Omega Therapeutics Q2 2024 Financial Results and Company Progress

Omega Therapeutics, Inc., a clinical-stage biotechnology firm listed on Nasdaq as OMGA, has disclosed its financial results for the second quarter ending June 30, 2024, along with updates on their recent progress. Omega is recognized for pioneering programmable epigenomic mRNA medicines, which offer a novel therapeutic approach by modulating gene expression.

President and CEO Mahesh Karande expressed optimism regarding the MYCHELANGELO™ I trial, which has demonstrated the potential of epigenomic controllers as a distinct class of programmable mRNA therapeutics. Anticipation builds as the company nears the determination of the recommended dose for expansion of OTX-2002, with plans to share updated dose escalation data and commence expansion cohorts in monotherapy and combination settings in the upcoming fourth quarter.

At the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting, Omega showcased new preclinical data illustrating the durable and robust upregulation of gene expression. The data underscored the potential of their OMEGA platform to manipulate gene expression across a wide range of diseases, further emphasizing the transformative potential of their technology.

Omega has made notable strides in the dose escalation phase of their Phase 1/2 MYCHELANGELO™ I clinical trial, which evaluates OTX-2002 in patients with hepatocellular carcinoma (HCC). The company is progressing towards identifying the recommended dose for expansion (RDE), with patient enrollment ongoing in Cohort 6 at the 0.2 mg/kg dose level in various sites in the U.S. and Asia. Updated clinical data and plans for expansion into monotherapy and combination settings are expected to be reported in the fourth quarter of 2024.

Additionally, Omega continues to enhance the OMEGA platform by evaluating multiple epigenomic controller programs in preclinical studies, including OTX-2101 for non-small cell lung cancer (NSCLC), an HNF4A program in liver regeneration, and a collaboration with Novo Nordisk on an epigenomic controller for obesity management. Core platform biology research, epigenomic controller design, and characterization of lipid nanoparticle (LNP) delivery to vital tissues like the lung are also progressing well.

On the corporate front, Omega strengthened its leadership team with the appointment of Kaan Certel, Ph.D., as Chief Business Officer and Richard N. Kender's election to the Board of Directors. Dr. Certel, an experienced biopharmaceutical leader, will oversee global business development activities, including strategic partnerships. Mr. Kender brings extensive expertise in corporate finance, business development, and licensing from his 35-year career at Merck & Co., Inc.

Financially, Omega reported cash and cash equivalents totaling $45.9 million as of June 30, 2024, expected to fund operations into Q1 2025. R&D expenses for Q2 2024 were $12.9 million, a significant decrease from $25.0 million in the same period in 2023, primarily due to reduced external research costs, contract manufacturing costs, and personnel-related expenses. General and administrative expenses also decreased to $5.8 million from $6.6 million. Overall, the net loss for Q2 2024 was $16.3 million, down from $29.7 million in Q2 2023, driven mainly by the reduction in R&D expenses.

Omega Therapeutics, established in 2017 by Flagship Pioneering, focuses on creating programmable epigenomic mRNA medicines that modulate gene expression pre-transcriptionally. This approach allows precise control over nearly all human genes, including those that are traditionally challenging to target. The company’s pipeline includes therapeutic candidates spanning oncology, regenerative medicine, and multigenic diseases such as inflammatory and cardiometabolic conditions. Omega remains committed to advancing genomic medicine through its innovative OMEGA platform.