Cullinan Therapeutics, Inc. - CGEM STOCK NEWS

Cullinan Oncology (Nasdaq: CGEM) announced its participation in the 4th Annual Evercore ISI HealthconX Conference from November 30 to December 2, 2021. CEO Nadim Ahmed will host a virtual fireside chat on December 1 at 2:15 PM ET. The management team will also engage in one-on-one investor meetings throughout the event, with interested investors encouraged to contact their Evercore representatives. Cullinan Oncology specializes in developing targeted oncology therapies aimed at addressing critical health challenges.

Cullinan Oncology, Inc. (CGEM) reported significant updates and financial results for Q3 2021. The company’s cash and investments totaled $445.4 million, supporting its clinical pipeline. The Phase 1/2a trial for CLN-081 in advanced NSCLC is progressing, with a clinical update expected in Q4 2021. Additionally, Cullinan plans to initiate clinical trials for CLN-619 and CLN-049 by year's end. R&D expenses rose to $12.7 million, while G&A expenses increased to $5.7 million, leading to a net loss of $18.3 million.

Cullinan Oncology (Nasdaq: CGEM) has appointed Nadim Ahmed as President and CEO, effective immediately. He succeeds Owen Hughes, who transitions to Strategic Advisor after building the company’s organization and pipeline. Ahmed's extensive oncology experience includes leadership roles at Bristol Myers Squibb and Celgene, where he successfully launched key cancer therapies. The company is advancing its pipeline with plans to initiate clinical trials for its immuno-oncology programs by year-end 2021, while updating on its flagship program, Pearl, in Q4 2021.

Cullinan Oncology, Inc. (Nasdaq: CGEM) announced its participation in two investor conferences. The Morgan Stanley 19th Annual Global Healthcare Conference is scheduled from September 9-15, featuring CEO Owen Hughes in a virtual chat on September 13 at 12:30 PM ET and a corporate update at 4:15 PM ET. Additionally, at the H.C. Wainwright 23rd Annual Global Investment Conference, Chief Development Officer Jennifer Michaelson will discuss engineered cytokines on September 14 from 1:30-3:00 PM ET. Management will also engage in one-on-one meetings.

Cullinan Oncology (Nasdaq: CGEM) reported strong Phase 1 trial results for Cullinan Pearl, showing a disease control rate (DCR) of 92% in the 100mg cohort. The company also achieved IND clearance for two new immuno-oncology programs: Cullinan MICA and Cullinan Florentine, with trial initiations targeted for 2H 2021. Financially, Cullinan maintained a robust cash position of $456.3 million as of June 30, 2021, despite a net loss of $16.4 million for Q2 2021, an increase from the previous year due to rising operational costs.

Cullinan Oncology (Nasdaq: CGEM) will participate in the 41st Annual Canaccord Genuity Growth Conference from August 10 to August 12, 2021. The company’s Chief Financial Officer, Jeff Trigilio, will present on August 12 at 4:00 PM ET, accessible via the conference portal. Additionally, management will conduct one-on-one investor meetings during the event. Cullinan focuses on building a diversified pipeline of therapeutic candidates, emphasizing novel technologies and advanced development stages.

Cullinan Oncology has received FDA clearance for the IND application of CLN-619, a first-in-class monoclonal antibody targeting MICA/B, set to enter human clinical trials in Q3 2021. The antibody aims to promote anti-tumor responses by activating both innate and adaptive immune cells. The initial trial will focus on evaluating CLN-619 as a monotherapy and in combination with checkpoint inhibitors. Preclinical studies show promising results, including significant tumor growth inhibition. The outcome could establish CLN-619 as a novel backbone for immuno-oncology treatments.

Cullinan Oncology (CGEM) announced that the FDA has cleared its IND application for CLN-049, a bispecific antibody targeting FLT3 and CD3 for treating relapsed/refractory acute myeloid leukemia (AML). The IND clearance allows Cullinan to initiate human dosing of CLN-049, emphasizing its potential to offer a differentiated treatment approach. Preclinical studies demonstrated that CLN-049 effectively killed leukemic cells and provided survival benefits in various models. This advancement reinforces Cullinan's strategy to develop innovative oncology treatments.

Cullinan Oncology (CGEM) announced promising results from the Phase 1/2a trial of CLN-081 in patients with Non-Small Cell Lung Cancer (NSCLC) harboring EGFR exon 20 insertion mutations. The trial saw an objective response rate of 46% at the 100 mg BID dose, with no Grade 3 treatment-related adverse events (TRAEs) for diarrhea or rash at doses below 150 mg. This ongoing study allows the enrollment of up to 36 patients in the Phase 2a expansion, indicating strong potential for CLN-081's future development in addressing significant unmet medical needs.