Hoffmann-La Roche, Inc.

Completed enrollment of BEACON and AURORA trials of bitopertin in erythropoietic protoporphyria (EPP); BEACON expanded to include adolescentsData from all adult patients in BEACON to be presented in an oral presentation at the 65th American Society of Hematology Annual Meeting and Exposition (ASH 2023), including the preliminary analysis of the precedented pivotal endpoint, cumulative time in sunlight over 6 months on days without painPreliminary pharmacodynamic data from the ongoing phase 1b/2 study of DISC-0974 in patients with myelofibrosis (MF) and anemia to be presented in a poster at ASH 2023, including changes in hemoglobin levelsData from the first 28 mg cohort of the phase 1b/2 study of DISC-0974 in patients with anemia of chronic kidney disease who are not receiving dialysis (NDD-CKD) to be presented as a part of a management call during ASH 2023 Initiated a Phase 1 trial of DISC-3405, an anti-TMPRSS6 antibody, in healthy volunteers and received fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of polycythemia vera (PV) WATERTOWN, Mass., Nov. 09, 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 third quarter ended September 30, 2023, and provided an update on recent program and corporate developments. “We made tremendous progress this quarter in advancing our portfolio, including a major milestone of completing enrollment of both BEACON and AURORA studies within a year, as well as advancing our third development program into the clinic,” said John Quisel, J.D., Ph.D., President and Chief Executive Officer of Disc. “We’re looking forward to the ASH 2023 meeting in December, when we will be presenting updated interim data from BEACON, as well as initial data for DISC-0974 in MF and CKD.” Recent Business Highlights and Upcoming 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. Completed enrollment for both BEACON, an open-label Phase 2 clinical study of bitopertin in patients with EPP and X-linked protoporphyria (XLP), and AURORA a Phase 2 randomized, placebo-controlled clinical study of bitopertin in adults with EPPExpanded enrollment of BEACON to include adolescents (ages 12-18)Updated BEACON data from all patients and with longer duration of therapy will be presented at ASH 2023, including measures of protoporphyrin IX (PPIX), photosensitivity, quality of life, safety, and tolerability, as well as preliminary analysis of the precedented pivotal endpoint, cumulative time in light over 6 months on days without painTopline AURORA data is expected to be presented in early 2024 DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression) DISC-0974 is an investigational anti-hemojuvelin monoclonal antibody and is designed to suppress hepcidin production and increase serum iron levels in patients suffering from anemia of inflammation. Ongoing enrollment and dose escalation in a Phase 1b/2 clinical study in MF patients with severe anemia on stable background therapy; initial data from 10-20 patients in the dose-escalation phase of the study, including safety and changes in hepcidin, iron, and hemoglobin levels, will be presented at ASH 2023Ongoing enrollment and dose escalation in a Phase 1b/2 clinical study of patients with anemia of chronic kidney disease who are not receiving dialysis (NDD-CKD); initial data from the 28 mg cohort will be presented as part of a management call in December DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction) DISC-3405 is an investigational, anti-TMPRSS6 (Transmembrane Serine Protease 6, also known as Matriptase-2) monoclonal antibody designed to increase hepcidin production and restrict serum iron. Initiated a Phase 1 study in healthy volunteers in October 2023Received FDA fast track designation in September 2023 for DISC-3405 for the treatment of PV Third Quarter 2023 Financial Results: Cash Position: Cash and cash equivalents were $370.5 million as of September 30, 2023, which are expected to fund our operational plans well into 2026.Research and Development Expenses: R&D expenses were $14.4 million for the quarter ended September 30, 2023, as compared to $7.9 million for the quarter ended September 30, 2022. The increase in R&D expenses were primarily driven by the progression of Disc’s portfolio, including bitopertin’s ongoing two Phase 2 clinical studies and drug manufacturing, study initiation for DISC-3405, and increased headcount.General and Administrative Expenses: G&A expenses were $4.5 million for the quarter ended September 30, 2023, as compared to $2.6 million for the same period in 2022. The increase in G&A expenses was primarily due to increased headcount.Net Loss: Net loss was $14.1 million for the quarter ended September 30, 2023, as compared to $16.2 million for the third quarter of 2022. Although operating expenses increased in the current period relative to the prior period due to increased product development activities, these increases were offset by increased interest income and the absence of the change in fair value of the derivative liability related to a one-time share issuance obligation to F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. in connection with the bitopertin license agreement which was settled in late 2022. 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 the results thereof, and its Phase 1b/2 study of bitopertin in Diamond-Blackfan Anemia, its Phase 1b/2 clinical studies of DISC-0974 in patients with MF and NDD-CKD patients with anemia, its Phase 1 clinical study of DISC-3405 in healthy volunteers; projected timelines for the initiation and completion of its clinical trials, anticipated timing of release of data, and other clinical activities; and Disc’s business plans and objectives; and Disc’s beliefs about operating expenses and that it will have capital to fund Disc well into 2026. 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; that enrollment timelines of both the BEACON and AURORA studies may not necessarily be predictive of future enrollment timelines; the timing of initiation of Disc’s planned clinical trials; Disc’s ability to retain and recognize the intended incentives conferred by Fast Track Designation for its product candidates including DISC-3405; 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 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, Quarterly Reports on Form 10-Q for the quarters ended March 31, 2023 and June 30, 2023, and other documents filed by Disc from time to time with the SEC, as well as discussions of potential risks, uncertainties, and other important factors in Disc’s subsequent filings with the SEC. 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) ​Three Months Ended September 30, Nine Months Ended September 30, ​ 2023 ​ 2022 ​ 2023 ​ 2022 Operating expenses:​ ​ ​ ​ Research and development​$14,419 ​$7,886 ​$46,699 ​$23,421 General and administrative​ 4,539 ​ 2,593 ​ 14,712 ​ 9,033 Total operating expenses​ 18,958 ​ 10,479 ​ 61,411 ​ 32,454 Loss from operations​ (18,958) ​ (10,479) ​ (61,411) ​ (32,454) Other income (expense), net 4,856 ​ (5,671) ​ 8,628 ​ (3,129) Income tax expense​ (20) — (67) — Net loss​$(14,122) ​$(16,150) ​$(52,850) ​$(35,583) Weighted-average common shares outstanding-basic and diluted​ 24,316,817 960,317 21,605,202 943,058 Net loss per share-basic and diluted​$(0.58) ​$(16.82) ​$(2.45) ​$(37.73) DISC MEDICINE, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands)(Unaudited) ​September 30, December 31, ​ 2023 ​ 2022 Assets​ ​ Cash and cash equivalents​$370,541 ​$194,611 Other current assets​ 3,722 ​ 3,880 Total current assets​ 374,263 ​ 198,491 Non-current assets​ 2,234 1,714 Total assets​$376,497 ​$200,205 Liabilities and Stockholders’ Equity​ ​ Current liabilities​$14,416 ​$22,578 Non-current liabilities​ 3,107 ​ 1,027 Total liabilities​ 17,523 ​ 23,605 Total stockholders’ equity​ 358,974 ​ 176,600 Total liabilities and stockholders’ equity​$376,497 ​$200,205 Media Contact Peg RusconiVerge Scientific Communicationsprusconi@vergescientific.com Investor Relations Contact Christina TartagliaStern Investor Relationschristina.tartaglia@sternir.com

SAB and MAG comprise global key opinion leaders in translationaltumor immunology and immunotherapy Paris, France – May9, 2023 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for cancer and inflammatory diseases based on its unique Mimicry platform, announces the creation of its international Scientific Advisory Board (SAB) and Medical Advisory Group (MAG) comprising highly respected and influential scientific and clinical leaders in oncology and immunotherapy. The newly formed SAB and MAG will provide strategic, scientific, and clinical guidance to Enterome as it progresses its pipeline of innovative OncoMimics™ immunotherapies targeting solid and liquid tumors. Enterome’s Scientific Advisory Board comprises (biographies below): David Klatzmann, MD, PhD - Professor of Immunology at the Sorbonne University (Paris, France) Pedro Romero, MD, PhD - Director of Scientific and Medical Affairs, Novigenix, Professor Emeritus at University of Lausanne (Lausanne, Switzerland) Justin Eyquem, PhD - Assistant Professor in Microbiology and Immunology at the University of California (San Francisco, CA, US) Enterome’s Medical Advisory Group comprises (biographies below): Zuzana Jirakova, MD, PhD - Chief Medical Officer at Highlight Therapeutics (Madrid, ES) Peter Kiener, PhD - Venture Partner at ICG Life Sciences (Portland, OR, US) Alexander Zukiwski, MD - Chief Medical Officer at CASI Pharmaceuticals (Rockville, MD, US) “We are very pleased to announce the creation of our Scientific Advisory Board and Medical Advisory Group,” commented Pierre Belichard, CEO at Enterome. “Their combined knowledge and experience in immune-oncology will be fundamental as we look to advance and expand our pipeline of OncoMimics immunotherapies into and through clinical development targeting solid and liquid cancers. Their insights and expertise will be crucial to Enterome as we approach important near-term clinical readouts from the ROSALIE trial with EO2401 in recurrent glioblastoma and from the SIDNEY trial with EO2463 in Non-Hodgkin Lymphoma and as we consider the design and strategy for potentially pivotal clinical trials with these candidates. In addition, we look forward to their input to the development strategies around our other OncoMimics candidates, which are planned to enter clinical trials in 2023, including EO2040 in colorectal cancer with ctDNA-defined, minimal residual disease, and EO4010 for third-line colorectal cancer.” Biographies Scientific Advisory Board David Klatzmann, MD, PhD is a world-renowned immunologist who contributed to the discovery of HIV (human immunodeficiency virus), revealing its preferential tropism and cytopathic effect- the first indication that HIV is the cause of AIDS. David is Professor of Immunology at the Sorbonne University. He also holds several roles at both the Pierre and Marie Curie Medical School and Pitié-Salpêtrière Hospital in Paris, including as Chief of Biotherapy, Coordinator of the Clinical Investigation Center for Biotherapy and Immunology. With a current focus on translational system immunology, David brings a wealth of expertise and knowledge on T cell-based therapies in cancer and auto-immune diseases. Pedro Romero, MD, PhD is a specialist in translational tumor immunology and immunotherapy of cancer as well as immune and tumoral responses. He currently serves as Deputy Scientific Director of the Lausanne branch of the Ludwig Institute for Cancer Research in Switzerland and in 2021 was made Honorary Professor of the University of Lausanne. He joined Novigenix, Lausanne, as Director of Scientific and Medical Affairs in April 2023. Pedro was a postdoctoral fellow at the Institute of Immunology, the National University of Colombia and New York University School of Medicine. Pedro’s research which has been published in leading scientific journals has been instrumental to tumor immunology and clinical cancer immunotherapy developments. Justin Eyquem, PhD is an Assistant Professor in the department of Medicine at the University of California, San Francisco (UCSF), Investigator at the Gladstone-UCSF Institute for Genomic Immunology and co-founder and scientific advisor for Mnemo Therapeutics. Justin brings with him a unique understanding of the engineering of T lymphocytes to enhance CAR T and natural killer (NK) cell functions in hematological and solid tumors. Justin earned his PhD from the University of Paris-Diderot (France) in collaboration with the biotech company Cellectis and trained as a postdoctoral fellow at the Memorial Sloan-Kettering Cancer Center in New York, US. Medical Advisory Group Zuzana Jirakova Trnkova, MD, PhD has over 20 years of pharmaceutical industry and leading biotech experience in global drug development. Zuzana serves as a Chief Medical Officer at Highlight Therapeutics. Previously, she was Vice President of Clinical Development and Medical Affairs Radiology at Bayer Pharmaceuticals. Before this, she served as Vice President of Clinical Research and Development at BioNTech in Germany. Zuzana earned her MD and PhD in immunology and molecular biology at Charles University in Prague, Czech Republic. Zuzana brings cross-disciplinary experience in early to late-stage oncology drug development of small molecules and biologics in various indications, translational research and clinical pharmacology. Peter Kiener, PhD has extensive experience in research and development in biologics, immunotherapy and biopharmaceuticals and a brings a wealth of knowledge in drug development from discovery through to approval. He is a Venture Partner at ICG Life Sciences and the former Chief Scientific Officer at Sucampo. Prior to this, he was President and co-founder of Zyngenia and has held R&D leadership roles at Ambrx, MedImmune/AstraZeneca and Bristol-Myers Squibb. Peter earned his PhD in biochemistry at the University of Oxford. Alexander Zukiwski, MD, has 25+ years of experience in global oncology drug development and serves as Chief Medical Officer at CASI Pharmaceuticals. He has held several leadership roles in the pharmaceutical industry, including in global drug development, clinical evaluation and registration of many successful oncology treatments at leading companies such as Hoffmann-LaRoche, Glaxo Wellcome, Johnson & Johnson, MedImmune, and Arno Therapeutics. Alexander received his MD from the University of Calgary and conducted his post-graduate training at St. Thomas Hospital Medical Center in Akron, Ohio, and the University of Texas MD Anderson Cancer Center. Contacts ENTEROME MEDIA RELATIONS Guillaume Bayre Head of External Communications Tel; +33 (0)1 76 21 58 15 communication@enterome.com Sylvie Berrebi / Mark Swallow / David Dible MEDiSTRAVA Consulting Tel. +44 (0) 203 928 6900 enterome@medistrava.com About Enterome Enterome is a clinical-stage biopharmaceutical company developing breakthrough immunomodulatory drugs for the treatment of cancer and immune diseases. Enterome’s pioneering approach to drug discovery is based on its unique and powerful bacterial Mimicry drug discovery platform, allowing it to analyze and uncover new biological insights from the millions of gut bacterial proteins in constant cross-talk with the human body. Its first-in-class small protein and peptide drug candidates modulate the immune system by closely mimicking the structure, effect or actions of specific antigens, hormones, or cytokines. The company’s two pipelines of drug candidates include: OncoMimics™ peptides, a pipeline of peptide-based immunotherapies. Lead candidate, EO2401, is in Phase 2 clinical trials in patients with glioblastoma and adrenal tumors and has demonstrated clinical proof of concept. EO2463 is in a Phase 1/2 clinical trial for indolent non-Hodgkin lymphomas, with clinical data expected in H1 2023. EO2040, a new immune therapy, is expected to start a Phase 2 trial in 2023 in patients suffering from colorectal cancer with ctDNA-defined, minimal residual disease. EO4010 is in development for third-line colorectal cancer and targeted to enter clinical trials in 2023. EndoMimics™ peptides, a pipeline of next generation bioactives acting like human hormones or cytokines, are being developed in collaboration with Nestlé Health Science, for food allergies and inflammatory bowel disease (IBD). Lead candidate, EB1010, expected to enter the clinic in 2024, is a potent local inducer of IL-10, designed to improve therapeutic outcomes for patients with IBD. Enterome employs 73 people and is headquartered in Paris, France. Since its inception, the company has raised a total of €116 million from Europe- and US-based life science investors and more than €100 million from pharmaceutical partnerships. For more information, please visit the company’s website at:

BERKELEY HEIGHTS, N.J., April 17, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced the appointment of Robert A. Stewart to the CorMedix Board of Directors. Following the appointment of Mr. Stewart, the Board will comprise 8 directors, 7 of which are independent. “We are pleased to welcome Rob Stewart to the CorMedix Board,” said Joseph Todisco, Chief Executive Officer of CorMedix. “Rob’s deep experience in global pharmaceutical management and broad professional network in the pharma space will be invaluable to CorMedix as we aim to transition from a development stage company to a commercial organization.” "I am thrilled to be joining the CorMedix board, and excited about the commercial potential for DefenCath,“ said Rob Stewart. “I believe my background and experiences in growth driven pharma companies will add value to the organization and complement the backgrounds and skills of the other board members and the executive leadership team. I look forward to working with everyone more closely.” Mr. Stewart is the Chief Executive Officer of Theramex, a private equity backed, global specialty pharmaceutical company dedicated to women’s health, and has served in this role since March 2020. Prior to this, Mr. Stewart served as Chief Executive Officer of Amneal Pharmaceuticals Inc. from 2018 to 2019, and from 2009 through 2018, Mr. Stewart served in senior roles with Allergan, formerly Watson and Actavis, most notably as Chief Operating Officer (2015-2018) and President, Global Operations (2009-2015). Mr. Stewart has also previously held management roles with Abbott Laboratories, Knoll Pharmaceutical Company, and Hoffmann La Roche, Inc. Mr. Stewart currently serves on the Board of Directors of Cipla Ltd and serves on the Board of Trustees for Fairleigh Dickinson University. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response Letter (CRL) from FDA stating that the original NDA could not be approved until deficiencies at the contract manufacturing organization (CMO) were satisfactorily resolved. FDA notified the Company in a second CRL that the refiled NDA could not be approved until satisfactory resolution of facility deficiencies identified during a pre-approval inspection at and conveyed to the CMO and during an inspection for an unrelated active pharmaceutical ingredient at and conveyed to the manufacturing facility for the heparin supplier for DefenCath. While the CMO and heparin supplier work to resolve outstanding deficiencies, CorMedix is simultaneously working to transfer the technology to an additional CMO and qualify an additional supplier of heparin. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information visit: . Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, including, but not limited to, statements regarding the Company’s ability to successfully transition from a development stage company to a commercial organization, should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of an FDA prior inspection; the ability of the Company’s heparin supplier to address the manufacturing deficiencies identified in the warning letter for non-heparin API; the resources needed to secure approval of the NDA for DefenCath from the FDA; the risks and uncertainties of the relationships with the additional CMO and supplier of heparin; the ability to submit a supplement to CorMedix’s NDA; the ability to secure final FDA approval prior to July 1, 2023 or obtain CMS approval of a resubmitted NTAP application; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact: Dan Ferry Managing Director LifeSci Advisors (617) 430-7576