On November 8, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a clinical-stage biotechnology company pioneering the first systematic approach to use mRNA therapeutics as a new class of programmable epigenetic medicines by leveraging its OMEGA Epigenomic Programming platform, reported financial results for the third quarter ended September 30, 2022 and highlighted recent Company progress (Press release, Omega Therapeutics, NOV 8, 2022, View Source [SID1234623393]).
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"The significant progress we are making on all fronts across our development pipeline is exciting, including the initiation of the MYCHELANGELO clinical program for OTX-2002, which represents the first-ever dosing of an epigenomic controller in a patient and marks a significant milestone in our journey to bring novel and programmable mRNA therapeutics to patients," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We were also delighted to announce our next development candidate, OTX-2101 for the treatment of patients with MYC-driven non-small cell lung cancer. Our focus is on advancing our lead programs, OTX-2002 and OTX-2101, as well as driving additional discovery and preclinical assets forward to further expand our pipeline."
Recent Corporate Highlights
Development Pipeline and Platform
First Patient Dosed in Landmark MYCHELANGELO I Clinical Trial for OTX-2002, the First-Ever Omega Epigenomic Controller (OEC): The Phase 1/2 study is the first-ever study to evaluate this new class of programmable mRNA therapeutics designed to treat or cure serious diseases through precision genomic control. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor 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 hepatocellular carcinoma (HCC) and other solid tumor types known for association with the c-Myc (MYC) oncogene. The study is expected to enroll approximately 190 patients at clinical trial sites in the United States, Asia, and Europe.
OTX-2002 Granted Orphan Drug Designation by U.S. Food and Drug Administration (FDA) for Hepatocellular Carcinoma (HCC): OTX-2002 is a rationally engineered, novel and programmable mRNA therapeutic designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The FDA’s Orphan Drug Designation Program provides orphan status to drugs intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States.
OTX-2101 for MYC-Driven Non-Small Cell Lung Cancer (NSCLC) Selected as Second Omega Epigenomic Controller Development Candidate: OTX-2101 is the second candidate in this new class of programmable mRNA therapeutics designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. Preclinical data presented at the 2022 American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting demonstrated OTX-2101 potently downregulates MYC in multiple NSCLC cell lines. OTX-2101 effectively reduced tumor growth in vivo and was well tolerated in murine xenograft models, further supporting its clinical potential. Investigational New Drug (IND)-enabling studies for OTX-2101 are underway.
Completed Development Candidate-enabling Activities for Several OECs: Beyond HCC and NSCLC, the Company continues to advance multiple OECs from the OMEGA Epigenomic Programming platform through preclinical studies. 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. The Company continues additional preclinical work for its OEC development programs spanning oncology, multigenic diseases including immunology, regenerative medicine, and select monogenic diseases.
Corporate
Rainer Boehm Appointed to Board of Directors: Mr. Boehm joined the Board on August 30, 2022. He serves on the Company’s audit and compensation committees. He brings over 30 years of successful and diverse clinical, managerial, drug development, and commercialization experience to Omega.
Third Quarter 2022 Financial Results
As of September 30, 2022, the Company had cash, cash equivalents and marketable securities totaling $148.3 million.
Research and development (R&D) expenses for the third quarter of 2022 were $20.7 million, compared to $12.3 million for the third quarter of 2021. The $8.4 million increase in R&D expense was primarily driven by an increase in personnel-related expenses, external manufacturing costs, and study costs in support of the advancement of our programs.
General and administrative (G&A) expenses for the third quarter of 2022 were $5.2 million, compared to $4.5 million for the third quarter of 2021. The $0.7 million increase in G&A expense was primarily driven by an increase in personnel-related expenses to support business growth.
Net loss for the third quarter of 2022 was $25.8 million, compared to $18.5 million for the third quarter of 2021, driven predominantly by increased R&D and G&A expenses to support the Company’s growth and operations as a public company.