Omega Therapeutics Reports Third Quarter 2023 Financial Results and Highlights Recent Company Progress
November 09 2023 - 7:00AM
Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage
biotechnology company pioneering the development of a new class of
programmable epigenomic mRNA medicines, today announced financial
results for the third quarter ended September 30, 2023, and
highlighted recent Company progress.
“The promising initial data from our ongoing MYCHELANGELO™ I
trial establish clinical proof for our pioneering OMEGA platform
and support the potential of epigenomic controllers, our
programmable mRNA candidates, as a new class of therapeutics,” said
Mahesh Karande, President and Chief Executive Officer of Omega
Therapeutics. “We are thrilled to have clearly demonstrated the
ability to site-specifically target and controllably modulate the
expression of MYC in all eight patients evaluated in the initial
two dose cohorts of the trial. MYC, considered a “holy grail”
oncogene, is just the first of many broadly-implicated targets in
oncology where an epigenomic controller may provide therapeutic
value. Moreover, these data highlight the promise of precision
epigenomic control to address a broad range of diseases.”
Mr. Karande added, “In parallel, we have made tremendous
progress advancing our pipeline, with recent and upcoming
presentations of new preclinical data demonstrating the breadth and
versatility of our platform capabilities at scientific and medical
meetings this fall. We look forward to building on this growing
body of data and delivering a new class of medicines to
patients.”
Recent Highlights and Key Anticipated
Milestones
Development Pipeline and Platform
- Reported promising preliminary
safety, tolerability, pharmacokinetic and translational data from
the ongoing MYCHELANGELO I clinical trial evaluating OTX-2002 (data
cut-off date of September 18, 2023):
- Data from the initial two dose level cohorts (n=8) from the
monotherapy dose escalation portion of the Phase 1/2 study
evaluating OTX-2002 in patients with hepatocellular carcinoma (HCC)
and other solid tumors associated with the c-MYC (MYC) gene showed
that all eight patients treated with OTX-2002 achieved highly
specific on-target genomic engagement, intended epigenetic state
change and rapid, robust and durable downregulation of MYC
expression.
- OTX-2002 was generally well tolerated at both dose levels, with
no dose-limiting toxicities. Consistent dose-dependent
pharmacokinetics were observed, and no drug accumulation was
observed following repeat doses.
- These data represent the first-known clinical observation of
pre-transcriptional gene modulation using a programmable epigenomic
mRNA candidate and establish clinical proof-of-platform.
- Based on these encouraging data, OTX-2002 continues to advance
in monotherapy dose escalation and the Company is actively
evaluating patients with HCC in Cohort 3. Omega expects to report
updated clinical data from monotherapy dose escalation in the first
half of 2024.
- The Company is planning to initiate expansion cohorts in
monotherapy and in combination settings with standard of care
agents mid-2024.
- Presented new preclinical data
supporting the potential of OTX-2101 for the treatment of non-small
cell lung cancer (NSCLC) at the 2023 AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics:
- The combination of a MYC-targeting epigenomic controller with
immune checkpoint or EGFR inhibitors significantly enhanced
anti-tumor activity in multiple preclinical models of NSCLC.
- Omega continues to advance OTX-2101 in Investigational New Drug
(IND)-enabling studies.
- Presented preclinical
proof-of-concept data for CXCL 1-8 program at the International
mRNA Health Conference:
- New preclinical data demonstrate the ability of the Company’s
CXCL 1-8-targeting epigenomic controller to multiplex and
specifically modulate gene expression of the multigenic locus in
multiple models of inflammatory disease.
- Omega has completed lead optimization activities for this
program, including demonstration of in vivo proof-of-concept
efficacy. The CXCL 1-8-targeting epigenomic controller has
potential in multiple inflammatory indications including
neutrophilic asthma, acute respiratory distress syndrome (including
COVID-19-related), dermatological and rheumatological indications,
and oncology, representing a potential franchise opportunity.
- Announced upcoming presentation of preclinical
proof-of-concept data on liver inflammation and fibrosis epigenomic
controller programs at the American Association for the Study of
Liver Diseases (AASLD) annual meeting: Omega will present
new preclinical data from its hepatology programs in two posters at
AASLD’s “The Liver Meeting®” annual meeting, being held November
10-14, 2023, in Boston, Massachusetts.
- One poster will highlight a CXCL 9-11-targeting epigenomic
controller candidate for the treatment autoimmune hepatitis
(AIH).
- A second poster will highlight new in vitro and in vivo data
demonstrating the ability of an investigational epigenomic
controller to durably upregulate HNF4α expression to drive liver
regeneration in preclinical models of fibrosis.
- Continued to advance and expand OMEGA platform
capabilities:
- The Company continues to advance multiple epigenomic controller
programs through discovery and lead optimization, and to further
progress and characterize its internal formulation and lipid
nanoparticle (LNP) delivery technologies for the delivery of
programmable mRNA therapeutics to the lung and other tissues.
Corporate
- Further strengthened Board of
Directors: In August, Omega announced the appointment of
Chris Schade as Chairman of the Board. In addition, Michelle C.
Werner, CEO of Alltrna and CEO-Partner at Flagship Pioneering,
joined the Board, bringing with her over 20 years of biopharma
experience spanning commercial and R&D responsibilities.
- Named to BioSpace’s Best Places
to Work 2024 report in small employer category: The annual
report lists 60 U.S. operating employers that are recognized as the
most sought-after in the industry by the life sciences community.
Recognition by BioSpace is determined by input from company
employees as well as voting from more than 3,000 life sciences
professionals.
Third Quarter 2023 Financial Results
As of September 30, 2023, the Company had cash, cash equivalents
and marketable securities totaling $89.3 million.
Research and development (R&D) expenses for the third
quarter of 2023 were $16.5 million, compared to $20.7 million for
the third quarter of 2022. The $4.2 million decrease in R&D
expenses was primarily driven by decreases in external
manufacturing costs and study costs, partially offset by an
increase in facilities expense and, to a lesser extent, increases
in personnel-related expenses and clinical development costs.
General and administrative (G&A) expenses for the third
quarter of 2023 were $7.9 million, compared to $5.2 million for the
third quarter of 2022. The $2.7 million increase in G&A
expenses was primarily driven by an increase in facilities expense
and, to a lesser extent, increases in professional and consulting
fees, partially offset by a decrease in personnel-related
expenses.
Net loss for the third quarter of 2023 was $22.2 million,
compared to $25.8 million for the third quarter of 2022, driven
predominantly by a decrease in R&D expenses.
About Omega Therapeutics
Omega Therapeutics is a clinical-stage biotechnology company
pioneering the development of a new class of programmable
epigenomic mRNA medicines to treat or cure a broad range of
diseases. By pre-transcriptionally modulating gene expression,
Omega’s approach enables precision epigenomic control of nearly all
human genes, including historically undruggable and
difficult-to-treat targets, without altering native nucleic acid
sequences. Founded in 2017 by Flagship Pioneering following
breakthrough research by world-renowned experts in the field of
epigenetics, Omega is led by a seasoned and accomplished leadership
team with a track record of innovation and operational excellence.
The Company is committed to revolutionizing genomic medicine and
has a diverse pipeline of therapeutic candidates derived from its
OMEGA platform spanning oncology, regenerative medicine, multigenic
diseases including immunology, and select monogenic diseases.
For more information, visit omegatherapeutics.com, or follow us
on X and LinkedIn.
About the OMEGA Platform
The OMEGA platform leverages the Company’s deep understanding of
gene regulation, genomic architecture and epigenetic mechanisms to
design programmable epigenomic mRNA medicines that precisely target
and modulate gene expression at the pre-transcriptional level.
Combining a biology-first approach and world-class data science
capabilities with rational drug design and customized delivery, 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. Omega’s modular and programmable mRNA
medicines, called epigenomic controllers, target specific genomic
loci within insulated genomic domains with high specificity to
durably tune single or multiple genes to treat and cure diseases
through unprecedented precision epigenomic control.
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
MYCHELANGELO™ I clinical trial and our preclinical studies, as
well as the timing of announcements of data related thereto; the
impact of Board composition changes on our long-term growth; the
potential of the OMEGA platform to engineer programmable epigenomic
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; 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; potential
franchise opportunities; and upcoming events and presentations.
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 epigenomic controller 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 Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023, 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 and per share data) |
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue from related party |
$ |
831 |
|
|
$ |
595 |
|
|
$ |
2,105 |
|
|
$ |
1,338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
16,475 |
|
|
|
20,670 |
|
|
|
61,454 |
|
|
|
54,329 |
|
General and administrative |
|
7,869 |
|
|
|
5,198 |
|
|
|
20,030 |
|
|
|
16,466 |
|
Related party expense, net |
|
(610 |
) |
|
|
712 |
|
|
|
183 |
|
|
|
2,342 |
|
Total operating expenses |
|
23,734 |
|
|
|
26,580 |
|
|
|
81,667 |
|
|
|
73,137 |
|
Loss from operations |
|
(22,903 |
) |
|
|
(25,985 |
) |
|
|
(79,562 |
) |
|
|
(71,799 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
684 |
|
|
|
184 |
|
|
|
2,323 |
|
|
|
(26 |
) |
Other income (expense), net |
|
(29 |
) |
|
|
2 |
|
|
|
25 |
|
|
|
(50 |
) |
Total other income (expense), net |
|
655 |
|
|
|
186 |
|
|
|
2,348 |
|
|
|
(76 |
) |
Net loss |
$ |
(22,248 |
) |
|
$ |
(25,799 |
) |
|
$ |
(77,214 |
) |
|
$ |
(71,875 |
) |
Net loss per common stock
attributable to common stockholders, basic and diluted |
$ |
(0.40 |
) |
|
$ |
(0.54 |
) |
|
$ |
(1.44 |
) |
|
$ |
(1.50 |
) |
Weighted-average common stock
used in net loss per share attributable to common stockholders,
basic and diluted |
|
55,140,058 |
|
|
|
47,854,965 |
|
|
|
53,629,468 |
|
|
|
47,837,490 |
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(22,248 |
) |
|
$ |
(25,799 |
) |
|
$ |
(77,214 |
) |
|
$ |
(71,875 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
85 |
|
|
|
89 |
|
|
|
393 |
|
|
|
(855 |
) |
Comprehensive loss |
$ |
(22,163 |
) |
|
$ |
(25,710 |
) |
|
$ |
(76,821 |
) |
|
$ |
(72,730 |
) |
Omega Therapeutics, Inc.Condensed
Consolidated Balance Sheets(Unaudited, In
thousands) |
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
81,768 |
|
|
$ |
70,615 |
|
Marketable securities |
|
7,532 |
|
|
|
54,063 |
|
Other assets |
|
128,508 |
|
|
|
21,320 |
|
Total assets |
$ |
217,808 |
|
|
$ |
145,998 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
Liabilities |
$ |
141,765 |
|
|
$ |
40,027 |
|
Stockholders’ equity |
|
76,043 |
|
|
|
105,971 |
|
Total liabilities and stockholders’ equity |
$ |
217,808 |
|
|
$ |
145,998 |
|
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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