Temple Therapeutics

Expanded Access / Compassionate Use / Right to Try Policy
Investigational Product: TTX-333 (Adhesion Prevention Drug Candidate)

1. Purpose and Guiding Principles

   Temple Therapeutics is committed to developing safe and effective therapies that address significant unmet
   medical needs in women’s health and beyond. TTX-333, our investigational adhesion prevention drug candidate, is
   currently being evaluated in clinical trials and has not yet been approved by any regulatory authority.We
   recognize that patients with serious conditions may seek access to investigational medicines outside of clinical
   trials. This policy outlines the framework under which Temple Therapeutics may consider providing
   Expanded Access (Compassionate Use, Early Access, or Right to Try) to TTX-333, in line with the
   21st Century Cures Act and applicable global regulations.

2. Eligibility Criteria

   Expanded Access to TTX-333 may be considered if the following conditions are met:

   1. No Approved Alternatives: The patient’s home country has no approved treatment for the
      condition, or available therapies have been exhausted.
   2. Trial Unavailability: The patient is not eligible for enrollment in an active clinical
      trial of TTX-333, or no trial is accessible within reasonable geographic or timing constraints.
   3. Completed or Closed Trials: Clinical trials have ended and patients are awaiting
      commercial supply, but still face significant unmet need.
   4. Risk-Benefit Assessment: The potential benefit to the patient, as assessed by the
      treating physician and Temple Therapeutics’ medical team, justifies the potential risks.
   5. Regulatory Compliance: Access can be provided in accordance with applicable laws,
      including FDA, EMA, and local health authorities.

3. Application Process

   Patients and Physicians

   • • Requests must be initiated by the patient’s treating physician, not by the patient
       directly.
     • The physician should provide:
       • Patient’s diagnosis and treatment history.
       • Rationale for Expanded Access request.
       • Confirmation of exhaustion of all approved options.
       • Informed consent documentation signed by the patient.

   Submission
   Requests should be submitted to Temple Therapeutics Medical Affairs at:
   info@templerx.com
   Temple Therapeutics will acknowledge receipt of the request within 5 business days.

4. Company Review and Decision

   • • Requests will be evaluated by the Temple Therapeutics Expanded Access Committee, which
       includes
       representatives from Clinical, Medical, and Regulatory Affairs.
     • Factors considered include:
       • Clinical evidence supporting the request.
       • Drug supply availability.
       • Impact on ongoing or planned clinical trials.
       • Regulatory requirements in the patient’s country.
     • Decisions will be communicated in writing to the requesting physician.

   Temple Therapeutics reserves the right to decline requests when:

   • • Criteria are not met,
     • Supply is limited and prioritized for clinical trials, or
     • Risks outweigh potential benefits.

5. Responsibilities

   Temple Therapeutics

   • Provide investigational product supply where feasible.
   • Ensure compliance with local regulatory frameworks.
   • Maintain oversight of safety reporting.

   Treating Physician

   • Submit and maintain regulatory approvals (e.g., FDA Expanded Access IND, EMA compassionate
     use
     application, or
     local equivalent).
   • Obtain and document informed consent from the patient.
   • Monitor and report adverse events promptly.

   Regulatory Authorities

   • Review and approve Expanded Access applications as required under local laws.
   • Provide oversight consistent with applicable national frameworks (e.g., FDA, EMA, MHRA,
     Health Canada).

6. Transparency

   Temple Therapeutics is committed to transparency and will:

   • Post this policy publicly on the company’s website.
   • Provide updates if policy changes occur.
   • Report Expanded Access use outcomes to regulators as required.

7. Policy Limitations

   • Expanded Access does not guarantee efficacy or safety.
   • Access is not a substitute for participation in clinical trials.
   • Provision of TTX-333 through this pathway is subject to supply, regulatory requirements, and
     Temple
     Therapeutics’ discretion.

8. Contact Information

   For all Expanded Access requests and inquiries:
   Temple Therapeutics – Medical Affairs
   info@templerx.com
   Effective Date: September 18, 2025
   Review Date: Annually

Temple Therapeutics remains focused on advancing TTX-333 through rigorous clinical development while working
with patients, physicians, and regulators to enable responsible access where appropriate.