– Completed enrollment and dosing in a Phase 1a clinical
trial in 72 healthy volunteers to assess safety and pharmacokinetic
(PK) properties of SAT-3247
– Presented initial Phase 1a data at Muscular Dystrophy
Association (MDA) Clinical & Scientific Conference showing
SAT-3247 was safe, well-tolerated and showed the intended PK
profile after both single- and repeated-dose administration
– Initiated enrollment in a Phase 1b clinical trial in up to
10 adults with Duchenne muscular dystrophy (DMD) with data expected
to be reported in Q2 2025
– Cash balance of $69.9 million as of December 31,
2024
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF)
(“Satellos” or the “Company”), a clinical-stage
biotechnology company developing life-improving medicines to treat
degenerative muscle diseases, announced today its financial results
and corporate highlights for the fourth quarter ended December 31,
2024. All references to currency in this press release are in
Canadian dollars unless otherwise noted.
“The fourth quarter and 2024 were pivotal for clinical trial
execution and advancement of SAT-3247, setting the stage for a
promising 2025,” said Frank Gleeson, Co-founder and Chief Executive
Officer. “Most importantly, we recently reported encouraging Phase
1a data that supports SAT-3247 as a potential first-of-its-kind
oral therapy for DMD. We believe this progress brings us one step
closer to our goal of delivering life improving medicines for
individuals with degenerative muscle diseases.”
SAT-3247 CLINICAL PROGRESS
- On Dec. 11, 2024, Satellos dosed the first DMD patient in its
Phase 1b trial of SAT-3247. Up to 10 DMD adult patients will be
enrolled. Satellos expects to report Phase 1b data in Q2,
2025.
- Satellos announced initial Phase 1a data for SAT-3247 at the
MDA Clinical & Scientific Conference in March.
- As of the Feb. 20, 2025, data cut-off, SAT-3247 was shown to be
safe and well tolerated across all cohorts, with no moderate or
severe drug-related adverse events and no adverse findings across
clinical parameters.
- Pharmacokinetic (PK) data aligned with preclinical results,
confirming sustained plasma concentrations in humans at levels
likely to support muscle regeneration and strength.
As a reminder, the Phase 1 clinical trial is comprised of two
portions. In the first portion of the trial (Phase 1a), 72 healthy
volunteers were enrolled in a blinded, randomized,
placebo-controlled, staggered, parallel design study to assess the
safety and PK properties of SAT-3247. Participants were randomized
across five single ascending dose cohorts, four multiple ascending
dose cohorts, and one food effect dose cohort. The second portion
of the trial (Phase 1b) is ongoing, and Satellos expects to enroll
and treat up to 10 adult volunteers with genetically confirmed DMD
in a 28-day, open-label, single daily-dose cohort, also designed to
assess safety and PK properties, and explore potential
pharmacodynamic markers.
CORPORATE ACHIEVEMENTS In December 2024, Satellos closed
an equity offering led by healthcare-specific institutional
investors of common shares and pre-funded warrants for gross
proceeds of US$40 million, strengthening the Company’s balance
sheet and providing the necessary capital to execute the planned
clinical strategy.
On November 14, 2024, Satellos appointed Stephanie Brown to its
Board of Directors. Ms. Brown brings over 30 years of Biopharma
industry experience, having held numerous executive roles
contributing to groundbreaking achievements in product
commercialization and organizational transformation.
On February 15, 2024, trading of the Company’s common shares
graduated from the TSX Venture Exchange to the Toronto Stock
Exchange, elevating the profile of Satellos and providing access to
a broader group of institutional investors.
FINANCIAL RESULTS (IN $C) Satellos had cash and cash
equivalents and short-term investments of $69.9 million as of
December 31, 2024, compared with $39.6 million on December 31,
2023. The increase in cash and cash equivalents and short-term
investments is due to proceeds of the US$40 million equity offering
completed in December 2024. Management estimates that based on
current projections cash on hand should provide operating runway
through 2026 and advance SAT-3247 through a Phase 2 clinical
study.
For the year ended December 31, 2024, Satellos reported a net
loss of $28.1 million ($0.25 loss per share), compared to a net
loss $15.9 million ($0.18 loss per share) for the year ended
December 31, 2023. The increase in net loss for the year ended
December 31, 2024, compared with the year ended December 31, 2023,
was primarily a result of increased research and development
(“R&D”) expenses associated with the development of SAT-3247,
as well as increased general and administrative (“G&A”)
expenses related to increased headcount to support expanded
operations. In addition, in the year ended December 31, 2024, the
Company recognized a non-cash impairment of $3.9 million to fully
write down the carrying value of an impaired intangible asset.
R&D expenses increased to $19.6 million for the year ended
December 31, 2024, compared to $8.8 million for the year ended
December 31, 2023. The increase in R&D expenses was the result
of: higher salaries and management fees, due to new hires to our
team – adding chemistry, manufacturing and controls (“CMC”), and
clinical expertise, preclinical expenses related to IND-enabling
studies for SAT-3247 conducted during the year to support the
initiation of the Phase 1 clinical trial, long-term toxicology work
to support later-stage clinical development, CMC expenses related
to the process development and manufacturing of SAT-3247 for
clinical use, and finally, clinical expenses associated with
initiating and conducting the Phase 1a healthy-volunteer clinical
study for which the first participant was dosed in Q3 2024 and the
Phase 1b component in adult DMD patients initiated in Q4 2024.
G&A expenses increased to $8.2 million for the year ended
December 31, 2024, as compared to $6.6 million for the year ended
December 31, 2023. The increase in G&A expenses in the current
year period is primarily the result of salary and management fees
related to increased headcount, salary adjustments, and variable
compensation in the year.
Satellos’ audited financial statements for the year ended
December 31, 2024, and the related management’s discussion and
analysis (MD&A) will be available on the Company website and
SEDAR+ at www.sedarplus.ca.
ABOUT SATELLOS BIOSCIENCE INC. Satellos is a
clinical-stage drug development company dedicated to developing
life-improving medicines to treat degenerative muscle diseases.
Satellos has invented SAT-3247 as a first-of-its-kind, orally
administered small molecule drug designed to restore skeletal
muscle regeneration in degenerative or injury conditions by
correcting muscle stem cell polarity. Satellos has generated a body
of preclinical evidence with SAT-3247 to support its discovery that
correcting muscle stem cell polarity has the potential to restore
skeletal muscle regeneration to repair and strengthen muscle that
has degenerated or been damaged. SAT-3247 is currently in clinical
development as a potential disease-modifying treatment initially
for DMD. Additionally, Satellos is leveraging its research and
proprietary discovery platform, MyoReGenX™, to identify additional
degenerative muscle diseases or injury conditions where deficits in
muscle regeneration occur that are amenable to therapeutic
intervention for future clinical development. 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,
expected timing for Phase 1a and Phase 1b data; estimated runway
based on cash on hand; statements regarding the potential for
SAT-3247 to represent a disease modifying approach to the
therapeutic treatment of people living with Duchenne; anticipated
benefits to patients from a small molecule treatment for Duchenne;
the advancement SAT-3247 through clinical trials; the
pharmacodynamic properties and mechanism-of-action of SAT-3247; the
potential of our approach in other degenerative muscle diseases;
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; 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, 2025
(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/20250326529831/en/
Investors: Liz Williams, CFO, ir@satellos.com
Media: Jessica Yingling, Ph.D., jessica@litldog.com
Clinical Trial Info: medicalinfo@satellos.com
Grafico Azioni Satellos Bioscience (TSX:MSCL)
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Grafico Azioni Satellos Bioscience (TSX:MSCL)
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