| Item 2.02 |
Results of Operations and Financial Condition. |
On October 20, 2025, Disc Medicine, Inc. (the “Company”) announced that its preliminary unaudited cash, cash equivalents and marketable securities as of September 30, 2025 were approximately $615.9 million.
The Company has not yet completed its quarter-end financial close process for the quarter ended September 30, 2025. This estimate of the Company’s cash, cash equivalents and marketable securities as of September 30, 2025 is preliminary, has not been audited and is subject to change upon completion of the Company’s financial statement closing procedures. Additional information and disclosure would be required for a more complete understanding of the Company’s financial position and results of operations as of September 30, 2025. The Company’s independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to this preliminary result and, accordingly, does not express an opinion or any other form of assurance about it. The information presented herein should not be considered a substitute for the financial information the Company files with the Securities and Exchange Commission (the “SEC”) in its quarterly report on Form 10-Q for the quarter ended September 30, 2025. The Company has no intention or obligation to update preliminary estimates of its cash, cash equivalents and marketable securities set forth above.
The information contained in Item 2.02 of this Current Report on Form 8-K is intended to be furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and 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 (the “Securities Act”), or the Exchange Act, except as expressly provided by specific reference in such filing.
| Item 7.01 |
Regulation FD Disclosure |
On October 20, 2025, the Company issued a press release providing an update on its hematology portfolio and outlining near-term business objectives and anticipated milestones. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in Item 7.01 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 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 or the Exchange Act, except as expressly provided by specific reference in such filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
Corporate Presentation
On October 20, 2025, the Company updated its corporate presentation. A copy of the updated corporate presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference. The corporate presentation will also be available in the investor relations section of the Company’s website at https://ir.discmedicine.com. Information contained on the Company’s website is not incorporated by reference into this Current Report on Form 8-K, and you should not consider any information on, or that can be accessed from, the Company’s website as part of this Current Report on Form 8-K.
Recent Developments
On October 20, 2025, the Company provided an update on its hematology portfolio and outlined its near-term business objectives and anticipated milestones for the rest of 2025 and 2026:
Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)
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Accelerate activities to support a potential US approval and launch in late 2025 or early 2026 based on accelerated review timeline associated with receipt of the FDA Commissioner’s National Priority Voucher (“CNPV”), which is designed to shorten the New Drug Application review process to 1-2 months |
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Drive enrollment of ongoing APOLLO confirmatory trial of bitopertin in erythropoietic protoporphyria that is intended to also support potential approval of bitopertin in territories outside the US |