Expanded Access Policy

Stamford Pharmaceuticals
Effective Date: 08 May 2026

Purpose

This policy describes Stamford’s approach to requests for Expanded Access (also referred to as compassionate use) for its investigational product, SP-002. Stamford is committed to advancing innovative therapies responsibly, with patient safety as the highest priority, while complying with applicable regulatory requirements and supporting the orderly development of our investigational programs.

Overview of Expanded Access

Expanded Access is a regulatory mechanism that may allow patients with serious or life-threatening conditions to receive investigational drugs outside of clinical trials when specific criteria are met. In general, expanded access requires that a product is sufficiently developed, authorized for investigational use, and available, and that providing access does not compromise patient safety or interfere with clinical development.

Current Development Status of SP-002

At this time, SP-002 is not ready for expanded access use. The program is currently in an early stage of development, and key requirements necessary to support investigational use outside of controlled clinical trials have not yet been met. These may include, but are not limited to:

  • Completion of required nonclinical and/or manufacturing activities
  • Availability of drug product in a suitable form and quantity
  • Regulatory authorization and infrastructure to support investigational use

Providing expanded access at this stage would present unacceptable safety and operational risks and could negatively impact the responsible advancement of the clinical development program.

Expanded Access Availability

As a result, Stamford is not able to offer expanded access to SP-002 at this time, including:

  • Single-patient expanded access (emergency or non-emergency)
  • Intermediate-size population access
  • Treatment use protocols

This position applies to all requests and reflects scientific, medical, regulatory, and operational considerations.

Future Consideration

Stamford may reassess the feasibility of expanded access later in development, once the investigational product has advanced sufficiently and the following conditions are met:

  • Adequate safety data are available to support use outside clinical trials
  • Appropriate regulatory authorization is in place
  • Sufficient drug supply and manufacturing controls are established
  • Expanded access would not interfere with ongoing or planned clinical studies

Any future expanded access program would be evaluated in accordance with applicable laws and regulations and on a case-by-case basis.

Clinical Trial Participation

When possible, participation in a clinical trial remains the preferred and safest pathway for patients to access investigational therapies. Information on ongoing or planned clinical trials may be available through:

Inquiries

Questions regarding this policy may be directed to:
Email: expandedaccess@stamfordpharmaceuticals.com

While inquiries are welcomed, requests for expanded access cannot be granted while the investigational product is being pursued for furthering clinical development crucial to its current stage of development.

Policy Review

This policy will be reviewed periodically and updated as the development status of SP-002 evolves.