Disc Medicine (Nasdaq: IRON) posts Q2 loss, advances hematology pipeline
Rhea-AI Filing Summary
Disc Medicine reported second-quarter 2026 results and highlighted progress across its hematology pipeline. A Type A meeting with the FDA confirmed that the Phase 3 APOLLO study of bitopertin in erythropoietic protoporphyria can, if successful, serve as the basis for a CRL response and could potentially support traditional approval, with topline APOLLO data expected in Q4 2026. The company also launched an Expanded Access Program for bitopertin and reported sustained efficacy and safety from the HELIOS extension trial.
For selcodebart (DISC-0974), updated Phase 2 RALLY-MF data in myelofibrosis showed a 56% Major anemia response rate and 72% overall anemia response rate, and the program received EU Orphan Drug Designation. Disc completed enrollment in the Phase 2 RESTORE-PV study of DISC-3405 in polycythemia vera, with initial data expected in Q3 2026, and is progressing a Phase 1b sickle cell disease study with data expected in Q4 2026.
Disc ended Q2 2026 with approximately $718 million in cash, cash equivalents, and marketable securities, which it expects to fund operations into 2029. Second-quarter research and development expenses were $46.9 million, selling, general and administrative expenses were $18.1 million, and net loss was $59.5 million, or $(1.54) per share.
Positive
- Alignment with the FDA that the APOLLO Phase 3 trial of bitopertin can, if successful, serve as the basis for a CRL response, together with approximately $718 million in cash providing runway into 2029, clarifies both the registrational path and funding horizon.
Negative
- None.
Filing Explained
At June 30, cash, cash equivalents, and marketable securities were $717.7 million, down from $791,152 thousand at December 31, 2025.
This July 30 Form 8-K furnishes Disc Medicine’s second-quarter results and corporate update; the disclosed balance sheet shows a lower liquidity balance, while no new ownership or dilution mechanics are reported.
Form 8-K is used to report specified material events, and this report’s Item 2.02 information, including its press-release exhibit, is furnished rather than filed for Exchange Act liability purposes.
At
The company says the June 30 liquidity balance is expected to fund operations into 2029, but that statement is a forward-looking expectation rather than a completed financing or a receipt of new proceeds.
8-K Event Classification
Key Figures
Key Terms
Type A meeting regulatory
CRL regulatory
Expanded Access Program (EAP) regulatory
Orphan Drug Designation regulatory
Major anemia response rate medical
hepcidin medical
Earnings Snapshot
Disc expects its cash, cash equivalents, and marketable securities to fund operational plans into 2029.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What were Disc Medicine (IRON)'s key financial results for Q2 2026?
What is the status of bitopertin in Disc Medicine (IRON)'s development pipeline?
What efficacy has Disc Medicine (IRON) reported for selcodebart (DISC-0974) in myelofibrosis?
What upcoming milestones are expected for DISC-3405 at Disc Medicine (IRON)?
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What were Disc Medicine (IRON)'s results for the first six months of 2026?
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On July 30, 2026, Disc Medicine, Inc. announced its financial results for the second quarter ended June 30, 2026 and provided a corporate update. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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Press release issued by Disc Medicine, Inc. on July 30, 2026, furnished herewith. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DISC MEDICINE, INC. |
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Date: |
July 30, 2026 |
By: |
/s/ John Quisel, J.D., Ph.D. |
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Name: John Quisel, J.D., Ph.D. |
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Exhibit 99.1 |
Disc Medicine Reports Second Quarter 2026 Financial Results and Provides Business Update
WATERTOWN, Mass., July 30, 2026 – 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 second quarter ended June 30, 2026, and provided a review of recent program and corporate developments.
“The anticipated readout of the Phase 3 APOLLO trial of bitopertin in EPP in Q4 marks a significant milestone. We have continued driving forward on this program over the past quarter with the launch of our EAP,” said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. “We also look forward to significant advancement across the rest of our pipeline in the second half of 2026. We saw strong demand for the Phase 2 RESTORE-PV trial of DISC-3405 in polycythemia vera, which is now fully enrolled with initial data coming ahead of schedule in Q3. Along with an expected end of Phase 2 FDA interaction on selcodebart in MF anemia in Q4, we will potentially be positioned to advance two more programs into pivotal-stage development in 2027.”
Recent Highlights and Anticipated Milestones:
Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)
Selcodebart (DISC-0974): Anti-Hemojuvelin Antibody (Hepcidin Suppression)
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DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)
Second Quarter 2026 Financial Results:
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.
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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 for traditional approval, the potential for the APOLLO clinical trial to serve as the basis for the CRL response and any such approval, and the timing of any such approval, if granted; anticipated discussions with regulatory agencies; 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
Christina Tartaglia
Precision AQ
christina.tartaglia@precisionaq.com
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DISC MEDICINE, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(In thousands, except share and per share amounts) |
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(Unaudited) |
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Three months ended |
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Six Months Ended |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
46,933 |
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$ |
46,319 |
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$ |
92,837 |
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$ |
74,082 |
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Selling, general and administrative |
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18,142 |
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15,091 |
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41,762 |
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27,274 |
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Total operating expenses |
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65,075 |
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61,410 |
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134,599 |
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101,356 |
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Loss from operations |
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(65,075 |
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(61,410 |
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(134,599 |
) |
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(101,356 |
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Other income (expense), net |
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5,612 |
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6,215 |
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11,683 |
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12,195 |
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Income tax expense |
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(69 |
) |
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(52 |
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(120 |
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(171 |
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Net loss |
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$ |
(59,532 |
) |
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$ |
(55,247 |
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$ |
(123,036 |
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$ |
(89,332 |
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Net loss per share, basic and diluted |
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$ |
(1.54 |
) |
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$ |
(1.58 |
) |
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$ |
(3.19 |
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$ |
(2.61 |
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Weighted-average common shares outstanding, basic and diluted |
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38,685,565 |
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35,024,592 |
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38,589,035 |
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34,179,364 |
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DISC MEDICINE, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(In thousands) |
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June 30, |
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December 31, |
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(Unaudited) |
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Assets |
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Cash, cash equivalents, and marketable securities |
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$ |
717,746 |
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$ |
791,152 |
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Other current assets |
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15,015 |
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12,746 |
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Total current assets |
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732,761 |
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803,898 |
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Non-current assets |
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2,310 |
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2,981 |
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Total assets |
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$ |
735,071 |
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$ |
806,879 |
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Liabilities and Stockholders’ Equity |
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Current liabilities |
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$ |
30,360 |
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$ |
36,641 |
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Non-current liabilities |
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60,547 |
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30,412 |
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Total liabilities |
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90,907 |
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67,053 |
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Total stockholders’ equity |
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644,164 |
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739,826 |
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Total liabilities and stockholders’ equity |
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$ |
735,071 |
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$ |
806,879 |
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