Amivantamab-VMJM

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 and announced its financial results for the first quarter ended March 31, 2026. “T cell engagers have the potential to transform outcomes for people living with autoimmune diseases and cancer, and emerging clinical data underscore their promise as a compelling therapeutic modality. We look forward to sharing initial clinical data for CLN-978 and velinotamig throughout 2026. CD19 and BCMA are now well-validated autoimmune targets, and by addressing both, we aim to comprehensively treat more diseases and redefine standards of care for more patients with these two clinical-stage programs. Similarly, the early success of CLN-049 in AML further reinforces the remarkable promise of T cell engagers in many high unmet need disease settings across immunology and oncology,” said Nadim Ahmed, President and CEO of Cullinan Therapeutics. “Further, with our partner Taiho, we announced FDA acceptance of our first NDA submission, representing a significant milestone for Cullinan Therapeutics and bringing zipalertinib meaningfully closer to being available for patients, with a PDUFA date of February 27, 2027. With multiple upcoming catalysts and milestones across the pipeline through 2026 and beyond, the company is well-positioned for continued momentum and 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 In June, the Company will share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, as well as other biomarker data and preliminary clinical activity data. The initial data will be presented in a poster session at the EULAR 2026 Congress on June 6, 2026. OUTRACE RA In June, the Company will share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data. The initial data will be presented in a poster session at the EULAR 2026 Congress on June 6, 2026. In Q3 2026, the Company plans to share initial multi-dose regimen data, including B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data. OUTRACE SjD In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data. Velinotamig (BCMAxCD3 T cell engager): treatment-refractory autoimmune diseases Genrix Bio is enrolling a Phase 1 study in China in patients with autoimmune diseases, starting with moderate to severe SLE and to be followed by planned expansion into other indications. Initial multi-dose regimen data from the dose escalation phase in patients with SLE are expected to be shared in Q4 2026. Cullinan intends to use the data generated to accelerate global clinical development. Oncology CLN-049 (FLT3xCD3 T cell engager): acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) 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 H2 2026. Dose level expansion continues in order to determine the recommended Phase 2 dose (RP2D) by Q4 2026 for a potential single-arm pivotal registrational trial. In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in patients with previously untreated AML. Enrollment continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy. 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. First Quarter 2026 Financial Results Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $393.3 million as of March 31, 2026. Cullinan expects its cash resources to provide runway into 2029 under its current operating plan. R&D Expenses: Research and development expenses were $42.1 million for the first quarter of 2026, compared to $41.5 million for the same period in 2025. G&A Expenses: General and administrative expenses were $11.6 million for the first quarter of 2026, compared to $13.5 million for the same period in 2025. Net Loss: Net loss was $49.7 million for the first quarter of 2026, compared to $48.5 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, high-impact therapies 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 , 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 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 the United States Food and Drug Administration or other global regulatory agencies are not cleared or approved 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) March 31, 2026 December 31, 2025 Cash, cash equivalents, investments, and interest receivable $ 393,282 $ 438,960 Total assets $ 402,984 $ 448,374 Total current liabilities $ 35,154 $ 37,741 Total liabilities $ 36,812 $ 39,644 Total stockholders’ equity $ 366,172 $ 408,730 Cullinan Therapeutics, Inc. Consolidated Statements of Operations (unaudited) (in thousands, except per share amounts) Three Months Ended March 31, 2026 2025 Operating expenses: Research and development $ 42,123 $ 41,459 General and administrative 11,574 13,537 Total operating expenses 53,697 54,996 Loss from operations (53,697 ) (54,996 ) Other income (expense): Interest income 4,098 6,580 Other income (expense), net (62 ) (85 ) Net loss $ (49,661 ) $ (48,501 ) Basic and diluted net loss per share: Common stock $ (0.75 ) $ (0.74 ) Preferred stock $ (7.52 ) $ (7.42 ) Weighted-average shares used in computing net loss per share: Common stock 60,462 58,905 Preferred stock 555 648 Contacts: Investors Nick Smith +1 401.241.3516 nsmith@cullinantx.com Media Rose Weldon +1 215.801.7644 rweldon@cullinantx.com

Announced selection of rinzimetostat RP3D in combination with darolutamide for Himalayas-1 Phase 3 global registrational trial in post-abiraterone mCRPC, expected to initiate in 1H 2026 Reported rinzimetostat data in post-abiraterone mCRPC supporting potential best-in-disease profile, including a highly differentiated safety profile and landmark rPFS consistent with competitor PRC2 inhibitor and substantially better than standard of care therapies in mCRPC Reported early rinzimetostat data in post-AR inhibitor mCRPC, demonstrating promising durability and reinforcing rinzimetostat’s potential to restore and sustain the benefit derived from AR inhibitors Anticipate rinzimetostat program update in 2H 2026 and several enozertinib clinical updates in 2H 2026 ahead of potential initiation of a registrational trial Cash and investments of approximately $420 million expected to provide runway into 2H 2028 and beyond anticipated primary endpoint readout from first Phase 3 trial for rinzimetostat SOUTH SAN FRANCISCO and SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and provided operational updates for the quarter ended March 31, 2026. “The first quarter marked a pivotal step for ORIC as we selected our Phase 3 dose for rinzimetostat, reported data supporting a potential best-in-disease profile, and moved toward the initiation of Himalayas-1, our first registrational trial,” said Jacob M. Chacko, M.D., president and chief executive officer. “With a strong cash position and multiple enozertinib clinical updates expected later this year, we see a clear path to building ORIC into a multi-asset, late-stage oncology company.” First Quarter 2026 and Other Recent Highlights Rinzimetostat: a potent and selective allosteric inhibitor of PRC2 Announced the selection of rinzimetostat 400 mg once daily as the Recommended Phase 3 Dose (RP3D) in combination with darolutamide for the Himalayas-1 Phase 3 global trial in post-abiraterone mCRPC. Reported rinzimetostat dose optimization data in post-abiraterone mCRPC supporting potential best-in-disease profile. As of the March 2026 presentation cutoff dates, rinzimetostat 400 mg once daily in combination with darolutamide demonstrated compelling safety and efficacy across multiple endpoints: The vast majority of treatment-related adverse events (TRAEs) were Grade 1 in severity and consistent with PRC2 and androgen receptor (AR) inhibition. A single Grade 3 TRAE was observed, and no Grade 4 or 5 AEs were attributed to rinzimetostat or darolutamide. Dose modifications were rare (one interruption and one discontinuation), with no dose reductions required. With a median follow up of 4.9 months, landmark rPFS rates of 93%, 84%, and 84% at 3, 4, and 5 months, respectively, are consistent with the competitor PRC2 inhibitor currently in Phase 3 in post-abiraterone mCRPC patients and superior to available standard-of-care therapies, including Xtandi®, Jevtana®, Taxotere®, and Pluvicto®. For reference, the 5-month landmark rPFS for these approved therapies ranges from approximately 60% to 75%. 47% of patients (7/15) achieved a PSA50 response, with 33% (5/15) confirmed. Impressive ctDNA reductions observed across a range of AR mutations, with 71% of patients (10/14) achieving >50% ctDNA reduction. Reported early rinzimetostat dose optimization data in patients with mCRPC previously treated with AR inhibitors. Rinzimetostat 400 mg once daily in combination with the AR inhibitor darolutamide demonstrated compelling landmark rPFS rates of 93%, 85%, and 85% at 3, 4, and 5 months, respectively, with a median follow-up of 4.8 months. For reference, the clinical benefit of androgen receptor pathway inhibitors in this setting is limited; for example, Zytiga® has demonstrated a median rPFS of 3.4 months. Presented preclinical data at AACR showing PRC2 inhibition reduces tumor adaptability and sustains the benefit derived from AR inhibition, with potential advantages of EED over EZH2 inhibition. The vast majority of treatment-related adverse events (TRAEs) were Grade 1 in severity and consistent with PRC2 and androgen receptor (AR) inhibition. A single Grade 3 TRAE was observed, and no Grade 4 or 5 AEs were attributed to rinzimetostat or darolutamide. Dose modifications were rare (one interruption and one discontinuation), with no dose reductions required. With a median follow up of 4.9 months, landmark rPFS rates of 93%, 84%, and 84% at 3, 4, and 5 months, respectively, are consistent with the competitor PRC2 inhibitor currently in Phase 3 in post-abiraterone mCRPC patients and superior to available standard-of-care therapies, including Xtandi®, Jevtana®, Taxotere®, and Pluvicto®. For reference, the 5-month landmark rPFS for these approved therapies ranges from approximately 60% to 75%. 47% of patients (7/15) achieved a PSA50 response, with 33% (5/15) confirmed. Impressive ctDNA reductions observed across a range of AR mutations, with 71% of patients (10/14) achieving >50% ctDNA reduction. Enozertinib: a brain-penetrant, selective inhibitor targeting EGFR exon 20 insertion mutations and EGFR atypical mutations Completed enrollment in the Phase 1b trial of enozertinib as a single-agent in first-line patients with advanced NSCLC harboring EGFR exon 20 insertion mutations. Continue to enroll Phase 1b trial of enozertinib as a single-agent in first-line patients with advanced NSCLC harboring EGFR atypical mutations. Continue to enroll Phase 1b trial of enozertinib in combination with subcutaneous (SC) amivantamab in first-line patients with advanced NSCLC harboring EGFR exon 20 insertion mutations. Anticipated Program Milestones: ORIC anticipates the following upcoming milestones: Rinzimetostat in mCRPC: 1H 2026: Initiate Himalayas-1 global Phase 3 registrational trial in post-abiraterone mCRPC 2H 2026: Program update Enozertinib in NSCLC: 2H 2026: 1L EGFR atypical monotherapy data 2H 2026: 1L EGFR exon 20 insertion monotherapy data and combination data with SC amivantamab 1H 2026: Initiate Himalayas-1 global Phase 3 registrational trial in post-abiraterone mCRPC 2H 2026: Program update 2H 2026: 1L EGFR atypical monotherapy data 2H 2026: 1L EGFR exon 20 insertion monotherapy data and combination data with SC amivantamab First Quarter 2026 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $419.7 million as of March 31, 2026, which includes $59.9 million in net proceeds raised from healthcare specialist funds during the quarter under the ATM (at-the-market) program. The company expects its cash and investments to fund the operating plan into 2H 2028. R&D Expenses: Research and development (R&D) expenses were $31.4 million for the three months ended March 31, 2026, compared to $24.6 million for the three months ended March 31, 2025, an increase of $6.8 million. The increase was primarily due to an increase in external expenses related to the advancement of rinzimetostat and enozertinib, offset primarily by lower preclinical costs. G&A Expenses: General and administrative (G&A) expenses were $8.2 million for the three months ended March 31, 2026, relatively consistent with $8.1 million for the three months ended March 31, 2025. About ORIC Pharmaceuticals, Inc. ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain-penetrant inhibitor targeting EGFR exon 20 insertion and EGFR atypical mutations, being developed for NSCLC. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the continued clinical development of rinzimetostat and enozertinib; the potential advantages of rinzimetostat and enozertinib; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; statements regarding the potential best-in-disease profile of rinzimetostat; the development plans and timelines for rinzimetostat and enozertinib; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of a registrational trial; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; and statements by the company’s chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of rinzimetostat, enozertinib or any other product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements or its clinical trial collaboration and supply agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on May 4, 2026, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Contact: Dominic Piscitelli, Chief Financial Officer dominic.piscitelli@oricpharma.com info@oricpharma.com All registered trademarks are the property of their respective owners.