- Company disclosed drug target for Duchenne program; remains on
track to initiate clinical trials mid-2024
- Satellos appointed Michael Cross, PhD, MBA, as Chief Business
Officer and other key leadership team members including Chief
Financial Officer and Senior Vice President, Clinical
Operations
- Cash balance at September 30, 2023, of $44.3 million provides
runway through 2025
Satellos Bioscience Inc. (TSXV: MSCL) (“Satellos”
or the “Company”), a regenerative medicine company aimed at
developing therapeutics that change the way degenerative muscle
diseases are treated, announced today its financial results and
operational highlights for the three months ending September 30,
2023. All references to currency in this press release are in
Canadian dollars unless otherwise noted.
“This quarter we’ve significantly expanded our leadership team
bringing essential experience and expertise to support advancing
our novel small molecule therapeutic approach for muscle
regeneration into clinical trials next year for Duchenne muscular
dystrophy,” said Frank Gleeson, Cofounder and CEO of Satellos. “We
are pleased that the ongoing preclinical studies for our Duchenne
program continue to support our drug target, mechanism of action,
and proprietary drug candidates, as we progress our lead drug
candidate in IND-enabling studies and GMP manufacturing and remain
on track to initiate clinical trials mid-2024.”
PROGRAM AND BUSINESS UPDATE:
Highlights for the three months ended September 30, 2023, along
with recent developments include:
Disclosed drug target for Duchenne program and SAT-3247
nominated as lead drug candidate (DC)
- Subsequent to the quarter end, on November 14, 2023, the
Company disclosed for the first time that the drug target for the
Duchenne program is AAK1 (formerly K9), a protein kinase in the
Notch pathway, which the Company discovered can be modulated to
enable muscle regeneration. Satellos also announced that SAT-3247
would be nominated as the lead DC based on results generated by the
Company during its preclinical studies. Preclinical data generated
by Satellos demonstrated that SAT-3153 and SAT-3247 have a similar
capacity to affect muscle regeneration and functional benefit in
the mdx mouse model of Duchenne. SAT-3247 also exhibited improved
oral bioavailability, target specificity and tissue distribution
when compared directly to SAT-3153 in preclinical studies. Satellos
is conducting IND-enabling studies and GMP manufacturing for
SAT-3247.
- The Company remains on track to initiate clinical trials
mid-2024
Expands key leadership team
- Satellos announces the appointment of Michael Cross, PhD, MBA,
as Chief Business Officer of the Company. Dr. Cross has more than
25 years of biotech and life science experience with demonstrated
success in financing and licensing transactions and leadership in
operations, clinical product development, and corporate
strategy.
- On September 5, 2023, Satellos announced the appointment of
Elizabeth Williams, CPA, CA, as Chief Financial Officer (CFO) of
the Company and that Warren Whitehead, CPA, CMA, who has served as
CFO for Satellos for two years, will now become Head of Corporate
Strategy. Ms. Williams has nearly 20 years of experience in
biotech, working with publicly listed entities in both Canada and
the United States.
- Satellos also announced the appointment of Ms. Courtney Wells
as Senior Vice President of Clinical Development Operations to lead
and implement the clinical trial plans. Ms. Wells has more than 20
years of experience in clinical development for large
pharmaceutical companies and innovative biotech companies,
including orphan diseases and Duchenne.
Financial Results
Satellos had cash and cash equivalents of $44.3 million as of
September 30, 2023, compared with $1.9 million at December 31,
2022. The increase in cash and cash equivalents is due to proceeds
of a $55 million equity offering completed in the quarter ended
June 30, 2023. Management estimates that cash on hand should
provide runway through 2025 and advance SAT-3247 through
pre-clinical work, IND submission, and subsequent Phase 1
studies.
For the three months ended September 30, 2023, Satellos reported
a net loss of $3.6 million ($0.03 loss per share), compared to a
net loss $1.9 million ($0.05 loss per share) for the three months
ended September 30, 2022. The increase in net loss was primarily
the result of increased R&D expenses associated with increased
headcount and development activity as well as increased G&A
expenses due to increased personnel, recruitment, travel, and
professional fees.
Research and development expenses increased by approximately
$1.8 million to $2.7 million for the three months ended September
30, 2023, as compared to $0.9 million for the comparative period in
2022. The increase in R&D costs is the result of an increase in
salaries, management fees and stock-based compensation related to
new hires to advance our research programs as well as pre-clinical
pre-IND-enabling expenses and chemistry and manufacturing controls
expenses for which there were no comparable costs in the prior
year. These increases were offset by lower discovery expenditures
as our lead program has moved from discovery into pre-clinical
development.
General and administrative expenses increased by approximately
$0.8 million to $1.8 million for the three months ended September
30, 2023, as compared to $0.9 million for the comparative period in
2022. The increase is primarily due to an increase in salaries,
management fees and stock-based compensation related to new hires
in the current year period as well as higher legal, investor
relations, and travel expenses associated with increased
activity.
Satellos’ interim condensed consolidated financial statements
for the three and nine months ended September 30, 2023, and the
related management’s discussion and analysis (MD&A) are
available on SEDAR+ at www.sedarplus.ca.
About Muscle Progenitor Cells and Duchenne Muscular
Dystrophy
Duchenne patients suffer from an inability to regenerate, grow,
and repair muscle. Muscle tissue is regenerated through asymmetric
division of muscle stem cells into stem and progenitor cells.
Duchenne patients have abundant muscle stem cells, but lack muscle
progenitor cells, which leads to a defect in muscle tissue
regeneration and results in progressive muscle loss. Satellos'
scientific founder, Dr. Michael Rudnicki, discovered and has
demonstrated how dystrophin is present in muscle stem cells and
coordinates a biological process known as “stem cell polarity” to
regulate asymmetric cell division. Furthermore, in the absence of
dystrophin, the ability to generate progenitor cells is lost, which
the Company believes is the underlying cause of Duchenne. For the
Company’s Duchenne program, Satellos has designed small molecules
to inhibit AAK1, a protein kinase member of the Notch pathway. The
Company believes AAK1 inhibition, independent of dystrophin, has
the capacity to regulate polarity to restore asymmetric muscle stem
cell division, generate muscle progenitor cells, and enable muscle
regeneration.
About Satellos Bioscience Inc.
Satellos is a publicly traded biotechnology company dedicated to
developing life-improving medicines to treat degenerative muscle
diseases. Satellos has incorporated breakthrough research in muscle
stem cell polarity into a proprietary discovery platform, called
MyoReGenXTM, to identify degenerative muscle diseases where
deficits in this process affect muscle regeneration and are
amenable to therapeutic intervention. With this platform, Satellos
is building a pipeline of novel therapeutics to correct muscle stem
cell polarity and promote the body’s innate muscle repair and
regeneration process. The Company’s lead program is an oral, small
molecule drug candidate in development as a potential
disease-modifying treatment for Duchenne muscular dystrophy.
Satellos is headquartered in Toronto, Ontario. For more
information, visit www.satellos.com.
Notice on Forward-Looking Statements
This press release includes forward-looking information or
forward-looking statements within the meaning of applicable
securities laws regarding Satellos and its business, which may
include, but are not limited to, statements regarding the
anticipated benefits to patients from a small molecule treatment
for Duchenne; the general benefits of modulating stem cell polarity
by administering small molecule drugs; its/their prospective impact
on Duchenne patients and muscle regeneration generally; the utility
of regenerating muscle by modulating polarity; adoption of
Satellos’ approach by the medical community; and Satellos’
technologies and drug development plans. All statements that are,
or information which is, not historical facts, including without
limitation, statements regarding future estimates, plans, programs,
forecasts, projections, objectives, assumptions, expectations or
beliefs of future performance, occurrences or developments, are
“forward-looking information or statements.” Often but not always,
forward-looking information or statements can be identified by the
use of words such as “shall”, “intends”, “anticipate”, “believe”,
“plan”, “expect”, “intend”, “estimate”, “anticipate”, “potential”,
“prospective” , “assert” or any variations (including negative or
plural variations) of such words and phrases, or state that certain
actions, events or results “may”, “might”, “can”, “could”, “would”
or “will” be taken, occur, lead to, result in, or, be achieved.
Such statements are based on the current expectations and views of
future events of the management of the Company. They are based on
assumptions and subject to risks and uncertainties. Although
management believes that the assumptions underlying these
statements are reasonable, they may prove to be incorrect. The
forward-looking events and circumstances discussed in this release,
may not occur and could differ materially as a result of known and
unknown risk factors and uncertainties affecting the Company,
including, without limitation, risks relating to the pharmaceutical
and bioscience industry (including the risks associated with
preclinical and clinical trials and regulatory approvals), and the
research and development of therapeutics, the results of
preclinical and clinical trials, general market conditions and
equity markets, economic factors and management’s ability to manage
and to operate the business of the Company generally, including
inflation and the costs of operating a biopharma business, and
those risks listed in the “Risk Factors” section of Satellos’
prospectus dated May 9, 2023 and Satellos’ Annual Information Form
dated April 27, 2023 (both of which are on Satellos’ profile at
www.sedarplus.ca). Although Satellos has attempted to identify
important factors that could cause actual actions, events or
results to differ materially from those described in
forward-looking statements, there may be other factors that cause
actions, events or results to differ from those anticipated,
estimated or intended. Accordingly, readers should not place undue
reliance on any forward-looking statements or information. No
forward- looking statement can be guaranteed. Except as required by
applicable securities laws, forward-looking statements speak only
as of the date on which they are made and Satellos does not
undertake any obligation to publicly update or revise any
forward-looking statement, whether resulting from new information,
future events, or otherwise
No regulatory authority has approved or disapproved the
content of this press release. Neither the TSX Venture Exchange nor
its Regulatory Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this press release.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231122423456/en/
Investors: Liz Williams, ir@satellos.com Business Development:
Ryan Mitchell, Ph.D., bd@satellos.com Media: Jessica Yingling,
Ph.D., jessica@litldog.com, +1.858.344.8091
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