PRINCETON, N.J., March 18, 2025 (GLOBE NEWSWIRE) -- 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 announced that the Company will host a conference call to report financial results for the year ended December 31, 2024, and provide a clinical programs update on Thursday, March 27, 2025, at 8:00 a.m. Eastern Time. Conference Call Details Date: March 27, 2025Time: 8 ...

Phase 1/2 trial evaluating the proprietary combination to be run under CRADA with the National Cancer Institute Second Versamune® platform candidate targets MUC1-positive solid tumors U.S. Patent #12,201,685 covering methods of using combinations of the Versamune® platform and various immunocytokines, including PDS01ADC recently issued PRINCETON, N.J., March 13, 2025 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused ...

Core Viewpoint - PDS Biotechnology Corporation has initiated the VERSATILE-003 Phase 3 clinical trial for its investigational immunotherapy Versamune HPV, aimed at treating recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC) [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers [4]. - The company is advancing its lead program in advanced HPV16-positive HNSCC through pivotal clinical trials [4]. Clinical Trial Details - The VERSATILE-003 trial is a global, multi-center, randomized, controlled, and open-label Phase 3 trial designed to evaluate the safety and efficacy of Versamune HPV in combination with pembrolizumab as a first-line treatment [2]. - Approximately 350 patients will be enrolled in a 2:1 ratio between the investigational arm and the control arm receiving pembrolizumab alone [2]. - The primary endpoint of the trial is overall survival, with secondary endpoints including objective response rate, progression-free survival, disease control rate, and duration of response [2]. Leadership and Expertise - Frank Bedu-Addo, PhD, serves as the President and CEO of PDS Biotech, expressing confidence in the potential of the combination therapy to improve patient outcomes [2]. - Kirk Shepard, M.D., the Chief Medical Officer, highlighted the significance of advancing into Phase 3 for improving treatment options for patients with HPV16-positive HNSCC [3]. Product Information - Versamune HPV is an HPV-specific T cell stimulating immunotherapy that has shown potential in stimulating high levels of HPV16-specific CD8+ and CD4+ T cells [3]. - The U.S. Food and Drug Administration granted Versamune HPV Fast Track designation based on data from the previous VERSATILE-002 Phase 2 trial [3].

Core Viewpoint - PDS Biotechnology Corporation has announced a registered direct offering of 7,330,121 shares of common stock and warrants, aiming to raise approximately $11 million for research and development and general corporate purposes [1][2]. Group 1: Offering Details - The offering includes 7,330,121 shares priced at $1.50 for institutional investors and $1.66 for certain directors, with warrants exercisable at $1.50 per share [1]. - The gross proceeds from the offering are expected to be around $11 million, with an additional potential $11 million from the exercise of warrants [2]. - The closing of the offering is anticipated on or about February 28, 2025, pending customary closing conditions [2]. Group 2: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [5]. - The company plans to initiate a pivotal clinical trial for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers [5]. - The lead investigational immunotherapy, Versamune® HPV, is being developed in combination with a standard immune checkpoint inhibitor and a triple combination including PDS01ADC [5].

Core Insights - Versamune HPV shows potential as a broadly effective treatment for HPV16-associated cancers, with a Phase 3 trial for HPV16-positive head and neck squamous cell carcinoma (HNSCC) planned for Q1 2025 [1][2][3] Group 1: Clinical Trial Results - The trial demonstrated that Versamune HPV combined with chemoradiation (CRT) led to greater and earlier clearance of HPV16-positive cancer cells from the bloodstream in patients with locally advanced cervical cancer [2][3] - 100% of patients with locally advanced HPV16 cervical cancer treated with Versamune HPV + CRT had no detectable HPV16 circulating tumor DNA (ctDNA) at 3-4 months, compared to 50% of patients receiving standard CRT [1][4] - Undetectable HPV ctDNA at 3-4 months was associated with improved 2-year recurrence-free survival (RFS) of 93% versus only 30% in patients with detectable HPV ctDNA [1][4] Group 2: Patient Outcomes - The median follow-up period was 23 months, with a strong correlation between HPV ctDNA clearance at 3-4 months and better 2-year RFS (92.9% vs. 30%, P = 0.0067) [4] - The strongest predictor of RFS was HPV ctDNA clearance at 3-4 months, achieving a concordance index score of 0.83 [4] - The 36-month overall survival (OS) rate was reported as 100% for 8 patients who received 5 doses of Versamune HPV + CRT, and an 84.4% OS rate for 17 patients who received at least 2 doses of Versamune HPV + CRT [5] Group 3: Future Plans and Regulatory Pathway - The company plans to initiate discussions with the U.S. Food and Drug Administration regarding the potential for an accelerated regulatory pathway, such as Breakthrough Therapy designation in cervical cancer [3] - The findings suggest that the reduction of ctDNA levels may also apply to other HPV16-positive cancers like HNSCC, which is included in the VERSATILE-003 Phase 3 clinical trial [3]

Core Viewpoint - PDS Biotechnology Corporation is set to initiate its VERSATILE-003 Phase 3 clinical trial for Versamune® HPV combined with pembrolizumab for treating recurrent and/or metastatic HPV16-positive head and neck squamous cell cancer in Q1 2025 [1][2]. Group 1: Clinical Trial Details - The updated clinical protocol was submitted on November 15, 2024, and the FDA comment period has concluded, allowing the company to proceed with site activation [2]. - The trial has received Fast Track designation from the FDA, indicating a priority review process for the combination therapy [2]. - A validated companion diagnostic will be used to confirm HPV16-positive status during patient screening for the trial [2][3]. Group 2: Market Context - HPV16-positive head and neck squamous cell carcinoma is expected to become the dominant type of HNSCC in the US and EU, highlighting the need for targeted therapies [3]. - The trial represents the first investigational use of a companion diagnostic in a Phase 3 clinical trial for HNSCC, which may enhance patient selection for the treatment [3]. Group 3: Company Overview - PDS Biotechnology is focused on immunotherapy, aiming to transform how the immune system targets and kills cancers, with a lead program in advanced HPV16-positive head and neck squamous cell cancers [4]. - The lead investigational therapy, Versamune® HPV, is being developed in combination with standard immune checkpoint inhibitors and a triple combination including PDS01ADC [4].

Core Viewpoint - PDS Biotechnology (PDSB) is experiencing significant selling pressure, having declined 35.7% over the past four weeks, but is now positioned for a potential trend reversal as it enters oversold territory, with analysts predicting better earnings than previously expected [1] Group 1: Technical Indicators - The Relative Strength Index (RSI) for PDSB is currently at 22.34, indicating that the heavy selling may be exhausting itself, suggesting a possible bounce back towards equilibrium in supply and demand [3] - A stock is generally considered oversold when its RSI falls below 30, which can signal potential entry opportunities for investors looking to benefit from a rebound [2] Group 2: Fundamental Analysis - There is strong consensus among sell-side analysts to raise earnings estimates for PDSB, with a 4.9% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [4] - PDSB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further indicating a potential turnaround [4]

Clinical Trial Results - The combination of Versamune®HPV and PDS01ADC resulted in a median overall survival of approximately 20 months in a Phase 2 trial for ICI resistant patients, compared to historical median survival of 3-4 months[93]. - In November 2023, updated survival data showed a 75% survival rate at 36 months for ICI naïve patients in the NCI-led Phase 2 trial involving Versamune®HPV, PDS01ADC, and an investigational immune checkpoint inhibitor[100]. - The VERSATILE-002 Phase 2 clinical trial has completed enrollment for both ICI naïve and ICI resistant arms, evaluating the efficacy and safety of Versamune®HPV in combination with Keytruda®[102]. - The company presented data at the 2023 American Society of Clinical Oncology showing a 41.2% confirmed and unconfirmed response rate in patients treated with Versamune®HPV and Keytruda®, compared to approximately 19% for approved ICIs[106]. - The estimated 12-month overall survival rate for the ICI naïve cohort was 87.1%, compared to published results of 36-50% for approved ICIs used alone[110]. - The median progression-free survival (PFS) for the ICI naïve cohort was 10.4 months, while published results for approved ICIs as monotherapy are 2-3 months[110]. - The confirmed overall response rate (ORR) for the ICI naïve cohort was 41.2%, with 26.5% of patients having confirmed responses[110]. - The 24-month overall survival rate for the combination of Versamune® HPV and Keytruda® was 74%, significantly higher than the published rate of less than 30% for approved ICIs[112]. - The median overall survival for the ICI naïve cohort with CPS > 1 was 30 months, compared to published results for ICIs of 7-18 months[113]. - The confirmed overall response rate (ORR) for the ICI naïve cohort was 34%, exceeding the published results of less than 20% for comparable patients receiving ICIs[113]. - The median overall survival (mOS) was reported as 30 months, with a lower 95% confidence interval of 19.7 months, while published mOS for pembrolizumab is 12-18 months[118]. - The disease control rate (DCR) was 77%, with 21% of patients experiencing deep tumor responses and shrinkage of 90-100%[118]. - The company announced a two-part registrational trial focused on the double combination of Versamune® HPV and pembrolizumab for first-line treatment in HPV16-positive recurrent/metastatic HNSCC[114]. - The company plans to initiate a registrational study in first-line treatment in HPV16-positive recurrent/metastatic HNSCC with the double combination of Versamune® HPV and pembrolizumab[116]. - 100% of patients treated with Versamune® HPV and CRT had an objective response, and 89% demonstrated a complete response on Day 170[127]. - The combination of Versamune® HPV and CRT resulted in 81.3% ctDNA clearance after 3 weeks compared to 30.3% with SOC CRT alone (p=0.0018)[128]. - 91.7% ctDNA clearance was observed at 5 weeks with Versamune® HPV plus CRT versus 53.1% with SOC (p=0.0179)[128]. Financial Performance - The company reported net losses of $29.7 million and $32.0 million for the nine months ended September 30, 2024 and 2023, respectively[145]. - As of September 30, 2024, the company had $49.8 million in cash and cash equivalents[147]. - The company has never generated revenues from commercial product sales and does not expect to do so in the near future[148]. - Research and development expenses are expected to increase significantly as the company advances its clinical candidates through trials and regulatory approvals[150]. - Research and development expenses increased to $6.8 million for Q3 2024, up from $6.4 million in Q3 2023, representing a 6% increase[154]. - General and administrative expenses decreased to $3.4 million for Q3 2024, down from $4.1 million in Q3 2023, reflecting a 17% decrease[155]. - Total operating expenses for Q3 2024 were $10.2 million, a decrease of 3% from $10.5 million in Q3 2023[153]. - For the nine months ended September 30, 2024, research and development expenses decreased to $18.0 million, down 11% from $20.3 million in the same period of 2023[157]. - General and administrative expenses for the nine months ended September 30, 2024, were $10.9 million, a decrease of 11% from $12.3 million in the same period of 2023[159]. - The net loss for Q3 2024 was $10.7 million, a slight improvement from a net loss of $10.8 million in Q3 2023[153]. - The company sold 3,428,681 shares of common stock with a net value of $19.4 million during the nine months ended September 30, 2024[162]. - Interest expense increased to $1.6 million for the nine months ended September 30, 2024, up 93% from $0.8 million in the same period of 2023[156]. - Net cash used in operating activities increased to $26.8 million for the nine months ended September 30, 2024, compared to $25.2 million in the same period of 2023, reflecting a $1.6 million increase primarily due to accounts payable and accrued expenses[176]. - Net cash used in investing activities was $29.0 thousand for the nine months ended September 30, 2024, compared to $0 in the same period of 2023[177]. - Net cash provided by financing activities was $20.0 million for the nine months ended September 30, 2024, up from $5.6 million in the same period of 2023, primarily from the sale of common stock[178]. - The company has not generated any product revenue to date and does not expect to do so until regulatory approval and commercialization of product candidates are achieved[179]. - The company anticipates continued losses as it develops and seeks regulatory approvals for its product candidates, with expected increases in losses as operations continue[179]. - There is substantial doubt about the company's ability to continue as a going concern for at least 12 months from the issuance of the financial statements due to reliance on available financial resources[180]. - The company plans to finance its cash needs through equity or debt financings, collaborations, or strategic alliances, but there is no assurance that financing will be available on acceptable terms[180]. - The company has no material non-cancelable purchase commitments with service providers, operating on a cancelable purchase order basis[183]. - The company is exposed to interest rate risk due to a floating interest rate under its Loan and Security Agreement, but historical fluctuations in interest rates have not materially impacted its operations[190]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the three months ended September 30, 2024[191]. Product Development and Pipeline - The proprietary combination of Versamune®HPV and PDS01ADC is designed to enhance T cell proliferation and longevity in the tumor microenvironment, addressing limitations of current therapies[93]. - The company executed an exclusive global license agreement with Merck KGaA for the tumor targeting IL-12 fused antibody drug conjugate, M9241, now known as PDS01ADC, in December 2022[93]. - In February 2023, the company completed a Type B meeting with the FDA regarding the clinical protocol for a potential registrational trial for the triple combination therapy[94]. - The investigational universal flu vaccine, PDS0202, demonstrated broad neutralization across multiple influenza strains, providing protection in animal studies presented in September 2023[95]. - The company has a growing pipeline of targeted cancer and infectious disease immunotherapies based on its Versamune® T cell activator technology[91]. - Interim data showed a decrease in PSA levels in all patients treated with PDS01ADC, with 61% experiencing at least a 60% decrease[137]. - The company is exploring the use of PDS01ADC in combination with other Versamune® based clinical candidates[139].

Financial Data and Key Metrics Changes - The net loss for Q3 2024 was approximately $10.7 million, or $0.29 per share, compared to a net loss of $10.8 million, or $0.35 per share in Q3 2023, primarily due to lower operating expenses [25][26] - Research and development expenses increased to approximately $6.8 million in Q3 2024 from $6.4 million in Q3 2023, attributed to higher manufacturing expenses [26] - General administrative expenses decreased to approximately $3.4 million in Q3 2024 from $4.1 million in Q3 2023, mainly due to lower personnel costs and professional fees [27] - Cash and cash equivalents totaled approximately $50 million as of September 30, 2024 [28] Business Line Data and Key Metrics Changes - The VERSATILE-003 trial design was updated to include approximately 350 patients, maintaining statistical power and a 2 to 1 randomization, with median overall survival as the primary endpoint [8][21] - The VERSATILE-002 study showed median overall survival remained at 30 months, with an objective response rate improving from 26% to 36% [10][11] Market Data and Key Metrics Changes - The population of HPV 16-positive patients is increasing significantly, with over 70% of new patients seen by key opinion leaders being HPV 16 positive [16][36] - Most HPV positive patients do not meet the inclusion criteria for the KEYNOTE-689 study, indicating that the potential use of Keytruda in early treatment will not significantly impact the target population for VERSATILE-003 [17][19] Company Strategy and Development Direction - The company aims to be the first to market an HPV-targeted immunotherapy for head and neck cancer, with a focus on the growing population of HPV 16-positive patients [13][21] - The company is exploring the next steps in the development of Versamune HPV for cervical cancer following promising data from the IMMUNOCERV Phase 2 trial [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the updated trial design for VERSATILE-003 and the potential for timely enrollment, with an FDA decision expected by mid-December [8][63] - The company believes that the increasing incidence of HPV 16-positive head and neck cancer presents a significant long-term opportunity [36][64] Other Important Information - The company is conducting an independent survey of oncologists to understand the treatment landscape and the impact of emerging therapies on their target population [15][16] - The company plans to initiate the VERSATILE-003 trial in early 2025, with a focus on a targeted subset of sites financed from existing resources [21][63] Q&A Session Summary Question: When would the company expect an interim look at the VERSATILE-003 data and thoughts on the opportunity given the changing landscape? - Management indicated that the enrollment duration is expected to be around 18 months, with the first interim data readout anticipated about six months after enrollment completion [39][41] Question: Plans for a Phase 3 trial for IMMUNOCERV and positioning against Merus EGFR bispecific? - Management highlighted the impressive data from Merus but emphasized that their focus is specifically on HPV 16-positive head and neck cancer, which is a rapidly growing population [44][45] Question: Status of the VERSATILE-003 trial arm with PDS01ADC? - Management confirmed that the focus is currently on getting VERSATILE-003 up and running, with plans for dose optimization of PDS01ADC to follow [61][62]

Financial Performance - Reported net loss for Q3 2024 was approximately $10.7 million, or $0.29 per share, compared to a net loss of $10.8 million, or $0.35 per share in Q3 2023[7]. - General and administrative expenses decreased to approximately $3.4 million in Q3 2024 from $4.1 million in Q3 2023, mainly due to lower personnel costs[9]. - Total operating expenses decreased to approximately $10.2 million in Q3 2024 from $10.5 million in Q3 2023[10]. - The company reported a decrease in total stockholders' equity to approximately $22.0 million as of September 30, 2024, from $26.1 million at the end of 2023[15]. - Long-term debt decreased to approximately $12.0 million as of September 30, 2024, from $19.5 million at the end of 2023[15]. Research and Development - Research and development expenses increased to approximately $6.8 million in Q3 2024 from $6.4 million in Q3 2023, primarily due to higher manufacturing expenses[8]. - The updated VERSATILE-003 trial design will include approximately 350 patients and aims for earlier interim readouts and reduced execution costs[4]. - The IMMUNOCERV Phase 2 trial data presented at ASTRO showed promising clinical activity and a compelling safety profile for Versamune® HPV[3]. Regulatory and Future Plans - The company plans to submit an updated IND application to the FDA, expecting clearance by mid-December 2024[2]. - Cash and cash equivalents as of September 30, 2024, totaled approximately $49.8 million, down from $56.6 million at the end of 2023[15].