Omega Therapeutics Reports Fourth Quarter and Full Year 2021 Financial Results and Outlines Key Corporate Objectives for 2022
"In 2021, we made significant strides across all aspects of our business highlighted by the successful completion of our initial public offering, the nomination of OTX-2002 as the industry's first programmable epigenetic medicine to be developed for the treatment of c-Myc (MYC)-driven hepatocellular carcinoma (HCC), and the continued development of our groundbreaking platform and pipeline," said
Recent Business Highlights and Corporate Update
Development Pipeline and Platform
American Association for Cancer Research (AACR) Annual Meeting 2022: An abstract titled, "Epigenetic Modulation of the MYC oncogene as a potential novel therapy for HCC" was selected for a poster presentation at the upcoming AACR 2022 Annual Meeting. The presentation will highlight the mechanism of action of OTX-2002 and its potential as a differentiated and viable approach to the treatment of HCC.
- OTX-2002: IND-enabling studies are ongoing for Omega's lead OEC candidate OTX-2002, a novel, engineered, and programmable mRNA therapeutic targeting the MYC oncogene in patients with HCC. In preclinical studies, OTX-2002 demonstrated its ability to potently downregulate MYC oncogene expression. The Company continues to be on track to file an IND for OTX-2002 in the first half of 2022.
Additional OEC Development : The Company is working on multiple programs in pre-clinical studies, including acute respiratory distress syndrome (ARDS) with CXCL1-3/IL8, non-small cell lung cancer (NSCLC) with MYC, alopecia with SFRP1, and liver disease with HNF4a.
- 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 a normal range 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 pre-clinical development programs in oncology, multigenic diseases including immunology, regenerative medicine, and select monogenic diseases.
Corporate
- In
January 2022 ,Yan Moore , M.D., was appointed Chief Medical Officer of Omega.Dr. Moore has extensive management, research, translational drug development and medical affairs experience across various pharmaceutical and biotechnology companies.
Anticipated Milestones and Key Priorities for 2022
- Complete IND-enabling studies for OTX-2002 and file the Company's first IND to the
U.S. Food and Drug Administration (FDA) during the first half of 2022.
- Declare two OEC development candidates in the first half of 2022.
- Target submission of an additional IND application in the second half of 2022 or early 2023.
- Continue to develop the OMEGA Epigenomic Programming platform and investigate additional development programs to expand pipeline.
- Publish and present relevant preclinical and early clinical data supporting programs and platform development.
Fourth Quarter and Full Year 2021 Financial Results
As of
Research and development (R&D) expenses for the fourth quarter of 2021 were
General and administrative expenses (G&A) for the fourth quarter of 2021 were
Net loss for the fourth quarter of 2021 was
About
For more information, visit omegatherapeutics.com, or follow us on Twitter and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our product candidates, including our lead OEC candidate OTX-2002; development timelines; anticipated timing of regulatory submissions and filings; the success of our collaboration with
Investor contact:
212.600.1902
ArgotOmega@argotpartners.com
Media contact:
646.751.4361
jbraco@lifescicomms.com
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||||||||||||||||
Consolidated statements of operations and comprehensive loss |
||||||||||||||||
(in thousands, except share and per share amounts) |
||||||||||||||||
Three months ended |
Year ended |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
Collaboration revenue from related party |
$ |
144 |
$ |
— |
$ |
144 |
$ |
— |
||||||||
Operating expenses: |
||||||||||||||||
Research and development |
14,676 |
7,099 |
47,865 |
21,063 |
||||||||||||
General and administrative |
5,659 |
1,858 |
16,603 |
6,236 |
||||||||||||
Related party expense, net |
473 |
286 |
1,708 |
1,346 |
||||||||||||
Total operating expenses |
20,808 |
9,243 |
66,176 |
28,645 |
||||||||||||
Loss from operations |
(20,664) |
(9,243) |
(66,032) |
(28,645) |
||||||||||||
Other expense, net: |
||||||||||||||||
Interest expense, net |
(170) |
(193) |
(910) |
(777) |
||||||||||||
Change in fair value of warrant liability |
— |
(1) |
(1,310) |
3 |
||||||||||||
Other expense, net |
(20) |
(28) |
(28) |
(28) |
||||||||||||
Total other expense, net |
(190) |
(222) |
(2,248) |
(802) |
||||||||||||
Net loss |
$ |
(20,854) |
$ |
(9,465) |
$ |
(68,280) |
$ |
(29,447) |
||||||||
Net loss per common stock attributable to common stockholders, |
$ |
(0.44) |
$ |
(2.18) |
$ |
(3.05) |
$ |
(7.54) |
||||||||
Weighted-average common stock used in net loss per share |
47,781,701 |
4,337,263 |
22,404,058 |
3,906,168 |
||||||||||||
Comprehensive loss: |
||||||||||||||||
Net loss |
$ |
(20,854) |
$ |
(9,465) |
$ |
(68,280) |
$ |
(29,447) |
||||||||
Other comprehensive loss: |
||||||||||||||||
Unrealized loss on marketable securities |
(62) |
— |
(62) |
— |
||||||||||||
Comprehensive loss |
$ |
(20,916) |
$ |
(9,465) |
$ |
(68,342) |
$ |
(29,447) |
|
|||||||
Condensed Consolidated Balance Sheets |
|||||||
(in thousands, except share and per share amounts) |
|||||||
|
|||||||
2021 |
2020 |
||||||
Assets |
|||||||
Cash and cash equivalents |
$ |
186,482 |
$ |
22,951 |
|||
Marketable securities |
38,845 |
— |
|||||
Other assets |
8,006 |
5,132 |
|||||
Total assets |
$ |
233,333 |
$ |
28,083 |
|||
Liabilities, redeemable convertible preferred stock, and stockholders' equity |
|||||||
Liabilities |
$ |
32,705 |
$ |
17,486 |
|||
Redeemable convertible preferred stock |
— |
75,225 |
|||||
Stockholders' equity (deficit) |
200,628 |
(64,628) |
|||||
Total liabilities, redeemable convertible preferred stock, and stockholders' equity |
$ |
233,333 |
$ |
28,083 |
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