CIRM CLIN2: Funding Opportunity for Clinical Trials

Executive Summary:

CIRM’s CLIN2 program provides up to $15M to advance interventional Phase 1–3 clinical trials for stem cell–based and genetic therapies addressing serious unmet needs. Applications are accepted quarterly, with 2026 deadlines falling on the last business day of January, April, July, and October at 2:00 PM PST.

How much funding would I receive?

Funding depends on the stage of your clinical trial:

• First-in-Human: Up to $8M (for-profit) / $12M (non-profit)

• Phase 2/Subsequent Phase 1: Up to $15M

• Phase 3/Pivotal: Up to $15M

What could I use the funding for?

The CLIN2 award supports completion of an interventional phase 1, 2 or 3 clinical trial for a stem-cell based or genetic therapeutic candidate and may also fund an associated natural-history comparator or lead-in normal healthy volunteer study. Applicants are encouraged to use accelerating trial designs where appropriate, such as basket trials or adaptive design dose-escalation protocols.

The CLIN2 Program aims to advance clinical candidates that have the potential for transformative patient impact and that address barriers to access and affordability. To support this goal, align with Proposition 14’s mandate, and remain responsive to an evolving scientific and regulatory landscape, funding preferences will be set on an annual basis. These preferences will be guided by portfolio analyses and other strategic considerations in a cyclical manner.

For fiscal year 2025-2026 CLIN2 cycles, the following modalities and project features will be prioritized:

• Pluripotent stem cell-derived therapies

• In vivo genetic therapies

• Therapies using non-viral nucleic acid delivery

• Projects addressing diseases of the brain and CNS

• Applications from California organizations

• Projects progressing from CIRM-funded IND-enabling or earlier phase clinical trial awards

• Projects with Fast Track, RMAT or Breakthrough designations

• Projects proposing pivotal clinical trials (as agreed-to by the FDA)

• Required Activities

  • All clinical operations activities needed to complete the trial according to the proposed timeline

  • Outreach, enrollment, and retention activities to achieve trial enrollment demographics reflecting the target patient population

  • Treatment of patients with the therapeutic candidate (or control) and follow-up visits per the clinical protocol

  • Sharing of any non-clinical as well as clinical data per the CIRM data sharing requirements

  • Establishment and regular convening of a Strategic Planning Committee (SPC) with clinical development expertise to provide forward-looking strategic advice

  • Activities associated with managing, preserving, and sharing data and knowledge from the study

  • Activities associated with access and affordability planning for the therapeutic candidate in the proposed indication

• Allowable Activities

  • Natural history studies needed for baseline or control data for the interventional trial

  • Lead-in studies in normal healthy volunteers for the interventional trial

  • Studies to develop biomarkers, understand mechanisms of action and develop a potency assay

  • Regulatory activities including FDA interactions and requests for designations

  • Non-clinical studies required by the FDA (FDA documentation required)

  • Strategic planning activities

  • Manufacturing activities to supply the current clinical trial, including technology transfer and FDA-approved comparability studies, if needed

• Conditionally Allowable Activity

  Manufacturing for the next phase trial. Funding of that activity will be conditioned on 1) an interim evaluation by CIRM and a panel of independent experts of the clinical trial data to date, and 2) provision of 50% co-funding for this activity, if co-funding is required as specified in “Award Amount and Duration” below

• Unallowable Activities

  • Costs incurred on or before the date of ICOC approval

  • Discovery or translational research

  • Activities already budgeted or paid for under a prior, existing or future CIRM award

  • The costs of activities performed by a separate out-of-state organization that retains intellectual property or independent publication rights in any intellectual property (e.g., invention, technology, data) arising out of the CIRM-funded project

Are there any additional benefits I would receive?

Government Validation and Credibility
CIRM’s rigorous review provides a powerful credibility signal to investors, strategic partners, and clinical collaborators.

Enhanced Visibility and Notoriety
Awardees benefit from increased recognition through CIRM communications and visibility across the state’s stem cell and gene therapy ecosystem.

Access to CIRM’s Specialized Infrastructure

• Alpha Clinics Network for trial acceleration and patient access

• GMP Manufacturing Network for cell and gene therapy manufacturing

• Industry Resource Partners including preferred CROs and CDMOs

Stronger Exit and Valuation Potential
Nondilutive capital allows companies to advance high-value programs without dilution, often increasing valuation and improving partnership or acquisition outcomes.

What is the timeline to apply and when would I receive funding?

Applications Accepted: Quarterly

• 2026 Deadlines: Last business day of January, April, July, October at 2:00 PM PST

• GWG Scientific Review: ~90 days after deadline

• Board Approval: ~60 days after review

• Project Start: Within 60 days of approval

Total time from submission to project kickoff: ~6 months.

Where does this funding come from?

Funding is provided by the California Institute for Regenerative Medicine (CIRM) through Proposition 14, which supports the advancement of stem cell and genetic medicine programs statewide.

Who is eligible to apply?

For-profit or non-profit organizations

1. FDA-cleared IND (or submitted IND for CIRM-funded programs with clearance within 30 days)

2. PI with ≥15% effort

3. Project Manager with ≥50% effort

4. Data Project Manager

5. Applicant must be the IND sponsor

6. At least one California trial site

7. Must begin work within 60 days of board approval

8. Must meet co-funding and solvency requirements

What companies and projects are likely to win?

CIRM scores applications across five scientific merit categories:

1. Value Proposition – Whether the therapy offers meaningful clinical improvement over existing options, addresses unmet need, and is practical for real-world uptake by patients, providers, and payors.

2. Scientific Rationale – Strength of the biological justification, robustness of supporting data, and evidence of disease-modifying activity from relevant models or prior clinical studies.

3. Project Plan & Design – Whether proposed activities efficiently advance development, enable clear go/no-go decisions, support timely enrollment, include appropriate manufacturing plans, and can be delivered within the proposed budget, timeline, and risk-mitigation strategy.

4. Team & Resources – Expertise and coordination of the project team, access to required facilities (including manufacturing), and track record with stem cell or gene therapy programs.

5. Population Impact – Understanding of the affected population and strength of plans for representative outreach, enrollment, and retention.

Are there any restrictions I should know about?

No funding for discovery or early translational research:

1. No pre-approval costs

2. No out-of-state work where the external organization retains IP/publication rights

3. Co-funding required for for-profits (30–50%)

4. Only one CLIN2 application per PI per cycle

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive proposal will likely take 150–250 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

How much would BW&CO Charge?

Our full service support is available for $15000 Initial Fee + a 3% Success Fee.

Fractional support is $300 per hour.

For startups, we offer a discounted rate of $250 per hour to make top-tier grant consulting more accessible while maintaining the same level of strategic guidance and proposal quality.

Additional Resources

View the Funding Announcement Here.