Disc Medicine, Inc. · NASDAQ:IRON
Disc Medicine — Corporate Update (February 2026)
11 slides from Disc Medicine's corporate update, Feb 17, 2026
Slide 1: Bitopertin Regulatory Update February 2026
Bitopertin Regulatory Update February 2026
Slide 2: Disclaimer and FLS
Disclaimer and FLS This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding Disc’s expectations with respect to its preclinical studies, clinical trials a
Slide 3: Bitopertin Regulatory Update
Bitopertin Regulatory Update Complete Response Letter (CRL) received on February 13, 2026 Type C Meeting EOP2 Meeting September 2024 December 2024 Pre-NDA Meeting June 2025 NDA Submitted September 2025 Awarded CNPV October 2025 NDA Accepted CRL Received November 2025 February 2026 Bitopertin receive
Slide 4: CRL Details
CRL Details Accelerated approval relies on (1) whether there is evidence of an effect on the proposed surrogate endpoint (% change in whole blood metal-free PPIX) and (2) whether the proposed surrogate endpoint, including the magnitude of change, is reasonably likely to predict a clinical benefit AU
Slide 5: Phase 2 AURORA Data
Phase 2 AURORA Data CONFIDENTIAL Demonstrated reductions in PPIX and improvements in clinical metrics Placebo Bitopertin 60 mg Phototoxic Reactions = Phototoxic Reaction = 2 Phototoxic Reactions Light Tolerance Measure (Mean ± SD) Tertile 1 (-89% to -38%) Tertile 2 (-38% to -7%) Tertile 3 (-7% to 19
Slide 6: APOLLO Trial Overview
APOLLO Trial Overview Closing enrollment in March; topline data expected Q4 2026 N Size ~150 patients across sites in the US, Canada, Europe, and Australia Trial Duration 6-month treatment period; Expected to fully enroll by March 2026 Trial Design Randomized 1:1, double-blind, placebo-controlled Tr
Slide 7: Robust Endpoints Provide Confidence in APOLLO
AURORA: Sunlight Tolerance Over Time† AURORA: PPIX Over Time Robust Endpoints Provide Confidence in APOLLO Co-primary Endpoints: Average Monthly Time in Light without Pain and PPIX Change from Baseline 2-Week Aggregated Time (hr) = last month of study = last 2-weeks of study p=0.013 vs PBO* p=0.03 v
Slide 8: Next Steps
Next Steps Disc plans to respond to the CRL with data from the ongoing APOLLO trial Expect to request Type A meeting with FDA to review our approach for resubmission Expect to complete enrollment in March 2026, several months ahead of guidance Expect to present topline data in Q4 2026 and use this d
Slide 9: Disc's EPP Community Commitment
Disc’s EPP Community Commitment Disc’s belief in the importance of bringing a potential disease modifying therapy to the EPP community and the potential for bitopertin to set a new standard of care in EPP has not changed Disc has made every effort to bring bitopertin to the EPP community more quickl
Slide 10: Corporate Outlook
Corporate Outlook Disc is well-capitalized through APOLLO readout and additional key pipeline milestones Program Indication 1H 2026 2H 2026 2027 Bitopertin Heme Synthesis Modulation Erythropoietic Porphyrias (EPP & XLP) HELIOS Update APOLLO topline – Q4 2026 Submit response to CRL – late 2026 FDA de
Slide 11: Q&A
Q&A