Processa Pharmaceuticals Faces Strategic Shift as Licensing Deal Collapses

Processa Pharmaceuticals loses a major licensing deal for PCS12852, forfeiting up to $452.5M in potential milestone payments and royalties, forcing a strategic reassessment.

Processa Pharmaceuticals is reevaluating its development roadmap following the breakdown of exclusive licensing negotiations. The company's potential agreement with Intact Therapeutics for the drug candidate PCS12852 has been terminated, eliminating the prospect of substantial milestone payments. This development forces a strategic reassessment of the asset's future.

A Strategic Setback for Non-Oncology Funding

The company's strategy involves leveraging value from programs outside its core oncology focus to fund cancer therapy development. The failure to secure the licensing deal for PCS12852, a treatment for gastroparesis, represents a notable setback to this plan. The non-binding term sheet, which had been in place since June 2025, expired on February 12 without a final agreement being reached. Consequently, both parties are now released from their preliminary commitments.

Significant Financial Implications

The collapse of the negotiations carries direct financial consequences. Processa loses access to a previously outlined capital infusion. The terms under discussion included an option fee of $2.5 million and potential milestone payments totaling up to $452.5 million. Also forfeited are prospective royalties in the double-digit percentage range on global net sales and an intended 3.5 percent equity stake in Intact Therapeutics.

With these potential revenue streams now void, Processa must independently determine how to advance PCS12852. Management is currently examining whether to seek a new collaboration partner for the compound or to fund its continued development using internal resources.

Oncology Pipeline Progress Unaffected

Despite this setback in its non-core portfolio, Processa confirms that clinical studies within its primary oncology division continue unabated. The company's focus remains on advancing its core pipeline of cancer therapies. The immediate challenge lies in managing the financial and strategic impact of the licensing deal's failure, ensuring it does not derail the broader corporate mission.

The path forward for PCS12852 is now uncertain. The company's next steps regarding this asset will be closely watched by investors as Processa navigates this unexpected strategic shift.