UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549


FORM 8-K


CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 11, 2021


PDS BIOTECHNOLOGY CORPORATION
(Exact Name of Registrant as Specified in Charter)

Delaware
001-37568
26-4231384



(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)

25B Vreeland Road, Florham Park, NJ 07932
(Address of Principal Executive Offices, and Zip Code)

(800) 208-3343
Registrant’s Telephone Number, Including Area Code


(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):


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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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 Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

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 ☐

Item 8.01.
Other Events.
 
On March 11, 2021, PDS Biotechnology Corporation (the “Company”) issued a press release, a copy of which is attached hereto as Exhibit 99.1 and incorporated herein by reference, announcing that its COVID-19 vaccine consortium consisting of the Company, Farmacore Biotechnology and Blanver Farmoquímica received a commitment from the Secretary for Research and Scientific Training of The Ministry of Science, Technology and Innovation of Brazil to fund up to approximately US$60 million to support clinical development and commercialization of a novel, Versamune®-based second generation COVID-19 vaccine in Brazil.

On March 11, 2021, the Company updated its corporate presentation slide deck. A copy of the corporate presentation slide deck is attached hereto as Exhibit 99.2 and incorporated herein by reference.

Item 9.01
Financial Statements and Exhibits.

(d)
Exhibits.

Exhibit
Number

Description




Press Release, dated March 11, 2021.

PDS Corporate Presentation March 2021.

Signature

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.



PDS BIOTECHNOLOGY CORPORATION



Date: March 11, 2021

By:
/s/ Frank Bedu-Addo, Ph.D.


Name:
Frank Bedu-Addo, Ph.D.


Title:
President and Chief Executive Officer


Exhibit 99.1

PDS Biotech Announces that its COVID-19 Vaccine Consortium Received a Commitment from The Ministry of Science, Technology and Innovation of Brazil (MCTI) to fund Clinical Development and Commercialization of a Versamune®-Based COVID-19 Vaccine with an Award of up to Approx. US$60 million

Development and commercialization of novel T-cell activating vaccine to be performed in Brazil by consortium of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica

Florham Park, NJ, March 11, 2021 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on PDS Biotech’s proprietary Versamune® T-cell activating technology, today announced that its COVID-19 vaccine consortium consisting of PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica, has received a commitment from the Secretary for Research and Scientific Training of the MCTI to fund up to approximately US$60 million to support the clinical development and commercialization of a novel, Versamune®-based, second generation COVID-19 vaccine in Brazil.

MCTI intends to start making the funds available to prepare to perform a combined Phase 1/2 clinical trial, upon authorization by the Brazilian regulatory agency, Agência Nacional de Vigilância Sanitária (Anvisa) to initiate the proposed Versamune®-based COVID-19 vaccine clinical program in Brazil.

The pre-IMPD package for the Phase 1/2 trial is currently under review by Anvisa and the trial is anticipated to begin by Q2/3 2021.  The majority of the capital provided by MCTI will fund the manufacturing process scale up, production and the Phase 3 trial, pending the results of the Phase 1/2 trial.  The consortium members will work under a mutually agreed work plan to guide the vaccine efficiently through development in compliance with regulatory standards. The consortium anticipates working to initiate manufacturing scale up activities in the second quarter.

This award is based on the preclinical studies of the Versamune®-based COVID-19 vaccine.  The vaccine combines PDS Biotech’s Versamune® T-cell activating platform technology with a SARS-CoV-2 recombinant protein derived from the spike (S) protein.  Notably, the protein in this fully synthetic vaccine includes conserved and non-mutating regions of the virus.  The vaccine has demonstrated strong potential in preclinical studies to efficiently promote the induction of killer (CD8+) and helper (CD4+) T-cells that recognize and induce immune responses against such non-mutating regions of the virus. The protein also includes regions of the spike protein that result in the induction of neutralizing antibodies.

The Phase 1 and 2 trials, which will be run together, are anticipated to enroll approximately 360 patients and will assess the safety and efficacy of the vaccine as well as both the antibody and killer T-cell responses induced by the vaccine to the novel coronavirus. The clinical trials are planned to be conducted in Brazil.

“PDS Biotech and Farmacore Biotechnology have taken the important step of advancing our Versamune®-based COVID-19 vaccine into the clinic,” said Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech.“ The preclinical results demonstrate the vaccine’s potential to induce a broad range of robust anti SARS-CoV-2 immune responses.  The rapidly increasing number of SARS-CoV-2 mutations highlights the need for novel, second generation vaccines capable of generating both killer and helper T-cells that can recognize and attack conserved and non-mutating regions of the virus.  We applaud Farmacore Biotechnology and Blanver Farmoquímica for reaching this important milestone and look forward to the results of the planned human clinical trials and hopefully a rapid advancement towards commercialization of the product.  These clinical trials will also advance our understanding of the potential for novel Versamune®-based vaccines to provide long-term protection against infection with viruses with pandemic potential such as SARS-CoV-2.”

“We are excited to continue advancing the program with PDS Biotech, and we are thrilled to have had the continued support of the Brazilian government as we finalize clinical study protocols with Anvisa for human testing of the novel vaccine combining the Versamune® T-cell activating technology with the SARS-CoV-2 recombinant protein antigen.  We are proud to advance this promising medicine in Brazil in the fight against this global pandemic,” said Helena Faccioli, CEO of Farmacore Biotechnology.

As the license holder of PDS0203 in Latin America, Farmacore Biotechnology will continue to lead the regulatory and clinical trial efforts in Brazil and has selected a top clinical research organization, to conduct clinical trials in Brazil.  PDS Biotech will continue to contribute scientific expertise and operational support and oversee scale up of the manufacturing process.  Blanver Farmoquímica will manufacture, promote, distribute, and commercialize the Versamune®-based COVID-19 vaccine in Latin America.
 
All funding is contingent on the availability of financial resources within the MCTI, and The Secretary for Research and Scientific Training of the MCTI has committed to making every effort to finance all clinical and development stages of the program.
 
About PDS Biotechnology
 
PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
 
About Farmacore Biotechnology
 
Farmacore Biotechnology is a biotechnology company, founded in 2005, focusing on R&D of innovative immunobiological products for use in the human and veterinary health sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them in all stages of development, from project design to biomolecule production www.farmacore.com.br.
 
About Blanver Farmoquímica
 
Blanver Farmoquímica e Farmacêutica S.A. is a Brazilian company, founded in 1984, focused on R&D, manufacture and sale of innovative medicines and active pharmaceutical ingredients. The company plays in the segments of HIV, Hepatitis, Oncology and Hematology, providing high quality products for expanding the population’s access to medicines through partnerships with the Ministry of Health and official laboratories.  Blanver Farmoquímica is committed in always looking for innovations that will improve people’s health and quality of life.
 
About PDS0203
 
PDS0203 is an investigational vaccine designed for the prevention of COVID-19 being jointly developed for Latin America by a consortium that includes PDS Biotech, Farmacore Biotechnology and Blanver Farmoquímica. The vaccine combines the utility of PDS Biotech’s Versamune® platform with a recombinant native Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) protein recognizable by our immune system (antigen). The Versamune® platform, due to its unique ability to induce both antibody and polyfunctional CD8+ killer and CD4+ helper T-cell responses is being utilized to develop a next generation vaccine that may more effectively prevent COVID-19.
 
Forward Looking Statements

This communication 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 PDS Biotechnology Corporation (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; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101 and PDS0203 ; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 and PDS0203 and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Jacob Goldberger
CG Capital
Phone: +1 (404) 736-3841
Email: jacob@cg.capital


Exhibit 99.2

   Nasdaq: PDSBDeveloping powerful, safe, versatileimmunotherapies  CORPORATE OVERVIEW  Frank Bedu-Addo Ph.D. President & CEO  MARCH 2021   
 
 2  Forward-Looking Statements  This presentation contains forward-looking statements about PDS Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development activities and timelines and market opportunities. All statements other than statements of historical facts included in this presentation are forward- looking statements. The words “anticipates,” “may,” “can,” “plans,” “believes,” “estimates,” “expects,” “projects,” “intends,” “likely,” “will,” “should,” “to be,” and any similar expressions or other words of similar meaning are intended to identify those assertions as forward-looking statements. These forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those anticipated.Factors that may cause actual results to differ materially from such forward-looking statements include those identified under the caption “Risk Factors” in the documents filed with the Securities and Exchange Commission from time to time, including its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this presentation. Except to the extent required by applicable law or regulation, PDSB undertakes no obligation to update the forward-looking statements included in this presentation to reflect subsequent events or circumstances. 
 
     Nasdaq: PDSB  3  PDS Biotech’s Versamune®-based immunotherapies promote a powerful in  The most significant  barrier to effective immunotherapy has been their inability to promote adequate CD8+ killer T-cell responses in vivo resulting in diminished efficacy  vivo tumor-specific CD8+ killer T-cell responseVersamune®-based therapies also:Generate a strong CD8+ T-cell memory response resulting in long-lasting efficacyGenerate potency without systemic side effectsAre versatile and shown to be effective on their own or in combination with other drug to improve their efficacy 
 
   Nasdaq: PDSB      Nasdaq: PDSB    PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform  4  NCI-initiated phase 2 HPV-cancer trial surpassed initial efficacy requirement prompting expansion to full enrollmentNovel COVID-19 vaccine being developed in Brazil with consortium partnersMCTI, Brazil to fund COVID-19 vaccinemanufacturing scale up & clinical trialsDemonstrated to work with a wide array of oncogenes and viral antigensMultiple composition and application patents valid through mid-2030s    Biopharma developing novel cancer treatments and T-cell-activating vaccine candidates for infectious diseasesThree phase 2 oncology clinical trials in progress to initial data releases in 2021Clinical partnerships with Merck, MDAnderson and National Cancer Inst.~15 employees with headquarters in Florham ParkDebt free with approximately $33.5M in cash as of 9/30/20    VERSAMUNE® PLATFORM  CORPORATE OVERVIEW 
 
   Nasdaq: PDSB      Nasdaq: PDSB  PDS Biotech’s robust Versamune®-based pipeline is being developed in partnership with the leaders in immuno-oncology and infectious disease  5  Reference: Data on file.  *  *  *Consortium of PDS Biotech, Farmacore and Blanver. Funding provided by The Ministry of Science, Technology and Innovation of Brazil (MCTI) 
 
   Nasdaq: PDSB      Nasdaq: PDSB  PDS Biotech executive team has demonstrated success in the development and commercialization of leading pharmaceutical products  6    Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposome Company/ Elan) PEG-Intron® (Schering-Plough/ Merck)      Frank Bedu-Addo, PhDChief Executive Officer  Co-founder>35 years of drug development experienceIn-depth experience with biotech drug discovery, product development and manufacturing  Gregory Conn, PhDChief Scientific Officer    >30 years of translational clinical research experienceFormer Director of Clinical Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch)  Lauren V. Wood, MDChief Medical Officer    Senior executive experience with over 20 years of experience in high tech companies  In-depth experience with M&A transactions, capital markets, business development and investor relations  Seth Van Voorhees, PhDChief Financial Officer 
 
 Introduction to the Versamune® Platform 
 
 Nasdaq: PDSB    Nasdaq: PDSB  Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered with a tumor-associated antigen  8  Reference: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induction of a Type I IFN response. J Immunol. 202 (12): 3524-3536.Smalley Rumfield C et al.. 2020.Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. J. for ImmunoTherapy of Cancer 8:e000612.  Promotes uptake of vaccine or immunotherapy and entry into lymph nodes  Promotes antigen processing and presentation to T-cells via MHC I and II pathways  Activates Type I Interferon pathway, enabling a powerful anti- tumor killer CD8+ T-cell response    Versamune® + Tumor- associated proteins  (antigens) 
 
   Nasdaq: PDSB      Nasdaq: PDSB  Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose  9  Single treatment dose  Results typical of current top clinical-stage HPV cancer vaccines    Tumor rechallenge at Day 60; complete and sustained cure of cancer  *Adjuvant = cytokine GMCSFReferences: J. Immunology, 2019 (202), 1215; Studies in TC-1 tumor model with other immunotherapies reported in: Vaccine 2009, January 14, 27 (3): 431; Science Translational Medicine 2016, 13 April, Vol 8 Issue 334; Vaccine 2009, September 25, 27 (42): 5906.                      0  50  100  200150  250  Adjuvant* + MUC1 4-Combo Adjuvant Antigen + MUC1 Antigen  Versamune + MUC1 Antigen  # of Antigen-Recognizing T-CellsIFN-γ Spot Forming Cells/1X106 Spleen Cells  Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies500450400350(PDS0101)300      (PDS0103)Polyfunctional T-Cells Monofunctional T-Cells 
 
   Nasdaq: PDSB      Phase 1 clinical trial: Powerful in-vivo CD8+ T-cell response results in regression of CIN cervical lesions supported continued clinical studies  10  * When treated with selected human clinical trial dosage (1mg and 3mg Versamune®)Nasdaq: PDSB References: L. Wood et al. A Novel Enantio-Specific Cationic Lipid R-DOTAP + HPV16 E6 & E7 Antigens Induces Potent Antigen-Specific CD8+ T Cell Responses In-Vivo in Subjects with CIN and High-Risk Human Papillomavirus Infection. Nov 8, 2019. SITC. Presentation O17.        Complete lesion regression  Partial regression (cytology only)  Non responders  Most patients infected with multiple strains of HPV  CIN lesion regression at 1-3 months    60%  20%  20%                  0  200  400  600  800  1000  1200  Pre-treatment baseline  Versamune® + HPV16 Antigen (PDS0101)Interferon-γ  # of Antigen-Recognizing T-Cells    Granzyme-b    Phase 1 trial results showed no serious or dose-limiting toxicities  Overcomes key limitation of immuno-oncology: > 20-fold increase in circulating dual INF-γ & Granzyme-binducing killer T-cells vs. pre-treatment at day 14 led to rapid clearance of lesions* 
 
     Nasdaq: PDSB    Versamune®-based Immunotherapies*  Checkpoint Inhibitors  Traditional Cancer Vaccines  CAR-T  Induction of high levels of active CD8+ (killer) T-cells          Induction of high levels of CD4+ (helper)T-cells          Ability to overcome tumor immune suppression          Induction of long-term memory CD8+ T-cells          No dose limiting toxicities          Initial data suggests Versamune® possesses the key characteristics of a safe and effective immunotherapeutic treatment  *Reference: J. Immunology, 2019 (202), 1215; PDS0101 clinical trial report (CSR U10-02-11-001)  11 
 
 PDS0101 Phase 2 Clinical Development 
 
   Nasdaq: PDSB      Nasdaq: PDSB  Combinations of PDS0101 with FDA-approved standard of careFirst line treatment of recurrent/metastatic HPV-positive head and neck cancerCombination with Keytruda®Treatment of advanced localized cervical cancerCombination with chemoradiotherapy  13  Novel combinations of PDS0101 with promising, investigational immunotherapeutic agentsTreatment of advanced HPV-associated cancers (anal, cervical, vaginal, head and neck etc.)Triple combination with Bintrafusp-alpha (bi- functional checkpoint inhibitor - M7824) and NHS-IL12 (antibody conjugated immuno- cytokine)      Clinical strategy: Develop PDS0101 in combination with established therapies for rapid proof-of-concept and risk mitigation 
 
 Indication  Patients with advanced HPV-associated cancer who have failed prior treatment  Clinical Agents  M7824: Bifunctional fusion protein - checkpoint inhibitor + TGF-b “TRAP” (ORR ~30%)NHS-IL12: Antibody-conjugated immuno-cytokinePDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ T-cells  Study goals  Group 1: Objective response rate (ORR) in checkpoint inhibitor (CPI) naïve patients Group 2: ORR in patients who have failed checkpoint inhibitor therapy (CPI refractory)  Timing  Full enrollment of 45 patients triggered following achievement of objective response in ≥ 3 checkpoint inhibitor naive patientsTrial completion expected in Q1 2022  Trial Sponsor    Nasdaq: PDSB    Nasdaq: PDSB  Phase 2 investigator-initiated clinical trial evaluating the combination of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer  14  Confirmation that PDS0101 enhances the therapeutic benefit of M7824 & NHS IL-12 may lead to expanded evaluation in several cancers with PDS0102-0104 
 
   Nasdaq: PDSB      Nasdaq: PDSB  15    M7824 (bi-functional checkpoint inhibitor)+ NHS-IL12 (immuno-cytokine)Tumor Regression: 8/16 (50%)T-cell Clones: 18  PDS0101 + M7824 + NHS-IL12Tumor Regression: 13/17 (76%)T-cell Clones: 3  *Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Cancer 2020; 8:e000612. doi: 10.1136/jitc-2020-000612  In a preclinical model, PDS0101 demonstrated enhanced ability to train tumor-specific T-cells effective in infiltrating and killing tumors  Red – CD8+ (killer) T-cells Green – CD4 + (helper) T-cells  T-cell clones per 25% of TCR repertoire (Average) 
 
   Nasdaq: PDSB      Nasdaq: PDSB  16  PDS Biotech-sponsored phase 2 trial evaluating the combination of PDS0101 and KEYTRUDA for first-line treatment of HPV-associated metastatic/recurrent head and neck cancer  Indication  First line treatment of patients with HPV-associated head and neck cancer whose cancerhas spread or returned  Clinical Agents  KEYTRUDA (Standard of Care): Anti-PD1 checkpoint inhibitor (ORR ~20%)PDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ and CD4+ T-cells  Study goals  Objective response rate (ORR) and overall survival (OS)  Timing  Preliminary data – Q4 2021/Q1 2022, ORR in first 20 patients (efficacy in 7 of 38 required to enroll all 96 patients)  Trial Partner    Confirmation that PDS0101 enhances the therapeutic benefit of checkpoint inhibitors could expand evaluation of Versamune®-based therapies in multiple cancer indications 
 
   Nasdaq: PDSB      Nasdaq: PDSB  17  A Phase 2, investigator-initiated clinical trial evaluating PDS0101 in combination with chemoradiation therapy in patients with advanced cervical cancer  Indication  Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA  Clinical Agents  Chemoradiotherapy (CRT – Standard of Care): Cisplatin & radiation therapy PDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ and CD4+ T-cells  Study goals  Rate of regression in patients with primary tumor ≥5cm  Timing  Preliminary data – Q4 2021/Q1 2022 – Rate of complete response by PET-CT at 6 monthsand rate of tumor volume reduction by MRI at 30-40 days from start of treatment  Trial Sponsor    Safety and enhanced efficacy could lead to broad applications of Versamune®-based immunotherapies in combination with chemotherapy or CRT to treat multiple cancers 
 
   Nasdaq: PDSB      Nasdaq: PDSB  Studies are designed to demonstrate efficacy and broad applicability of PDS0101 and the Versamune® T-cell activating platform  18  Potential to enhance anti-cancer efficacy of various cancer treatments: Combinations with checkpoint inhibitors, chemotherapy and novel therapies may demonstrate Versamune®’s versatility.  Broad potential for additional partnerships: Successful phase 2 studies with PDS0101 and PDS0203 could enable a broad pipeline of Versamune®-based products containing various antigens.  Potential to treat all types of HPV-cancer: PDS0101 Phase 2 clinical studies address all types of HPV-associated cancers.  Potential applications beyond oncology: PDS0203 COVID-19 phase 1/2 trials may demonstrate protection and induce durable T-cell responses against conserved regions of mutating viruses.       
 
 PDS0203 Phase 1/2 Clinical Development 
 
   Nasdaq: PDSB      Nasdaq: PDSB  Mt. Sinai data shows Versamune® promotes induction of neutralizing antibodies with lowest doses of SARS-CoV-2 antigen1    20  1Reference: Sun et al. 2020. Vaccines Volume 8, Issue 42Reference: Data on file  PDS Biotech generated data shows induction of SARS-CoV-2 specific CD8+ T-cells with Versamune®2  Preclinical studies show powerful induction of long-lasting polyfunctional CD8+ andCD4+ anti-SARS-CoV-2 T-cells  Developing a Versamune®-based COVID-19 vaccine candidate with the goal of promoting CD8+ T-cell responses and neutralizing antibodies 
 
     Nasdaq: PDSB  Development of PDS0203 may offer potential advantages as a second generation COVID-19 vaccine  May be effective against multiple COVID-19 variantsDemonstrated induction of killer CD8+ and helper CD4+ T cells that can target less variable regions of the SARS-CoV-19 virus and may be effective against currently circulating variants.May grant long-lasting immunityDemonstrated induction of long-lasting, virus-specific memory T-cells necessary for longer term protection.High potential for safetyPDS0203 is a subunit vaccine, and does not require the use of attenuated viruses, traditional adjuvants, DNA or RNA. Versamune®-based vaccines have shown no serious or dose limiting reactions.                  21 
 
 Looking Forward 
 
   Nasdaq: PDSB      Nasdaq: PDSB  23  Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the USIncidence rate is growing despite increased use of HPV preventative vaccinesSignificant unmet medical need across the spectrum of HPV-associated cancerExisting immunotherapies cost$120,000+ annually per patient2  1Markowitz et al. 2016. Centers for Disease Control and Prevention. 2018.2Hernandez et al. 2018. American Journal of Managed Care Volume 24, Issue 2; Company Research  Females (24,391)  Males (18,280)  US annual HPV-associated cancer incidence1    PDS0101 is designed to treat cancers caused by human papillomavirus (HPV) 
 
     Nasdaq: PDSB  Consortium has received a commitment of up to ~US$60 million from MCTI, Brazil to support phase 1-3 clinical development and manufacturing scale-upPhase 1/2 study anticipated to start in Q2/Q3 of 2021 pending approval from Anvisa, Brazilian regulatory agencyPending results, PDS0203 could be commercially available in Brazil in 2023Initial target market – Latin America ~ 650 million people (Brazil ~213 million people)1Based on public information, COVID-19 vaccine prices range from $20-74 for a two-dose regimen2  PDS0203 may offer another option to address the COVID-19 global health crisis  1The World Population Review. 2021.2Comparing COVID-19 Vaccines: Timelines, Types and Prices, BioSpace, 2/8/21; Company Research  24 
 
     Nasdaq: PDSB  Versamune® has demonstrated the potential for immunological compatibility with a wide array of tumor and pathogenic antigens  Reference: Clin Cancer Res. 2009 Sep 1;15(17):5323-37. doi: 10.1158/1078-0432.CCR-09-0737  Today, 4 tumor antigens are being utilized with the Versamune® platform, more than 75 tumor antigens have been identifiedWe are currently progressing two Versamune®-based infectious disease vaccines, one for SARS-COVID-19, and one for universal influenzaVersamune®’s unique flexibility means it may work well with a wide range of identified tumor and pathogenic antigensPotential to continuously expand development of Versamune®-based products through partnerships and licensing  25 
 
   Nasdaq: PDSB      Nasdaq: PDSB  Projected milestones through mid-2022*  *Based on current enrollment and forecast modeling as of February 2021. Subject to change.**Consortium funding provided by MCTI, Brazil    4Q22    3Q22    2Q22    1Q22    4Q21    3Q21    2Q21    1Q21                      Preliminary efficacy Data from advanced HPV-associated cancer trial (NCI)Interim Data from HPV- associated Cancer trial (NCI) expectedPreliminary Data from ImmunoCerv combo trial (MD Anderson) expectedPotential interim data from VERSATILE-002 (Keytruda combo)Completion of HPV-associated cancer trial (NCI)Initiation of Phase 1/2 COVID clinical trial of PDS0203Initiation of Phase 3 COVID clinical trial of PDS0203Efficacy data from Phase 3 COVID clinical trial of PDS0203      PDS0101    PDS0203**      26  PDS Biotech Funded Clinical Trials  Partner Co-Funded Clinical Trials 
 
   Nasdaq: PDSB      Nasdaq: PDSB    Rapid commercialization strategy  27  Promising early data in both oncology and infectious disease: Early clinical data and preclinical data suggest potential efficacy, safety and versatility of the Versamune® platformNear-term milestones: PDS0101 preliminary efficacy data anticipated in Q2 2021 and PDS0203 safety and immunogenicity data projected in Q4 2021/Q1 2022Validation of approach: All three on-going phase 2 clinical trials supported and partnered with leading and top-tier institutions in the field of cancer and immuno-oncologyCommercialization path: Anticipated commercialization of PDS0203 in Brazil in 2023 and clinical studies demonstrating enhancement of FDA-approved anti-cancer products may offer rapid path to marketRapid adoption strategy: Evaluation of PDS0101 in combination with standard of care in multiple HPV- associated cancers    Potential Advantages and Differentiators 
 
 Nasdaq: PDSBDeveloping powerful, safe, versatileimmunotherapies