Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage
biotechnology company pioneering the development of a new class of
programmable epigenetic mRNA medicines, today announced financial
results for the fourth quarter and full year ended December 31,
2022 and provided a corporate update.
“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.
- Presented a
Trial-in-Progress Poster at ASCO 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).
- 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
- 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.
- 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.
About Omega Therapeutics
Omega Therapeutics, founded by Flagship Pioneering, is a
clinical-stage biotechnology company pioneering the development of
a new class of programmable epigenetic mRNA medicines. The
Company's OMEGA platform harnesses the power of epigenetics, the
mechanism that controls gene expression and every aspect of an
organism's life from cell genesis, growth, and differentiation to
cell death. Using a suite of technologies, paired with Omega's
process of systematic, rational, and integrative drug design, the
OMEGA platform enables control of fundamental epigenetic processes
to correct the root cause of disease by returning aberrant gene
expression to a normal range without altering native nucleic acid
sequences. Omega's modular and programmable mRNA medicines, Omega
Epigenomic Controllers™, target specific epigenomic loci within
insulated genomic domains, EpiZips, from amongst thousands of
unique, mapped, and validated genome-wide DNA-sequences, with high
specificity to durably tune single or multiple genes to treat and
cure diseases through unprecedented precision epigenomic control.
Omega’s pipeline of product candidates spans a range of disease
areas, including oncology, regenerative medicine, multigenic
diseases including immunology, and select monogenic diseases.
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 the timing, progress and design of our Phase 1/2
MYCHELANGELOTM I clinical trial and our preclinical trials, as well
as the timing of announcements of data related thereto; the
sufficiency of our cash, cash equivalents and marketable
securities, including the proceeds from our registered direct
offering in February 2023, to fund our operations; the potential of
the OMEGA platform to engineer programmable epigenetic mRNA
therapeutics that successfully regulate gene expression by
targeting insulated genomic domains; expectations surrounding the
potential of our product candidates, including OTX-2002 and
OTX-2101; and expectations regarding our pipeline, including trial
design, initiation of preclinical studies and advancement of
multiple preclinical development programs in oncology, immunology,
regenerative medicine, and select monogenic diseases. These
statements are neither promises nor guarantees, but involve known
and unknown risks, uncertainties and other important factors that
may cause our actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: the novel
technology on which our product candidates are based makes it
difficult to predict the time and cost of preclinical and clinical
development and subsequently obtaining regulatory approval, if at
all; the substantial development and regulatory risks associated
with epigenomic controllers due to the novel and unprecedented
nature of this new category of medicines; our limited operating
history; the incurrence of significant losses and the fact that we
expect to continue to incur significant additional losses for the
foreseeable future; our need for substantial additional financing;
our investments in research and development efforts that further
enhance the OMEGA platform, and their impact on our results;
uncertainty regarding preclinical development, especially for a new
class of medicines such as epigenomic controllers; potential delays
in and unforeseen costs arising from our clinical trials; the fact
that our product candidates may be associated with serious adverse
events, undesirable side effects or have other properties that
could halt their regulatory development, prevent their regulatory
approval, limit their commercial potential, or result in
significant negative consequences; the impact of increased demand
for the manufacture of mRNA and LNP based vaccines to treat
COVID-19 on our development plans; difficulties manufacturing the
novel technology on which our OEC candidates are based; our ability
to adapt to rapid and significant technological change; our
reliance on third parties for the manufacture of materials; our
ability to successfully acquire and establish our own manufacturing
facilities and infrastructure; our reliance on a limited number of
suppliers for lipid excipients used in our product candidates; our
ability to advance our product candidates to clinical development;
and our ability to obtain, maintain, enforce and adequately protect
our intellectual property rights. These and other important factors
discussed under the caption "Risk Factors" in our Annual Report on
Form 10-K for the year ended December 31, 2022, and our other
filings with the SEC, could cause actual results to differ
materially from those indicated by the forward-looking statements
made in this press release. Any such forward-looking statements
represent management's estimates as of the date of this press
release. While we may elect to update such forward-looking
statements at some point in the future, we disclaim any obligation
to do so, even if subsequent events cause our views to change.
Omega Therapeutics, Inc.
Consolidated statements of operations and comprehensive
loss (Unaudited, In thousands except share data
and per share data)
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Collaboration revenue from related party |
$ |
735 |
|
|
$ |
144 |
|
|
$ |
2,073 |
|
|
$ |
144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
25,667 |
|
|
|
14,676 |
|
|
|
79,996 |
|
|
|
47,865 |
|
General and administrative |
|
5,355 |
|
|
|
5,659 |
|
|
|
21,821 |
|
|
|
16,603 |
|
Related party expense, net |
|
680 |
|
|
|
473 |
|
|
|
3,022 |
|
|
|
1,708 |
|
Total operating expenses |
|
31,702 |
|
|
|
20,808 |
|
|
|
104,839 |
|
|
|
66,176 |
|
Loss from operations |
|
(30,967 |
) |
|
|
(20,664 |
) |
|
|
(102,766 |
) |
|
|
(66,032 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
248 |
|
|
|
(170 |
) |
|
|
222 |
|
|
|
(910 |
) |
Change in fair value of warrant liability |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1,310 |
) |
Other income (expense), net |
|
(107 |
) |
|
|
(20 |
) |
|
|
(157 |
) |
|
|
(28 |
) |
Total other income (expense), net |
|
141 |
|
|
|
(190 |
) |
|
|
65 |
|
|
|
(2,248 |
) |
Net loss |
$ |
(30,826 |
) |
|
$ |
(20,854 |
) |
|
$ |
(102,701 |
) |
|
$ |
(68,280 |
) |
Net loss per common stock
attributable to common stockholders, basic and diluted |
$ |
(0.64 |
) |
|
$ |
(0.44 |
) |
|
$ |
(2.14 |
) |
|
$ |
(3.05 |
) |
Weighted-average common stock
used in net loss per share attributable to common stockholders,
basic and diluted |
|
47,895,083 |
|
|
|
47,781,701 |
|
|
|
47,880,819 |
|
|
|
22,404,058 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(30,826 |
) |
|
$ |
(20,854 |
) |
|
$ |
(102,701 |
) |
|
$ |
(68,280 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on
marketable securities |
|
438 |
|
|
|
(62 |
) |
|
|
(417 |
) |
|
|
(62 |
) |
Comprehensive loss |
$ |
(30,388 |
) |
|
$ |
(20,916 |
) |
|
$ |
(103,118 |
) |
|
$ |
(68,342 |
) |
Omega Therapeutics,
Inc.Consolidated Balance
Sheets(Unaudited, In thousands)
|
December 31, |
|
|
December 31, |
|
2022 |
|
|
2021 |
Assets |
|
|
|
|
Cash and cash equivalents |
$ |
70,615 |
|
$ |
186,482 |
Marketable securities |
|
54,063 |
|
|
38,845 |
Other assets |
|
21,320 |
|
|
8,006 |
Total assets |
$ |
145,998 |
|
$ |
233,333 |
Liabilities and
stockholders’ equity |
|
|
|
Liabilities |
$ |
40,027 |
|
$ |
32,705 |
Stockholders’ equity |
|
105,971 |
|
|
200,628 |
Total liabilities and stockholders’ equity |
$ |
145,998 |
|
$ |
233,333 |
CONTACT
Investor contact:
Eva Stroynowski
617.949.4370
estroynowski@omegatx.com
Media contact:
Jason Braco, LifeSci Communications
646.751.4361
jbraco@lifescicomms.com
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