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Here are 1-3 brief analogies for Processa Pharmaceuticals (PCSA):

• An early-stage Bristol Myers Squibb, focused on developing new cancer and rare disease treatments.
• Like a specialized, clinical-stage Pfizer for rare and debilitating diseases.
• A biotech startup developing novel cancer therapies, akin to a young Amgen or Genentech.

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• PCS6422: An investigational drug designed to enhance the effectiveness and reduce the toxicity of fluoropyrimidine-based chemotherapy by inhibiting the DPD enzyme.
• PCS499: An investigational drug candidate focused on the prevention and treatment of chemotherapy-induced peripheral neuropathy (CIPN).
• PCS11T: An orally administered investigational drug targeting symptomatic peripheral neuropathy, including diabetic neuropathy.
• PCS3117: An investigational drug candidate for the treatment of pancreatic cancer and other solid tumors, acting as a next-generation angiogenesis inhibitor.

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Processa Pharmaceuticals (PCSA) is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds. As such, it does not currently have major commercial customers from the sale of pharmaceutical products. The company's primary activities are research, development, and conducting clinical trials for its drug candidates.

However, if and when Processa Pharmaceuticals successfully develops and commercializes its drug candidates, it would primarily sell to other companies involved in the healthcare and pharmaceutical supply chain. These potential future major customers would typically include:

• Pharmaceutical Distributors: Companies like McKesson Corporation (MCK), AmerisourceBergen Corporation (ABC), and Cardinal Health, Inc. (CAH) that handle the logistics and distribution of pharmaceutical products to pharmacies and hospitals.
• Hospitals and Healthcare Systems: Large institutional buyers that purchase drugs for patient administration within their facilities.
• Pharmacy Chains: Such as CVS Health (CVS) and Walgreens Boots Alliance (WBA), which dispense prescription drugs to individuals.

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George Ng Chief Executive Officer

Mr. Ng is a seasoned life sciences industry executive and a Partner at PENG Life Science Ventures (PENG LSV). He co-founded and served as President of Scilex Pharmaceuticals, Inc. (now Scilex Holding Co), leading the company through development, clinical trials, FDA approval, a $140 million financing, commercial launch of its first FDA-approved drug product, and ultimate company sale. He has held various senior management positions, including Board Director, Managing Director, Chief Administrative Officer, Chief Business Officer, Corporate Secretary, Chief Legal Officer, General Counsel, Chief Compliance Officer, and Chief Intellectual Property Counsel, with publicly-traded and private biotechnology and pharmaceutical companies such as Sorrento Therapeutics, Inc., BioDelivery Sciences International, Inc., Spectrum Pharmaceuticals, Inc., and Alpharma, Inc. (now part of Pfizer Inc.). Mr. Ng was also a partner in two AMLAW 200 law firms.

Russell L. Skibsted Chief Financial Officer

Mr. Skibsted brings nearly 30 years of experience in the pharmaceutical industry, including expertise in financial management, global business development, capital markets, investor relations, and operations, having worked with public and private life sciences companies at all stages of development. Most recently, he served as Senior Vice President and CFO of Alimera Sciences, a publicly traded, global ophthalmic pharmaceuticals company, which is in the process of being acquired by ANI Pharmaceuticals. Previously, he was Executive Vice President, CFO, and Chief Business Officer at Rockwell Medical. Mr. Skibsted also served as CFO of BioTime (now Lineage Cell Therapeutics) and several of its public and private subsidiaries. Earlier in his career, he was a Portfolio Management Partner and CFO at Asset Management Company, a venture capital firm in Silicon Valley.

David Young, Pharm.D., Ph.D. President of Research & Development and Founder

Dr. Young has over 30 years of pharmaceutical research, drug development, and corporate experience. He was a Founder and CEO of Promet Therapeutics, LLC. Dr. Young also founded and served as CEO of GloboMax LLC, a CRO specializing in FDA drug development, which was purchased by ICON plc in 2003. From 2009 to 2014, he was Chief Scientific Officer of Questcor Pharmaceuticals (acquired by Mallinckrodt Pharmaceuticals in 2014), where he was instrumental in modernizing the Acthar Gel label and obtaining FDA approval in Infantile Spasms. During his involvement, Questcor transitioned from near bankruptcy to a valuation of approximately $5.6 billion.

Sian Bigora, Pharm. D. Chief Development Officer

Dr. Bigora has over 20 years of pharmaceutical research, regulatory strategy, and drug development experience. She was a Co-Founder, Director, and Chief Development Officer at Promet Therapeutics, LLC. Prior to Promet, Dr. Bigora was Vice President of Regulatory Affairs at Questcor Pharmaceuticals (acquired by Mallinckrodt Pharmaceuticals in 2014) from 2009-2015, where she led efforts on modernizing the Acthar Gel label and obtaining FDA approval in Infantile Spasms. Her experience also includes various regulatory affairs, operations, and project management roles at ICON, plc, and GloboMax LLC, and she operated her own consulting company as a regulatory and drug development expert.

Wendy Guy Chief Administrative Officer and Founder

Ms. Guy possesses more than 20 years of experience in business operations and has worked closely with Dr. Young for over 18 years in corporate management, operations, HR, and finance. She was a Co-Founder, Director, and Chief Administrative Officer of Promet Therapeutics, LLC. Before Promet, Ms. Guy was Senior Manager, Business Operation at Questcor Pharmaceuticals (acquired by Mallinckrodt Pharmaceuticals in 2014). She also held senior-level positions with the Strategic Drug Development Division of ICON, GloboMax, and Mercer Management Consulting.

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The key risks to Processa Pharmaceuticals (PCSA) are primarily centered around its financial viability, the success of its clinical pipeline, and its compliance with listing requirements.

1. Financial Instability and Going Concern: Processa Pharmaceuticals faces a significant existential threat due to ongoing losses, rapid cash burn, and a lack of revenue, which raises substantial doubt about its ability to continue as a going concern. The company is described as being "fueled entirely by investor belief, and crucially by fresh capital injections". This reliance on external funding creates a high potential for diluted funding, with new shares expected to be issued if the cash runway is short.
2. Clinical Trial Binary Outcome Risk: As a clinical-stage biopharmaceutical company with no current revenue, the future value of Processa Pharmaceuticals is almost entirely dependent on the success of its lead drug candidate, NGC-Cap. A key data readout from its Phase 2 trial for NGC-Cap, expected in January 2026, is considered a "binary catalyst," meaning its outcome will largely determine the market's perception and the company's long-term viability.
3. Nasdaq Delisting Risk: Processa Pharmaceuticals has received notification from Nasdaq regarding its failure to meet the minimum bid price requirement of $1.00 per share. The company has a 180-day grace period, ending on August 4, 2025, to regain compliance. Failure to do so could lead to delisting from The Nasdaq Capital Market, which would severely impact its ability to raise capital and its public visibility.

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The increasing shift in oncology towards highly targeted therapies, immunotherapies, and antibody-drug conjugates (ADCs) for cancers such as metastatic colorectal cancer and breast cancer. This trend threatens to diminish the market and clinical relevance of broad-spectrum chemotherapy regimens, including those based on fluoropyrimidines (like 5-FU), which Processa Pharmaceuticals' lead candidate PCS6422 is designed to enhance. As more effective and precise treatments become standard, the need to optimize older chemotherapy agents may decrease significantly, potentially reducing the addressable market and utility of PCSA's pipeline products focused on improving existing chemotherapies.

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Processa Pharmaceuticals (PCSA) focuses on developing drug products for serious medical conditions. The addressable markets for their main product candidates are as follows:

• PCS499:
  • Necrobiosis Lipoidica (NL): The global necrobiosis lipoidica market is estimated to be valued at USD 5.1 billion in 2025 and is projected to reach USD 9.1 billion by 2035, growing at a compound annual growth rate (CAGR) of 6.0%. Another estimate places the global NL treatment market at USD 150 million in 2023. The ulcerated necrobiosis lipoidica management market is projected to be valued at USD 4,946.6 million in 2025 and is anticipated to reach USD 8,611.2 million by 2035, reflecting a CAGR of 5.7%.
  • Focal Segmental Glomerulosclerosis (FSGS): The global Focal Segmental Glomerulosclerosis (FSGS) market was valued at USD 573.50 million in 2023 and is projected to reach USD 1010.84 million by 2032, growing at a CAGR of 6.50%. Another report indicates the FSGS market is projected to expand from USD 1.98 billion in 2024 to USD 2.13 billion in 2025, and is expected to reach USD 3.69 billion by 2032, at a CAGR of 8.07%. The FSGS therapeutic industry is valued at USD 3.31 billion in 2025 and is expected to reach USD 5.39 billion by 2035, growing at a CAGR of 5%. In the top 7 markets (US, EU4, UK, and Japan), the FSGS market reached USD 349.9 million in 2024 and is expected to reach USD 618.0 million by 2035, exhibiting a CAGR of 5.32%.
• PCS6422 (NGC-Cap) for Metastatic Colorectal Cancer and Metastatic Breast Cancer:
  • Metastatic Breast Cancer: The global metastatic breast cancer treatment market was valued at USD 20.08 billion in 2024 and is expected to reach USD 34.69 billion in 2029 at a CAGR of 11.5%. Other reports valued the global market at USD 17.13 billion in 2021, projected to reach USD 41.74 billion by 2030 with a CAGR of 10.4%. Another report estimates the global metastatic breast cancer market was valued at US$ 17 billion in 2021 and is expected to reach US$ 39.43 billion by 2030, registering a CAGR of 9.8%.
  • Metastatic Colorectal Cancer: The global metastatic colorectal cancer (mCRC) market was valued at US$ 5,662.9 million in 2023 and is forecasted to expand at a CAGR of 5.1% to reach US$ 9,787.5 million by 2034. Another source estimates the global market at USD 10.95 billion in 2025, expected to reach USD 19.13 billion by 2032, growing at a CAGR of 8.3%.
• PCS12852 for Gastroparesis: The global gastroparesis treatment market size was valued at USD 6.63 billion in 2024 and is predicted to increase to approximately USD 10.45 billion by 2034, expanding at a CAGR of 4.65%. Another report estimates the global gastroparesis treatment market to be valued at USD 8.33 billion in 2025 and is expected to reach USD 11.58 billion by 2032, exhibiting a CAGR of 4.8%. The global gastroparesis drugs market size was valued at USD 4.6 billion in 2023 and is expected to grow at a CAGR of 4.6% from 2024 to 2030.
• PCS11T (NGC-Irinotecan) for Various Cancers (Colorectal, Small Cell Lung, Pancreatic):
  • Colorectal Cancer (general therapeutics): The global colorectal cancer therapeutics market was valued at USD 12.79 billion in 2024 and is projected to reach USD 19.95 billion by 2034, at a CAGR of 4.55%. Another estimate places the global colorectal cancer therapeutics market at USD 11.5 billion in 2022, expected to grow to USD 16.7 billion in 2030 at a CAGR of 4.7%.
  • Small Cell Lung Cancer: The global small cell lung cancer therapeutics market size is estimated at USD 6.46 billion in 2024, grew to USD 7.25 billion in 2025, and is predicted to surpass around USD 20.6 billion by 2034, expanding at a CAGR of 12.30%. The global market for small-cell lung cancer (SCLC) drugs is expected to become USD 9.1 billion by 2033, expanding at a CAGR of 18.5%.
  • Pancreatic Cancer: The global pancreatic cancer market size is calculated at USD 3.25 billion in 2025 and is projected to surpass around USD 10.25 billion by 2034, growing at a CAGR of 13.62%. Another report estimates the pancreatic cancer market to be valued at USD 2.7 billion in 2025 and is projected to reach USD 9.7 billion by 2035, registering a CAGR of 13.5%.

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Processa Pharmaceuticals (PCSA), a clinical-stage biopharmaceutical company, anticipates its future revenue growth over the next 2-3 years to be driven by the advancement and potential monetization of its drug pipeline. As the company currently has no commercialized products, these drivers are centered on successful clinical development, regulatory milestones, and strategic collaborations.

Here are 3-5 expected drivers of future revenue growth:

1. Progression and Potential Commercialization/Licensing of NGC-Cap (PCS6422): NGC-Cap, Processa's lead oncology asset, is actively enrolling patients in a Phase 2 study for metastatic breast cancer, with initial data expected in the second half of 2025. Positive clinical outcomes and subsequent regulatory advancements or licensing agreements for this candidate are crucial for future revenue generation.

2. Development of NGC-Iri (PCS11T): This preclinical oncology asset, designed to enhance drug concentration in tumors while minimizing systemic toxicity, is undergoing further preclinical and clinical development. Defining its optimal therapeutic window and demonstrating efficacy could lead to a valuable asset for future commercialization or partnership opportunities.

3. Strategic Partnerships and Licensing Agreements for Pipeline Assets: Processa has a stated strategy of "unlocking hidden asset value through partnerships". An example is the binding term sheet granting an exclusive option to license PCS12852 for gastroparesis and related gastrointestinal motility disorders, which includes potential milestone payments and royalties on future sales. Further such agreements for other pipeline candidates would directly contribute to future revenue.

4. Advancement of NGC-Gem: Processa is evaluating NGC-Gem for its potential in pancreatic and other cancers, with an FDA meeting planned for late 2024/early 2025. Successful progression of NGC-Gem through early clinical stages would enhance the company's pipeline value and could lead to future investment or partnership opportunities, ultimately paving the way for revenue.

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Share Issuance

• In January 2025, Processa Pharmaceuticals raised $4.5 million in net proceeds from a public offering, which had gross proceeds of $5 million and involved the issuance of 8,050,672 shares of common stock along with Series A and Series B warrants.
• In June 2025, Processa announced a public offering of 28,000,000 shares of common stock (or pre-funded warrants) with common warrants, expecting gross proceeds of $7 million.
• The company completed a 1-for-20 reverse stock split in January 2024, decreasing issued common stock from 24,706,474 shares to 1,291,000 shares and outstanding common stock from 24,606,474 to 1,286,000 shares.

Inbound Investments

• Processa Pharmaceuticals secured an undisclosed strategic investment in August 2025.
• In November 2025, CVI Investments Inc., managed by Heights Capital, disclosed a passive stake of 5,000,000 shares (approximately 9%) of PCSA common stock, including warrants.
• In February 2021, Processa announced a private investment in public equity (PIPE) financing, raising $10.2 million through the sale of 1,321,132 shares at $7.75 each to institutional and accredited investors.

Outbound Investments

• In July 2025, Processa signed a binding term sheet granting Intact Therapeutics an exclusive option to license PCS12852. Under this agreement, Processa is eligible for up to $454 million in milestone payments, a 12% royalty on future sales, and a 3.5% equity stake in Intact Therapeutics.

Capital Expenditures

• Research and development expenses increased to $7.3 million in 2024 from $5.8 million in 2023, primarily due to higher costs associated with ongoing clinical trials and regulatory filings for NGC-Cap.
• The company plans to use net proceeds from offerings, such as the June 2025 $7 million offering, to continue its Phase 2 clinical trial for NGC-Cap and for general corporate purposes and working capital.
• Processa is designing a new adaptive pivotal Phase III study for PCS499 in rare kidney diseases.