Processa Pharmaceuticals has announced a significant licensing agreement with Intact Therapeutics for PCS12852, a promising gastroparesis treatment that could address substantial unmet medical needs in gastrointestinal motility disorders. The binding term sheet grants Intact exclusive option rights to license the Phase 2a-stage drug candidate, with total milestone payments potentially reaching $452.5 million.
Deal Structure and Financial Terms
Under the agreement terms, 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 double-digit royalties on worldwide net sales of licensed products, excluding South Korea, and provide a 3.5% equity stake in Intact upon closing.
The financial arrangement includes a revenue-sharing component, with Processa required to share 60% of any cash payments with its licensor, excluding the equity stake in Intact. This structure reflects the underlying licensing obligations that Processa maintains for the asset.
Clinical Profile and Therapeutic Potential
PCS12852 is a selective 5-HT4 receptor agonist that completed a Phase 2a trial demonstrating strong safety, tolerability, and efficacy signals in patients with diabetic gastroparesis. The drug candidate is designed to restore normal gastric emptying without the cardiovascular and central nervous system side effects associated with older agents in this therapeutic class.
Gastroparesis represents a debilitating condition affecting gastric motility with limited treatment options and high unmet medical need. The condition significantly impacts patient quality of life, making PCS12852's clinical profile particularly valuable for addressing this therapeutic gap.
Strategic Rationale and Company Positioning
"This agreement is another example of how we can unlock the value of our non-oncology assets while remaining laser-focused on our mission of developing next-generation cancer therapies," said George Ng, CEO of Processa. The company views Intact's innovative delivery platform and GI-focused strategy as ideal for advancing PCS12852 toward commercialization.
Ravi Pamnani, CEO and Co-Founder of Intact Therapeutics, emphasized the strategic fit: "At Intact, we are building a company around the idea that there remain significant unmet clinical needs in GI — not only to treat disease but also to radically improve patient quality of life. PCS12852's strong clinical data in improving gastric motility and clean safety profile make it an ideal candidate to add to our GI portfolio."
Scientific Validation and Expert Perspective
Lorin K. Johnson, Ph.D., Board Member and Scientific Advisor to Intact Therapeutics, highlighted the drug's therapeutic potential: "The safety profile and high selectivity of PCS12852 make it a promising therapeutic option for patients with a wide range of GI motility disorders. The partnership between Intact and Processa will provide strategic alignment and shared upside to create value for both companies."
The drug's selectivity for the 5-HT4 receptor represents a potentially best-in-class approach for treating gastroparesis and other gastrointestinal disorders, with clinical data supporting its differentiated profile compared to existing therapeutic options.
Company Backgrounds and Development Pipeline
Intact Therapeutics operates as a clinical-stage biopharmaceutical company pioneering next-generation therapies for gastrointestinal disease, including products leveraging its proprietary thermal hydrogel technology. The company spun out of Stanford University and has secured backing from investors including Y Combinator, Encube Ethicals, and Brightstone Capital, along with non-dilutive grants from the NIH, NSF, and California Institute of Regenerative Medicine.
Processa Pharmaceuticals focuses on developing Next Generation Cancer drugs with improved safety and efficacy, utilizing modifications of existing FDA-approved oncology therapies. The company's strategy involves altering the metabolism and distribution of proven cancer-killing molecules while maintaining their therapeutic mechanisms.
Implementation Timeline
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. This licensing deal represents a significant milestone for both companies in addressing unmet needs in gastrointestinal medicine while providing Processa with substantial financial upside from its non-oncology asset portfolio.
