OMGA Omega Therapeutics Inc

Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, today announced that management will host a conference call and webcast to discuss preliminary clinical data from the ongoing Phase 1/2 MYCHELANGELO™ I trial of OTX-2002 on Tuesday, September 26, 2023, at 8:00 a.m. ET.

The webcast will feature members of Omega’s leadership team as well as a moderated discussion with Gerard Evan, Ph.D., Principal Group Leader of the Francis Crick Institute in London and Professor of Cancer Biology, King's College London.

The live webcast can be accessed under “News & Events” on the investors section of Omega’s website at https://ir.omegatherapeutics.com/news-events/event-calendar. To participate in the live call, please register using this link. It is recommended that participants register at least 15 minutes in advance of the call. Once registered, participants will be informed of the dial-in numbers including PIN. The archived webcast will be available on Omega’s website for approximately 90 days following the event.

About OTX-2002

OTX-2002 is an mRNA therapeutic delivered via lipid nanoparticles (LNPs) designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. MYC is a master transcription factor that regulates cell proliferation, differentiation and apoptosis and plays a significant role in more than 50% of all human cancers. OTX-2002 has demonstrated the ability to control MYC expression pre-transcriptionally in multiple preclinical studies, including the successful downregulation of MYC in non-human primates. Additionally, OTX-2002 has shown robust anti-tumor activity alone and in combination with standard of care therapies in vivo in multiple preclinical models of HCC. Currently, OTX-2002 is being evaluated as a potential treatment for HCC and other solid tumors associated with MYC. 

About MYCHELANGELO™ I

MYCHELANGELO I (NCT05497453) is a Phase 1/2 open label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OTX-2002 as a monotherapy (Part 1) and in combination with standard of care therapies (Part 2) in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene. The study is currently enrolling patients in the U.S. and Asia.

About Omega Therapeutics

Omega Therapeutics is a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines to treat or cure a broad range of diseases. By pre-transcriptionally modulating gene expression, Omega’s approach enables controlled epigenomic modulation of nearly all human genes, including historically undruggable and difficult-to-treat targets, without altering native nucleic acid sequences. Founded in 2017 by Flagship Pioneering following breakthrough research by world-renowned experts in the field of epigenetics, Omega is led by a seasoned and accomplished leadership team with a track record of innovation and operational excellence. The Company is committed to revolutionizing genomic medicine and has a diverse pipeline of therapeutic candidates derived from its OMEGA platform spanning oncology, regenerative medicine, multigenic diseases including immunology, and select monogenic diseases.

For more information, visit omegatherapeutics.com, or follow us on X (formerly Twitter) and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the date and time of the upcoming conference call and webcast, the timing, progress and design of our Phase 1/2 MYCHELANGELO™ I clinical trial, including the anticipated announcement of preliminary data from the Phase 1 monotherapy dose escalation portion of the study; and expectations surrounding the potential of our product candidates, including OTX-2002. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the novel technology on which our product candidates are based makes it difficult to predict the time and cost of preclinical and clinical development and subsequently obtaining regulatory approval, if at all; the substantial development and regulatory risks associated with epigenomic controllers due to the novel and unprecedented nature of this new category of medicines; our limited operating history; the incurrence of significant losses and the fact that we expect to continue to incur significant additional losses for the foreseeable future; our need for substantial additional financing; our investments in research and development efforts that further enhance the OMEGA platform, and their impact on our results; uncertainty regarding preclinical development, especially for a new class of medicines such as epigenomic controllers; potential delays in and unforeseen costs arising from our clinical trials; the fact that our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences; the impact of increased demand for the manufacture of mRNA and LNP based vaccines to treat COVID-19 on our development plans; difficulties manufacturing the novel technology on which our OEC candidates are based; our ability to adapt to rapid and significant technological change; our reliance on third parties for the manufacture of materials; our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for lipid excipients used in our product candidates; our ability to advance our product candidates to clinical development; and our ability to obtain, maintain, enforce and adequately protect our intellectual property rights. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

CONTACT

Investor contact:
Eva Stroynowski
617.949.4370
estroynowski@omegatx.com

Media contact:
Jason Braco, LifeSci Communications
646.751.4361
jbraco@lifescicomms.com