Full Press Release Details
Developing Transformational Immunotherapies for Cancer NASDAQ: PDSB October 2023
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 other Versamune and Infectimune based product candidates; 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 other Versamune and Infectimune based product candidates 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 the Company's ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company's currently projected expenses), futility analyses,
presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), 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; to aid in the development of the Versamune platform; and other factors, including legislative, regulatory, political and economic developments not within the Company's control. 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, quarterly 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. Versamune and Infectimune are registered trademarks of PDS Biotechnology
Corporation KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic,
HPV16-positive head and neck squamous cell cancer (HNSCC) Fast Track Designation PDS0101 addresses large and growing market with significant unmet need Transformational data generated with PDS0101 and PDS0301 in multiple Phase 2 clinical
studies Financial: Cash as of June 30, 2023 - $60.6M- Adequate cash runway for the approximately the next 12 months with initiation of a registrational trial in 2023 Executive Summary: Positioned for Market Leadership Company Overview T
cell activating platforms and antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting cancer immunotherapies 1 2 3 4
Experienced Management Team Historical success in development and commercialization of
leading pharmaceutical products Frank Bedu-Addo, PhD Chief Executive Officer Senior executive experience with management of strategy and execution at both large pharma and biotechs Notable drug development: Abelcet (Liposome Company/
Elan) PEG-Intron (Schering-Plough/ Merck) Matthew Hill Chief Financial Officer 20 years of financial and operational leadership roles for life sciences companies Former Chief Financial Officer of several publicly traded companies Lauren
V. Wood, MD Chief Medical Officer 30 years of translational clinical research experience Former Vaccine Branch Clinical Director at National Cancer Institute Center for Cancer Research Gregory Conn, PhD Chief Scientific
Officer Co-founder 35 years of drug development experience In-depth experience with biotech drug discovery, product development and manufacturing
PDS Biotech Versamune Overview Designed to address limitations of current
immunotherapy PLATFORM: Induces powerful, long-lasting anti-tumor response by promoting uptake of tumor-specific proteins by the immune system and activates a specific signaling pathway that promotes the production of active
tumor-infiltrating multifunctional CD8 killer and CD4 helper T cells Versamune PDS0101 PDS0102 PDS0103 PDS0104 Product Candidates
Versamune Induces the Right Type, Potency and Quantity of Multifunctional Killer and
Helper T Cells Comprised of positively charged lipid (R-DOTAP) co-administered with proprietary tumor-specific proteins, delivered via subcutaneous injection Presents antigen to CD4 and CD8 T cells. Activates the Type I Interferon pathway,
leading to potent, multifunctional, antigen specific T cell responses Human clinical trials confirm induction and accumulation of multifunctional T cells in the tumor, which correlated with clinical response and elimination of circulating
tumor DNA and clinical response (SITC 2022) Recruits T cells to lymph nodes Trains T cells to target tumors Arms T cells to kill tumor cells 1 2 3 Injection Site Lymph Node Tumor Site References: 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.
IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial Killer (CD8) T Cells PDS0101
activates the immune system to generate active killer T cells (CD8 T) cells that induce a critical mediator of the T cell's tumor-killing function called granzyme-B Multifunctional killer T cells target, infiltrate and eliminate the cervical
cancer tumors 91.7% clearance of HPV16 ctDNA at week 5 vs 53.1% clearance with chemoradiation alone Quantity of tumor cell DNA circulating in the blood Killer T cells that infiltrated the tumors Representative Subject IMMUNOCERV
(PDS0101+Chemoradiation) Trial1,2: Predominantly stage III and IV cervical cancer Locally advanced cancer with tumors > 5cm (high-risk) 100% of patients had cancer spread to lymph nodes SITC 2022 100% (9/9) clinical response rate with
60 days No evidence of cancer in 89% (8/9) by Day 170 Induction of activated CD8 T cells correlates with elimination of circulating tumor DNA1,2 1Yoshida-Court et al,, IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific
T cell immunotherapy, with chemotherapy and radiation for treatment of locally advanced cervical cancers (NCT04580771); SITC 2022 2ASTRO 2023
HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC) Disease Overview and Market
Est. HPV16Locally Advanced,Unresectable andMetastatic HPV16-positive HNSCC Presents a
Significant Market Opportunity Largely Attributed to the High Rate of Oral HPV Infections in Men Data sources: 1 PD-L1 negative and PD-L1 positive populations (> 9000 incidence PD-L1
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5002133/ ~18,300 ~34,000 ~38,100 ~54,400 Est. U.S. HPV Positive Oral and Pharyngeal Cancer Est. U.S. Oral and Pharyngeal Cancer Est. HPV16 Genotype $2-3B Market Opportunity in US1 HPV
cancer incidences continue to increase despite preventive HPV vaccine HPV vaccination is not expected to impact the rate of HPV-positive cancer incidence for the near-term Existing immunotherapies cost $150,000+ annually per patient1 No
available HPV specific therapy Initial commercial opportunity for PDS0101
Targeted treatment option to address the growing population of HPV16-positive HNSCC and
improve outcomes Novel MOA that is clinically effective in a broader patient population and provides more durable responses. Safer and more effective treatments that may be used with or in place of current standard of care Better
tolerability and less toxic alternatives to chemotherapy Despite the Availability of Treatments, Significant Unmet Needs Remain in Recurrent or Metastatic HNSCC KEYTRUDA KEYTRUDA Plus Chemo Chemotherapy + EGFR Inhibitor Objective
Response Rate (ORR) 19% 36% 35% Progression Free Survival (PFS) 3.2 mos 5.0 mos 5.0 mos 12-Month Survival Rate 50% 55% 44% Median Overall Survival (OS) 12.3 mos 13.6 mos 10.3 mos Key Toxicities Anemia Fatigue Weight
loss Hypokalemia Additional to KEYTRUDA : Neutropenia Mucosal inflammation Thrombocytopenia Stomatitis Neutropenia Anemia Thrombocytopenia Nausea/vomiting Hypokalemia Rash Fatigue Mucosal inflammation Treatment Related Grade
3+ Toxicities 17% 72% 69% Oncologist2 - Stated Unmet Medical Needs in HNSCC Standard of Care for Recurrent or Metastatic HNSCC - Published Results*1 1KEYNOTE-048 Study Burtness B et al, Lancet 2019 2Primary Market Research 2022 * No
control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101
PDS0101 for HPV16-Positive HNSCC
VERSATILE-002 Phase 2 Clinical Trial - Results Support Initiation of Phase 3 Clinical
Trial in ICI Na ve R/M HNSCC Objective: To assess the combination of PDS0101 and KEYTRUDA in ICI na ve subjects with recurrent or metastatic HPV-positive HNSCC KEYTRUDA (pembrolizumab) FDA Approved Standard of Care Partner Study
Design Open-label, non-randomized, adaptive design study N=54 Enrollment complete Key Entry Criteria for ICI Na ve Subjects Recurrent or metastatic HNSCC 18 years of age HPV16-Positive tumor Combined positive score (CPS)
1 Pembrolizumab 200mg IV Q3W up to 35 Cycles (2 years) PDS0101 1 mL subcutaneous injection at Cycles 1, 2, 3, 4 and 12 Study Treatment Primary: Best overall response (BOR) of confirmed complete response (CR) or confirmed partial response
(PR) per RECIST 1.1 Key Secondary: Progression Free Survival (PFS) per RECIST 1.1 Overall Survival (OS) Safety and tolerability Achievement of Statistical Threshold for Efficacy Endpoints Fast TrackDesignation
Disease Stabilization or Tumor Reduction in 81% of Patients Tumor Shrinkage in 60%
(31/52) with Confirmed Objective Response in 27%1 (14/52) to Date Assessments based on Investigator assessment per RECIST 1.1 Data on File. 08/02/23 Data Cut. Burtness B et al., Lancet. 2019; 394:1915-1928. Best Percentage Change from
Baseline in Target Lesions (mITT population) VERSATILE-002 Months (95% CI) PDS0101+KEYTRUDA 8.1 KEYNOTE-048 (CPS 1) Months (95% CI) KEYTRUDA Monotherapy 3.2 KEYTRUDA + Chemo 5.0 EXTREME Chemo 5.0 Progression Free
Survival 1Achievement of Statistical Threshold for Efficacy
PDS0101 and KEYTRUDA Combination in ICI Na ve HNSCC Demonstrates Promising Patient
Survival to Date Median OS Not Yet Estimable Data on File. 08/02/23 Data Cut. Kaplan-Meier Estimates of Overall Survival (OS) (Intent-to-Treat Population) No. of Subjects at Risk (Events) 55 (0) 53 (2) 50 (3) 42 (5) 41 (6) 36 (7) 32
(8) 27 (8) 24 (8) 21 (8) 19 (9) 17 (9) 17 (9) 17 (9) 15 (9) 14 (9) 11 (10) 11 (10) 11 (10) 9 (10) 8 (10) 7 (10) 6 (10) 4 (10) 2 (10) 0 (10) 12 Month OS Rate - 80% 24 Month OS Rate - 74% 12-month OS Rates CPS 1-19 =
75% CPS 20 = 85% 24-month OS Rates CPS 1-19 = Not yet estimable CPS 20 = 85%
PDS0101 and KEYTRUDA Combination in ICI Na veHNSCC Demonstrates Promising Patient
Survival to Date Overall Survival is Primary Endpoint in Planned Phase 3 Study VERSATILE-003 * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101Data on File. 08/02/23 Data CutBurtness B et al.,
Lancet. 2019; 394:1915-1928 OS Rate (%) VERSATILE-002 VERSATILE-002 KEYNOTE-048(CPS 1) KEYNOTE-048(CPS 1) 12-month OS Rate 24-month OS Rate
Promising Survival with PDS0101 + KEYTRUDA 81% of subjects remain alive and continue to
be followed for survival Data on File. 08/02/23 Data Cut Assessments were based on Investigator assessment per RECIST 1.1 OS and PFS (mITT Population) Time to PFS OS Alive
The Addition of PDS0101 to KEYTRUDA Does not Appear to Compound Toxicity * No
controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101Data on File. 08/02/23 Data CutBurtness B et al., Lancet. 2019; 394:1915-1928 Ferris RL, et al. NEJM. 2016;375:1856-67. Only 8 subjects (13%) had
Grade 3 PDS0101-KEYTRUDA : Fatigue (2), Rash, Alanine aminotransferase increased, Blood alkaline phosphatase increased, Lymphocyte count decreased, Autoimmune colitis, Colitis, Headache, Acute kidney injury, Hyponatraemia, Hyperglycaemia
Published results 13-17% grade 3-5 TRAE with approved ICI immunotherapy No subjects had Grade 4 or 5 TRAEs PDS0101+KEYTRUDA Treatment Related Adverse Events (TRAE) 5% (Safety Population, N=62) Safety data in over 130 patients to date
across multiple Phase 1 and 2 Studies Safety data, anti-tumor responses and patient survival suggest that the Versamune based therapies such as PDS0101 could be ideal candidates for combination oncology treatments Preferred Term n (%) Any
Combination-TRAE 49 (79.0) Grade 1 23 (37.1) Grade 2 18 (29.0) Grade 3 8 (12.9) Grade 4 0 Grade 5 0
PDS0101 with KEYTRUDA Well Tolerated in VERSATILE-002 to Date with Few Serious
Toxicities Serious (Grade 3-5) Treatment Related Adverse Events *No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101 Data on File. 08/02/23 Data Cut Burtness B et al. Lancet.
2019;394:1915-1928 VERSATILE-002 No Grade 4 or 5 TRAE Subjects (%) KEYNOTE-048(CPS 1)
Data Continues to Hold Up as More Patients are Enrolled and Follow up Time is
Extended Data Summary Table Shows Consistency in Results PDS0101 KEYNOTE-048 Comments ASCO 2023 (06/05/23) KOL event (09/27/23) Cut-off Date January 13, 2023 August 02, 2023 Patients with CPS 1-19 50% 60% 48% Aug
02 cut off has a higher percentage of patients with CPS 1-19 (lower response to KEYTRUDA ). KEYNOTE rates among subjects with CPS 1. Patients with CPS 20 50% 40% 52% Disease Control Rate (SD+PR+CR) 70.6% 80.8% Patients with tumor
reduction 67.6% 59.6% Confirmed ORR on cut-off date 26.5% 26.9% 19% ORR steady as more patients enroll Median OS (CPS 1) Not yet estimable Not yet estimable 12.3 months KEYTRUDA exposes the cancer to the immune system (improves
with higher CPS score). Injection of PDS0101 activates T cells to infiltrate, weaken (disable) and, or kill the exposed cancer cells, thus providing the potential to promote prolonged survival. 12-month OS rate (CPS
1) 87% 80% 50% KEYTRUDA exposes the cancer to the immune system (improves with higher CPS score). Injection of PDS0101 activates T cells to infiltrate, weaken (disable) and, or kill the exposed cancer cells, thus providing the potential
to promote prolonged survival. 12-month OS rate (CPS 1-19) N/A 75% 44% 12-month OS rate (CPS 20) N/A 85% 56% 24-month OS rate (CPS 1) N/A 74% 29% PFS (CPS 1) 10.4 months 8.1 months 3.2 months PDS0101 promotes prolonged PFS
even in patients with lower CPS score. PFS for CPS 1 remains extended despite increased percentage of patients in lower CPS score group. PFS (CPS 1-19) 5.1 months 2.2 months PFS (CPS 20) 11.6 months 3.4 months * No control or
comparative studies have been conducted between immune checkpoint inhibitors and PDS0101 Burtness B et al. Lancet. 2019;394:1915-1928 Burtness, B. et al. J Clin Oncol. 2022;40:2321-2332.
Combination of PDS0101 & KEYTRUDA Continues to Show Promising Safety and Survival
Outcomes VERSATILE-002 Study Shows Potential Of PDS0101 to Safely Modify the Tumor Microenvironment to Promote Patient Survival The 24-month OS rate in the ICI na ve cohort is 74%; Published results of 29% in KEYNOTE-048 The 12-month OS rate