Disc Medicine Reports Third Quarter 2026 Financial Results and Provides Business Update
Disc Medicine, Inc. (IRON) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Disc Medicine Reports Third Quarter 2026 Financial Results and Provides Business Update • Pivotal Phase 3 APOLLO trial of bitopertin in erythropoietic protoporphyria (EPP) successfully met all primary and secondary endpoints • Bitopertin NDA resubmission planned by e
How this was made
The 30-second read
Why it matters
The APOLLO Phase 3 data met all endpoints, positioning bitopertin for an NDA resubmission by year‑end and a potential FDA decision in mid‑2027.
Market read
First‑report disclosure of pivotal trial success for a rare‑disease drug, a catalyst that can move the stock significantly.
What to watch
The sizable cash runway reduces near‑term financing risk, but dilution from future offerings could temper upside.
Disc Medicine reported a lower third-quarter net loss, positive pivotal Phase 3 APOLLO results for bitopertin in EPP, and cash runway into 2030 following an October public offering.
APOLLO met all primary and secondary endpoints, quarterly operating expenses and net loss declined from the prior-year period, and the company reported $682.8 million in cash, cash equivalents, and marketable securities before approximately $485.9 million of October offering proceeds. The company remains pre-commercial with a reported net loss of $59.5 million.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Research and development expenses, three months ended September 30GAAP | $44.1M | – | – |
| Selling, general and administrative expenses, three months ended September 30GAAP | $20.1M | – | – |
| Total operating expenses, three months ended September 30GAAP | $64.16M | – | – |
| Loss from operations, three months ended September 30GAAP | −$64.16M | – | – |
| Other income (expense), net, three months ended September 30GAAP | $4.74M | – | – |
| Income tax expense, three months ended September 30GAAP | −$109K | – | – |
| Net loss, three months ended September 30GAAP | −$59.53M | – | – |
| Net loss per share, basic and diluted, three months ended September 30GAAP | $(1.53) | – | – |
| Weighted-average common shares outstanding, basic and diluted, three months ended September 30GAAP | 38,904,676 | – | – |
| Research and development expenses, nine months ended September 30GAAP | $136.9M | – | – |
| Selling, general and administrative expenses, nine months ended September 30GAAP | $61.84M | – | – |
| Total operating expenses, nine months ended September 30GAAP | $198.8M | – | – |
| Loss from operations, nine months ended September 30GAAP | −$198.8M | – | – |
| Other income (expense), net, nine months ended September 30GAAP | $16.42M | – | – |
| Income tax expense, nine months ended September 30GAAP | −$229K | – | – |
| Net loss, nine months ended September 30GAAP | −$182.6M | – | – |
| Net loss per share, basic and diluted, nine months ended September 30GAAP | $(4.72) | – | – |
| Weighted-average common shares outstanding, basic and diluted, nine months ended September 30GAAP | 38,695,405 | – | – |
| Cash, cash equivalents, and marketable securities as of September 30, 2026GAAP | $682.8M | – | – |
| Cash, cash equivalents, and marketable securities as of December 31, 2025GAAP | $791.2M | – | – |
| Total current assets as of September 30, 2026GAAP | $697.4M | – | – |
| Total assets as of September 30, 2026GAAP | $699.5M | – | – |
| Total liabilities as of September 30, 2026GAAP | $95.24M | – | – |
| Total stockholders' equity as of September 30, 2026GAAP | $604.3M | – | – |
Amounts quoted below without a unit are in thousands, as in the filing’s tables. Per-share figures are as printed.
By end of 2026 through 2030 outlook
- NoteDisc plans to resubmit a New Drug Application (NDA) to the U.S. FDA by the end of 2026, with a decision from the agency anticipated by mid-2027.
- NoteFeedback from an end of phase 2 meeting with the FDA and plans for pivotal development in anemia of MF to be announced by the end of the year.
- NoteUpdated data from the RALLY-MF trial to be presented at ASH in December.
- NoteInitial data from the Phase 2 study of selcodebart in patients with inflammatory bowel disease (IBD) expected in 2027.
- NoteUpdated data from RESTORE-PV, including initial efficacy data on the Q4 weekly dosed cohort, to be presented at ASH in December.
- NoteInitial data from Phase 1b study of DISC-3405 in patients with sickle cell disease also to be presented at ASH.
- NoteCash, cash equivalents, and marketable securities will be sufficient to fund current operating and capital expenditure plans and debt service obligations into 2030.
What drove it
- APOLLO achieved statistical significance on both co-primary endpoints of reduction in whole blood metal-free PPIX from baseline and average monthly total time in sunlight without pain during month 6 of treatment vs. placebo.
- Bitopertin reduced whole-blood metal-free PPIX by 41.4% versus placebo (p<0.0001) and increased average monthly total time in light without pain by 12.2 hours during month 6 (p=0.0010).
- The R&D expense decrease was primarily driven by a $10.0 million milestone payment and drug manufacturing in the comparative period that did not recur in the current period.
- SG&A expense increased primarily due to increased headcount.
- DISC-3405 initial RESTORE-PV results demonstrated increased hepcidin and lower serum iron, translating to controlled hematocrit, reduced phlebotomy, and improved symptoms in PV patients.
Concerns
- Net loss was $(59,535) for the three months ended September 30, 2026.
- Nine-month net loss was $(182,571), compared with $(151,653) for the nine months ended September 30, 2025.
- Bitopertin NDA resubmission and a potential FDA decision remain future regulatory milestones.
- Dizziness was the most commonly reported treatment emergent adverse event in the bitopertin group (50%).
What to watch
- NDA resubmission for bitopertin by the end of 2026 and the anticipated FDA decision by mid-2027.
- The end of phase 2 FDA meeting feedback and pivotal-development plans for selcodebart in anemia of MF by the end of the year.
- Updated RALLY-MF, RESTORE-PV, and Phase 1b DISC-3405 sickle cell disease data at ASH in December.
- Initial selcodebart inflammatory bowel disease data expected in 2027.
- Execution against the stated cash runway into 2030.
Balance sheet and cash flow
- Cash, cash equivalents, and marketable securities were $682.8 million as of September 30, 2026.
- In October 2026, Disc completed a public offering with net proceeds of approximately $485.9 million.
- Current liabilities were $34,360 as of September 30, 2026.
- Non-current liabilities were $60,878 as of September 30, 2026.
Analysis
Disc Medicine's third quarter was defined by clinical progress rather than commercial activity. The pivotal Phase 3 APOLLO trial of bitopertin in EPP met both co-primary endpoints and all secondary endpoints were reported as positive and statistically significant. The company stated that bitopertin reduced whole-blood metal-free PPIX by 41.4% versus placebo and increased average monthly total time in light without pain by 12.2 hours during month 6. The stated next regulatory step is an NDA resubmission by the end of 2026, with an FDA decision anticipated by mid-2027.
The quarterly expense profile improved against the prior-year period. R&D expense was $44.1 million versus $50.3 million, while SG&A expense rose to $20.1 million from $17.4 million. The company attributed the R&D reduction primarily to a $10.0 million milestone payment and drug manufacturing in the comparative period that did not recur, partly offset by higher personnel-related costs and investment across the development portfolio. Total operating expenses were $64,161 versus $67,696, and net loss was $(59,535) versus $(62,321).
The nine-month financial picture reflects continued pipeline investment. R&D expense was $136,917 versus $124,416 and SG&A expense was $61,843 versus $44,636. Net loss for the nine months was $(182,571), compared with $(151,653). There was no revenue, gross-profit, margin, operating cash-flow, or free-cash-flow figure reported in the filing, consistent with the company's clinical-stage focus.
Liquidity was strengthened after quarter end. Cash, cash equivalents, and marketable securities were $682.8 million as of September 30, 2026, and Disc completed an October 2026 public offering with net proceeds of approximately $485.9 million. Management stated that cash, together with the offering proceeds, is sufficient to fund current operating and capital expenditure plans and debt service obligations into 2030. Investors will focus on the bitopertin NDA timing, FDA feedback on selcodebart in anemia of MF, and the planned December ASH updates for RALLY-MF and DISC-3405.
Management, verbatim
In our first pivotal trial readout as a company, APOLLO delivered strong and compelling evidence of the potential clinical benefit of bitopertin for patients with EPP.
John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc
We also made significant progress across our broader pipeline, including encouraging initial RESTORE-PV data that reinforce the potential of DISC-3405 to maintain target hematocrit levels and improve symptoms for patients with polycythemia vera.
John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc
Not in the filing
stated, not guessed- Revenue and prior-period revenue
- Segment revenue and segment profitability
- Gross profit and gross margin
- GAAP operating margin
- Non-GAAP financial metrics
- Operating cash flow
- Free cash flow
- Capital expenditures
- Debt amount or debt maturity detail
- Share repurchases
- Dividends
- Formal revenue guidance
- Formal gross-margin guidance
- Formal operating-expense guidance
- Formal tax-rate guidance
- Prior outlook for comparison
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was checked against the filing text, and a metric whose value, prior period and change do not add up is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
Disc Medicine (NASDAQ:IRON) is a clinical‑stage biotech focused on rare hematologic diseases.
Ticker impact
Disc Medicine filed its Q3 2026 results and disclosed positive Phase 3 APOLLO trial data for bitopertin in EPP.
upward pressure as market prices in the successful Phase 3 data and upcoming NDA filing
Phase 3 success is material for a clinical‑stage biotech; investors typically bid up shares on such news.
Market effects
Strengthens the hematology/iron‑homeostasis biotech niche and may boost peer valuations.
Positive for US biotech sector; limited direct impact on other regions.
Highlights continued pipeline momentum in rare‑disease therapeutics, a theme of global interest.
Counterpoint
If the FDA raises concerns on safety or efficacy, the stock could face a sharp correction despite the trial win.
Key entities
- companyDisc Medicine, Inc.
Biopharma developing treatments for EPP, PV, MF, and SCD.
- executiveJohn Quisel
President and CEO of Disc Medicine.