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Disc Medicine Announces Presentation of New Data from Phase 1b Trial of DISC-0974 in Patients with Chronic Kidney Disease (CKD) and Anemia at 2024 American Society of Nephrology (ASN) Kidney Week
GlobeNewswire News Room· 2024-10-11 12:00
Core Insights - Disc Medicine, Inc. is set to present clinical data on DISC-0974 at the 2024 ASN Kidney Week, focusing on its Phase 1b study in patients with non-dialysis dependent chronic kidney disease and anemia [1][2] - The study aims to evaluate safety and changes in hepcidin, iron levels, and hematologic parameters [1][2] Presentation Details - The presentation will include data from the 40mg and 60mg dose cohorts, covering safety, pharmacokinetics, and effects on hepcidin and anemia [2][3] - The abstract for the presentation is available on the ASN Kidney Week conference website [2] Company Overview - Disc Medicine is a clinical-stage biopharmaceutical company dedicated to developing novel treatments for serious hematologic diseases, focusing on red blood cell biology and iron homeostasis [4]
Disc Medicine to Participate in Upcoming Investor Conferences
GlobeNewswire News Room· 2024-08-30 12:00
Core Insights - Disc Medicine, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for serious hematologic diseases [3] - The company will participate in four upcoming investor conferences in September 2024 [1] Conference Participation - The company will present at the 2024 Wells Fargo Securities Healthcare Conference on September 6th at 10:15 a.m. ET [1] - The Morgan Stanley 22nd Annual Global Healthcare Conference will also feature the company on September 6th at 1:05 p.m. ET [1] - The H.C. Wainwright 26th Annual Global Investment Conference is scheduled for September 11th at 9:30 a.m. ET [1] - The 2024 Cantor Global Healthcare Conference will take place on September 19th at 8:00 a.m. ET [1] Webcast Information - A live webcast of the fireside chats will be available on the company's investor relations website, with an archived replay accessible after the events [2]
LEADING FINTECH MONEYTHUMB ACQUIRED BY IRON CREEK
Prnewswire· 2024-08-29 11:01
Company Overview - MoneyThumb is a leader in automated document evaluation and fraud detection solutions, founded in 2014, and specializes in underwriting automation software that enhances workflows for funders, lenders, and accountants by converting and analyzing PDF financial documents in seconds [3][6] - The company has developed an AI file tampering detection tool that identifies fraudulent activity quickly, providing lenders with a robust defense against risk and loan losses [3][6] Acquisition Details - MoneyThumb has been acquired by Iron Creek Partners LLC, a private investment firm focused on software, data, communications, and business services industries, with the transaction closing on August 19, 2024 [1][4] - The acquisition is expected to provide growth capital to meet MoneyThumb's strong industry demand, which has resulted in 100% year-over-year growth [1][4] Leadership Changes - Ryan Campbell, who has been with MoneyThumb since 2017, has been appointed as the new CEO and will join the investor group, while founder Ralph Mayer will transition to an advisory role and retain his board seat [2] Strategic Goals - The acquisition is seen as a milestone for MoneyThumb, with plans to accelerate growth and continue delivering exceptional software solutions to help lenders manage risk and provide capital to small businesses more efficiently [4] - Iron Creek Partners aims to leverage its sector experience and relationships to support MoneyThumb's growth and broaden its product suite [4][7]
Disc Medicine Announces Underwritten Offering of Common Stock
Newsfilter· 2024-06-14 12:03
The securities described above are being offered by Disc pursuant to a shelf registration statement on Form S-3 (No. 333-275652) that was declared effective by the Securities and Exchange Commission (SEC) on November 29, 2023. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC and will be available on the SEC's website at www. ...
Disc Medicine Announces Underwritten Offering of Common Stock
GlobeNewswire News Room· 2024-06-14 12:03
Company Overview - Disc Medicine, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel treatments for serious hematologic diseases [9]. Recent Offering - Disc announced the pricing of an underwritten offering of 4,944,000 shares of its common stock at a price of $36.00 per share, with expected gross proceeds of approximately $178.0 million before deductions [3]. - The offering is expected to close on June 17, 2024, subject to customary closing conditions [3]. Use of Proceeds - The net proceeds from the offering will be used to fund research and clinical development of current or additional product candidates, as well as for working capital and other general corporate purposes [2]. Financing Details - The financing was led by Frazier Life Sciences and Logos Capital, with participation from various institutional investors including Access Biotechnology and Wellington Management [7]. Regulatory Information - The securities are being offered pursuant to a shelf registration statement on Form S-3, which was declared effective by the SEC on November 29, 2023 [8].
Disc Medicine Presents Positive Clinical Data Across Portfolio at the European Hematology Association (EHA) 2024 Congress
GlobeNewswire News Room· 2024-06-14 11:30
WATERTOWN, Mass., June 14, 2024 (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 announced positive additional data for bitopertin in erythropoietic protoporphyria (EPP), including additional analyses of AURORA data that further demonstrated the clinical activity of bitopertin and highlighted meaningful improvements ...
Disc Medicine Announces Multiple Presentations Across Portfolio at the European Hematology Association (EHA) 2024 Congress
Newsfilter· 2024-05-14 14:30
Core Insights - Disc Medicine, Inc. is set to present data from its hematology portfolio at the European Hematology Association (EHA) 2024 Congress in Madrid from June 13-16, 2024 [1][2] - The company will showcase four posters highlighting the therapeutic potential of three clinical-stage drugs [2] - Management will conduct a call on June 14, 2024, to review the presented data [2] Presentation Details - Abstract P1575 will present topline results from the AURORA Trial, a Phase 2, randomized, double-blind, placebo-controlled trial of Bitopertin in Erythropoietic Protoporphyria, scheduled for June 14 at 6:00 pm CEST [4] - Abstract P1569 will cover results from the BEACON Trial, also scheduled for June 14 at 6:00 pm CEST [4] - Abstract P1059 will discuss a Phase 1b Trial of DISC-0974 in patients with Myelofibrosis and Anemia, and Abstract P1563 will present a Phase 1 study of DISC-3405 in healthy volunteers, both on June 14 at 6:00 pm CEST [5] Company Overview - Disc Medicine is a clinical-stage biopharmaceutical company focused on developing novel treatments for serious hematologic diseases [6] - The company aims to build a portfolio of innovative therapeutic candidates targeting red blood cell biology, specifically heme biosynthesis and iron homeostasis [6]
Disc Medicine(IRON) - 2024 Q1 - Quarterly Report
2024-05-09 12:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission File Number: 001-39438 Disc Medicine, Inc. (Exact name of registrant as specified in its charter) Delaware 85-1612845 ...
Disc Medicine(IRON) - 2024 Q1 - Quarterly Results
2024-05-09 12:07
[Company Overview](index=1&type=section&id=Company%20Overview) Disc Medicine is a clinical-stage biopharmaceutical company focused on developing novel treatments for serious hematologic diseases by targeting red blood cell biology pathways [Company Profile](index=1&type=section&id=Company%20Profile) Disc Medicine is a clinical-stage biopharmaceutical company developing novel treatments for serious hematologic diseases by targeting heme biosynthesis and iron homeostasis - Disc Medicine is a clinical-stage biopharmaceutical company focused on novel treatments for **serious hematologic diseases**[2](index=2&type=chunk)[9](index=9&type=chunk) - The company's portfolio targets fundamental biological pathways of red blood cell biology, including **heme biosynthesis and iron homeostasis**[9](index=9&type=chunk) [CEO's Strategic Summary](index=1&type=section&id=CEO's%20Strategic%20Summary) The CEO highlighted positive topline data from the AURORA study for bitopertin, confirming its activity in reducing toxic PPIX and improving quality of life in EPP patients, with upcoming data and regulatory interactions planned - Topline data from AURORA strengthened belief in bitopertin's activity, showing significant reduction in **toxic PPIX** in EPP patients, reduced phototoxic pain reactions, and improved **quality of life**[3](index=3&type=chunk) - Additional data from AURORA and BEACON studies, updated data for DISC-0974 in anemia of myelofibrosis, and initial data on DISC-3405 in healthy volunteers are expected in **June (Q2 2024)**[3](index=3&type=chunk) - Regulatory interactions for bitopertin are anticipated in the **second half of 2024**[3](index=3&type=chunk) [Recent Business Highlights and Upcoming Milestones](index=1&type=section&id=Recent%20Business%20Highlights%20and%20Upcoming%20Milestones) The company reported positive bitopertin AURORA study results, received FDA RPD designation, and anticipates further clinical data and regulatory interactions in 2024 for its pipeline [Bitopertin: GlyT1 Inhibitor (Heme Synthesis Modulator)](index=1&type=section&id=Bitopertin%3A%20GlyT1%20Inhibitor%20%28Heme%20Synthesis%20Modulator%29) Top-line AURORA Phase 2 results for bitopertin in EPP showed significant PPIX reduction and improved phototoxic reactions, with FDA RPD designation received and regulatory interactions planned - Presented top-line results from AURORA, the placebo-controlled phase 2 study of bitopertin in erythropoietic porphyrias (EPP), in **April 2024**[5](index=5&type=chunk) - Received **FDA Rare Pediatric Disease Designation (RPD)** in **May 2024** for the treatment of EPP[6](index=6&type=chunk) - Regulatory interactions to define optimal registrational endpoints for EPP are expected in the **second half of 2024**[6](index=6&type=chunk) [AURORA Phase 2 Study Results](index=1&type=section&id=AURORA%20Phase%202%20Study%20Results) The AURORA trial demonstrated significant, dose-dependent reductions in whole blood protoporphyrin IX (PPIX) levels and improvements in light tolerance and patient global impression of change, with statistical significance for the 60 mg dose group in reducing phototoxic reactions with pain - Significant, dose-dependent, and sustained reductions in **whole blood protoporphyrin IX (PPIX) levels** were observed[6](index=6&type=chunk) - Improvement on measures of light tolerance, but did not meet statistical significance due to a greater than expected benefit in the placebo arm[6](index=6&type=chunk) - Dose-dependent reductions in phototoxic reactions with pain, reaching **statistical significance for the 60 mg group**, and dose-dependent improvements in Patient Global Impression of Change[6](index=6&type=chunk) [Upcoming Bitopertin Milestones](index=1&type=section&id=Upcoming%20Bitopertin%20Milestones) Additional analyses from the BEACON and AURORA trials are on track to be delivered and presented in Q2 2024 - Additional analyses from the BEACON and AURORA trials are on track to be delivered in **Q2 2024**[5](index=5&type=chunk) - Additional analyses from the AURORA and BEACON trials to be presented in **Q2 2024**[6](index=6&type=chunk) [DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)](index=2&type=section&id=DISC-0974%3A%20Anti-Hemojuvelin%20Antibody%20%28Hepcidin%20Suppression%29) Updated Phase 1b/2 data for DISC-0974 in anemia of myelofibrosis (MF) patients, including safety and changes in hepcidin, iron, and hemoglobin levels, are expected to be presented in Q2 2024, with NDD-CKD data anticipated in H2 2024 - Updated phase 1b/2 data from DISC-0974 in anemia in MF patients will be presented in **Q2 2024**, including safety and changes in hepcidin, iron, and hemoglobin levels[12](index=12&type=chunk) - Updated phase 1b/2 data from DISC-0974 in anemia in non-dialysis-dependent chronic kidney disease (NDD-CKD) is expected to be shared in the **second half of 2024**[12](index=12&type=chunk) [DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)](index=2&type=section&id=DISC-3405%3A%20Anti-TMPRSS6%20Antibody%20%28Hepcidin%20Induction%29) Initial pharmacokinetic and pharmacodynamic data from single-ascending dose (SAD) cohorts of DISC-3405 in healthy volunteers are expected to be presented in Q2 2024 - Initial pharmacokinetic and pharmacodynamic data from SAD cohorts of DISC-3405 are expected to be presented in **Q2 2024**[7](index=7&type=chunk) - Initial single-ascending dose (SAD) data from the phase 1 study of DISC-3405 in healthy volunteers is planned for **Q2 2024**[5](index=5&type=chunk) [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) Disc Medicine reported an increased net loss for Q1 2024 due to higher R&D and G&A expenses, maintaining a strong cash position into 2026 [Financial Summary](index=2&type=section&id=Financial%20Summary) Disc Medicine reported a net loss of $26.9 million for Q1 2024, an increase from $22.8 million in Q1 2023, primarily due to increased R&D and G&A expenses driven by portfolio progression and headcount, with $342.6 million in cash and cash equivalents providing a runway well into 2026 Financial Performance Summary | Metric | Q1 2024 (in thousands) | Q1 2023 (in thousands) | Change (YoY) | | :-------------------------- | :--------------------- | :--------------------- | :----------- | | Research and Development | $23,704 | $20,180 | +17.46% | | General and Administrative | $7,758 | $4,945 | +56.89% | | Net Loss | $(26,949) | $(22,781) | +18.38% | | Net Loss per Share (Diluted)| $(1.09) | $(1.20) | -9.17% | - Cash and cash equivalents were **$342.6 million** as of March 31, 2024, expected to fund operational plans well into **2026**[5](index=5&type=chunk)[12](index=12&type=chunk) - Increase in R&D expenses was primarily driven by the progression of Disc's portfolio, including bitopertin's ongoing two phase 2 clinical studies and drug manufacturing, and increased headcount[12](index=12&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For the three months ended March 31, 2024, total operating expenses increased to $31.5 million from $25.1 million in the prior year, leading to a net loss of $26.9 million, or $(1.09) per share Condensed Consolidated Statements of Operations (in thousands) | Operating Expenses | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $23,704 | $20,180 | | General and administrative | $7,758 | $4,945 | | **Total operating expenses** | **$31,462** | **$25,125** | | Loss from operations | $(31,462) | $(25,125) | | Other income (expense), net | $4,518 | $2,367 | | Income tax expense | $(5) | $(23) | | **Net loss** | **$(26,949)** | **$(22,781)** | | Weighted-average common shares outstanding-basic and diluted | 24,809,869 | 18,954,914 | | Net loss per share-basic and diluted | $(1.09) | $(1.20) | [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) As of March 31, 2024, Disc Medicine reported total assets of $354.2 million, a decrease from $368.0 million at December 31, 2023, with cash and cash equivalents decreasing to $342.6 million and total liabilities decreasing to $16.1 million Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet Item | March 31, 2024 | December 31, 2023 | | :-------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $342,615 | $360,382 | | Total current assets | $351,948 | $365,662 | | Total assets | $354,182 | $367,996 | | Total liabilities | $16,111 | $22,875 | | Total stockholders' equity | $338,071 | $345,121 | [Additional Information](index=2&type=section&id=Additional%20Information) This section details how Disc Medicine disseminates material information and provides a cautionary statement regarding forward-looking statements and contact information [Available Information](index=2&type=section&id=Available%20Information) Disc Medicine disseminates material information to the public through SEC filings, press releases, public conference calls, webcasts, and its investor relations website to ensure broad distribution and compliance with Regulation FD - Disc announces material information via SEC filings, press releases, public conference calls, webcasts, and its investor relations website (ir.discmedicine.com) for broad, non-exclusionary distribution and **Regulation FD compliance**[10](index=10&type=chunk) [Disc Cautionary Statement Regarding Forward-Looking Statements](index=2&type=section&id=Disc%20Cautionary%20Statement%20Regarding%20Forward-Looking%20Statements) This section warns that the press release contains forward-looking statements regarding clinical trials, timelines, business plans, and financial projections, which are based on current beliefs and assumptions and are subject to risks and uncertainties, with actual results potentially differing materially - The press release contains forward-looking statements regarding clinical studies (AURORA, BEACON, DISC-0974, DISC-3405), timelines, business plans, and financial projections[11](index=11&type=chunk)[13](index=13&type=chunk) - These statements are based on current beliefs and assumptions and are subject to **risks and uncertainties**, meaning actual results or events could differ materially[13](index=13&type=chunk)[14](index=14&type=chunk) - Investors are cautioned not to place undue reliance on these forward-looking statements, and the company undertakes no obligation to update them[14](index=14&type=chunk) [Contacts](index=4&type=section&id=Contacts) Provides contact information for media and investor relations inquiries - Media Contact: **Peg Rusconi** at prusconi@vergescientific.com[18](index=18&type=chunk) - Investor Relations Contact: **Christina Tartaglia** at christina.tartaglia@sternir.com[18](index=18&type=chunk)
Disc Medicine(IRON) - 2023 Q4 - Annual Report
2024-03-21 12:15
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________to___________ Commission file number: 001-39438 Disc Medicine, Inc. (Exact name of registrant as specified in its charter) Delaware 85-1612845 (State or ...