Omega Therapeutics Reports Second Quarter 2024 Financial Results and Highlights Recent Company Progress
06 8월 2024 - 8:00PM
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 second quarter ended June 30, 2024, and highlighted
recent Company progress.
“We are excited by the meaningful progress achieved to date with
our MYCHELANGELO™ I trial, having generated clinical
proof-of-platform data that validates the potential of epigenomic
controllers as a new class of programmable mRNA therapeutics. As we
approach identification of the recommended dose for expansion for
OTX-2002, we look forward to sharing updated dose escalation data
and initiating expansion cohorts in monotherapy and combination
settings in the fourth quarter of this year,” said Mahesh Karande,
President and Chief Executive Officer of Omega Therapeutics. “We
are equally energized by the advances we have made with the OMEGA
platform, including new preclinical data presented at this year’s
ASGCT Annual Meeting showing durable and robust upregulation of
gene expression with epigenomic controllers across a broad range of
targets. We believe these achievements underscore the potential of
our platform to create tremendous value through its ability to
prospectively engineer epigenomic controllers with diverse and
meaningful therapeutic applications across nearly any human
disease.”
Recent Highlights and Key Anticipated
Milestones
Development Pipeline and Platform
- Progressed dose escalation
portion of Phase 1/2 MYCHELANGELO™ I clinical trial evaluating
OTX-2002 in patients with hepatocellular carcinoma (HCC):
Made steady progress towards identifying the recommended dose for
expansion (RDE) of OTX-2002, with patient enrollment ongoing in
Cohort 6 at the 0.2 mg/kg dose level across sites in the U.S. and
Asia. The Company expects to report updated clinical data and is
planning for expansion into monotherapy and combination settings in
the fourth quarter of 2024.
- Presented new preclinical data
demonstrating durable upregulation of gene expression at the
American Society of Gene and Cell Therapy (ASGCT) 27th Annual
Meeting: Data demonstrated durable and robust upregulation
of gene expression across a diverse set of gene types and
regulatory mechanisms, including turning on inactive genes,
augmenting expression of genes with existing but low baseline
expression levels, and increasing expression of poised genes that
are typically only responsive to certain external stimuli.
Additional data showed reversible downregulation and multiplexed
upregulation of gene expression. These findings further demonstrate
the OMEGA platform’s potential to engineer an entirely novel
therapeutic modality to directly target key drivers of disease
across therapeutic areas.
- Continued to advance and
enhance the OMEGA platform: The Company is evaluating
multiple epigenomic controller programs in preclinical studies,
including OTX-2101 for non-small cell lung cancer (NSCLC), an HNF4A
program in liver regeneration, and development of an epigenomic
controller for the management of obesity in collaboration with Novo
Nordisk. Core work on platform biology, epigenomic controller
design, and characterization of LNP delivery to the lung and other
high-value tissues continues to progress.
Corporate
- Strengthened leadership team
with appointment of Kaan Certel, Ph.D., as Chief Business Officer
and election of Richard N. Kender to Board of
Directors: Dr. Certel is a seasoned biopharmaceutical
leader and is responsible for Omega’s global business development
activities, including strategic partnerships. Mr. Kender brings
extensive expertise across corporate finance, business development
and corporate licensing, among other roles he held during his
career in the pharmaceutical industry, including 35 years spent at
Merck & Co., Inc.
Second Quarter 2024 Financial Results
As of June 30, 2024, the Company had cash and cash equivalents
totaling $45.9 million, which is expected to fund operations into
Q1 2025.
Research and development (R&D) expenses for the second
quarter of 2024 were $12.9 million, compared to $25.0 million for
the second quarter of 2023. The $12.1 million decrease in R&D
expenses was primarily driven by a decrease in external research
costs, contract manufacturing costs, and personnel-related
expenses.
General and administrative (G&A) expenses for the second
quarter of 2024 were $5.8 million, compared to $6.6 million for the
second quarter of 2023. The $0.8 million decrease in G&A
expenses was primarily driven by a decrease in personnel-related
expenses and consulting and professional fees.
Net loss for the second quarter of 2024 was $16.3 million,
compared to $29.7 million for the second quarter of 2023. The
decrease in net loss was driven predominantly by the 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 pipeline of therapeutic candidates derived from its OMEGA
platform spanning oncology, regenerative medicine, and multigenic
diseases including inflammatory and cardiometabolic conditions.
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 world-class data science capabilities with rational drug
design and customized delivery, the OMEGA platform enables control
of fundamental epigenetic processes and reprogramming of cellular
physiology to address the root cause of disease. 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 ongoing Phase 1/2
MYCHELANGELOTM I clinical trial and our preclinical studies, as
well as the timing of announcements of data related thereto; 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;
expectations regarding our pipeline, including trial design,
initiation of preclinical studies and advancement of multiple
preclinical development programs in oncology, regenerative
medicine, and multigenic diseases including inflammatory and
cardiometabolic conditions; potential franchise opportunities; our
anticipated cash runway into the first quarter of 2025; 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; volatility
in capital markets and general economic conditions; 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; 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 June 30, 2024, 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.
CONTACTInvestor contact:Eva
Stroynowski617.949.4370estroynowski@omegatx.com
Media contact:Jason Braco, LifeSci
Communications646.751.4361jbraco@lifescicomms.com
|
Omega Therapeutics, Inc.Consolidated
statements of operations and comprehensive loss
(Unaudited, In thousands except share and per share
data) |
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
Collaboration revenue |
$ |
2,134 |
|
|
$ |
759 |
|
|
$ |
4,494 |
|
|
$ |
1,274 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
12,940 |
|
|
|
25,042 |
|
|
|
28,355 |
|
|
|
45,132 |
|
|
General and administrative |
|
5,774 |
|
|
|
6,557 |
|
|
|
13,170 |
|
|
|
12,800 |
|
|
Total operating expenses |
|
18,714 |
|
|
|
31,599 |
|
|
|
41,525 |
|
|
|
57,932 |
|
| Loss
from operations |
|
(16,580 |
) |
|
|
(30,840 |
) |
|
|
(37,031 |
) |
|
|
(56,658 |
) |
| Other
income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
299 |
|
|
|
957 |
|
|
|
630 |
|
|
|
1,639 |
|
|
Other income (expense), net |
|
(24 |
) |
|
|
196 |
|
|
|
(33 |
) |
|
|
53 |
|
|
Total other income, net |
|
275 |
|
|
|
1,153 |
|
|
|
597 |
|
|
|
1,692 |
|
| Net
loss |
$ |
(16,305 |
) |
|
$ |
(29,687 |
) |
|
$ |
(36,434 |
) |
|
$ |
(54,966 |
) |
| Net loss
per common stock attributable to common stockholders, basic and
diluted |
$ |
(0.30 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.66 |
) |
|
$ |
(1.04 |
) |
|
Weighted-average common stock used in net loss per share
attributable to common stockholders, basic and diluted |
|
55,150,507 |
|
|
|
55,071,469 |
|
|
|
55,152,746 |
|
|
|
52,861,655 |
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
| Net
loss |
$ |
(16,305 |
) |
|
$ |
(29,687 |
) |
|
$ |
(36,434 |
) |
|
$ |
(54,966 |
) |
| Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on marketable securities |
|
— |
|
|
|
57 |
|
|
|
14 |
|
|
|
308 |
|
|
Comprehensive loss |
$ |
(16,305 |
) |
|
$ |
(29,630 |
) |
|
$ |
(36,420 |
) |
|
$ |
(54,658 |
) |
|
Omega Therapeutics, Inc.Condensed
Consolidated Balance Sheets(Unaudited, In
thousands) |
|
|
|
|
June 30, |
|
|
December 31, |
|
|
2024 |
|
|
2023 |
| Assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
45,852 |
|
|
$ |
68,443 |
|
Marketable securities |
|
— |
|
|
|
4,986 |
|
Other assets |
|
122,373 |
|
|
|
130,937 |
|
Total assets |
$ |
168,225 |
|
|
$ |
204,366 |
| Liabilities and
stockholders’ equity |
|
|
|
|
|
Liabilities |
$ |
141,963 |
|
|
$ |
146,350 |
|
Stockholders’ equity |
|
26,262 |
|
|
|
58,016 |
|
Total liabilities and stockholders’ equity |
$ |
168,225 |
|
|
$ |
204,366 |
Omega Therapeutics (NASDAQ:OMGA)
과거 데이터 주식 차트
부터 10월(10) 2024 으로 11월(11) 2024
Omega Therapeutics (NASDAQ:OMGA)
과거 데이터 주식 차트
부터 11월(11) 2023 으로 11월(11) 2024
