Cullinan Therapeutics, Inc. - CGEM STOCK NEWS

Cullinan Therapeutics (NASDAQ: CGEM) reported Q3 2024 financial results and corporate updates. The company received regulatory clearances to initiate a global Phase 1 study of CLN-978 in systemic lupus erythematosus, with initial data expected in Q4 2025. Their oncology pipeline is advancing with CLN-619's expansion cohort data in endometrial and cervical cancers expected in Q2 2025, and zipalertinib's pivotal Phase 2b study completed enrollment ahead of schedule. Financial highlights include cash position of $639.0 million, R&D expenses of $35.5 million, and a net loss of $40.6 million ($0.69 per share) for Q3 2024.

Cullinan Therapeutics (Nasdaq: CGEM) announced its participation in the Stifel 2024 Healthcare Conference in New York. The company's CEO Nadim Ahmed and CMO Jeffrey Jones will engage in a fireside chat on Tuesday, November 19, 2024, at 1:50 p.m. ET. The event will be accessible via webcast through the company's investor relations website under the Events and Presentations section. Cullinan is a biopharmaceutical company that specializes in developing modality-agnostic targeted therapies.

Cullinan Therapeutics announced upcoming presentation of preclinical data for CLN-978, a CD19xCD3 bispecific T cell engager, at ACR Convergence 2024 in Washington, D.C. The data demonstrates CLN-978's high potency in B cell depletion, supporting its development for autoimmune diseases. The company recently received FDA clearance for its Phase 1 clinical trial investigating CLN-978 for systemic lupus erythematosus (SLE) in the U.S., following previous HREC approval in Australia. An investor event featuring management discussions and clinical thought leaders will be held on November 16, 2024.

Cullinan Therapeutics (Nasdaq: CGEM) announced FDA clearance of its Investigational New Drug (IND) Application for CLN-978, allowing its global Phase 1 clinical trial to proceed in the U.S. for patients with moderate to severe systemic lupus erythematosus (SLE). CLN-978 is the first development stage CD19 T cell engager to receive FDA IND clearance in autoimmune diseases.

The trial will enroll patients with a SLEDAI score of 8 or greater who have had inadequate response to at least two treatments. It consists of Part A (dose escalation) and Part B (dose expansion). The primary objective is to evaluate CLN-978's safety, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity.

Cullinan Therapeutics aims to address the unmet medical need in SLE patients, as current therapies often fail to fully control disease activity and prevent long-term organ damage. CLN-978 offers a novel approach with off-the-shelf access and convenient subcutaneous dosing.

Cullinan Therapeutics (Nasdaq: CGEM) has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate its global Phase 1 clinical trial for CLN-978, a CD19xCD3 bispecific T cell engager, in treating systemic lupus erythematosus (SLE). The trial will assess safety, pharmacokinetics, and initial clinical activity of CLN-978 in SLE patients, which affects approximately 430,000 individuals globally. The study will be conducted across multiple sites in Australia and other countries worldwide.

CLN-978 is designed to deliver T cell-directed potency with off-the-shelf access and convenient dosing, potentially offering a best-in-class treatment for SLE. This approval marks a significant step in Cullinan's global clinical development strategy for autoimmune diseases. The company has also submitted an Investigational New Drug Application to the U.S. FDA for this study.

Cullinan Therapeutics (Nasdaq: CGEM) has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CLN-978, a CD19xCD3 bispecific T cell engager, to treat systemic lupus erythematosus (SLE). This marks a significant step towards advancing their global study of CLN-978 in SLE within the United States.

SLE affects over 160,000 people in the U.S., according to CDC estimates. Current treatments do not typically induce treatment-free remission, with most patients requiring lifelong immune suppression. CLN-978 is a novel, highly potent, half-life extended bispecific T cell engager that could potentially offer a disease-modifying, off-the-shelf option for SLE patients.

Cullinan Therapeutics (CGEM) presented updated data from Module C of the pivotal Phase 2b REZILIENT1 trial for zipalertinib at ESMO 2024. The study focused on patients with NSCLC harboring EGFR exon 20 insertion mutations who progressed after amivantamab treatment. Key findings include:

- 40% objective response rate (ORR) in 30 evaluable patients
- 90% disease control rate (DCR)
- 9.7 months median progression-free survival (PFS)
- Manageable safety profile with mostly grade 1/2 adverse events

The pivotal Phase 2b trial completed enrollment ahead of schedule. Cullinan's partnership with Taiho involves a $275M upfront payment and potential for $130M in additional regulatory milestones, with a 50/50 profit share in the U.S.

Cullinan Therapeutics (Nasdaq: CGEM), a biopharmaceutical company developing targeted therapies, has announced its participation in two upcoming investor conferences. CEO Nadim Ahmed and CMO Jeffrey Jones will engage in fireside chats at:

• The Morgan Stanley 22nd Annual Global Healthcare Conference in New York on September 5, 2024, at 4:05 p.m. EDT
• The 2024 Cantor Global Healthcare Conference in New York on September 19, 2024, at 10:20 a.m. EDT

Webcasts of both fireside chats will be accessible on Cullinan's investor relations website under the Events and Presentations section.

Cullinan Therapeutics (CGEM) provided a corporate update and Q2 2024 financial results. Key highlights include:

1. On track to file IND for CLN-978 in SLE in Q3 2024
2. Pursuing rheumatoid arthritis as second autoimmune indication for CLN-978
3. Presented promising CLN-619 combination therapy data at ASCO
4. Appointed Mary Thistle to Board of Directors
5. Cash position of $664.9 million as of June 30, 2024
6. Q2 2024 R&D expenses increased to $36.3 million
7. Q2 2024 net loss of $42.0 million
8. Discontinuing development of CLN-418

The company expects its cash resources to provide runway into 2028 based on current operating plans.