- Updated data in a canine model of Duchenne muscular dystrophy
(DMD) show further increased improvement in muscle force over
baseline of 195% at four-month point
- Receipt of Orphan Drug and Rare Pediatric Disease designations
from US FDA
- On track to dose first participant in Phase 1 clinical trial
with SAT-3247 in Q3 2024
- Cash balance of $27.7 million at June 30, 2024
Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF)
(“Satellos” or the “Company”), a public biotech
company developing new small molecule therapeutic approaches to
improve the treatment of muscle diseases and disorders, announced
today its financial results and operational highlights for the
three months ended June 30, 2024. All references to currency in
this press release are in Canadian dollars unless otherwise
noted.
“The second quarter continued to be momentous for Satellos,”
said Frank Gleeson, Co-founder and CEO, Satellos. “In addition to
advancing SAT-3247 through preclinical development and on July 10
filing a regulatory application in Australia to commence a Phase 1
clinical trial, we received Orphan Drug and Rare Pediatric Disease
Designations from the FDA and presented positive interim muscle
regeneration data in a canine model of DMD at the annual PPMD
conference. We ended the quarter with a cash balance of $27.7
million and are on track to initiate a Phase 1 clinical trial with
SAT-3247 in Q3 of 2024.”
Phil Lambert, PhD, Chief Scientific Officer of Satellos, said,
“Today, we are proud to announce additional data from the now
completed canine study in which we show that the interim positive
effects on the function of muscle in these animals were further
increased over the full four months of the study. We believe these
data are consistent with the positive results SAT-3247 treatment
has demonstrated in numerous mdx mouse models and other studies and
provide evidence in a large animal model of the potential for
SAT-3247 to represent a disease-modifying therapeutic approach for
people living with Duchenne.”
CANINE DATA UPDATE:
On July 2, 2024, Satellos announced data in a canine model of
DMD showing improved muscle repair and regeneration and improved
muscle force from SAT-3247 treatment. After treatment with SAT-3247
the animals showed an increase in Regenerative Index (RI), a
measure of the number of newly regenerated muscle fibers versus the
number of damaged and dying muscle fibers, suggesting that muscle
repair and regeneration is occurring. These results were updated
today, the results of which can be seen in our corporate
presentation here.
The highlighted results in the corporate presentation are from
two dystrophic animals in a pilot study in which each animal was
treated for four months (from eight to 12 months of age) with an
oral dose of SAT-3247. In addition to showing an improved RI,
treatment with SAT-3247 resulted in improvements in every force
parameter measured over baseline. The average force improvement
across all measures was 111% at two months and increased to 195% at
four months as compared with baseline.
PROGRAM AND BUSINESS UPDATE: Highlights for the quarter
ended June 30, 2024, along with recent developments include:
Advanced SAT-3247 On May 28, 2024, Satellos announced the
formation of a Clinical Advisory Board to support the advancement
of SAT-3247 in clinical trial development for DMD. Further details
on the members of the Advisory Board can be found here.
On June 27, 2024, the Company announced that Frank Gleeson,
Satellos CEO, would join leading members of the Duchenne medical
and scientific community during a panel discussion at Parent
Project Muscular Dystrophy’s 30th Annual Conference that was held
June 27-29, 2024, in Orlando, Florida.
Subsequent to the quarter end, on July 11, 2024, the Company
announced submission on July 10, 2024, 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.
Subject to approval by the HREC and acceptance of the CTN by
Australia’s TGA, the Phase 1 clinical trial is intended to enroll
healthy volunteers to assess the safety and pharmacokinetic
properties of SAT-3247. Following completion of this portion of its
program, if successful, Satellos plans to advance SAT-3247 into
clinical trials with DMD patients commencing in early 2025.
Subsequent to the quarter end, on August 7, 2024, Satellos
announced that the U.S. Food and Drug Administration (FDA) had
granted Rare Pediatric Disease Designation to SAT-3247 for the
potential treatment of DMD after receiving Orphan Drug Designation
earlier this year.
The company further updated that Satellos conducted all
preclinical and toxicology studies to the standards of relevant
global regulatory bodies and expect to be able to leverage the
results for additional Phase 1 and subsequent clinical trials in
Australia and further jurisdictions including the United States and
Canada.
The Company expects to dose the first participant in a Phase 1a
clinical trial in Q3 2024 to evaluate the safety and
pharmacokinetic (“PK”) properties of SAT-3247 in healthy human
volunteers.
Financial Results Satellos had cash and cash equivalents
and short-term investments of $27.7 million as of June 30, 2024,
compared with $39.6 million at December 31, 2023. The decrease in
cash and cash equivalents and short-term investments is due to cash
used in operating activities in the six months ended June 30,
2024.
For the three months ended June 30, 2024, Satellos reported a
net loss of $6.0 million ($0.05 loss per share), compared to a net
loss $4.1 million ($0.05 loss per share) for the three months ended
June 30, 2023. The increase in net loss for the three-month periods
ended June 30, 2024, compared with the same period in 2023 was a
result of increased research and development (R&D) expenses
related to higher headcount and R&D activities associated with
SAT-3247 as well as higher general and administrative expenses due
to increased personnel and professional fees to support expanded
operations.
Research and development expenses increased by approximately
$3.3 million to $4.9 million for the three months ended June 30,
2024, compared to $1.6 million for the three months ended June 30,
2023. 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
of approximately $1.6 million and increased chemistry,
manufacturing, and controls expenses of $560 thousand 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 of $663 thousand incurred in preparation of initiating a
Phase 1 clinical study in Q3 2024. Non-cash stock-based
compensation increased in the current year due to higher
amortization of grants in the current year period associated with
new hires and increased headcount.
General and administrative expenses increased by approximately
$311 thousand to $1.8 million for the three months ended June 30,
2024, as compared to $1.5 million for the three months ended June
30, 2023. The increase in general and administrative expenses in
the current year period is primarily the result of higher salary
and management fees related to increased headcount to support
operations offset by lower professional fees due to recruitment
costs incurred in the prior year period. Non-cash stock-based
compensation increased due to new grants issued in the second,
third and fourth quarters of fiscal 2023.
Satellos’ condensed consolidated interim financial statements
for the three and six months ended June 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 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 MyoReGenX™, 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 Satellos’ momentum, 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; 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/20240812475678/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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