Fulcrum Therapeutics Inc. (NASDAQ: FULC) reported Q3 EPS of ($0.70), $0.05 worse than the analyst estimate of ($0.65).

Third Quarter 2020 Financial Results

• Cash Position: As of September 30, 2020, cash, cash equivalents, and marketable securities were $127.0 million, as compared to $96.7 million as of December 31, 2019. Based on its current plans, the Company expects that its existing cash, cash equivalents, and marketable securities will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second quarter of 2022.
• R&D Expenses: Research and development expenses were $15.6 million for the third quarter of 2020, as compared to $13.5 million for the third quarter of 2019. The increase of $2.1 million was primarily due to increased costs to support our ongoing and planned clinical trials and increased personnel-related costs to support the growth of Fulcrum’s research and development organization, including increased stock-based compensation expense. Research and development expenses for the third quarter of 2019 include $2.5 million of one-time costs incurred associated with the achievement of a milestone under the Company’s license agreement with GSK for losmapimod.
• G&A Expenses: General and administrative expenses were $5.3 million for the third quarter of 2020, as compared to $3.5 million for the third quarter of 2019. The increase of $1.8 million was primarily due to increased costs associated with operating as a public company and increased personnel-related costs to support the growth of our organization, including increased stock-based compensation expense.
• Net Loss: Net loss was $19.0 million for the third quarter of 2020, as compared to a net loss of $16.5 million for the third quarter of 2019.

“We’ve made significant progress in 2020, which will lead to a number of key data readouts as we move into 2021,” said Robert J. Gould, Ph.D., president and chief executive officer. “We plan to announce full data from our ReDUX4 trial with losmapimod in facioscapulohumeral muscular dystrophy (FSHD), including the primary endpoint in the second quarter of 2021. We are encouraged by the interim analysis from ReDUX4, which assessed reductions in DUX4-driven gene expression, the root cause of the disease, via muscle biopsy. The full data will also contain a number of validated and novel endpoints and we look forward to presenting a comprehensive assessment of the data in its entirety. Our select hemoglobinopathy program, FTX-6058, a highly potent small molecule EED inhibitor, has made important progress as well, and we are currently screening healthy volunteers in our Phase 1 trial. We believe FTX-6058 has the potential to offer a transformative small molecule treatment option that could represent a significant development for sickle cell patients.”

“I am also pleased to report that Curtis Oltmans will be joining Fulcrum as Senior Vice President, General Counsel and Kim Hazen has been promoted to Senior Vice President, Human Resources,” continued Dr. Gould. “In addition, Alan Ezekowitz, MBChB, D.Phil will take on the responsibility of clinical advisor as Diego Cadavid, MD is leaving his position as Senior Vice President, Clinical Development. Curt has an extensive record of legal and corporate development accomplishments. Kim has made important contributions since joining Fulcrum in 2017 and Alan has served on our Board of Directors since 2016. We are thrilled to have them on our leadership team. We thank Diego for his many contributions to Fulcrum.”

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