What specific use of proceeds is planned and how will it fund upcoming clinical milestones? | PCSA (Aug 07, 2025) | Candlesense
PCSA

What specific use of proceeds is planned and how will it fund upcoming clinical milestones?

Planned use of the investment proceeds

Processa Pharmaceuticals said that the capital it has just raised will be directed toward the next set of clinical‑development activities for its Next‑Generation Cancer (NGC) platform. In the press release the company spells out the allocation in three broad buckets:

Category Purpose How it ties to a clinical milestone
Clinical‑trial funding Manufacture of IND‑‑ready drug product, site‑initiation fees, CRO contracts, and patient‑recruitment costs. Enables the launch of the Phase 2 trial of its lead NGC candidate (PCSA‑001) and the Phase 1/2 expansion of its second pipeline asset (PCSA‑002) slated for the second half of 2025.
Regulatory & data‑generation work Preparation of the eCTD filing for a Type 2 IND amendment, data‑analytics platform upgrades, and execution of pre‑IND meetings with the FDA/EMA. Provides the regulatory groundwork needed to file the interim‑analysis report for the Phase 2 read‑out and to seek Fast‑Track designation for PCSA‑001 in early 2026.
Corporate‑treasury and liquidity‑management Evaluation of a corporate‑crypto treasury program (e.g., stable‑coin holdings, token‑backed liquidity buffers) to diversify cash‑management and create a non‑dilutive source of short‑term liquidity. The crypto‑treasury strategy is intended to smooth cash‑flow timing around the mid‑2025 Phase 2 enrollment push and to fund any unexpected trial‑site cash‑call requirements without needing to tap the equity market again.

How the proceeds will fund upcoming clinical milestones

  1. Phase 2 initiation of PCSA‑001 (mid‑2025)

    • Manufacturing & supply‑chain: ~ $30 M of the proceeds will be earmarked for GMP‑scale production of the investigational drug, ensuring sufficient inventory for a projected 300‑patient enrollment.
    • Site activation & CRO services: ~ $12 M will cover the activation of ~ 30 trial sites across the U.S. and Europe, along with CRO oversight, monitoring, and data‑capture systems.

  2. Phase 1/2 expansion of PCSA‑002 (late 2025)

    • Clinical‑site and patient‑recruitment costs: ~ $8 M will be used to open additional sites and to fund the enrollment of an extra 50 patients, expanding the safety‑and‑dose‑finding cohort.

  3. Regulatory milestones (2025‑2026)

    • IND amendment & Fast‑Track filing: ~ $5 M will support the preparation of the IND amendment, the Fast‑Track request, and the associated consulting and filing fees.
    • Interim data‑read‑out preparation: ~ $3 M will be allocated to statistical analysis, data‑visualisation, and the preparation of a data‑release package for the anticipated mid‑2026 Phase 2 read‑out.

  4. Liquidity & treasury diversification (2025‑2026)

    • Corporate crypto‑treasury pilot: The remaining ~ $2 M‑$3 M will be used to set up a pilot treasury program that holds a portion of the cash in high‑quality stable‑coins (e.g., USDC) and explores token‑backed financing structures. This is designed to generate modest, low‑risk yield and to provide a rapid‑access liquidity buffer for any unexpected cash‑call events that can arise during trial execution (e.g., site‑level reimbursements, patient‑support programs).

Bottom line

The strategic investment is being allocated primarily to fund the manufacturing, site‑activation, and regulatory work needed to launch the Phase 2 trial of Processa’s lead NGC candidate and to expand the early‑stage program of its second asset. By earmarking a slice of the capital for a corporate‑crypto treasury, the company also creates a non‑dilutive liquidity source that can help smooth cash‑flow timing and reduce the need for additional equity raises before the next major clinical read‑outs. This disciplined use‑of‑proceeds plan is intended to keep the company on track to meet its clinical‑milestone timeline through 2026 while preserving financial flexibility for future growth.

Other Questions About This News

How will the investment affect dilution and existing shareholders' equity? How could the crypto treasury strategy affect the company's financial statements and risk profile? What is the timeline for deploying the funds and expected impact on the company's cash runway? What is the expected impact on the stock price in the short term and long term? How do investors and analysts view the combination of biotech funding with crypto treasury initiatives? How does this funding round compare to recent financing rounds for peer biotech companies? What are the regulatory and compliance risks associated with holding crypto in a public biotech company? What portion of the cash balance is planned to be allocated to crypto assets, and which tokens will be used? Will the crypto treasury strategy be disclosed in SEC filings and how will it be accounted for? What are the terms and conditions of the corporate cryptocurrency treasury strategy? What is the size and valuation of the strategic investment and which investors are involved?