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.

CIRM DISC5 Awards: Funding Opportunity for Discovery Stage Research

Executive Summary:

CIRM’s DISC5 Awards fund up to $2.5 million per project for small, collaborative teams to run high-risk, exploratory discovery research in stem cell biology, genetic research, and regenerative medicine. Each project must be co-led by a California-based Principal Investigator and Co-Investigator from different labs, with human stem cells or genetic research central to the approach. Applications for the current cycle open November 14, 2025 and are due January 30, 2026 at 2:00 pm PT.

How much funding would I receive?

Each DISC5 award can request up to $2,500,000 in total project costs (including direct, facilities, and indirect costs) for a project lasting up to 3 years. Budgets at or above $900,000 in any single project year require additional justification and may be adjusted during review and negotiation.

What could I use the funding for?

The DISC5 Awards will support exploratory and innovative foundational research led by pairs of interdisciplinary investigators applying a range of technologies and approaches to address fundamental knowledge gaps or bottlenecks in stem cell biology and/or regenerative medicine. Proposals should aim to achieve one or more of the following outcomes:

• Advancing fundamental understanding of human stem and progenitor cells as they pertain to human health and disease.

• Advancing the use of stem cells to interrogate disease mechanisms to uncover biological insights thatcould enable therapeutic target and/or biomarker discovery.

• Gaining mechanistic insights to address key scientific or technical bottlenecks in stem cell, genetherapy, and/or other regenerative medicine approaches.

• Advancing applicability of stem cells, gene therapies, and/or other regenerative medicine approaches to all affected populations.

Proposals focused on validating or optimizing a therapeutic approach or candidate are not aligned with this program’s focus on foundational discovery.

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

Allowable Activities:

• Any basic research activities that meet the DISC5 objective to address knowledge gaps or bottlenecks in stem cell biology with relevance to human biology and disease, where human stem cells or genetic research is part of the central approach or hypothesis, and that seek to achieve one or more of the outcomes listed in “Scope and Structure.”

• Partnering activities with patient-centered organizations or other project-relevant community groups.

• Travel and accommodation expenditures associated with attendance of CIRM organized meetings and conferences. See additional details in Discovery Program Meetings and Conferences, pg. 13.

• Activities to support outreach or communication of research plans or outcomes with the wider public.

• Engagement activities with trainees supported through CIRM’s EDUC or INFR programs

Unallowable Activities:

• Therapeutic or other commercial development activities including lead optimization, manufacturing, pre-clinical toxicology and pharmacology studies and other activities targeted by CIRM’s PDEV and CLIN programs.

• 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.

• Costs incurred on or before the date of ICOC approval.

• Activities already budgeted or paid for under a prior, existing or pending CIRM award or which are already supported by another funder.

Are there any additional benefits I would receive?

Beyond the direct funding, DISC5 awardees benefit from:

Visibility and credibility: CIRM is one of the nation’s most recognized regenerative medicine funders. A DISC5 award strengthens credibility with partners, investors, and follow-on funders.

Positioning for future non-dilutive funding: DISC5 supports early high-risk data generation, enabling teams to later apply for CIRM’s translational and clinical programs or alternative funding sources.

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

For the current cycle:

• Application deadline: January 30, 2026 at 2:00 pm PT

• Grants Working Group (GWG) review: ~60–90 days after the deadline

• Board approval and Notice of Award: ~150 days after the deadline

• Project start: Must begin within 90 days of award approval

  Most awardees can expect to start work approximately 6–8 months after the application deadline.

Where does this funding come from?

The DISC5 Awards are funded by the California Institute for Regenerative Medicine (CIRM), a voter-created state agency dedicated to accelerating stem cell, genetic, and regenerative medicine research. DISC5 is part of CIRM’s Discovery Program under its 2024 Strategic Allocation Framework.

Who is eligible to apply?

Eligible organizations:
Must be a California Organization (non-profit or for-profit) as defined by CIRM. More than 50% of W-2 employees must be full-time California residents paying CA income tax. The PI must be located in California. California subsidiaries must retain IP rights from the project.

Eligible teams:
• Exactly one PI and one Co-Investigator (Co-I).
• Both must be employed by California Organizations.
• Each must commit at least 5% effort.
• PI and Co-I must be from different labs.
• The team must include an experienced Data Project Manager.

Project requirements:
• Must include human stem cell and/or genetic research as a central component.
• Any non-human models must be strongly justified and validated with human models when possible.
• Applications must be complete, accurate, and non-duplicative across CIRM programs.

Application limits:
• An individual may serve as PI on only one DISC5 application per cycle.
• An individual may serve on no more than two DISC5 applications total per cycle (as PI or Co-I).
• Co-funding is not required.

What companies and projects are likely to win?

CIRM funds projects that score highly across five criteria:
• Significance: Advance foundational stem cell or regenerative medicine knowledge with broad impact.
• Innovation: Use novel approaches or cross-disciplinary methods.
• Rationale: Present a sound scientific basis and justified experimental models.
• Plan & Design: Offer a clear, feasible research plan with strong team coordination and realistic budgets/timelines.
• Population Impact: Consider genetic, environmental, and community factors to ensure findings apply across diverse California populations

Are there any restrictions I should know about?

Key restrictions include:

• No therapeutic development (manufacturing, lead optimization, preclinical tox/pharm, IND-enabling studies).
• Out-of-state organizations cannot retain IP or publication rights for any CIRM-funded work.
• No costs incurred prior to ICOC approval.
• Applications must be complete, accurate, and not duplicative with other pending CIRM submissions.
• Projects must start within 90 days of award approval.
• Only one no-cost extension (max 6 months) may be requested—and approval is not guaranteed.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive proposal will likely take 120–200 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 $13000 Initial Fee + a 5% 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.