On March 1, 2023 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenetic mRNA medicines, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update (Press release, Omega Therapeutics, MAR 1, 2023, View Source [SID1234627948]).

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"2022 was a pivotal year for Omega, marked by tremendous progress and consistent execution. Our first programmable epigenetic mRNA medicine, OTX-2002, received IND clearance and orphan drug designation from the FDA and we launched our landmark MYCHELANGELO I clinical trial for the treatment of hepatocellular carcinoma and other solid tumor types known for association with the MYC oncogene. We also made significant advancements across our pipeline, including the selection of our second development candidate, OTX-2101 for MYC-driven non-small cell lung cancer with a novel lung-targeting lipid nanoparticle, and characterized our CXCL1-8 preclinical program in multiple potential indications," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics.

"This year, we aim to generate clinical proof-of-platform through MYCHELANGELO I and replicate our preclinical findings for OTX-2002. In addition to characterizing safety and tolerability, we are collecting translational data, assessing epigenetic state changes, correlating mRNA and protein changes, and evaluating anti-tumor activity," Karande continued. "We are excited at the prospect to deliver on the promise of epigenetics and make a meaningful impact on transforming medicine in service of patients. With additional capital from our recently completed registered direct offering further strengthening our balance sheet, we believe we are well positioned to build on our momentum through the potential value inflection milestones this year

Recent Corporate Highlights and Upcoming Anticipated Milestones

Development Pipeline and Platform

Advanced MYCHELANGELO I Clinical Trial for OTX-2002, the Company’s Lead Omega Epigenomic Controller (OEC): Enrollment continues in the Phase 1/2 trial evaluating OTX-2002 as a monotherapy (Part I) 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 is progressing as planned with multiple clinical sites initiated across the U.S. and Asia; additional sites are expected to activate in these regions. Preliminary data from the Phase 1 monotherapy dose escalation portion of the study are anticipated in 2023.
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Presented a Trial-in-Progress Poster at ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium: In January 2023, a trial-in-progress poster titled "A phase 1/2 open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a single agent and in combination with standard of care in patients with hepatocellular carcinoma and other solid tumor types known for association with the MYC oncogene (MYCHELANGELO I)" was presented at the American Society for Clinical Oncology 2023 Gastrointestinal Cancers Symposium (ASCO-GI).
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Advanced Preclinical Development of Multiple OEC Programs: The Company continues to advance multiple OECs from the OMEGA platform through preclinical studies. OTX-2101, declared as Omega’s second development candidate, is being evaluated in Investigational New Drug (IND)-enabling studies for the treatment of MYC-driven non-small cell lung cancer (NSCLC), an area of significant unmet patient need. The CXCL 1-8-targeting OEC has been characterized in preclinical studies and has potential in several 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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Strengthened Balance Sheet with Registered Direct Offering: In February 2023, the Company closed a registered direct offering of its common stock resulting in net proceeds of approximately $39.7 million. The offering included participation from new and existing investors.
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Recognized for Culture and Innovation in Industry Awards: In November 2022, BioSpace named Omega among its Best Places to Work 2023 report in the small employers category. The Company was also named as a finalist for the Reuters Events Pharma Awards USA 2022 in the Health Entrepreneur category

Fourth Quarter and Full Year 2022 Financial Results

As of December 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $124.7 million. Subsequent to the close of 2022, the Company received approximately $39.7 million in net proceeds from a registered direct offering of common stock.

Research and development (R&D) expenses for the fourth quarter of 2022 were $25.7 million, compared to $14.7 million for the fourth quarter 2021. R&D expenses for 2022 were $80.0 million compared to $47.9 million in 2021. The $32.1 million increase in R&D expenses in 2022 compared to 2021 was primarily due to increases in discovery and preclinical development costs, clinical development costs, and personnel and related expenses as the Company continues to advance its pipeline and discovery portfolio.

General and administrative (G&A) expenses for the fourth quarter of 2022 were $5.4 million, compared with $5.7 million for the fourth quarter of 2021. G&A expenses for 2022 were $21.8 million, compared to $16.6 million in 2021. The $5.2 million increase in G&A expenses in 2022 compared to 2021 was primarily due to higher personnel and related expenses and increased costs to operate as a public company, in addition to higher professional fees to support business growth.

Net loss for the fourth quarter of 2022 was $30.8 million, compared with $20.9 million for the fourth quarter of 2021. Net loss for the year ended December 31, 2022 was $102.7 million, compared to a net loss of $68.3 million for the year ended December 31, 2021. The increase in net loss for 2022 compared to 2021 was primarily due to increases in R&D and G&A expenses to support the Company’s growth and operations as a public company.