WATERTOWN, Mass., March 31, 2023 (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 full year ended December 31, 2022 and business highlights.
“2022 was a year of transformation and tremendous achievement for Disc. During the past year, we became a publicly-traded company through our reverse merger with Gemini Therapeutics, strengthened our balance sheet, and advanced both bitopertin and DISC-0974 into patient studies. This puts us in a strong position for growth in 2023, when we anticipate our first data readouts in patients and will continue to execute on our vision of building a leading hematology franchise,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “In this past quarter, we have already expanded our pipeline by in-licensing a third, Phase 1-ready program, further strengthened our financial position with a registered direct offering led by Bain Capital Life Sciences, and initiated a Phase 1b/2 study of DISC-0974 in patients with CKD anemia. I want to thank the Disc team for their tireless efforts as we look forward to another exciting year in 2023.”
Business Highlights and Anticipated Milestones:
Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)
Bitopertin is an investigational, clinical-stage, orally-administered inhibitor of glycine transporter 1 (GlyT1) that is designed to modulate heme biosynthesis. GlyT1 is a membrane transporter expressed on developing red blood cells and is required to supply sufficient glycine for heme biosynthesis and support erythropoiesis. Disc is planning to develop bitopertin as a potential treatment for a range of hematologic diseases including erythropoietic porphyrias, where it has potential to be the first disease-modifying therapy.
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)
DISC-0974 is an investigational anti-hemojuvelin monoclonal antibody (mAb) and is designed to suppress hepcidin production and increase serum iron levels in patients suffering from anemia of inflammation.
MWTX-003: Anti-TMPRSS6 Antibody (Hepcidin Induction)
MWTX-003 is an investigational, anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibody designed to increase hepcidin production and suppress serum iron.
Corporate:
Full Year 2022 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 its AURORA Phase 2 and BEACON Phase 2 clinical studies of bitopertin, and anticipated study of bitopertin in Diamond-Blackfan Anemia, its Phase 1b/2 clinical study of DISC-0974 in NDD-CKD patients with anemia, its anticipated Phase 1 study of MWTX-003 and potential development of MWTX-003 as a treatment for polycythemia vera and other indications, projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; Disc’s business plans and objectives; and Disc’s beliefs about operating expenses and that it will have capital to fund Disc into 2025. 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 other risks and uncertainties described in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2022 and other documents filed by Disc from time to time with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Disc’s subsequent filings with the Securities and Exchange Commission. 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.
DISC MEDICINE, INC. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(In thousands, except share and per share amounts) | ||||||||
(Unaudited) | ||||||||
| Year Ended December 31, | |||||||
| 2022 | | 2021 | |||||
Operating expenses: | | | ||||||
Research and development | | $ | 33,437 | | $ | 25,170 | ||
General and administrative | | 14,038 | | 5,763 | ||||
Total operating expenses | | 47,475 | | 30,933 | ||||
Loss from operations | | (47,475 | ) | | (30,933 | ) | ||
Other income (expense), net | | 648 | | (5,036 | ) | |||
Net loss | | $ | (46,827 | ) | | $ | (35,969 | ) |
Weighted-average common shares outstanding-basic and diluted | | 1,039,490 | | 878,407 | ||||
Net loss per share-basic and diluted | | $ | (45.05 | ) | | $ | (40.95 | ) |
DISC MEDICINE, INC. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(In thousands, except share and per share amounts) | ||||||||
(Unaudited) | ||||||||
| December 31, | |||||||
| 2022 | | 2021 | |||||
Assets | | | ||||||
Cash and cash equivalents | | $ | 194,611 | | $ | 88,036 | ||
Other current assets | | 3,880 | | 2,448 | ||||
Total current assets | | 198,491 | | 90,484 | ||||
Other assets | | 1,714 | 1,927 | |||||
Total assets | | $ | 200,205 | | $ | 92,411 | ||
Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) | | | ||||||
Current liabilities | | 22,578 | | 13,424 | ||||
Non-current liabilities | | 1,027 | | 1,334 | ||||
Total liabilities | | 23,605 | | 14,758 | ||||
Total convertible preferred stock | | — | | 141,856 | ||||
Total stockholders’ equity (deficit) | | 176,600 | | (64,203 | ) | |||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | | $ | 200,205 | | $ | 92,411 |
Media Contact
Peg Rusconi
Verge Scientific Communications
prusconi@vergescientific.com
Investor Relations Contact
Suzanne Messere
Stern Investor Relations
suzanne.messere@sternir.com
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