Business

PDS Biotech raises up to USD 22.55m to advance IL-12 immunotherapy toward Phase III in CRC

PDS Biotech raises up to USD 22.55m to advance IL-12 immunotherapy toward Phase III in CRC

New Jersey-based PDS Biotechnology Corporation (Nasdaq: PDSB) has raised up to USD 22.55 million in a private investment in public equity (PIPE) transaction to advance its tumor-targeted interleukin-12 immunocytokine PDS0301 (also known as PDS01ADC or NHS-IL12) into late-stage clinical development, with the deal structured around promising Phase II data in a form of colorectal cancer that has historically resisted immunotherapy.

Nant Capital, LLC led the financing, with participation from existing investors. As part of the transaction, Nant Capital will have the right to designate two board members, one of whom will be Dr. Patrick Soon-Shiong, founder of NantWorks, for as long as Nant Capital beneficially owns 15% or more of the company's outstanding common stock. The PIPE is structured in two tranches: an initial closing expected around September 11, 2026, raising approximately USD 11.55 million, and a contingent milestone closing of USD 11 million — USD 10 million from Nant Capital and USD 1 million from AB Group Ltd. — triggered by submission of a registrational Phase III protocol for PDS0301 to the US FDA. PDS Biotechnology said it intends to use net proceeds to repay outstanding debt and fund working capital, clinical development, and general corporate purposes. As additional consideration, the company granted NantWorks, LLC, a Nant Capital affiliate, a one-year exclusive right to negotiate an exclusive license to PDS0101, its HPV16-targeted therapeutic cancer vaccine — consistent with the company's stated strategy of seeking external partners to fund PDS0101's Phase III development rather than self-financing it.

The financing follows a series of capital raises including a USD 22 million registered direct offering in February 2025 and a USD 6 million promissory note with Yorkville Advisors in June 2026, which was used to retire prior convertible debentures. PDS0301 itself was in-licensed from Merck KGaA in January 2023 under an exclusive global agreement carrying up to USD 105 million in commercial milestones and a 10% royalty on net sales.

The clinical case for PDS0301 centers on microsatellite stable (MSS) and mismatch repair-proficient (pMMR) metastatic colorectal cancer with liver metastases, a population with median overall survival of less than 12 months and limited response to existing immunotherapy. In a National Cancer Institute-led Phase II trial, PDS0301 added to standard-of-care therapy in 22 patients was reported to be well tolerated, with 80% of patients surviving at least 24 months. The NCI has also reported preliminary Phase II data for PDS0301 in third-line metastatic castration-resistant prostate cancer. PDS0301 is designed to concentrate IL-12 within the tumor microenvironment by binding DNA-histone complexes exposed in necrotic tumor tissue, limiting the systemic toxicity that historically made free IL-12 clinically unworkable.

The AllSci BriefFree, systematic R&D and deal news. Daily.

PDS0101 (Versamune HPV), the company's second clinical asset, is the focus of the Phase III VERSATILE-003 trial in first-line HPV16-positive head and neck squamous cell carcinoma. The company reached FDA alignment on progression-free survival as the primary endpoint for that trial in January 2026, with an amended protocol adopted the following month to support a potential accelerated approval pathway.

PDS0101 (Versamune HPV), the company’s HPV16-targeted cancer vaccine, had been in the Phase III VERSATILE-003 trial in first-line HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma. PDS discontinued the trial in August 2026 as part of a strategic refocus on PDS0301 and said it would seek a partner or other externally funded path for PDS0101. Earlier in 2026, the company had reached FDA alignment on progression-free survival as an interim primary endpoint that could potentially support accelerated approval.


Access the AllSci platform to explore the science behind the news.


Spot something wrong? Report an issue with this article