- Completed enrollment for SAT-3247 in Duchenne muscular
dystrophy (DMD) in the first three (of five) single-ascending dose
(SAD) cohorts with no safety concerns and initiated enrollment of
first multiple-ascending-dose (MAD) cohort
- Presented canine data for SAT-3247 at the 2024 World Muscle
Society Annual Congress showing improved measures of strength
reaching near normal levels
- Cash balance of $23.4 million as of September 30, 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 three months ended September 30,
2024. All references to currency in this press release are in
Canadian dollars unless otherwise noted.
“Throughout the third quarter, we made important progress marked
by the dosing of our first 24 (of 72) participants in our Phase 1
SAD and MAD trial of SAT-3247 in healthy volunteers,” said
Co-founder and Chief Executive Officer Frank Gleeson. “We also
reported key data from the open-label study of SAT-3247 in a
preclinical canine model of DMD at the 2024 World Muscle Society
Annual Congress in Prague. Building on this momentum, we remain on
track to complete enrollment in the healthy volunteer
single-ascending-dose arm by year end, complete enrollment in the
multiple-ascending-dose healthy volunteer arm in the first quarter
of 2025, and dose the first patient in the Phase 1a adult DMD trial
in the fourth quarter of 2024. The SAT-3247 first-in-human clinical
trial progress is a critical step in achieving our mission to
develop life-improving medicines to treat degenerative muscle
diseases.”
CLINICAL UPDATE: Satellos announced that the first three
cohorts (of five) of the single-ascending-dose (SAD) arm of the
Phase 1 clinical healthy volunteer trial for SAT-3247 have been
successfully completed and enrollment in the fourth cohort has
commenced and is ongoing. Satellos has also completed enrolment in
the food effect dose cohort. No drug-related adverse events have
been reported to date.
Based on the positive safety data from the first three SAD
cohorts, enrollment was initiated in the first cohort (of four) in
the multiple-ascending dose (MAD) arm of the Phase 1 study. The
Company remains on track to complete enrollment of the SAD cohorts
by year-end 2024 and MAD cohorts in the first quarter of 2025,
respectively.
PROGRAM AND BUSINESS UPDATE: Highlights for the quarter
ended September 30, 2024, along with recent developments
include:
SAT-3247 Development On July 11, 2024, the Company
announced submission of a clinical research proposal to a Human
Research Ethics Committee (HREC) in Australia seeking regulatory
authorization under their Therapeutic Goods Administration’s
(TGA’s) Clinical Trial Notification (CTN) scheme to conduct a
first-in-human Phase 1 clinical trial of SAT-3247. Satellos
announced on August 19, 2024, that the HREC submission had been
approved.
On August 8, 2024, Satellos announced that the U.S. FDA had
granted Rare Pediatric Disease Designation to SAT-3247 for the
potential treatment of DMD after receiving Orphan Drug Designation
earlier this year.
On September 18, 2024, Satellos announced that the first
participant in the first-in-human healthy volunteer Phase 1
clinical trial had been dosed.
The Phase 1 clinical trial is comprised of two portions. In the
first portion of the trial, 72 healthy volunteers are being
enrolled in a blinded, randomized, placebo-controlled, staggered,
parallel design study to assess the safety and pharmacokinetic
properties of SAT-3247. Participants are being randomized across
five SAD cohorts, four MAD cohorts, and one food effect dose
cohort. In the second portion of the trial, which is expected to
begin in late Q4 2024, 10 adult volunteers with genetically
confirmed DMD are expected to be enrolled in a 28-day, open-label,
single daily dose cohort designed primarily to confirm safety and
assess pharmacokinetic properties of SAT-3247 in a patient
population, and secondarily to explore potential pharmacodynamic
markers for possible utility in future clinical trials.
On October 1, 2024, Satellos reported data at the World Muscle
Society annual meeting. The presentation provided an overview of
key data collected during the open-label pilot study of SAT-3247 in
a preclinical canine model of DMD. The data presented from the
pilot study showed improved measures of muscle strength to near
normal levels in the two DMD canines treated with SAT-3247.
An initial summary of the data is presented below. After four
months of treatment (from ~nine to ~thirteen months of age) with a
daily oral dose of SAT-3247:
- Treatment with SAT-3247 resulted in improvements in every force
parameter measured over baseline. The average force improvement
following four months of treatment, across all measures, was 195%
(i.e., 2.95x) compared to baseline.
- Treated animals showed a return to muscle function near
healthy, non-diseased, age-matched animal levels when evaluated
against historical comparator data.
- The animals showed increases in the Regenerative Index (RI), a
measure of the ratio of new muscle to dying muscle, in the
diaphragm, gastrocnemius medialis (calf), and vastus lateralis
(quadriceps) skeletal muscles. This is in addition to previously
reported improvements in RI demonstrated in the bicep femoris.
- There were no adverse events and no significant changes in
hematology or clinical chemistry observed.
- Trends to lower creatine kinase levels were noted, a finding
that could be consistent with a Duchenne disease-modifying
treatment.
Financial Results (in $C) Satellos had cash and cash
equivalents and short-term investments of $23.4 million as of
September 30, 2024, compared to $39.6 million as of December 31,
2023. The decrease in cash and cash equivalents and short-term
investments is due to cash used in operating activities in the nine
months ended September 30, 2024.
For the three months ended September 30, 2024, Satellos reported
a net loss of $9.0 million ($0.08 loss per share), compared to a
net loss of $3.6 million ($0.03 loss per share) for the three
months ended September 30, 2023. The increase in net loss for the
three-month period ended September 30, 2024, compared with the same
period in 2023 was a result of increased research and development
(R&D) expenses related to the initiation of a Phase 1 clinical
trial, higher headcount and R&D activities associated with
SAT-3247. In addition, during the period ended September 30, 2024,
management determined that it was no longer likely that the sale of
AmpB (and its component assets, OralTrans and the investment in
NWMT) would be completed through the exercise of the call option or
completion of the put option. As such, the Company recognized a
non-cash impairment charge of $3.9 million to fully write down the
remaining carrying value of the intangible asset.
Research and development expenses increased by approximately
$529 thousand to $3.3 million for the three months ended September
30, 2024, compared to $2.7 million for the three months ended
September 30, 2023. The increase in R&D expenses was primarily
the result of increased preclinical IND-enabling costs 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 as well as clinical expenses
incurred to prepare for and initiate a Phase 1 clinical trial in Q3
2024. These increases were partially offset by a decrease in
non-cash stock-based compensation due to the forfeiture of stock
options in the current period related to staffing changes.
General and administrative expenses were relatively consistent,
at $1.8 million for the three months ended September 30, 2024, as
compared to $1.8 million for the three months ended September 30,
2023.
Satellos’ condensed consolidated interim financial statements
for the three and nine months ended September 30, 2024, and the
related management’s discussion and analysis (MD&A) will be
available on the Company’s website at www.satellos.com 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 initially in Duchenne muscular
dystrophy (DMD). Satellos has generated a significant body of
preclinical evidence in DMD to support that correcting muscle stem
cell polarity with SAT-3247 has the potential to restore skeletal
muscle regeneration to repair and strengthen muscle that has been
damaged. The Company’s lead drug candidate SAT-3247 is currently in
clinical development as a potential disease-modifying treatment
DMD. Additionally, Satellos is leveraging its breakthrough research
in muscle stem cell polarity and proprietary discovery platform
MyoReGenX™, to identify degenerative muscle diseases 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, statements regarding Satellos’
momentum; expected timing regarding enrollment and dosing with
respect to the Company's programs; 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 into clinical trials; the pharmacodynamic properties and
mechanism-of-action of SAT-3247; 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; 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/20241113662517/en/
Investors: Liz Williams, CFO, ir@satellos.com
Media: Jessica Yingling, Ph.D., jessica@litldog.com,
+1.858.344.8091
Satellos Bioscience (TSX:MSCL)
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