Processa Pharmaceuticals
Processa Pharmaceuticals is a pre-revenue, clinical-stage biopharmaceutical company that licenses and develops drug candidates for oncology and rare diseases using regulatory science expertise, planning to out-license assets to larger partners before or after pivotal studies.
- Company typePublic
- Founded2015
- HeadquartersHanover, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Processa Pharmaceuticals does
Processa Pharmaceuticals, Inc. (NASDAQ: PCSA) is a clinical-stage biopharmaceutical company headquartered in Hanover, Maryland, founded in 2015 by David Young, Sian Bigora, Wendy Guy, and Patrick Lin — veterans of Questcor Pharmaceuticals and Promet Therapeutics. The company develops drug candidates for oncology and other high unmet medical need diseases using a "regulatory science" approach: acquiring de-risked, clinical-stage assets from third-party licensors and applying the leadership team's cumulative 30+ years of FDA experience to design efficient approval pathways. Processa's pipeline consists of four licensed candidates: NGC-Cap (PCS6422 combined with capecitabine) for metastatic breast and colorectal cancer, where Phase 2 interim data showed up to 10x reduction in toxic catabolites; PCS499 for ulcerative necrobiosis lipoidica and Phase 2/3 FSGS; PCS12852 for gastroparesis (subject to a binding term sheet granting Intact Therapeutics an exclusive licensing option); and PCS11T for oncology applications.
The underlying technology is pharmaceutical rather than computational: NGC-Cap is a combination therapy in which PCS6422 modulates capecitabine metabolism to increase exposure to active anti-cancer metabolites while reducing toxic byproducts (FBAL). Processa's competitive differentiation is positioned as regulatory and operational expertise rather than novel molecular discovery, with the team claiming involvement in 100+ FDA meetings and 30+ drug approvals across prior roles at Questcor, Scilex, Alimera, and ICON.
Processa is pre-revenue with no commercial products and generates $0 in current revenue. Its business model is asset-light and partnership-driven: the company funds clinical development through small sequential public equity offerings (approximately $19M raised across three offerings in January 2024, January 2025, and June 2025), advances candidates to value-inflection milestones, and intends to out-license programs either before or after pivotal studies to larger pharmaceutical companies for commercialization. End-patient customers (cancer, NL, gastroparesis, and FSGS patients) are not yet reached directly; commercial counterparties are limited to licensing partners, with Intact Therapeutics representing the only announced out-licensing relationship to date. Marketing is conducted through SEC filings, press releases, and participation in healthcare conferences including BIO International Convention 2025 and the J.P. Morgan Healthcare Conference.
Processa Pharmaceuticals firmographics
Firmographics- Name
- Processa Pharmaceuticals
- Legal name
- Processa Pharmaceuticals, Inc.
- Website
- https://processapharmaceuticals.com
- Company type
- Public
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Processa Pharmaceuticals is a pre-revenue, clinical-stage biopharmaceutical company that licenses and develops drug candidates for oncology and rare diseases using regulatory science expertise, planning to out-license assets to larger partners before or after pivotal studies.
- Ownership category
- akta.pro rank
Processa Pharmaceuticals industry classification
Industry- Product category
- Clinical-stage biopharmaceutical drug development
- NAICS
- Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417)
- SIC
- Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE)
- akta.pro secondary industries
- Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH), CMC & Pharmaceutical Development (Formulation/Process/Analytical Development) (HLAIALAD)
Keywords
Where Processa Pharmaceuticals is headquartered
LocationHeadquarters
- HQ city
- Hanover
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Processa Pharmaceuticals business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Others
Revenue model
- Drug Licensing/Out-licensing: As a development-stage pharmaceutical company, Processa plans to out-license its drug candidates either just before or after pivotal studies. The company develops drugs and then identifies partners for commercialization.
- Future Product Sales: Pre-commercial stage company with no current revenue. Future revenue expected from pharmaceutical product sales upon FDA approval.
Go-to-market motion3 records
Distribution channels1 record
Marketing channels6 records
Processa Pharmaceuticals product offering
Product offeringCore offering
Processa Pharmaceuticals is a clinical-stage biopharmaceutical company that acquires and develops de-risked drug candidates for oncology and rare diseases with high unmet medical needs. The company leverages 30+ years of regulatory science expertise to advance pipeline assets through FDA approval, with plans to out-license candidates either before or after pivotal studies to larger pharmaceutical partners for commercialization.
Product overview
Processa Pharmaceuticals is a clinical-stage pharmaceutical company focused on developing Next Generation Chemotherapy (NGC) drugs and treatments for high unmet medical needs. The company's product portfolio includes NGC-Cap (a combination of PCS6422 and capecitabine for breast cancer), PCS499 for Ulcerative Necrobiosis Lipoidica and FSGS, PCS12852 for gastroparesis, and PCS11T for cancer treatment. Processa uses a regulatory science approach to de-risk drug development by acquiring clinical-stage assets and leveraging prior research to efficiently navigate FDA approval.
Differentiator
Problem solved
Functional benefit
Products and services
- NGC-Cap (PCS6422 + Capecitabine) Next Generation Chemotherapy (NGC) combination therapy pairing Processa's proprietary PCS6422 with capecitabine, designed to make standard chemotherapy safer and more effective for patients with advanced or metastatic breast and colorectal cancer.
- PCS499
Quantifiable outcome
- Phase 2 NGC-Cap treatment showed up to 10x reduction in toxic FBAL catabolites while maintaining comparable safety to standard capecitabine monotherapy
- +2 more outcomes
Companies that use Processa Pharmaceuticals
Customer profileSegments4 records
Ideal customer profiles2 records
Processa Pharmaceuticals technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Processa Pharmaceuticals partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered minor, strategic and core.
- J.P. Morgan Healthcare ConferenceminorProcessa Pharmaceuticals attended the 44th Annual J.P. Morgan Healthcare Conference to engage potential partners and investors.
- Intact TherapeuticsstrategicProcessa signed a binding term sheet granting Intact Therapeutics an exclusive option to license the Phase 2 gastroparesis drug candidate (PCS12852).
- BIO International Convention 2025minorProcessa participated in BIO International Convention 2025 to engage potential partners and investors.
- Elion Oncology, Inc.coreProcessa licensed PCS6422 from Elion Oncology, Inc. This is a core asset in their NGC (Next Generation Chemotherapy) pipeline for cancer treatment.
- CoNCERT Pharmaceuticals, Inc.coreProcessa licensed PCS499 from CoNCERT Pharmaceuticals, Inc. This drug candidate is being developed for ulcerative necrobiosis lipoidica and FSGS (Focal Segmental Glomerulosclerosis).
- Yuhan CorporationcoreProcessa licensed PCS12852 from Yuhan Corporation for gastroparesis and GI motility treatment development.
- Aposense, LTDcoreProcessa licensed PCS11T from Aposense, LTD for oncology applications.
Scale indicators11 records
Recent moves6 records
Expansion highlights5 records
Processa Pharmaceuticals competitors and assessment
Company assessmentDirect peers
- Heat Biologics: Clinical-stage immunotherapy company with multiple oncology programs and a small-cap public profile. Comparable in multi-asset oncology pipeline structure and clinical-stage development approach.
- Diffusion Pharmaceuticals: Small-cap, clinical-stage biotech developing novel oncology supportive-care and therapeutic candidates. Comparable in scale, oncology development focus, and reliance on partnership/capital markets.
- Aprea Therapeutics: Clinical-stage oncology-focused biotech developing small-molecule therapies targeting DNA damage response pathways. Comparable in oncology pipeline focus, clinical-stage development model, and small-cap public status.
- Capricor Therapeutics: Clinical-stage biotech with multiple late-stage programs in rare diseases and cell therapy. Comparable in small-cap public profile, multi-program pipeline, and reliance on partnership/external funding to advance trials.
- Tonix Pharmaceuticals: Small-cap, clinical-stage biopharmaceutical company developing multiple in-licensed/acquired candidates across CNS, immunology, and rare diseases. Closely comparable in scale, multi-asset pipeline structure, and out-licensing/partnership orientation.
- Moleculin Biotech: Clinical-stage pharmaceutical company developing oncology drug candidates with small headcount and public small-cap profile. Directly comparable business model and oncology pipeline focus.
- Aytu BioPharma: Small-cap specialty pharmaceutical company with a mix of clinical-stage and commercial assets. Comparable in sub-scale market cap, public listing structure, and pharma portfolio orientation.
- Celsion Corporation: Small-cap, clinical-stage oncology company with lead assets in late-stage trials. Comparable in oncology focus, sub-scale market cap, and clinical-milestone-driven valuation dynamics.
Broad incumbents
- Spectrum Pharmaceuticals: Larger specialty oncology pharmaceutical company with both clinical and commercial assets. Referenced in Processa's CEO/CFO background; comparable as a broader specialty pharma competitor in similar oncology indications, though operating at significantly greater scale.
Emerging players
- CoNCERT Pharmaceuticals: Clinical-stage small-molecule developer that licensed PCS499 to Processa. Comparable in clinical-stage small-molecule development approach and therapeutic-area focus (dermatology/rare disease), and serves as both licensor and developmental parallel.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Processa Pharmaceuticals social profiles
Digital presenceProcessa Pharmaceuticals financial estimates
Financial estimateRevenue estimate
Valuation estimate
Processa Pharmaceuticals leadership team
Management profileNumber of profiles
Profiles6 records
Processa Pharmaceuticals funding detail
Funding detailFunding overview
Funding rounds8 records
Investors10 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Processa Pharmaceuticals M&A and investment
M&A and investmentM&A1 record
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Processa Pharmaceuticals
What does Processa Pharmaceuticals do?
Processa Pharmaceuticals is a clinical-stage biopharmaceutical company that acquires and develops de-risked drug candidates for oncology and rare diseases with high unmet medical needs. The company leverages 30+ years of regulatory science expertise to advance pipeline assets through FDA approval, with plans to out-license candidates either before or after pivotal studies to larger pharmaceutical partners for commercialization.
Is Processa Pharmaceuticals a public or private company?
Processa Pharmaceuticals is a public company. It is classified as public and is currently operating.
When was Processa Pharmaceuticals founded?
Processa Pharmaceuticals was founded in 2015. It employs 11 to 50 people.
Where is Processa Pharmaceuticals based?
Processa Pharmaceuticals is headquartered in Hanover, United States, in the North America region.
How does Processa Pharmaceuticals make money?
Two revenue lines are on record. Drug Licensing/Out-licensing is the primary driver. The others are future Product Sales.
Who are Processa Pharmaceuticals's main competitors?
Direct peers on record are Heat Biologics, Diffusion Pharmaceuticals, Aprea Therapeutics, Capricor Therapeutics, Tonix Pharmaceuticals, Moleculin Biotech, Aytu BioPharma and Celsion Corporation. Spectrum Pharmaceuticals is listed as a broad incumbent. CoNCERT Pharmaceuticals is listed as an emerging player.
Does Processa Pharmaceuticals have an API?
No public API is recorded for Processa Pharmaceuticals.
What industry is Processa Pharmaceuticals in?
Processa Pharmaceuticals's product category is Clinical-stage biopharmaceutical drug development. Its primary akta.pro industry code is HLAIALAE, Clinical Development (Phase I–III Trial Design & Execution), with a secondary code of HLAIALAH, Regulatory Strategy & IND/NDA/BLA Submissions Support. Its NAICS code is 54171 and its SIC code is 8731.