- Conducted preclinical toxicology studies and GMP manufacturing
of SAT-3247
- On track to initiate Phase 1 first-in-human clinical trials
mid-2024
- Cash balance of $33.2 million at March 31, 2024
- Invited to present at PPMD 30th annual conference to be held
June 26-29, 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 March 31, 2024. All references to currency in
this press release are in Canadian dollars unless otherwise
noted.
“We are excited about progress made during the first quarter as
we get closer to initiating Phase 1 clinical development with
SAT-3247, our novel oral drug to treat Duchenne muscular dystrophy
and other degenerative muscle conditions,” said Frank Gleeson,
Co-founder and CEO, Satellos. “During the first quarter we
presented positive preclinical data at the MDA Clinical and
Scientific Conference, conducted preclinical safety and toxicology
studies, manufactured bulk quantities of SAT-3247 under GMP
conditions to support development through 2025, and formulated our
very first tablets of SAT-3247 for oral administration in upcoming
Phase 1 and subsequent clinical trials. We look forward to
submitting our regulatory package in the coming weeks seeking
approval to initiate our first-in-human Phase 1 clinical study of
SAT-3247 during the summer.”
PROGRAM AND BUSINESS UPDATE:
Highlights for the quarter ended March 31, 2024, 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 1a
clinical trial for SAT-3247, initiated requisite GLP toxicology
studies in two species with SAT-3247, made kilogram quantities of
SAT-3247 at the contract manufacturing organization it selected as
its manufacturing partner, and carried out GMP manufacturing and
tablet formulation of SAT-3247. The Company continues to be on
track to initiate a Phase 1a clinical trial in mid-2024 to evaluate
the safety and pharmacokinetic (“PK”) properties of SAT-3247 in
healthy human volunteers.
Also during the first quarter of 2024, Satellos further refined
its clinical development plan to incorporate an additional Phase 1b
clinical trial in healthy human volunteers, planned for early 2025,
intended to demonstrate SAT-3247’s pharmacodynamic (“PD”)
properties, which, if successful, may provide preliminary proof of
concept evidence for the potential of SAT-3247’s
mechanism-of-action (“MOA”) to have an effect in humans. The
Company continues with its intention to conduct a Phase 1b/2a
clinical trial in Duchenne patients in 2025, which is in the
planning stages.
On March 4, 2024, Satellos announced positive preclinical data
presented at the Muscular Dystrophy Association (MDA) Clinical and
Scientific Conference. The preclinical data presented showed the
broad potential of SAT-3247 to improve skeletal muscle function as
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
vehicle treatment.
Subsequent to the quarter end, the Company received Orphan Drug
status from the U.S. Food and Drug Administration (FDA) for
SAT-3247 and has submitted an application to the FDA for Rare
Pediatric Disease designation for SAT-3247.
Satellos is pleased to announce today that it has been invited
to present at Parent Project Muscular Dystrophy (“PPMD”)’s Annual
Conference scheduled for June 26-29, 2024, in Orlando Florida.
Satellos will speak on the development of SAT-3247 as part of the
Research Row: “PPMD Moving the Needle” session covering PPMD funded
research projects.
Financial Results
Satellos had cash and cash equivalents and short-term
investments of $33.2 million as of March 31, 2024, compared with
$39.6 million at December 31, 2023. The decrease in cash and cash
equivalents and short-term investments is due to the increase in
net loss in the current year period.
For the three months ended March 31, 2024, Satellos reported a
net loss of $6.9 million ($0.06 loss per share), compared to a net
loss $1.7 million ($0.04 loss per share) for the three months ended
March 31, 2023. The increase in net loss for the three months ended
March 31, 2024, compared with the same period in 2023 was a result
of increased R&D expenses related to increased headcount and
activities associated with SAT-3247 as we prepare to initiate first
in human clinical trials as well as increased G&A expenses due
to increased personnel and professional fees to support increased
operations.
Research and development expenses increased by approximately
$5.0 million to $5.9 million for the three months ended March 31,
2024, compared to $0.9 million for the three months ended March 31,
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 $1.5 million and increased chemistry,
manufacturing, and controls expenses of $2.1 million for work
ongoing in the current year as SAT-3247 advanced from the discovery
stage to 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 by approximately
$1.6 million to $2.3 million for the three months ended March 31,
2024, as compared to $0.7 million for the three months ended March
31, 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, higher professional fees due to non-recurring costs
associated with the TSX uplist and new corporate website and
branding as well as higher operating costs primarily related to
increase travel costs. 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 months ended March 31, 2024, 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 pharmacodynamic properties and
mechanism-of-action of our lead drug candidate; 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/20240514430572/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
