Full Press Release Details
Developing Transformational Immunotherapies for Cancer NASDAQ: PDSB May 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 is a registered trademark, and Infectimune is a trademark 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, HPV-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 March 31, 2023 $65.2M cash runway into Q3 2024 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 Director of Clinical Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch) 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 Mechanism of Action Comprised of cationic lipids (R-DOTAP)
co-administered with proprietary tumor antigens, delivered via subcutaneous injection Delivers 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 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
Versamune Based Oncology Pipeline Partnerships with World Class Institutions in
Immuno-Oncology Reference: Data on file. PDS Biotech Funded Candidate/ Study Indication Combination PC P1 P2 P3 R Partner(s) Clinical (Lead) PDS0101 (HPV)/ VERSATILE-002 Recurrent or metastatic HPV16-positive head and neck
cancer Arm 1: ICI na ve Arm 2: ICI refractory KEYTRUDA (standard of care) IIT Studies PDS0101 (HPV)/ IMMUNOCERV 1st-line treatment of locally advanced (IB3-IVA) cervical cancer Chemo-radiation (standard of care) PDS0101 (HPV)/ Mayo
Clinic Pre-metastatic HPV-positive oropharyngeal cancer (OPSCC) Arm 1: PDS0101 monotherapy Arm 2: PDS0101 + KEYTRUDA KEYTRUDA (standard of care) Preclinical Candidates PDS0102(TARP) TARP-positive AML, prostate and breast
cancers TBD PDS0103 (MUC1) MUC1-positive breast, colon, lung, ovarian and other cancers TBD PDS0104(TRP2) Melanoma TBD Partner Co-Funded Fast Track Designation
HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC) Disease Overview and
HNSCC is a Devastating Group of Cancers Reference: Noseyaba et al. 2018. Cancer.
Suicide Risk Among Cancer Survivors: Head and Neck Versus Other Cancers https://virologyj.biomedcentral.com/articles/10.1186/s12985-021-01688-9 https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.html *Human Papillomavirus Oral and
PharyngealCancers Genotype of *HPV-Positive Oral and Pharyngeal Cancer Paranasalsinuses Nasopharynx Oropharynx Hypopharynx Larynx Pharynx Tongue Salivaryglands OralCavity NasalCavity
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 2Primary Market Research
2022 * No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101
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 decades Existing immunotherapies cost $150,000+ annually per patient1 No available
HPV specific therapy Initial commercial opportunity for PDS0101
PDS0101 for HPV16-Positive HNSCC
PDS0101: A Novel Investigational HPV-Targeted Immunotherapy PDS0101 is given by
subcutaneous injection and stimulates a potent targeted T cell attack against HPV-positive cancers Interim VERSATILE-002 data suggests PDS0101 generates clinically effective immune responses The combination of PDS0101 with KEYTRUDA has
demonstrated a favorable safety profile to date PDS0101 with KEYTRUDA demonstrates significant disease control by shrinking tumors, delaying disease progression and prolonging survival
VERSATILE-002 Phase 2 Clinical Trial 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 Endpoints Fast TrackDesignation
Demographics of the ITT (Safety) and mITT (Efficacy) Populations Demographics and
Baseline Characteristics Demographic or Baseline Characteristic ITT Population (N=48) mITT Population (N=34) Age, Median (Min, Max) 62.5 (45, 83) 63.5 (46, 83) Sex, n (%) Male Female 45 (93.8) 3 (6.3) 32 (94.1) 2 (5.9) Race,
n (%) American Indian or Alaska Native Asian Black or African American Pacific Islander White Multiple Other 0 1 (2.1) 1 (2.1) 0 45 (93.8) 0 1 (2.1) 0 0 0 0 33 (97.1) 0 1 (2.9) ECOG, n (%) 0 1 30 (62.5) 18
(37.5) 20 (58.8) 14 (41.2) CPS, n (%)* <1 1-19 20 1 (2.1) 27 (56.3) 20 (41.7) 0 17 (50.0) 17 (50.0) Summary of Exposure Exposure ITT Population (N=48) PDS0101 doses, Median (Min, Max) 4.0 (1, 5) PDS0101 doses, n,
(%) 1 dose 2 doses 3 doses 4 doses 5 doses 46 (95.8) 40 (83.3) 36 (75.0) 27 (56.3) 11 (22.9) Pembrolizumab doses, Median (Min, Max) 5.0 (1, 29) Pembrolizumab doses, n (%) 1 dose 2 doses 3 doses 4 doses 5 doses 6
doses 7 doses 8 doses 9 doses 10 doses 48 (100) 40 (83.3) 36 (75.0) 28 (58.3) 27 (56.3) 23 (47.9) 20 (41.7) 16 (33.3) 15 (31.3) 13 (27.1) Duration of treatment (months), Median (Min, Max) 3.5 (0.0, 19.5)
To Date 70.6% of Patients have Achieved Disease Stabilization or Tumor
Shrinkage Confirmed best overall response was determined based on confirmed CR or confirmed PR per RECIST 1.1 per investigator assessment. One subject (NE) died prior to target lesion measurement and is included in the mITT population
denominator. Four subjects experienced unconfirmed tumor shrinkage and subsequently experienced progressive disease. 30%Shrinkage 14/34 (41.2%) Confirmed and Unconfirmed Objective Response 9/34 (26.5%) Confirmed Partial and Complete
Response 15/34 (44.1%) Stable Disease 9/34 (26.5%) Progressive Disease 1/34 (2.9%) Not Evaluable (not included in Waterfall plot) 23/34 (67.6%) Tumor Reduction
Compelling Durability of the Anti-Tumor Response Progressive Free Survival (PFS)
per Investigator Assessment (mITT Population) Number of Subjects at Risk (Events) CPI Na ve 34 (0) 33 (1) 32 (2) 27 (6) 25 (7) 16 (11) 14 (12) 12 (12) 12 (12) 10 (12) 9 (13) 8 (14) 6 (15) 4 (15) 4 (15) 3 (16) 1 (18) 1
(18) 1 (18) 0 (18) N Events Median (Months) 95% CI(Months) 34 18 10.4 (4.2, 15.3) PFS = 10.4 months Demonstrated median PFS of 10.4 months; published results of 2-3 months for approved immune checkpoint inhibitors* * No control or
comparative studies have been conducted between immune checkpoint inhibitors and PDS0101; Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrolizumab
alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE- 048): a randomized, open-label phase 3 study; Lancet 2019;
Promising Survival Benefit Overall Survival (OS) (ITT Population) Number of
Subjects at Risk (Events) CPI Na ve 47 (0) 41 (1) 36 (1) 31 (1) 29 (1) 26 (1) 23 (2) 19 (2) 17 (2) 16 (2) 13 (3) 13 (3) 13 (3) 13 (3) 12 (3) 11 (3) 6 (4) 5 (4) 4 (4) 3 (4) 2 (4) 0 (4) N Events Median (Months) 95%
CI(Months) 48 4 NE (15.3, NE) 12-month OS rate = 87.1% Demonstrated 12-month OS rate of 87.1%; published results of 35-50% for approved immune checkpoint inhibitors* * No control or comparative studies have been conducted between
immune checkpoint inhibitors and PDS0101; Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B et al., Pembrolizumab alone or with chemotherapy versus cetuximab with
chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE- 048): a randomized, open-label phase 3 study; Lancet 2019;
67.6% of Patients Experienced Tumor Shrinkage Overall response: CR=Complete
Response; PR=Partial Response; SD=Stable Disease; PD=Progressive Disease; NE=Not Evaluable. Overall response was based on investigator assessment per RECIST v1.1. Survival status: A=Alive; D=Deceased. Alive subjects were based on the last
contact date. Complete Response Partial Response Stable Disease Progressive Disease Demonstrated objective response rate of 41% (confirmed and unconfirmed) No control or comparative studies have been conducted between immune checkpoint
inhibitors and PDS0101
Several Patients Approaching Two Years of Survival Blue Dot: Timing of last scan
demonstrating PD; Red Bars - PD, Grey Bars - SD, Green Bars - PR, Black Bar - CR, Orange Bars - survival period through last known date alive Days on Treatment and Survival Grouped by Best Overall Response mITT Population (n=34) with at
least 1 scan No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101
Data Suggests Prolonged Responses (Durability) and Patient Survival PDS0101 +