On August 3, 2023 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 second quarter ended June 30, 2023, and highlighted recent Company progress (Press release, Omega Therapeutics, AUG 3, 2023, View Source [SID1234633789]).
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"This quarter, we continued to make progress with our clinical development plans and further establish our ability to generate a new class of programmable epigenomic mRNA medicines," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We continue to enroll patients in our Phase 1/2 first-in-human MYCHELANGELO I study, from which we expect to announce preliminary monotherapy dose-escalation data later this year. In addition to our clinical progress, we presented new preclinical data at the ASCO (Free ASCO Whitepaper) 2023 Annual Meeting that further validates the potential to combine MYC-targeting Omega Epigenomic Controllers (OECs) with checkpoint blockade immunotherapies and advanced multiple programs in preclinical studies. We also welcomed industry veteran Chris Schade to our Board of Directors, whose wealth of biopharma experience will support the long-term growth objectives of our Company. We look forward to building on this foundational work and steady momentum in the second half of this year and beyond."
Recent Corporate Highlights
Development Pipeline and Platform
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Advanced the MYCHELANGELO I Clinical Trial Evaluating OTX-2002: The Phase 1/2 trial is evaluating OTX-2002, the Company’s lead OEC, as a monotherapy (Part 1) and in combination with standard of care therapies (Part 2) in patients with relapsed or refractory hepatocellular carcinoma (HCC) and other solid tumor types known for association with the c-Myc (MYC) oncogene. Trial enrollment continues to progress as planned at clinical sites across the U.S. and Asia. Preliminary data from the Phase 1 monotherapy dose escalation portion of the study, including initial safety, tolerability, pharmacologic and translational data, are expected in the fourth quarter of 2023.
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Presented New Preclinical Data Demonstrating the Potential of MYC-targeting OECs to Synergize with Immunotherapies at the ASCO (Free ASCO Whitepaper) 2023 Annual Meeting: Results further validate the OMEGA platform, with MYC-targeting OECs demonstrating consistent anti-tumor activity across multiple tumor types, including HCC and non-small cell lung cancer (NSCLC). MYC OECs modulated the tumor microenvironment, enhanced response to checkpoint blockade immunotherapies and conferred immune memory in preclinical models. These data support Omega’s clinical strategy and planned combination with standard of care, including anti-PD-1 and anti-PD-L1 therapies, in the ongoing Phase 1/2 MYCHELANGELO I clinical trial.
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Progressed Preclinical Development of Multiple OEC Programs: The Company continues to advance multiple OECs from the OMEGA platform through preclinical studies. OTX-2101, the Company’s development candidate for the treatment of MYC-driven NSCLC, is being evaluated in Investigational New Drug (IND)-enabling studies. Additional preclinical work is ongoing for other OEC development programs, including HNF4a in liver disease and a CXCL 1-8-targeting OEC with potential in multiple indications including neutrophilic asthma, acute respiratory distress syndrome (including COVID-related), oncology, and dermatological and rheumatological indications, representing a potential franchise opportunity.
Corporate
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Appointed Chris Schade to Board of Directors: Mr. Schade joined the Board on July 10, 2023, and brings over 30 years of experience across the biopharma industry including deep expertise in building companies, strategic planning, financing, and business development. He has proven leadership in several executive roles and as a board member across private and public biopharma companies.
Second Quarter 2023 Financial Results
As of June 30, 2023, the Company had cash, cash equivalents and marketable securities totaling $113.0 million.
Research and development (R&D) expenses for the second quarter of 2023 were $25.0 million, compared to $19.4 million for the second quarter of 2022. The $5.6 million increase in R&D expenses was primarily driven by increases in clinical development costs, external manufacturing costs, and study costs to support the advancement of our programs, as well as facilities and personnel-related expenses, including stock-based compensation to support business growth.
General and administrative (G&A) expenses were $6.2 million for the second quarter of 2023 and 2022.
Net loss for the second quarter of 2023 was $29.7 million, compared to $25.9 million for the second quarter of 2022, driven predominantly by increased R&D expenses to support the Company’s growth.