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): May 19, 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, Suite 300, 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):
 
 
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
 
Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
 
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 May 20, 2021, PDS Biotechnology Corporation (the “Company”) issued a press release announcing publication of abstract #2501 by the American Society of Clinical Oncology (ASCO). The press release is filed as Exhibit 99.1 hereto and incorporated herein by reference.  The abstract #2501 is filed as Exhibit 99.2 hereto and incorporated herein by reference.

On May 19, 2021, the Company updated its corporate presentation slide deck.  A copy of the slide deck is filed as Exhibit 99.3 hereto and incorporated herein by reference.

 
Item 9.01
Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number
 
Description
     
 
Press Release, dated May 20, 2021.
99.2 Abstract # 2501.
99.3
Corporate Presentation May 19, 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: May 20, 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 Release of Abstract for PDS0101 in NCI-Led Phase 2 Clinical Study for Oral Presentation at 2021 ASCO Meeting

Objective responses (tumor reduction) observed in 83% (5 of 6) of HPV16-positive relapsed or refractory checkpoint inhibitor naïve patients and 63% (5 of 8) of HPV16-positive relapsed or refractory advanced cancer patients who have also failed checkpoint inhibitor therapy

Florham Park, NJ, May 20, 2021 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune® T-cell activating technology, today announced publication of abstract #2501 by the American Society of Clinical Oncology (ASCO).  The abstract summarizing interim data from the National Cancer Institute (NCI)-led phase 2 trial has been accepted for oral presentation at the 2021 ASCO Annual Meeting taking place June 4-8.  The presentation, scheduled for June 7, is expected to include results from a larger sample than the 14 patients included in the abstract.

Additional data highlights from abstract #2501 include:

 •
An overall objective response rate of 71% (10/14) in patients with refractory HPV16-associated cancers
 
o
1 complete response (anal cancer)
 
o
9 partial responses (3 cervical cancer, 2 vulvar/vaginal cancer, 2 anal cancer, 2 oropharyngeal cancer)
 •
90% of these of these responses are ongoing after a median 5 months of follow up (9/10)

The NCI Center for Cancer Research’s Laboratory of Tumor Immunology and Biology (LTIB) and Genitourinary Malignancies Branch (GMB) are jointly leading this Phase 2 trial (NCT04287868), which studies PDS0101 in combination with two investigational immune-modulating agents: bintrafusp alfa (M7824), a bifunctional “trap” fusion protein targeting TGF-β and PD-L1, and NHS-IL12 (M9241), a tumor-targeting immunocytokine. Bintrafusp alfa is being jointly developed by Merck KGaA, Darmstadt, Germany, and GlaxoSmithKline; NHS-IL12 is being developed by Merck KGaA, Darmstadt, Germany.

The trial is evaluating the treatment combination in both checkpoint inhibitor naïve and refractory patients with advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment. Objective response is measured by radiographic tumor responses according to RECIST 1.1.  These reported data validate the preclinical studies published by the NCI demonstrating that the complementary mechanisms of action of the three immunotherapies which involve potent in-vivo HPV16-specific killer and helper T-cell induction with effective T-cell tumor infiltration, blocking of immune checkpoints as well as targeting of TGF-β resulted in superior tumor regression.

“The achievement of a 71% objective response rate in a difficult to treat patient population continues to strengthen the evidence of our novel Versamune® platform’s potential ability to induce high levels of tumor-specific CD8+ killer T-cells that attack the cancer resulting in strong synergy with Bintrafusp alfa and NHS-IL12, thus leading to effective tumor regression,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “The initial data solidifies our belief that PDS0101’s published preclinical efficacy, when combined with these two immune-modulating agents, demonstrates the potential to significantly improve clinical outcomes for patients with advanced, refractory HPV-associated cancers who have limited treatment options.”


There are more than 630,000 cases of HPV-associated malignancies including cervical, oropharyngeal and anal cancer worldwide annually. HPV 16 is responsible for most of these cases. About 15-20% of HPV-associated malignancies respond to PD-(L)1 inhibitors.  However, for the overwhelming majority of patients who progress on these immunotherapies there is no effective standard of care therapy.

The abstract is now available online on the ASCO conference website: https://am.asco.org/.

Abstract Number: 2501
Abstract Title: Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.

Presenting Author: Julius Strauss, MD, National Cancer Institute
Session: Developmental Therapeutics—Immunotherapy
Date: June 7, 2021
Time: 3:00 PM-6:00 PM EDT

Dr. Julius Strauss, Staff Clinician, LTIB, is serving as the Principal Investigator of this phase 2 clinical trial in advanced HPV-associated cancers.  For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY:  1-800-332-8615), email NCIMO_Referrals@mail.nih.gov, and/or visit the website:  https://trials.cancer.gov.

About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Our Versamune®-based products may overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional  tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple investigational therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.
About PDS0101
PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.


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, PDS0203 and other Versamune® based products; 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, PDS0203 and other Versamune® based products 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 success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials;  any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical  results from its clinical development programs and any collaboration studies; 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 COVID-19. 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

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital
*Updated data and results to be presented in June at the ASCO meeting
1C.S. Rumfield et al., J. Journal for ImmunoTherapy of Cancer 2020;8:e000612. doi:10.1136/jitc-2020-000612)
2S. Gandhapudi et al, J. Immunology, 2019 (202), 1215



Exhibit 99.2

 

 
 
Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.  
     
Julius Strauss, Charalampos S. Floudas, Houssein Abdul Sater, Michell Manu, Elizabeth Lamping, Deneise C Francis, Lisa M. Cordes, Jenn Marte, Renee Nicole Donahue, Caroline Jochems, Jason Redman, Ravi Amrit Madan, Marijo Bilusic, Fatima Karzai, Scott Norberg, Christian S. Hinrichs, Lauren V Wood, Frank K Bedu-Addo, Jeffrey Schlom, James L. Gulley; Laboratory of Tumor Immunology and Biology, NCI, NIH, Bethesda, MD; Genitourinary Malignancies Branch, NCI, NIH, Bethesda, MD; NIH, Bethesda, MD; Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD; Laboratory of Tumor Immunology and Biology, National Cancer Institute, Bethesda, MD; National Cancer Institute-National Institute of Health, Bethesda, MD; National Cancer Institute at the National Institutes of Health, Bethesda, MD; PDS Biotechnology, Princeton, NJ; Genitourinary Malignancies Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD

**Note: The appearance of your abstract here is an approximation of how the abstract would appear in print, if accepted.

Background: There are more than 630,000 cases of HPV associated malignancies including cervical, oropharyngeal and anal cancer worldwide annually. HPV 16 is responsible for the majority of these cases. About 15-20% of HPV associated malignancies respond to PD-(L)1 inhibitors, but for the overwhelming majority of patients who progress on these immunotherapies there is no effective standard of care therapy. Preclinical studies have shown that the triple combination of PDS0101 (Versamune-HPV), a liposomal multipeptide therapeutic vaccine targeting HPV 16 E6/E7, M9241, a tumor-targeting immunocytokine composed of IL-12 heterodimers fused to a monoclonal antibody targeting free DNA in necrotic tumor regions, and bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD- L1, resulted in maximum HPV-specific T cell responses, T cell tumor infiltration and tumor reduction as compared to any one or two of these agents alone.
Methods: Fourteen pts with HPV 16+ relapsed or refractory advanced cancer were enrolled to the triple combination of PDS0101, M9241 and bintrafusp alfa (NCT04287868). Pts received bintrafusp alfa at 1200 mg flat dose i.v. every 2 weeks, M9241 at 16.8 mcg/kg s.c. every 4 weeks and PDS0101 given as two separate 0.5 ml s.c. injections every 4 weeks. Dose reductions of M9241 to 8 mcg/kg were allowed as well as skipped doses of any agent for ongoing toxicities.
Results: Fourteen pts with advanced HPV 16+ cancers (5 cervical, 2 vaginal/vulvar, 4 anal, 3 oropharyngeal) were treated. 4/14 (28.6%) pts had a grade 3 treatment related toxicity including grade 3 hematuria in 2 pts with cervical ca and prior pelvic radiation and grade 3 AST/ALT elevation in 2 pts, one with anal ca and one with vaginal ca. For one patient with grade 3 AST/ALT elevation dose reduction of M9241 from 16.8 to 8 mcg/kg allowed for continued treatment with AST/ALT remaining at grade 1 or less. One additional patient had transient asymptomatic grade 4 neutropenia. No other treatment related grade 3 or greater toxicities were  noted. 10/14 (71%) pts have had objective responses: 1 CR (anal ca) and 9 PRs (3 cervical, 2 vulvar/vaginal, 2 anal, 2 oropharyngeal) with 9/10 of these responses ongoing after a median 5 month of follow up. Of the 14 pts, 6 pts have checkpoint naïve disease and 8 pts have checkpoint refractory disease. 5/6 (83%) pts with checkpoint naïve disease and 5/8 (63%) pts with checkpoint refractory disease have had objective responses. Analyses of immune responses and other immune correlates are ongoing.

Conclusions: Triple combination of PDS0101, M9241 and bintrafusp alfa appears to have a manageable safety profile along with early evidence of notable clinical activity for pts with both checkpoint naïve as well as checkpoint refractory HPV 16+ advanced malignancies.

Title:
Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.
 
Is this abstract a clinical trial?
Yes
 
Registry Name:
Clinicaltrials.gov
 
Registration Number:
NCT04287868



Exhibit 99.3

 CORPORATE OVERVIEW  Frank Bedu-Addo Ph.D. President & CEO  MAY 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. 
 

   3    PDS Biotech’s Versamune®-based immunotherapies promote a powerful in vivo tumor-specific CD8+ killer T-cell response  Generate a strong CD8+ T-cell memory response resulting in long-lasting efficacy  Are versatile and shown to be effective on their own or in combination with other drugs to improve their efficacy  Generate potency without systemic side effects    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  Versamune®-based therapies also: 
 

 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 candidate being developed in Brazil with consortium partnersMCTI, Brazil to fund COVID-19 vaccine manufacturing scale up and clinical trialsPre-clinical studies demonstrated potential to work with a wide array of oncogenes and viral antigensMultiple composition and application patents valid through mid-2030s  Biopharma developing novel cancer treatment candidates 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, MD Anderson and National Cancer Institute~15 employees with headquarters in Florham Park, NJDebt free with approximately $25.0M in cash as of 3/31/21  Pipeline      Versamune® Platform  Corporate Overview 
 

 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) 
 

 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 experience In-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 companiesIn-depth experience with M&A transactions, capital markets, business development and investor relations  Seth Van Voorhees, PhDChief Financial Officer 
 

 Introduction to the Versamune® Platform 
 

 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) 
 

 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  Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies  Single treatment dose  Results typical of current topclinical-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.  (PDS0101) 
 

 PDS0101 Phase 2 Clinical Development 
 

 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  11  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 M9241 (antibody conjugated immuno-cytokine)  Clinical strategy: Develop PDS0101 in combination with established therapies for rapid proof-of-concept and risk mitigation 
 

 Phase 2 investigator-led clinical trial evaluating the combination of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer  12  Indication  Patients with advanced HPV-associated cancer who have failed prior treatment  Clinical Agents  Bintrafusp alfa (M7824): Bifunctional “trap” fusion proteinM9241 (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 patientsGroup 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    The objective of this trial is to confirm that PDS0101 enhances the therapeutic benefit of M7824 & NHS IL-12 and may lead to expanded evaluation in several cancers with PDS0102-0104 
 

 13  Bintrafusp alfa (bi-functional checkpoint inhibitor)+ M9241 (immuno-cytokine (NHS-IL12))  Tumor Regression: 8/16 (50%)T-cell Clones: 18  PDS0101 + Bintrafusp alfa + M9241  Tumor 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 to be effective in infiltrating and killing tumors   Red – CD8+ (killer) T-cellsGreen – CD4 + (helper) T-cells  T-cell clones per 25% of TCR repertoire (Average)  Combination of PDS0101 with M9241 or Bintrafusp alfa (M7824) generated superior targeted T-cell response; triple combination demonstrated superior efficacy 
 

 PDS0101 Phase 1 clinical trial: Powerful CD8+ T-cell response resulted in regression of CIN cervical lesions & supported continued clinical studies  14    * When treated with selected human clinical trial dosage (1mg and 3mg Versamune®)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.  Most patients infected with multiple strains of HPV  CIN lesion regression at 1-3 months    60%  20%  20%  Phase 1 trial results showed no serious or dose-limiting toxicities of PDS0101 monotherapy  Monotherapy overcomes key limitation of immuno-oncology: > 20-fold increase in circulating dual INF-γ & Granzyme-b inducing killer T-cells vs. pre-treatment at day 14 led to rapid clearance of lesions* 
 

   Triple combination of PDS0101, Binstrafusp alfa and M9241 works synergistically to induce targeted T-cells to attack and infiltrate the tumor  15  Bintrafusp alfa exposes the tumor to attack and M9241 issues a signal calling T-cells to the tumor  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      BINTRAFUSP ALFA  M9241                        PDS0101 induces a powerful, HPV16-targeted CD8+ and CD4+ T-cell response  PDS0101  Activated CD8+ killer T-cell  Activated CD4+ helper T-cell  The triple combination works in synergy to prompt targeted T-cells to infiltrate and destroy the tumor  TUMOR DESTROYED 
 

 Objective response rate is measured by RESCIST 1.1 and represents at least a 30% reduction in tumor sizeAdvanced recurrent/refractory HPV-related cancer that is checkpoint inhibitor naïve:Patients who fail chemotherapy and/or radiation progress to checkpoint inhibitor therapy12-24% ORR with standard of care checkpoint inhibitors30% ORR reported by experimental therapy Bintrafusp alfa is the highest reported to dateAdvanced recurrent/refractory HPV-related cancer that is checkpoint inhibitor refractory:Few treatment options exist for these patients5-10% ORR reported with checkpoint inhibitors  PDS0101 phase 2 triple combination trial: Evaluated potential for superior preclinical tumor regression in advanced HPV-related cancer  16  The most critical limitation of immunotherapy is the inability to induce large numbers of powerful tumor-attacking CD8+ (killer) T-cells within the body, that can result in tumor reduction or elimination in a significant number of advanced cancer patients  Strauss J, et al. J Immunother Cancer. 2020 Dec;8(2):e001395 
 

 Checkpoint inhibitor naïve patients (Relapsed or refractory advanced cancer)Tumor types represented in checkpoint inhibitor naïve study arm include anal, cervical, head and neck and vaginal  Triple combination achieved 83% ORR among 6 HPV16-positive patients  17    HPV16 positive subjects  CurrentStandard of Care(Checkpoint Inhibitors)  Number of subjects  6    Number of objective responses (tumor reduction)  5    Percentage of objective responses  83%  12-24%  Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2021 Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501.   * These numbers reflect data as of evaluation of 14 patients; numbers will change as more patients undergo evaluation  Preliminary results suggest PDS0101 induction of in-vivo tumor-attacking HPV16 killer (CD8+) T-cells may result in effective targeting of the HPV16-positive tumors resulting in disease reduction 
 

 Checkpoint inhibitor refractory patientsTumor types represented in checkpoint inhibitor naïve study arm include anal, cervical, head and neck and vulvar  Preliminary results suggest the triple combination may provide superior efficacy over checkpoint inhibitor monotherapy, even in immunologically limited patients  Triple combination achieved 63% ORR among 8 HPV16-positive checkpoint inhibitor refractory patients  18    HPV16 positive subjects  Current Standard of Care  Number of subjects  8    Number of objective responses (tumor reduction)  5    Percentage of objective responses  63%  5-12%  Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2021 Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501.   * These numbers reflect data as of evaluation of 14 patients; numbers will change as more patients undergo evaluation 
 

 19  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 cancer has 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    If achieved, confirmation that PDS0101 enhances the therapeutic benefit of checkpoint inhibitors could expand evaluation of Versamune®-based therapies in multiple cancer indications 
 

 20  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 therapyPDS0101: 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 months and rate of tumor volume reduction by MRI at 30-40 days from start of treatment  Trial Sponsor    If successful, this study could support further investigation of Versamune®-based immunotherapies in combination with chemotherapy or CRT to treat multiple cancers 
 

 Studies are designed to demonstrate efficacy and broad applicability of PDS0101 and the Versamune® T-cell activating platform  21  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 
 

 Mt. Sinai data shows Versamune® promotes induction of neutralizing antibodies with lowest doses of SARS-CoV-2 antigen1  23  1Reference: Sun et al. 2020. Vaccines Volume 8, Issue 42Reference: Data on file  PDS Biotech preclinical data shows induction of SARS-CoV-2 specific CD8+ T-cells with Versamune®2  Preclinical studies show potentially powerful induction of long-lasting polyfunctional CD8+ and CD4+ 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 
 

 Development of PDS0203, if successful, 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.   24 
 

 Looking Forward 
 

 26  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)  
 

 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 and regulatory procedures, 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, if development is successful, could 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  27 
 

 Projected milestones through 2022*  *Based on current enrollment and forecast modeling as of April 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) expected  Preliminary Data from ImmunoCerv combo trial (MD Anderson) expected  Potential interim data from VERSATILE-002 (Keytruda combo)  Initiation of Phase 1/2 COVID clinical trial of PDS0203  Initiation of Phase 3 COVID clinical trial of PDS0203  Efficacy data from Phase 3 COVID clinical trial of PDS0203            Completion of HPV-associated cancer trial (NCI)    PDS0101  PDS0203**    28    PDS Biotech Funded Clinical Trials  Partner Co-Funded Clinical Trials 
 

 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  We believe that Versamune®’s unique flexibility means it may work well with a wide range of identified tumor and infectious disease antigensToday, 4 tumor antigens are being utilized with the Versamune® platform, more than 75 tumor antigens have been identified in oncologyToday, 3 infectious disease antigens are being developed with the Versamune® platform, more than 12 infectious disease antigens have been identified as potential targetsProof of concept data from ongoing clinical trials could trigger development activities for Versamune®-based products through partnerships and licensing  29 
 

 Rapid commercialization strategy  30  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 potential for expedited programsRapid adoption strategy: Evaluation of PDS0101 in combination with standard of care in multiple HPV-associated cancers    Potential Advantages and Differentiators