Business Context and Reporting Period
This Form 8-K Current Report, dated July 17, 2026, covers Tempest Therapeutics, Inc. (TPST), a Delaware corporation focused on in vivo chimeric antigen receptor T cell (CAR-T) product candidates. The filing reports the entry into a material definitive agreement on July 17, 2026, with Heibei Senlang Biotechnology Co., Ltd. ("Senlang"), a Chinese biotechnology company.
Key Financial Metrics
This filing does not contain standard financial statements, revenue, profit, cash flow, or liquidity metrics. The only financial figures disclosed relate to the specific terms of the new collaboration agreement:
- Development Fees: Tempest will pay Senlang a fee ranging from $1.5 million to $2.0 million per product candidate.
- Fee Cap: The Company is not obligated to pay more than $2.0 million per product without prior written approval.
- Payment Structure: Fees are payable in installments based on the achievement of agreed milestones.
Material Changes and Agreement Details
The primary material change is the execution of a Product Development and Investigator-Initiated Trial (IIT) Collaboration Agreement. Key operational details include:
- Scope: Collaboration on product development and IIT activities in China for Tempest's CAR-T candidates.
- Initial Focus: Development of the TPST-4003 product candidate for myasthenia gravis (MG) or multiple sclerosis (MS).
- Trial Size: An IIT evaluating approximately 10 patients.
- Timeline: First patient enrollment and dosing are expected in the fourth quarter of 2026.
- Data Rights: Senlang must deliver complete data packages; Tempest retains worldwide, perpetual, royalty-free rights to use all generated data.
- China Rights: Upon completion of the IIT data package, Senlang has an exclusive 90-day option to negotiate a definitive license agreement to develop and commercialize the product in China.
- Term: The agreement has an initial term of three years, extendable in writing.
Guidance, Outlook, and Risks
Outlook: Management anticipates the commencement of the IIT for TPST-4003 in Q4 2026. The agreement is structured to facilitate data generation for potential future licensing in China.
Risks and Contingencies:
- Termination: Tempest may terminate the agreement or any Statement of Work (SOW) for convenience with 60 days' prior written notice.
- Breach: Either party may terminate upon material breach if not cured within 30 days.
- Intellectual Property: Tempest retains all rights to the Products and related IP; Senlang's rights to commercialize in China are contingent on successful negotiation of a separate license agreement.
Investor Verification Checklist
- Verify the specific milestones triggering the $1.5 million to $2.0 million development fee payments in the attached Exhibit 10.1.
- Confirm the regulatory status of TPST-4003 in China and the requirements for the proposed IIT.
- Monitor the execution of the definitive license agreement for China rights, which is contingent on the successful delivery of the IIT data package.
- Review the press release (Exhibit 99.1) for any additional commercial terms or strategic context not detailed in the 8-K summary.