CAMBRIDGE, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that Nadim Ahmed, Chief Executive Officer and Jeffrey Jones, MD, MBA, Chief Medical Officer, will participate in a fireside chat at the TD Cowen 5th Annual Oncology Innovation Summit: Insights for ASCO & EHA, being held virtually on May 28 and 29, 2024. The fireside chat is scheduled for Wednesday, May 29, 2024 a ...

Preliminary data from CLN-619 in combination with checkpoint inhibitor pembrolizumab show objective responses in patients with tumor types that are typically unresponsive to pembrolizumab, such as non-small cell lung cancer (NSCLC) with oncogenic mutations Longer term follow-up for patients treated with CLN-619 monotherapy demonstrates durable clinical benefit across multiple tumor types CLN-619 continues to demonstrate a favorable safety profile and is well tolerated both as monotherapy and in combination ...

Net Loss Attributable to Noncontrolling Interests Net loss attributable to noncontrolling interests is determined as the difference in the noncontrolling interests in the consolidated balance sheets between the start and end of each reporting period, after taking into account any capital transactions between our development subsidiaries and third parties. 14 Liquidity and Capital Resources Overview We have a history of significant operating losses and have had negative cash flows from operations since our i ...

[Portfolio Highlights](index=1&type=section&id=Portfolio%20Highlights) Cullinan Therapeutics provided updates on its clinical portfolio, including a strategic shift for CLN-978 to autoimmune diseases and key milestones for CLN-619 and Zipalertinib [CLN-619 (Anti-MICA/MICB monoclonal antibody)](index=1&type=section&id=CLN-619%20(Anti-MICA%2FMICB%20monoclonal%20antibody)) Initial combination and monotherapy dose escalation data for CLN-619 will be presented at ASCO 2024, with disease-specific expansion cohort data expected in H1 2025 - Initial combination and updated monotherapy dose escalation data will be presented in a poster session at the ASCO Annual Meeting on June 1, 2024[21](index=21&type=chunk) - The company remains on track to report initial data from disease-specific dose expansion cohorts in the first half of 2025[21](index=21&type=chunk) [CLN-978 (CD19xCD3 T cell engager)](index=1&type=section&id=CLN-978%20(CD19xCD3%20T%20cell%20engager)) CLN-978 development now focuses exclusively on autoimmune diseases, with SLE as the initial indication, following positive B-NHL study observations and planned Q3 2024 IND submission - Development focus has shifted exclusively to autoimmune diseases, with SLE as the initial indication[20](index=20&type=chunk)[23](index=23&type=chunk)[27](index=27&type=chunk) - An IND application for SLE is planned for submission in the third quarter of 2024[23](index=23&type=chunk) - Enrollment in the B-cell non-Hodgkin lymphoma (B-NHL) study has been discontinued to prioritize development in autoimmune diseases[23](index=23&type=chunk) - Recent clinical observations in the B-NHL study showed CLN-978 is clinically active with a favorable safety profile at its initial dose[22](index=22&type=chunk) [Zipalertinib (EGFR ex20ins inhibitor)](index=2&type=section&id=Zipalertinib%20(EGFR%20ex20ins%20inhibitor)) Cullinan expects to complete enrollment in the pivotal Phase 2b REZILIENT1 study for EGFR ex20ins NSCLC by year-end 2024 - Enrollment in the pivotal Phase 2b REZILIENT1 study is expected to be completed by year-end 2024[1](index=1&type=chunk) [Other Pipeline Programs](index=2&type=section&id=Other%20Pipeline%20Programs) Clinical data updates for CLN-049 in AML/MDS and CLN-418 in solid tumors are expected in H2 2024, with ongoing enrollment for CLN-617 Phase 1 study - A clinical data update for CLN-049 (FLT3xCD3) in r/r AML and MDS patients is expected in the second half of 2024[2](index=2&type=chunk)[16](index=16&type=chunk) - A clinical data update for CLN-418 (B7H4x4-1BB) from the Phase 1 dose escalation study in advanced solid tumors is expected in the second half of 2024[5](index=5&type=chunk)[16](index=16&type=chunk) - Enrollment continues in the ongoing Phase 1 study of CLN-617 (IL-2 and IL-12 cytokine fusion protein) in patients with advanced solid tumors[6](index=6&type=chunk) [Corporate Updates](index=3&type=section&id=Corporate%20Updates) Cullinan announced key leadership appointments, a strategic expansion into autoimmune diseases with a name change, and strengthened its financial position via a **$280 million** private placement - David Meek was appointed to the Board of Directors, effective May 15[7](index=7&type=chunk) - In April, the company appointed Mary Kay Fenton as Chief Financial Officer[9](index=9&type=chunk) - The company announced its strategic expansion into autoimmune diseases and changed its name to Cullinan Therapeutics[7](index=7&type=chunk) - Completed an oversubscribed **$280 million** private placement sale of common stock in April[8](index=8&type=chunk) [First Quarter 2024 Financial Results](index=3&type=section&id=First%20Quarter%202024%20Financial%20Results) Cullinan reported a Q1 2024 net loss of **$37.3 million**, an improvement from Q1 2023, driven by lower R&D expenses, ending with **$434.8 million** cash and an extended runway into 2028 - Cash, cash equivalents, investments, and interest receivable were **$434.8 million** as of March 31, 2024[10](index=10&type=chunk) - The company expects its cash resources to provide runway into 2028, bolstered by the April 2024 private placement[10](index=10&type=chunk)[25](index=25&type=chunk) Key Financial Metrics | Metric | Q1 2024 ($M) | Q1 2023 ($M) | Key Driver of Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $30.6 | $52.1 | Decrease primarily due to a one-time upfront in-licensing fee in 2023 | | G&A Expenses | $12.3 | $10.7 | Increase driven by personnel costs and non-cash equity-based compensation | | Net Loss | $37.3 | $58.1 | Reduction driven by lower R&D expenses | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported a Q1 2024 net loss of **$37.1 million** or **($0.86)** per share, an improvement from Q1 2023, primarily due to reduced research and development expenses | (in thousands, except per share amounts) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $30,646 | $52,096 | | General and administrative | $12,343 | $10,660 | | **Total operating expenses** | **$42,989** | **$62,756** | | **Loss from operations** | **($42,989)** | **($62,756)** | | Interest income | $5,693 | $4,508 | | **Net loss** | **($37,340)** | **($58,141)** | | Net loss per share (Basic and diluted) | ($0.86) | ($1.42) | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, Cullinan Therapeutics reported total assets of **$449.4 million**, total stockholders' equity of **$425.7 million**, and **$434.8 million** in cash, equivalents, investments, and interest receivable | (in thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, investments, and interest receivable | $434,827 | $468,264 | | Total assets | $449,430 | $484,182 | | Total liabilities | $23,765 | $30,287 | | Total stockholders' equity | $425,665 | $453,895 |

CAMBRIDGE, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on modality-agnostic targeted therapies, today announced the appointment of Mary Kay Fenton as Chief Financial Officer, beginning April 29. "I am pleased to welcome Mary Kay to Cullinan Therapeutics as Chief Financial Officer. This is a pivotal time for Cullinan as we expand into autoimmune diseases and continue to advance our clinical-stage oncology portfolio," said Nadim Ahme ...

CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on modality-agnostic targeted therapies, today announced that clinical data from its Phase 1 trial of CLN-619 in patients with advanced solid tumors will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31-June 4, 2024. The data will include first results from the dose escalation cohort of CLN-619 in combinati ...

CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted therapies, today announced that clinical data from its Phase 1 trial of CLN-619 in patients with advanced solid tumors will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31-June 4, 2024. The data will include first results from the dose escalation cohort of CLN-619 in combinat ...

CLN-978 clinical development to focus exclusively on autoimmune diseases, pursuing systemic lupus erythematosus as a first indication Clinical observations from CLN-978 B-NHL study show rapid, deep, and sustained B cell depletion and clinical activity Corporate name change to Cullinan Therapeutics reflects strategic expansion into autoimmune diseases Cullinan Therapeutics to host a virtual investor event taking place on April 16 at 8:00 am ET CAMBRIDGE, Mass., April 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Th ...

PART III Item 10. Directors, Executive Officers and Corporate Governance 115 Item 11. Executive Compensation 118 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 125 Item 13. Certain Relationships and Related Transactions, and Director Independence 129 Item 14. Principal Accountant Fees and Services 131 Unless otherwise stated or the context indicates otherwise, all references herein to "Cullinan," "Cullinan Oncology, Inc.," "we," "us," "our," "our comp ...

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 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 business highlights and announced its finan ...