Disc Medicine Reports Third Quarter 2025 Financial Results and Provides Business Update

Core Viewpoint - Disc Medicine, Inc. has made significant progress in its clinical pipeline, particularly with the NDA submission for bitopertin for erythropoietic protoporphyria (EPP) and the receipt of the FDA's Commissioner's National Priority Voucher (CNPV), which is expected to expedite the review process [2][5][6] Recent Developments - The company submitted a New Drug Application (NDA) for bitopertin on September 29, 2025, seeking accelerated approval based on clinical results [5][6] - The CNPV received will shorten the NDA review period to 1-2 months from acceptance [5][6] - Initial data from the Phase 2 study of DISC-0974 in myelofibrosis (MF) anemia is expected to be presented at the ASH conference in December 2025 [5][6] - Ongoing studies for DISC-3405 in polycythemia vera (PV) and sickle cell disease (SCD) are progressing, with initial data anticipated in 2026 [5][12] Financial Performance - As of September 30, 2025, the company reported approximately $616 million in cash, cash equivalents, and marketable securities, with a public offering in October 2025 expected to provide net proceeds of about $211 million, extending the cash runway into 2029 [12][15] - Research and Development (R&D) expenses for Q3 2025 were $50.3 million, up from $24.7 million in Q3 2024, primarily due to advancements in clinical studies and increased headcount [12][15] - Selling, General and Administrative (SG&A) expenses rose to $17.4 million in Q3 2025 from $8.2 million in Q3 2024, reflecting the establishment of infrastructure for potential commercialization [12][15] - The net loss for Q3 2025 was $62.3 million, compared to $26.6 million in Q3 2024, attributed to higher operating costs [12][15] Pipeline Overview - Bitopertin is a GlyT1 inhibitor aimed at treating EPP, with a focus on heme synthesis modulation [3] - DISC-0974 is an anti-hemojuvelin antibody targeting hepcidin suppression, with data from ongoing studies expected soon [4][12] - DISC-3405 is an anti-TMPRSS6 antibody aimed at hepcidin induction, with studies in both PV and SCD [4][12]