Processa Pharmaceuticals Inc (PCSA) News & EventsPCSAProcessa Pharmaceuticals Inc

Processa Acquires Vidya and Secures $200 Million Financing

Processa Pharmaceuticals announced it has acquired Vidya Therapeutics. Concurrent with the acquisition, Processa entered into a definitive agreement for a private placement financing expected to result in gross proceeds of approximately $200M, before deducting placement agent and other offering expenses, from a syndicate of new and existing investors, including Bain Capital Life Sciences, Janus Henderson Investors, RA Capital Management, SilverArc Capital, ADAR1 Capital Management, Cormorant Asset Management, Integral Health Asset Management, Marshall Wace, Octagon Capital, Soleus Capital, a large mutual fund, and other institutional investors. Processa expects to use the proceeds to support the advancement of VT-7208 through multiple clinical milestones, including data from a Phase 2 proof-of-concept study in food allergy anticipated in the second half of 2027, data from a Phase 2 proof-of-concept study in CSU anticipated in the first half of 2028, and data from a Phase 2 proof-of-concept study in RMS anticipated in the second half of 2028. The company's cash and cash equivalents at closing, including gross proceeds expected from the concurrent private placement financing, are expected to fund operations into the second half of 2029. The acquisition is structured as a stock-for-stock transaction, pursuant to which all outstanding equity interests of Vidya will be exchanged based on a fixed exchange ratio for a combination of 558,398 shares of Processa common stock, 142,744.100 shares of Series A non-voting convertible preferred stock. Concurrent with the acquisition, Processa entered into a definitive agreement for a private placement financing to raise approximately $200 million in gross proceeds, in which the investors will be issued 163,774.679 shares of Series A non-voting convertible preferred stock at a price of $1,221.19 per share. The private placement is expected to close on July 30, 2026. Subject to Processa stockholder approval in accordance with Nasdaq listing rules, each share of Series A non-voting convertible preferred stock will automatically convert into 1,000 shares of Processa common stock, subject to certain beneficial ownership limitations set by each holder. The acquisition was approved by the Board of Directors of Processa and the Board of Directors and stockholders of Vidya. The closings of the acquisition and the private placement are not subject to the approval of Processa's stockholders. The approval of Processa's stockholders is required, among other things, under the terms of the Series A non-voting convertible preferred stock in order for the Series A non-voting convertible preferred stock to be converted into shares of Processa's common stock, and Processa is required to hold a stockholder meeting for such vote. As a result of the transactions, stockholders of Processa immediately prior to the acquisition will own approximately 0.9% of Processa's common stock, equity holders of Vidya immediately prior to the acquisition will own approximately 46.0% of Processa common stock and investors in the private placement financing will own approximately 52.6% of Processa common stock, in each case, calculated on a fully-diluted basis (without giving effect to any beneficial ownership limitations and assuming the conversion in full of the Series A non-voting convertible preferred stock) and based on the implied equity values of Processa and Vidya. Following the closing of the private placement, Processa is expected to have projected cash runway into the second half of 2029.

Processa Completes Enrollment of 20 Patients for NGC-Cap Clinical Study

Processa Pharmaceuticals reported that it completed the enrollment and dosing of the 20 patients required for the planned formal interim analysis in its ongoing Phase 2 clinical study evaluating NGC-Cap, Processa's proprietary combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer. "This is an important milestone because it allows us to assess whether NGC-Cap can demonstrate a meaningful improvement over capecitabine monotherapy in both safety and efficacy for patients who have already undergone multiple prior cancer treatments.," said George Ng, CEO of Processa Pharmaceuticals. The randomized, FDA-recommended Phase 2 study is designed to compare NGC-Cap with standard-of-care capecitabine monotherapy in patients with advanced or metastatic breast cancer. Patients enrolled in the study were required to have received at least one prior cancer treatment, with a median of two to three prior treatment regimens across the enrolled population. The formal interim analysis will compare safety and preliminary efficacy outcomes between the NGC-Cap and Mono-Cap treatment arms and is expected to be completed in the first quarter of 2026. Key objectives of the interim analysis include: Evaluating the comparative safety and efficacy of NGC-Cap versus Mono-Cap; Determining whether a higher or lower dose of NGC-Cap should be added as a third study arm; Assessing whether the overall sample size of the Phase 2 study should be adjusted based on interim findings.

Processa Pharmaceuticals Updates on NGC-Cap Clinical Trial Progress

Processa Pharmaceuticals provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer. Data from the first 16 of 19 patients enrolled indicate that NGC-Cap significantly increases exposure to capecitabine cancer-killing drug metabolites without increasing the severity of side effects compared to standard monotherapy capecitabine therapy. This profile suggests the potential for improved clinical efficacy while maintaining manageable safety, a key objective of Processa's NGC platform. The full interim analysis from the first 20 patients enrolled in the study, which will include efficacy and safety data, is expected in early 2026.