Disc Medicine(IRON)
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Disc Medicine(IRON) - 2025 Q1 - Quarterly Results
2025-05-07 12:05
Exhibit 99.1 Disc Medicine Reports First Quarter 2025 Financial Results and Provides Business Update WATERTOWN, Mass., May 7, 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 first quarter ended March 31, 2025, and provided a recap of recent program and corporate developments. "2025 is off to a ...
Disc Medicine Reports First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-07 12:00
Core Insights - Disc Medicine, Inc. reported strong operational progress in Q1 2025, with a focus on advancing its lead program, bitopertin, for erythropoietic protoporphyria (EPP) [2][5] - The company has a solid financial foundation, with cash reserves expected to fund operations into 2028, following a public offering that raised $259 million [3][9] Financial Performance - Cash, cash equivalents, and marketable securities totaled $694.7 million as of March 31, 2025, compared to $489.9 million at the end of 2024 [20] - Research and Development (R&D) expenses increased to $27.8 million in Q1 2025 from $23.7 million in Q1 2024, driven by advancements in clinical studies and increased headcount [14] - Selling, General and Administrative (SG&A) expenses rose to $12.2 million in Q1 2025 from $7.8 million in Q1 2024, reflecting the establishment of infrastructure for potential commercialization [14] - The net loss for Q1 2025 was $34.1 million, compared to a net loss of $26.9 million in Q1 2024 [14] Clinical Development Updates - The APOLLO trial for bitopertin has been initiated, aimed at supporting the conversion of a potential accelerated approval to full approval [6] - The company plans to submit a New Drug Application (NDA) for bitopertin in EPP in the second half of 2025 [5][6] - Data readouts for the DISC-0974 program, including results from the Phase 2 study for myelofibrosis (MF) anemia and the Phase 1b study for non-dialysis dependent chronic kidney disease (NDD-CKD) anemia, are expected in the second half of 2025 [5][7] - A Phase 2 study of DISC-3405 in polycythemia vera (PV) is set to be initiated in the first half of 2025 [8]
Disc Medicine to Host Webinar with Key Opinion Leaders on Anemia of Myelofibrosis (MF)
Globenewswire· 2025-04-29 12:00
Core Viewpoint - Disc Medicine, Inc. is hosting a virtual KOL investor event to discuss anemia of myelofibrosis (MF) and the treatment landscape, including clinical data and development plans for its investigational drug DISC-0974 [1][2] Group 1: Event Details - The virtual event is scheduled for May 9, 2025, at 1:00 PM ET / 10:00 AM PT [1] - Presentations will include insights from leading experts on myeloproliferative neoplasms (MPNs) and the unmet need for anemia-focused treatments [2] - A live webcast will be available on Disc's Investor Relations page, with a replay accessible for 90 days [3] Group 2: DISC-0974 Overview - DISC-0974 is a monoclonal antibody targeting hemojuvelin (HJV) to suppress hepcidin production and increase serum iron levels in patients with anemia of inflammation [4] - The drug was in-licensed from AbbVie in 2019 and has shown clinical proof-of-mechanism in previous trials [4] - Ongoing clinical trials include a Phase 2 trial in MF anemia and a Phase 1b/2a trial in chronic kidney disease patients [4] Group 3: Anemia of Myelofibrosis - Myelofibrosis affects an estimated 25,000 patients in the U.S., with over 80% presenting with anemia at diagnosis [6] - Hepcidin levels are approximately 12-fold elevated in MF patients, correlating with disease severity and the need for red blood cell transfusions [6] Group 4: Company Background - Disc Medicine is focused on developing novel treatments for serious hematologic diseases, targeting biological pathways related to red blood cell biology [7][8]
Disc Medicine: Forging Ahead In Hematology
Seeking Alpha· 2025-04-09 11:13
Core Insights - Disc Medicine (NASDAQ: IRON) presents an intriguing investment opportunity for those interested in clinical-stage biotech, particularly in the niche of rare hematologic diseases [1] - The company is entering a critical phase, indicating potential for growth and development in its sector [1] Company Analysis - The focus on high-growth companies aligns with sectors expected to experience exponential expansion, highlighting the strategic positioning of Disc Medicine [1] - The analysis emphasizes the importance of innovation and disruptive technologies in generating substantial returns, which is relevant to the company's future prospects [1]
All You Need to Know About Disc Medicine, Inc. (IRON) Rating Upgrade to Buy
ZACKS· 2025-03-14 17:05
Disc Medicine, Inc. (IRON) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.T ...
Wall Street Analysts Predict a 68.78% Upside in Disc Medicine, Inc. (IRON): Here's What You Should Know
ZACKS· 2025-03-03 16:00
Shares of Disc Medicine, Inc. (IRON) have gained 0.7% over the past four weeks to close the last trading session at $56.18, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $94.82 indicates a potential upside of 68.8%.The average comprises 11 short-term price targets ranging from a low of $73 to a high of $118, with a standard deviation of $13.84. While the lowest estimate indica ...
Disc Medicine(IRON) - 2024 Q4 - Annual Report
2025-02-27 13:17
Financial Performance - The company reported total operating expenses of $129.72 million for the year ended December 31, 2024, an increase of $38.60 million from $91.13 million in 2023[577]. - The net loss for the year ended December 31, 2024, was $109.36 million, compared to a net loss of $76.43 million in 2023, representing an increase in loss of $32.93 million[577]. - The company reported a net cash used in operating activities of $93.9 million for 2024, compared to $73.5 million in 2023, primarily due to a net loss of $109.4 million[589]. - The company has an accumulated deficit of $298.0 million as of December 31, 2024, and anticipates ongoing significant expenses[586]. - The company expects to continue incurring significant operating losses and may require additional capital to fund operations, potentially through equity or debt financing[583]. Expenses - Research and development expenses rose to $96.67 million in 2024, up from $69.26 million in 2023, reflecting an increase of $27.41 million[577]. - Selling, general and administrative expenses increased to $33.05 million in 2024, compared to $21.86 million in 2023, marking an increase of $11.19 million[577]. - Research and development expenses increased to $96.7 million in 2024 from $69.3 million in 2023, a rise of $27.4 million, primarily due to higher personnel-related costs and external development expenses[578]. - Selling, general and administrative expenses rose to $33.0 million in 2024 from $21.9 million in 2023, an increase of $11.2 million, mainly driven by higher personnel-related costs[580]. Cash and Securities - The company had cash, cash equivalents, and marketable securities of $489.9 million as of December 31, 2024, and raised approximately $243.3 million from a public offering in January 2025[567]. - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $489.9 million, an increase from $360.4 million as of December 31, 2023[617]. - The company completed an underwritten offering in January 2025, expected to generate net proceeds of approximately $243.3 million[585]. - Total contractual obligations as of December 31, 2024, amounted to $3.98 million, with payments due over various periods[597]. Product Development - Bitopertin, the lead product candidate, showed significant reduction in the toxic metabolite protoporphyrin IX (PPIX) in clinical trials, with plans to submit a New Drug Application (NDA) for accelerated approval in the second half of 2025[562]. - DISC-0974, another key product candidate, completed a Phase 1 clinical trial with positive results and is currently in Phase 1b/2 trials for anemia of myelofibrosis and chronic kidney disease[563]. - The company plans to initiate a Phase 2 clinical trial for DISC-3405 in polycythemia vera in the first half of 2025, following the completion of initial trials[566]. - The company has not generated any revenue since inception and does not expect to do so in the near future, pending successful commercialization of product candidates[568]. Income and Interest - Interest income increased to $21.29 million in 2024 from $14.80 million in 2023, while interest expense was $572, reflecting a new debt issuance[577]. - Other income increased to $20.7 million in 2024 compared to $14.8 million in 2023, reflecting a $5.9 million rise in interest income[581]. Market and Economic Factors - If U.S. market interest rates were to increase by one percentage point, the net fair value of the company’s marketable securities would decrease by approximately $1.4 million[617]. - The company has minimal exposure to foreign currency exchange rate fluctuations due to the short duration of transactions[618]. - Inflation has not materially affected the company’s business, financial condition, or results of operations during the years ended December 31, 2024, and 2023[619]. Accounting and Valuation - The company’s stock-based compensation expense is based on fair value estimates using the Black-Scholes option-pricing model, which involves subjective assumptions[606]. - Prior to the merger closing, the estimated fair value of the company’s common stock was determined based on third-party valuations and management assessments[609]. - After the merger, the fair value of the company’s common stock is now determined based on the quoted market price[613]. - The company was classified as an "emerging growth company" until December 31, 2024, allowing it to benefit from certain reporting exemptions[615]. - The company’s accounting policies and estimates are critical to the preparation of its consolidated financial statements, affecting reported amounts of assets and liabilities[602].
Disc Medicine(IRON) - 2024 Q4 - Annual Results
2025-02-27 13:11
Financial Performance - Disc Medicine reported a net loss of $109.4 million for the full year 2024, compared to a net loss of $76.4 million in 2023, reflecting an increase of 43%[13] - Total operating expenses for 2024 were $129.7 million, compared to $91.1 million in 2023, marking a 42% increase[17] - Total stockholders' equity increased to $443.6 million as of December 31, 2024, compared to $345.1 million in 2023[19] Research and Development - Research and development expenses increased to $96.7 million in 2024 from $69.3 million in 2023, driven by advancements in clinical studies and increased headcount[13] - Positive data from the Phase 1b trial of DISC-0974 in myelofibrosis anemia was presented, with initial data from the ongoing Phase 2 expected in H2 2025[4] - The company presented positive preclinical data for DISC-3405 in sickle cell disease, highlighting its potential therapeutic benefits[4] Cash Position and Funding - The company ended 2024 with $490 million in cash, cash equivalents, and marketable securities, up from $360.4 million at the end of 2023, providing a cash runway into 2028[4] - The company completed a public offering in January 2025, raising approximately $259 million, which will support ongoing operations[4] Future Plans - The company plans to submit a New Drug Application (NDA) for bitopertin in the second half of 2025, targeting accelerated approval based on clinical data[4] - The company is on track to initiate the APOLLO trial for bitopertin by mid-2025, following alignment with the FDA on trial design[4]
Disc Medicine Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Globenewswire· 2025-02-27 13:00
Core Insights - Disc Medicine, Inc. reported significant progress in 2024, particularly with the potential accelerated approval for bitopertin based on Phase 2 results in erythropoietic protoporphyria (EPP) patients [2][5] - The company plans to initiate the APOLLO trial in mid-2025 and submit a New Drug Application (NDA) in the second half of 2025 [2][5] - Positive clinical data was reported across the company's portfolio, including for DISC-0974 in anemias of myelofibrosis (MF) and non-dialysis-dependent chronic kidney disease (NDD-CKD) [2][5] Recent Highlights and Anticipated Milestones - Bitopertin is positioned for NDA submission in EPP through an accelerated approval pathway, with the APOLLO trial set to begin by mid-2025 [5][6] - Positive updates from Phase 1b trials of DISC-0974 in MF and NDD-CKD were presented, with initial data from ongoing studies expected in H2 2025 [5][6] - The company also plans to initiate a Phase 2 study for DISC-3405 in polycythemia vera (PV) in H1 2025 [5][6] Financial Overview - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $489.9 million, an increase from $360.4 million in 2023 [9][18] - Research and development expenses rose to $96.7 million in 2024 from $69.3 million in 2023, driven by advancements in clinical studies and increased headcount [9][15] - The net loss for 2024 was $109.4 million, compared to $76.4 million in 2023, attributed to higher operating costs [9][16]
Disc Medicine Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update
Newsfilter· 2025-02-27 13:00
Core Insights - Disc Medicine, Inc. reported significant progress in 2024, particularly with the potential accelerated approval for bitopertin based on Phase 2 results in erythropoietic protoporphyria (EPP) patients [2][5] - The company plans to initiate the APOLLO trial in mid-2025 and submit a New Drug Application (NDA) in the second half of 2025 [2][5] - Positive clinical data was reported across the company's portfolio, including for DISC-0974 in anemias of myelofibrosis (MF) and non-dialysis-dependent chronic kidney disease (NDD-CKD) [2][5] Recent Highlights and Anticipated Milestones - Bitopertin is positioned for NDA submission in EPP through an accelerated approval pathway, with the APOLLO trial set to begin by mid-2025 [5][6] - Positive updates from Phase 1b trials of DISC-0974 in MF and NDD-CKD were presented, with initial data from ongoing studies expected in H2 2025 [5][6] - The company also plans to initiate a Phase 2 study for DISC-3405 in polycythemia vera (PV) in H1 2025 [5][6] Financial Overview - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities totaling $489.9 million, an increase from $360.4 million in 2023 [10][19] - Research and development expenses rose to $96.7 million in 2024 from $69.3 million in 2023, reflecting advancements in clinical studies and increased headcount [10][17] - The net loss for 2024 was $109.4 million, compared to $76.4 million in 2023, primarily due to higher operating costs [10][18]