4D Molecular Therapeutics Named Top Biotech Pick by B. Riley on Gene Therapy Promise

B. Riley Securities has reiterated its Buy rating and $37 price target for 4D Molecular Therapeutics (NASDAQ: FDMT), reaffirming the company as one of its top year-end picks. The brokerage's positive outlook is driven by the launch of a Phase 3 trial for the company's lead gene therapy candidate, 4D-150, in diabetic macular edema (DME) and encouraging two-year clinical data.

Key Clinical Developments

4D Molecular Therapeutics has begun enrolling patients in its 4SIGHT Phase 3 trial for DME. This follows progress in its two 4FRONT trials evaluating the same therapy, 4D-150, in patients with wet age-related macular degeneration (wet AMD).

B. Riley highlighted supportive two-year data from the SPECTRA study, which showed sustained efficacy at the planned Phase 3 dose. Patients in the study experienced a 10.8-letter vision gain and required an average of only 5.2 supplemental injections following initial loading doses. The brokerage also noted a favorable safety profile, with no intraocular inflammation or serious ocular adverse events reported across the 22-patient study population.

A Potential Dosing Advantage

The core value proposition for 4D-150 is its potential to significantly reduce the frequency of eye injections compared to current standards of care. As a gene therapy, it is designed to continuously express an anti-VEGF protein, a key mechanism in treating both wet AMD and DME. B. Riley estimates a substantial reduction in treatment burden over five years:

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• Aflibercept: Approximately 34 injections
• Eylea HD or Vabysmo: Roughly 18-23 injections
• Zenkuda (peer candidate): Approximately 21 injections
• 4D-150: An estimated 8-12 injections

The brokerage noted that recent data from a peer, Kodiak Sciences, showed that even with a long-acting therapy, a notable portion of patients (17%) still required frequent injections, highlighting the market opportunity for a more durable treatment like 4D-150.

Valuation and Market Potential

B. Riley's valuation is based on a sum-of-the-parts discounted cash-flow model. The firm projects risk-adjusted peak global sales for 4D-150 of approximately $1.44 billion. This estimate includes around $599 million from the wet AMD indication and $338 million from DME.

Data from the company's three Phase 3 studies, which will include approximately 780 eyes treated with 4D-150, will be critical in determining how the therapy competes with established treatments like Eylea HD and Vabysmo, as well as potential new entrants.