Cullinan Therapeutics, Inc. 8-K

What Happened

• Cullinan Therapeutics (CGEM) filed a Form 8‑K on January 8, 2026 reporting a preliminary, unaudited cash, cash equivalents, short- and long-term investments, and interest receivable balance of $439.0 million as of December 31, 2025 and stating this cash runway is expected to extend into 2029 under the current plan. The company also provided a corporate update with anticipated 2026 milestones across its immunology and oncology programs and furnished a press release (Exhibit 99.1).
• The company emphasized the cash figure is preliminary and subject to change pending quarter‑end close and audit procedures; the independent auditor has not reviewed or audited the preliminary data. The filing includes forward‑looking statement disclosures about risks and uncertainties.

Key Details

• Cash and investments: $439.0 million (unaudited, preliminary) as of 12/31/2025; company expects runway into 2029.
• CLN‑978 immunology program: Phase 1 OUTRACE dose escalation ongoing in RA and SLE (currently enrolling 30 µg cohort); RA single‑dose data planned Q2 2026 and repeat‑dosing data Q3 2026; Sjögren’s initial Part A data expected Q4 2026.
• Velinotamig: Partner Genrix initiated a Phase 1 study in China in Dec 2025; initial data expected Q4 2026; Cullinan will lead further global development after Genrix study completion.
• CLN‑049 (oncology): Received FDA Fast Track for relapsed/refractory AML (Dec 2025); monotherapy dose expansion to start Q2 2026, completion of dose expansion/enrollment and initiation of a Phase 1/2 combo in frontline AML targeted for Q4 2026.
• Zipalertinib (partnered with Taiho): Taiho began a rolling NDA submission in Nov 2025 (expected complete Q1 2026); pivotal trial enrollment (REZILIENT3) expected complete H1 2026. Cullinan is eligible for up to $130M in U.S. regulatory milestones and 50% of future U.S. pre‑tax profits.

Why It Matters

• The preliminary $439M balance and stated runway into 2029 indicate Cullinan expects sufficient funding to advance multiple clinical programs through several near‑term catalysts. For investors, this highlights upcoming binary events (data readouts, dose expansions, NDA milestones) in 2026 that could materially affect the stock.
• The cash figure is unaudited and subject to change, so investors should treat it as provisional until final financials are released. The timetable of clinical and regulatory milestones provides a clear roadmap of near‑term catalysts but carries the usual clinical and regulatory risks noted in the filing.