2 Catalysts That Could Move The Share Price Of 4D Molecular Therapeutics In Q4

Shares of 4D Molecular Therapeutics Inc. (FDMT) have more than halved from their 52-week high of $54.98, recorded in March of this year, to trade around $26.

4D Molecular Therapeutics is a clinical-stage gene therapy company focusing on Ophthalmology, Cardiology, and Pulmonology.

The lead candidate in the ophthalmology program, 4D-125, is under a phase I/II dose escalation and dose expansion clinical trial in X-Linked Retinitis Pigmentosa (XLRP).
As of the data cutoff date (September 1, 2021), eight patients with clinically advanced XLRP due to RPGR gene mutation had been enrolled.

Interim data, reported from this trial yesterday, demonstrate clinical proof-of-concept for safety, tolerability and clinical activity. The company plans to continue enrolling patients in the dose expansion cohort, including treatment of patients with less advanced disease who are evaluable for both anatomical and functional endpoints.

XLRP is a slowly progressing inherited retinal dystrophy that leads to vision loss and ultimately blindness. There are currently no treatment options for XLRP patients.

The second product candidate in the ophthalmology program is 4D-110, which is under a phase I clinical trial in choroideremia, a rare eye disease. Initial safety results from this trial, reported in June of this year, showed that 4D-110 had favorable tolerability without any dose-limiting toxicity.

4D Molecular was partnered with Roche for the development of 4D-110. Roche terminated their collaboration and license agreement covering 4D-110 with effect from September 16, 2021.

Initial clinical activity data from the phase I clinical trial of 4D-110 in choroideremia is expected this quarter (4Q, 2021).

4D Molecular’s ophthalmology program includes one more product candidate – 4D-150 for wet age-related macular degeneration – which is expected to enter a phase I/II trial before year-end.

The company’s Cardiology program focuses on 4D-310 for Fabry Disease while the Pulmonology program includes 4D-710 for Cystic Fibrosis.

A phase I/II clinical trial of 4D-310 in Fabry disease is underway, with initial data expected in the fourth quarter of 2021.

4D-710 for the treatment of patients with cystic fibrosis is expected to advance into a phase I/II clinical study before this year-end.

Cash position:

The company’s cash and cash equivalents were $243.7 million as of June 30, 2021.

4D Molecular went public on the Nasdaq Global Select Market on December 11, 2020, offering its shares at a price of $23 each.

FDMT has thus far hit a low of $21.40 and a high of $55.11. The Stock closed Monday’s trading at $26.01, up 13.48%.

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