CGEM - Earnings announcements

Initial clinical data in SLE and RA for CLN-978, a CD19 T cell engager, to be presented at the EULAR 2026 Congress in June; multi-dose regimen data in RA expected in Q3 2026  Zipalertinib NDA for relapsed EGFR ex20ins NSCLC accepted by U.S. FDA; PDUFA target action date of February 27, 2027 Cash and investments of $393.3 million as of March 31, 2026; runway into 2029 CAMBRIDGE, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today provided an update on recent and anticipated business highlights

Initial clinical data for CLN-978 in SLE and RA confirmed for Q2 2026; repeat dosing data in RA confirmed for Q3 2026 Zipalertinib rolling NDA submission completed; enrollment of REZILIENT3 frontline study completed with top-line results available by year-end 2026 Cash and investments of $439.0 million as of December 31, 2025; runway into 2029 CAMBRIDGE, Mass., March 10, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today provided an update on recent and anticipated business highlights and announced its fin

CLN-978 program now actively enrolling across Phase 1 studies in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and Sjögren's disease BCMA-directed bispecific T cell engager velinotamig in-licensed from Genrix Bio Zipalertinib REZILIENT1 pivotal results shared in oral presentation at ASCO 2025 and in Journal of Clinical Oncology; multiple new data sets across a range of disease settings to be shared at IASLC 2025 WCLC and ESMO Congress 2025 Company appoints Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., to its Board of Directors CAMBRIDGE, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a biopharmaceutical company focu

Advances Cullinan's leadership in T cell engager (TCE) development for autoimmune diseases with both a CD19 TCE and BCMA TCE in its pipeline Strengthens Cullinan portfolio of autoimmune programs with the opportunity to address a broader range of diseases while maintaining cash runway into 2028 Company to host conference call today at 4:30 pm ET CAMBRIDGE, Mass., June 04, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that it has entered into an agreement with Genrix Bio for a global (ex-Greater China), all indication, exclusive license to velinotamig,

Company received approval from European Medicines Agency (EMA) for CLN-978; Phase 1 study in active, difficult-to-treat rheumatoid arthritis to initiate in Q2 2025 CLN-978 expands into Sjögren's disease; Phase 1 study in active, moderate to severe patients to initiate in the U.S. in Q2 2025 Zipalertinib REZILIENT1 results to be shared in oral presentation at 2025 ASCO Annual Meeting CAMBRIDGE, Mass., May 08, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported recent and anticipated business highlights and announced its financial results for the first

Initial clinical data from global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) expected in Q4 2025; CLN-978 remains the first and only development-stage CD19 T cell engager in an autoimmune disease clinical trial in the U.S. Zipalertinib pivotal Phase 2b study met primary endpoint; full results mid-year 2025 and NDA submission planned H2 2025, pending regulatory discussions Cash and investments of $606.9 million as of December 31, 2024, continues to provide runway into 2028 CAMBRIDGE, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a biopharmaceutical company focused on developing modality-agnostic targeted t

Global Phase 1 study of CLN-978 in systemic lupus erythematosus (SLE) cleared to initiate in U.S. and Australia; initial clinical data expected in Q4 2025 CLN-619 on-track for initial expansion cohort data in endometrial and cervical cancers in Q2 2025 Zipalertinib pivotal Phase 2b study enrollment completed ahead of schedule; results expected mid-year 2025 CAMBRIDGE, Mass., Nov. 07, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan")), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported recent and anticipated business highlights and announced its financial results for the third quarter ended September 30, 202

Investigational New Drug (IND) application for CLN-978 in systemic lupus erythematosus (SLE) remains on track to be filed in third quarter of 2024 Company to pursue rheumatoid arthritis (RA) as second autoimmune indication for CLN-978 development CLN-619 combination therapy data presented at ASCO demonstrated objective responses in oncogenic driver mutation NSCLC, which is typically unresponsive to checkpoint inhibition Company appoints Mary Thistle to its Board of Directors CAMBRIDGE, Mass., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan"))), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported re

Combination and monotherapy solid tumor dose escalation data for CLN-619 to be presented in a poster session at ASCO 2024 Annual Meeting CLN-978 development to focus exclusively on autoimmune diseases, starting with systemic lupus erythematosus (SLE) as the first indication Cash and investments of $434.8 million as of March 31, 2024, plus gross proceeds of $280 million from April private placement extends cash runway into 2028 Company appoints David Meek to its Board of Directors CAMBRIDGE, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM, "Cullinan"))), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reporte

Cullinan remains on track to report additional solid tumor dose escalation data for CLN-619 in the second quarter of 2024 and recently received FDA clearance for an IND to evaluate CLN-619 in relapsed/refractory multiple myeloma The company is exploring development of its CD19xCD3 T cell engager CLN-978 in autoimmune disorders Cash and investments of $468.3 million as of December 31, 2023 continues to provide runway into the second half of 2026 CAMBRIDGE, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM, "Cullinan"))), a biopharmaceutical company focused on developing modality-agnostic targeted oncology therapies, today reported on recent and upcoming busin

Cullinan to provide clinical data updates on three novel targeted oncology programs and complete enrollment in the pivotal Phase 2b portion of the zipalertinib REZILIENT1 study in 2024 Initial CLN-619 clinical biomarker data support mechanism of action and demonstrate monotherapy clinical activity in patients with tumors not typically responsive to checkpoint inhibitor therapy Cash and investment position of $482 million as of September 30, 2023 expected to provide runway into the second half of 2026, vs into 2026 previously CAMBRIDGE, Mass., Nov. 08, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM, "Cullinan"))) a biopharmaceutical company focused on modality-agnostic tar

Phase 3 first-line study of zipalertinib in EGFR exon 20 insertion mutation non-small-cell lung cancer (NSCLC) patients (REZILIENT-3) open to enrollment Initial monotherapy clinical data for CLN-619 presented at ASCO 2023 Annual Meeting; initiated monotherapy expansion cohorts in endometrial and cervical cancers First patient dosed in Phase 1 study of CLN-978 in relapsed/refractory (R/R) B Cell non-Hodgkin lymphoma (B-NHL) Cash and investment position of $512.1 million as of June 30, 2023 continues to provide runway into 2026 CAMBRIDGE, Mass., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM, "Cullinan"))) a biopharmaceutical company focus

        Zipalertinib pivotal trial now enrolling at the 100mg BID dose only First clinical data for CLN-049 and CLN-619 to be reported at EHA 2023 Congress and ASCO 2023 Annual Meeting, respectively Cash and investment position of $503.5 million as of March 31, 2023 continues to give runway into 2026 CAMBRIDGE, Mass., May 11, 2023 (GLOBE NEWSWIRE) --  -- Cullinan Oncology, Inc. (NASDAQ:CGEM, "Cullinan"))) a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today reported on recent and upcoming business highlights and announced its financial results for the first quarter ended March 31, 2023. "We made important progress in the first quar

Expanded clinical stage portfolio through licensing of U.S. rights to CLN-418 Received FDA clearance of IND application for CLN-978; submitted IND application for CLN-617 Initial clinical data updates for CLN-049 and CLN-619 on track for mid-2023 Potential for 6 clinical stage programs by year end and cash runway into 2026 CAMBRIDGE, Mass., March 09, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM, "Cullinan"))) a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today reported on recent and upcoming business highlights and announced its financial results for the fourth quarter and full year ended December 31, 202

CAMBRIDGE, Mass., Feb. 13, 2023 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) and Harbour BioMed (HKEX: 02142) today announced that Cullinan Oncology has entered into an exclusive license with Harbour BioMed for the development and commercial rights of HBM7008 (CLN-418) in the U.S. CLN-418/HBM7008 is a B7H4 x 4-1BB bispecific immune activator developed from next-gen heavy chain only antibody (HCAb)-based multi-specific antibody discovery platform HBICE®, currently in a Phase 1 clinical study being conducted at U.S. and Australian sites in patients with advanced solid tumors. "We are pleased to bring CLN-418, a potential first-in-class, clinical-stage bispecific immune activato

Initiated pivotal study for zipalertinib (CLN-081/TAS6417) Increased ownership in MICA subsidiary, which holds worldwide rights to CLN-619, from 54% to 92% Continued enrollment in CLN-049 and CLN-619 clinical studies with initial clinical data updates on track for mid-2023 Cash and investments of approximately $607 million as of September 30, 2022 CAMBRIDGE, Mass., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM) a biopharmaceutical company focused on modality-agnostic targeted oncology, today reported on recent and upcoming business highlights and announced its financial results for the third quarter ended September 30, 2022. "We continued t

Completed agreement for strategic collaboration to jointly develop and commercialize CLN-081 with Taiho Pharmaceutical Presented updated Phase 1/2a data for CLN-081 at the 100mg BID dose showing median duration of response greater than 21 months and median progression-free survival of 12 months at the American Society for Clinical Oncology (ASCO) Annual Meeting Cash and investments of $656 million1 as of June 30, 2022 expected to provide runway through 2026. CAMBRIDGE, Mass., Aug. 10, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapeutic candidates across multiple modalities for pa

Announced U.S. co-development and co-commercialization agreement for CLN-081 with Taiho Pharmaceutical; updated CLN-081 data accepted for oral presentation at the American Society for Clinical Oncology (ASCO) meeting in June CLN-049 and CLN-619 Phase I dosing continues with initial clinical data on track for mid-2023; CLN-081 and CLN-978 IND submissions on track for 1H 2023 Cash of $685 million1, including upfront payment for the Taiho collaboration, provides expected runway through 2026. CAMBRIDGE, Mass., May 16, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted t

Taiho obtains exclusive global rights to CLN-081/TAS6417 outside the U.S.; in the U.S., Taiho and Cullinan Oncology to jointly develop and co-commercialize CLN-081/TAS6417 Cullinan Oncology will receive an upfront cash payment of $275 million, with potential to receive up to an additional $130 million in regulatory-based milestone payments Cullinan Oncology and Taiho will equally share future profits in the U.S. CAMBRIDGE, Mass., May 12, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Cullinan Oncology) (NASDAQ:CGEM) and Taiho Pharmaceutical Co., Ltd. (Taiho) today announced an agreement through which Taiho will acquire Cullinan Pearl Corp. (Cullinan Pearl) and co-develop and co-comm

CLN-081 clinical data support a differentiated clinical profile; regulatory update planned for first quarter 2022 CLN-049 and CLN-619 patient dosing initiated in December 2021 for first-in-human clinical trials; initial clinical data expected by mid-2023 Portfolio advancement and expansion highlighted through multiple AACR abstract acceptances and HPK1 protein degrader collaboration with Mount Sinai CAMBRIDGE, Mass., March 17, 2022 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies for patients with cancer, today reported on recent and upcoming business highlights and announced its fi

Cullinan Pearl clinical update, including data from patients enrolled in the Phase 2a expansion 100 mg BID cohort, planned for fourth quarter 2021 Cullinan MICA and Cullinan Florentine programs to advance into clinical trials by year end 2021 Strong balance sheet with cash and investments of $445.4 million CAMBRIDGE, Mass., Nov. 09, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing a diversified pipeline of targeted therapies, today reported on recent and upcoming business highlights and announced its financial results for the third quarter ended September 30, 2021. "Our organization has made great progress advancing our p

Follow-up Cullinan Pearl data from Phase 1 portion of ongoing trial showed increased disease control rate (DCR) of 92% in the 100mg dose cohort IND clearance of two immuno-oncology pipeline programs, Cullinan MICA and Cullinan Florentine, with clinical trial starts for each program expected in 2H 2021 Strong balance sheet with cash and investments of $456.3 million as of June 30, 2021 CAMBRIDGE, Mass., Aug. 10, 2021 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), an oncology company seeking to drive shareholder returns by focusing on the patient, today announced its financial results for the second quarter ended June 30, 2021 and reported on recent business highli