Full Press Release Details
Developing Transformational Immunotherapies for Cancer NASDAQ: PDSB December
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 Q1 2024 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 PDS01ADC in multiple Phase
2 clinical studies Financial: Cash as of September 30, 2023 - $54.3M - Adequate cash runway into Q3 2024 with initiation of a registrational trial in 2024 Executive Summary: Positioned for Market Leadership Company Overview T cell
activating platforms and antibody conjugated immunocytokine 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) Lars Boesgaard Chief Financial Officer 20 years of financial leadership roles in healthcare Former Chief Financial Officer of publicly traded healthcare and biotech
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
Proprietary Investigational Drug AssetsFocused on Targeting the Immune Response
to the Tumor Water-insoluble Fatty acids/hydrocarbon chains Immunologically active R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium-propane (R-DOTAP) Water-soluble and positively charged head-group coats the particle surface References:
Gandhapudi SK, et al. 2019. J. for ImmunoTherapy of Cancer 8:e000612 Greiner.JW et al ImmunoTargets and Therapy 2021:10 155-169 Versamune T Cell Activating Platform IL-12 Fused Antibody Drug Conjugate (ADC)PDS01ADC (NHS-IL12) NHS76
(DNA-binding Ab) IL-12 (p40 clipping-resistant) De-immunized junction
Profile of PDS01ADCIL-12 fused antibody drug conjugate (tumor
targeted) PDS01ADC (M9241, NHS-IL12) immunocytokine is administered by subcutaneous injection Recombinant fusion protein consisting of the human monoclonal IgG1 antibody NHS76 fused to two molecules of the human IL-12 heterodimer at each
CH3 C-terminus NHS76 is a second-generation tumor necrosis-targeting (TNT) antibody that has been clinically validated for its ability to target lung tumors following systemic administration NHS76 targets exposed DNA/histone sites, and as a
result directs the proinflammatory cytokine IL-12 to intra-tumoral necrotic regions PDS01ADC tumor accumulation demonstrated to increase when combined with tumor necrosis-inducing agents e.g., HDAC inhibitors, chemotherapy,
radiation Safety: Evaluated in >250 subjects: Antibody modification improves safety and therapeutic profile of IL-12. Well tolerated at all doses as monotherapy, dual combination with SOC (chemotherapy, radiation etc.), and as a triple
combination with ICI and PDS0101 References: Toney NJ et al, International Immunopharmacology 116 (2023) 109736 Greiner.JW et al ImmunoTargets and Therapy 2021:10 155-169
Profile of Versamune Designed to direct powerful CD4 (helper) and CD8 (killer)
T cells into tumors 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 (HPV16) HPV+ Cancers PDS0102 (TARP) Prostate, Breast, AML PDS0103 (MUC1) NSCLC, Colon, Gallbladder, etc. PDS0104 Melanoma 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. J Immunol. 202 (12): 3524-3536. Smalley Rumfield C et al. 2020J. 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
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 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 Phase 2 Clinical Studies
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 R/M =
recurrent and metastatic
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 No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101 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
Survival Rates Demonstrate Potential Contribution of PDS0101 to Survival in
Advanced Head and Neck Cancer PDS0101 + KEYTRUDA Shows Promising Survival Benefit Even in ICI Resistant Patients * 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 Ferris RL, et al. NEJM. 2016;375:1856-67. Bila M, et al. Frontiers in Oncology. Jan 2022;12:761428.R/M = recurrent and metastatic 12-month Overall Survival Rate First-line R/M
HNSCC ICI Refractory HNSCC 12-month Overall Survival Rate Progression ICI-Resistant HNSCC No salvage chemotherapy
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 ICI na ve subjects
(13%) and only 1 ICI resistant subject (4%) had Grade 3 PDS0101+KEYTRUDA TRAE Published results 13-17% grade 3-5 TRAE with approved ICI immunotherapy in the ICI na ve population No subjects had Grade 4 or 5 TRAEs PDS0101+KEYTRUDA
Treatment Related Adverse Events (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 ICI Na ve Cohort
PDS0101+KEYTRUDA Treatment Related Adverse Events (Safety Population, N=25) Preferred Term n (%) Any Combination-TRAE 21 (84.0) Grade 1 13 (52.0) Grade 2 7 (28.0) Grade 3 1 (4.0) Grade 4 0 Grade 5 0 ICI Resistant Cohort