4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, reported second quarter 2022 financial results and provided a 4D-310 program update.
"Maintaining our momentum from the first quarter, we continued to execute towards our clinical and corporate milestones, including progress across all of our five clinical-stage product candidates,” said David Kirn, M.D., Co-founder, President and Chief Executive Officer of 4DMT. “In addition, the protocol amendment for the 4D-310 Phase 1/2 clinical trial in Fabry disease will expand access to include female patients, a large and significantly affected patient population with Fabry disease. We have maintained our focus on efficient cash utilization, with current cash available to support our operations into the first half of 2025. Our team is committed to relentless execution as we make progress toward key clinical data readouts in the first half of 2023 and beyond.”
Update on 4D-310 Phase 1/2 Clinical Trial for Fabry Disease
In June 2022, 4DMT filed a protocol amendment with the U.S. Food and Drug Administration (FDA) for the ongoing Phase 1/2 clinical trial of 4D-310 for Fabry disease. The protocol amendment is intended to expand the eligible patient population, including the addition of female Fabry patients with symptomatic disease. The inclusion of female patients in the phase 1/2 clinical trial was supported by clinical experience to-date, as well as a GLP toxicology study in female mice. The company continues to expect to provide a clinical data update on 4D-310 in the 1st half of 2023.
Second Quarter 2022 Financial Results
Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities were $261.6 million as of June 30, 2022. We expect cash, cash equivalents and marketable securities to be sufficient to fund operations into the first half of 2025.
Revenue: Total revenue for the quarter ended June 30, 2022, was $0.2 million, as compared to $14.6 million for the quarter ended June 30, 2021.
R&D Expenses: Research and development expenses were $20.4 million for the quarter ended June 30, 2022, as compared to $15.2 million for the quarter ended June 30, 2021. This increase was primarily driven by the progression of our five existing clinical product candidates, including 4D-150 (for wet AMD), 4D-310 (for Fabry disease) and 4D-710 (for cystic fibrosis lung disease).
G&A Expenses: General and administrative expenses were $8.2 million for the quarter ended June 30, 2022, as compared to $7.0 million for the quarter ended June 30, 2021. This increase was primarily due to increased payroll, stock-based compensation, insurance, and professional service expenses.
Net Loss: Net loss was $28.1 million for the quarter ended June 30, 2022, as compared to $7.6 million for the quarter ended June 30, 2021.