Cullinan Oncology Inc - CGEM STOCK NEWS

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.

Cullinan Oncology (Nasdaq: CGEM) announced that Jon Wigginton, M.D. will step down as Chief Medical Officer to assume the role of Chairman of the Scientific Advisory Board and Senior Advisor to the CEO. CEO Owen Hughes acknowledged Wigginton's significant contributions to the company's transition to a clinical-stage biotech and the establishment of its clinical infrastructure. Wigginton expressed his enthusiasm to continue working closely with Cullinan's team to advance their innovative cancer therapies.

Cullinan Oncology (Nasdaq: CGEM) has announced a clinical update on its investigational oral EGFR inhibitor, CLN-081, during a webinar on June 4, 2021. The update will review safety and efficacy results from an ongoing Phase 1/2a trial for Non-Small Cell Lung Cancer (NSCLC) patients with EGFR Exon 20 insertion mutations. Data from this trial will also be presented at the 2021 ASCO Annual Meeting. The webinar and poster will take place on the same day, with the poster accessible for on-demand viewing starting at 9:00 am ET.

Cullinan Oncology, Inc. (Nasdaq: CGEM) reported its Q1 2021 financial results, highlighting cash reserves of $473 million as of March 31, 2021, significantly up from $210.2 million at year-end 2020. The company initiated a Phase 2a expansion of its Cullinan Pearl trial for NSCLC patients with EGFRex20ins mutations and plans to present updated data at the 2021 ASCO Annual Meeting. Q1 expenses included $12.4 million in R&D and $5.2 million in G&A. Net income was reported at $1.4 million, driven by $18.9 million revenue from its license agreement with Zai Lab.

Cullinan Oncology (Nasdaq: CGEM) has announced that CFO Jeff Trigilio will present at the 20th Annual Needham Virtual Healthcare Conference on April 13, 2021, at 11:45 am EDT. The presentation will be accessible only to registered attendees through the Needham conference portal. Interested investors can schedule meetings with Trigilio by contacting their Needham representative. Cullinan Oncology is focused on developing a diversified pipeline of targeted and immuno-oncology therapeutic candidates to drive shareholder returns.