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Disc Medicine Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update Targeting NDA submission for bitopertin in erythropoietic protoporphyria (EPP) in H2 2025 through accelerated approva

Key Takeaway: Disc Medicine reported its fourth quarter and full year 2024 financial results, highlighting significant milestones such as positive Phase 2 results for bitopertin and ongoing preparations for the APOLLO trial. The company aims to submit a New Drug Application (NDA) in the second half of 2025, potentially leading to accelerated approval for treatments related to erythropoietic protoporphyria (EPP). Despite these advancements, Disc reported a net loss and faces challenges in maintaining operational funding and managing the timelines of ongoing clinical trials.

Market Sentiment Analysis

POSITIVE FACTORS

  • Potential for accelerated approval of bitopertin based on Phase 2 results
  • Positive clinical data readouts for each clinical program
  • Upcoming initiation of the APOLLO trial supporting clinical development
  • Strong financial position with increased cash reserves reported

CONCERNS & RISKS

  • Continuous operational losses reported for 2024
  • Risks associated with the successful initiation and completion of clinical trials
  • Possible delays in the timeline for NDA submission could impact projections

Full Press Release Details

Disc Medicine Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
WATERTOWN, Mass. (February 27, 2025) 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 fourth quarter and full year ended December 31, 2024, and provided a recap of recent
program and corporate developments.
2024 was a transformative year for Disc, marked by the achievement of several milestones, most notably opening
the door to a potential accelerated approval for bitopertin based on Phase 2 results linking PPIX reduction to improvement on clinical outcomes in EPP patients, and subsequently gaining alignment on the design of the APOLLO trial as a confirmatory
study, said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. These achievements bring us meaningfully closer to delivering a potentially disease-modifying and life-altering treatment to patients. We expect to
initiate the APOLLO trial in mid-2025 followed by an NDA submission in the second half of this year and are diligently preparing for the opportunity to bring bitopertin to market. In addition, we saw momentum
across our portfolio, presenting positive clinical data readouts for each of our clinical programs. This included exciting data updates for DISC-0974 in anemias of MF and NDD-CKD, both serious conditions with
high unmet patient need and significant opportunity for better treatment options. These latest clinical results strengthen our belief in the potential of our iron homeostasis portfolio assets to address a range of hematological diseases.
Recent Highlights and Anticipated Milestones:
Bitopertin: GlyTI Inhibitor (Heme Synthesis Modulator)
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)
Full Year 2024 Financial Results:
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: expectations with respect to the next stages of its development programs for bitopertin, 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 accelerated approval; the potential of its development programs in new indications; 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, opportunity, 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.
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; and the other risks and uncertainties described in
Disc s filings with the SEC, including in the Risk Factors section of our Annual Report on Form 10-K for the year ended December 31, 2024. 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)
Year Ended December 31,
2024 2023
Operating expenses:
Research and development $ 96,671 $ 69,264
Selling, general and administrative 33,049 21,861
Total operating expenses 129,720 91,125
Loss from operations (129,720 ) (91,125 )
Other income (expense), net 20,718 14,795
Income tax expense (355 ) (99 )
Net loss $ (109,357 ) $ (76,429 )
Weighted-average common shares outstanding, basic and diluted 27,606,022 22,315,877
Net loss per share, basic and diluted $ (3.96 ) $ (3.42 )
DISC MEDICINE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands)
December 31, December 31,
2024 2023
Assets
Cash, cash equivalents, and marketable securities $ 489,881 $ 360,382
Other current assets 3,734 5,280
Total current assets 493,615 365,662
Non-current assets 3,158 2,334
Total assets $ 496,773 $ 367,996
Liabilities and Stockholders Equity
Current liabilities $ 23,316 $ 21,439
Non-current liabilities 29,870 1,436
Total liabilities 53,186 22,875
Total stockholders equity 443,587 345,121
Total liabilities and stockholders equity $ 496,773 $ 367,996
Investor Relations Contact

Frequently Asked Questions

What are the key achievements of Disc Medicine in 2024?

Disc Medicine achieved significant milestones, including a potential accelerated approval pathway for bitopertin and positive clinical data for DISC-0974 and NDD-CKD.

When will the APOLLO trial for bitopertin begin?

The APOLLO trial for bitopertin is expected to start in mid-2025.

What is Disc Medicine's focus in biopharmaceuticals?

Disc Medicine focuses on discovering and developing treatments for serious hematologic diseases.

What did Disc Medicine report for its 2024 financial results?

In 2024, Disc Medicine reported operating expenses of $129.7 million and a net loss of $109.4 million.

How did Disc Medicine's net loss in 2024 compare to 2023?

Disc Medicine's net loss increased to $109.4 million in 2024 from $76.4 million in 2023.

Last updated: Feb 27, 2025