On May 6, 2024 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, reported financial results for the first quarter ended March 31, 2024, and highlighted recent Company progress (Press release, Omega Therapeutics, MAY 6, 2024, View Source [SID1234642680]).
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"Our consistent focus on execution in the past quarter led to meaningful progress in both our clinical and preclinical programs as we work to maximize the value and potential of our unique OMEGA platform," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We continue to evaluate OTX-2002 in the ongoing MYCHELANGELO I trial, including the advancement to a higher dose of 0.3 mg/kg in Cohort 5. We expect to present safety and preliminary efficacy data from dose escalation as well as expand into Phase 2 settings in mid-2024. We continue to enhance our platform capabilities with the evaluation of new targets, advancement of upregulation and multiplexed epigenomic control and further progress our internal delivery efforts to the lung and other high-value tissues. We look forward to executing on these important milestones as we advance on our mission to bring programmable epigenomic mRNA medicines to patients in need."
Recent Highlights and Key Anticipated Milestones
Development Pipeline and Platform
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Advanced to Cohort 5 in dose escalation of the Phase 1/2 MYCHELANGELO I clinical trial evaluating OTX-2002 in patients with hepatocellular carcinoma (HCC): The trial is currently enrolling patients in Cohort 5 at the 0.3 mg/kg dose level at clinical sites across the U.S. and Asia. The Company expects to report additional clinical data from monotherapy dose escalation and expand into monotherapy and combination settings in mid-2024.
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Presented new preclinical data supporting the development of a MYC-targeting epigenomic controller for EGFR inhibitor-resistant non-small cell lung cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024: Data demonstrated the anti-tumor effect of a MYC-targeting epigenomic controller
(MYC-EC) in preclinical models of EGFR inhibitor (EGFRi)-resistant non-small cell lung cancer (NSCLC), regardless of the underlying resistance mechanism. These data support potential development of a NSCLC MYC-EC in EGFR-mutant NSCLC as a combination therapy with osimertinib, and as a monotherapy in osimertinib-resistant NSCLC. The Company also presented preclinical data validating a novel pharmacodynamic biomarker assay for monitoring on-target engagement and activity of OTX-2002.
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New preclinical data demonstrating durable upregulation of gene expression, further supporting Omega’s diverse platform capabilities, to be presented at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 27th Annual Meeting: Poster titled "Tuned Upregulation of Diverse Gene Targets Using Programmable Epigenomic Controllers" to be presented during the Epigenetic Editing and RNA Editing poster session on May 8, 2024, from 12:00 p.m. to 7:00 p.m. ET.
First Quarter 2024 Financial Results
As of March 31, 2024, the Company had cash and cash equivalents totaling $60.0 million. This cash balance, along with a cost reduction and strategic prioritization initiative that occurred during the first quarter, is expected to fund operations into Q1 2025.
Research and development (R&D) expenses for the first quarter of 2024 were $15.4 million, compared to $20.1 million for the first quarter of 2023. The $4.7 million decrease in R&D expenses was primarily driven by a decrease in external research and manufacturing costs, personnel-related expenses, and clinical development costs, partially offset by an increase in facilities expenses.
General and administrative (G&A) expenses for the first quarter of 2024 were $7.4 million, compared to $6.2 million for the first quarter of 2023. The $1.2 million increase in G&A expenses was primarily driven by an increase in facilities expenses.
Net loss for the first quarter of 2024 was $20.1 million, compared to $25.3 million for the first quarter of 2023. The decrease in net loss was driven predominantly by the decrease in R&D expenses.