Disc Medicine Reports Third Quarter 2026 Financial Results and Provides Business Update
October offering proceeds of approximately $485.9 million support an expected cash runway into 2030.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Disc Medicine (NASDAQ:IRON) reported that its pivotal Phase 3 APOLLO trial of bitopertin met all primary and secondary endpoints. In erythropoietic protoporphyria (EPP), bitopertin reduced the blood biomarker metal-free PPIX by 41.4% versus placebo and increased average monthly pain-free time in light by 12.2 hours during month 6. Disc plans to resubmit its U.S. approval application by end-2026 and anticipates an FDA decision by mid-2027.
Third-quarter net loss narrowed to $59.535 million from $62.321 million a year earlier. Cash, cash equivalents and marketable securities totaled $682.816 million at September 30. An October offering raised approximately $485.9 million net; Disc expects funding to last into 2030. Initial Phase 2 DISC-3405 results showed hematocrit control and reduced phlebotomy in polycythemia vera. Selcodebart FDA meeting feedback and pivotal-development plans are expected by year-end.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointAPOLLO met both co-primary endpoints: PPIX reduction of 41.4% versus placebo and 12.2 additional pain-free light hours during month 6.
- Moderate pointAPOLLO achieved statistically significant secondary and exploratory results, including phototoxic-reaction reductions, light tolerance and quality of life.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Bitopertin approval application resubmission is planned by end-2026; Disc anticipates an FDA decision by mid-2027.
- Moderate point. Forward-looking: it has not happened yet and may not happen.October public offering raised approximately $485.9 million net; Disc expects cash runway into 2030. 13% of market cap
- Moderate pointRESTORE-PV initial Phase 2 results showed controlled hematocrit, reduced phlebotomy and improved symptoms across escalation and maintenance.
5 minor points
- Minor pointThird-quarter R&D expenses declined to $44.080 million from $50.334 million a year earlier.
- Minor pointThird-quarter net loss narrowed to $59.535 million, or $1.53 per share, from $62.321 million, or $1.77.
- Minor pointDISC-3405 was generally well-tolerated in RESTORE-PV, with a low rate of mild, self-limited injection-site reactions.
- Minor point. Forward-looking: it has not happened yet and may not happen.Selcodebart pivotal-development plans and FDA meeting feedback are expected by year-end for myelofibrosis-related anemia.
- Minor point. Forward-looking: it has not happened yet and may not happen.Selcodebart Phase 2 study in inflammatory bowel disease is progressing, with initial data expected in 2027.
Negative
- Minor pointBitopertin-associated dizziness occurred in 50% of treated patients; events were mild or moderate and generally transient.
- Minor pointThird-quarter selling, general and administrative expenses rose to $20.081 million from $17.362 million a year earlier.
- Minor pointNine-month net loss widened to $182.571 million, or $4.72 per share, from $151.653 million, or $4.39.
- Minor pointNine-month R&D expenses increased to $136.917 million from $124.416 million a year earlier.
- Minor pointNine-month selling, general and administrative expenses rose to $61.843 million from $44.636 million a year earlier.
3 minor points
- Minor pointCash, equivalents and marketable securities fell to $682.816 million at September 30 from $791.152 million at December 31.
- Minor pointTotal liabilities increased to $95.238 million at September 30 from $67.053 million at December 31.
- Minor pointStockholders’ equity declined to $604.250 million at September 30 from $739.826 million at December 31.
Key Figures
- Whole-blood metal-free PPIX reduction
- 41.4% vs. placebo (p<0.0001)
- Phase 3 APOLLO co-primary endpoint
- Pain-free time in light
- 12.2 additional hours
- Average monthly total during month 6; p=0.0010
- Dizziness incidence
- 50%
- Most commonly reported treatment-emergent adverse event; mild or moderate and generally transient
- Bitopertin NDA timeline
- Resubmission by end of 2026; FDA decision anticipated by mid-2027
- Erythropoietic protoporphyria
- Cash, cash equivalents, and marketable securities
- $682.8 million
- As of September 30, 2026
- Stated funding runway
- Into 2030
- Company's stated outlook after the October offering
- Net loss
- $59.5 million vs. $62.3 million
- Three months ended September 30, 2026 vs. 2025
Previous Earnings Reports
-
FDA alignment allowed successful APOLLO data to support a CRL response; topline results remained pending.
-
Company had submitted bitopertin's NDA and held a voucher intended to shorten FDA review.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
erythropoietic protoporphyria medical
co-primary endpoints technical
new drug application regulatory
treatment emergent adverse event medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Pivotal Phase 3 APOLLO trial of bitopertin in erythropoietic protoporphyria (EPP) successfully met all primary and secondary endpoints
- Bitopertin NDA resubmission planned by end of 2026, with an FDA decision for potential approval in EPP anticipated by mid-2027
- Feedback from the upcoming end of phase 2 meeting with the FDA on selcodebart in anemia of myelofibrosis (MF) and plans for pivotal development in anemia of MF to be announced by the end of the year
- Presented positive initial results from the Phase 2 RESTORE-PV study of DISC-3405 in polycythemia vera (PV)
- Updated data from RESTORE-PV and initial data from a Phase 1b study of DISC-3405 in sickle cell disease (SCD) to be presented at the 68th American Society of Hematology (ASH) annual meeting in December 2026
- Strong financial position ending Q3 with approximately
$683 million in cash, cash equivalents, and marketable securities; completed a public offering in October 2026, with net proceeds of approximately$486 million extending cash runway into 2030
WATERTOWN, Mass., Nov. 05, 2026 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today reported financial results for the third quarter ended September 30, 2026, and provided a review of recent program and corporate developments.
“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,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “We look forward to engaging with regulators with the goal of bringing an important, innovative medicine to this community as efficiently as possible.”
“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,” Dr. Quisel added. “Alongside our anticipated end-of-Phase 2 FDA meeting for selcodebart in anemia of myelofibrosis in the fourth quarter and a strengthened balance sheet, we are well positioned to support the anticipated launch of bitopertin and advance two additional programs toward pivotal-stage development in 2027.”
Recent Highlights and Anticipated Milestones:
Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)
- Positive topline data from the Phase 3 APOLLO clinical trial of bitopertin in EPP 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. The data showed:
- 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) - Positive and statistically significant results from all secondary endpoints, including reductions in phototoxic reactions and improvements on multiple measures of light tolerance. Exploratory endpoints of quality-of-life benefits were also positive and statistically significant.
- Bitopertin reduced whole-blood metal-free PPIX by
- Bitopertin was generally well-tolerated. Consistent with prior studies, dizziness was the most commonly reported treatment emergent adverse event (TEAE) in the bitopertin group (
50% ) and was mild or moderate and generally transient. There were no TEAEs above Grade 3. - Successful APOLLO results add to bitopertin’s robust clinical data package. Based on these results, Disc 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
Selcodebart (DISC-0974): Anti-Hemojuvelin Antibody (Hepcidin Suppression)
- Updated data from the RALLY-MF trial to be presented at ASH in December
- Feedback 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
- Progressing Phase 2 study of selcodebart in patients with inflammatory bowel disease (IBD) with initial data expected in 2027
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)
- Presented positive initial results from the RESTORE-PV Phase 2 clinical trial of DISC-3405 in patients with PV at the SOHO Annual Meeting. Efficacy data was presented for the Q2 weekly dosed cohort. Across escalation and maintenance periods, results demonstrated:
- DISC-3405 increased hepcidin and lowered serum iron, translating to controlled hematocrit, reduced phlebotomy, and improved symptoms in PV patients
- Generally well-tolerated with adverse events that are consistent with underlying disease and a low rate of injection site reactions which were mild and self-limited
- Updated data from RESTORE-PV, including initial efficacy data on the Q4 weekly dosed cohort, to be presented at ASH in December
- Initial data from Phase 1b study of DISC-3405 in patients with sickle cell disease also to be presented at ASH
Third Quarter 2026 Financial Results:
- Cash Position: 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 . Together with such net proceeds, we believe that our cash, cash equivalents, and marketable securities will be sufficient to fund our current operating and capital expenditure plans and our debt service obligations into 2030. - Research and Development Expenses: R&D expenses were
$44.1 million for the three months ended September 30, 2026, as compared to$50.3 million for the three months ended September 30, 2025. The decrease in R&D expenses 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. These decreases were partially offset by increased investment across our development portfolio, including higher personnel-related costs driven by increased headcount. - Selling, General and Administrative Expenses: SG&A expenses were
$20.1 million for the three months ended September 30, 2026, as compared to$17.4 million for the three months ended September 30, 2025. The increase in SG&A expenses was primarily due to increased headcount. - Net Loss: Net loss was
$59.5 million for the three months ended September 30, 2026, as compared to$62.3 million for the three months ended September 30, 2025. The decrease was primarily due to lower research and development expenses resulting from costs incurred in the prior-year period that did not recur in the current period, partially offset by continued investment in advancing our pipeline and higher personnel-related costs.
About Disc Medicine
Disc Medicine (NASDAQ:IRON) is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, potentially first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. For more information, please visit www.discmedicine.com.
Available Information
Disc announces material information to the public about the Company, its products and services, and other matters through a variety of means, including filings with the U.S. Securities and Exchange Commission (SEC), press releases, public conference calls, webcasts and the investor relations section of the Company website at ir.discmedicine.com in order to achieve broad, non-exclusionary distribution of information to the public and for complying with its disclosure obligations under Regulation FD.
Disc Cautionary Statement Regarding Forward-Looking Statements
This press release 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 the next stages of its development programs for bitopertin, selcodebart (DISC-0974) and DISC-3405, including projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; the registrational pathway for bitopertin, including the potential timeline for an NDA resubmission and the timing of an FDA decision; anticipated discussions with regulatory agencies; the potential launch and commercialization of bitopertin, if approved; and the strength of its financial position and its anticipated cash runway. The use of words such as, but not limited to, “believe,” “expect,” “estimate,” “project,” “intend,” “future,” “potential,” “continue,” “may,” “might,” “plan,” “will,” “should,” “seek,” “anticipate,” or “could” or the negative of these terms and other similar words or expressions that are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Disc’s current beliefs, expectations and assumptions regarding the future of Disc’s business, future plans and strategies, clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Disc may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and investors should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of a number of material risks and uncertainties including but not limited to: the adequacy of Disc’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; the nature, strategy and focus of Disc; the difficulty in predicting the time and cost of development of Disc’s product candidates; Disc’s plans to research, develop and commercialize its current and future product candidates; the timing of initiation of Disc’s planned preclinical studies and clinical trials; the timing of the availability of data from Disc’s clinical trials; Disc’s ability to identify additional product candidates with significant commercial potential and to expand its pipeline in hematological diseases; the timing and anticipated results of Disc’s preclinical studies and clinical trials and the risk that the results of Disc’s preclinical studies and clinical trials may not be predictive of future results in connection with future studies or clinical trials and may not support further development and marketing approval; the content and timing of decisions made by the FDA and other regulatory authorities; and the other risks and uncertainties described in Disc’s filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Disc’s Annual Report on Form 10-K for the year ended December 31, 2025, and in subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement speaks only as of the date on which it was made. None of Disc, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law.
Media Contact
Peg Rusconi
Deerfield Group
peg.rusconi@deerfieldgroup.com
Investor Relations Contact
Kevin Lui
Precision AQ
kevin.lui@precisionaq.com
| DISC MEDICINE, INC. | ||||||||||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
| (In thousands, except share and per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| | Three months ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| | 2026 | | 2025 | | 2026 | | 2025 | |||||||||
| Operating expenses: | | | | | ||||||||||||
| Research and development | | $ | 44,080 | $ | 50,334 | $ | 136,917 | $ | 124,416 | |||||||
| Selling, general and administrative | | 20,081 | 17,362 | 61,843 | 44,636 | |||||||||||
| Total operating expenses | | 64,161 | | 67,696 | | 198,760 | | 169,052 | ||||||||
| Loss from operations | | (64,161 | ) | | (67,696 | ) | | (198,760 | ) | | (169,052 | ) | ||||
| Other income (expense), net | 4,735 | | 5,477 | | 16,418 | | 17,672 | |||||||||
| Income tax expense | | (109 | ) | (102 | ) | (229 | ) | (273 | ) | |||||||
| Net loss | | $ | (59,535 | ) | | $ | (62,321 | ) | | $ | (182,571 | ) | | $ | (151,653 | ) |
| Net loss per share, basic and diluted | | $ | (1.53 | ) | | $ | (1.77 | ) | | $ | (4.72 | ) | | $ | (4.39 | ) |
| Weighted-average common shares outstanding, basic and diluted | | 38,904,676 | 35,178,691 | 38,695,405 | 34,516,134 | |||||||||||
| DISC MEDICINE, INC. | ||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
| (In thousands) | ||||||||
| | September 30, 2026 | December 31, 2025 | ||||||
| (Unaudited) | ||||||||
| Assets | | |||||||
| Cash, cash equivalents, and marketable securities | | $ | 682,816 | $ | 791,152 | |||
| Other current assets | | 14,589 | 12,746 | |||||
| Total current assets | | 697,405 | 803,898 | |||||
| Non-current assets | | 2,083 | 2,981 | |||||
| Total assets | | $ | 699,488 | $ | 806,879 | |||
| Liabilities and Stockholders’ Equity | | |||||||
| Current liabilities | | $ | 34,360 | $ | 36,641 | |||
| Non-current liabilities | | 60,878 | 30,412 | |||||
| Total liabilities | | 95,238 | 67,053 | |||||
| Total stockholders’ equity | | 604,250 | 739,826 | |||||
| Total liabilities and stockholders’ equity | | $ | 699,488 | $ | 806,879 | |||
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Disc Medicine's Phase 3 APOLLO trial show for bitopertin?
APOLLO met both co-primary endpoints, with a 41.4% reduction in whole-blood metal-free PPIX versus placebo and a 12.2-hour increase in average monthly pain-free time in light during month 6. The respective p-values were less than 0.0001 and 0.0010, indicating statistical significance. All secondary endpoints also achieved statistical significance.
When does Disc Medicine expect an FDA decision on bitopertin?
Disc anticipates an FDA decision on potential bitopertin approval for EPP by mid-2027, following a planned application resubmission by the end of 2026.
What clinical updates will Disc Medicine present at ASH in December 2026?
Disc plans to present updated RALLY-MF and RESTORE-PV data and initial Phase 1b DISC-3405 data in sickle cell disease at ASH in December 2026. The RESTORE-PV update will include initial efficacy results from the cohort dosed every four weeks.
Why did Disc Medicine's third-quarter 2026 R&D expenses decline?
The decline primarily reflected a $10.0 million milestone payment and drug-manufacturing costs in the prior-year period that did not recur. Increased development-portfolio investment, including higher personnel costs from increased headcount, partially offset those reductions.
What safety findings did Disc Medicine report from APOLLO?
Dizziness was the most common treatment-emergent adverse event in the bitopertin group, affecting 50% of patients. It was mild or moderate and generally transient. There were no treatment-emergent adverse events above Grade 3.