Disc Medicine expects bitopertin FDA decision mid-2027
Disc says its September cash balance and October offering proceeds will fund current plans and debt service 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 Filing Summary
Disc Medicine, Inc. reported third-quarter 2026 results and positive Phase 3 APOLLO findings for bitopertin in erythropoietic protoporphyria. The trial met both co-primary endpoints: whole-blood metal-free PPIX was 41.4% lower than placebo, and average monthly total time in light without pain increased by 12.2 hours during month 6.
Disc plans to resubmit bitopertin’s New Drug Application by the end of 2026, with an FDA decision anticipated by mid-2027. It plans to announce selcodebart’s end-of-Phase 2 FDA feedback and pivotal-development plans by year-end. Initial Phase 2 DISC-3405 results in polycythemia vera were positive; updated RESTORE-PV data and initial sickle cell disease data are to be presented at ASH in December 2026.
Cash, cash equivalents and marketable securities were $682.8 million as of September 30, 2026; the October 2026 public offering produced approximately $485.9 million in net proceeds. Disc believes these resources will fund current operating and capital expenditure plans and debt service into 2030. Third-quarter R&D expense was $44.1 million versus $50.3 million a year earlier, SG&A was $20.1 million versus $17.4 million, and net loss was $59.5 million versus $62.3 million.
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.
Positive
- Major pointAPOLLO met both co-primary endpoints; PPIX was 41.4% lower than placebo.
Negative
- None.
8-K Event Classification
Key Figures
Key Terms
co-primary endpoints medical
metal-free PPIX medical
New Drug Application regulatory
treatment emergent adverse event medical
Earnings Snapshot
Disc believes its cash, cash equivalents and marketable securities, together with October 2026 public offering net proceeds, will fund current operating and capital expenditure plans and debt service into 2030.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
When does Disc Medicine expect an FDA decision on bitopertin?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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
Date of Report (Date of earliest event reported): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
|
|||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
|
|
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 November 5, 2026, Disc Medicine, Inc. announced its financial results for the third quarter ended September 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. |
|
Description |
99.1 |
|
Press release issued by Disc Medicine, Inc. on November 5, 2026, furnished herewith. |
104 |
|
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.
|
|
|
DISC MEDICINE, INC. |
|
|
|
|
Date: |
November 5, 2026 |
By: |
/s/ John Quisel, J.D., Ph.D. |
|
|
|
Name: John Quisel, J.D., Ph.D. |
|
Exhibit 99.1 |
Disc Medicine Reports Third Quarter 2026 Financial Results and Provides Business Update
WATERTOWN, Mass., November 5, 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 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)
|
|
Selcodebart (DISC-0974): Anti-Hemojuvelin Antibody (Hepcidin Suppression)
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)
Third 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.
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 |
|
|
Nine Months Ended |
|
||||||||||
|
|
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, |
|
|
December 31, |
|
||
|
|
(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 |
|