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Tempest Therapeutics secures exclusive option to license Senlang's in vivo CAR-T platform
Filed September 17, 2026 · Period ending September 14, 2026 · ~1 min read
Key Changes
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high
Entered exclusive option agreement with Senlang for worldwide (ex-Greater China) rights to its in vivo CAR-T technology, exercisable within four months.
Item 1.01 verify on EDGAR → -
high
Lead candidate is a BCMA/GPRC5D dual-targeting in vivo CAR-T in Phase 1 for relapsed/refractory multiple myeloma; early data show no Grade 3+ CRS or ICANS.
Exhibit 99.1 view on EDGAR → -
high
If option exercised, Tempest pays ~$447K exercise fee, escalating annual maintenance fees ($10M–$14M), 6% royalty on net sales, and sublicense revenue share.
Item 1.01 verify on EDGAR → -
medium
License would require commercially reasonable efforts to develop at least one product and meet IND-filing or business-development milestones.
Item 1.01 verify on EDGAR → -
low
Press release furnished under Regulation FD; information not filed.
Item 7.01 verify on EDGAR →
Summary
Tempest Therapeutics has entered an exclusive option agreement with Hebei Senlang Biotechnology, a Chinese biotech, granting Tempest the right—but not the obligation—to license Senlang's in vivo CAR-T technology for development and commercialization worldwide excluding Greater China. The option is exercisable within four months for a fee of approximately $447,000.
If exercised, the license would require escalating annual maintenance fees of $10 million to $14 million over the first three years, a 6% royalty on net sales, and a share of sublicense revenue. Tempest would also commit to commercially reasonable efforts to develop at least one licensed product and meet specified milestones.
The lead asset under the option is a BCMA/GPRC5D dual-targeting in vivo CAR-T candidate currently in Phase 1 dose escalation for relapsed/refractory multiple myeloma. Early clinical observations as of August 25, 2026, show no Grade 3 or higher cytokine release syndrome and no immune effector cell-associated neurotoxicity syndrome, with evidence of in vivo CAR-T generation and expansion at the highest evaluable dose. The platform is positioned as complementary to Tempest's existing LNP-based approach. A key concern is the company's going concern risk: the forward-looking statements explicitly state Tempest needs additional capital to fund its programs and continue operations. The option structure defers significant financial commitments until exercise, but the ongoing capital needs remain a material risk for investors.
Section-by-Section Diff
Event · Item 1.01 — Entry into a Material Definitive Agreement
Item 1.01 — Entry into a Material Definitive Agreement filed; see Key Changes for terms.
Added in current filing · verify on EDGAR →
On September 14, 2026, Tempest Therapeutics, Inc. entered into an exclusive collaboration, option and license agreement with Heibei Senlang Biotechnology Co., Ltd., a PRC company, under which Senlang granted the Company an exclusive option, exercisable within four months, to obtain an exclusive, royalty-bearing, sublicensable license to develop and commercialize Senlang’s in vivo CAR-T technology worldwide excluding Greater China.
Tempest Therapeutics has entered into a material agreement with Senlang, a Chinese biotech company, granting Tempest an exclusive option to license Senlang's in vivo CAR-T technology for development and commercialization outside Greater China. The option is exercisable within four months, giving Tempest a defined window to decide whether to proceed with the license.
Added in current filing · verify on EDGAR →
If exercised (upon payment of an option exercise fee of approximately $447,000)
To exercise the option and obtain the license, Tempest would need to pay an option exercise fee of approximately $447,000. This is a relatively modest upfront cost for access to a potentially valuable technology platform.
Added in current filing · verify on EDGAR →
The agreement also grants each party a right of first negotiation for Greater China rights and includes customary termination provisions for material breach, bankruptcy, patent challenges by the Company, or termination for convenience by the Company on 90 days’ notice.
The agreement includes a right of first negotiation for Greater China rights and standard termination provisions. Tempest can terminate for convenience on 90 days' notice, providing flexibility to exit the agreement if needed.
Event · Item 7.01 — Regulation FD Disclosure
Tempest Therapeutics furnished a press release under Regulation FD related to Item 1.01 matters.
Show 1 minor / wording change
Added in current filing · verify on EDGAR →
On September 15, 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 company issued a press release on September 15, 2026, related to matters described in Item 1.01 of the same 8-K. The press release is furnished as Exhibit 99.1 and incorporated by reference into Item 7.01. The information is furnished, not filed, under Regulation FD. Note: these figures were previously disclosed in the company's Jul 22, 2026 8-K.
Event · Exhibit 99.1
Tempest secures exclusive option to license Senlang's CD7-targeted lentiviral in vivo CAR-T platform and clinical-stage candidates.
Added in current filing · view on EDGAR →
it has entered into an exclusive option agreement with Hebei Senlang Biotechnology Co., Ltd. (“Senlang”).
Tempest announced an exclusive option agreement with Senlang covering Senlang's CD7-targeted lentiviral vector platform and a portfolio of in vivo CAR-T product candidates. The agreement gives Tempest the right, but not the obligation, to license the platform and candidates.
Added in current filing · view on EDGAR →
As of August 25, 2026, no Grade 3 or higher cytokine release syndrome and no immune effector cell-associated neurotoxicity syndrome were observed.
Early Phase 1 data show no Grade 3+ cytokine release syndrome and no immune effector cell-associated neurotoxicity syndrome as of August 25, 2026. The filing also states early observations demonstrate in vivo CAR-T generation and expansion at the current highest evaluable dose.
Added in current filing · view on EDGAR →
Upon exercise of the option, the CD7-targeted lentiviral platform would complement our targeted LNP platform, providing two distinct approaches to generating CAR-T cells directly within patients.
Tempest frames the Senlang lentiviral platform as complementary to its existing CD7-targeted lipid nanoparticle (LNP) in vivo CAR-T delivery platform. The LNP platform offers transient CAR expression while the lentiviral platform is designed for durable CAR-cell generation.
Added in current filing · view on EDGAR →
Tempest’s need for additional capital to fund its planned programs and operations and to continue to operate as a going concern
The forward-looking statements section explicitly lists Tempest's need for additional capital to continue as a going concern as a risk. This is a material disclosure about the company's financial condition.
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Figures/quotes linked to EDGAR · Narrative written by AI · Sep 17, 2026 · How we verify