- Engaged CRO for first-in-human SAT-3247 Phase 1 clinical
study
- Initiated GLP toxicity studies and GMP manufacturing of
SAT-3247
- Continues to be on track to initiate first-in-human clinical
trials mid-2024
- Cash balance of $39.6 million as at December 31, 2023
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF)
(“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 year ended
December 31, 2023. All references to currency in this press release
are in Canadian dollars unless otherwise noted.
“2023 has been a pivotal year in transitioning Satellos from a
discovery-stage company to a preclinical company, positioning
Satellos to further transition into a clinical-stage company during
2024 as we work to advance our lead drug candidate, SAT-3247, into
first-in-human studies,” said Frank Gleeson, Co-founder and CEO,
Satellos. “We’ve generated and publicly presented exciting
preclinical data showing the broad potential of SAT-3247 to
regenerate muscle tissue and disclosed its molecular drug target as
AAK1. We look forward to initiating our clinical development
program with a Phase 1 study of SAT-3247 mid-year.”
PROGRAM AND BUSINESS UPDATE:
Highlights for the year ended December 31, 2023, along with
recent developments include:
Advanced SAT-3247
During Q1, 2024, the Company engaged a contract research
organization (“CRO”) to design and implement its planned Phase 1
clinical trial for SAT-3247, initiated requisite GLP toxicology
studies in two species with SAT-3247, made kilogram quantities of
SAT-3247 under GLP conditions at the contract manufacturing
organization it selected as its manufacturing partner, and
initiated GMP manufacturing for SAT-3247. The Company continues to
be on track to initiate and conduct a Phase 1 clinical trial in
2024 with SAT-3247.
Subsequent to the year end, on March 4, 2024, Satellos announced
positive preclinical data presented at the Muscular Dystrophy
Association Clinical and Scientific Conference. The preclinical
data presented show the broad potential of SAT-3247 to improve
skeletal muscle function as has been demonstrated in three mouse
models of muscle degeneration: mdx model of Duchenne muscular
dystrophy (DMD), FLExDUX4 model of facioscapulohumeral muscular
dystrophy (FSHD), and a muscle injury model in wildtype mice. In
all instances, treatment with SAT-3247 over a three-to-four-week
period resulted in a statistically significant improvement in
muscle force versus animals receiving placebo.
On November 14, 2023, the Company disclosed for the first time
that the molecular 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 its
lead development candidate with SAT-3153 becoming the backup
development candidate. The Company based this change on preclinical
data it generated demonstrating that, compared to SAT-3153,
SAT-3247 exhibits improved oral bioavailability, target
specificity, and tissue distribution. In addition, SAT-3247
exhibits a similar capacity to SAT-3153 to effect muscle
regeneration and functional benefit in the mdx mouse model of
Duchenne. These properties of SAT-3247 are viewed by the Company as
important enhancements for clinical development of a novel
therapeutic drug.
On August 1, 2023, Satellos announced that the U.S. Food and
Drug Administration (FDA) had granted Orphan Drug Designation and
Rare Pediatric Disease Designation to SAT-3153 for the potential
treatment of DMD. Subsequent to year-end, Satellos submitted
similar applications to the FDA for Orphan Drug and Rare Pediatric
Disease Designations for SAT-3247.
Progressed Capital Markets Strategy
As reported, during May 2023, Satellos closed an equity offering
led by healthcare specific institutional investors of common shares
and pre-funded warrants for gross proceeds of $55 million.
Investors purchased a total of 110,000,000 securities consisting of
70,297,220 common shares and 39,702,780 pre-funded warrants.
Subsequent to the year end, on February 15, 2024, trading of the
Company’s common shares graduated from the TSX Venture Exchange to
the Toronto Stock Exchange.
Throughout 2023 and to date in 2024, Satellos has increased
investor exposure through invitations to attend and present at
numerous bank sponsored conferences and through being named as Life
Sciences Ontario ‘Company of the Year’ and recognized as a Top 50
TSX Venture Company.
Expanded Leadership Team
Following the $55 million financing in May 2023, Satellos
expanded its leadership team to fulfill key positions
including:
- Elizabeth Williams, CPA, CA, as Chief Financial Officer (CFO)
of the Company. Ms. Williams has nearly 20 years of experience in
biotech, working with publicly listed entities in both Canada and
the United States.
- Michael Cross, PhD, MBA, as Chief Business Officer. Dr. Cross
has more than 25 years of biotech and life science experience
including financing and licensing transactions, operations,
clinical development, and corporate strategy.
- Courtney Wells as Senior Vice President of Clinical Development
Operations. Ms. Wells has more than 20 years of experience in
clinical development including orphan and neuromuscular diseases.
Among other achievements, Ms. Wells led the clinical trial programs
resulting in regulatory approvals of the corticosteroid Emflaza®
(deflazacort) for the treatment of DMD and the first-ever gene
therapy for the treatment of spinal muscular atrophy,
Zolgensma®.
- In addition to these appointments, Dr. Phil Lambert was
appointed Chief Scientific Officer and Dr. Michael Rudnicki as
Chief Discovery Officer.
Financial Results
Satellos had cash and cash equivalents and short-term
investments of $39.6 million as of December 31, 2023, compared with
$1.9 million at December 31, 2022. The increase in cash and cash
equivalents and short-term investments is due to proceeds of the
$55 million equity offering completed during 2023. Management
estimates that based on current estimates 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 year ended December 31, 2023, Satellos reported a net
loss of $15.9 million ($0.18 loss per share), compared to a net
loss $11.3 million ($0.32 loss per share) for the year ended
December 31, 2022. The increase in net loss for the year ended
December 31, 2023, compared with the year ended December 31, 2022,
was primarily a result of higher R&D and G&A expenses in
the current year period.
Research and development expenses increased to $8.8 million for
the year ended December 31, 2023, compared to $3.7 million for the
year ended December 31, 2022. The increase in R&D expenses was
the result of higher salary and management fees related to new
hires to advance our research programs, increased preclinical
pre-IND-enabling expenses and chemistry, manufacturing, and
controls expenses for work ongoing in the current year as SAT-3247
advanced from the discovery stage to the pre-clinical stage of
development. These increases were offset by lower discovery
expenditures as the Company selected its lead candidate in 2023 and
has advanced into the pre-clinical stage of development. Non-cash
stock-based compensation increased in the current year due to more
grants in the current year period associated with new hires and
increased headcount.
General and administrative expenses increased to $6.6 million
for the year ended December 31, 2023, as compared to $4.7 million
for the year ended December 31, 2022. The increase in general and
administrative expenses in the current year period is primarily the
result of increased salary and management fees related to increased
headcount, salary adjustments, and variable compensation in the
year, higher professional fees associated with increased legal
fees, consultant fees, and investor relations expenses. Non-cash
stock-based compensation increased due to new grants issued in the
current fiscal year offset by higher fair value of options granted
in the prior periods.
Satellos’ audited financial statements for the year ended
December 31, 2023, and the related management’s discussion and
analysis (MD&A) will be available on SEDAR+ at
www.sedarplus.ca.
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 advancement of our lead drug candidate into
clinical trials; the potential of our approach in other
degenerative muscle diseases or in muscle injury or trauma; the
general benefits of modulating stem cell polarity by administering
small molecule drugs; its/their prospective impact on Duchenne
patients, patients with other degenerative muscle disease or muscle
injury or trauma, and on 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’
Annual Information Form dated March 26, 2024 (which is located 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240327207964/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
Satellos Bioscience (TSX:MSCL)
過去 株価チャート
から 11 2024 まで 12 2024
Satellos Bioscience (TSX:MSCL)
過去 株価チャート
から 12 2023 まで 12 2024
