Securities Issuance - The Company is issuing securities to Purchasers under an effective registration statement, with a Per Share Purchase Price of $0.91, subject to adjustments[20] - The Common Stock has a par value of $0.00033 per share, and the securities include Common Stock and Common Warrants[10] - The Company agrees to sell an aggregate of $5,278,000 of Shares and Warrants to Purchasers[39] - Each Purchaser will receive a Common Warrant to purchase up to 100% of their Shares plus Pre-Funded Warrant Shares, with an exercise price of $1.00[41] - The exercise price for Pre-Funded Warrants is set at $0.0001[41] - The Company has reserved a sufficient number of shares of Common Stock to issue Shares and Warrant Shares as per the Agreement[123] Transaction Details - The Closing Date for the transaction is set for the first Trading Day following the execution of the Transaction Documents[9] - The Subscription Amount for each Purchaser will be specified on the signature page of the Agreement, paid in United States dollars[32] - The Agreement includes provisions for Exempt Issuance of securities under specific conditions[17] - The Agreement outlines the definitions and terms relevant to the transaction, including "Material Adverse Effect" and "Indebtedness"[19][18] - The Company must deliver Warrant Shares by 4:00 p.m. on the Closing Date for any Notice(s) of Exercise received by 12:00 p.m. on the same day[39] Compliance and Legal Matters - The Company is subject to compliance with the Securities Act of 1933 and the Securities Exchange Act of 1934[30][16] - The Company’s Board of Directors is involved in approving certain transactions and issuances of securities[6] - The Company has filed all required SEC Reports on time, including financial statements that comply with GAAP and fairly present the financial position of the Company[56] - The Company is in compliance with all applicable environmental laws and has received all necessary permits for its operations[63][64] - The Company has not received any notices regarding non-compliance with the Sarbanes-Oxley Act or related regulations[71] Financial Health - As of the latest audited financial statements, there have been no material adverse events or liabilities incurred by the Company[57] - The Company has not issued any capital stock since its most recent periodic report, except for employee stock options and stock purchase plans[54] - The Company has good and marketable title to all real and personal property material to its business, free of significant liens[65] - The Company has no outstanding debts exceeding $50,000, and is not in default with respect to any indebtedness[80] - The Company has filed all required tax returns and paid all material taxes due, with no claims for unpaid taxes in any material amount[81] Risk Management - The Company is insured against losses and risks in amounts deemed prudent and customary for its business[68] - The Company has maintained compliance with all applicable data privacy laws, including GDPR, over the past three years[93] - The Company has not experienced any security breaches affecting its IT Systems and Data, ensuring compliance with privacy and security laws[90] - The Company has taken necessary actions to ensure compliance with listing and maintenance requirements of the trading market[75] Purchaser Obligations - The obligations of the Company are contingent upon the accuracy of representations and warranties made by Purchasers[42] - The Purchasers' obligations are contingent upon the accuracy of representations and warranties made by the Company[43] - The Purchasers are not acquiring the Securities as a result of any general solicitation or advertisement[107] - Each Purchaser's obligations under the Transaction Documents are independent, and no Purchaser is responsible for the obligations of any other Purchaser[152] Post-Transaction Conditions - The Company is prohibited from issuing any shares of Common Stock or Common Stock Equivalents for 45 days after the Closing Date, with exceptions for specific registration statements[126] - For six months after the Closing Date, the Company cannot enter into Variable Rate Transactions involving the issuance of Common Stock or Common Stock Equivalents[127] - The Company must maintain the eligibility of its Common Stock for electronic transfer through established clearing corporations[125] - The Company will take necessary actions to secure the listing of all Shares and Warrant Shares on any new Trading Market it applies to[124] Indemnification and Remedies - The Company will indemnify Purchasers against losses related to breaches of representations and warranties made by the Company[122] - The Company acknowledges that monetary damages may not be adequate compensation for breaches of obligations under the Transaction Documents, allowing for specific performance as a remedy[150] - If any payments made to Purchasers are later invalidated or required to be refunded, the original obligations will be revived as if the payments had not been made[151] Miscellaneous Provisions - The Company acknowledges that confidentiality obligations will terminate upon the issuance of the press release[116] - The parties have mutually reviewed and revised the Transaction Documents, ensuring that ambiguities are not resolved against the drafting party[156] - The Securities Purchase Agreement has been duly executed by authorized signatories of the Company and Purchasers[159]

Core Viewpoint - PDS Biotechnology Corporation has completed the VERSATILE-002 Phase 2 trial for PDS0101 in combination with pembrolizumab, showing promising results that lead the company to seek an expedited approval pathway in the ongoing VERSATILE-003 Phase 3 trial [1][2][3]. Clinical Update - The VERSATILE-002 trial demonstrated a median overall survival (mOS) of 39.3 months for patients with CPS ≥ 1, with a 95% confidence interval lower limit of 23.9 months [4]. - Progression-free survival (PFS) was reported at 6.3 months for the same patient group [4]. - The company plans to amend the ongoing VERSATILE-003 trial to potentially reduce its size while maintaining statistical power, with mOS remaining the primary endpoint for full FDA approval [4][3]. Financial Results - For Q3 2025, the company reported a net loss of $9.0 million, or $0.19 per share, a decrease from a net loss of $10.7 million, or $0.29 per share, in Q3 2024 [5][16]. - Research and development expenses were $4.6 million, down from $6.8 million in the same quarter of the previous year, attributed to lower manufacturing and clinical expenses [6][16]. - General and administrative expenses increased to $3.6 million from $3.4 million year-over-year, primarily due to higher professional fees [7][16]. Cash Position - As of September 30, 2025, the company's cash balance was $26.2 million, a decrease from $41.7 million as of December 31, 2024 [8][15]. - The company raised approximately $5.3 million by selling 5,800,000 shares and accompanying warrants on November 12, 2025 [9]. Additional Clinical Developments - The National Cancer Institute presented new clinical data at the 2025 Society for Immunotherapy of Cancer Annual Meeting, highlighting the immunological properties of PDS0101 and PDS01ADC [4]. - Preliminary results from the colorectal cancer cohort of the Phase 2 clinical trial with PDS01ADC met the criteria for expansion to Stage 2, confirming at least 6 of 9 objective responses [4].

Core Viewpoint - PDS Biotechnology Corporation has announced a securities purchase agreement to raise approximately $5.3 million through the sale of 5,800,000 shares of common stock at a price of $0.91 per share, with potential additional proceeds of up to $5.8 million from warrants [1][3] Group 1: Offering Details - The offering includes 5,800,000 shares of common stock or pre-funded warrants, with accompanying warrants to purchase an additional 5,800,000 shares at an exercise price of $1.00 per share [1][3] - The offering is expected to close on or about November 12, 2025, subject to customary closing conditions [1] - Craig-Hallum is acting as the exclusive placement agent for the offering [2] Group 2: Use of Proceeds - The net proceeds from the offering are intended for the continuation of the VERSATILE-003 Phase 3 clinical trial, discussions with the FDA for protocol amendments, and other research and development expenses [3] Group 3: Financial Position - As of September 30, 2025, the company reported approximately $26.2 million in cash and cash equivalents, subject to final adjustments [4] Group 4: Regulatory Compliance - The offering is being made pursuant to a "shelf" registration statement on Form S-3, previously filed with the SEC [5] Group 5: Existing Warrants Amendment - The company will amend existing warrants issued in February 2025, reducing the exercise price from $1.50 to $1.00 per share, effective upon the closing of the offering [6] Group 6: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune responses to target and kill cancers, with a pivotal clinical trial for its lead program in advanced HPV16-positive head and neck squamous cell cancers [8][9]

Core Insights - PDS Biotechnology Corporation announced positive clinical and translational data for its investigational immunotherapies PDS0101 and PDS01ADC at the 2025 Society for Immunotherapy of Cancer Annual Meeting, highlighting their potential in treating advanced cancers [1][3][13] Group 1: Clinical Data and Presentations - The studies were conducted under a collaborative research and development agreement with the National Cancer Institute, featuring one rapid oral abstract and two poster presentations at SITC 2025 [2] - PDS0101 demonstrated strong clinical activity across three phase 2 trials, establishing a link between immune signatures and clinical response, supporting future biomarker-guided optimization [6][4] Group 2: Mechanisms of Action - PDS01ADC reprograms natural killer (NK) cells to enhance their cancer-killing capabilities and promotes the generation of stem cell-like killer T cells and memory T cells, contributing to long-lasting anti-tumor activity [8][11] - Analysis of 50 patients with advanced HPV16-positive cancers showed significant immune activation and increases in pro-inflammatory cytokines, which are crucial for T cell recruitment and potency [9] Group 3: Future Development and Trials - PDS Biotech is advancing PDS0101 in a phase 3 clinical trial in combination with Keytruda for HPV16-positive recurrent/metastatic head and neck cancer, while PDS01ADC is being evaluated in multiple phase 2 trials for various cancer types [13][17] - The findings from SITC 2025 strengthen the scientific foundation of the company's immunotherapy platforms and support ongoing regulatory and clinical milestones [13][17]

Core Viewpoint - PDS Biotechnology Corporation is set to host a conference call on November 13, 2025, to report its financial results for Q3 2025 and provide updates on its clinical programs [1][2]. Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [3]. - The company has initiated a pivotal clinical trial for its lead program targeting advanced HPV16-positive head and neck squamous cell cancers [3]. - PDS0101 (Versamune HPV), the company's lead investigational targeted immunotherapy, is being developed in combination with a standard immune checkpoint inhibitor and in a triple combination with PDS01ADC and a standard immune checkpoint inhibitor [3]. - PDS01ADC, an IL-12 fused antibody drug conjugate, is currently being evaluated in multiple phase 2 trials across various cancer indications [3]. Conference Call Details - The conference call is scheduled for November 13, 2025, at 8:00 a.m. Eastern Time [2]. - Dial-in numbers are provided for both domestic and international participants [2]. - The event will be archived on the company's website for six months following the live webcast [2]. Contact Information - Investor contact is Mike Moyer from LifeSci Advisors, reachable at +1 (617) 308-4306 [7]. - Media contact is David Schull from Russo Partners, reachable at +1 (858) 717-2310 [7].

Core Insights - PDS Biotechnology Corporation announced that the National Cancer Institute (NCI) will present new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting, focusing on its investigational immunotherapy platforms [1][4] - The presentations will include three abstracts that highlight clinical and translational findings related to PDS Biotech's immunotherapy candidates, including PDS0101 and PDS01ADC [1][4] Company Overview - PDS Biotechnology is a late-stage immunotherapy company dedicated to transforming immune system responses to cancer [4] - The company is advancing its lead program, PDS0101, in pivotal clinical trials for treating advanced HPV16-positive head and neck squamous cell cancers [5] Clinical Data Presentation - The NCI will present three abstracts at SITC, including: 1. Early changes in serum proteomic profiles predicting anti-tumor activity in patients with advanced HPV-associated malignancies [3] 2. A tumor-targeting IL-12 immunocytokine therapy that increases peripheral natural killer (NK) cells associated with enhanced tumor cell lysis [3] 3. Increases in peripheral memory T cells with self-renewing properties in patients treated with IL-12 immunocytokine therapy [3] Leadership Commentary - The CEO of PDS Biotechnology expressed optimism about the collaboration with NCI and the potential of their platforms to enhance immune system recognition and elimination of cancer [2]

Core Insights - PDS Biotechnology Corporation is seeking an expedited approval pathway from the FDA for its immunotherapy PDS0101 targeting HPV16-positive head and neck cancer, projected to be the most prevalent type of head and neck cancer in the US by the mid-2030s [1][2] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative cancer treatments, particularly through its lead program PDS0101, which is being developed in combination with standard immune checkpoint inhibitors [4] Clinical Trials - The VERSATILE-002 trial has shown promising results, reporting a median overall survival (mOS) of 39.3 months and a median progression-free survival (PFS) of 6.3 months, leading to a proposed amendment in the ongoing VERSATILE-003 trial to include PFS as an earlier primary endpoint [1][2][3] - The VERSATILE-002 trial is an open-label, multi-center Phase 2 study evaluating the safety and efficacy of PDS0101 in combination with pembrolizumab for patients with unresectable, recurrent, or metastatic HPV16-positive head and neck cancer [3] Regulatory Strategy - The company plans to meet with the FDA to discuss changes to the current trial protocol, aiming to shorten the trial duration by making PFS an earlier primary endpoint, which could facilitate an accelerated approval submission [1][2]

Core Insights - PDS Biotechnology Corporation announced that its combination therapy of PDS0101 (Versamune HPV) and Keytruda (pembrolizumab) achieved a median overall survival (mOS) of 29.5 months in patients with low PD-L1 expression (CPS 1-19), significantly outperforming Keytruda alone (10.8 months) and Keytruda plus chemotherapy (12.3 months) [1][7] Group 1: Clinical Trial Results - The VERSATILE-002 Phase 2 clinical trial evaluated the efficacy of PDS0101 in combination with Keytruda for patients with HPV16-positive recurrent and/or metastatic head and neck squamous cell cancer [1][4] - Approximately 60% of the patients enrolled in the trial had low PD-L1 expression, indicating a challenging subset of the overall patient population [3] - The full study population reported an mOS of 39.3 months, with detailed data expected to be published later this year [3] Group 2: Expert Commentary - Prof. Kevin Harrington highlighted the significance of the results, noting the potential for a well-tolerated treatment option without chemotherapy for patients [2] - Dr. Kirk Shepard emphasized that the findings suggest PDS0101 may enhance survival outcomes for patients who typically have limited treatment options and poor prognosis [3] Group 3: Company Overview - PDS Biotechnology is focused on developing immunotherapy treatments that enhance the immune system's ability to target and kill cancer cells, with a pivotal clinical trial underway for advanced HPV16-positive head and neck squamous cell cancers [5] - The company is also exploring a triple combination therapy involving PDS01ADC, an IL-12 fused antibody drug conjugate, alongside standard immune checkpoint inhibitors [5]

Core Insights - PDS Biotechnology Corporation is a late-stage immunotherapy company focused on enhancing the immune system's ability to target and eliminate cancers [3] - The company will participate in the 27th Annual H.C. Wainwright Global Investment Conference from September 8-10, 2025, in New York and virtually, with key executives available for one-on-one meetings with investors [1][2] Company Overview - PDS Biotechnology is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers through a pivotal clinical trial [3] - The lead investigational targeted immunotherapy, PDS0101 (Versamune HPV), is being developed in combination with the immune checkpoint inhibitor pembrolizumab [3] Investor Relations - Investors interested in engaging with the management team are encouraged to contact their H.C. Wainwright representative [2]

Core Insights - PDS Biotechnology Corporation announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial, showing a median overall survival (mOS) of 39.3 months in patients with CPS ≥ 1, significantly outperforming the best published result of 17.9 months with standard care pembrolizumab or pembrolizumab + chemotherapy [1][2][7] Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to cancer, particularly through its lead investigational product PDS0101 (Versamune HPV) [5] - The company is advancing its lead program in advanced HPV16-positive head and neck squamous cell cancers, with ongoing pivotal clinical trials [5] Clinical Trial Details - The VERSATILE-002 trial is an open-label, multi-center Phase 2 study evaluating the safety and efficacy of PDS0101 in combination with pembrolizumab for unresectable, recurrent or metastatic HPV16-positive head and neck squamous cell cancer [4] - The trial enrolled 53 patients, with PDS0101 administered via subcutaneous injection alongside IV infusion of pembrolizumab during the first four treatment cycles [7] Survival Data and Efficacy - The mOS of 39.3 months was achieved in patients with CPS ≥ 1, with a 95% confidence interval lower limit of 23.9 months [7] - The durable patient survival is attributed to high levels of long-lasting, multifunctional HPV16-specific CD8+ T cells induced by PDS0101, consistent across various patient demographics and clinical characteristics [7] Market Position and Future Outlook - PDS Biotech is positioned for leadership in the rapidly growing segment of HPV16-positive head and neck cancer, addressing a significant unmet medical need [3] - The combination therapy of PDS0101 and pembrolizumab is reported to be well tolerated, with no patients discontinuing due to treatment-related adverse events [3]