UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

☒ ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2023

For the transition period from ________to ________

Commission file number 001-37568

PDS Biotechnology Corporation

(Exact name of registrant as specified in its charter)

303A College Road EastPrinceton, NJ08540

(Address of principal executive offices)

(800) 208-3343

(Registrant’s telephone number)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class Trading symbol(s) Name of each exchange on which registered

Common Stock, par value $0.00033 per share PDSB The NASDAQ Stock Market LLC

Securities registered pursuant to Section 12(b) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of

1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405

of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company

or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

☐ Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any

new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☐

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal

control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based

compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

The aggregate market value of the voting and non-voting common equity held by non-affiliates (without admitting that any person whose shares are not

included in such calculation is an affiliate) of the registrant as of June 30, 2023, was $148,298,700 (based on the closing price for

shares of the registrant’s common stock as reported on the Nasdaq Capital Market on that date).

The number of shares of the registrant’s common stock, par value $0.00033 per share, outstanding as of March 21, 2024 was 36,679,275.

Documents Incorporated By Reference

Portions of registrant’s definitive proxy statement relating to registrant’s 2024 Annual Meeting of Stockholders (the “Proxy Statement”) to be filed

with the Securities and Exchange Commission pursuant to Regulation 14A, not later than 120 days after the close of the registrant’s fiscal year ended December 31, 2023, are incorporated by reference in Part III of this Annual Report on Form 10-K.

Except with respect to information specifically incorporated by reference in this Annual Report on Form 10-K, the Proxy Statement is not deemed to be filed as part of this Annual Report on Form 10-K.

PDS BIOTECHNOLOGY CORPORATION

FORM 10-K FOR THE YEAR ENDED DECEMBER 31, 2023

INDEX

PAGE

PART I

Item 1 Business 4

Item 1A Risk Factors 48

Item 1B Unresolved Staff Comments 86

Item 1C Cybersecurity 86

Item 2 Properties 86

Item 3 Legal Proceedings 86

Item 4 Mine Safety Disclosures 86

PART II

Item 7A Qualitative and qualitative disclosures about market risk 102

Item 8 Financial Statements and Supplementary Data 102

Item 9A Controls and Procedures 103

Item 9B Other Information 103

Item 9C Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 103

PART III

Item 10 Directors, Executive Officers and Corporate Governance 104

Item 11 Executive Compensation 104

Item 14 Principal Accountant Fees and Services 104

PART IV

Item 15 Exhibits and Financial Statement Schedules 104

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Cautionary Note Regarding Forward-Looking Statements

This Annual Report on Form 10-K (this “Annual Report”) contains forward-looking statements (including within the meaning of Section 21E of the United States Securities

Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning the Company and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends,

events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally

include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,”

“intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future

performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation.

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

Any forward-looking statements in this Annual Report reflect our current views with respect to future events or to our future financial performance and involve known and

unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking

statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, whether as a

result of new information, future events or otherwise.

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

to PDS Biotechnology Corporation, a Delaware corporation.

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PART I

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

Biotechnology Corporation and our subsidiary.

ITEM 1. Business

Company Overview

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer 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. 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. When paired with an antigen, which is a disease-related protein that is recognizable by the immune system,

Versamune® and Infectimune® have both been shown to induce, in vivo, large quantities of high-quality, highly potent polyfunctional disease-specific CD4 helper and CD8 killer T cells, a specific

sub-type of T cell that has shown potential to be more effective at killing infected or target cells. Infectimune® is also designed to promote the induction of disease-specific neutralizing antibodies. PDS01ADC is an investigational tumor

targeting IL-12 that we believe may enhance the proliferation, potency and longevity of T cells in the tumor microenvironment and reduces the prevalence of immune suppressive cells and components within the tumor. We believe 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 37th

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”.

In December 2022, we executed an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor targeting IL12 fused antibody drug conjugate, M9241, which joined our

pipeline as PDS01ADC. 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.

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

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

Scientific Working Group on Influenza (ESWI) conference. This data demonstrated broad neutralization across multiple influenza strains in animals and provided protection against infection after challenging animals not previously exposed to flu

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. 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, interim safety and immune response data was presented for the first-in-human Phase 1/2 clinical trial evaluating PDS01ADC in combination with current SOC chemotherapy, docetaxel,

to treat metastatic castration sensitive and castration resistant prostate cancer. The data was featured in an oral presentation at the 11th Annual Meeting of the

International Cytokine & Interferon Society.

In October 2023, immune response data from a preliminary analysis of a subset of patients in our VERSATILE-002 Phase 2 clinical trial was presented at the European Society for Medical Oncology

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 38th Annual Meeting.

The challenges to effective immunotherapy

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

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

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

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Cancer Immunotherapy

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

cancer immunotherapy is to improve patient quality of life and to extend patient life by slowing down progression of the cancer, causing shrinkage of the tumors and in some cases eradication of the cancer. The body’s immune system is a complex,

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

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

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

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

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

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

● Activate, arm and expand large numbers of T cells that recognize the tumor

As stated in the June 2019 issue of The Journal of Immunology, a leading peer-reviewed journal in the field of immunology, our Versamune® platform possesses each of

these attributes, inducing potent anti-tumor responses in preclinical studies. (Gandhapudi, et al., J. Immunology, June 2019; Rumfield et al, J. Journal for ImmunoTherapy of Cancer, May 2020). We

believe our Versamune® technology platform 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. bacteria and viruses). The presentation of an antigen to T cells is implemented

primarily in the lymph nodes by specialized antigen presenting cells known as dendritic cells which are programmed specially to identify foreign antigens, process them and to present them to T cells. Unique proteins on the surface of dendritic

cells, known as major histocompatibility complex (MHC) molecules, bind to the foreign antigen and display them on the cell surface for recognition by the appropriate T cells. Then, once presented, a sub-population of T cells known as the CD8 or

killer T cells, are primed and respond to the specific foreign antigen by attacking and killing the cells containing the abnormal protein. Other T cell sub-populations, such as CD4 or helper T cells, are also critical in regulating immune

responses.

Cells communicate via chemical signaling. For an immune response to be triggered and to be effective, important immune signaling pathways must be activated to enable the

body to induce messenger proteins known as cytokines and chemokines. Some of these cytokines and chemokines serve both to activate and expand T cells and to arm the T cells with the appropriate cancer-killing function.

An effective cancer immunotherapy must modulate these complex processes, enhancing activation and producing robust expansion of the critically important high-quality,

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

a patient’s own body has been a major limitation of cancer immunotherapy.

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

stems from the fact that cancer cells have the unique ability to evade the immune system; they camouflage themselves or suppress T cell attack by activating immune mechanisms that suppress the ability of T cells to detect or attack them. They

accomplish this in part by increasing the population of immune suppressive cells, including cells known as regulatory T cells (Treg) as well as other cell types, within the tumor microenvironment. An effective immunotherapy must overcome the

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

Finally, cancers can be difficult to cure because they may recur even after successful initial treatment due to micro-metastatic (hidden) tumors that are not completely

eradicated after treatment and that eventually expand. It is yet another task of the immune system to remain vigilant over a sustained period to mitigate the risk of recurrence. Such vigilance may be mediated by memory T cells which serve as

the immune system’s long-term memory. To be durable and effective over an extended period after treatment, and to minimize the likelihood of cancer recurrence, immunotherapy should enhance this immune function as well.

Versamune®Platform

Versamune® has 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® derived products are based on positively charged (cationic) and immune activating lipids that form spherical nanoparticles in aqueous media. These lipids include the R-enantiomer of

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

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

system and uptake by dendritic cells.

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

pharmaceutical product for simple subcutaneous injection.

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

One of the biggest challenges in developing a potent immunotherapy is 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. 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

draining lymph node were found to have taken up the Versamune® based immunotherapy.

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

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

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

endosomes in the cell, promoting efficient entry of the antigen into the cell compartment where processing can take place. Processed antigen is turned into peptides that then present in both the MHC class I and class II pathways. The MHC class I

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

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

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

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

Lymph Nodes

Ultimately mature dendritic cells migrate into lymph nodes, small glands located throughout the body containing white blood cells including T cells, where much of the key

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

antigen expressed by the cancer. Importantly, Versamune® has also demonstrated the potential to upregulate type I interferon genes (type I IFN), which are responsible for critical immunological processes. Upregulation of type I IFN induces an

important immunological protein called CD69 that facilitates interactions between the dendritic cell and T cells in the lymph nodes.

Upregulation of type I IFN signaling also induces multiple immune messenger proteins called cytokines and chemokines that further signal T cells to infiltrate into the lymph

nodes. Powerful activators of CD8 killer T cells, such as CCL2 and CXCL10 are documented to be induced by Versamune® as well. As the Versamune® induced production of chemokines appears to be restricted to the lymph nodes, the site of T cell

activation, it provides for both superior activation and expansion of CD8 killer T cells. Localization of these immune messengers within the lymph nodes and their limited presence in the blood circulation enhances the safety of the Versamune®

based immunotherapies. Thus, through the versality of its mechanisms of action, as understood to date, we believe that Versamune® may safely promote the efficient and robust expansion in-vivo of large numbers of highly potent (polyfunctional)

CD8 killer T cells, both critical factors in developing a successful immunotherapy.

Versamune® has the potential to overcome immune suppression

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

cancer however, they are utilized by the cancer cells to suppress immune detection. Versamune® may contribute to significant alteration of the tumor microenvironment by dramatically reducing the Treg to killer CD8 T cell ratio thus making the

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

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

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

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

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

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

tumor’s protective immune suppression mechanism.

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Versamune® has the potential to induce Immune Memory

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

recurrence. Preliminary studies demonstrated that Versamune® protected mice that had experienced tumor regression against tumor reestablishment even when the mice were reinjected with the same tumor cells. This sustained protection was evidence

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

based immunotherapies to induce immune memory was also demonstrated in a Phase 1 clinical trial in humans.

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

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

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

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

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

treatments.

As noted, Versamune® is injected subcutaneously (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. Very low quantities of Versamune® were detected in the blood or in any organ outside of the lymph nodes.

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

for short- or long-term accumulation of the nanoparticles. These preclinical observations have been confirmed by early clinical data documenting that this localized, and highly specific cascade of immune activity was associated with an absence

of significant systemic toxicity at all doses tested. In a Phase 1 clinical trial designed to evaluate safety, all patients had transient swelling and redness at the injection site due to initiation of the immunological cascade at the injection

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

safety concerns were attributed to PDS0101 since 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,

Versamune® induces a strong T cell response to the antigen. All the antigens currently being evaluated in combination with Versamune® are present primarily in cancer cells which should therefore result in tumor-specific T cell attack, thereby

minimizing off-target toxicity and potential destruction of healthy cells and tissue.

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

ctDNA is tumor-derived fragmented DNA that is released into a person’s blood stream by cancerous cells and tumors. It can come from primary or metastatic cancer sites. We

believe that the reduction of ctDNA, as a biomarker, has the potential to signify a potential reduction or elimination of cancer. As noted, we believe Versamune® may safely promote the efficient and robust expansion in-vivo of large numbers of

highly potent (polyfunctional) CD8 killer T cells. In 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

proliferated in the tumor microenvironment as seen in a representative patient in the chart below.

Versamune®’ s potential as a cancer immunotherapy platform

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

variety of cancers. Further, its diverse mechanisms of action together with its favorable safety profile suggest therapeutic promise when used in combination with other treatment modalities or immunotherapies such as immune checkpoint inhibitors

as well as in the single-agent monotherapy setting.

PDS0101: Human Papillomavirus (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

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. The clinical data was presented at the 34th Annual Society for the Immunotherapy of Cancer Conference in November 2019 (Wood, et al., 2019). Based on this encouraging preclinical and human data, PDS0101 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.

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

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

year. Approximately 90% of prostate cancers and 50% of breast cancers overexpress the TARP tumor antigen. In a human clinical trial, the NCI demonstrated that its proprietary TARP antigens were effectively recognized by the immune system in

prostate cancer patients with PSA biochemical recurrence leading to a notable reduction in tumor growth rate. In preclinical studies, a dramatically enhanced TARP-specific killer T cell response was observed when our designed TARP antigens were

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

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

prostate and breast cancers. Preclinical development is ongoing.

PDS0103:Mucin-1 (MUC1)-Related Cancers

MUC1 is highly expressed in multiple solid tumor types and has been shown to be associated with drug resistance and poor disease prognosis. We are developing PDS0103, a

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

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

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. In the ICI resistant group, the 12-month OS rate was 72% and the triple combination achieved a median OS of approximately 20 months.

PDS01ADC monotherapy has shown activation of an immune response and correlation with clinical benefit in metastatic solid tumors

We believe PDS01ADC monotherapy promotes therapeutically relevant immune responses, and stronger immune activation has been observed at higher doses. An analysis of patients at

baseline and after PDS01ADC monotherapy treatment documented in the graphs below. Interferon-gamma is associated with the induction of natural killer (NK) cells and T cells. Granzyme B is associated with the induction of active killer CD8 T

cells. Importantly, higher levels of these CD8 T cells were associated with improved clinical outcomes. (Toney NJ et al. International Immunopharmacology 116 (2023) 109736).

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PDS01ADC is differentiated from other IL-12 treatments

PDS01ADC is a novel investigational immune-cytokine fusion protein composed of two molecules of IL-12 fused to each of the two heavy-chains of a human IGg1 antibody. The

IGg1 antibody targets the DNA/histones exposed in necrotic areas of solid tumors, thus delivering the IL-12 into the tumor and limiting its systemic accumulation. As seen in the chart below, PDS01ADC (PDS0301) shows low accumulation in blood

circulation potentially promoting safety.

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

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

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

PDS0202: Universal influenza vaccine

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

effective response to the influenza vaccine. In the fourth quarter of 2021, we entered into a Patent License Agreement with the University of Georgia (UGA) which provides a nonexclusive license to the patent rights for UGA’s COBRA antigens to

develop and commercialize a universal influenza vaccine worldwide. The UGA Patent License Agreement includes customary milestone payments and royalties.

In February 2023, we announced preclinical Infectimune® publication in peer reviewed journal Viruses showing unique induction of high levels of multifunctional CD4+ T cells capable of broadly protective functions compared to leading commercial vaccine technologies (Henson TR et al. Viruses 2023, 15, 538).

Also in February 2023, we announced a second preclinical Infectimune® publication in peer reviewed journal Viruses showing complete protection in animal studies with PDS0202, a novel recombinant investigational protein-based universal flu vaccine (Gandhapudi SK et al. Viruses 2023, 15, 432).

Oncology Development Strategy

The unique combination of high potency and favorable safety profile of the Versamune® platform observed in preclinical studies was corroborated in the successfully completed

12-patient PDS0101 monotherapy Phase 1/2a clinical trial. All patients were infected with cancer causing (high risk) strains of HPV, which are less likely to spontaneously regress. In September 2019, we reported retrospective clinical outcome

data from this trial. Despite most of the patients being infected with multiple HPV strains including or excluding 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.

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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

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. In

February 2021, the NCI’s Phase 2 clinical trial of PDS0101 for the treatment of advanced HPV-positive cancers had achieved its preliminary objective response target in patients naïve to check point inhibitors which allowed for full enrollment of

approximately 20 patients in this group. In addition, based on promising results in the ICI naïve arm, the trial was amended to allow enrollment of a separate cohort of IC -resistant patients for assessment of safety and activity of the triple

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

Preclinical study results arising from this CRADA were published in the Journal for ImmunoTherapy of Cancer, Immunomodulation to enhance the efficacy of an HPV

therapeutic vaccine (Journal for ImmunoTherapy of Cancer2020;8:e000612. Doi:10.1136/ jitc-2020-000612), and indicate that PDS0101 generated both HPV-specific T cells and anassociatedantitumor response when used as a monotherapy. When PDS0101 was combined with the two other novel clinical-stage anti-canceragents, Bintrafusp Alfa and M9241 (which

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

regression when compared to any of the agents alone or the 2-component combinations. The published preclinical data demonstrating powerful activity of the triplecombination appears to be corroborated in

the Phase 2 trial, and this triple combination could form the basis of a unique platform providing improved cancer treatments across multiple cancers.

In 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. J Clin Oncol 40, 2022 [suppl 16; abstr 2518]). This included data from 30 HPV16-positive patients and highlights were as follows:

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

● Similar OR and survival were seen across all types of HPV16-positive cancers.

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.

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

In December 2022, we presented interim data as follows:

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. 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:

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

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.

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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

(suppl 16; 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:

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

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

● 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. In

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:

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

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

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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:

● 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.

Highlights form the ICI refractory cohort include:

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.

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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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

(ctHPV-DNA), a potential predictive biomarker of treatment response. The data from the IMMUNOCERV Phase 2 clinical trial was featured in an oral presentation at the American Society for Radiation Oncology Annual Meeting which included the

following:

Mayo Clinic: 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. The trial is being led by Drs. David Routman, Katharine Price, Kathryn Van Abel, and Ashish Chintakuntlawar at Mayo

Clinic, a nationally and internationally recognized center of excellence for the treatment of head and neck cancers. We believe that this trial not only broadens our addressable patient population of those affected by the increasing incidence

of HPV(+)OPSCC, but also allows us to better understand the activity of PDS0101 alone or in combination with Keytruda® in earlier stages of disease. This trial is currently open for enrollment.

In this trial, treatment will be administered before patients proceed to transoral robotic surgery (TORS) with curative intent. Treatment in this setting is referred to as

neoadjuvant treatment. PDS0101 has been shown to induce killer T cells that target and kill HPV-positive cancers, either alone or in combination with ICIs in preclinical studies, and in combination in clinical studies of patients with advanced

recurrent/metastatic HPV-positive cancers. This trial will explore whether PDS0101 with or without checkpoint inhibition may increase HPV-specific anti-tumor responses, potentially resulting in tumor shrinkage, pathologic regression, and

decreases in circulating tumor DNA (ctDNA).

PDS0102

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

PDS0102 is designed to treat TARP-associated cancers, including acute myeloid leukemia (AML), prostate and breast cancer. In our preclinical work, in the administration of PDS0102, the Versamune®+TARP antigen combination led to the induction of

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).

PDS0103

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. 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.

MUC1 is highly expressed in several types of cancer and has been shown to be associated with drug resistance and poor disease prognosis in breast, colorectal, lung and ovarian cancers, for which

PDS0103 is being developed. Expression of MUC1 is often associated with poor disease prognosis, due in part to drug resistance. In preclinical studies, and similarly to PDS0101, PDS0103 demonstrated the ability to generate powerful MUC1-specific

CD8 killer T cells. In 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.

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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:

In October 2023, interim safety and immune response data was presented for the first-in-human Phase 1/2 clinical trial evaluating PDS01ADC in combination with current SOC chemotherapy,

docetaxel, to treat metastatic castration sensitive and castration resistant prostate cancer. The data was featured in an oral presentation at the 11th Annual

Meeting of the International Cytokine & Interferon Society. Data presented as follows:

We are working closely with the NCI to determine the best pathway forward for the prioritized PDS01ADC studies, as well as evaluating the use of PDS01ADC in combination with other Versamune®

based clinical candidates.

Infectimune® Development Strategy

We believe that the key differentiating attributes of the Infectimune® platform technology are strong induction of CD8 and CD4 T cells as well as antibodies which can be leveraged to improve

treatment and preventive options in several infectious disease indications.

In January 2022, we presented preclinical data on our universal flu program sponsored by the National Institute of Allergy and Infectious Disease (NIAID) demonstrating the potential of the

Infectimune® technology with computationally designed influenza proteins developed by the laboratory of Dr. Ted Ross at the University of Georgia to generate broadly protective anti-influenza immune responses across multiple strains of influenza

in animals. 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

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®.

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In July 2022, universal flu vaccine preclinical data for PDS0202 at the 41st 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

2023: 1. preclinical studies demonstrating complete protection against sickness after lethal challenge with live SARS-CoV-2 or influenza viruses (Gandhapudi SK et al. Viruses 2023, 15, 432) and 2. Dramatically enhanced CD4 T cell responses to recombinant influenza proteins compared to leading commercial vaccine adjuvants (Henson TR et al. Viruses

2023, 15, 538).

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

PDS0202; 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.

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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. We have funded our operations primarily from the issuance of common

stock. We have not generated any product revenue to date. We have never been profitable and have incurred net losses in each year since our inception.

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

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

● the ability to repay debt financings including interest payments;

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

Development Pipeline

Our current program development pipeline is shown below:

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Leadership

We are led by a team of executives and directors with significant experience in drug discovery, development and commercialization. The following table

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

Name Age Position

Gregory L. Conn, Ph.D. 69 Chief Scientific Officer

Kirk V. Shepard, M.D. 72 Chief Medical Officer

Frank Bedu-Addo, Ph.D.

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

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

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

Before his tenure at KBI, he successfully started and managed Cardinal Health’s East Coast biotechnology drug development and manufacturing operations. Prior to Cardinal Health, Dr. Bedu-Addo was an Associate Director at Akzo-Nobel, Senior

Scientist at Elan (The Liposome Co.), and Principal Scientist at Schering-Plough. In these positions, he contributed to the development of numerous drugs, including antiviral and anticancer products. Dr. Bedu-Addo obtained both his M.S. in

Chemical Engineering and Ph.D. in Pharmaceutics from the University of Pittsburgh.

Gregory L. Conn, Ph.D.

Dr. Conn was a founding member of the PDS Biotech team in 2005 as Chief Scientific Officer and continues to serve PDS Biotech in that role. He has more than 35 years of

drug-development expertise, including development of antiviral and anticancer drugs through to commercialization. He is a graduate of the Albert Einstein College of Medicine, where he obtained both his M.S. and Ph.D., discovering novel

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

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

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

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

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

Kirk V. Shepard, M.D.

Dr. Shephard has served as Chief Medical Officer of PDS Biotech since January 2024. Dr. Shepard is a board-certified medical oncologist and hematologist with more than 30

years of experience in the pharmaceutical industry. His experience spans multiple therapeutic areas and includes operational and strategic product development from Phases 1 through 4 and diverse disciplines of medical affairs and product

commercialization. Prior to joining PDS Biotech, Dr. Shepard was Chief Medical Officer, Senior Vice President and Head of the Global Medical Affairs Oncology Business Group at Eisai Pharmaceutical Company from March 2017 to August 2023. Dr.

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

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

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

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

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Lars Boesgaard

Mr. Boesgaard has served as our Chief Financial Officer since December 2023. Mr. Boesgaard has had a career spanning more than 25 years in healthcare and has deep capital

markets and investor relations experience with global clinical and commercial-stage pharmaceutical and biotechnology companies. He has prepared and executed corporate transactions and built financial frameworks for rapidly growing

organizations. Mr. Boesgaard served as CFO of AM-Pharma B.V. from September 2021 to August 2023. Mr. Boesgaard also served as CFO of Columbia Care from August 2018 to August 2021, where he completed key transactions including an IPO/reverse

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

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

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

Spencer Brown

Mr. Brown has served as Senior Vice President, General Counsel of PDS Biotech since June 2022. He was appointed as Compliance Officer in October 2023. Mr. Brown previously

served as Vice President, Legal Affairs from January 2018 to January 2022 and as Senior Vice President, Legal Affairs and Compliance Officer from January 2022 to May 2022, for Aclaris Therapeutics, Inc. (Nasdaq: ACRS). Prior to joining Aclaris

Therapeutics, Inc., Mr. Brown worked nearly eight years at GE Healthcare as Senior Commercial Counsel for the Life Sciences Core Imaging business in Princeton, New Jersey. Prior to that, Mr. Brown spent almost ten years at AstraZeneca

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

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

We are also supported by scientific leaders in the field of vaccine development and oncology. Dr. 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. Dr. 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. Dr. Neil D. Gross, Professor and Director of Clinical Research, Department of Head and Neck Surgery, Division of Surgery, The University of

Texas MD Anderson Cancer Center. Dr. Jon Wigginton, President, Research and Development Bright Peak Therapeutics and former President of Society for Immunotherapy of Cancer. Dr. 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. We currently rely on third-party contract manufacturing organizations to produce the amounts of our product candidates necessary for our preclinical research and clinical studies. As part of the manufacture and design

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

contractors.

Our research and development activities are located at the Princeton Innovation Center BioLabs, 303A College Road East, Princeton, NJ 08540, which provides first-rate

development facilities for biotech companies. All animal toxicology and efficacy testing are done via third-party contracts and collaborations to provide maximum flexibility and to minimize operational costs and overhead. This approach allows

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

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

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

will be capable of efficiently manufacturing our products.

For our Versamune® PDS0101 and PDS01ADC product candidate, 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. 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. 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.

Intellectual Property

Patents

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

patents, patent applications, substantial know-how and trade secrets related to our platforms. We strive to protect and enhance our proprietary technology, inventions and improvements that are commercially important to our business, including

seeking, maintaining, and defending patent rights. We also rely on trade secrets relating to our platforms and on know-how, continuing technological innovation to develop, strengthen and maintain its proprietary position in the vaccine field.

In addition, we rely on regulatory protection afforded through data exclusivity, market exclusivity and patent term extensions where available. We also utilize trademark protection for our company name and we expect to do so for products and/or

services as they are marketed.

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

technology. These issued patents will expire in 2028 through 2037, or later if patent term extension applies. Included in the patents above is a patent protecting the use of Versamune® in combination with IL-12.

Licensed Patents

We have licensed patented antigens from the US government for use worldwide in our cationic lipid immunotherapies. We have licensed T cell receptor gamma alternate reading

frame protein (“TARP”) from the National Cancer Institute (“NCI”) to develop and commercialize TARP peptide-based therapies in combination with our Versamune® technology and any other of our proprietary technologies for prostate and breast

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

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

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

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

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We entered into a non-exclusive agreement to license COBRA universal influenza antigens with the University of Georgia Research Foundation to develop, manufacture and use

COBRA antigens in a clinical trial for a universal influenza vaccine worldwide. These antigens are developed by Dr. Ted Ross at the University of Georgia. We believe that the combination of these antigens with our proprietary Infectimune®

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

Exclusive License Agreements

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

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

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

collaborations between Merck KGaA, Darmstadt, Germany and academic institutions to allow such academic institutions to exercise their rights granted under such collaborations. We agreed to use commercially reasonable efforts to develop,

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

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

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

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

Pursuant to the Merck KGaA License Agreement, we agreed to make (i) development and first commercial sale milestone payments totaling up to $11 million upon the achievement

of certain milestones, including the dosing of the fifth patient in a Phase 3 trial of the Product and first commercial sale of the Product for a first and second indication in a major market, and (ii) up to $105 million upon achieving certain

aggregate sales levels of the Product.

We also agreed to pay Merck KGaA, Darmstadt, Germany a royalty of 10% on aggregate net sales of Product as specified in the Merck KGaA License Agreement on a

Product-by-Product and country-by-country basis until the later of: (i) ten years after the first commercial sale of a Product in a given country; and (ii) the expiration or invalidation of the licensed patents covering the Compound or Product

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PDSB · 10-K · period ended 2023-12-31

ITEM 1. Business

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