Processa inks licensing deal with Intact for gastroparesis drug

HANOVER, Md. - Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a micro-cap biotech company currently trading at $0.23 per share with a market capitalization of $2.68 million, has entered into a binding term sheet with Intact Therapeutics, Inc. for an exclusive option to license PCS12852, a 5-HT4 receptor agonist developed for gastroparesis and other gastrointestinal motility disorders. According to InvestingPro analysis, the company maintains a strong liquidity position with more cash than debt on its balance sheet.

Under the agreement announced Tuesday, Processa is eligible to receive a $2.5 million option exercise fee, up to $20 million in development and regulatory milestone payments, and over $432.5 million in commercial milestone payments based on net product sales. Intact will also pay Processa a double-digit royalty on worldwide net sales of licensed products, excluding South Korea, and provide Processa with an equity stake in Intact upon closing. This deal comes at a crucial time for Processa, as InvestingPro data shows the company has been rapidly burning through cash, with a current ratio of 2.93x providing some near-term stability.

Processa must share 60% of any cash payments with its licensor under existing agreements, excluding the equity stake in Intact.

"This agreement is another example of how we can unlock the value of our non-oncology assets while remaining focused on our mission of developing next-generation cancer therapies," said George Ng, CEO of Processa, in the press release. The strategic move comes as the company’s stock has experienced significant pressure, down nearly 88% over the past year. Get deeper insights into Processa’s financial health and 12 additional ProTips with InvestingPro.

PCS12852 has completed a Phase 2a trial that demonstrated safety, tolerability, and efficacy signals in patients with diabetic gastroparesis, a condition affecting gastric motility with limited treatment options.

Ravi Pamnani, CEO and Co-Founder of Intact Therapeutics, stated that PCS12852’s "clinical data in improving gastric motility and clean safety profile make it an ideal candidate to add to our GI portfolio."

The exclusive license will become effective upon completion of definitive agreements and satisfaction of closing conditions, including an amendment of the license agreement between Processa and its licensor.

Intact Therapeutics is a clinical-stage biopharmaceutical company that originated as a spinout from Stanford University, focusing on gastrointestinal disease treatments.

In other recent news, Processa Pharmaceuticals has presented significant updates at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The company showcased three abstracts focusing on their Next Generation Cancer drug candidates, PCS6422 and PCS11T, which aim to enhance efficacy and safety in cancer treatment. A key highlight was the ongoing Phase 2 adaptive design trial for PCS6422, targeting advanced or metastatic breast cancer. This trial combines eniluracil and capecitabine to explore optimal dosing and personalized medicine strategies. Additionally, two abstracts provided insights into the Phase 1b trial of PCS6422, establishing the Maximum Tolerated Dose and Recommended Phase 2 Dose Range, and a preclinical study on PCS11T, designed to improve tumor targeting while reducing systemic toxicity. Dr. David Young, the company’s Founder and President of Research & Development, emphasized the importance of these advancements in addressing unmet needs in cancer therapy. Processa Pharmaceuticals is focused on modifying existing FDA-approved oncology therapies to improve their metabolism and distribution. The company advises investors to consider potential risks and uncertainties outlined in their SEC filings.

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