Gamida Cell Ltd. - GMDA STOCK NEWS

Gamida Cell (NASDAQ: GMDA) announced a real-world analysis of its cell therapy candidate, omidubicel, presented at the 64th ASH Annual Meeting in New Orleans. The study, utilizing the CIBMTR database, demonstrated superior neutrophil recovery with omidubicel (median 10 days) compared to other donor sources (median 15-20 days). While platelet recovery was slower, omidubicel's safety profile showed comparable rates of severe graft versus host disease. The ongoing BLA review for omidubicel is targeted for January 30, 2023, aiming to position it as a leading treatment for patients with blood cancers.

Gamida Cell Ltd. (NASDAQ: GMDA) will highlight its corporate advancements at the Cell & Gene Meeting on the Mesa from October 11-13, 2022, in Carlsbad, California. COO Michele Korfin will discuss 2022 milestones including the U.S. market potential for omidubicel pending FDA approval and the progress of the GDA-201 NK cell therapy for lymphomas. The conference features over 90 presentations on cell and gene therapies. Virtual attendance is available. Omidubicel aims to be the first allogeneic stem cell therapy for blood cancer patients with a PDUFA date of January 30, 2023.

Gamida Cell Ltd. (Nasdaq: GMDA) presented new long-term data on omidubicel at the Tenth Annual Meeting of the Society of Hematologic Oncology in Houston, Texas. This data disclosed a three-year overall survival rate of 63% and a disease-free survival rate of 56% for patients who underwent treatment with omidubicel. Furthermore, the therapy demonstrated improved health-related quality of life compared to umbilical cord blood. The company highlights its commitment to advancing cell therapy as it approaches the FDA's PDUFA date of January 30, 2023, for omidubicel.

Gamida Cell Ltd. (NASDAQ: GMDA) has priced a follow-on public offering of 12,905,000 ordinary shares at $1.55 each, aiming for gross proceeds of $20 million. The offering, expected to close by September 30, 2022, includes an option for underwriters to purchase an additional 1,935,750 shares. Proceeds will fund commercial readiness for omidubicel, ongoing clinical trials for NK product candidates, and general corporate purposes. Piper Sandler & Co. and JMP Securities are leading the offering.

Gamida Cell Ltd. (NASDAQ: GMDA) has entered into a Commitment Letter with Highbridge Capital Management for a $25 million senior secured, convertible term loan, contingent on a $20 million equity offering. The loan has a maturity of 24 months and an annual interest rate starting at 7.50%, with potential increases. Obligations will be secured by the company's assets. Gamida Cell is advancing its omidubicel therapy, a promising stem cell treatment that has shown significant clinical benefits for hematologic malignancies.

Gamida Cell Ltd. (Nasdaq: GMDA) has announced a follow-on public offering of its ordinary shares to fund commercial readiness for its investigational product omidubicel, further clinical development of NK product candidates, and general corporate purposes. The offering includes a potential 30-day option for underwriters to purchase an additional 15% of the shares. The offering is subject to market conditions and is expected to provide the necessary capital for key upcoming initiatives.

Gamida Cell Ltd. (NASDAQ: GMDA) announced the retirement of CEO Julian Adams, Ph.D., who will remain on the Board. Abigail Jenkins has been appointed as the new President and CEO. Jenkins, with over 20 years of biopharmaceutical experience, aims to fulfill the company's mission of developing cures for blood cancers. Key achievements under Adams include the submission of the Biologics License Application (BLA) for omidubicel, a NAM-enabled cell therapy candidate. The BLA for omidubicel has a target action date of January 30, 2023, positioning Gamida Cell for potential market advancement.

Gamida Cell (NASDAQ: GMDA) announced significant findings at the 2022 Cord Blood Connect Meeting regarding its cell therapy candidate, omidubicel, for patients with blood cancers needing stem cell transplants. Key data revealed that patients treated with omidubicel experienced superior health-related quality of life scores compared to those receiving umbilical cord blood transplants. Omidubicel also demonstrated robust T cell reconstitution, leading to lower infection rates. The therapy aims to mitigate racial and ethnic disparities in access and outcomes for transplant-eligible patients, with FDA priority review anticipated by January 30, 2023.

Gamida Cell Ltd. (Nasdaq: GMDA) announced the FDA's acceptance of its Biologics License Application (BLA) for omidubicel, granting Priority Review with a target action date set for January 30, 2023. The company reported a net loss of $18.6 million for Q2 2022, improving from $23.6 million in Q2 2021. Gamida Cell also initiated a Phase 1/2 study of GDA-201, targeting follicular and diffuse large B-cell lymphomas. With $55.1 million in cash, the company is funded through mid-2023, excluding commercialization costs for omidubicel.