Cullinan Therapeutics, Inc.
CGEM evidence brief
What we can confirm
- BioSniper Score:
- 6.5 / 10
- Market Cap:
- $1.33B
- Lead Asset:
- CLN-418 (Phase 1/Phase 2)
What it means
What to watch
Prepared research question
What matters most for CGEM—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · CGEM
Cullinan Therapeutics, Inc. (CGEM) is a clinical-stage biopharmaceutical company developing T cell engagers and targeted therapies for oncology and autoimmune diseases, with a lead NDA under FDA review for zipalertinib in EGFR exon 20 insertion NSCLC.
Key risk: No approved products
BioSniper Score
Based on 4 of 6 signals
Market Cap
$1.33B
Cash Runway
—
Lead Asset
CLN-418 (Phase 1/Phase 2)Next Catalyst
Phase1_Start · Oct 15, 2026Financial data as of Jun 30, 2026.
Tracking 4 pipeline candidates · 8 clinical trials · 3 catalysts for Cullinan Therapeutics, Inc..
Cullinan Therapeutics, Inc. (CGEM) is a clinical-stage biopharmaceutical company developing T cell engagers and targeted therapies for oncology and autoimmune diseases, with a lead NDA under FDA review for zipalertinib in EGFR exon 20 insertion NSCLC.
- Cash and equivalents of $78.6M as of 2026-06-30 [sec].
- Zipalertinib NDA for relapsed EGFR ex20ins NSCLC accepted by U.S. FDA with PDUFA target action date of February 27, 2027 [sec_mda · as of 2026-08-06].
- Initial clinical data for CLN-978 in SLE and RA confirmed for Q2 2026; repeat dosing data in RA confirmed for Q3 2026 [news · published 2026-03-10].
- Cash and investments of $393.3 million as of March 31, 2026; runway into 2029 [news · published 2026-05-07].
- Planned Q4 2026 data readouts for three T cell engager programs: velinotamig (BCMA TCE), CLN-978 (CD19 TCE), and CLN-049 (FLT3 TCE) [news · published 2026-09-24].
What works
- Zipalertinib has a confirmed PDUFA date of February 27, 2027, indicating regulatory progress for a potential first approval [sec_mda · as of 2026-08-06].
- Cash runway into 2029 provides extended non-dilutive funding for ongoing clinical programs [news · published 2026-05-07].
- Multiple T cell engager programs (velinotamig, CLN-978, CLN-049) are generating clinical data across immunology and oncology, diversifying pipeline risk [news · published 2026-09-24].
What to weigh
- The company has no approved products and remains pre-revenue, with all financial support dependent on cash reserves and future financing [sec_mda · as of 2026-08-06].
- Clinical development timelines are subject to significant uncertainty, including costs, third-party performance, and trial results [sec_mda · as of 2026-08-06].
- Zipalertinib faces at least three competitors in the EGFR ex20ins NSCLC space, creating commercial risk even if approved [pipeline].
From the filings
Quoted directly from source documents.
Zipalertinib NDA accepted with PDUFA date
“The U.S. FDA assigned a Prescription Drug User Fee Act target action date of February 27, 2027.”
SEC MD&A · August 6, 2026
Cash and investments as of March 31, 2026
“Cash and investments of $393.3 million as of March 31, 2026; runway into 2029”
News · May 7, 2026
Planned Q4 2026 data readouts for three T cell engagers
“Velinotamig (BCMA TCE) multi-dose regimen data in SLE at ACR Convergence 2026 in November CLN-978 (CD19 TCE) multi-dose regimen data in SLE, RA and Sjögren’s disease in December CLN-049 (FLT3 TCE) updated data from the Phase 1 dose escalation study in December”
News · September 24, 2026
Catalyst timeline
- 2026-10-15 · Phase1_Start: A Phase 1b Dose Escalation and Dose Expansion Study of CLN 049 in Combination With Azacitidine and Venetoclax for the Treatment of Adult Patients With Newly Diagnosed, Acute Myeloid Leukemia — Initiation of a new combination study for CLN-049 in AML.
- 2026-12-01 · Phase2_Start: A Phase 1b/2a, Open-label Study of Velinotamig for the Treatment of Adults With Relapsing and Refractory Immune Thrombocytopenia and Warm Autoimmune Hemolytic Anemia — Start of a Phase 1b/2a study for velinotamig in autoimmune indications.
- 2027-02-27 · PDUFA: 0001193125-26-411011 — PDUFA target action date for zipalertinib NDA for relapsed EGFR ex20ins NSCLC.
Risks & what to watch (3)›
Key risks
- No approved products — Cullinan has no marketed products; all value depends on clinical and regulatory success of pipeline candidates [sec_mda · as of 2026-08-06].
- Clinical trial uncertainty — Development timelines and costs are subject to significant risks, including third-party performance and trial results [sec_mda · as of 2026-08-06].
- Competitive pressure on zipalertinib — Zipalertinib faces at least three competitors in the EGFR ex20ins NSCLC space [pipeline].
What to watch
- PDUFA decision for zipalertinib on February 27, 2027 [sec_mda · as of 2026-08-06].
- Q4 2026 data readouts for velinotamig, CLN-978, and CLN-049 [news · published 2026-09-24].
- Phase 2 start of CLN-049 after FDA discussions [news · published 2026-09-26].
- Cash burn rate and any new financing activities given $78.6M cash as of 2026-06-30 [sec].
Sources: Catalysts · News · Pipeline · SEC MD&A · Generated October 5, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
Financial health data unavailable
Lead: Phase 3
4 candidates
3 upcoming, next in ~1d
0 buys · 4 sells (180d)
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
173
Total value held
$899.2M
| Holder | Shares | Value |
|---|---|---|
| lynx1 capital management lp | 8,963,500 | $127.4M |
| mpm bioimpact llc | 7,648,268 | $108.7M |
| bvf inc/il | 5,750,683 | $81.7M |
| blackrock, inc. | 4,449,966 | $63.2M |
| kynam capital management, lp | 3,114,132 | $44.3M |
| state street corp | 2,544,115 | $36.2M |
| vanguard capital management llc | 2,483,034 | $35.3M |
| blue owl capital holdings lp | 1,909,764 | $27.1M |
| rtw investments, lp | 1,705,960 | $24.2M |
| venrock adviser, llc | 1,379,965 | $19.6M |
Showing top 10 of 173 institutional holders of Cullinan Therapeutics, Inc.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 20.3%
- Days to cover
- 12.5
- Shares short
- 8,799,071
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
CGEM short interestGovernance
Frequently asked questions
What is the AI investment thesis for Cullinan Therapeutics, Inc.?
Cullinan Therapeutics, Inc. (CGEM) is a clinical-stage biopharmaceutical company developing T cell engagers and targeted therapies for oncology and autoimmune diseases, with a lead NDA under FDA review for zipalertinib in EGFR exon 20 insertion NSCLC.
What is Cullinan Therapeutics, Inc.'s lead drug candidate?
Cullinan Therapeutics, Inc.'s most advanced tracked candidate is CLN-418 (Phase 1/Phase 2) for Patients with advanced solid tumors; targets cancers with high B7H4 expression.
What is Cullinan Therapeutics, Inc.'s next catalyst?
Cullinan Therapeutics, Inc.'s next tracked catalyst is a Phase1_Start event — "Phase1_Start: A Phase 1b Dose Escalation and Dose Expansion Study of CLN 049 in Combination With Azacitidine and Venetoclax for the Treatment of Adult Patients With Newly Diagnosed, Acute Myeloid Leukemia" — expected October 15, 2026.
Who is the CEO of Cullinan Therapeutics, Inc.?
Mr. Nadim Ahmed M.S. is the chief executive officer of Cullinan Therapeutics, Inc. (CGEM).
Where is Cullinan Therapeutics, Inc. headquartered?
Cullinan Therapeutics, Inc. (CGEM) is headquartered in Cambridge, MA, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.