On May 4, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega"), a development-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 first quarter ended March 31, 2022, and highlighted recent Company progress (Press release, Omega Therapeutics, MAY 4, 2022, View Source [SID1234613521]).
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"We are delighted with the preclinical data emerging from our OMEGA platform, for example, from our OTX-2002 program where we demonstrated the ability to downregulate the overexpression of the c-Myc (MYC) oncogene in models of hepatocellular carcinoma (HCC) as shared at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2022 Annual Meeting," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "We also recently announced additional preclinical data that will be presented at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting, in which a different Omega Epigenomic ControllerTM (OEC) candidate showed the ability to regulate MYC expression resulting in decreased viability of cancer cells in both in vitro and in vivo models of non-small cell lung cancer (NSCLC). We are pleased to see this further validation of our targeted mRNA therapeutics and their potential to control gene expression through epigenomic programming. We look forward to advancing a broad portfolio of OECs and are keenly focused on advancing into the clinic this year, starting with our expected Investigational New Drug (IND) Application for OTX-2002 in the first half of 2022."
Recent Business Highlights
Development Pipeline and Platform
OTX-2002: OTX-2002 is a novel, engineered, and programmable mRNA therapeutic targeting MYC in patients with HCC. In preclinical studies, OTX-2002 demonstrated its ability to potently downregulate MYC oncogene expression by epigenetically targeting the MYC insulated genomic domain (IGD). The Company is pleased to announce that it remains on track to file an IND for OTX-2002 in the first half of 2022.
Presented New OTX-2002 Preclinical Data in Hepatocellular Carcinoma at AACR (Free AACR Whitepaper) 2022 that Highlighted the Potential of OTX-2002 to Downregulate Overexpression of the MYC Oncogene in Models of HCC: Results showed that OTX-2002 suppresses MYC gene expression resulting in a loss of cancer cell viability in vitro and reduces tumor growth in in vivo HCC xenograft models. The data also demonstrated the potential of the OMEGA platform to engineer programmable epigenetic mRNA therapeutics that successfully regulate gene expression by targeting IGDs. The poster presentation can be accessed on our website at View Source
Abstract on OEC for Non-Small Cell Lung Cancer Selected for Presentation at the Upcoming American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting: New data highlight the potential of an OEC to downregulate overexpression of the MYC oncogene in models of NSCLC. The results showed on-target changes to the epigenetic profile of the MYC IGD. Treatment also resulted in dose-dependent downregulation of MYC mRNA expression, leading to significant reduction of cell viability in NSCLC cell lines as well as decreased tumor growth in murine xenograft NSCLC models. Results will be further discussed during a poster presentation on May 18, 2022, from 5:30 p.m. through 6:30 p.m. EDT.
Additional OEC Development: Beyond HCC and NSCLC, the Company is working on multiple programs in preclinical studies, including acute respiratory distress syndrome (ARDS) with CXCL1-3/IL8, alopecia with SFRP1, liver disease with HNF4a, and additional undisclosed targets. Omega continues to anticipate nominating two OEC development candidates in the middle of 2022.
OMEGA Epigenomic Programming Platform: Omega is creating a new generation of programmable epigenetic mRNA medicines that are designed to control the fundamental epigenetic processes to correct the root cause of disease by restoring aberrant gene expression to homeostasis without altering native nucleic acid sequences. Omega has developed a highly rational and deterministic approach to drug design that enables the Company to rapidly develop and optimize novel OECs with high target specificity to durably tune the expression of single or multiple genes. Omega is advancing multiple preclinical development programs in oncology, immunology, regenerative medicine, and select monogenic diseases.
Corporate
Joshua Reed to join as Chief Financial Officer, employment expected to commence on May 23, 2022: Mr. Reed has experience in finance, capital raising, business development, investor relations, and managing all aspects of the financial close process.
Roger Sawhney, M.D., to serve as Chief Business Officer effective on the date of the commencement of Mr. Reed’s employment: In this new role, Mr. Sawhney, currently Omega’s Chief Financial Officer, will focus on the Company’s business development efforts as Omega looks to accelerate the potential of its epigenomic programing platform.
Ling Zeng, Esq., appointed Chief Legal and Administrative Officer: Ms. Zeng has extensive management experience working with companies in the healthcare industry at various stages of their lifecycle, with responsibilities around legal, operations, reputation, intellectual property, corporate governance, and compliance.
Kevin McManus appointed Chief Human Resources Officer: Mr. McManus has extensive experience in developing and implementing strategies to enhance growth and attract and retain talent while strengthening company culture.
First Quarter 2022 Financial Results
As of March 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $200.8 million.
Research and development (R&D) expenses for the first quarter of 2022 were $14.2 million, compared to $9.7 million for the first quarter of 2021. The $4.5 million increase in R&D expense was primarily related to discovery and preclinical development costs and personnel-related expenses as the Company continues to support research and development growth and advance its pipeline and discovery portfolio.
General and administrative (G&A) expenses for the first quarter of 2022 were $5.4 million, compared to $2.7 million for the first quarter of 2021. The $2.7 million increase in G&A expense was primarily related to personnel-related expenses and increased costs to operate as a public company, and higher professional fees to support business growth.
Net loss for the first quarter of 2022 was $20.2 million, compared to $13.5 million for the first 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.