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Pipeline (10 active programs)

Discontinued (7)

• CLN-978 — B-Cell Non-Hodgkin Lymphoma · development of CLN-978 in relapsed/refractory B-NHL was discontinued in early 2024
• CLN-619 — Endometrial Cancer · discontinuation of further development of CLN-619 in patients with gynecological cancers as preliminary results did not meet internal threshold for advancement
• CLN-619 — Cervical Cancer · discontinuation of further development of CLN-619 in patients with gynecological cancers as preliminary results did not meet internal threshold for advancement
• CLN-619 — Non-Small Cell Lung Cancer · In November 2025, after a review of the emerging clinical data in patients with NSCLC and multiple myeloma, we discontinued further development of CLN-619.
• CLN-619 — Multiple Myeloma · In November 2025, after a review of the emerging clinical data in patients with NSCLC and multiple myeloma, we discontinued further development of CLN-619.
• CLN-617 — undisclosed · In November 2025, after a review of the emerging clinical data in patients with advanced solid tumors, we discontinued further development of CLN-617.
• CLN-418 — undisclosed · discontinued development of CLN-418 and returned development and commercial rights for CLN-418 to Harbour

Capital (as filed)

Cash

$78.6M cash and cash equivalents · Jun 30, 2026 (10-Q)

Short-term investments

$256M Jun 30, 2026

Long-term investments

$19.0M Jun 30, 2026

Operating cash flow

−$38.2M quarter Mar 31, 2026 → Jun 30, 2026, year-to-date difference (10-Q)

As stated in coverage

$393M cash, runway 2029 per the update of Jul 28, 2026 — the company's own words as read there, not the filed figure

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (12)

• 2026-10-02 UPDATE: Cullinan Therapeutics (CGEM) - The Frontline Filing Jumps the Line 🔒 Paid
• 2026-09-24 UPDATE: Cullinan Therapeutics (CGEM) - The Q3 Print Slides to December 🔒 Paid
• 2026-09-15 UPDATE: Cullinan Therapeutics (CGEM) - The Hazard Ratio Finally Shows Up 🔒 Paid
• 2026-08-14 UPDATE: Cullinan Therapeutics (CGEM) - The Safety Net Turns Into a Second Engine 🔒 Paid
• 2026-07-28 UPDATE: Cullinan Therapeutics (CGEM) - The AML Hammer Gets a Regulatory Runway 🔒 Paid
• 2026-06-10 UPDATE: Cullinan Therapeutics (CGEM) - The Second Leg Lands
• 2026-06-08 UPDATE: Cullinan Therapeutics (CGEM) - The Full Poster Lands, the Stock Sells the News
• 2026-05-19 UPDATE: Cullinan Therapeutics (CGEM) - The Abstract Drop Front-Runs EULAR 🔒 Paid
• 2026-05-08 UPDATE: Cullinan Therapeutics (CGEM) - The Catalyst Has a Date and a Stage 🔒 Paid
• 2026-04-29 UPDATE: Cullinan Therapeutics (CGEM) - The PDUFA Lands, the ATM Opens 🔒 Paid
• 2026-03-14 UPDATE: Cullinan Therapeutics (CGEM) - A 14% Haircut on Housekeeping Filings 🔒 Paid
• 2026-01-22 Cullinan Therapeutics (CGEM): Scientific Deep Dive for CLN-978 and Pipeline Products 🔒 Paid

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (12 calls)

Every verdict Biotech Distilled has published on Cullinan Therapeutics, oldest first — the full history, never a selection. How calls are scored: the track record.

1. 2026-01-22 Speculative buy speculative Cullinan Therapeutics (CGEM): Scientific Deep Dive for CLN-978 and Pipeline Products Cash runway and Zipalertinib milestones mitigate downside enough to make the CLN-978 autoimmune lotto ticket worth the price of admission, provided position is sized assuming the autoimmune program could fail.
2. 2026-03-14 Speculative buy speculative UPDATE: Cullinan Therapeutics (CGEM) - A 14% Haircut on Housekeeping Filings The 14% drop was a paperwork panic with no change to the binary CLN-978 catalyst path; fortress balance sheet and Zipalertinib floor remain intact.
3. 2026-04-29 Speculative buy speculative UPDATE: Cullinan Therapeutics (CGEM) - The PDUFA Lands, the ATM Opens Zipalertinib NDA acceptance gives the valuation floor a hard PDUFA date, but the $200M ATM facility introduces a dilution optionality that softens the 'no dilution before data' pillar; Q2 CLN-978 readout remains the dominant variable.
4. 2026-05-08 Speculative buy speculative UPDATE: Cullinan Therapeutics (CGEM) - The Catalyst Has a Date and a Stage CLN-978 catalyst crystallized to June 6 EULAR poster, ATM discipline held with zero Q1 draw, and cash burn-only decline confirms fortress balance sheet; binary safety readout 30 days away.
5. 2026-05-19 Buy core UPDATE: Cullinan Therapeutics (CGEM) - The Abstract Drop Front-Runs EULAR EULAR abstract preview shows robust tissue-level B-cell depletion, clinical activity in RA and SLE, and a 'favorable safety profile' with no ICANS signal, materially de-risking the binary CLN-978 readout.
6. 2026-06-08 Buy core UPDATE: Cullinan Therapeutics (CGEM) - The Full Poster Lands, the Stock Sells the News Full EULAR poster (n=29) confirms 5 DORIS remissions in SLE, tissue B-cell depletion in synovium, and zero ICANS; Grade 3 CRS at 45 µg defines the dosing ceiling but does not break the program; 10.7% sell-the-news drop appears to be a misread of the cohort-4 closure.
7. 2026-06-10 Buy core UPDATE: Cullinan Therapeutics (CGEM) - The Second Leg Lands CLN-978 multi-dose tolerability held in first repeat-dose patients including a rituximab-refractory remission, and velinotamig's first human data showed two complete renal responses with zero CRS/ICANS, giving the platform a credible second engine; sell-the-news mechanics look like setup not signal.
8. 2026-07-28 Buy core UPDATE: Cullinan Therapeutics (CGEM) - The AML Hammer Gets a Regulatory Runway FDA agreed a seamless, potentially registrational single-arm Phase 2 for CLN-049 in R/R AML starting Q3 2026, adding a third engine with a defined regulatory pathway; stock up 45% from June low but thesis breadth improved simultaneously.
9. 2026-08-14 Buy core UPDATE: Cullinan Therapeutics (CGEM) - The Safety Net Turns Into a Second Engine REZILIENT3 Phase 3 met primary PFS endpoint early at planned interim, upgrading zipalertinib from a safety net to a franchise asset and firming the floor, though no effect size was disclosed and immunology remains the re-rating variable.
10. 2026-09-15 Buy core UPDATE: Cullinan Therapeutics (CGEM) - The Hazard Ratio Finally Shows Up REZILIENT3 full data (HR 0.50, P=0.00015, mPFS 14.5 vs 8.5 months) presented at WCLC Presidential Symposium is a decisive randomized result that retires the 'no numbers' caveat from August; floor quality improves again but immunology Q3 durability read still decides the next leg.
11. 2026-09-24 Buy core UPDATE: Cullinan Therapeutics (CGEM) - The Q3 Print Slides to December CLN-978 multi-dose RA durability read slipped from Q3 to a combined December package; no science broke but two soft timing signals warrant a timeline asterisk; floor from REZILIENT3 and PDUFA unchanged; entry near $15.44 may interest investors who missed the run above $20.
12. 2026-10-02 Buy core UPDATE: Cullinan Therapeutics (CGEM) - The Frontline Filing Jumps the Line Rolling frontline zipalertinib NDA under RTOR with full submission expected by year-end accelerates the $100M frontline milestone and makes a 2027 frontline approval decision plausible, firming the floor further; immunology December binary still decides the ceiling.

• Long call · opened Jan 22, 2026 at $12.57 · -10.0% vs XBI +15.7% (Nov 6, 2026)

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Timing, in the company's words (8 quotes from 4 filings)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

• 2026-10-02 8-K in filings ↓

  • “An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027.”

    matched to Zipalertinib (2L+ EGFR ex20ins NSCLC, REZILIENT1 NDA) · regulatory decision · read as February 27, 2027
• 2026-08-06 10-Q in filings ↓

  • “The U.S. FDA assigned a Prescription Drug User Fee Act target action date of February 27, 2027.”

    matched to CLN-049 · readout other · read as February 27, 2027

  • “We plan to share a clinical data update from the dose escalation portion of the trial in the fourth quarter of 2026.”

    matched to CLN-049 · readout other · read as fourth quarter of 2026

  • “We plan to share initial clinical data in patients with Sjögren’s disease in the fourth quarter of 2026.”

    matched to CLN-978 · readout other · read as fourth quarter of 2026
• 2026-08-06 8-K in filings ↓

  • “The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027. o In February, Taiho completed enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC.”

    matched to CLN-049 · readout other · read as February 27, 2027
• 2026-08-06 10-Q in filings ↓

  • “The U.S. FDA assigned a Prescription Drug User Fee Act target action date of February 27, 2027.”

    matched to CLN-049 · readout other · read as February 27, 2027

  • “We plan to share initial clinical data in patients with Sjögren’s disease in the fourth quarter of 2026.”

    matched to CLN-978 · readout other · read as fourth quarter of 2026 / matched to CLN-978 · topline data · read as fourth quarter of 2026

  • “Additional multi-dose regimen data from the trial are expected to be shared in the fourth quarter of 2026.”

    matched to Velinotamig · Global basket trial in autoimmune cytopenias (ITP/AIHA) initiation · read as fourth quarter of 2026

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (38)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from May 7, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

• Nov 4, 2026ReleaseCullinan Therapeutics Announces Presentations for CLN-049, a FLT3 T Cell Engager, and Velinotamig, a BCMA T Cell Engager, at the 68th ASH Annual MeetingSummary on the 8-K
• Nov 4, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1The CLN-049 Phase 1 dataset — 87 patients, optimized dosing at 6 and 12 µg/kg — landed this morning and the stock dropped 20.7%, but the headline CRc compression vs. earlier data may be less damning than the tape suggests when you read the regimen change that drove it.
• Oct 27, 2026ReleaseCullinan Therapeutics Advances Velinotamig into Global Clinical Development for Autoimmune Cytopenias Following IND Clearance by the U.S. FDAVelinotamig's FDA and Australian TGA IND clearances arrived roughly a quarter ahead of the Q1 2027 calendar I'd been tracking — the global ITP/wAIHA basket trial is now enrolling, with the ACR November 8 data readout 12 days away as the next live catalyst.
• Oct 19, 2026ReleaseZipalertinib Demonstrates Clinically Meaningful Intracranial Antitumor Activity in Patients with NSCLC with EGFR Exon 20 Insertion or Uncommon EGFR Mutations and Active CNS MetastasesThe prospective REZILIENT2 CNS cohort delivers a 30.2% intracranial ORR in 43 evaluable patients with active brain metastases — the first dedicated iORR dataset for zipalertinib and a commercial argument that strengthens the ATM Machine floor ahead of the February 2027 PDUFA and rolling frontline NDA.BD extracted 1 program update from this document → CGEM pipeline
• Oct 8, 2026ReleaseCullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid LeukemiaThe AML Hammer just enrolled its first patient in the pivotal Phase 2 — closing the open question I flagged in the October 2 update and formally activating Cullinan's third clinical engine alongside an exploratory TP53-mutated cohort that could be the differentiator.BD extracted 1 program update from this document → CGEM pipeline
• Oct 2, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1→ BD updateCullinan has initiated the frontline NDA submission for zipalertinib plus chemo under FDA's Real-Time Oncology Review program, targeting year-end 2026 completion — and the $100M first-line approval milestone just moved from hypothetical to imminent.BD extracted 1 program update from this document → CGEM pipeline
• Oct 1, 2026ReleaseNew Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review ProgramBD extracted 1 program update from this document → CGEM pipeline
• Sep 24, 2026ReleaseCullinan Therapeutics Highlights Fourth Quarter 2026 Milestones Across Immunology and Oncology T Cell Engager Portfolio→ BD updateSummary on the 8-K
• Sep 24, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1→ BD updateCGEM is down 24.3% from the September 14 WCLC high — not on new bad news, but into a hard Q4 catalyst calendar that crystallizes three data drops across CLN-978, velinotamig, and CLN-049 between November and December.BD extracted 3 program updates from this document → CGEM pipeline
• Sep 21, 2026ReleaseCullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum
• Sep 14, 2026ReleaseCullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer→ BD updateSummary on the 8-K
• Sep 14, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1→ BD updateThe REZILIENT3 numbers are finally in the open — a 6-month median PFS gain (14.5 vs. 8.5 months, HR 0.50, p=0.00015) and a 65% response rate in first-line EGFR exon 20 insertion NSCLC, presented in a Presidential Symposium at WCLC 2026, turning the ATM Machine thesis from a topline assumption into a quantified, conference-validated data set.BD extracted 1 program update from this document → CGEM pipeline
• Sep 13, 2026ReleaseZipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer→ BD updateSummary on the 8-K of Sep 14, 2026BD extracted 1 program update from this document → CGEM pipeline
• Sep 10, 2026ReleaseCullinan Therapeutics to Host Virtual Analyst and Investor Event to Showcase Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung CancerBD extracted 1 program update from this document → CGEM pipeline
• Aug 19, 2026ReleaseZipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung CancerBD extracted 1 program update from this document → CGEM pipeline
• Aug 13, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1
• Aug 12, 2026ReleaseZipalertinib Plus Chemotherapy Meets Primary Endpoint of Progression-Free Survival in Planned Interim Analysis of Phase 3 REZILIENT3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small CellBD extracted 1 program update from this document → CGEM pipeline
• Aug 6, 2026ReleaseCullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial ResultsBD extracted 1 program update from this document → CGEM pipeline
• Aug 6, 20268-KCurrent report: results of operations · EX-99.1
• Aug 6, 202610-QQuarterly reportBD extracted 1 program update from this document → CGEM pipeline
• Jul 28, 2026ReleaseCullinan Therapeutics Announces Positive End-of-Phase 1 Meeting with FDA for CLN-049 and Advances Program to a Potentially Registrational Phase 2 Study in AML
• Jun 16, 20268-KCurrent report: shareholder vote
• Jun 10, 2026ReleaseCullinan Therapeutics Shares New Clinical Data Across Its Portfolio of T Cell Engager Programs Targeting CD19 and BCMA in Autoimmune DiseasesBD extracted 3 program updates from this document → CGEM pipeline
• Jun 10, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1
• Jun 8, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1
• Jun 6, 2026ReleaseCullinan Therapeutics Presents Initial Clinical Data for CLN-978, a CD19xCD3 T Cell Engager, at the EULAR 2026 CongressBD extracted 1 program update from this document → CGEM pipeline
• May 26, 2026ReleaseCullinan Therapeutics to Host Immunology Day to Showcase Promising Initial Clinical Data in Autoimmune Diseases for CLN-978, a CD19 T Cell Engager, and Velinotamig, a BCMA T Cell Engager
• May 19, 2026ReleaseCullinan Therapeutics Receives FDA Orphan Drug Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia
• May 18, 2026ReleaseCullinan Therapeutics to Present Initial Clinical Data for CLN-978 in Treatment-Refractory Rheumatoid Arthritis and Systemic Lupus Erythematosus at EULAR 2026 Congress
• May 18, 20268-KCurrent report: Reg FD disclosure, other events · EX-99.1
• May 7, 2026ReleaseCullinan Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results
• May 7, 20268-KCurrent report: results of operations · EX-99.1
• May 7, 202610-QQuarterly report
• Apr 28, 2026S-3ASRAutomatic shelf registration
• Apr 28, 2026DEFA14AProxy soliciting material
• Apr 28, 2026DEF 14AProxy statement
• Mar 10, 20268-KCurrent report: results of operations · EX-99.1
• Mar 10, 202610-KAnnual report