4D Molecular Therapeutics reports clinical, financial and governance developments for a late-stage biotechnology company developing disease-targeted gene therapy product candidates. Its recurring updates center on 4D-150 for retinal vascular diseases, including wet age-related macular degeneration and diabetic macular edema, and on clinical programs such as 4FRONT, PRISM and SPECTRA.
Company news also covers quarterly and annual financial results, cash runway commentary, collaboration and license revenue tied to Otsuka, investor conference participation, board and leadership changes, and employment inducement equity grants. The company states that its product candidates remain in clinical or preclinical development and have not been approved for marketing by the FDA or other regulatory authorities.
4D Molecular Therapeutics (Nasdaq: FDMT) announced participation in a fireside chat at the Evercore ISI HealthCONx 2021 Conference on December 2, 2021, at 10:55 a.m. ET. This event offers insights into the company's advances in gene therapy.
A live audio webcast will be accessible via the Investors & Media section on the company's website, with a replay available for two weeks post-event. The company is focused on ophthalmology, cardiology, and pulmonology, and is developing five product candidates currently in clinical trials.
4D Molecular Therapeutics (Nasdaq: FDMT) reported its Q3 2021 financial results and operational milestones. The company showcased promising clinical data for three product candidates, including 4D-310 for Fabry disease, which demonstrated significantly enhanced AGA enzyme activity. The company raised approximately $111 million through a follow-on stock offering, strengthening its financial position with cash and equivalents totaling $227 million. However, total revenue decreased to $1.4 million, compared to $7.4 million in the same quarter last year, primarily due to a terminated collaboration.
4D Molecular Therapeutics, Inc. (Nasdaq: FDMT) has announced a public offering of 4,750,000 shares of its common stock at $25.00 per share, aiming for gross proceeds of approximately $118.8 million. The offering, which includes a 30-day option for underwriters to purchase an additional 712,500 shares, is set to close on November 2, 2021. The company focuses on targeted gene therapies and currently has five clinical candidates, including 4D-310 for Fabry disease and 4D-125 for XLRP.
4D Molecular Therapeutics (Nasdaq: FDMT) announced an underwritten public offering of 4,500,000 shares of its common stock, with a 30-day option for underwriters to purchase an additional 675,000 shares. The offering is managed by Goldman Sachs, SVB Leerink, and Evercore ISI. The registration statement is pending effectiveness with the SEC, and shares cannot be sold before this occurs. 4DMT is focused on targeted gene therapies for ophthalmology, cardiology, and pulmonology, advancing five product candidates currently in clinical development.
4D Molecular Therapeutics (FDMT) presented promising interim clinical data from its Phase 1/2 trial of 4D-310 for Fabry disease, marking the first clinical activity data from a product developed via their proprietary Therapeutic Vector Evolution platform. All three patients treated exhibited serum AGA enzyme activity significantly above the normal range, with increases of 25-fold in two cases. Safety data showed a manageable profile with no dose-limiting toxicities, although one patient experienced a transient adverse event. The company is committed to enrolling a diverse patient population moving forward.
4D Molecular Therapeutics (Nasdaq: FDMT) announced interim data from its Phase 1/2 clinical trial of 4D-125 for advanced X-linked retinitis pigmentosa (XLRP). The treatment was well tolerated in all 8 patients, showing no serious adverse events. Clinical activity was noted with reduced photoreceptor loss and improvements in retinal sensitivity. The company plans to continue patient enrollment in a higher dose cohort and explore treatment for less advanced patients. The results validate the therapeutic potential of their platform, with expectations for further developments in other products.
4D Molecular Therapeutics (Nasdaq: FDMT) announced FDA clearance for its 4D-150 Investigational New Drug Application, enabling the initiation of Phase 1/2 clinical trials for treating wet age-related macular degeneration (wet AMD). The trials are projected to start before year-end and will involve approximately 60 adults. 4D-150 is a dual-transgene intravitreal gene therapy aiming for robust efficacy at lower doses compared to existing therapies. This product candidate marks significant advancements in AAV gene therapy, specifically targeting multiple angiogenic factors.
4D Molecular Therapeutics (Nasdaq: FDMT) announced FDA clearance for its 4D-710 Investigational New Drug Application, allowing the initiation of Phase 1/2 clinical trials for treating cystic fibrosis patients. The trial will evaluate safety, tolerability, and clinical activity in approximately 18 patients who cannot use existing modulator therapies. In conjunction, the CF Foundation will purchase 125,715 shares for about $4 million to support 4D-710's development. This therapy aims to address the unmet needs of 10-15% of cystic fibrosis patients.
4D Molecular Therapeutics (Nasdaq: FDMT) will participate in Chardan's 5th Annual Genetic Medicines Conference on October 4, 2021, at 2:30 p.m. ET. This virtual event will feature a fireside chat format, offering insights into the company's advancements in gene therapy. A live webcast will be accessible on the 4DMT website, with a replay available for two weeks post-event. 4DMT utilizes directed evolution to develop targeted gene therapies focusing on ophthalmology, cardiology, and pulmonology, currently conducting clinical trials for three product candidates.
4D Molecular Therapeutics (Nasdaq: FDMT) announced a late-breaking presentation of preliminary clinical data from its ongoing Phase 1/2 trial of 4D-125 for X-Linked Retinitis Pigmentosa (XLRP) at the Annual Society of Retina Specialists (ASRS) 2021, occurring from October 8-12 in San Antonio, TX. The presentation will be led by Dr. Cagri G. Besirli and is scheduled for October 10 at 2:56 p.m. CDT. This trial aims to evaluate the safety and effectiveness of 4D-125, with a primary focus on safety and secondary goals including visual function and anatomical endpoints.