Summary of PDS Biotechnology (PDSB) FY Conference Call Company Overview - **Company**: PDS Biotechnology (PDSB) - **Focus**: Developing targeted immunotherapies for cancer, specifically their lead product, Versamune HPV, which is in a Phase III clinical trial for recurrent or metastatic HPV16 positive head and neck cancers [1][5][29] Industry Context - **Market Opportunity**: The market for HPV16 positive head and neck cancers is estimated to be between $4 billion to $5 billion in the United States and Europe [7] - **Epidemic Status**: Head and neck cancer is described as a "silent epidemic," with projections indicating a 30% annual increase in incidence by 2030 [5][6] Core Product Insights - **Versamune HPV**: - Targeting HPV16 positive cancers, which are expected to dominate head and neck cancer cases by the 2030s [6] - Fast track designation granted by the FDA based on Phase II trial data [7] Clinical Trial Data - **Phase II VERSATILE 002 Trial**: - Median overall survival of 30 months compared to 12-13 months for standard therapies [14][15] - 100% elimination of circulating tumor HPV16 DNA in patients treated with Versamune HPV plus standard care, versus 50% reduction in those receiving only standard care [11] - 92% two-year recurrence-free survival for patients with no detectable circulating tumor DNA [11] - **Phase III VERSATILE 003 Trial**: - Designed to have median overall survival as the primary endpoint, with a two-to-one randomization [17][18] - Anticipated interim data readouts to facilitate early discussions with the FDA [18] Competitive Advantages - **Immunotherapy vs. Traditional Treatments**: - Current treatments like chemotherapy and EGFR inhibitors have limited effectiveness in long-term survival [9] - Versamune HPV aims to train the immune system to target specific cancer markers, potentially improving outcomes [10][12][13] Future Developments - **Upcoming ASCO Presentation**: Three abstracts accepted, including updates on VERSATILE 002 and details on the VERSATILE 003 trial [20][21] - **Market Potential**: Beyond head and neck cancers, Versamune HPV may also target other HPV16 positive cancers, potentially leading to a market opportunity exceeding $10 billion [29] Additional Notes - **Collaboration with National Cancer Institute**: Ongoing work on the MAC1 program, focusing on MUC1 sequences for various cancers [25][27] - **Regulatory Updates**: IND approval for new trials is pending, with timelines still to be determined [28] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic focus, clinical advancements, and market potential.

Core Viewpoint - PDS Biotechnology Corporation is participating in the A.G.P. Virtual Annual Healthcare Company Showcase, highlighting its focus on immunotherapy for cancer treatment [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company dedicated to transforming the immune system's ability to target and eliminate cancers [3]. - The company has initiated a pivotal clinical trial for its lead program, which targets advanced HPV16-positive head and neck squamous cell cancers [3]. - The lead investigational therapy, Versamune HPV, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination with PDS01ADC, an IL-12 fused antibody drug conjugate [3]. Event Details - The A.G.P. Virtual Annual Healthcare Company Showcase is scheduled for May 21, 2025, with a fireside chat featuring the CEO of PDS Biotech from 5:20 to 5:40 p.m. ET [2]. - An archived replay and transcript of the fireside chat will be available on the company's Investor Relations website following the event [2].

Clinical Trials and Efficacy - The company reported a 75% survival rate for ICI naïve patients at 36 months in a Phase 2 trial involving the combination of Versamune® HPV, PDS01ADC, and an investigational immune checkpoint inhibitor [89]. - The VERSATILE-003 Phase 3 clinical trial is set to enroll 351 patients, with approximately 234 receiving the combination treatment of Versamune® HPV and pembrolizumab [92]. - Updated interim data from the VERSATILE-002 Phase 2 trial showed promising results based on an August 2, 2023 cut-off, with data presented on 52 patients [98]. - The company completed enrollment in the ICI naïve arm of the VERSATILE-002 trial in May 2023 and filed an amended IND with the FDA in Q3 2023 [96]. - The VERSATILE-002 trial aims to evaluate the efficacy and safety of Versamune® HPV combined with Keytruda® in patients with recurrent/metastatic head and neck cancer [94]. - Interim safety and immune response data for PDS01ADC in combination with docetaxel was presented at a major conference, indicating progress in treating metastatic prostate cancer [87]. - Estimated 12-month overall survival rate was 87.1%, compared to published results of 36-50% with approved ICIs used alone [100]. - Median overall survival was reported at 30 months, while published results for pembrolizumab are 12-18 months [107]. - Objective response rate (ORR) of 36% (19/53), with published ORR for pembrolizumab being 19-25% [107]. - Disease control rate (DCR) is 77% (41/53), indicating a strong efficacy in the patient cohort [107]. - 12-month overall survival rate of 80%, with published results of 30-50% for approved ICIs [100]. - 75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months, compared to a published median overall survival of 7-11 months [111]. - 81.3% clearance of circulating tumor DNA (ctDNA) after 3 weeks with Versamune® HPV plus chemoradiation, versus 30.3% with standard of care (p=0.0018) [112]. - 44.1% (15/34) of patients had stable disease, demonstrating the treatment's potential for disease management [100]. - The combination of Versamune® HPV and Keytruda® showed a confirmed overall response rate of 34% (18/53) to date, with published results for comparable patients receiving treatment with ICIs being less than 20% [100]. - 9% (5/53) of patients had a complete response, indicating significant treatment efficacy [107]. Financial Performance - The company reported a net loss of $8.5 million for the three months ended March 31, 2025, compared to a net loss of $10.6 million for the same period in 2024, representing a 20% decrease in losses [132]. - Research and development expenses decreased to $5.8 million for the three months ended March 31, 2025, down from $6.7 million in the same period of 2024, a reduction of 13% [133]. - The company had $40.0 million in cash and cash equivalents as of March 31, 2025 [121]. - The company has an accumulated deficit of $190.6 million as of March 31, 2025, primarily due to research and development costs [120]. - The company has never been profitable and does not expect to generate revenue from commercial product sales in the near future [128]. - The company incurred total operating expenses of $9.1 million for the three months ended March 31, 2025, a decrease of 10% from $10.1 million in the same period of 2024 [132]. - Net cash used in operating activities was $9.0 million for the three months ended March 31, 2025, a decrease from $9.9 million in the same period of 2024 [150]. - Net cash provided by financing activities decreased by $12.7 million, primarily due to a $19.2 million decrease in proceeds from common stock issuance [151]. - The company has not generated any product revenue to date and anticipates continued losses as it develops and seeks regulatory approvals for its product candidates [152]. - Substantial doubt exists about the company's ability to continue as a going concern for at least 12 months from the issuance of the financial statements [148]. Research and Development Initiatives - Data from a preclinical trial indicated that the investigational universal flu vaccine, PDS0202, demonstrated broad neutralization across multiple influenza strains [84]. - The company confirmed the required contents of a clinical protocol for a potential registrational trial following a successful Type B meeting with the FDA in February 2023 [82]. - The company is developing a pipeline of targeted immunotherapies, including Versamune® and Infectimune®, aimed at oncology and infectious diseases [80]. - The company is focused on enhancing the proliferation and potency of T cells in the tumor microenvironment through its proprietary combinations of immunotherapies [81]. - The company is advancing multiple clinical trials for PDS01ADC, including a Phase 1/2 trial in combination with docetaxel for prostate cancer [119]. - The company plans to focus on developing a universal seasonal flu vaccine based on preclinical data demonstrating broad protective immune responses [125]. Capital and Financing Activities - The company sold 205,350 shares of common stock for a net value of $0.3 million during the three months ended March 31, 2025, under its New Sales Agreement [137]. - The company issued warrants to purchase a total of 381,625 shares at an initial exercise price of $3.6685 per share [139]. - The company received approximately $0.9 million from the net sale of tax benefits for tax year 2022 [140]. - The company received approximately $1.2 million from the net sale of tax benefits for tax year 2023 [141]. - The February 2025 Offering generated approximately $11 million in gross proceeds, with net proceeds of approximately $10.05 million [143]. - The company entered into a Securities Purchase Agreement to sell senior secured convertible debentures totaling $22,222,222 and warrants for $20 million [144]. - As of March 31, 2025, the company had $40.0 million in cash and cash equivalents [145].

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of approximately $8.5 million, or about $0.21 per share, compared to a net loss of $10.6 million, or $0.30 per share, in Q1 2024, reflecting a decrease due to increased tax benefits and lower operating expenses [12][13] - Research and development expenses were $5.8 million for Q1 2025, down from $6.7 million in the prior year, primarily due to lower clinical trial expenses [12] - General and administrative expenses were $3.3 million for Q1 2025, compared to $3.4 million in the prior year [13] - Total operating expenses decreased to $9.1 million in Q1 2025 from approximately $10.1 million in Q1 2024 [13] - Cash balance as of March 31, 2025, was $40 million, down from $41.7 million as of December 31, 2024 [13] Business Line Data and Key Metrics Changes - The company initiated the VERSAL-three registrational trial for Versamune HPV plus pembrolizumab, targeting recurrent or metastatic HPV16 positive head and neck cancer, which is projected to become the most prevalent type of head and neck cancer by the mid-2030s [6][8] - The VERSAL-three trial design includes approximately 350 patients, with a two-arm design approved by the FDA [7] Market Data and Key Metrics Changes - The company highlighted the growing population in need of targeted therapies for HPV16 positive head and neck cancer, which is difficult to treat and represents a significant market opportunity [5][6] Company Strategy and Development Direction - The company is focused on advancing its clinical programs, particularly the VERSAL-three trial, which is the first phase three trial in the high-risk HPV16 population [8][54] - The company aims to leverage its strong relationship with the National Cancer Institute to progress its MUC1 program, which is part of a collaborative research agreement [11][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Versamune HPV and pembrolizumab combination to significantly improve patient outcomes, citing encouraging clinical responses and survival data from previous trials [8][27] - The management team emphasized the importance of durability in treatment responses, noting that patients in the VERSAL-two trial had a median overall survival of 30 months compared to the standard of care's 12 months [27][28] Other Important Information - The company raised approximately $11 million through a securities purchase agreement and completed a refinancing of its debt, extending the term to 36 months [14][15] - The company plans to present updated results from the VERSAL-two study at the upcoming ASCO Annual Meeting [54] Q&A Session Summary Question: Impact of Keytruda head and neck neoadjuvant data on enrollment expectations for Phase III - Management clarified that the KEYNOTE-689 trial focused mainly on HPV negative patients and should not affect enrollment in the VERSAL-three trial, as very few HPV positive patients are eligible for surgery [22][23] Question: Insights on durability from the upcoming ASCO presentation - Management indicated that the upcoming ASCO presentation will provide additional data on durability and survival, highlighting the long-term responses observed in the VERSAL-two trial [24][27] Question: Enrollment status for the VERSAL-three trial - Management stated that enrollment details have not been publicly disclosed yet, as the activation of sites and patient screening processes are ongoing [48][49] Question: Future operating expenses expectations - Management noted that while they do not provide specific financial guidance, they expect a relatively stable trial spend going forward, with higher initial expenses typical in the early stages of a trial [51]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported a net loss of approximately $8.5 million, or about $0.21 per share, compared to a net loss of $10.6 million, or $0.30 per share, in Q1 2024, reflecting improved tax benefits and lower operating expenses [12][14] - Research and development expenses decreased to $5.8 million from $6.7 million year-over-year, primarily due to lower clinical trial expenses [12] - General and administrative expenses were $3.3 million, slightly down from $3.4 million in the prior year [12] - Total operating expenses for the quarter were $9.1 million, down from approximately $10.1 million in the previous year [12] - Cash balance as of March 31, 2025, was $40 million, compared to $41.7 million as of December 31, 2024 [13] Business Line Data and Key Metrics Changes - The company is advancing its clinical programs, particularly the Versamune HPV plus pembrolizumab treatment for HPV16 positive head and neck cancer, with the initiation of the VERSAL-three registrational trial [5][8] - The VERSAL-three trial design includes approximately 350 patients and has received FDA approval [6][8] Market Data and Key Metrics Changes - The company anticipates that by the mid-2030s, HPV16 positive head and neck cancer will become the most prevalent type of head and neck cancer in the U.S. and Europe [5] - The VERSAL-three trial is the first phase three trial targeting the high-risk HPV16 population [8] Company Strategy and Development Direction - The company is focused on the potential of Versamune HPV in improving outcomes for patients with recurrent and metastatic HPV16 positive head and neck cancer [5][8] - There is a strong emphasis on collaboration with institutions like the Mayo Clinic and the National Cancer Institute to enhance research and development efforts [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Versamune HPV and pembrolizumab combination to significantly improve patient outcomes, citing encouraging clinical response durability [7][28] - The management team highlighted the importance of maintaining long-term clinical responses, with a median overall survival of 30 months observed in the VERSAL-two trial compared to the standard of care's 12 months [28][29] Other Important Information - The company raised approximately $11 million through a securities purchase agreement and completed a refinancing of its debt, extending the term to 36 months [14] - The upcoming ASCO Annual Meeting will feature presentations on the VERSAL-two trial and other studies, which are expected to provide further insights into the company's clinical advancements [9][54] Q&A Session Summary Question: Impact of Keytruda head and neck neoadjuvant data on enrollment expectations for VERSAL-three - Management clarified that the KEYNOTE-689 trial primarily involved HPV negative patients, and thus, it should not affect enrollment in the VERSAL-three trial, which focuses on HPV positive patients [22][23] Question: Insights on durability from the upcoming ASCO presentation - Management indicated that the ASCO presentation will provide updates on the durability of responses observed in the VERSAL-two trial, emphasizing the long-term survival benefits compared to standard treatments [24][30] Question: Enrollment status for VERSAL-three and operational expenses outlook - Management stated that enrollment details have not been publicly disclosed yet, and they expect a steady recruitment state as more sites are activated [47][50]

Conference call and webcast today at 8:00 a.m. Eastern Time PRINCETON, N.J., May 14, 2025 -- PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late- stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a clinical and corporate update and reported financial results for the first quarter ended March 31, 2025. "The first quarter of 2025 and recent weeks have been productive for PDS Biotech, highlighted by the initiati ...

Core Viewpoint - PDS Biotechnology Corporation is advancing its clinical programs, particularly the VERSATILE-003 Phase 3 trial for its investigational therapy Versamune® HPV targeting HPV16-positive head and neck squamous carcinoma, while also reporting improved financial results for Q1 2025 compared to the previous year [3][4][6]. Clinical Updates - The VERSATILE-003 Phase 3 clinical trial has been initiated to evaluate Versamune® HPV in recurrent/metastatic HPV16-positive head and neck squamous carcinoma, with site activations progressing, including the addition of Mayo Clinic sites [4]. - The trial is designed to include approximately 350 patients and is a two-arm controlled trial with a 2:1 randomization, focusing on median overall survival as the primary endpoint [6]. - The company received FDA Fast Track designation for the combination of Versamune® HPV and pembrolizumab in recurrent/metastatic head and neck squamous carcinoma [6]. Financial Results - For Q1 2025, the reported net loss was approximately $8.5 million, or $0.21 per share, a decrease from a net loss of $10.6 million, or $0.30 per share, in Q1 2024 [6][7]. - Research and development expenses were $5.8 million in Q1 2025, down from $6.7 million in Q1 2024, primarily due to lower clinical trial expenses [7]. - Total operating expenses for Q1 2025 were $9.1 million, compared to approximately $10.1 million in Q1 2024 [8]. Cash Position - As of March 31, 2025, the company's cash balance was $40 million, a slight decrease from $41.7 million as of December 31, 2024 [8][16]. - The company has entered into securities purchase agreements for the sale of 7,330,121 shares of common stock, raising approximately $11 million upon closing, with potential for an additional $11 million from warrant exercises [6]. Upcoming Events - Three abstracts on Versamune® HPV have been selected for presentation at the 2025 American Society of Clinical Oncology Annual Meeting, scheduled for May 30-June 3, 2025 [6].

Core Insights - PDS Biotechnology Corporation has initiated the VERSATILE-003 Phase 3 clinical trial for its investigational therapy Versamune® HPV targeting recurrent/metastatic HPV16-positive head and neck squamous carcinoma [4][9] - The company reported a net loss of approximately $8.5 million for Q1 2025, a decrease from $10.6 million in Q1 2024, attributed to lower operating expenses and increased tax benefits [6][7] - PDS Biotech's cash balance as of March 31, 2025, was $40 million, down from $41.7 million at the end of 2024 [8][15] Clinical Updates - The VERSATILE-003 trial is designed to include around 350 patients and is a two-arm controlled trial with a 2:1 randomization [6][4] - The primary endpoint of the trial is median overall survival, with interim readouts included in the study design [6][4] - The FDA has granted Fast Track designation for the combination of Versamune® HPV and pembrolizumab in treating recurrent/metastatic HNSCC [6][4] Financial Performance - Research and development expenses for Q1 2025 were $5.8 million, down from $6.7 million in Q1 2024, primarily due to reduced clinical trial expenses [7][6] - General and administrative expenses were slightly lower at $3.3 million for Q1 2025 compared to $3.4 million in Q1 2024 [7][6] - Total operating expenses decreased to $9.1 million in Q1 2025 from approximately $10.1 million in Q1 2024 [8][6] Corporate Developments - Three abstracts on Versamune® HPV were selected for presentation at the 2025 ASCO Annual Meeting scheduled for May 30-June 3, 2025 [6][4] - The company has entered into securities purchase agreements for the sale of 7,330,121 shares of common stock, raising approximately $11 million upon closing [6][4]

Core Insights - PDS Biotechnology Corporation has granted a nonstatutory stock option to an employee in its clinical department as part of its 2019 Inducement Plan, which aims to attract new talent [1][2] - The stock option allows the purchase of 5,000 shares at an exercise price of $1.31, the closing price on the grant date, and vests over a four-year period [2] - PDS Biotechnology is focused on immunotherapy, particularly in developing its lead program, Versamune HPV, for advanced HPV16-positive head and neck squamous cell cancers [3] Company Overview - PDS Biotechnology is a late-stage immunotherapy company aiming to change how the immune system targets and kills cancers [3] - The company is conducting a pivotal clinical trial for its lead investigational targeted immunotherapy, Versamune HPV, in combination with standard immune checkpoint inhibitors and other therapies [3]

Core Insights - PDS Biotechnology Corporation is advancing its investigational flu vaccine, Infectimune, which has shown promising preclinical immune response data at the IMMUNOLOGY2025™ Annual Meeting [1][2] - The vaccine has demonstrated a significantly greater frequency of multifunctional, influenza-specific CD4 T cells compared to current vaccine approaches, indicating its potential effectiveness [2] - Infectimune-based universal flu vaccines have shown excellent breadth of protective immune response against multiple strains of influenza in preclinical studies [3] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to target and kill cancers and infectious diseases [1][5] - The company is currently conducting a pivotal clinical trial for its lead program, Versamune HPV, aimed at treating advanced HPV16-positive head and neck squamous cell cancers [5] - PDS Biotech is leveraging collaborations to enhance its research while focusing resources on its immuno-oncology programs [4]