Disc Medicine reported its fourth‑quarter and full‑year 2025 financial results, showing a net loss of $212.2 million, or $6.01 per share, compared with a $109.4 million net loss in 2024. The increase in loss reflects a $61.2 million rise in research and development expenses, which climbed to $170.6 million, and a $9.8 million increase in selling, general and administrative costs, which totaled $65.4 million. The company’s cash, cash equivalents and marketable securities stood at $791.2 million as of December 31, 2025, giving it a runway that extends into 2029.
The company reported zero product revenue for both the quarter and the year, consistent with its status as a clinical‑stage biopharmaceutical. While the absence of revenue is expected, the disclosure of the cash balance and burn rate provides investors with a clear view of the company’s financial sustainability. The net loss per share, while higher than the prior year, is driven primarily by the company’s intensified investment in its pipeline rather than a decline in operating efficiency.
Disc Medicine’s pipeline remains a key focus. The Phase 3 APOLLO study of bitopertin for erythropoietic proerythroblastosis (EPP) is expected to complete enrollment in March 2026, with topline data slated for Q4 2026. The company received a Complete Response Letter from the FDA in February 2026 but is pursuing a traditional approval path and has requested a Type A meeting. Management expressed confidence in the program, stating, "We remain confident in the bitopertin program and the Phase 3 APOLLO study. We are fully committed to working closely with the FDA to position bitopertin for approval following the completion of APOLLO at the end of the year."
Other programs also show progress: DISC‑0974 achieved positive Phase 2 data in myelofibrosis anemia, and a Phase 2 study in inflammatory bowel disease and anemia began in Q1 2026 with data expected in 2027. DISC‑3405 is advancing a Phase 2 study in polycythemia vera and a Phase 1b study in sickle cell disease, with data anticipated in the second half of 2026. These developments underscore the company’s strategy of diversifying its therapeutic portfolio while maintaining a strong cash position.
The company did not provide forward guidance for the upcoming period. However, investors reacted positively earlier in the week to the company’s plan to address the FDA’s CRL, reflecting confidence in the company’s regulatory strategy and the potential upside of the APOLLO data.
The financial results highlight a widening net loss driven by increased R&D and SG&A spending, but the robust cash reserves and ongoing pipeline progress suggest that Disc Medicine remains well positioned to navigate the regulatory landscape and fund future development.
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