PCSANasdaqPharmaceutical PreparationsUS GAAP · USD

Processa Pharmaceuticals, Inc.

Processa Pharmaceuticals, Inc. is a U.S.-based clinical-stage biopharmaceutical company developing small-molecule drug candidates for cancer and other therapeutic areas. Its pipeline includes next-generation oncology programs such as NGC-Cap, NGC-Gem, and NGC-Iri, along with two non-oncology candidates that may be pursued through partnering or licensing.

Ask about the company
Operating profit (EBIT)-14.0m USD
−16.1 %y/y
Net income-13.6m USD
−14.5 %y/y

Fiscal year 2025 · change from previous year

Development 2020–2025

-30-20-100m USD2020: EBIT -15 m USD20202021: 0.00 m USD2021: EBIT -12 m USD20212022: 0.00 m USD2022: EBIT -28 m USD20222023: EBIT -11 m USD20232024: EBIT -12 m USD20242025: EBIT -14 m USD2025-14
RevenueOperating profit (EBIT)

Business

Share of revenue
Oncology pipeline0 %

Small-molecule cancer therapy candidates designed to improve efficacy and reduce toxicity.

Non-oncology pipeline0 %

Additional drug candidates outside oncology that may be advanced or partnered.

Drug development services100 %

Internal research, preclinical work, and clinical trial execution for company-owned assets.

Customers

Processa does not currently sell approved products; its economic counterparties are primarily clinical research organizations, research institutions, investigators, regulators, and potential licensing or collaboration partners. If its programs succeed, the end customers would be oncology patients and the physicians and hospitals that prescribe or administer the therapies.

Clinical research organizations and trial sites

They perform and manage preclinical studies and clinical trials for Processa's drug candidates.

Research institutions

They provide scientific services, testing, and study execution support for development programs.

Potential licensing and collaboration partners

They may acquire rights to non-oncology assets or co-develop programs to share risk and funding.

Future oncology prescribers and patients

They would use approved therapies if the company's oncology candidates reach commercialization.

Strategy

The company is focused on advancing a small pipeline of next-generation cancer therapies using a regulatory science approach intended to improve the odds of approval. It also evaluates non-oncology assets for out-licensing or partnership, which can help fund development while preserving value in the portfolio.

Advance NGC-Cap and other oncology candidates through clinical developmentShort term

Clinical data is the main value driver for a biopharma pipeline and determines future partnering or approval potential.

Use regulatory science to improve approval probabilityMedium term

A clearer regulatory path can reduce development risk and improve the attractiveness of the assets to partners.

Monetize non-oncology assets through partneringMedium term

Out-licensing can create non-dilutive funding and reduce the need to carry every program internally.

Geography

Processa is headquartered in the United States and its development, financing, and regulatory activities are centered there. Its clinical and regulatory exposure is primarily U.S.-based, although drug development and eventual commercialization could involve foreign trial sites, partners, or markets.

Risks

The company faces the core risks of clinical-stage drug development: trial failure, safety issues, regulatory delays, and the possibility that programs are terminated before commercialization. It also depends on external financing, so dilution, unfavorable deal terms, or inability to raise capital could constrain development and threaten the pipeline.

Sorted by severity
LowMediumHighLowMediumHighImpact →Likelihood →Clinical development failure1Financing and dilution risk2Regulatory delay or non-approval3Nasdaq listing compliance risk4
Impact is the risk’s severity and likelihood how probable it is over the next few years, both assessed from the company’s reports. Numbers match the list.
  1. Clinical development failureImpact: CriticalLikelihood: High

    Drug candidates can be halted if scientific progress is insufficient or results are not commercially viable.

    Exposure: All pipeline programs

  2. Financing and dilution riskImpact: HighLikelihood: High

    The company depends on equity, debt, or partnering to fund operations until commercialization.

    Exposure: Corporate-wide

  3. Regulatory delay or non-approvalImpact: HighLikelihood: Medium

    FDA and other agencies can delay, request more data, or reject applications, extending timelines and costs.

    Exposure: Oncology pipeline

  4. Nasdaq listing compliance riskImpact: MediumLikelihood: High

    Failure to meet exchange requirements could reduce liquidity and access to capital.

    Exposure: Public equity market access

  5. Clinical trial execution and accrual estimation riskImpact: Medium

    Trial costs depend on enrollment, site activity, and third-party performance, which can differ from estimates.

    Exposure: R&D expense recognition

Accounting

Judgemental items
Clinical trial accrual estimates

Management estimates patient enrollment and CRO services, so changes can shift R&D expense between periods.

Impact: Quarterly R&D comparability

Preclinical and clinical prepaid expenses

Advance payments are capitalized as prepaid expenses and recognized later, affecting timing of expense recognition.

Impact: Balance sheet and period expense timing

Going-concern and financing dependence

The company relies on external funding to continue operations, which affects disclosure and valuation assumptions.

Impact: Liquidity presentation and investor assessment

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Last updated: 24/09/2026