EWTX - Edgewise: Intriguing Drug Candidate But Consider Selling After Recent Run

2024-05-10 13:49:03 ET

Summary

• Edgewise Therapeutics, Inc. reported its first quarter earnings, revealing a strong cash position of $532m and a net loss of $(28.5m).
• The company is advancing two clinical-stage programs, including a pivotal trial for Becker muscular dystrophy and a Phase 1 trial for hypertrophic cardiomyopathy for a second candidate.
• Sevasemten, the lead drug candidate, showed positive results in a two-year study for Becker muscular dystrophy, supporting the hypothesis that it can preserve and improve muscle function.
• An FDA Fast Track designation for sevasemten has triggered a bull run that has seen the share price gain by >250%.
• A lack of genuinely meaningful catalysts in 2024, and a lengthy wait until an application for approval can be made, make this a good time to sell, in my view, although long-term, there are signs the drug is approvable.

Investment Overview

Edgewise Therapeutics, Inc. ( EWTX ) announced its first quarter earnings for quarter one, 2024 yesterday. Boulder, Colorado-based Edgewise is focused on rare muscle disorders, and its IPO in April 2021 raised ~$150m at ~$15 per share. Current traded share price is ~$20.

According to Edgewise's quarterly report / Q1 2024 10Q submission :

We are advancing two clinical-stage programs and a number of preclinical programs. Sevasemten (EDG-5506) is an orally administered skeletal myosin inhibitor in a pivotal stage trial for Becker muscular dystrophy as well as ongoing phase 2 programs in Duchenne muscular dystrophy.

EDG-7500, currently in a Phase 1 and Phase 2 trial, is a novel cardiac sarcomere modulator for the treatment of hypertrophic cardiomyopathy ("HCM") and other disorders of diastolic dysfunction.

For further details see: