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): February 3, 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):


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 February 3, 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 the National Cancer Institute’s Phase 2 clinical study of PDS0101 for the treatment of advanced human papilloma virus-associated cancers that have progressed or returned after treatment achieved its preliminary objective response.

On February 3, 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 February 3, 2021.
Corporate Presentation dated February 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: February 3, 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 Preliminary Efficacy Achievement in Phase 2
Combination Trial of PDS0101 Led by the National Cancer Institute

Full enrollment triggered by observation of 3 objective responses in continued evaluation of the initial group of 8 patients

Florham Park, NJ, February 3, 2021 - PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology, today announced that the National Cancer Institute’s (NCI) Phase 2 clinical study of PDS0101 for the treatment of advanced human papillomavirus (HPV)-associated cancers that have progressed or returned after treatment achieved its preliminary objective response. The trial, which studies PDS0101 in combination with two investigational immune-modulating agents bintrafusp alfa (M7824), a TGF-β “trap”/ anti-PD-L1 bifunctional fusion protein, and NHS-IL12 (M9241), a DNA-targeted immunocytokine, will now progress to full enrollment of approximately 20 in this group of checkpoint inhibitor (CPI) naïve patients.  As a result of achieving this milestone, preliminary efficacy assessment of the triple combination in an added group of approximately 20 patients who have failed prior therapy with checkpoint inhibitors (CPI refractory) is ongoing.

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. The trial is evaluating the treatment combination in two patient groups: one in patients who failed prior treatment, but are naïve to checkpoint inhibitor treatment; and the second in patients who have failed treatment with checkpoint inhibitors. As prespecified in the clinical trial design, the achievement of an objective response as measured by radiographic tumor responses according to RECIST 1.1 or iRECIST among at least three of the first eight patients allows the trial to progress to full enrollment.

Pooled data from phase 1 and 2 trials reported in the October 2020 issue of the Journal for Immunotherapy of Cancer (J ImmunoTher Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395) showed that bintrafusp alfa (M7824) a first-in-class bifunctional fusion protein composed of the extracellular domain of human TGF-β (TGF-β “trap”) fused to an IgG1 antibody blocking PD-L1 (anti–PD-L1) protein, demonstrated efficacy in checkpoint inhibitor-naïve patients with HPV-associated malignancies. The observed response rate was 30.5%.  M9241 is an immunocytokine composed of 2 heterodimers of IL-12 fused to the heavy chains of a human antibody targeting DNA released from necrotic tumor cells. In preclinical studies performed at the NCI comparing each drug alone versus all three agents used in combination, the triple combination achieved the highest induction of tumor-specific CD8+ killer T-cells and superior antitumor effect (J ImmunoTher Cancer 2020;8:e000612. doi:10.1136/jitc-2020-000612).

“The achievement of this important milestone in this NCI-led Phase 2 clinical trial strengthens 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 to achieve tumor regression,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech. “The initial data solidifies our belief that PDS0101’s demonstrated preclinical efficacy when combined with these two immune-modulating agents, has the potential to significantly improve clinical outcomes for patients with advanced and currently untreatable HPV-associated cancers.”



The studies are being performed as part of a Cooperative Research and Development Agreement (CRADA) between PDS Biotech and the NCI.  Dr. Jeffrey Schlom, Chief, LTIB, and Dr. James Gulley, Chief, GMB, at NCI are serving as principal investigators for the NCI, while Dr. Frank Bedu-Addo and Dr. Lauren Wood, PDS Biotech’s Chief Executive Officer and Chief Medical Officer respectively, are serving as PDS Biotech’s investigators.

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), email NCIMO_Referrals@mail.nih.gov, or visit the website: https://trials.cancer.gov.

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 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 studying a combination of PDS0101 and KEYTRUDA® to a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. In separate partnership with the National Cancer Institute (NCI), and The University of Texas MD Anderson Cancer Center, PDS Biotech is conducting additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer 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 its lead asset PDS0101; 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 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 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

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




Exhibit 99.2

 CORPORATE OVERVIEW  Frank Bedu-Addo Ph.D. President & CEO  FEBRUARY 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+ killerT-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  Versatile, potent T-cell-activating platform demonstrating efficacy without dose limiting toxicity in clinical trialsClinically supported in vivo induction of antigen-specific killer and helper T-cells Demonstrated to work with a wide array of oncogenes and viral antigensMultiple composition and application patents valid through mid-2030sClinical partnerships with Merck, MD Anderson and National Cancer Inst.  Biopharma developing novel treatments for cancer and T-cell activating infectious disease vaccinesThree phase 2 oncology clinical trials in progress to initial data releases in 2021Publicly listed on NASDAQ: PDSB~15 employees with headquarters in Florham Park and Princeton, NJDebt free with approximately $33.5M in cash as of 9/30/20  Pipeline      Versamune® Platform  Corporate Overview 
 

 PDS Biotech’s robust Versamune®-based pipeline being developed in partnership with the leaders in immuno-oncology  5  Reference: Data on file. 
 

 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  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) 
 

 Phase 1 clinical trial: Powerful in-vivo CD8+ T-cell response results in regression of CIN cervical lesions – supports preclinical studies  10    * 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  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* 
 

 11    Versamune®-basedImmunotherapies*  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          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) 
 

 Mt. Sinai data shows Versamune® promotes induction of neutralizing antibodies with lowest doses of SARS-CoV-2 antigen1  12  1Reference: Sun et al. 2020. Vaccines Volume 8, Issue 42Reference: Data on file  PDS 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+ and CD4+ anti-SARS-CoV-2 T-cells  Development of PDS0203 - A second generation COVID-19 vaccine that promotes powerful T-cell responses and neutralizing antibodies 
 

 13  Versamune® has demonstrated 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 
 

 PDS0101 Phase 2 Clinical Development 
 

 15  PDS0101 is designed to treat cancers caused by human papillomavirus (HPV)  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 
 

 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  16  Novel combinations of PDS0101 with promising 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 to evaluate improved therapy: Combine PDS0101 with established therapies for rapid proof-of-concept and risk mitigation 
 

 17  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    Confirmation that PDS0101 enhances the therapeutic benefit of checkpoint inhibitors could expand evaluation of Versamune®-based therapies in multiple cancer indications 
 

 18  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    Safety and enhanced efficacy could lead to broad applications of Versamune®-based immunotherapies in combination with chemotherapy or CRT to treat multiple cancers 
 

 19  M7824 (bi-functional checkpoint inhibitor)+ NHS-IL12 (immuno-cytokine)  Tumor Regression: 8/16 (50%)T-cell Clones: 18  PDS0101 + M7824 + NHS-IL12  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  PDS0101 enhanced treatment by training tumor-specific T-cells (fewerT-cell clones) effective in infiltrating and killing tumors   Red – CD8+ (killer) T-cellsGreen – CD4 + (helper) T-cells  T-cell clones per 25% of TCR repertoire (Average) 
 

 Phase 2 investigator-initiated clinical trial evaluating the combination of PDS0101, M7824 and NHS-IL12 in advanced HPV-associated cancer  20  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 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    Confirmation that PDS0101 enhances the therapeutic benefit of M7824 & NHS IL-12 may lead to expanded evaluation in several cancers with PDS0102-0104 
 

 Studies are designed to demonstrate efficacy and broad applicability of PDS0101 and the Versamune® T-cell activating platform  21  Enhance anti-cancer efficacy of various cancer treatments: Combinations with checkpoint inhibitors, chemotherapy and novel therapies may demonstrate Versamune®’s versatility.  Broad partnerships: Successful phase 2 studies with PDS0101 and PDS0203 could enable development of 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.  Applications beyond oncology: PDS0203 COVID-19 phase 1/2 trials may demonstrate powerful preventive ability and induce durable T-cell responses against conserved regions of mutating viruses. 
 

 Looking Forward 
 

 Financial position to support PDS0101 projected milestones through mid-2022*  23  *Based on current enrollment and forecast modeling as of November 2020. Subject to change. 
 

 Positioned for accelerated development  24  Enhanced anti-cancer efficacy: Early clinical data and preclinical data suggest potentially superior efficacy, safety and versatility of the platformNear-term milestone: PDS0101 preliminary data Q1-Q2 2021Validation 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: Clinical studies evaluating the potential to safely enhance the clinical efficacy of FDA-approved anti-cancer products presents a potentially rapid path to commercializationRapid adoption strategy: Evaluation of PDS0101 in combination with standard of care in multiple HPV-associated cancers  Pipeline    Key Advantages and Differentiators