Tempest Therapeutics (Nasdaq: TPST) plans China IIT for TPST-4003 CAR-T
Rhea-AI Filing Summary
Tempest Therapeutics entered a product development and investigator-initiated trial collaboration with Hebei Senlang Biotechnology to advance TPST-4003, an in vivo CD7-targeted CAR-T therapy, via an IIT in China in approximately 10 myasthenia gravis or multiple sclerosis patients, with first dosing expected in the fourth quarter of 2026.
The agreement sets per-product development fees between $1.5 million and $2.0 million, grants Tempest worldwide perpetual rights to all generated data, and gives Senlang an exclusive 90-day option after data delivery to negotiate China commercialization rights. The initial term is three years, and Tempest anticipates initial safety and pharmacodynamic data as early as the first half of 2027.
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Filing Explained
Tempest now has a signed development framework, but China commercialization remains a post-data negotiation option and fees remain $1.5 million to $2.0 million per Product.
The
For each Product, the agreement establishes a development fee of
Tempest retains its existing Product-related intellectual property and receives worldwide, perpetual rights to use the generated development and trial data.
Senlang’s disclosed China right is an exclusive 90-day option, available only after delivery of the agreed data package, to negotiate a definitive license; the filing does not disclose a completed China license.
The agreement has an initial three-year term, but Tempest may terminate it or an applicable statement of work for convenience on 60 days’ notice.
The next specified resolution points are the applicable statement of work, which is expected to set the budget, timeline and milestones, and any later exercise of Senlang’s option after data delivery.
8-K Event Classification
Key Figures
Key Terms
investigator-initiated trial regulatory
pharmacodynamic medical
CD7-targeted mRNA/LNP delivery technical
dual-target CD19/BCMA CAR architecture technical
B-cell lineage depletion and reset medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What collaboration did Tempest Therapeutics (TPST) announce with Senlang?
What are the development fees in the Tempest (TPST) and Senlang agreement?
How is the initial TPST-4003 trial under the Tempest (TPST) collaboration designed?
What China rights could Senlang obtain under the Tempest (TPST) agreement?
What are the key timelines for TPST-4003 in Tempest Therapeutics’ (TPST) plan?
How long does the Tempest (TPST) and Senlang collaboration last and how can it end?
UNITED STATES
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CURRENT REPORT
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| Item 1.01 | Entry into a Material Definitive Agreement. |
On July 17, 2026, Tempest Therapeutics, Inc., a Delaware corporation (the “Company” or “Tempest”), entered into a product development and investigator-initiated trial (“IIT”) collaboration agreement (“Collaboration Agreement”) with Heibei Senlang Biotechnology Co., Ltd., a company organized under the laws of the People’s Republic of China (“Senlang”). Pursuant to the Collaboration Agreement, the Company and Senlang agreed to collaborate with respect to product development activities and investigator-initiated trial activities in China for certain of the Company’s in vivo chimeric antigen receptor T cell (“CAR-T”) product candidates (each, a “Product” and, collectively, the “Products”). Under the agreement, Tempest and Senlang will collaborate to develop Tempest’s proprietary TPST-4003 product candidate, beginning with an IIT in China evaluating TPST-4003 in approximately 10 patients with myasthenia gravis (“MG”) or multiple sclerosis (“MS”). The Company expects first patient enrollment and dosing to occur in the fourth quarter of 2026.
Collaboration Activities. Under the Collaboration Agreement, collaboration activities for each Product will be governed by the Collaboration Agreement and a separate statement of work (“SOW”), which is expected to include the applicable product development plan, budget, timeline, and other specified terms related to the development plan.
Development Fees. The development fee payable by the Company to Senlang for each Product shall be within the range of $1.5 million to $2.0 million, to be determined by the parties. The Collaboration Agreement provides that the Company will not be obligated to pay amounts in excess of $2.0 million for any Product unless the Company expressly approves such additional amount in writing in advance. Unless otherwise specified in an applicable SOW, the development fee for each Product will be payable in installments based on the achievement of agreed milestones.
Data Rights and Deliverables. Senlang is required to deliver to the Company complete and timely data packages generated from the IIT activities for each Product, and has granted the Company a worldwide, perpetual, irrevocable, royalty-free, fully paid-up right to use all data generated from the Product development activities and IIT activities for research, development, regulatory, financing, partnering, licensing, commercialization, publication, investor communication, due diligence and other business purposes.
China Rights. Subject to the terms of the Collaboration Agreement and the execution of a definitive license agreement, Senlang may obtain China rights to develop and commercially exploit one or more Products after completion of the agreed IIT data package for the relevant Product. Upon Senlang’s completion of the applicable SOW and delivery of an agreed data package for each Product, and subject to the rights of any third party, Senlang will have an exclusive option, exercisable within 90 days after delivery of such data package, to negotiate and enter into a definitive license agreement for the relevant Product in China on terms mutually agreeable to the parties.
Intellectual Property; Non-Use. The Company retains all rights, title and interest in and to the Products and related intellectual property owned or controlled by the Company prior to or outside the Collaboration Agreement, and any intellectual property as specified in the Collaboration Agreement that is specific to any Product or derived from the Company’s Product or related information as specified in the Collaboration Agreement will be owned by the Company.
Term and Termination. Unless earlier terminated, the Collaboration Agreement will remain in effect for an initial term of three years, which may be extended in writing. The Company may terminate the Collaboration Agreement or any SOW for convenience upon 60 days’ prior written notice to Senlang. Either party may terminate the Collaboration Agreement or any SOW upon written notice if the other party materially breaches the Collaboration Agreement and fails to cure such breach within 30 days after receiving written notice of the breach. The Company may also terminate the Collaboration Agreement or any SOW immediately upon written notice upon the occurrence of certain specified events.
The foregoing description of the Collaboration Agreement is only a summary and is qualified in its entirety by reference to the full text of the Collaboration Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and incorporated by reference herein.
Item 7.01 Regulation FD Disclosure.
On July 21, 2026, the Company issued a press release with respect to the matters described in Item 1.01 of this Current Report on Form 8-K, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference in this Item 7.01.
The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is “furnished” and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. Such information shall not be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent such other filing specifically incorporates such information by reference.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| 10.1 | Product Development and Investigator-Initiated Trial (IIT) Collaboration Agreement, dated July 17, 2026, by and between Tempest Therapeutics, Inc. and Heibei Senlang Biotechnology Co., Ltd. | |
| 99.1 | Press Release, dated July 21, 2026 | |
| 104 | Cover Page Interactive Data File (formatted in Inline XBRL) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TEMPEST THERAPEUTICS, INC. | ||||||
| Date: July 22, 2026 | By: | /s/ Matthew Angel | ||||
| Name: | Matthew Angel | |||||
| Title: | President and Chief Executive Officer | |||||
Exhibit 99.1
Tempest Announces Development Collaboration with Senlang Biotechnology for TPST-4003, a CD7-Targeted Next-Generation In Vivo CAR-T
| • | Tempest’s TPST-4003 is a next-generation in vivo CAR-T candidate combining proprietary CD7-targeted mRNA/LNP delivery with a dual-target CD19/BCMA CAR construct designed to enable broad B-cell lineage depletion and immune reset for autoimmune and oncology indications |
| • | Senlang Biotechnology, a clinical-stage cell therapy company with established expertise in CD7-targeted CAR-T development, will conduct a first-in-human investigator-initiated trial of TPST-4003 in approximately 10 patients with neurological autoimmune diseases, initially including myasthenia gravis and multiple sclerosis, with first patient dosing expected in the fourth quarter of 2026 |
Brisbane, CA, July 21, 2026 – Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company developing a pipeline of advanced chimeric antigen receptor T-cell (“CAR-T”) product candidates, today announced a strategic partnership with Hebei Senlang Biotechnology Co., Ltd. (“Senlang”), a clinical-stage cell therapy company with extensive expertise in CD7-targeted CAR-T development and clinical translation. Under the agreement, Tempest and Senlang will collaborate to develop Tempest’s proprietary TPST-4003 product candidate, beginning with an investigator-initiated trial (“IIT”) in China evaluating TPST-4003 in approximately 10 patients with myasthenia gravis (“MG”) or multiple sclerosis (“MS”). The company expects first patient enrollment and dosing to occur in the fourth quarter of 2026.
The initial study is designed to generate clinical evidence of safety, pharmacodynamic (“PD”) activity, and therapeutic potential of TPST-4003, building on promising findings from related pipeline preclinical and clinical research. Under the agreement, Senlang will coordinate and support trial execution in China, leveraging its extensive experience in clinical development of advanced CAR-T therapies. Additionally, the agreement grants Senlang an exclusive option to negotiate and enter into a definitive license agreement for TPST-4003 in China.
“This collaboration represents an important step in developing TPST-4003,” said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. “Through this partnership, we plan to rapidly and efficiently advance into first-in-human studies to generate clinical evidence in support of our next generation in vivo CAR-T pipeline and platform technologies. We expect to begin dosing patients in the fourth quarter of this year with initial safety and PD data from the first patients expected as early as the first half of 2027.”
“Based on our extensive clinical-stage experience in CD7-targeted CAR-T therapies, we believe CD7 represents a highly attractive target for next-generation cell therapies,” said Shengmin Guo, Founder and Chief Executive Officer of Senlang Biotechnology. “We are excited to partner with Tempest to combine our CD7 expertise with Tempest’s innovative CD7-targeted mRNA/LNP delivery platform and clinically validated CD19/BCMA CAR architecture to advance TPST-4003 into first-in-human studies.”
The initial trial is expected to assess the safety, cellular kinetics and pharmacodynamic activity of TPST-4003 in patients with MG or MS. Key assessments are expected to include treatment-emergent adverse events; the generation and expansion of peripheral blood CD4+ and CD8+ CAR-T cells and CD56+ CAR-NK cells; CAR transgene copy number; and the depth and kinetics of CD19+ B-cell depletion and B-cell subset reconstitution. Where clinically appropriate, exploratory assessments may also include the detection of CAR-positive immune cells in cerebrospinal fluid and the evaluation of B-cell depletion in lymphoid tissue. Disease-specific clinical activity will be evaluated using established measures.
About TPST-4003
TPST-4003 is an in vivo dual-targeting CD19/BCMA CAR-T product candidate that combines proprietary CD7-targeted mRNA/LNP delivery with a clinically validated dual-target CAR architecture utilized in the company’s TPST-2003 CAR-T program. Targeting broad B-cell lineage depletion and reset, TPST-4003 is being designed to address a range of autoimmune and oncology indications, initially including myasthenia gravis and multiple sclerosis. TPST-4003 differentiates from other in vivo CAR-T approaches through its CD7-targeted mRNA/LNP delivery strategy, which is designed to enable direct engagement of endogenous CD4+ and CD8+ T-cell populations for CAR generation in vivo.
About Tempest Therapeutics
Tempest is a clinical-stage biotechnology company pioneering a pipeline of next generation in vivo CAR-T cell therapies for autoimmune and oncology indications. Tempest’s immune reset technology is embodied in TPST-4003, the company’s lead in vivo CAR-T product candidate, which combines a dual-target CD19/BCMA CAR structure with the company’s proprietary CAR-T delivery platform to support broad B-cell lineage reset across multiple indications. The company’s additional preclinical programs leverage advanced payloads to create a modular in vivo CAR-T portfolio. Tempest envisions a world in which immune reset therapies bring safe, effective, and broadly accessible therapeutic options to patients in need. For additional information, visit Tempest’s website at https://www.tempesttx.com.
About Hebei Senlang Biotechnology
Hebei Senlang Biotechnology Co., Ltd., is a clinical-stage cell therapy company focused on next-generation CAR-T technologies, with specialized expertise in CD7-targeted CAR-T development. Senlang has established end-to-end capabilities spanning CAR design, vector and plasmid development, GMP manufacturing and clinical trial execution, and is currently advancing multiple CD7 CAR-T programs, including a pivotal CD7 CAR-T clinical trial for relapsed or refractory T-cell lymphoblastic lymphoma/leukemia (“T-LBL/ALL”).
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, concerning Tempest. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest, as well as assumptions made by, and information currently available to, management of Tempest. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “goal”, “suggest”, “target” and other similar expressions. All statements that are not historical facts are forward-looking statements, including but not limited to, statements regarding: Tempest’s collaboration with Senlang and the advancement, development, design and potential benefits of TPST-4003; the planned investigator-initiated trial of TPST-4003, including the expected patient population, indications, number of patients, timing of first patient enrollment and dosing, expected assessments and anticipated timing and nature of initial and interim clinical data; Senlang’s ability to conduct, coordinate and support the IIT and related development activities in China; the potential negotiation and entry into a definitive license agreement with Senlang for TPST-4003 in China, including the timing, terms and outcome of any such negotiations; the potential ability of TPST-4003 to enable broad B-cell lineage depletion and reset; the potential applicability of Tempest’s platform and
product candidates across autoimmune and oncology indications; and Tempest’s ability to achieve its operational plans. All forward-looking statements in this press release are based on Tempest’s current expectations, estimates and projections about its industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to Tempest’s need for additional capital to fund its planned programs and operations and to continue to operate as a going concern; unexpected safety or efficacy data observed during preclinical or clinical trials; the possibility that results from prior clinical trials and preclinical studies may not necessarily be predictive of future results; past results may not be indicative of future results; clinical trial site activation or enrollment rates that are lower than expected; loss of key personnel; changes in expected or existing competition; changes in the regulatory environment; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; and unexpected litigation or other disputes. These and other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of Tempest’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on March 30, 2026, and in other documents filed by Tempest from time to time with the SEC. Except as required by applicable law, Tempest undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest’s views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest.
Investor Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com