Cargo Therapeutics Stock Price, News & Analysis

CARGO Therapeutics (NASDAQ: CRGX) announced the discontinuation of FIRCE-1, its Phase 2 clinical study of firi-cel for large B-cell lymphoma patients resistant to CD19 CAR T-cell therapy. The decision follows an ad hoc analysis showing unfavorable benefit-risk profile, with data from 51 patients showing 77% overall response rate and 43% complete response rate, but only 18% durability at three months.

The study revealed concerning safety data, with 18% of patients developing severe immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS), including grade 4 and 5 serious adverse events. In response, CARGO will implement a 50% workforce reduction to preserve cash. The company will continue advancing CRG-023, its tri-specific CAR T, into Phase 1 trials and develop its allogeneic platform while evaluating strategic options. With $368.1 million in preliminary cash as of December 31, 2024, CARGO expects to extend its runway into mid-2028.

CARGO Therapeutics has provided a corporate update and outlined anticipated milestones for 2025. As of December 31, 2024, 71 patients have been dosed in the potentially pivotal Phase 2 clinical study of firicabtagene autoleucel (firi-cel). Interim analysis results are expected in the first half of 2025. The FDA has cleared the IND application for CRG-023, CARGO’s tri-specific CAR T-cell therapy, with Phase 1 study enrollment expected to begin mid-2025. Additionally, CARGO has announced a novel allogeneic platform designed to limit immune-based rejection of CAR T-cell therapies. This platform aims to convert autologous CAR T-cell therapies into allogeneic products for broader patient benefit.

Financially, CARGO reported preliminary cash, cash equivalents, and marketable securities of $368.1 million as of December 31, 2024, which is expected to fund operations through 2026. Gina Chapman, President and CEO, emphasized the company’s progress and future potential at the 43rd Annual J.P. Morgan Healthcare Conference.

CARGO Therapeutics (NASDAQ: CRGX), a clinical-stage biotech company focused on developing next-generation cell therapies for cancer patients, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The conference will take place from January 13-16, 2025, in San Francisco, California.

President and CEO Gina Chapman will deliver a presentation on Monday, January 13, at 10:30 a.m. PT. The presentation will be accessible via live webcast in the Investors section of CARGO's website under News & Events, with a replay available for approximately 30 days following the presentation.

CARGO Therapeutics (NASDAQ: CRGX) reported Q3 2024 financial results and business updates. The company has dosed 57 patients in its Phase 2 FIRCE-1 study of firi-cel, with interim analysis expected in 1H25. Their cash position stands at $404.8 million, projected to fund operations through 2026. Q3 financial results show R&D expenses of $35.9 million and G&A expenses of $11.2 million, with a net loss of $41.9 million ($0.88 per share). The company plans to submit an IND for CRG-023 in Q1'25 and will present pre-clinical data at ASH 2024. CFO Anup Radhakrishnan has been appointed as COO while retaining his CFO role.

CARGO Therapeutics (NASDAQ: CRGX), a clinical-stage biotechnology company focused on developing next-generation cell therapies for cancer patients, has announced its participation in two upcoming investor conferences. Gina Chapman, President and CEO, will participate in fireside chats at the Jefferies London Healthcare Conference on November 20 at 11:00 a.m. GMT, and at the Piper Sandler 36th Annual Healthcare Conference on December 4 at 10:30 a.m. EST. Live webcasts will be available in the Investors section of CARGO's website, with replays accessible for approximately 90 days after the presentations.

CARGO Therapeutics announced its first abstract on CRG-023, a novel tri-specific CAR T-cell therapy targeting CD19, CD20, and CD22 B-cell antigens, will be presented at ASH 2024. CRG-023 is designed to provide durable responses by addressing common relapse causes in existing CAR T therapies.

The preclinical data demonstrated sustained anti-tumor activity, resistance to exhaustion during repeated tumor challenges, and robust anti-lymphoma activity at low doses. The therapy features a unique tri-cistronic design expressing three independent CARs from a single vector, each with distinct co-stimulatory domains. The company is actively preparing for an IND submission based on encouraging results.

CARGO Therapeutics (NASDAQ: CRGX) reported Q2 2024 financial results and provided a business update. Key highlights include:

- 38 patients dosed in the potentially pivotal Phase 2 FIRCE-1 study of firicabtagene autoleucel (firi-cel)

- Completed a $110 million private placement equity financing, extending cash runway through 2026

- $443.5 million in cash, cash equivalents, and marketable securities as of June 30, 2024

- Q2 2024 net loss of $44.3 million, or $1.02 per share

- R&D expenses of $37.5 million and G&A expenses of $11.9 million for Q2 2024

The company expects to complete its interim analysis and report results for the FIRCE-1 study in H1 2025.

CARGO Therapeutics announced that data from their Phase 1 clinical study of Firi-cel CAR T-cell therapy has been published in The Lancet. The study focused on patients with relapsed or refractory large B-cell lymphoma (LBCL) who did not respond to CD19 CAR T-cell therapy. Results showed a 68% overall response rate (ORR) and a 53% complete response (CR) rate, with a median follow-up of 23.3 months.

Notably, 36% of patients previously refractory to all therapies achieved CR. The selected dose for the Phase 2 study, DL1, had a 66% ORR and a 52% CR rate, showing an estimated one- and two-year survival rate of 57% and 52%, respectively. The therapy showed no severe cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome.

These results underscore the promising efficacy and safety profile of firi-cel, which has received Breakthrough Therapy Designation from the FDA. The ongoing Phase 2 study, FIRCE-1, is on track for interim analysis in the first half of 2025.

CARGO Therapeutics has appointed Jane Pritchett Henderson as an Independent Director to its Board. Henderson brings extensive experience in healthcare investment banking and executive leadership in biotech companies.

She will also serve on the audit and compensation committees. This appointment comes as CARGO advances its Phase 2 clinical study for the CAR T-cell therapy candidate, firicabtagene autoleucel (firi-cel), and progresses the CRG-023 program incorporating tri-specific CAR T-cells with CD2 co-stimulation.

Henderson has a strong background in finance and operations, having held key roles at Apogee Therapeutics, Adagio Therapeutics, Turnstone Biologics, and Voyager Therapeutics. Her current board positions include Akero Therapeutics and Ventus Therapeutics.