Three abstracts accepted for presentation, including one rapid oral abstract sessionPresentations to highlight ongoing clinical and translational research across PDS Biotechnology’s immunotherapy platforms PRINCETON, N.J., Oct. 30, 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 National Cancer Institute (NCI) will presen ...

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]

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) This section provides details on the Form 10-Q filing for PDS Biotechnology Corporation, including its filer status and registered stock information [Filing Details](index=1&type=section&id=Filing%20Details) This document is a Quarterly Report on Form 10-Q for PDS Biotechnology Corporation, covering the period ended June 30, 2025. The company is a non-accelerated filer and a smaller reporting company - The report is a Quarterly Report on Form 10-Q for the period ended June 30, 2025[2](index=2&type=chunk) - PDS Biotechnology Corporation is a non-accelerated filer and a smaller reporting company[3](index=3&type=chunk)[4](index=4&type=chunk) Title of each class | Title of each class | Trading symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, par value $0.00033 per share | PDSB | The Nasdaq Stock Market LLC | [Table of Contents](index=3&type=section&id=INDEX) This section provides an organized list of all chapters and sub-sections within the report for easy navigation [Part I — Financial Information](index=4&type=section&id=Part%20I%20%E2%80%94%20Financial%20Information) This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for PDS Biotechnology Corporation, including Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Changes in Stockholders' Equity, and Statements of Cash Flows, along with their accompanying notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased from **$45.36 million** at December 31, 2024, to **$40.48 million** at June 30, 2025, with notable decreases in cash and equity ASSETS | ASSETS | June 30, 2025 (unaudited) ($) | December 31, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | **Current assets:** | | | | Cash and cash equivalents | $31,873,495 | $41,689,591 | | Prepaid expenses and other assets | $1,774,550 | $3,364,852 | | Total current assets | $33,648,045 | $45,054,443 | | **Noncurrent assets:** | | | | Prepaid expenses | $6,554,064 | - | | Property and equipment, net | $131,102 | $142,020 | | Financing lease right-to-use assets | $142,854 | $162,194 | | **Total assets** | **$40,476,065** | **$45,358,657** | LIABILITIES AND STOCKHOLDERS' EQUITY | LIABILITIES AND STOCKHOLDERS' EQUITY | June 30, 2025 (unaudited) ($) | December 31, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | **Current liabilities:** | | | | Accounts payable | $4,497,434 | $1,684,868 | | Accrued expenses | $1,482,081 | $2,841,214 | | Note payable - short term | $5,500,000 | $12,500,000 | | Financing lease obligation-short term | $51,937 | $61,119 | | Total current liabilities | $11,531,452 | $17,087,201 | | **Noncurrent liabilities:** | | | | Note payable, net of debt discount | $12,943,656 | $9,204,755 | | Financing lease obligation-long term | $41,173 | $61,853 | | **Total liabilities** | **$24,516,281** | **$26,353,809** | STOCKHOLDERS' EQUITY | STOCKHOLDERS' EQUITY | June 30, 2025 (unaudited) ($) | December 31, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | Common stock | $15,390 | $12,536 | | Additional paid-in capital | $215,978,568 | $201,103,311 | | Accumulated deficit | $(200,034,174) | $(182,110,999) | | **Total stockholders' equity** | **$15,959,784** | **$19,004,848** | | **Total liabilities and stockholders' equity** | **$40,476,065** | **$45,358,657** | - Cash and cash equivalents decreased by **$9.8 million** from **$41.7 million** at December 31, 2024, to **$31.9 million** at June 30, 2025[9](index=9&type=chunk) - Total stockholders' equity decreased by **$3.0 million** from **$19.0 million** at December 31, 2024, to **$16.0 million** at June 30, 2025[9](index=9&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to **$9.43 million** for Q2 2025 but decreased to **$17.92 million** for H1 2025, influenced by lower operating expenses and higher interest expenses Operating expenses: | Operating expenses: | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------- | :------------- | :------------- | :------------- | | Research and development expenses | $4,212,918 | $4,527,698 | $10,043,918 | $11,231,862 | | General and administrative expenses | $3,410,433 | $4,156,606 | $6,685,191 | $7,550,069 | | Total operating expenses | $7,623,351 | $8,684,304 | $16,729,109 | $18,781,931 | | Loss from operations | $(7,623,351) | $(8,684,304) | $(16,729,109) | $(18,781,931) | | Interest income (expenses), net | $(1,810,857) | $(512,762) | $(2,363,886) | $(1,018,612) | | Benefit from income taxes | - | $869,169 | $1,169,820 | $869,169 | | Net loss and comprehensive loss | $(9,434,208) | $(8,327,897) | $(17,923,175) | $(18,931,374) | | Net loss per share, basic and diluted | $(0.21) | $(0.23) | $(0.41) | $(0.53) | | Weighted average common shares outstanding, basic, and diluted | 45,902,502 | 36,693,561 | 43,226,618 | 35,754,715 | - Net loss increased by **13%** to **$9.43 million** for the three months ended June 30, 2025, compared to **$8.33 million** for the same period in 2024[11](index=11&type=chunk) - Net loss decreased by **5%** to **$17.92 million** for the six months ended June 30, 2025, compared to **$18.93 million** for the same period in 2024[11](index=11&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity decreased from **$19.00 million** to **$15.96 million** by June 30, 2025, primarily due to a **$17.92 million** net loss, partially offset by stock and warrant issuances Stockholders' Equity Changes | | Common Stock ($) | Additional Paid-in Capital ($) | Accumulated Deficit ($) | Total Equity ($) | | :-------------------------------- | :------------- | :------------------------- | :------------------ | :----------- | | **January 1, 2025** | $12,536 | $201,103,311 | $(182,110,999) | $19,004,848 | | Stock-based compensation expense | - | $1,253,882 | - | $1,253,882 | | Issuance of common stock for consulting agreement | $50 | $203,451 | - | $203,501 | | Issuances of common stock from the Sales Agreement, net | $68 | $306,047 | - | $306,115 | | Issuances of common stock, net of issuance costs | $2,111 | $6,919,908 | - | $6,922,019 | | Issuance of pre-funded warrants | - | $1,009,969 | - | $1,009,969 | | Issuance of warrants | - | $2,150,771 | - | $2,150,771 | | Exercise of pre-funded warrants | $233 | $(162) | - | $71 | | Net loss | - | - | $(8,488,967) | $(8,488,967) | | **Balance - March 31, 2025** | **$14,998** | **$212,947,177** | **$(190,599,966)** | **$22,362,209** | | Stock-based compensation expense | - | $448,029 | - | $448,029 | | Issuances of common stock from the Sales Agreement, net | $317 | $1,460,325 | - | $1,460,642 | | Issuances of common stock, net of issuance costs | - | $50,000 | - | $50,000 | | Issuance of warrants | - | $1,073,089 | - | $1,073,089 | | Exercise of pre-funded warrants | $75 | $(52) | - | $23 | | Net loss | - | - | $(9,434,208) | $(9,434,208) | | **Balance - June 30, 2025** | **$15,390** | **$215,978,568** | **$(200,034,174)** | **$15,959,784** | - Total stockholders' equity decreased by **$3.0 million** from **$19.0 million** at January 1, 2025, to **$16.0 million** at June 30, 2025[14](index=14&type=chunk) - The accumulated deficit increased to **$200.0 million** as of June 30, 2025, from **$182.1 million** at January 1, 2025, primarily due to net losses[14](index=14&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities decreased to **$18.13 million**, while net cash provided by financing activities significantly decreased to **$8.32 million**, resulting in a **$9.82 million** net decrease in cash Cash flows from operating activities: | Cash flows from operating activities: | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | Net loss | $(17,923,175) | $(18,931,374) | | Net cash used in operating activities | $(18,133,379) | $(18,796,097) | | Net cash used in investing activities | - | $(28,999) | | Net cash provided by financing activities | $8,317,283 | $19,998,303 | | Net decrease in cash and cash equivalents | $(9,816,096) | $1,173,207 | | Cash and cash equivalents at beginning of period | $41,689,591 | $56,560,517 | | Cash and cash equivalents at the end of period | $31,873,495 | $57,733,724 | | Supplemental information of cash and non-cash transactions: | | | | Cash paid for interest | $1,581,846 | $2,362,716 | - Net cash used in operating activities decreased by **$0.66 million (3.5%)** for the six months ended June 30, 2025, compared to the same period in 2024[17](index=17&type=chunk) - Net cash provided by financing activities decreased by **$11.68 million (58.4%)** for the six months ended June 30, 2025, compared to the same period in 2024[17](index=17&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's operations, accounting policies, liquidity, capital resources, fair value, leases, accrued expenses, stock-based compensation, income taxes, commitments, and debt agreements, including new financing and going concern assessment [Note 1 – Nature of Operations](index=8&type=section&id=Note%201%20%E2%80%93%20Nature%20of%20Operations) PDS Biotechnology Corporation is a clinical-stage immunotherapy company developing targeted immunotherapies for oncology and infectious diseases using its proprietary Versamune®, PDS01ADC, and Infectimune® platforms - PDS Biotech is a clinical-stage immunotherapy company developing targeted immunotherapies for oncology and infectious diseases[19](index=19&type=chunk) - Key proprietary platforms include Versamune® (alone or with PDS01ADC for oncology) and Infectimune® (for infectious diseases), designed to induce potent T cell responses and neutralizing antibodies[19](index=19&type=chunk) - The company is developing product candidates for HPV-associated cancers, melanoma, colorectal, lung, breast, prostate cancers, and universal influenza vaccines[19](index=19&type=chunk) [Note 2 – Summary of Significant Accounting Policies](index=8&type=section&id=Note%202%20%E2%80%93%20Summary%20of%20Significant%20Accounting%20Policies) Unaudited interim financial statements adhere to U.S. GAAP, with R&D and patent costs expensed as incurred, stock-based compensation valued by Black-Scholes, and ASC 842 applied to leases, with ASU 2023-07 adopted retrospectively - Unaudited interim financial statements are prepared in U.S. dollars and in accordance with U.S. GAAP for interim reporting, consistent with annual policies[20](index=20&type=chunk) - Research and development costs and patent costs are expensed as incurred[25](index=25&type=chunk)[27](index=27&type=chunk) - The company adopted ASU 2023-07, Segment Reporting, retrospectively for the annual period ended December 31, 2024, enhancing disclosures about significant segment expenses[34](index=34&type=chunk) [Note 3 – Liquidity and Capital Resources](index=11&type=section&id=Note%203%20%E2%80%93%20Liquidity%20and%20Capital%20Resources) As of June 30, 2025, cash and cash equivalents totaled **$31.9 million**; ongoing net losses and negative cash flows raise substantial doubt about the company's going concern, necessitating recent equity and debt financings - As of June 30, 2025, cash and cash equivalents totaled **$31.9 million**[38](index=38&type=chunk) - The company has experienced net losses and negative cash flows from operations since inception and expects this to continue, leading to substantial doubt about its ability to continue as a going concern[38](index=38&type=chunk)[46](index=46&type=chunk)[48](index=48&type=chunk) - Recent financing activities include: **$1.5 million** (Q2 2025) from the New Sales Agreement, **$1.2 million** from NJ NOL program (2025), **$10.05 million** net from February 2025 Offering, and **$20.0 million** total purchase price from April 2025 Securities Purchase Agreement (Debentures and Warrants), with **$19 million** used to retire previous debt[40](index=40&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) [Note 4 – Fair Value of Financial Instruments](index=13&type=section&id=Note%204%20%E2%80%93%20Fair%20Value%20of%20Financial%20Instruments) Cash and cash equivalents are Level 1 fair value measurements, and the Debentures' carrying value approximated fair value due to their variable interest rate as of June 30, 2025 Fair Value Measurements | | Total ($) | Quoted Prices in Active Markets (Level 1) ($) | Quoted Prices in Inactive Markets (Level 2) ($) | Significant Unobservable Inputs (Level 3) ($) | | :-------------------------- | :------------ | :---------------------------------------- | :---------------------------------------- | :---------------------------------------- | | **As of June 30, 2025:** | | | | | | Cash and cash equivalents | $31,873,495 | $31,873,495 | $ - | $ - | | **As of December 31, 2024:** | | | | | | Cash and cash equivalents | $41,689,591 | $41,689,591 | $ - | $ - | - The carrying value of the Debentures approximated its fair value as of June 30, 2025, due to the variable interest rate[50](index=50&type=chunk) [Note 5 – Leases](index=13&type=section&id=Note%205%20%E2%80%93%20Leases) The company holds a month-to-month operating lease for research facilities and financing leases for laboratory equipment, with total future minimum financing lease payments of **$101,757**, including **$34,925** due in 2025 - The company maintains a month-to-month operating lease for its research facilities[51](index=51&type=chunk) Future Minimum Financing Lease Payments | Year ended December 31, | Amount ($) | | :---------------------- | :--------- | | 2025 | $34,925 | | 2026 | $40,108 | | 2027 and after | $26,724 | | Total future minimum lease payments | $101,757 | | Less imputed interest | $(8,647) | | Remaining lease liability | $93,110 | - Financing leases for laboratory equipment have a total cost of **$251,959** with four to five-year terms and a **9.15%** capitalized interest rate[53](index=53&type=chunk) [Note 6 – Accrued Expenses](index=14&type=section&id=Note%206%20%E2%80%93%20Accrued%20Expenses) Total accrued expenses decreased to **$1.48 million** at June 30, 2025, from **$2.84 million** at December 31, 2024, primarily due to reduced accrued research and development and professional fees Accrued Expenses | Accrued expenses | As of June 30, 2025 ($) | As of December 31, 2024 ($) | | :-------------------------- | :------------- | :------------- | | Accrued research and development | $178,192 | $1,267,627 | | Accrued professional fees | $315,420 | $657,498 | | Accrued compensation | $988,101 | $663,399 | | Accrued interest on debt | - | $252,322 | | Accrued rent | $368 | $368 | | **Total** | **$1,482,081** | **$2,841,214** | - Accrued research and development decreased significantly from **$1.27 million** to **$0.18 million**[54](index=54&type=chunk) - Accrued professional fees decreased from **$0.66 million** to **$0.32 million**[54](index=54&type=chunk) [Note 7 – Stock-Based Compensation](index=14&type=section&id=Note%207%20%E2%80%93%20Stock-Based%20Compensation) Equity incentive plans were amended to increase authorized shares; stock-based compensation expense for H1 2025 was **$1.70 million**, a decrease from **$3.43 million** in the prior year, with **6,397,184** options outstanding at a **$5.88** weighted average exercise price - The Third Restated Plan was amended to increase authorized shares for issuance to **9,709,584** shares, with **3,409,087** shares available for grant as of June 30, 2025[58](index=58&type=chunk) - The Inducement Plan was amended to increase authorized shares to **2,100,000**, with **957,407** shares available for grant as of June 30, 2025[60](index=60&type=chunk)[61](index=61&type=chunk) Stock-Based Compensation | Stock-Based Compensation | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------- | :------------- | :------------- | :------------- | :------------- | | Research and development | $(316,466) | $609,828 | $204,061 | $1,161,746 | | General and administrative | $764,495 | $1,185,894 | $1,497,850 | $2,263,987 | | **Total** | **$448,029** | **$1,795,722** | **$1,701,911** | **$3,425,733** | Stock Option Activity (Six months ended June 30, 2025) | Stock Option Activity (Six months ended June 30, 2025) | Number of Options / Price ($) | | :-------------------------------- | :------------- | | Options outstanding at December 31, 2024 | 5,373,063 | | Granted options | 1,246,500 | | Forfeited and expired | (222,379) | | Options outstanding at June 30, 2025 | 6,397,184 | | Weighted average exercise price of all outstanding options | $5.88 | [Note 8 – Income Taxes](index=16&type=section&id=Note%208%20%E2%80%93%20Income%20Taxes) A full valuation allowance was recorded against net deferred tax assets, resulting in no income tax benefit for Q2 2025, but a **$1.2 million** income tax benefit was recognized for H1 2025 from selling New Jersey NOL carryforwards, up from **$0.9 million** in the prior year - The company recorded a full valuation allowance against net deferred tax assets due to expected operating losses, resulting in no income tax benefit for the three months ended June 30, 2025[65](index=65&type=chunk)[66](index=66&type=chunk) - Income tax benefit from the New Jersey Technology Business Tax Certificate Transfer NOL program was **$1.2 million** for the six months ended June 30, 2025, compared to **$0.9 million** in 2024[68](index=68&type=chunk) [Note 9 – Commitments and Contingencies](index=16&type=section&id=Note%209%20%E2%80%93%20Commitments%20and%20Contingencies) The company has rent commitments and an exclusive global license agreement with Merck KGaA for PDS01ADC, involving potential milestone payments up to **$116 million** and a **10%** royalty on net sales, with no material pending legal proceedings - Rent expense for the three and six months ended June 30, 2025, was **$64,200** and **$129,900**, respectively[69](index=69&type=chunk) - Under the Merck KGaA License Agreement for PDS01ADC, the company may pay up to **$11 million** in development and first commercial sales milestones and up to **$105 million** for aggregate sales levels[70](index=70&type=chunk) - A **10%** royalty on aggregate net sales of PDS01ADC is payable to Merck KGaA, subject to certain reductions[71](index=71&type=chunk) - The company is not a party to any material pending legal proceedings[72](index=72&type=chunk) [Note 10 – Venture Loan and Security Agreement](index=17&type=section&id=Note%2010%20%E2%80%93%20Venture%20Loan%20and%20Security%20Agreement) The August 2022 Venture Loan and Security Agreement was fully retired using proceeds from the April 2025 Securities Purchase Agreement; interest expense was **$277,859** for Q2 2025 and **$1,206,035** for H1 2025, including a **$1,107,005** debt extinguishment expense in Q2 2025 - The Venture Loan and Security Agreement was fully satisfied and retired with proceeds from the April 2025 Securities Purchase Agreement[73](index=73&type=chunk)[78](index=78&type=chunk) - Interest expense recognized for this loan was **$277,859** for the three months ended June 30, 2025, and **$1,206,035** for the six months ended June 30, 2025[74](index=74&type=chunk) - A **$1,107,005** interest expense was recognized during Q2 2025 due to the extinguishment of this debt[75](index=75&type=chunk) [Note 11 – Securities Purchase Agreement](index=17&type=section&id=Note%2011%20%E2%80%93%20Securities%20Purchase%20Agreement) On April 30, 2025, the company sold **$22.22 million** in senior secured convertible debentures and warrants for **1 million** common shares for **$20 million**, using **$19 million** to retire prior debt; debentures carry a coupon rate of prime plus **5.0%** (minimum **11.0%**) and an effective annual interest rate of approximately **24.1%** - On April 30, 2025, the company sold **$22,222,222** in senior secured convertible debentures and warrants to purchase **1,000,000** shares of common stock[76](index=76&type=chunk) - The total purchase price for these securities was **$20,000,000**[76](index=76&type=chunk) - Approximately **$19 million** of the proceeds were used to satisfy the previous Loan and Security Agreement[78](index=78&type=chunk) - The debentures have a coupon rate of prime plus **5.0%** (minimum **11.0%**) and an effective annual interest rate of approximately **24.1%** as of June 30, 2025[79](index=79&type=chunk) - Interest expense of **$757,257** was recognized for the debentures for the three and six months ended June 30, 2025[80](index=80&type=chunk) [Note 12 – Retirement Plan](index=18&type=section&id=Note%2012%20%E2%80%93%20Retirement%20Plan) The company contributed **$51,293** to its 401(k) plan for Q2 2025 and **$116,833** for H1 2025, a slight increase from the prior year 401(k) Employer Contributions | 401(k) Employer Contributions | Three Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2025 ($) | | :-------------------------- | :------------- | :------------- | | **2025** | $51,293 | $116,833 | | **2024** | $46,995 | $113,483 | [Note 13 – Segment Reporting](index=18&type=section&id=Note%2013%20%E2%80%93%20Segment%20Reporting) The company operates as a single reportable segment focused on developing immunotherapies, with performance measured by net income/loss attributable to shareholders and detailed operating and segment expenses - The company operates as a single reportable segment, developing targeted immunotherapies[82](index=82&type=chunk) - The Chief Executive Officer, as the chief operating decision maker, assesses performance and allocates resources based on consolidated financial statements[82](index=82&type=chunk)[83](index=83&type=chunk) Segment expenses | Segment expenses | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------- | :------------- | :------------- | :------------- | :------------- | | Salaries and Benefits | $2,857,617 | $4,124,151 | $6,686,838 | $8,307,421 | | Professional fees | $1,278,581 | $1,688,412 | $2,405,627 | $2,765,678 | | Clinical development expenses | $2,017,145 | $1,004,848 | $2,455,049 | $2,846,909 | | Other development expenses | $1,082,111 | $1,487,988 | $4,449,344 | $4,118,356 | | **Total operating and segment expenses** | **$7,623,351** | **$8,684,304** | **$16,729,109** | **$18,781,931** | | Segment and consolidated net loss | $(9,434,208) | $(8,327,897) | $(17,923,175) | $(18,931,374) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, highlighting its clinical-stage immunotherapy focus, pipeline developments, financial performance, liquidity, capital resources, and going concern assessment [Company Overview](index=21&type=section&id=Company%20Overview) PDS Biotech is a clinical-stage immunotherapy company developing targeted cancer and infectious disease immunotherapies using its Versamune®, PDS01ADC, and Infectimune® platforms to induce potent T cell responses - PDS Biotech is a clinical-stage immunotherapy company developing targeted cancer and infectious disease immunotherapies[90](index=90&type=chunk) - The company's platforms, Versamune®, Versamune® in combination with PDS01ADC, and Infectimune®, are designed to induce high-quality CD4 helper and CD8 killer T cells and neutralizing antibodies[90](index=90&type=chunk)[91](index=91&type=chunk) - PDS01ADC is an investigational tumor-targeting IL-12 fusion protein designed to enhance T cell proliferation, potency, and longevity in the tumor microenvironment[91](index=91&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20Developments) In March 2025, the VERSATILE-003 Phase 3 trial for PDS0101 in HPV16-positive HNSCC began, and in July 2025, a Phase 2 colorectal cancer cohort with PDS01ADC met expansion criteria - Initiation of VERSATILE-003 Phase 3 clinical trial for PDS0101 in HPV16-positive first-line recurrent/metastatic head and neck squamous cell carcinoma in March 2025[92](index=92&type=chunk) - Colorectal cancer cohort of a Phase 2 clinical trial with PDS01ADC met pre-defined criteria for expansion to stage 2 in July 2025, following positive stage 1 results[92](index=92&type=chunk) [Clinical Candidate Pipeline](index=21&type=section&id=Clinical%20Candidate%20Pipeline) The clinical pipeline includes Versamune® and PDS01ADC therapies, with VERSATILE-003 (Phase 3) and VERSATILE-002 (Phase 2) showing promising results for HPV16-positive HNSCC, alongside NCI and MD Anderson collaborations and advancements for other cancers [VERSATILE-003: PDS0101 (Versamune® HPV) + pembrolizumab](index=21&type=section&id=VERSATILE-003:%20PDS0101%20(Versamune%C2%AE%20HPV)%20%2B%20pembrolizumab) The VERSATILE-003 Phase 3 trial is enrolling **351** patients with HPV16-positive recurrent/metastatic HNSCC, evaluating PDS0101 with pembrolizumab, with median overall survival as the primary endpoint and interim data expected at 6 and 18 months - Phase 3 trial (VERSATILE-003) initiated for PDS0101 + pembrolizumab in HPV16-positive first-line recurrent/metastatic HNSCC, enrolling **351** patients[93](index=93&type=chunk) - Primary endpoint is median overall survival; secondary endpoints include objective response rate, disease control rate, duration of response, and progression-free survival[94](index=94&type=chunk) - Interim data readouts are estimated at 6 and 18 months, with final readout expected 24 months after full enrollment[94](index=94&type=chunk) [VERSATILE-002: PDS0101 + Keytruda®](index=21&type=section&id=VERSATILE-002:%20PDS0101%20%2B%20Keytruda%C2%AE) The VERSATILE-002 Phase 2 trial for PDS0101 + Keytruda® in HPV16-positive HNC completed enrollment, showing promising interim overall survival (e.g., **30 months** median OS, **74%** 24-month OS in ICI naïve) and objective response rates (**36%** overall), leading to a two-part registrational trial strategy - VERSATILE-002 Phase 2 trial evaluating PDS0101 + Keytruda® for HPV16-positive recurrent/metastatic head and neck cancer has completed enrollment in both ICI naïve and ICI resistant arms[95](index=95&type=chunk)[97](index=97&type=chunk) - Updated interim data (May 2024 cut-off) for ICI naïve cohort with CPS > 1 showed a median overall survival of **30 months** (published ICIs: 7-18 months) and an objective response rate of **34%** (published ICIs: <20%)[100](index=100&type=chunk)[101](index=101&type=chunk) - Updated data (May 2024 cut-off) showed an overall median OS of **30.0 months**, ORR of **35.8%**, and DCR of **77.4%**[107](index=107&type=chunk) - The company announced an updated clinical strategy for a two-part registrational trial focusing on the double combination of Versamune® HPV + pembrolizumab[102](index=102&type=chunk)[103](index=103&type=chunk) [National Cancer Institute: PDS0101 + PDS01ADC +Bintrafusp Alfa](index=23&type=section&id=National%20Cancer%20Institute:%20PDS0101%20%2B%20PDS01ADC%20%2BBintrafusp%20Alfa) An NCI-led Phase 2 trial for PDS0101 + PDS01ADC + Bintrafusp Alfa in advanced HPV-positive cancers closed enrollment, showing promising preliminary efficacy in ICI-resistant patients, with **75%** of ICI-naïve patients alive at **36 months** and a **72%** 12-month survival rate in ICI-resistant patients - NCI-led Phase 2 trial evaluating PDS0101 + PDS01ADC + Bintrafusp Alfa for advanced HPV-positive cancers has closed for enrollment, with evaluation of long-term patient survival ongoing[105](index=105&type=chunk) - Updated interim survival data (November 2023) showed **75%** of ICI-naïve patients alive at **36 months** (historical 7-11 months) and a **12-month** survival rate of **72%** in ICI-resistant patients (median OS ~20 months vs. historical 3.4 months)[110](index=110&type=chunk)[112](index=112&type=chunk) - Preclinical data suggested synergistic activity of the triple combination, corroborated by Phase 2 trial results[108](index=108&type=chunk) [MD Anderson Cancer Center (IMMUNOCERV): PDS0101 + Chemoradiotherapy](index=24&type=section&id=MD%20Anderson%20Cancer%20Center%20(IMMUNOCERV):%20PDS0101%20%2B%20Chemoradiotherapy) A Phase 2 IIT at MD Anderson is investigating PDS0101 with standard-of-care chemoradiotherapy for locally advanced cervical cancer, with October 2023 data showing PDS0101 plus CRT associated with earlier and greater ctDNA clearance - Phase 2 IIT at MD Anderson is actively recruiting patients for PDS0101 in combination with standard-of-care chemo-radiotherapy for locally advanced cervical cancer[110](index=110&type=chunk) - Data from October 2023 demonstrated earlier and greater ctDNA clearance with PDS0101 plus CRT (**81.3%** clearance after 3 weeks vs. **30.3%** with SOC) and **91.7%** clearance at 5 weeks vs. **53.1%** with SOC[111](index=111&type=chunk)[113](index=113&type=chunk) [Mayo Clinic: PDS0101 (Versamune® HPV) Monotherapy and in combination with Keytruda®](index=24&type=section&id=Mayo%20Clinic:%20PDS0101%20(Versamune%C2%AE%20HPV)%20Monotherapy%20and%20in%20combination%20with%20Keytruda%C2%AE) An IIT (MC200710) at Mayo Clinic is evaluating PDS0101 alone or with Keytruda® as neoadjuvant treatment for HPV-positive oropharyngeal cancer patients at high risk of recurrence, aiming to assess HPV-specific anti-tumor responses, tumor shrinkage, and ctDNA decreases - IIT MC200710 initiated in February 2022 at Mayo Clinic for PDS0101 alone or with Keytruda® in HPV-positive oropharyngeal cancer patients at high risk of recurrence[111](index=111&type=chunk) - Treatment is administered as neoadjuvant therapy before transoral robotic surgery (TORS) with curative intent[114](index=114&type=chunk) - The trial will explore if the treatment increases HPV-specific anti-tumor responses, tumor shrinkage, pathologic regression, and decreases in circulating tumor DNA (ctDNA)[114](index=114&type=chunk) [PDS0103 (Versamune® MUC1)](index=25&type=section&id=PDS0103%20(Versamune%C2%AE%20MUC1)) PDS0103, an investigational immune therapy for MUC1-associated cancers, combines Versamune® with NCI-developed MUC1 agonist epitopes, with FDA IND clearance in March 2025 for combination with PDS01ADC in metastatic colorectal cancer - PDS0103 is an investigational immune therapy for MUC1-associated cancers (ovarian, breast, colorectal, lung)[115](index=115&type=chunk)[116](index=116&type=chunk) - FDA cleared IND application for PDS0103 and PDS01ADC combination in metastatic colorectal cancer in March 2025[117](index=117&type=chunk) [PDS0102](index=25&type=section&id=PDS0102) PDS0102 is an investigational immunotherapy utilizing TARP antigen from the NCI, designed to treat TARP-associated cancers, with preclinical work showing it induced large numbers of tumor-targeted killer T cells - PDS0102 is an investigational immunotherapy utilizing TARP antigen from the NCI, targeting AML, prostate, and breast cancer[118](index=118&type=chunk) - Preclinical studies demonstrated that PDS0102 (Versamune®+TARP antigen) induced large numbers of tumor-targeted killer T cells[118](index=118&type=chunk) [IL-12 Oncology Immunocytokine Pipeline](index=25&type=section&id=IL-12%20Oncology%20Immunocytokine%20Pipeline) PDS01ADC is a novel IL-12 fused antibody drug conjugate designed to enhance T cell activity, with interim Phase 1/2 data for metastatic prostate cancer showing PSA level decreases and favorable immune changes - PDS01ADC is a novel investigational IL-12 fused antibody drug conjugate designed to enhance T cell proliferation, potency, and longevity in the tumor microenvironment[119](index=119&type=chunk) - Interim Phase 1/2 data for PDS01ADC with docetaxel in metastatic prostate cancer showed PSA level decreases in all patients (**61%** with ≥**60%** decrease) and favorable immune changes (decreased T reg cells, increased NK cells, memory CD8 T cells, proliferating CD4/CD8 T cells, and cytokines)[121](index=121&type=chunk)[124](index=124&type=chunk) - PDS01ADC is being evaluated in several NCI-sponsored IIT Phase 2 trials, including combinations for HPV-positive malignancies, prostate cancer, and MUC1-positive cancers, as well as monotherapy for Kaposi Sarcoma[120](index=120&type=chunk) [Infectimune® Development Strategy](index=27&type=section&id=Infectimune%C2%AE%20Development%20Strategy) The Infectimune® platform aims to improve infectious disease treatments and prevention by inducing strong T cells and antibodies, with near-term focus on universal flu vaccines aligned with NIAID's CIVICs program, supported by preclinical data for broad and durable protection - Infectimune® platform aims to induce strong CD8 and CD4 T cells and antibodies for improved infectious disease treatment and prevention[126](index=126&type=chunk) - Near-term focus is on developing a universal seasonal flu vaccine and potentially a universal pandemic influenza vaccine, aligning with NIAID's CIVICs program[127](index=127&type=chunk) - Preclinical data published in Viruses (February 2023) demonstrated complete protection against sickness after lethal challenge with live SARS-CoV-2 or influenza viruses and dramatically enhanced CD4 T cell responses[128](index=128&type=chunk) - Preclinical data on investigational universal flu vaccine PDS0202 (September 2023) showed active neutralization across multiple influenza viruses and protection against infection and weight loss in animals[129](index=129&type=chunk) [Selected Financial Operations Overview](index=27&type=section&id=SELECTED%20FINANCIAL%20OPERATIONS%20OVERVIEW) The company has not generated product revenue and anticipates increasing R&D expenses as clinical candidates advance, with uncertain project duration, completion costs, and no assurance of marketing approval or profitability - The company has not generated any revenues from commercial product sales and does not expect to in the near future[130](index=130&type=chunk) - Research and development expenses are expected to increase significantly as clinical trials advance and regulatory approvals are pursued[132](index=132&type=chunk) - The company is unable to determine the duration and completion costs of R&D projects or when revenue will be generated due to numerous risks and uncertainties[133](index=133&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) For Q2 2025, net loss increased by **13%** to **$9.43 million** due to a **253%** rise in net interest expense, despite a **12%** operating expense decrease; for H1 2025, net loss decreased by **5%** to **$17.92 million** due to **11%** lower operating expenses and a **35%** income tax benefit, offset by a **132%** increase in net interest expense Three Months Ended June 30, 2025 vs. 2024 | Operating expenses: | 2025 (in thousands $) | 2024 (in thousands $) | Increase (Decrease) $ Amount (in thousands $) | Increase (Decrease) % | | :-------------------------------- | :------------------ | :------------------ | :--------------------------- | :-------------------- | | Research and development expenses | $4,213 | $4,528 | $(315) | (7)% | | General and administrative expenses | $3,410 | $4,156 | $(746) | (18)% | | Total operating expenses | $7,623 | $8,684 | $(1,061) | (12)% | | Loss from operations | $(7,623) | $(8,684) | $1,061 | (12)% | | Interest income (expense), net | $(1,811) | $(513) | $(1,298) | 253% | | Benefit from income taxes | - | $869 | $(869) | 100% | | Net loss and comprehensive loss | $(9,434) | $(8,328) | $(1,106) | 13% | Six Months Ended June 30, 2025 vs. 2024 | Operating expenses: | 2025 (in thousands $) | 2024 (in thousands $) | Increase (Decrease) $ Amount (in thousands $) | Increase (Decrease) % | | :-------------------------------- | :------------------ | :------------------ | :--------------------------- | :-------------------- | | Research and development expenses | $10,044 | $11,232 | $(1,188) | (11)% | | General and administrative expenses | $6,685 | $7,550 | $(865) | (11)% | | Total operating expenses | $16,729 | $18,782 | $(2,053) | (11)% | | Loss from operations | $(16,729) | $(18,782) | $2,053 | (11)% | | Interest income (expense), net | $(2,364) | $(1,019) | $(1,345) | 132% | | Benefit from income taxes | $1,170 | $869 | $301 | 35% | | Net loss and comprehensive loss | $(17,923) | $(18,932) | $1,009 | (5)% | - Research and development expenses decreased by **$0.3 million (7%)** for the three months ended June 30, 2025, primarily due to decreases in manufacturing and personnel costs, offset by increased clinical trial costs[135](index=135&type=chunk) - General and administrative expenses decreased by **$0.8 million (18%)** for the three months ended June 30, 2025, mainly due to lower personnel costs and professional fees[135](index=135&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$31.9 million** in cash and cash equivalents, funding operations through various equity and debt financings, but recurring losses and capital needs raise substantial doubt about its going concern ability - As of June 30, 2025, the company had **$31.9 million** in cash and cash equivalents[149](index=149&type=chunk) - The company sold **1,165,861** shares of common stock for a net value of **$1.8 million** through the New Sales Agreement during the six months ended June 30, 2025[143](index=143&type=chunk) - Net proceeds of approximately **$10.05 million** were received from the February 2025 Offering of common stock and warrants[147](index=147&type=chunk) - The April 2025 Securities Purchase Agreement provided **$20 million**, with approximately **$19 million** used to retire previous debt[148](index=148&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern for at least 12 months due to recurring losses and the need for additional financing[152](index=152&type=chunk) [Cash Flows](index=31&type=section&id=Cash%20Flows) Net cash used in operating activities decreased by **$0.7 million** to **$18.1 million** due to lower stock-based compensation and reduced net loss, while net cash provided by financing activities decreased by **$11.7 million** due to loan repayment and lower stock issuance proceeds, partially offset by new loan and warrant issuances Cash Flows (in thousands) | Cash Flows (in thousands) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------- | :------------- | | Net cash used in operating activities | $(18,133) | $(18,796) | | Net cash used in investing activities | - | $(29) | | Net cash provided by financing activities | $8,317 | $19,998 | | Net (decrease) increase in cash and cash equivalents | $(9,816) | $1,173 | - Net cash used in operating activities decreased by **$0.7 million** for the six months ended June 30, 2025, primarily due to a decrease in non-cash stock-based compensation expense and a decrease in net loss[154](index=154&type=chunk) - Net cash provided by financing activities decreased by **$11.7 million**, mainly due to a **$22.8 million** decrease from loan repayment and a **$17.7 million** decrease from common stock issuance via Sales Agreement, offset by **$19.2 million** from the Securities Purchase Agreement and **$10.2 million** from the February 2025 Offering[156](index=156&type=chunk) [Operating Capital Requirements](index=31&type=section&id=Operating%20Capital%20Requirements) The company anticipates continued losses and substantial additional funding for R&D and clinical trials, planning to seek equity, debt, collaborations, or licenses, but faces risks of delays or termination if financing is inadequate, compounded by a minimum cash covenant in its Debentures - The company expects to incur additional costs associated with operating as a public company and anticipates substantial additional funding for continuing operations[157](index=157&type=chunk) - Future funding requirements depend on factors like timing and costs of clinical trials, regulatory approvals, and potential collaborations[159](index=159&type=chunk)[166](index=166&type=chunk) - Failure to obtain adequate financing could lead to delays, reductions, or termination of product development, or granting rights to third parties[151](index=151&type=chunk) - The Securities Purchase Agreement allows lenders to call outstanding Debentures if minimum cash balances are not maintained[151](index=151&type=chunk)[158](index=158&type=chunk) [Critical Accounting Policies and Estimates](index=32&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Financial statements are prepared under U.S. GAAP, requiring management estimates and assumptions, with no material changes to critical accounting policies or estimates during the six months ended June 30, 2025, compared to the 2024 Annual Report on Form 10-K - Financial statements are prepared in accordance with U.S. GAAP, requiring management estimates and assumptions[162](index=162&type=chunk) - No material changes to critical accounting policies and estimates occurred during the six months ended June 30, 2025, compared to the Annual Report on Form 10-K for 2024[163](index=163&type=chunk) [Off-Balance Sheet Arrangements](index=32&type=section&id=Off-Balance%20Sheet%20Arrangements) The company did not have any material off-balance sheet arrangements during the periods presented and does not currently have any - The company did not have any off-balance sheet arrangements during the periods presented and does not currently have any[164](index=164&type=chunk) [Smaller Reporting Company](index=32&type=section&id=Smaller%20Reporting%20Company) The company is a 'smaller reporting company' and intends to rely on exemptions from certain disclosure requirements applicable to larger public companies - The company is a 'smaller reporting company' as defined in Rule 12b-2 under the Securities Exchange Act of 1934[165](index=165&type=chunk) - It intends to rely on exemptions from certain disclosure requirements applicable to other public companies[165](index=165&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk from cash equivalents and floating-rate debentures, though historical impact has been immaterial, and inflation has not materially affected its business during the six months ended June 30, 2025 - The company is exposed to interest rate risk from bank deposits, money market accounts, and floating-rate debentures (pegged to prime rate)[167](index=167&type=chunk) - Historically, the net impact of interest rate fluctuations has not been material[167](index=167&type=chunk) - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the six months ended June 30, 2025[168](index=168&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that disclosure controls and procedures were effective as of June 30, 2025[169](index=169&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[170](index=170&type=chunk) [Part II — Other Information](index=34&type=section&id=Part%20II%20%E2%80%94%20Other%20Information) This part covers legal proceedings, risk factors, unregistered sales of equity securities, defaults, and other miscellaneous information [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to any material pending legal proceedings, as referenced in Note 9 to the Condensed Consolidated Financial Statements - The company is not a party to any material pending legal proceedings[172](index=172&type=chunk) - Information regarding legal proceedings is incorporated by reference from Note 9 to the Condensed Consolidated Financial Statements[172](index=172&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Substantial doubt exists about the company's going concern ability, potentially impacting stock price and financing, with new risks including operating restrictions and repayment obligations under the April 2025 Debentures, global economic uncertainty, geopolitical conflicts, and changing regulatory policies - Substantial doubt exists about the company's ability to continue as a going concern, which may adversely affect its stock price and ability to obtain financing[174](index=174&type=chunk)[176](index=176&type=chunk) - The April 2025 Debentures impose covenants restricting operations (e.g., incurring indebtedness, granting liens, paying dividends) and require maintaining a minimum cash balance, with potential for immediate repayment upon default[177](index=177&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk) - Global economic uncertainty, geopolitical conflicts (e.g., Russia-Ukraine, Middle East), and changing U.S. administration policies (e.g., tariffs, drug pricing regulations) could adversely affect the company's business, financial condition, and results of operations[180](index=180&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk)[186](index=186&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) On April 30, 2025, the company sold **$22,222,222** in Senior Secured Convertible Debentures and warrants for **1,000,000** common shares for a total of **$20,000,000**, exempt from registration under Section 4(a)(2) of the Securities Act - On April 30, 2025, the company sold **$22,222,222** in Senior Secured Convertible Debentures and warrants to purchase **1,000,000** shares of common stock[189](index=189&type=chunk) - The total purchase price for these securities was **$20,000,000**[189](index=189&type=chunk) - The issuance was exempt from registration under the Securities Act pursuant to Section 4(a)(2)[189](index=189&type=chunk) [Item 3. Defaults Upon Senior Securities](index=37&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the reporting period - No defaults upon senior securities[190](index=190&type=chunk) [Item 4. Mine Safety Disclosures](index=37&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable[191](index=191&type=chunk) [Item 5. Other Information](index=37&type=section&id=Item%205.%20Other%20Information) There is no other information to report under this item - No other information to report[192](index=192&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including the Securities Purchase Agreement, Amendment Agreement, Registration Rights Agreement, Security Agreement, Subsidiary Guarantee, amendments to the Equity Incentive Plan, certifications, and XBRL documents - Exhibits include the Securities Purchase Agreement, Amendment Agreement, Registration Rights Agreement, Security Agreement, and Form of Subsidiary Guarantee related to the April 30, 2025, financing[194](index=194&type=chunk) - An Amendment to the Third Amended and Restated PDS Biotechnology Corporation 2014 Equity Incentive Plan is also filed[194](index=194&type=chunk) - Certifications of Principal Executive Officer and Principal Financial Officer (pursuant to Sections 302 and 906 of Sarbanes-Oxley Act) and Inline XBRL documents are included[194](index=194&type=chunk) [Signatures](index=40&type=section&id=SIGNATURES) This section contains the official signatures of the company's principal executive and financial officers, certifying the report's accuracy [Signatures](index=40&type=section&id=Signatures) The report was duly signed on August 13, 2025, by Frank Bedu-Addo, Ph.D., President and Chief Executive Officer, and Lars Boesgaard, Chief Financial Officer - The report was signed on August 13, 2025[198](index=198&type=chunk) - Signatories include Frank Bedu-Addo, Ph.D., President and Chief Executive Officer, and Lars Boesgaard, Chief Financial Officer[198](index=198&type=chunk)

Financial Data and Key Metrics Changes - The company reported a net loss of approximately $9.4 million or $0.21 per basic and diluted share for the three months ended June 30, 2025, compared to a net loss of $8.3 million or $0.23 per share for the same period in 2024, indicating an increase in net loss primarily due to higher net interest expenses [19][20] - Research and development expenses decreased to $4.2 million for the three months ended June 30, 2025, from $4.5 million for the same period in 2024, attributed to lower personnel costs [19] - General administrative expenses were $3.4 million for the three months ended June 30, 2025, down from $4.2 million in the same period last year, primarily due to lower personnel costs and professional fees [20] - The cash balance as of June 30, 2025, was $31.9 million, compared to $41.7 million as of December 31, 2024 [21] Business Line Data and Key Metrics Changes - The VERSAL three phase three clinical trial is ongoing, evaluating PDS0101 in HPV16 positive recurrent and/or metastatic head and neck cancer, with enrollment complete and 22 patients being followed for survival [6][12] - The VERSAL two trial presented positive updated data, demonstrating durable clinical benefits, with median overall survival remaining steady at 30 months over the last 1.5 years [11][12] - The colorectal cancer cohort of the phase two clinical trial with PDS-one ADC met criteria for expansion to stage two following positive stage one results, with a promising response rate observed [15] Market Data and Key Metrics Changes - Over 50% of head and neck cancer cases in the United States are HPV16 positive, representing a significant unmet medical need as there are currently no targeted therapies for this population [7][9] - HPV16 positive oropharyngeal cancer is projected to become the most prevalent type of head and neck cancer in the United States and Europe by the mid-2030s [9] Company Strategy and Development Direction - The company is focused on advancing its VERSAL three registrational trial specifically targeting HPV16 positive head and neck cancer, which is the first phase three clinical trial in this area [40] - The company aims to leverage the strong results from the VERSAL two trial and its Fast Track designation to enhance the potential of PDS0101 in head and neck cancer [40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the combination of PDS0101 and pembrolizumab to significantly improve outcomes for patients with recurrent and/or metastatic HPV16 positive head and neck cancer [13] - The management highlighted the importance of tolerability and ease of administration of their therapies, which are critical factors for oncologists when considering treatment options [27][36] Other Important Information - The company announced preclinical efficacy and immune response data for a novel universal flu vaccine, which was presented at the American Association of Immunologists Annual Meeting [17][18] - Collaborations with leading clinical institutions such as the National Cancer Institute and MD Anderson Cancer Center are ongoing to support the development of the company's pipeline [18] Q&A Session Summary Question: Follow-up on VERSAL two ASCO data and its impact on enrollment - Management anticipates final data readout for the VERSAL two trial to be presented or published by the end of this calendar year or early next year, which is expected to drive enrollment in the VERSAL three trial [24][25] Question: Competing trials and Mayo Clinic study update - There are fewer competing trials now, with only one major trial by BioNTech in the same space, and the Mayo Clinic study remains important for future study designs [31][32] Question: Specificity of HPV16 positive therapy - The specificity of the trial for HPV16 positive patients is a significant advantage, and the management emphasized the importance of safety and tolerability in treatment options [36][37]

Press Release Header & Executive Summary [Q2 2025 Announcement & CEO Commentary](index=1&type=section&id=Q2%202025%20Announcement%20%26%20CEO%20Commentary) PDS Biotech announced its Q2 2025 financial results and provided a business update, highlighting significant progress in its VERSATILE-003 Phase 3 clinical trial for HPV16-positive HNSCC and positive data from the VERSATILE-002 trial, which CEO Frank Bedu-Addo believes demonstrates PDS0101's potential for durable clinical benefit - PDS Biotech reported **Q2 2025 financial results** and a business update on August 13, 2025[2](index=2&type=chunk) - CEO highlighted continued progress in **VERSATILE-003 Phase 3 clinical trial** for PDS0101 (Versamune® HPV) in HPV16-positive R/M HNSCC[3](index=3&type=chunk) - Announcement and presentation of data from **VERSATILE-002 trial**, demonstrating potential durable clinical benefit of PDS0101[3](index=3&type=chunk) Clinical and Corporate Update [Clinical Program Progress](index=1&type=section&id=Clinical%20Program%20Progress) The company announced that the colorectal cancer cohort of its Phase 2 clinical trial with PDS01ADC met criteria for expansion to Stage 2 following positive Stage 1 results, showing a promising response rate. The VERSATILE-003 trial for PDS0101 continues as the only registrational stage trial specifically targeting HPV16-positive HNSCC patients - Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC met criteria for expansion to Stage 2 following positive Stage 1 results[4](index=4&type=chunk) - Metastatic colorectal cancer cohort demonstrated **promising response rate (≥6 of 9 confirmed objective responses by RECIST v1.1)**, triggering enrollment expansion[4](index=4&type=chunk) - VERSATILE-003 trial is the only registrational stage trial specifically targeting HPV16-positive HNSCC patients[3](index=3&type=chunk) [Scientific Presentations & Preclinical Data](index=1&type=section&id=Scientific%20Presentations%20%26%20Preclinical%20Data) PDS Biotech presented three abstracts on PDS0101 at the 2025 ASCO annual meeting, featuring updated positive data from the VERSATILE-002 trial and other trials for head and neck cancers. Additionally, preclinical immune response data for a novel Infectimune® based universal flu vaccine was presented at IMMUNOLOGY2025™ - Three abstracts on PDS0101 (Versamune® HPV) were presented at the **2025 American Society of Clinical Oncology (ASCO) annual meeting**, highlighting updated positive data from the VERSATILE-002 trial[4](index=4&type=chunk) - Preclinical immune response data with a novel Infectimune® based universal flu vaccine were featured in two presentations at the American Association of Immunologists' **IMMUNOLOGY2025™ Annual Meeting**[4](index=4&type=chunk) Second Quarter 2025 Financial Results [Consolidated Financial Performance](index=2&type=section&id=Consolidated%20Financial%20Performance) PDS Biotech reported a net loss of $9.4 million, or $0.21 per basic and diluted share, for Q2 2025, an increase from $8.3 million, or $0.23 per share, in Q2 2024. This increase in net loss was primarily driven by higher net interest expenses, partially offset by lower personnel costs Net Loss and EPS (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | | :--------------------------------- | :---------- | :---------- | | Net Loss | $(9.4) million | $(8.3) million | | Net Loss per Share (basic & diluted) | $(0.21) | $(0.23) | - The increase in net loss was primarily due to higher net interest expenses, partially offset by lower personnel costs[5](index=5&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Total operating expenses decreased to $7.6 million in Q2 2025 from $8.7 million in Q2 2024. This reduction was primarily due to lower personnel costs in both research and development ($4.2M vs $4.5M) and general and administrative expenses ($3.4M vs $4.2M), with G&A also benefiting from lower professional fees Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 | Q2 2024 | | :-------------------------- | :---------- | :---------- | | Research and development | $4.2 million | $4.5 million | | General and administrative | $3.4 million | $4.2 million | | Total operating expenses | $7.6 million | $8.7 million | - Research and development expenses decreased primarily due to lower personnel costs, partially offset by higher manufacturing costs[6](index=6&type=chunk) - General and administrative expenses decreased primarily due to lower personnel costs and lower professional fees[7](index=7&type=chunk) [Net Interest Expenses](index=2&type=section&id=Net%20Interest%20Expenses) Net interest expenses significantly increased to $1.8 million in Q2 2025, up from $0.5 million in Q2 2024, primarily attributable to debt repayment costs Net Interest Expenses (Three Months Ended June 30) | Metric | Q2 2025 | Q2 2024 | | :------------------ | :---------- | :---------- | | Net interest expenses | $1.8 million | $0.5 million | - The increase in net interest expenses was primarily due to debt repayment costs[8](index=8&type=chunk) [Cash and Liquidity](index=2&type=section&id=Cash%20and%20Liquidity) The company's cash balance as of June 30, 2025, was $31.9 million, a decrease from $41.7 million as of December 31, 2024 Cash Balance | Date | Amount | | :-------------------- | :----------- | | June 30, 2025 | $31.9 million | | December 31, 2024 | $41.7 million | Company Overview & Conference Call [About PDS Biotechnology](index=2&type=section&id=About%20PDS%20Biotechnology) PDS Biotechnology is a late-stage immunotherapy company focused on transforming cancer treatment by targeting the immune system. Its lead program, PDS0101 (Versamune® HPV), is in a pivotal clinical trial for advanced HPV16-positive HNSCC, developed in combination with immune checkpoint inhibitors and PDS01ADC - PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers[10](index=10&type=chunk) - The Company has initiated a pivotal clinical trial to advance its lead program **PDS0101 (Versamune® HPV)** in advanced HPV16-positive head and neck squamous cell cancers[10](index=10&type=chunk) - PDS0101 is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC[10](index=10&type=chunk) [Conference Call Details](index=2&type=section&id=Conference%20Call%20Details) PDS Biotech hosted a conference call and webcast on August 13, 2025, at 8:00 a.m. Eastern Time to discuss the second quarter financial results and provide clinical program updates - Conference call date: **August 13, 2025**[10](index=10&type=chunk) - Conference call time: **8:00 a.m. Eastern Time**[10](index=10&type=chunk) - Dial-in and webcast registration details were provided[10](index=10&type=chunk) Forward-Looking Statements [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This section contains a standard disclaimer regarding forward-looking statements, emphasizing that they are subject to various risks and uncertainties. These include the company's ability to protect intellectual property, capital requirements, dependence on additional financing, limited operating history, and the timing, success, and cost of clinical trials - Forward-looking statements are predictive in nature and depend upon or refer to future events or conditions, subject to risks and uncertainties[12](index=12&type=chunk) - Risks include the Company's ability to protect its intellectual property rights, anticipated capital requirements, dependence on additional financing, limited operating history, and the timing, success, and cost of clinical trials[12](index=12&type=chunk) - The Company undertakes no obligation to revise or update any forward-looking statement[12](index=12&type=chunk) Financial Tables [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This table provides the unaudited condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2025, and 2024, detailing operating expenses, interest income/expense, net loss, and per share information Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development expenses (USD) | $4,212,918 | $4,527,698 | $10,043,918 | $11,231,862 | | General and administrative expenses (USD) | $3,410,433 | $4,156,606 | $6,685,191 | $7,550,069 | | Total operating expenses (USD) | $7,623,351 | $8,684,304 | $16,729,109 | $18,781,931 | | Net interest income (expense) (USD) | $(1,810,857) | $(512,762) | $(2,363,886) | $(1,018,612) | | Net loss and comprehensive loss (USD) | $(9,434,208) | $(8,327,897) | $(17,923,175) | $(18,931,374) | | Net loss per share, basic and diluted (USD) | $(0.21) | $(0.23) | $(0.41) | $(0.53) | | Weighted average common shares outstanding (Shares) | 45,902,502 | 36,693,561 | 43,226,618 | 35,754,715 | [Selected Balance Sheet Data](index=6&type=section&id=Selected%20Balance%20Sheet%20Data) This table presents key unaudited balance sheet figures as of June 30, 2025, and December 31, 2024, including cash and cash equivalents, working capital, total assets, long-term debt, accumulated deficit, and total stockholders' equity Selected Balance Sheet Data | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :-------------- | :---------------- | | Cash and cash equivalents (USD) | $31,873,495 | $41,689,591 | | Working capital (USD) | $22,116,593 | $27,967,242 | | Total assets (USD) | $40,476,065 | $45,358,657 | | Long term debt (USD) | $12,943,656 | $9,204,755 | | Accumulated deficit (USD) | $(200,034,174) | $(182,110,999) | | Total stockholders' equity (USD) | $15,959,784 | $19,004,848 | Contact Information [Investor & Media Contacts](index=4&type=section&id=Investor%20%26%20Media%20Contacts) This section provides the contact details for investor relations and media inquiries for PDS Biotechnology - Investor Contact: Mike Moyer, LifeSci Advisors, Phone **+1 (617) 308-4306**, Email: mmoyer@lifesciadvisors.com[13](index=13&type=chunk) - Media Contact: David Schull, Russo Partners, Phone **+1 (858) 717-2310**, Email: david.schull@russopartnersllc.com[13](index=13&type=chunk)

Core Insights - PDS Biotechnology Corporation reported a net loss of $9.4 million for Q2 2025, an increase from $8.3 million in Q2 2024, primarily due to higher net interest expenses [5][8] - The company is advancing its VERSATILE-003 Phase 3 clinical trial for PDS0101 (Versamune HPV) targeting HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma [3][11] - PDS Biotech presented three abstracts at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, showcasing positive data from the VERSATILE-002 trial [10] Financial Performance - The reported net loss for Q2 2025 was $9.4 million, or $0.21 per share, compared to a loss of $8.3 million, or $0.23 per share, in Q2 2024 [5][16] - Research and development expenses decreased to $4.2 million in Q2 2025 from $4.5 million in Q2 2024, attributed to lower personnel costs [6] - General and administrative expenses also fell to $3.4 million in Q2 2025 from $4.2 million in Q2 2024, mainly due to reduced personnel costs and professional fees [7] Cash Position and Debt - As of June 30, 2025, the company's cash balance was $31.9 million, down from $41.7 million at the end of 2024 [8][15] - Long-term debt increased to $12.9 million as of June 30, 2025, compared to $9.2 million at the end of 2024 [15] Clinical Trials and Developments - The VERSATILE-003 trial is the only registrational stage trial specifically targeting HPV16-positive head and neck cancer patients [3][11] - The colorectal cancer cohort in the Phase 2 clinical trial with PDS01ADC met criteria for expansion to Stage 2 following positive Stage 1 results [10] - The company plans to publish the full data set for the VERSATILE-002 trial later this year [3]

Core Insights - PDS Biotechnology Corporation has completed patient recruitment for Stage 1 of a clinical trial for its PDS01ADC therapeutic in combination with floxuridine for metastatic colorectal cancer, leading to an expansion into Stage 2 of the study [1][2] Group 1: Clinical Trial Details - The trial is an open-label, single-center, non-randomized Phase 2 study with three cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer [2] - The colorectal cancer cohort achieved the milestone of at least 6 out of 9 participants showing an objective response, allowing enrollment to continue up to 22 participants [2] - The study is conducted under a collaborative research and development agreement with the National Cancer Institute (NCI) [2] Group 2: Product Information - PDS01ADC is a fused antibody drug conjugate that targets tumor necrosis by binding to exposed DNA [3] - The investigational approach aims to minimize systemic exposure to IL-12, potentially reducing treatment-limiting toxicities [4] Group 3: Market Context - Colorectal cancer is a significant health issue, with over 930,000 deaths globally in 2020, highlighting the need for more effective treatments [4] - In the U.S., over 150,000 new cases of colorectal cancer are diagnosed annually, with 20% already metastatic at diagnosis [4]