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Dec 31, 2020
Fulcrum Therapeutics Q4 2020 Earnings Report
Fulcrum Therapeutics reported Q4 and full year 2020 financial results and provided a business update.
Key Takeaways
Fulcrum Therapeutics reported fourth quarter 2020 financial results, including collaboration revenue of $4.2 million and a net loss of $17.7 million. The company discontinued its Phase 3 COVID-19 trial and extended its cash runway into Q4 2022.
The company is on track to present data from Phase 2b ReDUX4 trial with losmapimod in facioscapulohumeral muscular dystrophy (FSHD) in late 2Q 2021.
The company is on track to report results from Phase 1 trial in healthy adult volunteers with FTX-6058 for sickle cell disease in mid-2021.
The company decided to discontinue Phase 3 COVID-19 trial (LOSVID).
The company extended cash runway into 4Q 2022; raised $50.6 million in gross proceeds from January 2021 public offering.
Fulcrum Therapeutics
Fulcrum Therapeutics
Forward Guidance
Fulcrum expects that its cash, cash equivalents, and marketable securities as of December 31, 2020, together with the net proceeds of $46.4 million from the sale of its common stock in a public offering on January 22, 2021, will be sufficient to enable Fulcrum to fund operating expenses and capital expenditure requirements into the fourth quarter of 2022.
Positive Outlook
- On track to report data from ReDUX4, a Phase 2b trial of losmapimod, a selective p38a/b mitogen activated protein kinase (MAPK) inhibitor, in FSHD late in the second quarter of 2021.
- Data will include the primary endpoint, reduction from baseline of DUX4-driven gene expression, as well as a pre-specified sensitivity analysis assessing biopsies with the highest pre-treatment level of DUX4-driven gene expression.
- Secondary endpoints, including skeletal muscle MRI and exploratory endpoints, including clinical outcome assessments and patient reported outcomes will also be reported.
- On track to report results from the Phase 1 trial in healthy adult volunteers with FTX-6058 in development for sickle cell disease (SCD) in mid-2021, and to begin dosing patients with SCD by year end.
- Losmapimod was generally well tolerated in LOSVID, and an independent data safety monitoring board did not identify any safety concerns related to losmapimod.
Challenges Ahead
- After careful consideration, Fulcrum is discontinuing LOSVID, a Phase 3 trial with losmapimod for hospitalized subjects with COVID-19, due to significant changes in the COVID-19 treatment paradigm, including new therapeutic options and emerging vaccines.
- Multiple scientific meeting presentations.
- CEO transition: On March 4, 2021, Fulcrum announced that Bryan E. Stuart will be promoted to president and chief executive officer and Robert J. Gould, Ph.D. will retire from his role as president and chief executive officer, each effective March 31, 2021.
- CSO transition: On January 19, 2021, Fulcrum announced that Chris Moxham, Ph.D. was promoted to chief scientific officer and Owen Wallace, Ph.D. stepped down from his role as chief scientific officer, each effective February 5, 2021.
- Net loss was $17.7 million for the fourth quarter of 2020, as compared to a net loss of $16.1 million for the fourth quarter of 2019.