Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results
Cullinan Therapeutics (NASDAQ:CGEM) provided a comprehensive Q2 2025 corporate update, highlighting significant progress across its immunology and oncology portfolios. The company reported $510.9 million in cash and investments, providing runway into 2028. Key developments include active enrollment in Phase 1 studies for CLN-978 across multiple autoimmune conditions, the in-licensing of velinotamig from Genrix Bio for $20 million upfront, and advancement of zipalertinib's pivotal trials.
Financial results show R&D expenses of $61.0 million (up from $36.3M in Q2 2024) and a net loss of $70.1 million (increased from $42.0M). The company strengthened its board with the appointments of Drs. Mittie Doyle and Andrew Allen, while announcing upcoming data presentations across multiple programs at major medical conferences.
Cullinan Therapeutics (NASDAQ:CGEM) ha fornito un aggiornamento aziendale completo per il secondo trimestre del 2025, evidenziando progressi significativi nei suoi portafogli di immunologia e oncologia. La società ha riportato 510,9 milioni di dollari in contanti e investimenti, garantendo liquidità fino al 2028. Tra gli sviluppi chiave si segnalano l'arruolamento attivo negli studi di Fase 1 per CLN-978 in diverse condizioni autoimmuni, la licenza in entrata di velinotamig da Genrix Bio con un pagamento iniziale di 20 milioni di dollari e l'avanzamento degli studi pivotali su zipalertinib.
I risultati finanziari mostrano spese di R&S pari a 61,0 milioni di dollari (in aumento rispetto ai 36,3 milioni del secondo trimestre 2024) e una perdita netta di 70,1 milioni di dollari (in crescita rispetto ai 42,0 milioni). La società ha rafforzato il consiglio di amministrazione con le nomine dei dottori Mittie Doyle e Andrew Allen, annunciando inoltre prossime presentazioni di dati su più programmi in importanti conferenze mediche.
Cullinan Therapeutics (NASDAQ:CGEM) proporcionó una actualización corporativa integral del segundo trimestre de 2025, destacando avances significativos en sus carteras de inmunología y oncología. La compañía reportó 510,9 millones de dólares en efectivo e inversiones, asegurando recursos hasta 2028. Entre los desarrollos clave se incluye la inscripción activa en estudios de Fase 1 para CLN-978 en múltiples condiciones autoinmunes, la licencia de velinotamig de Genrix Bio con un pago inicial de 20 millones de dólares y el avance de los ensayos pivotales de zipalertinib.
Los resultados financieros muestran gastos en I+D de 61,0 millones de dólares (aumento desde 36,3 millones en el segundo trimestre de 2024) y una pérdida neta de 70,1 millones de dólares (incremento desde 42,0 millones). La compañía fortaleció su junta directiva con los nombramientos de los doctores Mittie Doyle y Andrew Allen, y anunció próximas presentaciones de datos en múltiples programas en importantes congresos médicos.
Cullinan Therapeutics (NASDAQ:CGEM)� 2025� 2분기 기업 업데이트� 통해 면역� � 종양� 포트폴리� 전반� 걸친 중요� 진전� 발표했습니다. 회사� 5� 1,090� 달러� 현금 � 투자 자산� 보유하고 있어 2028년까지 자금 운용� 가능하다고 밝혔습니�. 주요 개발 사항으로� 여러 자가면역 질환� 대상으� � CLN-978 1� 시험� 적극적인 등록, Genrix Bio로부� velinotamig� 2,000� 달러 선불� 라이선스 �, 그리� zipalertinib� 중추 임상시험 진행� 포함됩니�.
재무 결과� 연구개발� 6,100� 달러(2024� 2분기 3,630� 달러 대� 증가)와 순손� 7,010� 달러(42,000� 달러에서 증가)� 보여줍니�. 회사� Dr. Mittie Doyle� Dr. Andrew Allen� 이사회에 영입하며 이사회를 강화했으�, 주요 의학 학회에서 여러 프로그램� 데이� 발표� 앞두� 있음� 발표했습니다.
Cullinan Therapeutics (NASDAQ:CGEM) a publié une mise à jour complète pour le deuxième trimestre 2025, soulignant des progrès significatifs dans ses portefeuilles d'immunologie et d'oncologie. La société a déclaré disposer de 510,9 millions de dollars en liquidités et investissements, assurant une trésorerie jusqu'en 2028. Parmi les développements clés figurent l'inscription active aux études de phase 1 pour CLN-978 dans plusieurs maladies auto-immunes, la licence d'velinotamig auprès de Genrix Bio avec un paiement initial de 20 millions de dollars, et l'avancement des essais pivots de zipalertinib.
Les résultats financiers montrent des dépenses en R&D de 61,0 millions de dollars (en hausse par rapport à 36,3 M$ au T2 2024) et une perte nette de 70,1 millions de dollars (en augmentation depuis 42,0 M$). La société a renforcé son conseil d'administration avec la nomination des Drs. Mittie Doyle et Andrew Allen, tout en annonçant des présentations de données à venir sur plusieurs programmes lors de grandes conférences médicales.
Cullinan Therapeutics (NASDAQ:CGEM) gab ein umfassendes Unternehmensupdate für das zweite Quartal 2025 bekannt und hob bedeutende Fortschritte in den Bereichen Immunologie und Onkologie hervor. Das Unternehmen meldete 510,9 Millionen US-Dollar an Barmitteln und Investitionen, was eine Finanzierung bis 2028 sichert. Zu den wichtigsten Entwicklungen zählen die aktive Rekrutierung in Phase-1-Studien für CLN-978 bei verschiedenen Autoimmunerkrankungen, die Lizenzierung von velinotamig von Genrix Bio für eine Vorauszahlung von 20 Millionen US-Dollar sowie der Fortschritt der entscheidenden Studien zu zipalertinib.
Die Finanzergebnisse zeigen F&E-Ausgaben von 61,0 Millionen US-Dollar (gestiegen von 36,3 Mio. im Q2 2024) und einen Nettoverlust von 70,1 Millionen US-Dollar (gestiegen von 42,0 Mio.). Das Unternehmen stärkte seinen Vorstand durch die Ernennung von Dr. Mittie Doyle und Dr. Andrew Allen und kündigte bevorstehende Datenpräsentationen zu mehreren Programmen auf wichtigen medizinischen Konferenzen an.
- Strong cash position of $510.9 million providing runway into 2028
- Strategic in-licensing of velinotamig expanding autoimmune disease portfolio
- Multiple Phase 1 studies actively enrolling across three autoimmune conditions
- Planned NDA submission for zipalertinib in relapsed EGFR ex20ins NSCLC by end of 2025
- Multiple data readouts expected across pipeline in Q4 2025
- Increased net loss to $70.1 million from $42.0 million year-over-year
- R&D expenses significantly increased to $61.0 million from $36.3 million year-over-year
- $20 million upfront payment plus potential $692 million in milestone payments for velinotamig license
Insights
Cullinan shows strong pipeline progress with clinical advancement in autoimmune and oncology programs, maintaining solid $510.9M cash position.
Cullinan Therapeutics has posted a productive Q2 2025 with significant advancements across both its immunology and oncology portfolios. The company is now actively enrolling patients in three separate Phase 1 studies for its CD19xCD3 bispecific T cell engager (CLN-978) targeting autoimmune conditions including lupus, rheumatoid arthritis, and Sjögren's disease. This accelerated clinical development demonstrates Cullinan's strategic focus on establishing leadership in T cell engagers for autoimmune diseases.
The company has further strengthened its immunology portfolio through the in-licensing of velinotamig, a BCMAxCD3 bispecific T cell engager from Genrix Bio for
In oncology, Cullinan's partner Taiho is preparing an NDA submission for zipalertinib in relapsed EGFR ex20ins NSCLC by year-end, following the presentation of pivotal REZILIENT1 data at ASCO 2025. Additional data readouts are planned across multiple programs, with CLN-049 (FLT3xCD3) data in relapsed/refractory AML and MDS expected in Q4 2025.
Financially, Cullinan maintains a strong balance sheet with
Cullinan's strategic focus on T cell engagers for autoimmune diseases represents a promising therapeutic approach with significant market potential.
Cullinan's expansion in the autoimmune disease space represents a scientifically compelling approach targeting the underlying disease mechanisms. The CLN-978 program, a CD19xCD3 bispecific T cell engager, is now in three simultaneous Phase 1 trials across systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren's disease - all conditions with substantial unmet medical needs despite recent therapeutic advances.
The company's strategic acquisition of velinotamig, a BCMAxCD3 bispecific T cell engager, is particularly noteworthy. By targeting both CD19 (with CLN-978) and BCMA (with velinotamig), Cullinan now has comprehensive coverage of the B cell compartment. This dual approach could provide complementary mechanisms for addressing B cell-mediated autoimmune conditions, as different B cell subsets may predominate in various diseases or disease stages.
Recent data presented at EULAR (referenced but not detailed in the release) apparently supports the potential of T cell engagers as disease-modifying therapies for autoimmune conditions. This therapeutic class offers the theoretical advantage of more selective immunomodulation compared to broader immunosuppressive approaches. The initial safety and B cell depletion data from the SLE study expected in Q4 2025 will be critical in validating this approach, as will the rheumatoid arthritis data anticipated in H1 2026.
The multi-center, global approach to clinical development (studies running across the US, Europe, and Australia) and collaboration with academic centers of excellence like FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore suggests a robust clinical development strategy. This globally diversified enrollment approach should accelerate timelines and potentially improve the generalizability of results across patient populations.
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) -- (Nasdaq: CGEM; “Cullinan�), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today provided an update on recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2025.
“I am proud of the team’s strong execution throughout the first half of the year as we continue to advance the CLN-978 program across three active studies in SLE, RA, and Sjögren’s disease. With the addition of velinotamig, we further solidified our leadership position in the development of T cell engagers for autoimmune diseases. With these two programs, our portfolio covers the entire breadth of the B cell compartment. Recent data presented at the European Alliance of Associations for Rheumatology (EULAR) meeting reinforced the potential of T cell engagers as disease-modifying therapies across a wide spectrum of autoimmune diseases,� said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.
“We also continue making important progress across our oncology portfolio, recently sharing results from the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib at the 2025 ASCO Annual Meeting, and we look forward to sharing multiple new data sets at upcoming medical conferences. Pending discussions with the U.S. FDA, our partner Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC later this year and expects to complete enrollment of the frontline study REZILIENT3 in the first half of 2026. We also plan to share clinical data for CLN-049, our FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory AML and MDS later this year. With
Portfolio Highlights
Immunology
- CLN-978 (CD19xCD3 bispecific T cell engager): Systemic lupus erythematosus, rheumatoid arthritis, and Sjögren’s disease
- The global Phase 1 study in patients with moderate to severe SLE is enrolling in the United States, Europe, and Australia, and the Company plans to share initial safety data and B cell depletion data from Part A of the study in Q4 2025.
- The Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis is enrolling in Europe. This company-sponsored study is being led by sites at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy. The Company plans to share initial data from this study during the first half of 2026.
- The global Phase 1 study in patients with active, moderate to severe Sjögren’s disease is enrolling in the U.S. and is now also active in Europe following recent regulatory approval.
- Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
- In June 2025, the Company entered into an agreement with Genrix Bio for an exclusive global (ex-Greater China) license to velinotamig. Under the agreement, Cullinan paid Genrix Bio an upfront license fee of
$20 million . In the future, Genrix Bio will also be eligible to receive up to$292 million in development and regulatory milestones plus up to an additional$400 million in sales-based milestones, as well as tiered royalties on potential ex-Greater China net sales. - Genrix Bio plans to initiate a Phase 1 study in patients with autoimmune diseases in China by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
- In June 2025, the Company entered into an agreement with Genrix Bio for an exclusive global (ex-Greater China) license to velinotamig. Under the agreement, Cullinan paid Genrix Bio an upfront license fee of
Oncology
- Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
- In June 2025, results from the pivotal Phase 2b portion of REZILIENT1 in patients with EGFR ex20ins NSCLC who have received prior therapy were shared at the 2025 ASCO Annual Meeting and published simultaneously in the Journal of Clinical Oncology. Cullinan plans to share updated efficacy and safety data in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC.
- Pending discussions with the U.S. Food and Drug Administration, Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026.
- Taiho plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC. Taiho also plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with active brain metastases at the ESMO Congress 2025.
- CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
- Enrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS and the company plans to share clinical data from this study in Q4 2025.
- Enrollment also continues in the Phase 1 study in patients with measurable minimal residual disease in AML.
- CLN-619 (Anti-MICA/MICB monoclonal antibody): NSCLC and multiple myeloma
- Enrollment continues in the Phase 1 expansion cohorts in patients with NSCLC and the Phase 1 study in patients with relapsed/refractory multiple myeloma.
- CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
- Enrollment continues in the Phase 1 study in patients with advanced solid tumors.
- Enrollment continues in the Phase 1 study in patients with advanced solid tumors.
Corporate Updates
- Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., were appointed to the Board of Directors, effective August 7, 2025. Both board directors bring significant leadership experience, with Dr. Doyle having extensive immunology clinical development expertise, and Dr. Allen with extensive oncology clinical development experience. Anne-Marie Martin, Ph.D., and David Ryan, M.D., will resign from Cullinan’s Board of Directors effective August 7, 2025.
Second Quarter 2025 Financial Results
- Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were
$510.9 million as of June 30, 2025. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan. - R&D Expenses: Research and development expenses were
$61.0 million for the second quarter of 2025, compared to$36.3 million for the same period in 2024. - G&A Expenses: General and administrative expenses were
$14.8 million for the second quarter of 2025, compared to$13.8 million for the same period in 2024. - Net Loss: Net loss attributable to Cullinan was
$70.1 million for the second quarter of 2025, compared to$42.0 million for the same period in 2024.
About Cullinan Therapeutics
(岹: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan’s portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at, and follow us onԻ.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our preclinical and clinical developments plans and timelines for our product candidates, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, our research and development activities, our plans regarding future data presentations, our cash runway, and other statements that are not historical facts. The words “believe,� “continue,� “could,� “estimate,� “expect,� “intends,� “may,� “plan,� “potential,� “project,� “pursue,� “will,� and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs, NDAs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors� in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.
Cullinan Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (unaudited) (in thousands) | ||||||||
June30, 2025 | December31, 2024 | |||||||
Cash, cash equivalents, investments, and interest receivable | $ | 510,898 | $ | 606,917 | ||||
Total assets | $ | 520,329 | $ | 621,824 | ||||
Total current liabilities | $ | 28,058 | $ | 30,647 | ||||
Total liabilities | $ | 28,183 | $ | 31,496 | ||||
Total stockholders� equity | $ | 492,146 | $ | 590,328 |
Cullinan Therapeutics, Inc. Consolidated Statements of Operations (unaudited) (in thousands, except per share amounts) | ||||||||||||||||
Three Months Ended June30, | Six Months Ended June30, | |||||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | $ | 61,030 | $ | 36,259 | $ | 102,489 | $ | 66,905 | ||||||||
General and administrative | 14,768 | 13,768 | 28,305 | 26,111 | ||||||||||||
Total operating expenses | 75,798 | 50,027 | 130,794 | 93,016 | ||||||||||||
Loss from operations | (75,798 | ) | (50,027 | ) | (130,794 | ) | (93,016 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Interest income | 5,924 | 8,071 | 12,504 | 13,764 | ||||||||||||
Other income (expense), net | (181 | ) | (72 | ) | (266 | ) | (116 | ) | ||||||||
Net loss | (70,055 | ) | (42,028 | ) | (118,556 | ) | (79,368 | ) | ||||||||
Net loss attributable to noncontrolling interests | � | � | � | (192 | ) | |||||||||||
Net loss attributable to Cullinan | $ | (70,055 | ) | $ | (42,028 | ) | $ | (118,556 | ) | $ | (79,176 | ) | ||||
Basic and diluted net loss per share attributable to Cullinan: | ||||||||||||||||
Common stock | $ | (1.07 | ) | $ | (0.68 | ) | $ | (1.81 | ) | $ | (1.43 | ) | ||||
Preferred stock | $ | (10.70 | ) | $ | (6.83 | ) | $ | (18.12 | ) | $ | (14.26 | ) | ||||
Weighted-average shares used in computing net loss per share attributable to Cullinan: | ||||||||||||||||
Common stock | 59,015 | 55,052 | 58,960 | 49,031 | ||||||||||||
Preferred stock | 648 | 648 | 648 | 648 |
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