Core Viewpoint - PDS Biotechnology Corporation has received a new patent in Japan for PDS0101, enhancing its intellectual property portfolio and providing market exclusivity for the product into the 2040s [2][4]. Group 1: Patent and Intellectual Property - The Japan Patent Office has issued Patent No. 7783866 for PDS0101, granting broad composition of matter and methods of use claims [2]. - This new patent expands previously granted patents in Japan and adds to the company's existing patents in the United States, China, Australia, and Hong Kong [2]. - The company has additional patent applications pending in several other countries, reinforcing its global intellectual property position [4][5]. Group 2: Market Context and Product Development - The incidence of HPV16-related cancers is rapidly increasing in the US and Europe, which highlights the potential market for PDS0101 [3]. - PDS0101 is currently being studied in a Phase 3 trial in combination with pembrolizumab for HPV16-positive recurrent/metastatic head and neck cancer [3][6]. - The company aims to advance broad intellectual property protections for PDS0101 and its other investigational agents in development [5].

Core Viewpoint - PDS Biotechnology (PDSB) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in a company's earnings picture, with the Zacks Consensus Estimate reflecting EPS estimates from sell-side analysts [1][2]. - There is a strong correlation between earnings estimate revisions and near-term stock price movements, influenced by institutional investors who adjust their valuations based on these estimates [4][6]. Company Performance and Outlook - The upgrade for PDS Biotechnology suggests an improvement in the company's underlying business, which could lead to an increase in stock price as investors respond positively to this trend [5][10]. - For the fiscal year ending December 2025, PDS Biotechnology is expected to earn -$0.77 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 9.4% over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of performance, particularly for Zacks Rank 1 stocks which have generated an average annual return of +25% since 1988 [7][9]. - PDS Biotechnology's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Core Viewpoint - PDS Biotechnology Corporation is seeking an accelerated approval pathway for its investigational treatment PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer, following positive results from the VERSATILE-002 trial [2][3] Group 1: FDA Meeting and Approval Pathway - The FDA has accepted PDS Biotechnology's request for a Type C Meeting to discuss the proposed accelerated approval pathway for PDS0101 [1] - The proposed amendment to the VERSATILE-003 Phase 3 trial aims to change the progression-free survival (PFS) endpoint to a surrogate primary endpoint, allowing for earlier evaluation with significant statistical power [2] - Median overall survival (mOS) will remain the primary endpoint for full approval as originally recommended by the FDA [2] Group 2: Clinical Trial Insights - The VERSATILE-002 trial demonstrated promising median overall survival and durable progression-free survival in patients with CPS ≥ 1 [2] - The company believes that the positive PFS data from VERSATILE-002 presents an opportunity to shorten the duration to a primary endpoint and potentially accelerate regulatory submission [3] Group 3: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on transforming immune system responses to cancer [4] - The lead investigational treatment, PDS0101 (Versamune HPV), is being developed in combination with a standard-of-care immune checkpoint inhibitor and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate [4]

Group 1 - B. Riley has lowered the price target on PDS Biotechnology (PDSB) to $3 from $5 while maintaining a Buy rating on the shares [1] - The shares are considered attractively valued with near-zero enterprise value (EV) that does not reflect the impact of the recent strategic pivot on enrollment size, efficacy endpoint durations, and an enriched p16+ve population with limited competing trials [1]

Clinical Trials and Research - The Company initiated the VERSATILE-003 Phase 3 clinical trial for PDS0101 (Versamune® HPV) in HPV16-positive first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma, aiming to enroll 351 patients[94]. - The colorectal cancer cohort of the Phase 2 trial with PDS01ADC met pre-defined criteria for expansion to stage 2 following positive stage 1 results[94]. - The estimated 12-month overall survival rate for the ICI naïve cohort in the VERSATILE-002 trial was 87.1%, significantly higher than the published results of 36-50% for approved ICIs used alone[105]. - The median progression-free survival (PFS) in the ICI naïve cohort was reported at 10.4 months, compared to published results of 2-3 months for approved ICIs[105]. - The disease control rate in the ICI naïve cohort was 70.6%, with a confirmed and unconfirmed objective response rate of 41.2%[105]. - The Company plans to investigate a triple combination of PDS0101 + PDS01ADC + pembrolizumab as a first-line treatment in HPV16-positive recurrent/metastatic HNSCC[107]. - The Company has requested a meeting with the FDA to seek an expedited pathway for the VERSATILE-003 trial, proposing to include progression-free survival as an early primary endpoint[96]. - 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[102]. - The Company reported that 60% of patients in the VERSATILE-002 trial had a CPS score of 1-19, indicating a generally weaker response to Keytruda®[105]. - The Company announced a temporary pause to VERSATILE-003 during the FDA's review of the proposed changes to the trial's design[96]. - Median Overall Survival (mOS) was 30 months, with a lower 95% confidence interval of 19.7 months; published mOS for pembrolizumab is 12-18 months[111]. - Objective Response Rate (ORR) of 36% (19/53); published ORR for pembrolizumab is 19-25%[111]. - Disease Control Rate (DCR) is 77% (41/53)[111]. - Median Progression-Free Survival (mPFS) was 6.3 months overall; 14.1 months for patients with CPS≥20[116]. - 75% of immune checkpoint inhibitor (ICI) naïve patients remain alive at 36 months; published median overall survival in similar patients is 7-11 months[117]. - Significant tumor shrinkage with confirmed ORR of 75% in HPV16-positive immune checkpoint inhibitor naïve patients; historically published result is 11-24%[122]. - Earlier and greater proportion of ctDNA clearance with PDS0101 plus chemoradiation (CRT) vs. SOC CRT alone (81.3% clearance after 3 weeks vs. 30.3% with SOC, p=0.0018)[123]. - Decrease in PSA levels was seen in all patients at all three tested doses of PDS01ADC, with 61% of patients having at least a 60% decrease in PSA levels[129]. - The combination of PDS0101 and Keytruda® appeared to be well tolerated, with 11% of patients experiencing Grade 3 treatment-related adverse events[110]. - 21% of patients had deep tumor responses and shrinkage of 90-100%[111]. Financial Performance - As of September 30, 2025, the company reported net losses of $26.9 million and $29.7 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $209.0 million[131][138]. - The company had $26.2 million in cash and cash equivalents as of September 30, 2025[132]. - Research and development expenses decreased to $4.6 million for the three months ended September 30, 2025, down from $6.8 million for the same period in 2024, representing a 33% decrease[142][143]. - General and administrative expenses increased to $3.6 million for the three months ended September 30, 2025, up from $3.4 million in 2024, a 6% increase[142][144]. - Total operating expenses for the three months ended September 30, 2025, were $8.1 million, a decrease of 20% from $10.2 million in 2024[142]. - The net loss for the three months ended September 30, 2025, was $9.0 million, a 16% improvement from the $10.7 million loss in 2024[142]. - For the nine months ended September 30, 2025, research and development expenses totaled $14.6 million, down 19% from $18.0 million in 2024[146][147]. - The company sold 2,237,941 shares of common stock for a net value of $3.0 million during the nine months ended September 30, 2025[152]. - The company expects significant increases in research and development expenses as it advances its clinical candidates and prepares for potential commercial launches[140]. - The company has not generated any revenues from commercial product sales and does not expect to do so in the near future[138]. - The company received $24.6 million in net proceeds from a Loan and Security Agreement with Horizon Technology Finance Corporation[153]. - Approximately $0.9 million was received from the net sale of tax benefits for tax year 2022[154]. - The company raised approximately $11 million in gross proceeds from the February 2025 Offering, with net proceeds of approximately $10.05 million[156]. - As of September 30, 2025, the company had $26.2 million in cash and cash equivalents, primarily used for operating expenses and research and development[159]. - Net cash used in operating activities was $24.0 million for the nine months ended September 30, 2025, a decrease from $26.8 million in 2024[165]. - The company anticipates continued losses as it develops and seeks regulatory approvals for its product candidates, with no product revenue generated to date[168]. - The company has substantial doubt about its ability to continue as a going concern for at least 12 months from the issuance of its financial statements[162]. - Net cash provided by financing activities decreased by $11.4 million for the nine months ended September 30, 2025, primarily due to a decrease in proceeds from the Loan and Security Agreement[167]. - The company plans to fund operations through existing cash and additional equity and/or debt financing, but there is uncertainty regarding the availability of such financing[161]. - The company has no material non-cancelable purchase commitments with service providers, operating on a cancelable basis[172].

Financial Data and Key Metrics Changes - The company reported a net loss of $9 million or $0.19 per basic and diluted share for Q3 2025, compared to a net loss of $10.7 million or $0.29 per basic share in the prior year's quarter, indicating a decrease in net loss primarily due to lower operating expenses [15][16] - Research and development expenses were $4.6 million for Q3 2025, down from $6.8 million in the prior year, attributed to lower manufacturing and clinical expenses [16] - General and administrative expenses increased to $3.6 million in Q3 2025 from $3.4 million in the prior year, mainly due to higher professional fees [16] - Total operating expenses were $8.1 million for Q3 2025, down from $10.2 million in the prior year [17] - Cash balance as of September 30, 2025, was $26.2 million, down from $41.7 million at the beginning of the year [17] Business Line Data and Key Metrics Changes - The VERSATILE-002 trial showed a median overall survival of 39.3 months for patients with a combined positive score (CPS) of greater than or equal to one, with a progression-free survival (PFS) of 6.3 months among these patients [5][6] - The company plans to amend the VERSATILE-003 trial to include PFS as a primary endpoint alongside median overall survival, based on the strong data from VERSATILE-002 [8][9] Market Data and Key Metrics Changes - The company highlighted that HPV-positive head and neck cancer is becoming a significant medical issue, with over 90% of HPV-positive oropharyngeal cancers being HPV-16 positive [11][30] - Recent market research indicates a growing incidence of HPV-positive head and neck cancer, with traditional causes like tobacco and alcohol declining [30] Company Strategy and Development Direction - The company is focusing on HPV-16 positive head and neck cancer, believing it will become the dominant type of head and neck cancer in the next decade [30][31] - The company is engaging with the FDA to discuss amendments to the VERSATILE-003 trial protocol, aiming to potentially shorten the time to regulatory submission while maintaining median overall survival as an endpoint for full approval [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of PDS0101 as a well-tolerated treatment option for HPV-16 positive patients, who currently lack effective therapies [11][30] - The management noted that the industry is recognizing the growing problem of HPV-positive head and neck cancer, which is reflected in recent publications and market research [10][30] Other Important Information - The National Cancer Institute presented new clinical data at the 2025 Society for Immunotherapy of Cancer meeting, validating the scientific basis of the company's immunotherapy platforms [12][13] - The colorectal cancer cohort of the phase two clinical trial with PDS01ADC met criteria for expansion to stage two following positive results [13] Q&A Session Summary Question: How will the company handle patients already enrolled in the VERSATILE-003 trial during the protocol pause? - The company will continue to treat patients already enrolled in the trial and will discuss their incorporation into the trial with the FDA [20][22] Question: What is the expected PFS for the control Keytruda? - The company conservatively assumes that the PFS in the control arm will be around three months, based on previous studies [26][27] Question: How is the company addressing physician training and awareness regarding pseudoprogression in the VERSATILE-003 study? - The company has trained investigators to recognize pseudoprogression and will conduct central reviews of scans to ensure accurate assessments [39][40]

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]