Core Insights - Cullinan Therapeutics, Inc. is participating in the Stifel 2024 Healthcare Conference, highlighting its focus on developing targeted therapies [1][2] Company Overview - Cullinan Therapeutics is a biopharmaceutical company dedicated to creating new standards of care for patients, with a diversified portfolio of clinical-stage assets targeting autoimmune diseases and cancer [3] - The company employs a modality-agnostic approach, aiming to develop transformative therapeutics by inhibiting key disease drivers or harnessing the immune system [3] - Cullinan's strategy includes rigorous candidate selection and development processes to fast-track promising molecules to clinical trials and commercialization [3]

Core Viewpoint - Cullinan Therapeutics has received FDA clearance for its Investigational New Drug application for CLN-978, marking it as the first CD19 T cell engager in development for autoimmune diseases, specifically targeting systemic lupus erythematosus (SLE) [1][4]. Group 1: Clinical Trial Details - The global Phase 1 clinical trial will assess CLN-978 in patients with moderate to severe SLE, specifically those with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater and who have not responded adequately to at least two prior treatments [2]. - The trial consists of two parts: Part A is a dose escalation phase starting at 10 micrograms to determine the target dose, while Part B will explore multiple dose schedules based on data from Part A [2]. Group 2: Objectives and Mechanism - The primary objective of the study is to evaluate the safety of CLN-978 for treating active moderate to severe SLE, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity [3]. - CLN-978 is a bispecific T cell engager designed to target CD19, facilitating the lysis of CD19-expressing cells, and is engineered for high affinity binding to efficiently target B cells, including those with low CD19 levels [5]. Group 3: Market Need and Company Background - There is a significant unmet medical need for effective treatments in SLE, as current therapies often fail to control disease activity and prevent long-term organ damage [4]. - Cullinan Therapeutics is focused on developing targeted therapies across various modalities for autoimmune diseases and cancer, aiming to create new standards of care [7].

Core Insights - Updated data indicates a consistent objective response rate (ORR) of 40% and a manageable safety profile for zipalertinib in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have progressed after prior amivantamab treatment [1][4] - The pivotal Phase 2b trial has completed enrollment ahead of schedule, originally planned for the end of 2024 [5] Clinical Trial Data - As of March 29, 2024, 45 patients were enrolled, with a median of three prior systemic anti-cancer regimens received [2] - Among 30 evaluable patients, 1 patient (3%) achieved a complete response (CR), 11 patients (37%) had a partial response (PR), and 15 patients (50%) had stable disease (SD) [3] - The confirmed ORR for Module C was 40%, compared to 41% in the previously reported Phase 1/2a results [4] Safety Profile - Zipalertinib demonstrated a manageable safety profile, with the most common treatment-related adverse events being rash (38%), paronychia (36%), anemia (24%), dry skin (20%), dermatitis acneiform (16%), nausea (16%), and stomatitis (11%) [4] Company and Product Overview - Zipalertinib is an orally available small molecule designed to target activating mutations in EGFR, specifically engineered to inhibit EGFR variants with exon 20 insertion mutations while sparing wild-type EGFR [8] - Cullinan Therapeutics has a partnership with Taiho, which includes an upfront cash payment of $275 million and potential additional payments totaling $130 million for U.S. regulatory milestones [7] - The company retains a 50/50 profit share in the U.S. for zipalertinib [7] Future Development - Cullinan and Taiho have a broad development program for zipalertinib, including ongoing pivotal studies in first-line and second-line NSCLC, as well as studies in other patient populations [6]

Core Insights - Cullinan Therapeutics, Inc. is actively participating in investor conferences to enhance visibility and engagement with stakeholders [1][2] Company Overview - Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company focused on developing targeted therapies that are modality-agnostic [3] - The company has built a diversified portfolio of clinical-stage assets aimed at inhibiting key disease drivers and harnessing the immune system for treating autoimmune diseases and cancer [3] - Cullinan's approach includes rigorous candidate selection and development processes to fast-track promising therapeutic molecules [3] Upcoming Events - The CEO and CMO of Cullinan will participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024 [1] - Additionally, they will engage in a fireside chat at the 2024 Cantor Global Healthcare Conference on September 19, 2024 [2] - Webcasts of these events will be available on the company's investor relations website [2]

Financial Position - The company has received net proceeds of $842.2 million from equity financings as of June 30, 2024[48]. - As of June 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $664.9 million[48]. - Net cash used in operating activities for the first half of 2024 was $74.5 million, an improvement from $82.0 million in the same period of 2023[56]. - Net cash provided by financing activities in the first half of 2024 was $263.3 million, significantly higher than $40.4 million in the same period of 2023, primarily due to a private placement[56]. - The company completed a private placement in April 2024, raising $262.7 million after deducting offering costs[55]. - The company has sold approximately 3.3 million shares under its at-the-market equity offering program, receiving net proceeds of $38.4 million as of June 30, 2024[55]. - As of June 30, 2024, total future minimum lease payments were $3.0 million, with $1.4 million payable within twelve months[61]. - The market value of the company's common stock held by non-affiliates exceeded $700 million as of June 30, 2024[62]. Operating Losses and Deficits - The company reported an accumulated deficit of $280.0 million as of June 30, 2024, and expects to continue generating operating losses for the foreseeable future[48]. - The company has not generated any revenue from product sales since inception and does not expect to do so in the near future[49]. - The company has not yet commercialized any products and does not expect to generate revenue from product sales for several years[55]. - Net loss for Q2 2024 was $42.0 million, compared to a net loss of $32.2 million in Q2 2023, reflecting a 30% increase in losses[55]. Research and Development - The company plans to submit an IND application for CLN-978 in patients with systemic lupus erythematosus in Q3 2024[46]. - Preliminary clinical data for CLN-619 showed a clinical benefit rate of 41.4% across multiple tumor types, with one complete response and two partial responses observed[47]. - The ongoing Phase 1 clinical trial of CLN-049 is investigating its use in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome[47]. - Research and development expenses for Q2 2024 increased by $8.9 million (24%) to $36.3 million compared to Q2 2023, driven by higher clinical, CMC, and preclinical costs[55]. Expenses and Future Funding - General and administrative expenses for Q2 2024 rose by $3.6 million (35%) to $13.8 million compared to Q2 2023, primarily due to increased equity-based compensation and personnel costs[55]. - The company expects ongoing increases in expenses related to clinical trials, manufacturing, and public company operations, necessitating potential future funding[59]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute current ownership interests[60]. - The company is unable to estimate exact working capital requirements due to numerous risks and uncertainties associated with research, development, and commercialization of product candidates[60]. Licensing and Collaboration Agreements - The company terminated the Harbour License Agreement for CLN-418, effective November 2024, and will discontinue its development[44]. - The company has certain payment obligations under license and collaboration agreements, contingent upon achieving specified development, clinical, regulatory, and commercial milestones[61]. - The company may have to relinquish valuable rights to technologies or future revenue streams if additional funds are raised through collaborations or licensing arrangements[60]. Regulatory and Compliance - The company qualifies as an "emerging growth company" and will cease this status as of December 31, 2024, requiring the adoption of all new accounting pronouncements[62]. - The company is subject to new requirements under the Sarbanes-Oxley Act due to its status change from an emerging growth company[62]. - Recently issued accounting pronouncements that may impact financial position and results of operations are disclosed in the quarterly report[63]. - The company has not materially changed its critical accounting policies from those described in the 2023 10-K[61].

Exhibit 99.1 Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results 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 ...

Core Insights - Cullinan Therapeutics announced positive initial data for zipalertinib in patients previously treated with amivantamab in the pivotal Phase 2b REZILIENT1 clinical trial [1][4] - The drug demonstrated promising efficacy and a manageable safety profile, comparable to results seen in patients who progressed after platinum-based chemotherapy [4][5] Patient Data and Efficacy - As of January 12, 2024, 31 patients were enrolled, with a median of three prior systemic anti-cancer regimens [2] - Among 18 evaluable patients, the objective response rate (ORR) was 39%, and the disease control rate (DCR) was 94%, similar to the Phase 1/2a results where ORR was 41% and DCR was 97% [3] Safety Profile - Zipalertinib exhibited a manageable safety profile, with no grade 4 or grade 5 treatment-related adverse events reported [3] Development and Partnerships - The company has a comprehensive development plan for zipalertinib, which includes ongoing pivotal studies in first-line and second-line treatment for non-small cell lung cancer (NSCLC) [4][5] - Cullinan entered a partnership with Taiho in 2022, involving an upfront payment of $275 million and additional payments totaling $130 million for regulatory approvals in the U.S. [4] Future Plans - Enrollment for the pivotal Phase 1/2b REZILIENT1 trial is expected to be completed by the end of 2024 [5] - An investor event is scheduled to present the zipalertinib data, indicating ongoing engagement with stakeholders [6][7]

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 ...