CLN-978 (CD19 TCE) multi-dose regimen data in RA in Q3 2026 and SLE in Q4 2026; Phase 2 expansion studies to begin early 2027

Velinotamig (BCMA TCE) multi-dose regimen data in SLE in Q4 2026; Phase 1/2 basket study in autoimmune cytopenias to begin early 2027

CLN-049 (FLT3 TCE) potentially registrational Phase 2 study in R/R AML to begin in Q3 2026

Cash and investments of $356 million as of June 30, 2026; runway into 2029

CAMBRIDGE, Mass., Aug. 06, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today provided an update on recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2026.

"At our recent Immunology Day event, we shared compelling initial clinical data for CLN-978 and velinotamig, two T cell engagers with potential to achieve immune reset and transform outcomes for people living with autoimmune diseases. We look forward to sharing additional clinical data throughout the remainder of 2026 as we rapidly advance these programs towards Phase 2 studies," said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

"Additionally, following a positive End-of-Phase 1 meeting with the FDA in July, we will begin a potentially registrational Phase 2 study in patients with relapsed or refractory AML this quarter. CLN-049 represents a promising novel immunotherapeutic approach for a broad population of AML patients who currently have limited treatment options and poor prognosis. With our leadership position in the T cell engager space, we are quickly advancing a differentiated pipeline across immunology and oncology to late-stage development. Together with multiple upcoming catalysts, the company is very well-positioned for significant value creation."

Portfolio Highlights and 2026 Milestones

Immunology

   -- CLN-978 (CD19xCD3 T cell engager): treatment-refractory moderate to 
      severe systemic lupus erythematosus $(SLE)$, difficult-to-treat rheumatoid 
      arthritis $(RA)$, and treatment-refractory moderate to severe 
      Sjögren's disease (SjD) 
 
   -- OUTRACE SLE 
 
          -- At the EULAR 2026 Congress in June, the Company presented 
             promising initial single target dose data, which demonstrated the 
             potential for immune reset in a refractory and heterogeneous SLE 
             population. CLN-978 also improved lab markers of disease activity 
             and demonstrated deep, dose-dependent B cell depletion in 
             peripheral blood as well as dose-dependent recovery with a 
             favorable safety profile. 
 
          -- In Q4 2026, the Company plans to share initial multi-dose regimen 
             data. The Company also plans to begin Phase 2 expansion in early 
             2027 in patients with SLE and in patients with lupus nephritis. 
 
   -- OUTRACE RA 
 
          -- At the EULAR 2026 Congress and the Company's Immunology Day event 
             in June, the Company presented promising initial single target 
             dose and multi-dose regimen data, which demonstrated the potential 
             for immune reset in a heavily pretreated RA population with high 
             baseline disease activity. CLN-978 improved disease activity in 
             most patients, including two DAS28-ESR remissions in 
             poly-refractory patients. CLN-978 also reduced autoantibody levels 
             while preserving vaccine titers, and demonstrated deep, 
             dose-dependent B cell depletion in peripheral blood and tissues 
             with a favorable safety profile. 
 
          -- In Q3 2026, the Company plans to share additional multi-dose 
             regimen data. The Company also plans to begin Phase 2 expansion in 
             early 2027. 
 
   -- OUTRACE SjD 
 
          -- In Q4 2026, the Company plans to share initial data from the 
             single target dose escalation portion of the study. 
 
   -- Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune 
      diseases driven by long-lived plasma cells 
 
          -- At the Company's Immunology Day event in June, encouraging early 
             clinical observations from the Genrix Bio Phase 1/2 study in China 
             were shared. Two patients with SLE and nephritis treated with 
             multi-dose velinotamig achieved complete renal response, and a 
             favorable safety profile was observed. Additional multi-dose 
             regimen data from the study are expected to be shared in Q4 2026. 
 
          -- Cullinan plans to initiate a global Phase 1/2 basket study in 
             early 2027 in patients with autoimmune cytopenias, including 
             immune thrombocytopenia $(ITP)$ and autoimmune hemolytic anemia 
             (AIHA). 

Oncology

   -- CLN-049 (FLT3xCD3 T cell engager): acute myeloid leukemia (AML) and 
      myelodysplastic syndrome (MDS) 
 
          -- Following a positive End-of-Phase 1 meeting with the U.S. FDA in 
             July, the Company will initiate a potentially registrational Phase 
             2 study in patients with relapsed/refractory AML in Q3 2026. The 
             study will begin with a dose-optimization phase with seamless 
             progression to a single-arm expansion cohort at the recommended 
             Phase 2 dose (RP2D). 
 
          -- The Company plans to share an update from the dose escalation 
             portion of the Phase 1 study in patients with relapsed/refractory 
             AML or MDS in Q4 2026. 
 
          -- In Q4 2026, the Company will initiate a Phase 1/2 study evaluating 
             the combination of CLN-049, venetoclax, and azacitidine in 
             patients with previously untreated AML. 
 
   -- Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: 
      EGFR ex20ins NSCLC 
 
          -- In April, the U.S. FDA accepted an NDA for zipalertinib for the 
             treatment of patients with locally advanced or metastatic EGFR 
             ex20ins NSCLC whose disease has progressed on or after 
             platinum-based chemotherapy, with or without amivantamab. The 
             Prescription Drug User Fee Act (PDUFA) target action date is 
             February 27, 2027. 
 
          -- In February, Taiho completed enrollment of the pivotal study 
             REZILIENT3 in 1L EGFR ex20ins NSCLC. Taiho expects to obtain 
             top-line results by the end of 2026. 
 
          -- Cullinan is eligible to receive $30 million and up to $100 million 
             upon 2L and 1L U.S. regulatory approvals, respectively, and a 
             50/50 profit share in the U.S. 

Second Quarter 2026 Financial Results

   -- Cash Position: Cash, cash equivalents, short- and long-term investments, 
      and interest receivable were $356.0 million as of June 30, 2026. Cullinan 
      expects its cash resources to provide runway into 2029 under its current 
      operating plan. 
 
   -- R&D Expenses: Research and development expenses were $44.4 million for 
      the second quarter of 2026, compared to $61.0 million for the same period 
      in 2025. 
 
   -- G&A Expenses: General and administrative expenses were $12.8 million for 
      the second quarter of 2026, compared to $14.8 million for the same period 
      in 2025. 
 
   -- Net Loss: Net loss was $53.7 million for the second quarter of 2026, 
      compared to $70.1 million for the same period in 2025. 

About Cullinan Therapeutics

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow Cullinan on LinkedIn and X.

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 clinical development plans and anticipated 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 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.