Disc Medicine Inc (NASDAQ:IRON) Reports Wider-Than-Expected Q3 2025 Loss Amid Pipeline Advancements

Disc Medicine Inc (NASDAQ:IRON) reported its third quarter 2025 financial results, revealing a net loss that came in wider than analyst expectations. The clinical-stage biopharmaceutical company, which has no approved products on the market, continues to invest heavily in its pipeline of novel hematologic treatments.

Earnings and Revenue Versus Estimates

The company's financial performance for the quarter was squarely in line with its clinical-stage status, reporting no revenue as expected. The focus for investors remains on the company's operational expenditures and progress toward key clinical milestones.

• Earnings Per Share (EPS): Reported Non-GAAP EPS of -$1.77, which was below the analyst consensus estimate of -$1.51.
• Revenue: Reported $0.0 million, matching the $0.0 million analyst estimate.

The wider-than-expected loss was driven by a significant ramp-up in operational spending. Research and Development (R&D) expenses more than doubled year-over-year to $50.3 million, up from $24.7 million in Q3 2024. Similarly, Selling, General, and Administrative (SG&A) expenses rose to $17.4 million from $8.2 million in the prior year period. This increased burn rate reflects the company's accelerated clinical activities and investments in building a commercial infrastructure.

Market Reaction

The market's immediate response to the earnings report was negative. In pre-market trading, shares of Disc Medicine were down approximately 5.8%. This reaction suggests investor disappointment with the larger-than-anticipated quarterly loss, despite the company's significant pipeline advancements. The sell-off indicates that the market was weighing the increased near-term cash burn more heavily than the positive clinical updates.

Key Business Updates and Pipeline Progress

Beyond the financial figures, the earnings report highlighted several critical developments, particularly the advancement of the company's lead asset, bitopertin.

• Bitopertin NDA Submission: The company submitted a New Drug Application (NDA) for the accelerated approval of bitopertin for the treatment of erythropoietic protoporphyria (EPP) on September 29, 2025.
• FDA Priority Review Voucher: Disc Medicine was awarded a FDA Commissioner’s National Priority Voucher (CNPV), which is designed to shorten the NDA review period to just 1-2 months from the date of acceptance. This potentially paves the way for a U.S. approval and launch in late 2025 or early 2026.
• Robust Financial Position: The company ended the quarter with a strong cash position of $615.9 million. Following a public offering in October that raised approximately $211 million in net proceeds, management believes its cash runway now extends into 2029, providing ample resources to fund operations through multiple milestones.
• Upcoming Data Catalysts: Initial data from the Phase 2 study of DISC-0974 in anemia of myelofibrosis is expected to be presented at the ASH conference in December 2025. Data from studies of DISC-3405 in polycythemia vera and sickle cell disease are anticipated in 2026.

Outlook and Analyst Estimates

The press release did not provide specific financial guidance for the coming quarters. The company's primary focus remains on the regulatory review of bitopertin and the progression of its broader clinical pipeline. For the next quarter (Q4 2025), analysts are estimating an EPS of -$1.52 on revenue of $0.0 million. For the full year 2025, the EPS estimate stands at -$5.74.

For a detailed breakdown of past and estimated future earnings, you can view more on the earnings and estimates page for IRON.

Disclaimer: This article is for informational purposes only and does not constitute investment advice, financial advice, or a recommendation to buy or sell any security. The performance data and estimates are based on publicly available information and are subject to change. Investors should conduct their own research and consult with a qualified financial advisor before making any investment decisions.