Lucid Diligence Brief: Tempest Therapeutics and Factor Bioscience dual-CAR T deal

Timos Papagatsias

1 day ago

Lucid Diligence Brief: Tempest Therapeutics and Factor Bioscience dual-CAR T deal

Professional audiences only. Not investment research or advice. UK readers: for persons under Article 19(5) or Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this communication.

Dive deeper

Seven questions, 60-second thesis frame.

What changed, and when

Tempest Therapeutics and Factor Bioscience dual-CAR T deal signed on 19 Nov 2025, involving acquisition of dual-targeting CAR-T programs from Factor Bioscience. This is an all-stock deal that also introduces leadership changes and a projected cash runway to mid-2027 (Tempest press release).
An accompanying Form 8-K filed the same day adds key terms, including that Erigen LLC and Factor are the sellers, issuance of 8,268,495 TPST shares at closing, pre-closing financing conditions by 05 Dec 2025, and an outside date of 19 Mar 2026 (SEC Form 8-K). Independent coverage has begun to circulate consistent deal details (Investing.com brief, StreetInsider summary).

60-second thesis frame

This is a high-dilution pivot that could transform Tempest from a small-molecule oncology shop into a hybrid cell-therapy player, if execution and financing land quickly. The asset centerpiece is a dual CD19/BCMA autologous CAR-T, with Phase 1 completed in relapsed multiple myeloma and China BLA targeted for 2027, while Tempest receives ex-China, ex-India, ex-Turkey, ex-Russia rights plus the right to reference China data (Tempest press release). The 8-K adds real contingency, including a pre-closing financing condition by 05 Dec 2025 and a March 2026 outside date, so deal closure and runway are not yet locked (SEC Form 8-K). Meanwhile, Tempest keeps optionality for amezalpat pivotal plans in first-line HCC, which already has NMPA pivotal clearance in China, and TPST-1495 in FAP, which is NCI-funded and listed by NCI as a Phase 2 study (Tempest IR, NMPA pivotal clearance 30 Jun 2025, NCI trial page for TPST-1495 Phase 2). Context: Tempest announced strategic alternatives and laid off most staff in April 2025, highlighting the financing risk this transaction attempts to solve (BioPharma Dive, 10 Apr 2025, Fierce Biotech, 21 Apr 2025).

The seven diligence questions

Clinical

Is the dual CD19/BCMA construct and process identical to programs already dosing in China, and will Tempest have clean access to the full clinical package and CMC needed for ex-China registrational work (reference rights are stated, but confirm scope of raw data and tech transfer) (Tempest press release)?
What is the clinically meaningful edge versus approved BCMA CAR-T products in rrMM, especially for extramedullary disease, and what effect sizes are expected in 2026 readouts (context on dual-target strategies and POEMS/autoimmune explorations exists, but asset-level data are not yet public) (ClinicalTrials.gov example, dual BCMA/CD19, Nature Rev. Clin. Oncol. context)?

Payer or Access

For a U.S. rrMM path starting in 2027, do Medicare and major PBMs treat a dual-target autologous CAR-T differently on site-of-care, outlier, and carve-out policies relative to Abecma and Carvykti analogues (code and payment analogues to be mapped)?
Outside the U.S., how will ex-China rights translate into EU and UK regulatory and HTA strategies if Tempest’s pivotal package relies on China data bridging plus a U.S. registrational study starting 2027 (Tempest press release)?

Ops or Adoption

Can Tempest stand up or partner for autologous CAR-T manufacturing and vein-to-vein logistics on a realistic timeline and budget given its prior small-molecule footprint and April 2025 downsizing (Fierce Biotech, 21 Apr 2025)?

Competitive

What is the head-to-head or cross-trial differentiated profile versus approved BCMA CAR-Ts and emerging dual-target approaches, and how will this compete against rapidly scaling Carvykti capacity and bispecifics in earlier lines (context) (Fierce Biotech landscape piece)?

Team or Cap table

Post-closing, how is potential role overlap managed if incoming CEO Matt Angel remains affiliated with Factor or related entities, and what governance mitigants protect minority holders after 65% new issuance to a Factor affiliate (Tempest press release, SEC Form 8-K, Factor CEO bio)?

Red flags

Deal close depends on a pre-closing financing being satisfied by 05 Dec 2025, plus shareholder approval, and has an outside date of 19 Mar 2026, any slip could void the runway narrative (SEC Form 8-K).
Material dilution, 8,268,495 new shares issued, equal to 65% of outstanding post-issuance as of 19 Nov 2025, with additional warrants to existing holders, changes control dynamics materially (Tempest press release).
Operating reset history and staffing reductions raise execution risk for building a cell-therapy capability without a large-cap partner (BioPharma Dive, 10 Apr 2025, Fierce Biotech, 21 Apr 2025).

Next catalyst

Pre-closing financing milestone due by 05 Dec 2025 and scheduling of the shareholder vote on the asset purchase and share issuance, both gating deal close targeted for early 2026 (SEC Form 8-K).

FAQ

What exactly changed by Tempest’s strategic acquisition of new dual-CAR T programs from Factor news on 19 Nov 2025, and why does it matter for multiple myeloma and POEMS?
Tempest agreed to acquire a dual CD19/BCMA autologous CAR-T and related programs, to pivot into cell therapy and extend its cash runway to mid-2027, pending conditions and approvals (Tempest press release). The 8-K confirms sellers include Erigen LLC with Factor, and details financing and timing conditions (SEC Form 8-K).
What leadership changes were tied to Tempest’s 19 Nov 2025 announcement about the acquisition of the new dual-CAR T programs from Factor Bioscience?
Upon closing, Factor’s Matt Angel, PhD, will become Tempest CEO, with current CEO Stephen Brady moving to chair the board, aligning sponsor know-how with the acquired programs (Tempest press release, Factor CEO bio).
What is the regulatory path after Tempest’s 19 Nov 2025 announcement about the acquisition of the new dual-CAR T programs from Factor Bioscience and what are the next formal steps in the U.S., UK, and EU?
Tempest plans a potential U.S. registrational rrMM study starting 2027 using reference to China data and parallel development, which means IND work, CMC transfer, and ex-China comparability will be central (Tempest press release). Deal close is contingent on financing by 05 Dec 2025 and stockholder approval, so corporate actions precede ex-U.S. filings (SEC Form 8-K).
Which endpoints or readouts are expected post-Tempest and Factor Bioscience deal, and when?
The company guides to additional rrMM data in 2026 and a China BLA in 2027 for the dual CD19/BCMA program, plus POEMS data in 2027, with Tempest holding ex-China rights to the program (Tempest press release). Parallel programs at Tempest include amezalpat, which received NMPA clearance for a pivotal HCC trial in China on 30 Jun 2025 (Tempest IR, NMPA pivotal clearance).
How does the Tempest and Factor Bioscience deal interact with Tempest’s April 2025 strategic alternatives process and staffing cuts?
The acquisition attempts to resolve financing and pipeline durability issues flagged earlier in 2025 by adding clinical-stage cell therapy and a committed investment, but execution risk remains until conditions are satisfied (BioPharma Dive, 10 Apr 2025, Fierce Biotech, 21 Apr 2025).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 19 Nov 2025, 11:00 London. Purpose: general and impersonal information. Not investment research or advice, no offer or solicitation, no suitability assessment. UK: directed at investment professionals under Article 19(5) and certain high-net-worth entities under Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this. Sources and accuracy: public sources believed reliable, provided “as is,” may change without notice. No duty to update. Past performance is not reliable. Forward-looking statements carry risks. Methodology: questions-first framework using public sources. No conflicts. Authors do not hold positions unless stated. © 2025 LucidQuest Ventures Ltd.

Entities / Keywords

Tempest Therapeutics; TPST; Factor Bioscience; Erigen LLC; dual CAR-T; CD19; BCMA; extramedullary disease; multiple myeloma; POEMS syndrome; TPST-2003; ERI-2003; autologous CAR-T; allogeneic CAR-T; CD70; TPST-2206; ERI-2206; ERI-3003; ERI-3206; amezalpat; TPST-1120; NMPA; China BLA; FAP; TPST-1495; NCI; Cancer Prevention Clinical Trials Network; HCC; first-line HCC; shareholder vote; pre-closing financing; SEC 8-K; runway to mid-2027; leadership transition; Matt Angel; Stephen Brady.

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