PDS Biotechnology Corporation filings document the formal disclosures of a late-stage biotechnology company developing targeted immunotherapies for cancer. Recent 8-K reports furnish operating and financial results, business updates, corporate presentations, and press-release exhibits covering PDS0101, VERSATILE-003, PDS01ADC, and related clinical and biomarker data.
The filing record also includes material-event disclosures on FDA and IND protocol matters, Nasdaq listing-compliance correspondence, exhibit filings, capital-structure topics, shareholder voting matters, and the risk and forward-looking-statement language attached to the company’s clinical-development and financing activities.
PDS Biotechnology reported another quarterly loss as it continues to fund its cancer and infectious disease immunotherapy pipeline with no product revenue. For the three months ended March 31, 2026, net loss was $7.3 million, improving from $8.5 million a year earlier, mainly because research and development spending fell to $3.5 million from $5.8 million. General and administrative costs eased slightly to $3.1 million.
Cash and cash equivalents were $21.7 million at March 31, 2026, down from $40.0 million a year earlier, after using $4.4 million in operating cash during the quarter and making $1.5 million of principal payments on senior secured convertible debentures. Total assets were $24.7 million and stockholders’ equity declined to $3.9 million, with an accumulated deficit of $224.0 million.
The company reiterates that it has no revenues, expects ongoing operating losses, and faces restrictive covenants on its $22.2 million debentures, including minimum cash requirements. Management concludes that these conditions raise substantial doubt about its ability to continue as a going concern over the next 12 months. Subsequent to quarter-end, PDS agreed to issue a $6.0 million promissory note with attached warrants and plans to redeem all outstanding debentures for cash in June 2026, subject to closing conditions.
PDS Biotechnology reported first quarter 2026 results and a clinical pipeline update. Net loss was about $7.3 million, or $0.13 per share, improving from a loss of $8.5 million, or $0.21 per share, a year earlier.
Research and development expenses fell to $3.5 million from $5.8 million, mainly from lower clinical and manufacturing costs, while general and administrative expenses edged down to $3.1 million. Cash and cash equivalents were $21.7 million as of March 31, 2026, with long‑term debt of $10.6 million and stockholders’ equity of $3.9 million.
Management highlighted progress on the amended VERSATILE‑003 Phase 3 trial in HPV16‑positive head and neck cancer and ongoing Phase 2 studies of PDS01ADC in metastatic colorectal and advanced castration‑resistant prostate cancers.
PDS Biotechnology Corporation entered into a financing deal with YA II PN, LTD., agreeing to issue a $6,000,000 promissory note and a warrant for 2,158,274 common shares at an exercise price of $1.1824 per share. The note, sold for $5,760,000, carries 10% annual interest, matures 12 months after closing, and can become convertible at a discount to market prices if the company is late on payments, subject to ownership and Nasdaq 19.99% caps. PDS will also enter an at-the-market sales agreement with Yorkville Securities, LLC and has delivered notices to redeem its existing senior secured convertible debentures at 103% of principal plus interest on June 12, 2026, using cash.
PDS Biotechnology Corporation filed an amended annual report to add detailed Part III information on its board, executive team, compensation, ownership and auditor fees for the year ended December 31, 2025. The amendment does not change previously reported financial results.
The company reports aggregate market value of common equity held by non-affiliates of $60,145,221 as of June 30, 2025, and 55,815,653 common shares outstanding as of March 23, 2026. It describes a classified board structure, committee memberships, independence determinations, executive pay (including salary, options and severance terms), equity incentive and inducement plans, and KPMG LLP audit fees.
PDS Biotechnology Corporation amended its Form S-3 registration to register an aggregate initial offering price of $200,000,000 of common stock, preferred stock, debt securities, warrants, units and rights. The amendment updates Nasdaq market price information, removes a prior at-market sales agreement covering up to $20.0 million, files updated exhibits including a KPMG LLP consent, and makes related conforming changes to the prospectus.
The prospectus states the last reported Nasdaq sale price was $0.9281 per share and reports a public float of $73,989,796 based on 54,404,262 shares held by non-affiliates (price cited from April 15, 2026). Shares outstanding were 55,815,653 as of April 23, 2026.
PDS Biotechnology filed an 8-K to share an updated April 2026 corporate presentation highlighting its cancer immunotherapy pipeline. The deck focuses on lead HPV16-targeted drug PDS0101, which showed a median overall survival of 39.3 months in recurrent/metastatic head and neck cancer, compared with a 12–18 month benchmark for Keytruda-based regimens. In a prior Phase 2 study, PDS0101 plus pembrolizumab achieved a 77.4% disease control rate and a 35.8% overall response rate, with 21% of patients experiencing 90–100% tumor regression.
The company is running the VERSATILE‑003 pivotal Phase 3 trial in first-line HPV16‑positive recurrent/metastatic head and neck cancer, with FDA alignment on progression-free survival as an interim primary endpoint for an accelerated approval pathway. Beyond PDS0101, the presentation details tumor-targeting IL‑12 antibody-drug conjugate PDS01ADC in multiple Phase 2 trials across colorectal, prostate and liver-associated cancers, and outlines upcoming data readouts through 2027.
PDS Biotechnology Corporation reported positive interim results from Stage 1 of an NCI-led Phase 2 trial of its tumor-targeted IL‑12 immunocytokine PDS01ADC in metastatic colorectal cancer with liver metastases. In nine patients who had failed at least one prior chemotherapy line, adding PDS01ADC to hepatic artery infusion pump therapy produced a 78% objective response rate, compared with 35% in a parallel trial without PDS01ADC. The two-year survival rate exceeded 80%, versus about 35% in the parallel trial, in this largely immunotherapy‑resistant microsatellite stable or mismatch repair‑proficient population.
PDS Biotechnology Corporation files its annual report describing a clinical-stage immunotherapy pipeline focused on cancer and infectious disease. The company is built around its Versamune T cell activator, PDS01ADC IL‑12 antibody–drug conjugate, and Infectimune vaccine platform, with multiple Phase 2 and Phase 3 oncology trials underway, including the VERSATILE-003 head and neck cancer study.
PDS Biotech remains pre-revenue and reported a net loss of $34.5 million for the year ended December 31, 2025, slightly improved from $37.6 million in 2024. As of that date, it had $26.7 million in cash and cash equivalents and an accumulated deficit of $216.6 million, underscoring ongoing funding needs to support its development programs.
As of March 23, 2026, 55,815,653 common shares were outstanding, and the aggregate market value of non‑affiliate equity was $60.1 million as of June 30, 2025. Management highlights extensive intellectual property around its platforms, collaborations with institutions such as the National Cancer Institute and MD Anderson, and an experienced leadership team in oncology drug development.
PDS Biotechnology reported full-year 2025 results and detailed progress in its cancer immunotherapy pipeline. Net loss narrowed to $34.5 million, or $0.74 per share, from $37.6 million, or $1.03, in 2024 as operating expenses declined.
Research and development spending fell to $19.0 million and general and administrative expenses to $12.5 million, bringing total operating expenses down to $31.5 million. Cash and cash equivalents were $26.7 million at year-end, with total stockholders’ equity of $9.3 million and long-term debt of $11.7 million.
The company updated its PDS0101 Phase 3 VERSATILE-003 trial, incorporating progression-free survival as an interim primary endpoint, which it expects will shorten trial duration and reduce costs while keeping overall survival for full approval. PDS Biotech also highlighted new U.S. and Japanese patents that extend Versamune® platform protection into the 2040s.