Processa Pharmaceuticals Inc.

11/05/2026 | Press release | Distributed by Public on 11/05/2026 07:10

Material Event (Form 8-K)



Dear Processa Stockholder,
In July, Processa acquired Vidya Therapeutics and completed a concurrent private placement financing of approximately $200 million supported by leading institutional healthcare investors. This transaction established a new strategic direction for the company focused on advancing differentiated therapeutic programs for immunological and inflammatory (I&I) diseases, led by VT-7208, Vidya's lead investigational product candidate.
We believe this combination creates a meaningful opportunity for Processa and its stockholders: a lead clinical-stage program addressing large patient populations, a growing I&I pipeline, a clear development plan with multiple potential value-driving milestones, and financing expected to support the company through key development milestones. Since closing the transaction, we have begun to deliver against that plan, including advancing VT-7208 into Phase 2 development, expanding the company's pipeline and strengthening its leadership.
With this letter, we want to explain the opportunity, how we are funded to execute and what stockholders should expect next.
A Lead Program Addressing Significant Unmet Need

VT-7208 is an oral, once-daily investigational product candidate that inhibits Bruton's tyrosine kinase, or BTK. BTK is a protein involved in signaling within immune cells. When that signaling becomes dysregulated, it can contribute to autoimmune and inflammatory disease. BTK has already been clinically validated as a therapeutic target across several diseases.
VT-7208 was designed to reach both the immune system throughout the body and the central nervous system, which includes the brain and spinal cord. The company is initially advancing the product candidate in three conditions where there remains significant unmet medical need:
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Food Allergy: approximately 17 million people in the United States, including an estimated 3.6 million children, are affected by some form of food allergy. For many patients, management still relies heavily on avoiding allergens and being prepared to treat potentially serious reactions if exposure occurs.


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Chronic Spontaneous Urticaria (CSU): a chronic form of hives that can cause recurring itching, swelling and discomfort. An estimated 1.6 to 2 million people in United States are affected by CSU with a roughly two-to-one female predominance. The FDA has cleared the IND application for our planned Phase 2 clinical trial of VT-7208 in CSU, allowing us to move forward with the study in this large patient population.
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Relapsing Multiple Sclerosis (MS): a chronic autoimmune disease in which the immune system damages the central nervous system, potentially affecting movement, vision and other functions. Approximately 1 million people in the United States are estimated to have relapsing MS, and disease progression can continue despite available treatments.
These patient populations illustrate the large unmet need we are targeting and why we believe VT-7208 has substantial commercial potential if its profile is validated in clinical development.
A Clear Execution Roadmap

The July financing generated approximately $183.3 million in net proceeds and is expected to fund operations into the second half of 2029, including support for the previously disclosed Phase 2 proof-of-concept development plan across the three indications we are initially pursuing: food allergy, CSU and relapsing MS.
Beyond VT-7208, we are building a broader pipeline of differentiated therapies for immune-mediated diseases. Our second program is a novel, oral macrocyclic peptide-based neonatal Fc receptor, or FcRn, antagonist program being advanced through a research collaboration and exclusive option agreement with Generian Pharmaceuticals.
FcRn is a clinically validated target in autoimmune disease, and inhibition of this target is designed to reduce circulating IgG antibodies, including pathogenic antibodies that contribute to a number of autoimmune diseases. The preclinical data supports the development of differentiated oral therapeutic alternatives to injectable FcRn therapies and complements VT-7208 within our broader immunology pipeline.
Since the July transaction, we have continued to advance the company's strategy and build the leadership team for what comes next. Dr. Sheila Gujrathi has been appointed Executive Chair of the Processa Board, and we are adding four experienced biotechnology leaders to the team: Gregory J. Flesher as Chief Operating Officer; Craig Coburn, Ph.D., as Executive Vice President, Head of Research; Ashley Hall, J.D., as Executive Vice President, Development; and Michael P. Cruse as Executive Vice President, Business Operations.


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Mr. Flesher will play a central role in leading Processa through its next stage of growth, alongside a team with complementary strengths across discovery, development and operations. Dr. Coburn also brings a unique connection to our lead program as one of the scientists who helped invent VT-7208, giving the team deep continuity from the program's origins through its next stage of clinical development.
Understanding Processa's Expected Capitalization

The transaction changed Processa's expected capitalization. The table below summarizes the current common shares outstanding and the expected share count on an as-converted basis.
EXPECTED CAPITALIZATION
APPROXIMATE SHARES
Common shares currently outstanding
2.8 million
Series A preferred, as-converted to common*
306.5 million
Total common shares, as-converted
309.3 million
* Subject to stockholder approval and applicable beneficial ownership limitations. Excludes outstanding options, restricted stock units, warrants and any potential reverse stock split.
The approximately 2.8 million common shares currently trading represent only a small portion of the company's expected share count after conversion of the preferred stock. We believe the approximately 309.3 million-share as-converted figure provides a more complete picture of Processa's expected capital structure.
Over the course of the next few months, we will solicit stockholder approvals of several matters, including an approval to permit conversion of the Series A non-voting preferred stock that was issued in connection with the Vidya acquisition and private placement into shares of common stock, and several other proposals to support continued compliance with Nasdaq listing standards, an increase to our equity incentive plans to help the company recruit and retain qualified talent, and matters necessary to continue operating as a public company.
We will be holding two separate special meetings and soliciting two separate stockholder votes. The proxy materials for each special meeting will set forth the specific proposals, the Board's recommendations and the rationale for each recommendation, and detailed voting instructions. The definitive proxy materials for the first meeting were filed on October 22, 2026, and we have commenced mailing. Definitive proxy materials for the second special meeting are forthcoming. Once filed and delivered, we encourage stockholders to please read the definitive proxy materials carefully and in their entirety before voting. Stockholders will receive separate proxy materials for each special meeting and must vote separately at each: a vote cast at one special meeting will not count as, or substitute for, voting at the other.


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What To Expect From Us

Our focus is now on executing our broader I&I strategy: advancing the planned Phase 2 proof-of-concept programs for VT-7208, progressing our FcRn program, selectively expanding the pipeline, managing our capital responsibly and communicating clearly as the company progresses.
The Vidya transaction gave Processa a lead clinical-stage program, the foundation for a broader I&I pipeline, a defined development strategy and financing expected to support operations for the planned Phase 2 proof-of-concept clinical trials in all three initial indications. With our first regulatory milestone now achieved following FDA clearance of the IND for the planned Phase 2 clinical trial of VT-7208 in CSU and additional clinical milestones ahead with sufficient funds to advance our clinical trials towards such milestones, we believe stockholders have a clear framework for evaluating our progress.
We appreciate your continued support and look forward to keeping you informed.
Sincerely,
George Ng
Sheila Gujrathi, M.D.
Chief Executive Officer
Executive Chair
Processa Pharmaceuticals
Processa Pharmaceuticals Board of Directors



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Processa Pharmaceuticals Inc. published this content on November 05, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on November 05, 2026 at 13:13 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]