Disc Medicine Announces Multiple Presentations Across Hematology Portfolio at the 64th American Society of Hematology Annual Meeting

CAMBRIDGE, Mass., Nov. 3, 2022 /PRNewswire/ -- Disc Medicine, a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, today announced that five abstracts related to several of its hematology programs have been accepted for poster presentation at the upcoming 64th American Society of Hematology (ASH) Annual Meeting and Exposition, which will be held in New Orleans, LA on December 10-13, 2022. 

"We are pleased to have five abstracts selected for presentation at ASH," said John Quisel, JD, PhD, Chief Executive Officer at Disc Medicine. "The number of abstracts selected, covering three different Disc programs, demonstrates the breadth of our pipeline and underscores our commitment to addressing unmet needs for patients with serious hematologic conditions."

The full abstracts are now available through the ASH conference website.

Details of the presentations are as follows:

Abstract Number: 2339
Title: DISC-0974, an α-HJV Antibody, Reduces Hepcidin and Mobilizes Iron in Healthy Volunteers
Date / Time: Sunday, December 11, 6:00-8:00 PM
Session: 102. Iron Homeostasis and Biology: Poster II
Presenter: Natasha Novikov, MD, PhD

Abstract Number: 2346
Title: Phase 2, Randomized, Open-label Trial of Bitopertin in Erythropoietic Protoporphyria: BEACON Trial Design
Date / Time: Sunday, December 11, 6:00-8:00 PM
Session: 102. Iron Homeostasis and Biology: Poster II
Presenter: Will Savage, MD, PhD

Abstract Number: 3661
Title: Bitopertin, a Selective Glycine Transporter 1 Inhibitor, Reduced PPIX Level and Improved Liver Fibrosis in a Mouse Model of Erythropoietic Protoporphyria (EPP)
Date / Time: Monday, December 12, 6:00-8:00 PM
Session: 102. Iron Homeostasis and Biology
Presenter: Min Wu, PhD

Abstract Number: 3641
Title: DISC-0974, an Anti-HJV Monoclonal Antibody, Reduced Hepcidin and Improved Anemia in a Rat Model of Chronic Kidney Disease
Date / Time: Monday, December 12, 6:00-8:00 PM
Session: 101. Red Cells and Erythropoiesis, Excluding Iron
Presenter: Min Wu, PhD

Abstract Number: 3657
Title: Preclinical Pharmacokinetics and Pharmacodynamics of DISC-0998, a Humanized Anti-Hemojuvelin (HJV) Monoclonal Antibody to Suppress the Production of Hepcidin
Date / Time: Monday, December 12, 6:00-8:00 PM
Session: 102. Iron Homeostasis and Biology
Presenter: Yue Chen, MS

Disc Medicine is a clinical-stage biopharmaceutical company that is dedicated to transforming the lives of patients with hematologic disorders. We are building a portfolio of innovative, potential first-in-class therapeutic candidates that affect fundamental pathways of red blood cell biology. We are committed to developing treatments that empower and bring hope to the many patients who suffer from hematologic diseases. For more information, please visit www.discmedicine.com.

On August 10, 2022, Gemini Therapeutics, Inc. (Nasdaq: GMTX) ("Gemini") and Disc Medicine, Inc. ("Disc"), announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on advancing Disc's pipeline of hematology programs, including multiple clinical trials for its clinical-stage programs bitopertin and DISC-0974. Upon shareholder approval, the combined company is expected to operate under the name Disc Medicine, Inc. and trade on the Nasdaq Global Market under the ticker symbol IRON. The merger and related financing are expected to close in the fourth quarter of 2022. For more information visit: https://www.discmedicine.com/news/gemini-therapeutics-and-disc-medicine-announce-merger-agreement/.

Disc has a development pipeline composed of investigational product candidates that affect heme biosynthesis and iron metabolism. Disc's programs are designed to target pathways with established, clinically-validated biology and have the potential to address multiple indications. This includes:

Bitopertin (Heme Synthesis Modulator): Bitopertin is an investigational, orally administered inhibitor of glycine transporter 1, GlyT1. Bitopertin was in-licensed by Disc from Roche in 2021 and has previously demonstrated tolerability and effects on heme biosynthesis in over 4,000 individuals across multiple clinical trials. Inhibition of heme biosynthesis has the potential to address a wide range of hematologic disorders. Disc recently initiated AURORA, a randomized, double-blind, placebo-controlled Phase 2 trial of bitopertin in patients with EPP, a rare, debilitating and potentially fatal genetic disorder that results in dysregulated heme biosynthesis and where bitopertin has the potential to become the first disease-modifying treatment. Bitopertin is also currently being studied in BEACON, an open-label Phase 2 clinical trial in patients with EPP and X-linked protoporphyria (XLP), which was initiated in August 2022 and is being conducted in Australia. Additional clinical trials in Diamond-Blackfan Anemia (DBA) and other indications are being planned.

DISC-0974 (Hepcidin Suppression): DISC-0974 is an investigational monoclonal antibody (mAb) targeting a BMP-signaling co-receptor called hemojuvelin (HJV) and is designed to suppress hepcidin production and increase serum iron levels in patients suffering from anemia of inflammation. DISC-0974 was in-licensed by Disc from AbbVie in 2019. Anemia of inflammation arises from abnormally elevated hepcidin and is the most common form of anemia, affecting millions of patients in the US across numerous diseases such as chronic kidney disease, myelofibrosis, cancer, autoimmune diseases, and other conditions with an inflammatory component. Disc has established clinical proof-of-mechanism of DISC-0974 in a Phase 1 trial of healthy volunteers and initiated a Phase 1b/2a clinical trial of DISC-0974 in patients with myelofibrosis and anemia. Disc plans to initiate a Phase 1b/2a clinical trial of DISC-0974 in patients with chronic kidney disease and anemia in late 2022.

DISC-0998: DISC-0998 is an investigational anti-HJV mAb with an engineered Q and L mutation (QL-mutation) in the Fc region, aimed to alter binding to the FcRn receptor, resulting in an increased PK half-life. Preclinical studies have demonstrated that DISC-0998 has shown biological activity, low immunogenicity potential, and desirable pharmacokinetic (PK) and pharmacodynamic (PD) properties in monkeys. The company will present data in cynomolgus monkeys at the 64^th ASH Annual Meeting and Exposition that allow for the prediction of PK/PD profiles in humans and support further development of DISC-0998 for anemia of inflammation related disorders with the potential of long intervals in between dosing.

Matriptase-2 Inhibitor (Hepcidin Induction): Disc has a preclinical research program designed to identify orally available, small molecules to inhibit Matriptase-2 (referred to as Mat-2 or TMPRSS6) and increase the production of hepcidin and restrict iron availability. The therapeutic role of hepcidin has been established by third parties in patients with polycythemia vera (PV) and hereditary hemochromatosis. Disc is initially focused on developing its Mat-2 program as a potential treatment for PV, diseases of iron overload, and other conditions where restriction of iron would have therapeutic benefit.

Certain statements in this press release may constitute "forward-looking statements" for purposes of the federal securities laws concerning the proposed transaction between Disc and Gemini Therapeutics, Inc. (Gemini) including whether and when the proposed transaction will be consummated; statements about the structure, timing and completion of the proposed transaction; and other matters, including Disc's expectations with respect to its AURORA and BEACON clinical trials, its plans to initiate a Phase 1b/2a clinical study of DISC-0974, and other statements that are not historical in nature. These forward-looking statements include express or implied statements relating to Disc's management team's expectations, hopes, beliefs, intentions or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Disc, Gemini or the proposed transaction will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Disc's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the conditions to the closing of the transaction are not satisfied, including the failure to obtain stockholder approval for the transaction; the risk that the concurrent financing is not completed in a timely manner or at all; uncertainties as to the timing of the consummation of the transaction and the ability of each of Gemini and Disc to consummate the transaction, including the concurrent financing; risks related to Gemini's continued listing on the Nasdaq Stock Market until closing of the proposed transaction; risks related to Gemini's and Disc's ability to correctly estimate their respective operating expenses and expenses associated with the transaction, as well as uncertainties regarding the impact any delay in the closing would have on the anticipated cash resources of the combined company upon closing and other events and unanticipated spending and costs that could reduce the combined company's cash resources; the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement; the effect of the announcement or pendency of the merger on Gemini's or Disc's business relationships, operating results and business generally; costs related to the merger; the outcome of any legal proceedings that may be instituted against Gemini, Disc or any of their respective directors or officers related to the merger agreement or the transactions contemplated thereby; the ability of Gemini or Disc to protect their respective intellectual property rights; competitive responses to the transaction; unexpected costs, charges or expenses resulting from the transaction; potential adverse reactions or changes to business relationships resulting from the announcement or completion of the transaction; and legislative, regulatory, political and economic developments.  The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the proxy statement/prospectus included in the registration statement on Form S-4 (the "Initial Registration Statement"), which was initially filed on September 2, 2022, as amended by Amendment No. 1 to the Initial Registration Statement filed with the SEC on October 7, 2022[ and Amendment No. 2 to the Initial Registration Statement filed with the SEC on [●], 2022] (together with the Initial Registration Statement, the "Registration Statement") in connection with the transaction and other documents filed by Gemini from time to time with the SEC. Should one or more of these risks or uncertainties materialize, or should any of Disc's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Some of these risks and uncertainties may in the future be amplified by the ongoing COVID-19 pandemic and there may be additional risks that we consider immaterial or which are unknown. It is not possible to predict or identify all such risks. Disc's forward-looking statements only speak as of the date they are made, and Gemini and Disc do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transaction or otherwise, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act. Subject to certain exceptions to be approved by the relevant regulators or certain facts to be ascertained, the public offer will not be made directly or indirectly, in or into any jurisdiction where to do so would constitute a violation of the laws of such jurisdiction, or by use of the mails or by any means or instrumentality (including without limitation, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or any facility of a national securities exchange, of any such jurisdiction.

In connection with the proposed transaction between Gemini and Disc, Gemini intends to file relevant materials with the SEC, including the Registration Statement, that contains a proxy statement/prospectus of Gemini and information statement of Disc. DISC URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT GEMINI, DISC, THE PROPOSED TRANSACTION AND RELATED MATTERS. Investors and shareholders will be able to obtain free copies of the proxy statement/prospectus/information statement and other documents filed by Gemini with the SEC (when they become available) through the website maintained by the SEC at www.sec.gov. In addition, investors and shareholders should note that Gemini communicates with investors and the public using its website (www.geminitherapeutics.com), the investor relations website (https://investors.geminitherapeutics.com/) where anyone will be able to obtain free copies of the proxy statement/prospectus/information statement and other documents filed by Gemini with the SEC and stockholders are urged to read the Registration Statement and the other relevant materials when they become available before making any voting or investment decision with respect to the proposed transaction.

Each of Gemini, Disc and their directors and executive officers may be deemed to be participants in the solicitation of proxies in connection with the proposed transaction. Information about Gemini's directors and executive officers is included in Gemini's most recent Annual Report on Form 10-K, including any information incorporated therein by reference, as filed with the SEC, and the Registration Statement and any amendments thereto as filed with the SEC. These documents can be obtained free of charge from the sources indicated above.

SOURCE Disc Medicine