PDS Biotechnology(PDSB) - 2025 Q2 - Quarterly Results

Press Release Header & Executive Summary Q2 2025 Announcement & CEO Commentary 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] - CEO highlighted continued progress in VERSATILE-003 Phase 3 clinical trial for PDS0101 (Versamune® HPV) in HPV16-positive R/M HNSCC[3] - Announcement and presentation of data from VERSATILE-002 trial, demonstrating potential durable clinical benefit of PDS0101[3] Clinical and Corporate Update Clinical Program Progress 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] - Metastatic colorectal cancer cohort demonstrated promising response rate (≥6 of 9 confirmed objective responses by RECIST v1.1), triggering enrollment expansion[4] - VERSATILE-003 trial is the only registrational stage trial specifically targeting HPV16-positive HNSCC patients[3] Scientific Presentations & Preclinical Data 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] - 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] Second Quarter 2025 Financial Results Consolidated Financial Performance 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] Operating Expenses 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] - General and administrative expenses decreased primarily due to lower personnel costs and lower professional fees[7] Net Interest Expenses 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] Cash and Liquidity 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 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] - 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] - PDS0101 is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC[10] Conference Call Details 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] - Conference call time: 8:00 a.m. Eastern Time[10] - Dial-in and webcast registration details were provided[10] Forward-Looking Statements Disclaimer and Risk Factors 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] - 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] - The Company undertakes no obligation to revise or update any forward-looking statement[12] Financial Tables Condensed Consolidated Statements of Operations and Comprehensive Loss 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 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 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] - Media Contact: David Schull, Russo Partners, Phone +1 (858) 717-2310, Email: david.schull@russopartnersllc.com[13]