number 695, “Immune correlates associated with clinical benefit in patients with immune checkpoint refractory HPV-associated malignancies treated with triple combination immunotherapy”.

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

In December 2022, we executed an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting IL-12 fused antibody drug conjugate, M9241, which joined our

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PDS01ADC is a novel investigational tumor-targeting fusion protein of IL-12 that enhances the proliferation, potency, infiltration and longevity of T cells in the tumor microenvironment and is therefore designed to overcome

the limitations of cytokine therapy, specifically high toxicity and limited therapeutic potential.

The proprietary combination of Versamune® and PDS01ADC is designed to overcome tumor immune suppression utilizing a different mechanism from immune

checkpoint inhibitors (ICI).

The combination of Versamune® and IL-12 to overcome immune suppression is patented by PDS Biotech, and we believe our ownership of both assets will streamline the clinical

development, registrational process and their potential therapeutic use .

In a Phase 2 National Cancer Institute (NCI)-led clinical trial in Immune checkpoint

inhibitor (ICI) resistant patients, the combination of PDS0101 and PDS01ADC administered with an investigational bi-functional ICI resulted in a median overall survival of approximately 20 months.

The historical median survival reported in ICI

resistant HPV-positive cancers when treated with ICIs is 3-4 months and best reported median survival to date with systemic therapy is 8.2 months in ICI resistant head and neck cancer.

In February 2023, we announced a successful completion of a Type B meeting with the FDA for the triple combination of PDS0101 and PDS01ADC with an FDA-approved immune

checkpoint inhibitor for the treatment of recurrent/metastatic, ICI resistant head and neck cancer that is positive for the human papilloma virus (HPV) type 16.

In recent interactions with the FDA, we confirmed the required contents of a clinical

protocol for the potential registrational trial.

the limitations of cytokine therapy which today have resulted in high toxicity and limited therapeutic potential.

The proprietary combination of Versamune® HPV and PDS01ADC is designed to overcome tumor immune suppression utilizing a different

mechanism from immune checkpoint inhibitors (ICI).

The combination of Versamune® and PDS01ADC to overcome immune suppression is patented by us, and we believe our ownership of both assets will streamline the

clinical development, registrational process and their potential therapeutic use.

In a Phase 2 National Cancer Institute (NCI)-led clinical trial in ICI-resistant patients, the combination of Versamune® HPV and PDS01ADC administered with an investigational bi-functional ICI resulted in a median overall survival of approximately 20 months.

The historical median survival reported in ICI-resistant HPV-positive cancers when

treated with ICIs is 3-4 months and best reported median survival to date with systemic therapy is 8.2 months in ICI-resistant head and neck cancer.

In February 2023, we announced completion of a Type B meeting with the FDA for the triple combination of Versamune® HPV and

PDS01ADC with an FDA-approved immune checkpoint inhibitor for the treatment of recurrent/metastatic, ICI-resistant head and neck cancer that is positive for the human papilloma virus (HPV) type 16.

In recent interactions with the FDA, we

confirmed the required contents of a clinical protocol for the potential registrational trial.

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 Naïve Cohort from Study of

PDS0101 and Pembrolizumab in HPV16-Positive Head and Neck Squamous Cell Carcinoma (HNSCC)”.

Versamune® HPV and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC)”.

The abstract was also selected as one of the featured posters reviewed by an expert panel in the Head and Neck Cancer discussion session.

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with lethal doses of the pandemic H1N1 flu virus.

In October 2023, data demonstrating PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus-positive circulating cell-free

DNA (ctHPV-DNA), a potential predictive biomarker of treatment response.

In October 2023, data demonstrating Versamune® HPV in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus-positive 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.

In October 2023, updated interim data 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 the FDA-approved standard of care for first-line treatment of recurrent/metastatic head and neck cancer was presented at a Company-sponsored key opinion leader roundtable.

In October 2023, updated interim data based on an August 2, 2023 cut off from our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV 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 was presented at a Company-sponsored key opinion leader roundtable.

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,

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Congress 2023.

In November 2023, we announced updated survival data from our NCI-led Phase 2 trial investigating the triple combination of PDS0101, PDS01ADC and an investigational ICI in two groups of advanced

cancer patients with various types of human papillomavirus (HPV) 16-positive cancers.

In November 2023, preclinical data from our NCI-led trial including PDS0101, PDS01ADC and an HDAC inhibitor in ICI-resistant HPV-16 positive cancer was presented during a poster presentation at

the Society for Immunotherapy of Cancer 38 th Annual Meeting.

In November 2023, we announced updated survival data from our NCI-led Phase 2 trial investigating the triple combination of Versamune® HPV, PDS01ADC and an investigational ICI in two groups of

advanced cancer patients with various types of human papillomavirus (HPV)16-positive cancers.

The data showed 75% survival of ICI-naïve patients at 36 months.

In November 2023, preclinical data from our NCI-led trial including Versamune® HPV, PDS01ADC and an HDAC inhibitor in ICI-resistant HPV16-positive cancer was presented during a poster

presentation at the Society for Immunotherapy of Cancer 38 th Annual Meeting.

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 Versamune® HPV with chemoradiation to treat locally advanced cervical cancer presented at the

American Society for Radiation Oncology (ASTRO) annual meeting 2024.

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.

(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.

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.

Cancer Immunotherapy

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Journal for ImmunoTherapy of Cancer, May 2020 ).

believe our Versamune® technology platform 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.

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 scan for 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.

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

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.

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.

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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;

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.

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Versamune® Platform

Versamune® has shown the potential to overcome the challenges of immunotherapy

Versamune® is a proprietary lipid nanoparticle and T cell activating platform designed to overcome the challenges of current immunotherapy and improve the treatment outcomes

of patients with cancer.

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.

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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.

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.

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

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

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, 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.

evaluating the uptake of Versamune® nanoparticles by dendritic cells and epithelial cells, found almost exclusive uptake by the dendritic cells.

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, about 80% of the dendritic cells in the

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Versamune® has been demonstrated to promote presentation of antigens to CD4 helper T cells as well.

Versamune® has the potential to promote efficient activation and robust expansion of high quality polyfunctional CD8 killer T cells and CD4 helper in

Versamune® has the potential to promote efficient activation and robust expansion of high quality polyfunctional CD8 killer T cells and CD4 helper in Lymph

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

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

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

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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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

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:

This sustained protection was evidence of immune

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.

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.

Today, many cancer immunotherapies produce serious systemic autoimmune effects due to blockage of existing regulatory mechanisms such as the immune checkpoints as well as

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As noted, Versamune® is injected subcutaneously (under the skin) 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.

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.

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

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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 three of the four studies were initiated in 2020.

safety concerns were attributed to Versamune® HPV since three of the four 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,

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highly potent (polyfunctional) CD8 killer T cells.

In an MD Anderson led Phase 2 clinical trial, IMMUNOCERV, where the ctHPV 16 DNA biomarker measured in certain patients decreased in the blood by Day 170 (T5) as HPV16-specific 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.

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as well as in the single-agent monotherapy setting.

Human Papillomavirus (HPV)-Related Cancers

Versamune® HPV 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 cancer-causing HPV16

HPV infection occurs in both men

and women and is associated with head and neck (oropharyngeal), cervical, anal, vaginal, vulvar and penile cancers.

Versamune® HPV is our lead Versamune® based immunotherapy.

Versamune® HPV combines Versamune® with a mixture of short proteins (peptides) derived from the cancer-causing 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, 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.

In a preclinical study in the most widely utilized animal HPV-cancer tumor model, Versamune® HPV 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 Versamune® HPV in women with cervical intraepithelial

neoplasia (CIN) infected with high-risk HPV types.

The data demonstrated that Versamune® HPV 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 Versamune® HPV 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 34 th Annual Society for the Immunotherapy of Cancer Conference in November 2019 (Wood, et al., 2019).

Based on this encouraging preclinical and human data, PDS0101 is being studied in multiple Phase 2

clinical trials in various HPV-related cancers one sponsored by the Company in collaboration with Merck 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 demonstrated favorable results.

Based on this encouraging preclinical and human data, Versamune®

HPV is being studied in multiple Phase 2 clinical trials in various HPV-related cancers one sponsored by the Company in collaboration with Merck 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 and 2024 demonstrated favorable results.

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

The TARP antigen is strongly associated with prostate and breast cancers.

450,000 patients are projected to be diagnosed with prostate or breast cancer this

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®.

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

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.

Preclinical development is ongoing.

Department of Health and Human Services, as represented by the NCI of the National Institutes of Health (NIH).

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.

Mucin-1 (MUC1)-Related Cancers

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

Preclinical development is ongoing.

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.

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 (formerly known as PDS0301/NHS-IL-12/M9241) 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 given by a simple 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.

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.

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 by shrinking tumors and/or prolonging life.

a completed Phase 2 clinical trial conducted by NCI, evaluating Versamune® HPV 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.

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An analysis of patients at

baseline and after PDS01ADC monotherapy treatment documented in the graphs below.

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.

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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.

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.

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 (PDS0301) shows low accumulation in blood

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Infectimune® has potential as an infectious disease vaccine platform

PDS Biotech has developed a second cationic platform that is being applied to the development of infectious disease vaccines and this specific formulation has been

trademarked Infectimune®.

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.

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.

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According to the World Health Organization, influenza causes 3 to 5 million cases and approximately 290,000 to 650,000 deaths each year.

Due to the existence of multiple

strains of flu, a new seasonal flu vaccination is usually developed to provide protection against the strains predicted to be prevalent in an upcoming flu season.

As a result, the protective efficacy of the current vaccines varies widely from

season to season.

Due to the existence of multiple strains

of flu, a new seasonal flu vaccination is usually developed to provide protection against the strains predicted to be prevalent in an upcoming flu season.

As a result, the protective efficacy of the current vaccines varies widely from season to

We are developing a new generation of flu vaccines with the potential to provide long-lasting, and broad protection against multiple strains of the virus.

We believe that the successful development of a universal flu vaccine

could eliminate the need to create a vaccine to protect against each year’s predicted variants.

We believe that the successful development of a universal flu vaccine could

eliminate the need to create a vaccine to protect against each year’s predicted variants.

Our Infectimune® platform is combined with computationally optimized broadly reactive antigen (COBRA) to potentially provide longer lasting, more

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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.

12-patient Versamune® HPV 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 HPV 16, 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.

In September 2019, we reported retrospective clinical

outcome data from this trial.

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 Versamune® HPV administration that were clinically active.

As a result of this information and the documentation in the trial of Versamune® HPV’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 Versamune® HPV 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-002:

Versamune® HPV + Keytruda®

In November 2020, our VERSATILE-002 Phase 2 clinical trial evaluating the combination of Versamune® HPV 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 will evaluate 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 us, patients whose cancer has returned following initial treatment or spread will be treated with the combination of Versamune® HPV and Keytruda®

to evaluate if the addition of Versamune® HPV might improve the efficacy reported in published studies of Keytruda® alone.

Patients in the trial will receive 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 two cohorts 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).

In May 2023, we completed enrollment in the ICI naïve arm.

We filed our amended IND with the FDA in the third quarter of 2023.

In October 2023, we received feedback from the FDA

on the amended IND.

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 Versamune® HPV 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:

Estimated 12-month overall survival rate was 87.1%.

Published results are 36-50% with approved ICIs used alone.

Median progression-free survival was 10.4 months (95% CI 4.2, 15.3).

Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels.

A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)

Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data previously reported by us at ASCO 2022 (7/17 patients).

To date these

responses have been confirmed in nine of the 34 patients (26.5%), including one complete response.

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

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

4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE).

No Grade 4 or higher TRAEs were observed.

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

Versamune® HPV 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.

from the roundtable based on investigator assessment was as follows:

Highlights from the ICI naïve cohort included:

24-month overall survival (OS) rate of 74%;

published 24-month survival rate of less than 30% for approved ICI.

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.

Median progression-free survival (PFS) of 8.1 months to date;

published results of 2-3 months PFS with approved ICIs.

13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE;

published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.

60% (33/55) of patients had CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (22/55) have CPS score >20 (who generally have a higher response to Keytruda®).

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 VERSATILE-002 Phase 2 clinical trial evaluating the

combination of Versamune® HPV 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 from 53 patients was

The data from the event based on investigator assessment was as follows:

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

Median overall survival of 30 months;

published results for ICIs are 7-18 months.

Confirmed overall response rate ORR of 34% (18/53) to date;

published results for comparable patients receiving treatment with ICIs are less than 20%.

Confirmed complete responses, partial responses and stable disease according to RECIST v1.1 were seen in 75.5% of patients.

Median progression-free survival (PFS) of 6.3 months to date;

published results of 2-3 months PFS with approved ICIs.

The combination of Versamune® HPV and Keytruda® appeared to be well tolerated with 11% (7/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 2% (1/62) experienced Grade 4 or 5

published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.

60% (32/53) of patients had CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (21/53) have CPS score >20 (who generally have a higher response to Keytruda®).

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:

Median Overall Survival of 30 months, consistent with data presented our key opinion leader event in May of 2024, which was based on a data cut as of November 30, 2023.

27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2 patients had been lost to follow-up, and

18 patients had died.

The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of patients continue to be followed for survival.

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 Versamune® HPV + 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:

Median Overall Survival (mOS) was 30 months with a lower 95% confidence interval of 19.7 months;

Published mOS for pembrolizumab is 12-18 months

Objective Response Rate (ORR) of 36% (19/53);

Published ORR for pembrolizumab is 19-25%

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

Treatment-related adverse events of Grade ≥3 were seen in 9 patients (Grade 3, n=8 and Grade 4, n=1)

National Cancer Institute:

Versamune® PDS0101+ PDS01ADC (formerly known as PDS0301/M9241/NHS-IL-12) +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 our product candidates

PDS0101 and PDS01ADC in combination with M7824 (Bintrafusp alfa), a bi-functional immune checkpoint inhibitor (ICI) which is owned by EMD Serono (Merck KGaA) in patients with advanced HPV-positive cancers who have failed prior treatment.

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 IC -resistant patients for assessment of safety and activity of the triple

Versamune® HPV + 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 Versamune® HPV with an

IL-12 ADC now 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 Versamune® HPV

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 IC -resistant patients for assessment of safety and activity of the triple combination.

The trial has been closed for enrollment.

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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 an associated antitumor response when used as a monotherapy.

When PDS0101 was combined with the two other novel clinical-stage anti-cancer agents, Bintrafusp Alfa and M9241 (which

is now owned by us and referred to as PDS01ADC), the preclinical data suggested that all three therapeutic agents worked synergistically 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 triple combination 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.

Doi:10.1136/ jitc-2020-000612) , and indicate that Versamune® HPV generated both HPV-specific T cells and an associated antitumor response when used as a monotherapy.

When Versamune® HPV was combined with the two other novel clinical-stage anti-cancer agents,

Bintrafusp Alfa and M9241 (which is now owned by us and referred to as PDS01ADC), the preclinical data suggested that all three therapeutic agents worked synergistically 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 triple combination

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 June 2022, at the 2022 ASCO Annual Meeting, the NCI provided an update to the preliminary data presented at the 2021 meeting (Strauss J et al.

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Objective response (OR = > 30% tumor reduction) was seen in 88% (7/8) of patients with ICI-naive disease;

4/7 (57%) patients’ responses were ongoing (median 17 months).

4/7 (57%) patients’ responses are ongoing (median 17 months).

With ICI-resistant patients:

PDS01ADC dosing appeared to affect response rates, with 5/8 (63%) patients receiving PDS01ADC at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients who received PDS01ADC

at 8 mcg/kg achieving an OR;

4/6 (67%) patients’ responses were ongoing (median 12 months).

PDS01ADC dosing appears to affect response rates, with 5/8 (63%) patients receiving PDS01ADC at 16.8 mcg/kg achieving an OR compared to 1/14 (7%) patients

who received PDS01ADC at 8 mcg/kg achieving an OR;

4/6 (67%) patients’ responses are ongoing (median 12 months).

Tumor reduction was seen in 45% (10/22) of patients with ICI-resistant disease, including patients receiving high or low dose PDS01ADC.

In ICI-resistant patients treated with high or low dose PDS01ADC, survival outcomes were similar (p=0.96 by Kaplan Meier analysis).

At a median of 12 months of follow up 17/22 (77%) of patients were alive.

At a median of 12 months of follow up 17/22 (77%) of

patients were alive.

In ICI naïve patients, 6/8 (75%) were alive at median 17 months of follow up.

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13/30 (43%) of patients experienced Grade 3 treatment-related adverse events (AEs), and 2/30 patients (7%) experienced Grade 4 AEs.

There were no grade 5 treatment-related AEs.

We believe the trial results to date strongly suggest, in agreement with the published preclinical studies, that all 3 drugs contribute to the clinical outcomes.

In September 2022, we determined, in agreement with the NCI, to select the ICI resistant patients as the preferred treatment group in the on-going PDS0101-based triple

combination therapy in advanced HPV-positive cancers and the trial was closed to further enrollment given the ICI resistant arm had been fully recruited.

There were no grade 5

treatment-related AEs.

We believe the trial results to date suggest that all 3 drugs contribute to the clinical outcomes, consistent with the published preclinical studies.

In September 2022, we determined, in agreement with the NCI, to select the ICI-resistant patients as the preferred treatment group in the on-going Versamune®

HPV -based triple combination therapy in advanced HPV-positive cancers and the trial was closed to further enrollment given the ICI-resistant arm had been fully recruited.

In October 2022, we presented additional interim data as follows:

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48% (24/50) patients experienced Grade 3 treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 AEs.

There were no Grade 5 treatment-related AEs.

There were no Grade 5 treatment-related

HPV16-positive ICI naïve patients:

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Median OS was 21 months in 29 checkpoint inhibitor resistant patients who received the triple combination.

The reported historical median OS in patients with ICI resistant disease is 3-4 months seen with

checkpoint inhibitors and best reported median survival to date with systemic therapy of 8.2 months in ICI resistant head and neck cancer.

In ICI naïve subjects, 75% remained alive at a median follow-up of 27 months.

The reported historical median OS in patients with ICI-resistant disease is

3-4 months with checkpoint inhibitors and best reported median survival to date with systemic therapy of 8.2 months in ICI-resistant head and neck cancer.

In ICI naïve subjects, 75% remain alive at a median follow-up of 27 months.

As a result, median OS had not yet been reached.

Historically, observed median OS for similar patients with platinum

Historically, median OS for similar patients with platinum

experienced ICI naïve disease is 7-11 months.

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In current approaches ORR is reported to be less than 10%.

ORR in ICI naïve patients with the triple combination was reported as 88%.

ORR in ICI naïve patients with the triple combination is 88%.

In current approaches ORR is reported to be less than 25% with FDA-approved ICIs in HPV-positive cancers.

Safety data had not changed since October’s update.

48% (24/50) of patients experienced Grade 3 (moderate) treatment-related adverse events (AEs), and 4% (2/50) patients experienced Grade 4 (severe) AEs,

compared with approximately 70% of patients receiving the combination of ICIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.

In February 2023, we announced the successful completion of a Type B meeting with the FDA for the combination therapy of PDS0101, PDS01ADC, and an FDA-approved immune

checkpoint inhibitor for the treatment of recurrent/metastatic HPV-positive ICI-resistant head and neck cancer.

48% (24/50) of patients experienced Grade 3 (moderate) treatment-related adverse events (AEs), and 4% (2/50) patients experienced

Grade 4 (severe) AEs, compared with approximately 70% of patients receiving the combination of ICIs and chemotherapy reporting Grade 3 and higher treatment-related AEs.

In February 2023, we announced the completion of a Type B meeting with the FDA for the combination therapy of Versamune® HPV, PDS01ADC, and an FDA-approved immune checkpoint

inhibitor for the treatment of recurrent/metastatic HPV-positive ICI-resistant head and neck cancer.

We confirmed the required contents of the trial design for a potential registrational trial of the combination.

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

75% of ICI naïve patients remain alive at 36 months;

published median OS in similar patients is 7-11 months

12-month survival rate in ICI resistant patients was 72%

Median OS in ICI resistant HPV-positive patients is approximately 20 months;

75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months;

published median overall survival (mOS) in similar patients is 7-11 months

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

Median OS in ICI-resistant HPV-positive patients of approximately 20 months;

published median OS is 3.4 months

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 was designed to

evaluate 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 PDS Biotech-sponsored trial 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 which was administered every three weeks until disease progression.

The primary endpoint of VERSATILE-002 is the objective response rate (ORR) at six months

following initiation of treatment.

There are two cohorts 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).

In February 2022, we achieved the preliminary efficacy milestone of at least four or more objective responses among the first 17 patients in the ICI naïve arm, allowing that arm to proceed to

full enrollment.

We also announced detailed preliminary safety data which showed that the combination was well tolerated without evidence of enhanced or significant toxicity in the first 18 patients in the ICI naïve arm.

We also completed enrollment in Stage 1 of the ICI resistant arm and were awaiting sufficient follow-up to conduct the futility analysis .

In May 2022, we expanded this trial into Europe and in June 2022, we received Fast Track designation from the U.S.

FDA for PDS0101 in combination with pembrolizumab.

In June 2022, we presented additional preliminary efficacy and safety data from this trial at the ASCO Annual Meeting (Weiss J et al.

J Clin Oncol 40, 2022

abstr 6041)) .

The abstract provided preliminary data on 19 patients (safety) with available imaging data for 17 of the 19 patients (efficacy).

Data on 17 patients was presented.

Highlights from the abstract were as follows:

Confirmed and unconfirmed objective response rates (ORR) thus far (tumor shrinkage greater than 30%) was seen in 7/17 (41.2%) patients with 2 of the 7 having complete responses (CR).

Published results state ORR of approximately 19% for

approved ICIs, used as monotherapy for recurrent or metastatic head and neck cancer.

Stable disease (SD) was reported in 6/17 (35.3%) patients, with 4 of the 6 (67%) experiencing tumor shrinkage of less than 30%

Clinical efficacy (ORR + SD) was seen in 13/17 (76.5%) patients

Progressive/ongoing disease was reported in 4/17 (23.5%) patients

Patients had received a median of 4/5 doses of PDS0101 (range 1-5) and 9/35 doses of Keytruda® (range 1-18)

There were no treatment-related adverse events greater than or equal to Grade 3 (N=19)

No patients required dose interruption or reduction on the combination treatment

No patients discontinued the combination treatment

At 9 months of follow up (median not yet achieved):

Progression free survival (PFS) rate was 55.2%

Overall survival (OS) rate was 87.2%

No control or comparative studies have been conducted between ICIs and PDS0101

In August 2022, our independent Data Monitoring Committee (DMC) met and evaluated data from 43 patients and noted there were no Grade 3 or greater treatment-related adverse events attributed to

the combination.

The DMC recommended continuing the trial with no modifications.

In October 2022, we announced the results of an end-of-phase 2 meeting with the FDA for PDS0101 in combination with Keytruda®.

We have completed the plan for the Phase 3 clinical program that

will support the submission of a BLA for PDS0101 and have submitted it to the FDA.

In December 2022, we completed the first stage of enrollment in the ICI resistant arm.

Cohort follow-up is in progress that will permit a futility analysis to determine

progression to stage 2 enrollment is in progress.

In May 2023, we completed enrollment in the ICI naïve arm.

We filed our amended Investigational New Drug (IND) application with the FDA in the third quarter of 2023.

October 2023, we received feedback from the FDA on the amended IND.

Later in October, as part of business development discussions, we received insights from potential business partners on the Phase 3 clinical protocol.

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:

Estimated 12-month overall survival rate was 87.1%.

Published results are 36-50% with approved ICIs used alone.

Median progression-free survival was 10.4 months (95% CI 4.2, 15.3).

Published results are median PFS of 2-3 months for approved ICIs when used as monotherapy in patients with similar PD-L1 levels.

A disease control rate (disease stabilization or tumor shrinkage) of 70.6% (24/34)

Confirmed and unconfirmed objective response rate is 41.2% (14/34 patients), which is identical to the preliminary response rate data PDS Biotech previously reported at ASCO 2022 (7/17 patients).

To date, these responses have been

confirmed in 9 of the 34 patients (26.5%), including one complete response.

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

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

4/48 (8.3%) of patients had a Grade 3 treatment-related adverse event (TRAE).

No Grade 4 or higher TRAEs were observed.

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 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 include:

24-month overall survival rate is 74%;

published 24-month survival rate of less than 30% for approved ICI.

12-month OS rate is 80%;

published results of 30-50% with approved ICIs.

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

Confirmed overall response rate is 27% (14/52) to date.

Median progression-free survival is 8.1 months to date;

published results of 2-3 months PFS with approved ICIs.

13% (8/62) of patients experienced Grade 3 treatment-related adverse events (TRAE) and 0% (0/62) experienced Grade 4 or 5 TRAE;

published results report 13-17% Grade 3-5 TRAE with approved ICI monotherapy.

60% (33/55) of patients have CPS score of 1-19 (who generally have a weaker response to Keytruda®), and 40% (22/55) have CPS score >20 (who generally have a higher response to Keytruda®).

Highlights form the ICI refractory cohort include:

The 12-month OS rate is 56%.

The published median 12-month OS rate is 17% with no salvage chemotherapy following tumor progression on ICI (ICI Resistant).

0% (0/21) confirmed ORR suggests that PDS0101’s impact on survival does not appear to be dependent on tumor shrinkage.

4% (1/25) of patients experienced Grade 3 TRAE and 0% (0/21) patients experienced Grade 4 and 5 TRAE.

MD Anderson Cancer Center (IMMUNOCERV):

PDS0101+ Chemoradiotherapy

In October 2020, a PDS0101 Phase 2 IIT was initiated with The University of Texas MD Anderson Cancer Center and is actively recruiting patients.

This clinical trial is investigating 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.

Versamune® HPV + 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 is

investigating the safety and anti-tumor efficacy of Versamune® HPV 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.

In November 2022, data from this trial was included in a poster presentation at the 2022 SITC Annual Meeting which included the following:

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with advanced cervical cancer (FIGO stage III or IV).

100% (9/9) of patients treated with the combination of PDS0101 and CRT had an objective response.

89% (8/9) of patients treated with the combination of PDS0101 and CRT demonstrated a complete response (CR) on Day 170 by PET CT.

One patient who received 3 of the 5 scheduled doses of PDS0101 showed signs

of residual disease.

100% (9/9) of patients treated with the combination of Versamune® HPV and CRT had an objective response.

89% (8/9) of patients treated with the combination of Versamune® HPV and CRT demonstrated a complete response (CR) on Day 170 by PET CT.

One patient who received 3 of

the 5 scheduled doses of Versamune® HPV showed signs of residual disease.

One patient who had a CR died from an event unrelated to either their underlying disease or treatment.

1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of PDS0101 and CRT.

As previously reported, data confirm PDS0101 treatment activates HPV16-specific CD8 T cells.

This increase was not seen in patients who did not receive PDS0101.

The increase in HPV16-specific T cells

generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.

Toxicity of PDS0101 remains limited to low-grade local injection site reactions.

In October 2023, data demonstrated that PDS0101 in combination with standard-of-care (SOC) chemoradiotherapy was associated with a rapid decline in human papillomavirus circulating cell-free DNA

1-year disease-free survival and 1-year overall survival of 89% (8/9) in patients treated with the combination of Versamune® HPV and CRT.

As previously reported, data confirm Versamune® HPV treatment activates HPV16-specific CD8 T cells.

This increase was not seen in patients who did not receive Versamune® HPV.

The increase in HPV16-specific T

cells generated by the treatment is positively correlated with tumor cell death, suggesting cytotoxic CD8 T cells are important mediators of antigen-specific immunity.

The data affirms that Versamune® HPV activates Type 1 interferon pathway in humans, mimicking the mechanism previously demonstrated in preclinical studies in animal models.

Toxicity of Versamune® HPV remains limited to low-grade local injection site reactions.

In October 2023, data demonstrating Versamune® HPV 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

Earlier and greater proportion of ctDNA clearance with PDS0101 plus chemoradiation (CRT) vs.

Earlier and greater proportion of ctDNA clearance with Versamune® HPV plus chemoradiation (CRT) vs.

SOC CRT alone 81.3% clearance after 3 weeks vs.

30.3% with SOC (p=0.0018), and 91.7% of clearance at 5 weeks vs.

53.1% with SOC (p=0.0179).

53.1% with SOC

Baseline ctDNA levels correlated with the International Federation of Gynecology and Obstetrics (FIGO) stage and lymph node involvement;

100% of patients treated with PDS0101 had cancer that had spread to the lymph nodes.

PDS0101 Monotherapy and in combination with Keytruda®

In February 2022, we initiated an Investigator-Initiated Trial (ITT), MC200710, for PDS0101 alone or in combination with the immune checkpoint inhibitor, Keytruda® , in patients with HPV-positive oropharyngeal cancer (HPV(+)OPSCC) at high risk of recurrence.

100% of patients treated with Versamune® HPV had cancer that had spread to the lymph nodes.

Versamune® HPV Monotherapy and in combination with Keytruda®

In February 2022, we initiated an IIT, MC200710, for Versamune® HPV alone or in combination with the immune checkpoint inhibitor, Keytruda®, 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.

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 may provide additional information regarding patients receiving fewer doses of Versamune® HPV in a patient population affected by the increasing incidence of

HPV(+)OPSCC, and also allows us to better understand the activity of Versamune® HPV alone or in combination with Keytruda® in earlier stages of disease.

This trial is currently open for enrollment.

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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).

Versamune® HPV 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 Versamune® HPV 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).

PDS0102 is an investigational immunotherapy utilizing tumor-associated and immunologically active T cell receptor gamma alternate reading framed protein (TARP) from the NCI.

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large numbers of tumor targeted killer T cells.

In addition, the TARP tumor antigen alone has already been studied at the NCI in men with prostate cancer and been shown to be safe, immunogenic with slowing tumor growth rates (NCT00972309).

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 us and designed to treat cancers associated with the mucin-1, or MUC1, oncogenic protein.

In addition, the TARP tumor antigen alone has already been studied at the NCI in men with prostate cancer and has been shown to be safe, and immunogenic with slowing tumor growth rates

(NCT00972309).

In April 2020, the above mentioned CRADA between us and the NCI was expanded beyond Versamune® HPV to include clinical and preclinical development of PDS0103.

PDS0103 is an investigational immune

therapy owned by us 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.

PDS0103 is currently in the tech transfer and clinical scale up and manufacturing stage.

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

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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 the first quarter of 2022, we held a pre-IND meeting with the FDA on PDS0103, and we are prepared to submit our IND package by the second half of 2024.

In preclinical studies, and similarly to Versamune® HPV, PDS0103 demonstrated the ability to generate powerful

MUC1-specific CD8 killer T cells.

IL-12 Oncology Immunocytokine Pipeline

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:

Phase 2 Study Evaluating ICI Naïve and Resistant Patients with HPV-positive malignancies treated with PDS01ADC, PDS0101 and bintrafusp alfa.

A Phase 2 Study Evaluating T-Cell Clonality After Stereotactic Body Radiation Therapy Alone and in Combination with the Immunocytokine PDS01ADC in Localized High and Intermediate Risk Prostate Cancer Treated with Androgen Deprivation

A Phase 1/2 Study of PDS01ADC in Combination with Docetaxel in Adults with Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

Phase 1/2 of PDS01ADC going forward as a Monotherapy in Advanced Kaposi Sarcoma

Phase 1/2 of PDS01ADC in Combination of with a Histone Deacetylase (HDAC) Inhibitor in ICI resistant MUC1-positive colon and bladder cancers among others

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.

Versamune®, PDS01ADC is administered by 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 Versamune® HPV 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®.

informative preclinical studies, a number of IIT Phase 2 trials are currently in progress at the NCI, some of which are outlined below:

Phase 2 trial evaluating ICI naïve and resistant patients with HPV-positive malignancies treated with PDS01ADC, Versamune® HPV and bintrafusp alfa.

A Phase 2 trial evaluating T-cell clonality after stereotactic body radiation therapy alone and in combination with the immunocytokine PDS01ADC in localized high and intermediate risk prostate cancer treated with androgen deprivation

A Phase 1/2 trial of PDS01ADC in combination with docetaxel in adults with metastatic castration sensitive and castration resistant prostate cancer

Phase 1/2 trial evaluating PDS01ADC going forward as a monotherapy in advanced kaposi sarcoma

Phase 1/2 trial of PDS01ADC in combination of with a histone deacetylase (HDAC) inhibitor in ICI-resistant MUC1-positive colon and bladder cancers among others

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,

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Meeting of the International Cytokine & Interferon Society.

Data presented as follows:

The data presented included the following:

Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC and 61% of patients had at least a 60% decrease in PSA levels.

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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

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 data with the universal seasonal flu vaccine in animals and the current focus of the NIAID in developing more effective flu vaccines, we have decided to focus our near-term

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, which is based on similar computationally designed antigens that have shown promise with Infectimune®.

In July 2022, universal flu vaccine preclinical data for PDS0202 at the 41 st American Society of Virology meeting:

Abstract number 3733830, Infectimune® enhances antibodies elicited by COBRA hemagglutinin influenza vaccine.

We are evaluating the next steps in the clinical development and funding for PDS0202.

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

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:

preclinical studies demonstrating complete protection against sickness after lethal challenge with live SARS-CoV-2 or influenza viruses (Gandhapudi SK et al.

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2023, 15 , 538).

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

Scientific Working Group on Influenza (ESWI) conference.

These 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 not previously exposed to flu.

Universal Flu

Based on the key characteristics of Infectimune®, we are progressing development of PDS0202, a universal influenza vaccine candidate, which combines Infectimune® with novel

Computationally Optimized Broadly Reactive (COBRA) influenza vaccine antigens designed by renowned influenza expert Dr.

Ted Ross and licensed from the University of Georgia.

PDS0202 preclinical development was supported by an agreement with

the NIAID CIVICs, program, with a goal of progressing into a human clinical trial with nondilutive financing.

Preclinical development studies were performed at three sites:

our Princeton, NJ laboratories, The University of Kentucky School of

Medicine, and the CIVICs Center for Influenza Vaccine Research for High-Risk Populations.

The data produced in the preclinical studies showed significant levels of hemagglutinin inhibition (HAI) titer levels when utilizing PDS0202 as compared

to COBRA antigens alone ranging from 28x to 62x on various strains of the H1N1 influenza virus.

The preclinical data also showed all animals in the control group, when challenged by the flu virus became sick and died while all animals treated with either a 3mcg (high dose) or .012mcg (low dose) of PDS0102

remained alive and healthy.

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

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.

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

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, advancing preclinical programs, conducting clinical trials, manufacturing PDS0101 and PDS01ADC for clinical trials, and providing general and administrative support.

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,

advancing preclinical programs, conducting clinical trials, manufacturing Versamune® HPV and PDS01ADC for clinical trials, and providing general and administrative support.

We have funded our operations primarily from the issuance of common

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the timing and costs of our planned clinical trials and manufacturing of our clinical products;

the timing and costs of our planned preclinical studies of our lead program of Versamune® PDS0101 in combination with PDS01ADC and an immune checkpoint inhibitor, as well as other earlier-stage programs;

the timing and costs of our planned preclinical studies of our lead program of Versamune® HPV in combination with PDS01ADC and an immune checkpoint inhibitor, as well as other earlier-stage programs;

the outcome, timing and costs of seeking regulatory approvals;

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

Development Pipeline

Our current program development pipeline is shown below:

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:

The following table sets

forth certain information about our executive officers as of the date of the filing of this Annual Report:

Frank Bedu-Addo, Ph.D.

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Chief Financial Officer, Principal Financial Officer and Principal Accounting Officer

Stephan Toutain

Chief Operating Officer

Spencer Brown

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

Bedu-Addo is a veteran biotech executive with experience

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 both operational and drug development strategies in both large organizations and emerging biotechnology

He has been responsible for the oversight, development and implementation of operational and drug development strategies in both large organizations and emerging biotechnology

Bedu-Addo was a member of the senior executive team at KBI BioPharma, Inc.

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Shephard has served as Chief Medical Officer of PDS Biotech since January 2024.

Shepard is a board-certified medical oncologist and hematologist with more than 30

years of experience in the pharmaceutical industry.

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

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Lars Boesgaard

Boesgaard has served as our Chief Financial Officer since December 2023.

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.

Boesgaard has served as Chief Financial Officer of PDS Biotech since December 2023.

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

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

Stephan Toutain

Toutain has served as Chief Operations Officer of PDS Biotech since May 2024.

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.

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.

Toutain has also held various U.S.

commercial, marketing and product

management positions with Celgene Corporation and Johnson & Johnson.

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

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Brown earned his bachelor’s degree at Princeton University and obtained his juris doctorate degree from the University of Pennsylvania Carey School of Law.

We are also supported by scientific leaders in the field of vaccine development and oncology.

Lisa Rohan, one of our founders, is Chair of the Scientific

Advisory Board.

She is a professor in the department of Pharmaceutical Sciences at the University of Pittsburgh where she also holds appointments in the Department of Obstetrics, Gynecology and Reproductive Sciences in the School of Medicine

and the Clinical Translational Science Institute.

Mark Einstein, Professor and Chair in the Department of OB/ GYN & Women’s Heath at Rutgers University Medical School is an expert in HPV-related pathogenesis, therapy and prevention of

lower anogenital tract and gynecologic cancers.

He is an active leader for management guidelines and translating clinical study and translational data for the World Health Organization, American Cancer Society, Society of Gynecologic Oncology

and the American College of Obstetrics and Gynecology.

Gross, Professor and Director of Clinical Research, Department of Head and Neck Surgery, Division of Surgery, The University of

Texas MD Anderson Cancer Center.

Jon Wigginton, President, Research and Development Bright Peak Therapeutics and former President of Society for Immunotherapy of Cancer.

Olivera Finn is a Distinguished Professor of Immunology at the

University of Pittsburgh School of Medicine and she discovered the MUC1 antigen.

Our Principal Investigator for the PDS0101 Head and Neck Trial with Keytruda® for first-line treatment of recurrent/

metastatic Head and Neck Cancer is Dr.

Jared Weiss, Associate Professor of Medicine, University of North Carolina Lineberger Comprehensive Cancer Center, who is an expert in head and neck thoracic oncology with a focus on immunotherapeutic

approaches for these diseases.

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.

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.

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will be capable of efficiently manufacturing our products.

For our Versamune® PDS0101 and PDS01ADC product candidate, we continue to progress our ongoing Phase 2 clinical trials.

For our Versamune® HPV and PDS01ADC product candidates, we continue to progress our ongoing Phase 2 clinical trials.

This process is described further under “U.S.

Product Development Process.” The final protocols for all Phase 2 clinical trials were submitted to the FDA prior to trial initiation and information for all three trials are on www.clinicaltrials.gov.

Development Process.” The final protocols for all Phase 2 clinical trials were submitted to the FDA prior to trial initiation and information for all trials are available on www.clinicaltrials.gov.

To conform to the FDA electronic Common

Technical Document format requirement and submission of the cGMP material that will be used in the Phase 2 trials for PDS0101, we submitted a Chemistry, Manufacturing, and Controls amendment to our IND application, related to our Phase 2

studies with PDS0101 to the FDA in 2020.

We anticipate that we would 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.

Technical Document format requirement and submission of the cGMP material that will be used in the Phase 2 trials for Versamune® HPV, we submitted a Chemistry, Manufacturing, and Controls amendment to our IND application, related to our Phase 2

studies with Versamune® HPV to the FDA in 2020.

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 plan to work to develop data with the goal of progressing to an IND submission in 2024 and progressing

clinical development to first-in-human trials with these products.

We have engaged with the FDA and received useful initial feedback on the clinical trial design for the PDS0103 program and this information will influence our strategy for

regulatory submissions and the protocol development.

For our earlier stage, preclinical product candidate PDS0103, we submitted an IND for a Phase 1 trial in colorectal cancer in January 2025.

Intellectual Property

We seek to maintain high barriers to entry around our product our product candidates and the markets in which they are utilized by using a multiple layered approach to our

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.

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We have developed numerous patents and patent applications and own substantial know-how and trade secrets related to our Versamune® platform.

As of March 1, 2024, PDS Biotech

holds thirteen (13) U.S.

patents with granted claims directed to its platform technology and twenty-four (24) pending U.S.

As of March 1, 2025, we hold fourteen

patents with granted claims directed to its platform technology and twelve (12) pending U.S.

patent applications.

These issued patents will expire in 2026 to 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 1, 2024, PDS Biotech holds seventy-four (74) issued foreign patents and forty-four (44) 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

These issued patents will expire in 2028 through 2037, or later if patent term extension applies.

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 1, 2025, we hold seventy-seven (77) issued foreign patents and twenty-eight (28) pending or published foreign patent

applications.

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.

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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.

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®.

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.

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.

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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.

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

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.

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:

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.

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.

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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 the proprietary rights.

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

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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 PDS Biotech a nonexclusive license to certain patent rights for the development of a therapeutic cancer

vaccine specifically in combination with PDS Biotech’s 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 PDS Biotech is in default in the performance of any material obligation under the Patent License Agreement.

PDS Biotech may unilaterally terminate the Patent

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

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;

(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 PDS Biotech must pay to third parties;

(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

(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;

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.

(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.

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

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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 the Versamune®

technology and any other of our proprietary technologies for prostate and breast cancers and Acute Myeloid Leukemia.

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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.

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

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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 PDS Biotech’s preclinical and clinical-stage formulations based on HPV, TARP, MUC1, Melanoma antigens as specified more fully in the statement of work.

The cost reimbursement agreement has been renewed

annually, and was renewed on June 30, 2023, for an anticipated cost of $628,171.

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 cost reimbursement agreement has been renewed annually, and

was renewed on June 30, 2024, for an anticipated cost of $722,760.

The agreement terminates on June 30, 2025, unless extended by written mutual agreement of parties or is terminated by one of the parties.

Either party may terminate

the Cost Reimbursement Agreement for any reason with thirty (30) days written notice.

Either party may terminate the Cost

Reimbursement Agreement for any reason with thirty (30) days’ written notice.

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 the University of Kentucky Research Foundation (“UKRF”),

pursuant to which UKRF agreed to test PDS Biotech’s preclinical and clinical-stage formulations based on HPV, TARP, MUC1, Melanoma antigens as specified more fully in the statement of work.

The cost reimbursement agreement has been renewed

annually, and was renewed on June 30, 2023, for an anticipated cost of $13,897.

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 cost reimbursement agreement has been renewed annually, and

was renewed on June 30, 2024, for an anticipated cost of $14,022.

The agreement terminates on June 30, 2025, unless extended by written mutual agreement of parties or is terminated by one of the parties.

Either party may terminate

the Cost Reimbursement Agreement for any reason with thirty (30) days written notice.

Either party may terminate the Cost

Reimbursement Agreement for any reason with thirty (30) days’ written notice.

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)

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

In the event the CTCSA is terminated by Merck upon a material breach by PDS Biotech, PDS Biotech 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

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

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., Versamune® HPV, 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.

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,

Versamune® HPV, with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab), in a Phase 2 clinical trial.

The modification to the clinical trial design to evaluate Versamune® HPV 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

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Research Plan.

Under the agreement, we will collaborate with the NCI’s Genitourinary Malignancies Branch (“GMB”) and Laboratory of Tumor Immunology and Biology (“LTIB”) with plans to conduct a Phase 2 clinical trial evaluating PDS0101 with

novel immune-modulating agents M7824 and NHS-IL12 being studied at NCI as part of a CRADA with EMD Serono (“Merck KGaA”).

with novel immune-modulating agents M7824 and NHS-IL12 being studied at NCI as part of a CRADA with EMD Serono (“Merck KGaA”).

The Phase 2 clinical trial was initiated in June of 2020.

The CRADA also involves preclinical evaluation of PDS0101 in

combination with other therapeutic modalities upon the mutual agreement of both parties.

In April 2020, this agreement was amended to include PDS0103, in preclinical and clinical development for treatment of ovarian, breast, colorectal and lung

The CRADA also involves preclinical evaluation of

Versamune® HPV in combination with other therapeutic modalities upon the mutual agreement of both parties.

In April 2020, this agreement was amended to include PDS0103, in preclinical and clinical development for treatment of ovarian, breast,

colorectal and lung cancers.

The term of the CRADA is five (5) years, starting April 22, 2019.

Pursuant to Appendix A, we agreed to provide $110,000 annually, the first payment of which is to be made on

the first anniversary of the CRADA Effective date or upon the initiation of a Phase 2 clinical trial as the NIH Clinical Center, whichever comes first for NCI to use in connection with acquiring technical, statistical, and administrative support

for the clinical research activities, as well as to pay for supplies and travel expenses and infrastructure costs.

Pursuant to Appendix A, we agreed to provide $110,000 annually, the first payment of which is to be made on the

first anniversary of the CRADA Effective date or upon the initiation of a Phase 2 clinical trial as the NIH Clinical Center, whichever comes first for NCI to use in connection with acquiring technical, statistical, and administrative support for

the clinical research activities, as well as to pay for supplies and travel expenses and infrastructure costs.

The CRADA may be terminated by either party at any time by mutual written consent.

Either party may unilaterally terminate the

CRADA at any time by providing sixty (60) days written notice.

If we terminate prior to the completion of all approved or active study protocol(s) pursuant to the CRADA, we must supply enough study test product to complete these study protocol(s)

unless termination is for safety reasons.

If the CRADA is mutually or unilaterally terminated by PDS Biotech before its expiration, we must pay non-cancellable obligations for personnel for a period of six (6) months after the termination date or

until the expiration date of the CRADA, whichever is sooner.

If we suspend development on the test article without the transfer of its active development efforts, assets, and obligations to a third party within ninety (90) days of

discontinuation, NCI may continue development.

In such event, we must transfer all information necessary to enable NCI to contract for the manufacture of the test article and grant NCI a nonexclusive, irrevocable, worldwide, paid-up license

regarding same.

Either party may unilaterally terminate the CRADA at

any time by providing sixty (60) days’ written notice.

If we terminate prior to the completion of all approved or active study protocol(s) pursuant to the CRADA, we must supply enough study test product to complete these study protocol(s) unless

termination is for safety reasons.

If the CRADA is mutually or unilaterally terminated by us before its expiration, we must pay non-cancellable obligations for personnel for a period of six (6) months after the termination date or until the

expiration date of the CRADA, whichever is sooner.

If we suspend development on the test article without the transfer of its active development efforts, assets, and obligations to a third party within ninety (90) days of discontinuation, NCI may

continue development.

In such event, we must transfer all information necessary to enable NCI to contract for the manufacture of the test article and grant NCI a nonexclusive, irrevocable, worldwide, paid-up license regarding same.

Option to License with the University of Georgia Research Foundation of Georgia Research Foundation

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In addition, there are many development-stage biotechnology companies in various immunotherapy and vaccine development

including, but not limited to Merus N.V., F-Star Therapeutics, Inovio, Kite Pharma, Hookipa, Moderna, ZIOPHARM Oncology, Heat Biologics, Harpoon Therapeutics, BioNTech, Osivax, Medicago, Vaxart, and Flugen.

If one or more of these companies is

successful in developing their technologies, it could materially impact our business.

While we believe that the Versamune®, Versamune® in combination with PDS01ADC and Infectimune® platforms provide us with competitive advantages, we face competition from

many different sources, including biotechnology and pharmaceutical companies, academic institutions, government agencies, as well as public and private research institutions.

Any products that we may commercialize will have to compete with

existing products and therapies as well as new products and immunotherapies that may become available in the future.

including, but not limited to, Merus, F-Star Therapeutics, Inovio, Kite Pharma, Hookipa, Moderna, ZIOPHARM Oncology, Heat Biologics, Harpoon Therapeutics, BioNTech, Osivax, Medicago, Vaxart, IO Biotech, Exelixis and Flugen.

If one or more of

these companies is successful in developing their technologies, it could materially impact our business.

While we believe that the Versamune®, Versamune® in combination with PDS01ADC and Infectimune® platforms provide us with competitive advantages, we face competition from many

different sources, including biotechnology and pharmaceutical companies, academic institutions, government agencies, as well as public and private research institutions.

Any products that we may commercialize will have to compete with existing

products and therapies as well as new products and immunotherapies that may become available in the future.

We anticipate that we will face intense and increasing competition as new immunotherapies enter the market and advanced technologies become available.

We expect any

products that we develop and commercialize to compete based on, among other things, efficacy, safety, convenience of administration and delivery, price, availability of therapeutics, the level of generic competition and the availability of

reimbursement from government and other third-party payors.

Our competitors may obtain FDA or other regulatory approval for their products more rapidly than us and may obtain approval for their products, which could result in our competitors

establishing a strong market position before we are able to enter the market.

We expect any products

that we develop and commercialize to compete based on, among other things, efficacy, safety, convenience of administration and delivery, price, availability of therapeutics, the level of generic competition and the availability of reimbursement

from government and other third-party payors.

Our competitors may obtain FDA or other regulatory approval for their products more rapidly than us and may obtain approval for their products, which could result in our competitors establishing a

strong market position before we are able to enter the market.

In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products.

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Our product candidates must be approved by the FDA before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in foreign countries.

Generally, its activities in other countries will be subject to regulation that is similar in nature and scope as that imposed in the United States.

The process for obtaining regulatory marketing approvals and the subsequent compliance with

appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.

process for obtaining regulatory marketing approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources.

Product Development Process

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administrative or judicial action.

FDA decisions or enforcement actions could include, among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls or withdrawals from

the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

Any agency or judicial enforcement action

could have a material adverse effect on PDS Biotech.

FDA decisions or enforcement actions could include, among other actions, refusal to approve pending applications, withdrawal of approval, a clinical hold, warning letters, product recalls or withdrawals from the

market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties.

Any agency or judicial enforcement action could

have a material adverse effect on the Company.

The process required by the FDA before a biological drug product may be marketed in the United States generally involves the following:

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controls are adequate to preserve the biological product’s identity, strength, quality and purity;

pre-approval inspection by the FDA of the sponsor (or any third-party service providers) relative to oversight of clinical studies, clinical trial sites that generated the data in support of the BLA, and any manufacturing facilities to

assure compliance with GCPs and the integrity of clinical data;

pre-license or pre-approval inspection by the FDA of the sponsor (or any third-party service providers) relative to oversight of clinical studies, clinical trial sites that generated the data in support of the BLA, and any

manufacturing facilities to assure compliance with GCPs and the integrity of clinical data;

payment of user fees;

FDA review and approval, or licensure, of the BLA;

Compliance with any post-approval requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct post-approval studies

Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity, and novelty of the product candidate or disease.

clinical hold may occur at any time during the life of an IND and may affect one or more specific trials or all trials conducted under the IND.

The testing and approval process requires substantial time, effort, and financial resources.

Compliance with any post-approval commitments or requirements, including the potential requirement to implement a Risk Evaluation and Mitigation Strategy, or REMS, and the potential requirement to conduct

post-approval studies

Satisfaction of FDA pre-market approval requirements typically takes many years and the actual time required may vary substantially based upon the type, complexity, and novelty of the product

candidate or disease.

A clinical hold may occur at any time during the life of an IND and may affect one or more specific trials or all trials conducted under the IND.

The testing and approval process requires substantial time, effort, and

financial resources.

Preclinical studies

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The IND and IRB processes

An IND is an exemption from the FDCA that allows an unapproved drug to be shipped in interstate commerce for use in an investigational clinical trial and a request for FDA authorization to

administer an investigational drug to humans.

An IND is an exemption from the FDCA and PHSA that allows an unapproved drug to be shipped in interstate commerce for use in an investigational clinical trial and a request for FDA authorization

to administer an investigational drug to humans.

Such authorization must be secured prior to interstate shipment and administration of any new drug that is not the subject of an approved NDA or BLA.

In support of a request for an IND, a sponsor must

submit, among other things, a protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND.

In support of a request for an IND, a sponsor

must submit, among other things, a protocol for each clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND.

The sponsor may be a company seeking to develop the drug or, as in the case of an

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and plans for clinical trials, among other things, are submitted to the FDA as part of an IND.

The FDA requires a 30-day waiting period after the filing of each IND before clinical trials may begin.

This waiting period is designed to allow the

FDA to review the IND to determine whether human research subjects will be exposed to unreasonable health risks.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the

proposed clinical studies and places the study on a clinical hold within that 30-day time period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical study can begin.

The FDA may also impose

clinical holds on a biological product candidate at any time before or during clinical studies due to safety concerns or non-compliance.

If the FDA imposes a clinical hold, studies may not recommence without FDA authorization and then only under

terms authorized by the FDA.

Accordingly, PDS Biotech cannot be sure that submission of an IND will result in the FDA allowing clinical studies to begin, or that, once begun, issues will not arise that suspend or terminate such studies.

The FDA requires a 30-day waiting period after the filing of each IND before the IND is considered effective and clinical trials may begin.

waiting period is designed to allow the FDA to review the IND to determine whether human research subjects will be exposed to unreasonable health risks.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA

raises concerns or questions regarding the proposed clinical studies and places the study on a clinical hold within that 30-day time period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical

study can begin.

The FDA may also impose clinical holds on a biological product candidate at any time before or during clinical studies due to safety concerns or non-compliance.

If the FDA imposes a clinical hold, studies may not recommence

without FDA authorization and then only under terms authorized by the FDA.

Accordingly, we cannot be certain that submission of an IND will result in the FDA allowing clinical studies to begin, or that, once begun, issues will not arise that

suspend or terminate such studies.

Following commencement of a clinical trial under an IND, the FDA may also place a clinical hold or partial clinical hold on that trial.

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The IRB must continue to oversee the clinical trial while it is being conducted, including any changes to the study plans.

Additionally, some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board or committee.

This group provides

authorization for whether or not a trial may move forward at designated check points based on access that only the group maintains to available data from the trial.

Suspension or termination of development during any phase of clinical trials can

occur if it is determined that the participants or patients are being exposed to an unacceptable health risk.

Other reasons for suspension or termination may be made by us based on evolving business objectives and/or competitive climate.

Additionally, some trials are overseen by an independent group of qualified experts organized by the trial sponsor, known as a data safety monitoring board (DSMB) or committee.

provides authorization for whether or not a trial may move forward at designated check points based on access that only the group maintains to available data from the trial.

Suspension or termination of development during any phase of clinical

trials can occur if it is determined that the participants or patients are being exposed to an unacceptable health risk.

Other reasons for suspension or termination may be made by us based on evolving business objectives and/or competitive

Information about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health, or NIH, for public dissemination on its ClinicalTrials.gov website.

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non-orphan indication.

Within 60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the agency accepts it for

The FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.

Within 60 days following submission of the application, the FDA reviews a BLA submitted to determine if it is substantially complete before the agency accepts it for filing.

FDA may refuse to file any BLA that it deems incomplete or not properly reviewable at the time of submission and may request additional information.

In this event, the BLA must be resubmitted with the additional information.

resubmitted application also is subject to review before the FDA accepts it for filing.

The resubmitted

application also is subject to review before the FDA accepts it for filing.

Once the submission is accepted for filing, the FDA begins an in-depth substantive review of the BLA.

The FDA has agreed to specified performance goals in

the review process of BLAs.

The FDA has agreed to specified performance goals in the review

process of BLAs.

Most such applications are meant to be reviewed within ten months from the filing date, and most applications for “priority review” products are meant to be reviewed within six months of the filing date.

process and the PDUFA goal date may be extended by the FDA for three additional months to consider new information or clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original

The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, potent, and/or effective for its intended use, and has an acceptable purity

profile, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, strength, quality, potency and purity.

The FDA may refer an application to an advisory committee for review,

evaluation and recommendation as to whether the application should be approved, and applications for new molecular entities and original BLAs are generally discussed at advisory committee meetings unless the FDA determines that this type of

consultation is not needed under the circumstances.

The review process and

the PDUFA goal date may be extended by the FDA for three additional months to consider new information or clarification provided by the applicant to address an outstanding deficiency identified by the FDA following the original submission.

The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, potent, and effective for its intended use, and has an acceptable purity profile,

and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, safety, strength, quality, potency and purity.

The FDA may refer an application to an advisory committee for review, evaluation

and recommendation as to whether the application should be approved, and applications for new molecular entities and original BLAs are generally discussed at advisory committee meetings unless the FDA determines that this type of consultation

is not needed under the circumstances.

The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

During the biological product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy, or REMS, is necessary to assure the safe use

of the biological product.

During the biological product approval process, the FDA also will determine whether a Risk Evaluation and Mitigation Strategy, or REMS, is necessary to assure the safe use of

the biological product.

To determine whether a REMS is needed, the FDA will consider the size of the population likely to use the product, seriousness of the disease, expected benefit of the product, expected duration of treatment, and

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Before approving a BLA, the FDA will typically inspect the facilities at which the product is manufactured.

These pre-licensing inspections may cover all facilities

associated with a BLA submission, including component manufacturing, finished product manufacturing, and control testing laboratories.

The FDA will not approve the product unless it is satisfied that the manufacturing establishments and

processes supporting the BLA meet the appropriate requirements and comply with the applicable regulations (including cGMP requirements and adequate assurance for consistent commercial production of the product within required specifications).

These pre-licensing inspections may cover all facilities associated

with a BLA submission, including component manufacturing, finished product manufacturing, and control testing laboratories.

The FDA will not approve the product unless it is satisfied that the manufacturing establishments and processes

supporting the BLA meet the appropriate requirements and comply with the applicable regulations (including cGMP requirements and adequate assurance for consistent commercial production of the product within required specifications).

Additionally, before approving a BLA, the FDA will typically conduct a pre-approval inspection of regulated participants in clinical trials (for example, the sponsor, investigators responsible for specific sites, and CROs) to assure that the

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criteria for approval.

If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited,

which could restrict the commercial value of the product.

If a product receives regulatory approval, the approval may be significantly limited to specific diseases and dosages or the indications for use may otherwise be limited, which

could restrict the commercial value of the product.

Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling.

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to further testing requirements and FDA review and approval.

In addition, under the Pediatric Research Equity Act, a BLA or supplement to a BLA for a new indication, dosage form, dosage regimen, or route of administration must contain

data that is adequate to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is

safe and effective.

In addition, under the Pediatric Research Equity Act, a BLA or supplement to a BLA for a new indication, dosage form, dosage regimen, or route of administration must contain data

that is adequate to assess the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe

and effective.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers from the

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Fast track, breakthrough therapy and priority review designations

The FDA is authorized to designate certain products for expedited review if they are intended to address an unmet medical need in the treatment of a serious or

life-threatening disease or condition.

The FDA is authorized to designate certain products for expedited review if they are intended to address an unmet medical need in the treatment of a serious or life-threatening

disease or condition.

These programs are referred to as fast track designation, breakthrough therapy designation and priority review designation.

In May 2014, the FDA published a final Guidance for Industry titled “Expedited

Programs for Serious Conditions-Drugs and Biologics,” which provides guidance on the FDA programs that are intended to facilitate and expedite development and review of new product candidates as well as threshold criteria generally applicable to

concluding that a product candidate is a candidate for these expedited development and review programs.

In May 2014, the FDA published a final Guidance for Industry titled “Expedited Programs for Serious

Conditions-Drugs and Biologics,” which provides guidance on the FDA programs that are intended to facilitate and expedite development and review of new product candidates as well as threshold criteria generally applicable to concluding that a

product candidate is a candidate for these expedited development and review programs.

Specifically, the FDA may designate a product for fast track review if it is intended, whether alone or in combination with one or more other products, for the treatment of a

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and taking other steps to design the clinical trials in an efficient manner.

Third, the FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in

safety or effectiveness.

Third, the FDA may designate a product for priority review if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety

or effectiveness.

The FDA determines, on a case-by-case basis, whether the proposed product represents a significant improvement when compared with other available therapies.

Significant improvement may be illustrated by evidence of

increased effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes, and evidence of

safety and effectiveness in a new subpopulation.

A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application from

ten months to six months.

Significant improvement may be illustrated by evidence of increased

effectiveness in the treatment of a condition, elimination or substantial reduction of a treatment-limiting product reaction, documented enhancement of patient compliance that may lead to improvement in serious outcomes, and evidence of safety

and effectiveness in a new subpopulation.

A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the FDA’s goal for taking action on a marketing application from ten

months to six months.

Accelerated approval pathway

The FDA may grant accelerated approval to a drug for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients over existing

treatments based upon a determination that the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

The FDA may grant accelerated approval to a drug for a serious or life-threatening condition that provides meaningful therapeutic advantage to patients over existing treatments

based upon a determination that the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

The FDA may also grant accelerated approval for such a condition when the product has an effect on an

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traditional approval.

For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is

thought to predict clinical benefit, but is not itself a measure of clinical benefit.

For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to

predict clinical benefit, but is not itself a measure of clinical benefit.

Surrogate endpoints can often be measured more easily or more rapidly than clinical endpoints.

An intermediate clinical endpoint is a measurement of a

therapeutic effect that is considered reasonably likely to predict the clinical benefit of a drug, such as an effect on IMM.

The FDA has limited experience with accelerated approvals based on intermediate clinical endpoints, but has indicated

that such endpoints generally may support accelerated approval where the therapeutic effect measured by the endpoint is not itself a clinical benefit and basis for traditional approval, if there is a basis for concluding that the therapeutic

effect is reasonably likely to predict the ultimate clinical benefit of a drug.

An intermediate clinical endpoint is a measurement of a therapeutic effect

that is considered reasonably likely to predict the clinical benefit of a drug, such as an effect on IMM.

The FDA has limited experience with accelerated approvals based on intermediate clinical endpoints, but has indicated that such endpoints

generally may support accelerated approval where the therapeutic effect measured by the endpoint is not itself a clinical benefit and basis for traditional approval, if there is a basis for concluding that the therapeutic effect is reasonably

likely to predict the ultimate clinical benefit of a drug.

The accelerated approval pathway is most often used in settings in which the course of a disease is long, and an extended period of time is required to measure the intended

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in which the goal of therapy is generally to improve survival or decrease morbidity and the duration of the typical disease course requires lengthy and sometimes large trials to demonstrate a clinical or survival benefit.

The accelerated approval pathway is contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe

the drug’s clinical benefit.

The accelerated approval pathway is contingent on a sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the

drug’s clinical benefit.

As a result, a drug candidate approved on this basis is subject to rigorous post-marketing compliance requirements, including the completion of Phase 4 or post-approval clinical trials to confirm the effect on the

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candidates approved under accelerated regulations are subject to prior review by the FDA.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the

time period for FDA review or approval will not be shortened.

In addition, the manufacturer of an investigational drug for a serious or life-threatening disease is required to make available, such as by posting on its website, its policy on

responding to requests for expanded access.

Furthermore, fast track designation, breakthrough therapy designation, accelerated approval and priority review do not change the standards for approval and may not ultimately expedite the development

or approval process.

Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time

period for FDA review or approval will not be shortened.

In addition, the manufacturer of an investigational drug for a serious or life-threatening disease is required to make available, such as by posting on its website, its policy on responding

to requests for expanded access.

Post-Approval Requirements

Any products for which PDS Biotech receives FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements,

reporting of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include,

among others, standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses or consistent with the approved labeling, known as

‘off-label’ use, limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet.

Although physicians may prescribe legally available products for off-label uses, if

the physicians deem to be appropriate in their professional medical judgment, manufacturers may not market or promote such off-label uses.

Recent court decisions have impacted the FDA’s enforcement activity regarding off-label promotion in

light of First Amendment considerations;

Any products for which PDS Biotech receives FDA approvals are subject to continuing regulation by the FDA, including, among other things, record-keeping requirements, reporting

of adverse experiences with the product, providing the FDA with updated safety and efficacy information, product sampling and distribution requirements, and complying with FDA promotion and advertising requirements, which include, among others,

standards for direct-to-consumer advertising, restrictions on promoting products for uses or in patient populations that are not described in the product’s approved uses or consistent with the approved labeling, known as ‘off-label’ use,

limitations on industry-sponsored scientific and educational activities, and requirements for promotional activities involving the internet.

Although physicians may prescribe legally available products for off-label uses, if the physicians deem

to be appropriate in their professional medical judgment, manufacturers may not market or promote such off-label uses.

Recent court decisions have impacted the FDA’s enforcement activity regarding off-label promotion in light of First Amendment

considerations;

however, there are still significant risks in this area in part due to the potential False Claims Act exposure.

Further, the FDA has not materially changed its position on off-label promotion following

legal setbacks on First Amendment grounds and the DOJ has consistently asserted in FCA briefings that “speech that serves as a conduit for violations of the law is not constitutionally protected.”

After approval, most changes to the approved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval.

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continuing, annual user fee requirements for any marketed products and the establishments at which such products are manufactured, as well as new application fees for supplemental applications with clinical data.

In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the long-term stability

of the product.

In addition, quality control and manufacturing procedures must continue to conform to applicable manufacturing requirements after approval to ensure the long-term stability of

cGMP regulations require among other things, quality control and quality assurance as well as the corresponding maintenance of records and documentation and the obligation to investigate and correct any deviations from cGMP.

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samples continues to be regulated under the PDMA, and some states also impose regulations on drug sample distribution.

Once an approval is granted, the FDA may withdraw the approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the

product reaches the market.

Later discovery of previously unknown problems with a product, including AEs of unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in

revisions to the approved labeling to add new safety information;

Once approval is granted, the FDA may withdraw such approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product

reaches the market.

to the approved labeling to add new safety information;

imposition of post-market studies or clinical trials to assess new safety risks;

or imposition of distribution or other restrictions under a REMS program.

Other potential

consequences include, among other things:

Other potential consequences

include, among other things:

restrictions on the marketing or manufacturing of the product, including total or partial suspension of production, complete withdrawal of the product from the market or product recalls;

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injunctions or the imposition of civil or criminal penalties.

In addition, the distribution of prescription drug products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug

samples at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states.

Both the PDMA and state laws limit the distribution of prescription drug product samples and impose requirements to

ensure accountability in distribution.

In addition, the distribution of prescription drug products is subject to the Prescription Drug Marketing Act, or PDMA, which regulates the distribution of drugs and drug samples

at the federal level, and sets minimum standards for the registration and regulation of drug distributors by the states.

Both the PDMA and state laws limit the distribution of prescription drug product samples and impose requirements to ensure

accountability in distribution.

Failure to comply with any of the FDA’s requirements could result in significant adverse enforcement actions.

These include a variety of administrative or judicial sanctions,

such as refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, modification of promotional

materials or labeling, product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution, debarment, injunctions, fines, consent decrees, corporate integrity

agreements, refusals of government contracts and new orders under existing contracts, exclusion from participation in federal and state healthcare programs, restitution, disgorgement or civil or criminal penalties, including fines and

imprisonment.

It is also possible that failure to comply with the FDA’s requirements relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as

well as state consumer protection laws.

These include a variety of administrative or judicial sanctions, such

as refusal to approve pending applications, license suspension or revocation, withdrawal of an approval, imposition of a clinical hold or termination of clinical trials, warning letters, untitled letters, modification of promotional materials or

labeling, product recalls, product seizures or detentions, refusal to allow imports or exports, total or partial suspension of production or distribution, debarment, injunctions, fines, consent decrees, corporate integrity agreements, refusals of

government contracts and new orders under existing contracts, exclusion from participation in federal and state healthcare programs, restitution, disgorgement or civil or criminal penalties, including fines and imprisonment.

It is also possible

that failure to comply with the FDA’s requirements relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection

Any of these sanctions could result in adverse publicity, among other adverse consequences.

The FDA also may require post-marketing testing, known as Phase 4 testing, and surveillance to monitor the effects of an approved product.

Discovery of previously unknown

problems with a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising

or communications with doctors, and civil or criminal penalties, among others.

Discovery of previously unknown problems

with a product or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial or administrative enforcement, warning letters from the FDA, mandated corrective advertising or

communications with doctors, and civil or criminal penalties, among others.

Newly discovered or developed safety or effectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and

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Once its BLA is approved (“date of first licensure”) the reference biologic is entitled to a period of four years

after its date of first licensure during which time FDA is prohibited from accepting a marketing application that would seek approval of any products that are biosimilar to the branded product.

In addition, the reference biologic is entitled

to a period of 12 years after its date of first licensure during which time the FDA is prohibited from approving marketing applications for any products that are biosimilar to the branded product.

In addition, the first interchangeable

biosimilar may be entitled to a period of one year after its date of first licensure, or other periods keyed to the outcome of patent litigation if instituted, during which the FDA is prohibited from finding that any other biosimilars are

interchangeable to the same reference biologic.

after its date of first licensure during which time FDA is prohibited from accepting a marketing application that would seek approval of any products that are biosimilar to the branded product, known as a data exclusivity because it prohibits

the submission of a BLA application and attendant data.

In addition, the reference biologic is entitled to a period of 12 years after its date of first licensure during which time the FDA is prohibited from approving marketing applications for

any products that are biosimilar to the branded product, known as marketing exclusivity, because it prohibits the approval of a BLA for marketing.

In addition, the first interchangeable biosimilar may be entitled to marketing exclusivity for a

period of one year after its date of first licensure, or other periods keyed to the outcome of patent litigation if instituted, during which the FDA is prohibited from finding that any other biosimilars are interchangeable to the same reference

The reference biologic may also be entitled to regulatory exclusivity under other statutory provisions that apply to biologics and small molecule drugs.

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The FDA may revoke orphan drug designation, and if it does, it will publicize that the drug is no longer designated as an orphan drug.

If the sponsor of a product with orphan designation receives the first FDA approval for that drug for the disease or condition for which it has such designation or for a

select indication or use within the rare disease or condition for which it was designated, the product generally will receive orphan product exclusivity.

Orphan product exclusivity means that the FDA may not approve any other applications for

the same product for the same indication for seven years, except in certain limited circumstances.

If a drug or drug product designated as an orphan product ultimately receives marketing approval for an indication broader than what was

designated in its orphan product application, it may not be entitled to exclusivity.

Orphan drug exclusivity, however, could also block the approval of one of our therapeutic candidates for seven years if a competitor obtains orphan drug

designation and FDA approval of the same therapeutic candidate for the same condition or disease as our orphan-designated drug.

If the sponsor of a product with orphan designation receives the first FDA approval for that drug for the disease or condition for which it has such designation or for a select

indication or use within the rare disease or condition for which it was designated, the product generally will receive orphan product exclusivity.

Orphan product exclusivity provides marketing exclusivity which means that the FDA may not

approve any other applications for the same product for the same indication for seven years, except in certain limited circumstances.

If a drug or drug product designated as an orphan product ultimately receives marketing approval for an

indication broader than what was designated in its orphan product application, it may not be entitled to exclusivity.

Orphan drug exclusivity, however, could also block the approval of one of our therapeutic candidates for seven years if a

competitor obtains orphan drug designation and FDA approval of the same therapeutic candidate for the same condition or disease as our orphan-designated drug.

Orphan exclusivity will not bar approval of another product under certain circumstances, including if a subsequent product with the same active ingredient for the same

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The sponsor may apply to FDA to issue a WR.

Pediatric exclusivity operates by adding six months of exclusivity to the end of the latest-expiring form of exclusivity and

may apply to patent rights or to FDA regulatory exclusivities.

Pediatric exclusivity operates by adding six months of marketing exclusivity to the end of the latest-expiring form of

exclusivity and may apply to patent rights or to FDA regulatory exclusivities.

To qualify for pediatric exclusivity, at least one of those rights must still be currently in force at the time FDA approves the pediatric studies.

Under the Pediatric Research Equity Act of 2003, an NDA, BLA, or supplement thereto must contain data that is adequate to assess the safety and effectiveness of the drug

product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

With enactment of the Food and Drug

Administration Safety and Innovation Act of 2012 (FDASIA), sponsors must also submit pediatric study plans prior to the assessment data.

Under the Pediatric Research Equity Act of 2003, an NDA, BLA, or supplement thereto must contain data that is adequate to assess the safety and effectiveness of the drug product

for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

With enactment of the Food and Drug Administration Safety

and Innovation Act of 2012 (FDASIA), sponsors must also submit pediatric study plans prior to the assessment data.

Those plans must contain an outline of the proposed pediatric study or studies the applicant plans to conduct, including study objectives and design, any deferral or waiver

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request an amendment to the plan at any time.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for

use in adults, or full or partial waivers from the pediatric data requirements.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in

adults, or full or partial waivers from the pediatric data requirements.

Additional requirements and procedures relating to deferral requests and requests for extension of deferrals are contained in FDASIA.

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under patent protection.

In the U.S., a patent claiming a new drug product may be eligible for a limited patent term extension under the Hatch-Waxman Act, which permits a patent restoration of up to five years for patent term lost during product

development and the FDA regulatory review.

The restoration period granted is typically one-half the time between the effective date of an IND and the submission date of an NDA less any time the applicant did not act with due diligence during the

period, plus the time between the submission date of an NDA and the ultimate approval date less any time the applicant did not act with due diligence during the period.

Patent term restoration cannot be used to extend the remaining term of a

patent past a total of 14 years from the product’s approval date.

Only one patent applicable to an approved drug product is eligible for the extension, only those claims covering the approved drug, a method for using it, or a method for

manufacturing it may be extended, and the application for the extension must be submitted prior to the expiration of the patent in question.

A patent that covers multiple drugs for which approval is sought can only be extended in connection with

one of the approvals.

The USPTO reviews and approves the application for any patent term extension or restoration in consultation with the FDA.

Similar provisions are available in Europe and other foreign jurisdictions to extend the term of a

patent that covers an approved drug.

In the future, if and when our products receive FDA approval, we expect to apply for patent term extensions on patents covering those products.

We plan to seek patent term extensions to any of our issued

patents in any jurisdiction where these are available, however there is no guarantee that the applicable authorities, including the FDA in the United States, will agree with our assessment of whether such extensions should be granted, and if

granted, the length of such extensions.

For more information regarding the risks related to our intellectual property, see “Risk Factors—Risks Related to Our Intellectual Property.”

In the U.S., a patent claiming a new drug product may be eligible for a limited patent term extension or PTE under the Hatch-Waxman Act, which permits the extension of a patent term by up to five years for patent term

lost during product development and the FDA regulatory review.

The PTE period granted is typically one-half the time between the effective date of an IND and the submission date of an NDA less any time the applicant did not act with due diligence

during the period, plus the time between the submission date of an NDA and the ultimate approval date less any time the applicant did not act with due diligence during the period.

A PTE cannot extend the remaining term of a patent past a total of

14 years from the product’s approval date.

Only one patent applicable to an approved drug product is eligible for the PTE, only those claims covering the approved drug, a method for using it, or a method for manufacturing it may be extended, and

the application for the PTE must be submitted prior to the expiration of the patent in question.

A patent that covers multiple drugs for which approval is sought can only be extended in connection with one of the approvals.

The USPTO reviews and

approves the application for any PTE in consultation with the FDA.

Similar provisions are available in Europe and other foreign jurisdictions to extend the term of a patent that covers an approved drug.

In the future, if and when our products

receive FDA approval, we expect to apply for PTE on patents covering those products.

We plan to seek PTEs to any of our issued patents in any jurisdiction where these are available, however there is no guarantee that the applicable authorities,

including the FDA in the United States, will agree with our assessment of whether such extensions should be granted, and if granted, the length of such extensions.

For more information regarding the risks related to our intellectual property, see

“Risk Factors—Risks Related to Our Intellectual Property.”

Healthcare Laws and Compliance Requirements

In the United States, PDS Biotech’s activities are potentially subject to regulation, either directly or indirectly, by various federal, state and local authorities in

addition to the FDA, including but not limited to, the Centers for Medicare and Medicaid Services, or CMS, other divisions of the U.S.

In the United States, PDS Biotech’s activities are potentially subject to regulation, either directly or indirectly, by various federal, state and local authorities in addition

to the FDA, including but not limited to, the Centers for Medicare and Medicaid Services, or CMS, other divisions of the U.S.

Department of Health and Human Services, for instance the Office of Inspector General (OIG), the U.S.

Department of Justice (DOJ), and individual U.S.

Department of

Justice (DOJ), and individual U.S.

Attorney offices within the DOJ, and state and local governments.

For example, sales, marketing and scientific/educational grant programs must comply with the anti-fraud and abuse provisions of

the Social Security Act, the criminal provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the federal Anti-Kickback Statute, the federal false claims laws, the physician payment transparency laws, and similar

state laws, each as amended.

For example, sales, marketing and scientific/educational grant programs must comply with the anti-fraud and abuse provisions of the Social

Security Act, the criminal provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the federal Anti-Kickback Statute, the federal false claims laws, the physician payment transparency laws, and similar state laws,

each as amended.

The compliance and enforcement landscape, and related risk, is informed by government enforcement precedent and settlement history, Advisory Opinions, and Special Fraud Alerts.

Our approach to compliance may evolve

over time in light of these types of developments.

The federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting or receiving any

remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid

or other federal healthcare programs.

Our approach to compliance may evolve over time in

light of these types of developments.

The federal Anti-Kickback Statute prohibits, among other things, any person or entity, from knowingly and willfully offering, paying, soliciting or receiving any remuneration,

directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable under Medicare, Medicaid or other

federal healthcare programs.

The term remuneration has been interpreted broadly to include anything of value.

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follow-on civil litigation, among other things, for both entities and individuals.

Additionally, the intent standard under the Anti-Kickback Statute was amended by the Affordable Care Act to a stricter standard such that a person or entity no longer needs

to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

Additionally, the intent standard under the Anti-Kickback Statute was amended by the Affordable Care Act to a stricter standard such that a person or entity no longer needs to

have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

In addition, the Affordable Care Act codified case law that a claim including items or services resulting from a violation of the

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connection with the delivery of or payment for healthcare benefits, items or services.

The civil monetary penalties statute imposes penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a

claim to a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.

The Federal Civil Monetary Penalties Law authorizes the imposition of substantial civil

monetary penalties against an entity, such as a pharmaceutical manufacturer, that engages in activities including, among others (1) knowingly presenting, or causing to be presented, a claim for services not provided as claimed or that is

otherwise false or fraudulent in any way;

The civil monetary penalties statute imposes penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to

a federal health program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent.

The Federal Civil Monetary Penalties Law authorizes the imposition of substantial civil monetary

penalties against an entity, such as a pharmaceutical manufacturer, that engages in activities including, among others (1) knowingly presenting, or causing to be presented, a claim for services not provided as claimed or that is otherwise false

or fraudulent in any way;

(2) arranging for or contracting with an individual or entity that is excluded from participation in federal healthcare programs to provide items or services reimbursable by a federal healthcare program;

(3) violations of the federal Anti-Kickback Statute;

(3) violations

of the federal Anti-Kickback Statute;

or (4) failing to report and return a known overpayment.

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these laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product.

Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of the product for unapproved, and thus non-reimbursable,

HIPAA created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false

or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or

Other companies have been prosecuted for causing false claims to be submitted because of the companies’ marketing of the product for unapproved, and thus non-reimbursable, uses.

HIPAA created new federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or

fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors and knowingly and willfully falsifying, concealing or

covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

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PDS Biotech may be subject to data privacy and security regulations by both the federal government and the states in which it conducts its business.

We are not a covered

entity under HIPAA and have not functioned as a business associate under HIPAA that would cause the HIPAA Security Rule and provisions of the Privacy Rule to apply directly to us as a business associate.

To the extent that we ever function in

a business associate capacity, HIPAA, as amended by the HITECH Act, and its respective implementing regulations, including the final omnibus rule published on January 25, 2013, imposes requirements relating to the privacy, security and

We are not a covered entity

under HIPAA and have not functioned as a business associate under HIPAA that would cause the HIPAA Security Rule and provisions of the Privacy Rule to apply directly to us as a business associate.

To the extent that we ever function in a

business associate capacity, HIPAA, as amended by the HITECH Act, and its respective implementing regulations, including the final omnibus rule published on January 25, 2013, imposes requirements relating to the privacy, security and

transmission of individually identifiable health information.

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to incur substantial costs and expenses to comply.

Even for entities that are not deemed “covered entities” or “business associates” under HIPAA, according to the United States Federal Trade Commission, or the FTC, failing to

take appropriate steps to keep consumers’ personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act, or the FTCA, 15 USC § 45(a).

Even for entities that are not deemed “covered entities” or “business associates” under HIPAA, according to the United States Federal Trade Commission, or the FTC, failing to take

appropriate steps to keep consumers’ personal information secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act, or the FTCA, 15 USC § 45(a).

The FTC expects a

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authority under Section 5 is concurrent with HIPAA’s jurisdiction and with any action taken under state law.

Additionally, the Federal Physician Payments Sunshine Act under the Affordable Care Act, and its implementing regulations, require that certain manufacturers of drugs,

devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with certain exceptions, report information related to certain payments or other transfers of value

made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held

by physicians and their immediate family members.

Failure to timely, accurately, and completely submit the required information may result in civil monetary penalties of up to an aggregate of $150,000 per year and up to an aggregate of $1

million per year for “knowing failures”.

In 2022 the Sunshine Act reporting will be extended to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level practitioners (with reporting requirements going

into effect in 2022 for payments made in 2021).

Additionally, the Federal Physician Payments Sunshine Act under the Affordable Care Act, and its implementing regulations, require that certain manufacturers of drugs, devices,

biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with certain exceptions, report information related to certain payments or other transfers of value made or

distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by

physicians and their immediate family members.

Failure to timely, accurately, and completely submit the required information may result in civil monetary penalties of up to an aggregate of $150,000 per year and up to an aggregate of $1 million

per year for “knowing failures”.

effect in 2022 for payments made in 2021).

Certain states also mandate implementation of compliance programs, impose restrictions on pharmaceutical manufacturer marketing practices and/or require the tracking and reporting of gifts,

compensation and other remuneration to healthcare providers and entities.

In order to distribute products commercially, PDS Biotech must also comply with state laws that require the registration of manufacturers and wholesale distributors of drug

and biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state.

In order to distribute products commercially, we must also comply with state laws that require the registration of manufacturers and wholesale distributors of drug and

biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state.

Several states have enacted

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All of PDS Biotech’s activities are potentially subject to federal and state consumer protection and unfair competition laws.

We expect that one or more of our products, if approved, may be eligible for coverage under Medicare, the federal health care program that provides health care benefits to

the aged and disabled, including coverage for outpatient services and supplies, such as certain drug products, that are medically necessary to treat a beneficiary’s health condition.

We expect that one or more of our products, if approved, may be eligible for coverage under Medicare, the federal health care program that provides health care benefits to the

aged and disabled, including coverage for outpatient services and supplies, such as certain drug products, that are medically necessary to treat a beneficiary’s health condition.

In addition, one or more of our products, if approved, may be

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outpatient drugs purchased by statutorily defined covered entities that participate in the program.

In addition, federal law requires that, in order for payment to be available for a manufacturer’s drugs under Medicaid and Medicare Part B, as well as to be purchased by

certain federal agencies and grantees, it must also participate in the Department of Veterans Affairs (“VA”) Federal Supply Schedule (“FSS”) pricing program.

To participate, manufacturers are required to enter into an FSS contract and other

agreements with the VA for their covered drugs.

Under these agreements, manufacturers must make their covered drugs available to the “Big Four” federal agencies— the VA, the Department of Defense (“DoD”), the Public Health Service (including

the Indian Health Service), and the Coast Guard—at pricing that is capped pursuant to a statutory federal ceiling price, or FCP, formula.

The FCP is based on a weighted average non-federal average manufacturer price, which manufacturers are

required to report on a quarterly and annual basis to the VA.

Further, pursuant to regulations issued by the DoD to implement Section 703 of the National Defense Authorization Act for Fiscal Year 2008, manufacturers may enter into an agreement

with the Defense Health Agency (DHA) under which they agree to honor “Big Four” pricing for their covered drugs when they are dispensed to TRICARE beneficiaries by TRICARE retail network pharmacies.

In addition, federal law requires that, in order for payment to be available for a manufacturer’s drugs under Medicaid and Medicare Part B, as well as to be purchased by certain

federal agencies and grantees, it must also participate in the Department of Veterans Affairs (“VA”) Federal Supply Schedule (“FSS”) pricing program.

To participate, manufacturers are required to enter into an FSS contract and other agreements

with the VA for their covered drugs.

Health Service), and the Coast Guard—at pricing that is capped pursuant to a statutory federal ceiling price, or FCP, formula.

The FCP is based on a weighted average non-federal average manufacturer price, which manufacturers are required to

report on a quarterly and annual basis to the VA.

Further, pursuant to regulations issued by the DoD to implement Section 703 of the National Defense Authorization Act for Fiscal Year 2008, manufacturers may enter into an agreement with the

Defense Health Agency (DHA) under which they agree to honor “Big Four” pricing for their covered drugs when they are dispensed to TRICARE beneficiaries by TRICARE retail network pharmacies.

As part of the requirements to participate in these government programs, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the

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Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs.

possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations, guidance, case law or other applicable law.

If our operations are found to be in violation of any of

these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, individual imprisonment, exclusion from participation in federal health care

programs, such as Medicare and Medicaid, disgorgement, reputational harm, additional oversight and reporting obligations pursuant to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with applicable

laws and regulations, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to market our products, if approved, and adversely impact our financial results.

Although effective compliance

programs can mitigate the risk of investigation and prosecution for violations of these laws and regulations, these risks cannot be eliminated entirely.

Any action against us for an alleged or suspected violation could cause us to incur

significant legal expenses and could divert our management’s attention from the operation of our business, even if our defense is successful.

If any of the physicians or other healthcare providers or entities with whom we expect to do business

is found not to be in compliance with applicable laws, it may be costly to us in terms of money, time and resources, and they may be subject to criminal, civil or administrative sanctions, including exclusions from government-funded healthcare

It is possible

that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations, guidance, case law or other applicable law.

If our operations are found to be in violation of any of these laws

or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, individual imprisonment, exclusion from participation in federal health care programs,

such as Medicare and Medicaid, disgorgement, reputational harm, additional oversight and reporting obligations pursuant to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with applicable laws and

regulations, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to market our products, if approved, and adversely impact our financial results.

Although effective compliance programs can

mitigate the risk of investigation and prosecution for violations of these laws and regulations, these risks cannot be eliminated entirely.

Any action against us for an alleged or suspected violation could cause us to incur significant legal

expenses and could divert our management’s attention from the operation of our business, even if our defense is successful.

If any of the physicians or other healthcare providers or entities with whom we expect to do business is found not to be

in compliance with applicable laws, it may be costly to us in terms of money, time and resources, and they may be subject to criminal, civil or administrative sanctions, including exclusions from government-funded healthcare programs.

The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of

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and resource-consuming and can divert management’s attention from the business, even if investigators ultimately find that no violation has occurred.

If PDS Biotech operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental regulations that applies to

it, PDS Biotech may be subject to penalties, including without limitation, civil, criminal and/or administrative penalties;

If PDS Biotech operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental regulations that applies to it,

PDS Biotech may be subject to penalties, including without limitation, civil, criminal and/or administrative penalties;

disgorgement;

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administrative burdens;

profits and future earnings;

diminished profits and future

and the curtailment or restructuring of its operations;

any of which could adversely affect PDS Biotech’s ability to operate its business and its results of operations.

In addition to the laws discussed above, we may see more stringent state and federal privacy legislation in the future, as the increased instances of cyber-attacks have

heightened attention to data privacy and security in the U.S.

In addition to the laws discussed above, we may see more stringent state and federal privacy legislation in the future, as the increased instances of cyber-attacks have heightened

attention to data privacy and security in the U.S.

and other jurisdictions.

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Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which PDS Biotech obtains regulatory approval.

In the United States

and markets in other countries, sales of any products for which PDS Biotech receives regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors provide coverage, and establish adequate reimbursement

levels for such products.

Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we obtain regulatory approval.

In the United States and markets in

other countries, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors provide coverage, and establish adequate reimbursement levels for such products.

In the United States, third-party payors include federal and state healthcare programs, private managed care providers, health insurers and other organizations.

The process for determining whether a third-party payor

will provide coverage for a product may be separate from the process for setting the price of a product or for establishing the reimbursement rate that such a payor will pay for the product.

Third-party payors may limit coverage to specific

products on an approved list, also known as a formulary, which might not include all of the FDA-approved products for a particular indication.

Third-party payors are increasingly challenging the price, examining the medical necessity, and

reviewing the cost-effectiveness of medical products, therapies and services, in addition to questioning their safety and efficacy.

PDS Biotech may need to conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity

and cost-effectiveness of its product candidates, in addition to the costs required to obtain the FDA approvals.

PDS Biotech’s product candidates may not be considered medically necessary or cost-effective.

A payor’s decision to provide coverage

for a product does not imply that an adequate reimbursement rate will be approved.

No uniform policy requirement for coverage and reimbursement exists among third-party payors in the United States, which causes significant uncertainty related to

the insurance coverage and reimbursement of newly approved products, and the procedures which may utilize such newly approved products.

Further, one payor’s determination to provide coverage for a product does not assure that other payors will

also provide coverage for the product.

The process for determining whether a third-party payor will provide coverage for a

product may be separate from the process for setting the price of a product or for establishing the reimbursement rate that such a payor will pay for the product.

Third-party payors may limit coverage to specific products on an approved list,

also known as a formulary, which might not include all of the FDA-approved products for a particular indication.

Third-party payors are increasingly challenging the price, examining the medical necessity, and reviewing the cost-effectiveness of

medical products, therapies and services, in addition to questioning their safety and efficacy.

We may need to conduct expensive pharmaco-economic studies in order to demonstrate the medical necessity and cost-effectiveness of our product

candidates, in addition to the costs required to obtain the FDA approvals.

Our product candidates may not be considered medically necessary or cost-effective.

A payor’s decision to provide coverage for a product does not imply that an adequate

reimbursement rate will be approved.

No uniform policy requirement for coverage and reimbursement exists among third-party payors in the United States, which causes significant uncertainty related to the insurance coverage and reimbursement of

newly approved products, and the procedures which may utilize such newly approved products.

Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product.

Therefore, coverage and reimbursement can differ significantly from payor to payor and health care provider to health care provider.

As a result, the coverage determination process is often a time-consuming

and costly process that requires the provision of scientific and clinical support for the use of new products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the

first instance.

Adequate third-party reimbursement may not be available to enable PDS Biotech to maintain price levels sufficient to realize an appropriate return on its investment in product development.

As a result, the coverage determination process is often a time-consuming and costly process that requires the

provision of scientific and clinical support for the use of new products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

Adequate third-party

reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on its investment in product development.

Different pricing and reimbursement schemes exist in other countries.

Some jurisdictions operate positive and negative list systems under which products may only be

marketed once a reimbursement price has been agreed.

To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical studies that compare the cost-effectiveness of a particular product candidate to

currently available therapies.

Some jurisdictions operate positive and negative list systems under which products may only be marketed

once a reimbursement price has been agreed.

To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical studies that compare the cost-effectiveness of a particular product candidate to currently

available therapies.

Other countries allow companies to fix their own prices for medicines, but monitor and control company profits.

The downward pressure on health care costs has become very intense.

As a result, increasingly high

barriers are being erected to the entry of new products.

As a result, increasingly high barriers are

being erected to the entry of new products.

In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.

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coverage policies and reimbursement rates may be implemented in the future.

There may be significant delays in obtaining coverage and reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product

is approved by the FDA.

Moreover, eligibility for coverage and reimbursement does not imply that a product, or the procedures which utilize such product, will be paid for in all cases or at a rate which the health care providers who purchase

those products will find cost effective.

Additionally, we expect pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance

organizations, and additional legislative changes.

We cannot be sure that coverage and reimbursement will be available for any product that we commercialize, or the procedures which utilize such product, and, if reimbursement

is available, what the level of reimbursement will be.

There may be significant delays in obtaining coverage and reimbursement for newly approved products, and coverage may be more limited than the purposes for which the product is

approved by the FDA.

products will find cost effective.

Additionally, we expect pricing pressures in connection with the sale of any of our product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations,

and additional legislative changes.

We cannot be sure that coverage and reimbursement will be available for any product that we commercialize, or the procedures which utilize such product, and, if reimbursement is

available, what the level of reimbursement will be.

Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval.

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above, are the following:

an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in

certain federal programs identified in the PPACA;

expansion of beneficiary eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain individuals with income at or below 138% of the federal

poverty level, thereby potentially increasing manufacturers’ Medicaid rebate liability;

an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain

federal programs identified in the PPACA;

level, thereby potentially increasing manufacturers’ Medicaid rebate liability;

expansion of manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both branded and generic drugs and revising the definition of “average manufacturer

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annual reporting of certain information regarding drug samples that manufacturers and distributors provide to licensed practitioners.

The framework of the PPACA continues to evolve as a result of executive, legislative, regulatory, and administrative developments that have challenged the law and

contribute to legal uncertainty that could affect the profitability of our products.

While the United States Congress has not enacted legislation to comprehensively repeal the PPACA, legislation affecting the PPACA has been signed into law,

including the elimination, effective January 1, 2019, of the tax-based shared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year, which is commonly

referred to as the “individual mandate.” In December 2018, a federal district court in Texas ruled that the PPACA’s individual mandate, without the penalty that was eliminated effective January 1, 2019, was unconstitutional and could not be

severed from the PPACA.

The framework of the PPACA continues to evolve as a result of executive, legislative, regulatory, and administrative developments that have challenged the law and contribute to

legal uncertainty that could affect the profitability of our products.

While the United States Congress has not enacted legislation to comprehensively repeal the PPACA, legislation affecting the PPACA has been signed into law, including the

elimination, effective January 1, 2019, of the tax-based shared responsibility payment imposed by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year, which is commonly referred to as the

“individual mandate.” In December 2018, a federal district court in Texas ruled that the PPACA’s individual mandate, without the penalty that was eliminated effective January 1, 2019, was unconstitutional and could not be severed from the

As a result, the court ruled the remaining provisions of the PPACA were also invalid.

The Fifth Circuit Court of Appeals affirmed the district court’s ruling that the individual mandate was unconstitutional, but it

remanded the case back to the district court for further analysis of whether the mandate could be severed from the PPACA (i.e., whether the entire PPACA was therefore also unconstitutional).

The Fifth Circuit Court of Appeals affirmed the district court’s ruling that the individual mandate was unconstitutional, but it remanded the case back

to the district court for further analysis of whether the mandate could be severed from the PPACA (i.e., whether the entire PPACA was therefore also unconstitutional).

On June 17, 2021, the U.S.

Supreme Court dismissed

this challenge without specifically ruling on the constitutionality of the PPACA.

Supreme Court dismissed this challenge without

specifically ruling on the constitutionality of the PPACA.

Effective January 1, 2019, the Bipartisan Budget Act of 2018, among other things, further amended portions of the Social Security Act implemented as part of the PPACA to

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In addition, other legislative changes have been proposed and adopted since the PPACA was enacted.

For example, the Budget Control Act of 2011, among other things, resulted

in reductions in payments to Medicare providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislation, will remain in effect through 2031, with the exception of a temporary suspension of the payment

For example, the Budget Control Act of 2011, among other things, resulted in

reductions in payments to Medicare providers of 2% per fiscal year, which went into effect on April 1, 2013 and, due to subsequent legislation, will remain in effect through 2031, with the exception of a temporary suspension of the payment

reduction which occurred from May 1, 2020 through March 31, 2022 due to the coronavirus pandemic.

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profitability, or commercialize products for which we may receive regulatory approval in the future.

Most recently, on August 16, 2022 the Inflation Reduction Act of 2022, or IRA was signed into law.

Among other things, the IRA requires manufacturers of certain drugs to

engage in price negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap;

On August 16, 2022 the Inflation Reduction Act of 2022, or IRA, was signed into law.

Among other things, the IRA requires manufacturers of certain drugs to engage in price

negotiations with Medicare (beginning in 2026), with prices that can be negotiated subject to a cap;

imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023);

and replaces the Part D coverage gap discount program with a new discounting program (beginning in 2025).

The IRA permits the Secretary of the Department of Health and Human Services (HHS) to implement many of these provisions through

guidance, as opposed to regulation, for the initial years.

the Part D coverage gap discount program with a new discounting program (beginning in 2025).

The IRA permits the Secretary of the Department of Health and Human Services (HHS) to implement many of these provisions through guidance, as opposed

to regulation, for the initial years.

For that and other reasons, it is currently unclear how the IRA will be effectuated, and the impact of the IRA on the pharmaceutical industry cannot yet be fully determined.

We expect that these and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and/or new payment methodologies,

and place additional downward pressure on the price that we receive for any approved product and/or the level of reimbursement physicians and other healthcare providers receive for administering any approved product we might bring to market.

Reductions in reimbursement levels and imposition of more rigorous coverage criteria or new payment methodologies may negatively impact the prices we receive or the frequency with which our products are prescribed or administered.

or reimbursement policies instituted by Medicare or other federal health care programs may result in similar policies from private payors.

The implementation of cost containment measures or other healthcare reforms may affect our ability to

generate revenue, attain or maintain profitability, or commercialize our drug candidates.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal

and state governments will pay for healthcare products and services, which could result in reduced demand for our drug candidates or additional pricing pressures.

We expect that these and other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and/or new payment methodologies, and

place additional downward pressure on the price that we receive for any approved product and/or the level of reimbursement physicians and other healthcare providers receive for administering any approved product we might bring to market.

Reductions in reimbursement levels and implementation of more rigorous coverage criteria or new payment methodologies may negatively impact the prices we receive or the frequency with which our products are prescribed or administered.

coverage or reimbursement policies instituted by Medicare or other federal health care programs may result in similar policies from private payors.

The implementation of cost containment measures or other healthcare reforms may affect our

ability to generate revenue, attain or maintain profitability, or commercialize our drug candidates.

We expect that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that

federal and state governments will pay for healthcare products and services, which could result in reduced demand for our drug candidates or additional pricing pressures.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including

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Our management team possesses considerable experience in drug development research, manufacturing, clinical development and regulatory matters.

PDS Biotech’s virtual

operating strategy of collaborating with scientific and clinical experts in cancer immunology, tumor immunology and gynecological oncology provides additional considerable experience in immunotherapy development, clinical design and execution.

We have no collective bargaining agreements with our employees, and we have not experienced any work stoppages.

PDS Biotech’s virtual operating

strategy of collaborating with scientific and clinical experts in cancer immunology, tumor immunology and gynecological oncology provides additional considerable experience in immunotherapy development, clinical design and execution.

collective bargaining agreements with our employees, and we have not experienced any work stoppages.

As of December 31, 2024, we had 24 employees, all of whom were full time employees.

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We believe we are compliant in all material respects with applicable environmental laws.

Presently, we do not anticipate such compliance will have a material effect on

capital expenditures, earnings, or our competitive position with respect to any of our operations.

Presently, we do not anticipate such compliance will have a material effect on capital

expenditures, earnings, or our competitive position with respect to any of our operations.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business