Company will begin trading on Nasdaq under
trading symbol "SYRE" effective November 28,
2023
Biotechnology leader Cameron Turtle, DPhil, appointed as Chief
Executive Officer and Member of the Board of Directors alongside
industry veterans Jeffrey Albers and
Laurie Stelzer
Management team with deep IBD experience
expanded to advance pipeline of product candidates designed to
improve both efficacy and convenience of therapies for IBD
patients, including half-life extended antibodies
targeting α4β7 (SPY001) and TL1A (SPY002), which are both on
track to enter clinical studies in 2024
$205 million of
cash, cash equivalents, marketable securities, and restricted cash
as of September 30, 2023, with
expected runway into 2026
WALTHAM,
Mass., Nov. 27, 2023 /PRNewswire/ -- Aeglea
BioTherapeutics, Inc. (NASDAQ: AGLE) (the "Company" or "Spyre"), a
development-stage biotechnology company, today announced its name
change to Spyre Therapeutics, Inc. Effective as of market open
on November 28, 2023, Spyre will
trade on Nasdaq under the ticker symbol "SYRE". The name change
follows the acquisition of privately held Spyre Therapeutics, Inc.
by the Company in June of 2023. Named to reflect the Company's
ambition to achieve new heights in efficacy and convenience of
Inflammatory Bowel Disease (IBD) therapies, Spyre aims to create a
next-generation of IBD products by combining best-in-class antibody
engineering, rational therapeutic combinations, and precision
patient selection approaches to enhance efficacy for patients.
Appointment of Cameron Turtle
as CEO and Member of the Board of Directors
The Company also announced today the appointment of Cameron Turtle, DPhil as Chief Executive Officer
(CEO) and member of the Board of Directors. Prior to his
appointment as CEO, Dr. Turtle was the Chief Operating Officer of
Spyre and previously served as the Chief Strategy Officer of
BridgeBio Pharma, Inc. and Chief Business Officer of Eidos
Therapeutics, Inc.
"The Spyre team is dedicated to materially improving upon
today's standard of care for the treatment of IBD," said Dr.
Turtle. "I am delighted to lead this team of knowledgeable and
passionate industry experts as we seek to deliver infrequently
administered, subcutaneous antibody combinations targeting the best
validated therapeutic pathways for this disease. We look forward to
initiating clinical studies of our lead programs against α4β7 and
TL1A next year, followed shortly thereafter by our IL-23 program.
These programs are expected to be the basis of combination therapy
studies to follow."
Expanded Leadership Team to Advance a Potential Best-in-Class
IBD Pipeline
Spyre is also announcing several new additions to the management
team to advance its pipeline of IBD antibody product candidates,
including:
- Joshua Friedman, MD, PhD, SVP of
Clinical Development (Previously VP and Head of Translational
Sciences at Spark Therapeutics, and earlier Gastroenterology
Translational Sciences Lead at Johnson & Johnson)
- Deanna Nguyen, MD, SVP of
Clinical Development (Previously VP of Clinical Development at
Prometheus Biosciences and earlier positions of increasing
responsibility at Theravance Biopharma in clinical
development)
- MiRa Huyghe, SVP of Development
Operations (Previously VP of Clinical Operations at Prometheus
Biosciences and earlier positions of increasing responsibility at
Ventyx Biosciences, Escalier Biosciences, and Conatus
Pharmaceuticals in clinical operations)
- Brian Connolly, Chief Technical
Officer (Previously VP and Head of CMC at Prometheus Biosciences
earlier positions of increasing responsibility at Catalyst
Biosciences, Viewpoint Therapeutics, Achaogen and Genentech in CMC
and product development)
- Paul Fehlner, PhD, JD, SVP and
Chief IP Counsel (Previously Chief Legal Officer and Corporate
Secretary for Axcella Therapeutics, and earlier Global Head of
Intellectual Property for Novartis)
The expanded leadership team will support advancing our lead
candidates, SPY001 and SPY002, into the clinic in 2024, followed
shortly thereafter by our SPY003 program.
SPY001 is a highly potent and selective anti-α4β7 monoclonal
antibody product candidate engineered with half-life extension
technology and formulated for high concentration, convenient
subcutaneous dosing. SPY001 is currently progressing through
IND-enabling studies and is expected to enter first-in-human
("FIH") studies in the first half of 2024. Healthy volunteer
pharmacokinetics and pharmacodynamic data are expected by the end
of 2024 to validate a potential best-in-class every other month or
quarterly ("Q8-Q12W") subcutaneous dosing profile.
SPY002 is a highly potent and selective anti-TL1A monoclonal
antibody product candidate engineered with half-life extension
technology. TL1A has emerged as one of the most promising targets
in IBD and broader immunology indications. SPY002 has a potential
best-in-class profile with expected Q8W-Q12W subcutaneous dosing
and picomolar affinity for both TL1A monomers and trimers. Spyre
expects to begin FIH studies of SPY002 in the second half of 2024
and healthy volunteer data is expected in the first half of
2025.
SPY003 is a highly potent and selective monoclonal antibody
product candidate targeting the p19 subunit of IL-23 engineered
with half-life extension technology. The Company continues
preclinical development efforts on a potential best-in-class IL-23
monoclonal antibody. Recent data from the Phase 3 SEQUENCE study of
risankizumab versus ustekinumab in Crohn's disease validates the
Company's targeting of the p19 subunit as it demonstrated
superiority to targeting the p40 subunit of IL-23. An
Investigational New Drug ("IND") application is expected in
2025.
Appointment of Industry Veterans Jeffrey Albers and
Laurie Stelzer to Board of
Directors
The Company also announced the appointment of industry veterans
Jeffrey Albers and Laurie Stelzer to its Board of Directors. These
new appointments bring valuable expertise to advance the Company's
development of its potentially best-in-class IBD pipeline.
Mr. Albers has more than 25 years of experience working in the
biopharmaceutical industry. He currently serves as the Chairman of
the Board at Blueprint Medicines, where he served as CEO from
2014-2022 and grew the business into a leading precision medicine
company with global commercial operations, two FDA-approved
therapies, and a promising pipeline.
Ms. Stelzer will serve as chair of the Company's audit committee
and has over 25 years of experience supporting the finance
functions of biopharma companies. She currently serves as CFO at
ReNAgade Therapeutics and previously served as CFO of Mirati
Therapeutics and as CFO of Arena Pharmaceuticals, where she helped
lead the growth of the company towards its $6.7B acquisition by Pfizer.
In connection with Mr. Albers' and Ms. Stelzer's appointments to
the Company's Board, Hunter Smith
and Ivana Magovčević-Liebisch have resigned effective November 22, 2023. Their contributions have been
invaluable to the Company's mission and they played a pivotal role
in navigating the new direction of the Company with the acquisition
of the privately held Spyre Therapeutics, Inc.
"I want to express our heartfelt gratitude to Hunter and Ivana
for their dedicated service and unwavering commitment to our
mission," said Mr. Russell Cox,
Chairman of the Board. "Simultaneously, we are thrilled to welcome
Jeff and Laurie, whose expertise will strengthen our Board as we
pursue this new journey as Spyre and focus our efforts with the
goal of breaking the efficacy ceiling in IBD."
As of September 30, 2023, Spyre
had cash, cash equivalents, marketable securities, and restricted
cash of approximately $205 million,
which is expected to provide cash runway into 2026.
About Spyre Therapeutics
Spyre Therapeutics is a biotechnology company that aims to
create the next-generation of inflammatory bowel disease (IBD)
products by combining best-in-class antibody engineering, rational
therapeutic combinations, and precision medicine approaches for
patient selection. Spyre's pipeline includes extended half-life
antibodies targeting α4β7, TL1A, and IL-23. For more information,
visit Spyre's website at www.spyre.com.
Follow Spyre Therapeutics on social media: @spyretx and
LinkedIn
Forward-Looking Statements
Certain statements in this
press release, other than purely historical information, may
constitute "forward-looking statements" within the meaning of the
federal securities laws, including for purposes of the safe harbor
provisions under the United States Private Securities Litigation
Reform Act of 1995, concerning Spyre and other matters. These
forward-looking statements include, but are not limited to, express
or implied statements relating to Spyre's management team's
expectations, hopes, beliefs, intentions or strategies regarding
the future including, without limitation, Spyre's ability to
achieve the expected benefits or opportunities and related timing
with respect to its acquisition of the privately held Spyre
Therapeutics, Inc., Spyre's future results of operations and
financial position, business strategy, the length of time that
Spyre's management believes its existing cash resources will fund
its operations, Spyre's potential growth opportunities, Spyre's
preclinical and future clinical development activities, the
potential therapeutic benefits and economic value of Spyre's
product candidates, the timing and results of preclinical studies
and clinical trials, Spyre's business plans and the anticipated
benefits of the management changes. In addition, any statements
that refer to projections, forecasts or other characterizations of
future events or circumstances, including any underlying
assumptions, are forward-looking statements. The words
"opportunity," "potential," "milestones," "pipeline," "can,"
"goal," "aim," "strategy," "target," "seek," "anticipate,"
"achieve," "believe," "contemplate," "continue," "could,"
"estimate," "expect," "intends," "may," "might," "plan,"
"possible," "predict," "project," "should," "will," "would" and
similar expressions (including the negatives of these terms or
variations of them) may identify forward-looking statements, but
the absence of these words does not mean that a statement is not
forward-looking. These forward-looking statements are based on
current expectations and beliefs concerning future developments and
their potential effects. There can be no assurance that future
developments affecting Spyre will be those that have been
anticipated. These forward-looking statements involve a number of
risks, uncertainties (some of which are beyond Spyre's control) or
other assumptions that may cause actual results or performance to
be materially different from those expressed or implied by these
forward-looking statements. These risks and uncertainties include,
but are not limited those uncertainties and factors described under
the heading "Risk Factors" and "Note about Forward-Looking
Statements" in Spyre's most recent Quarterly Report on Form 10-Q
filed with the SEC, as well as discussions of potential risks,
uncertainties, and other important factors included in other
filings by Spyre from time to time. Should one or more of these
risks or uncertainties materialize, or should any of Spyre's
assumptions prove incorrect, actual results may vary in material
respects from those projected in these forward-looking statements.
Nothing in this press release should be regarded as a
representation by any person that the forward-looking statements
set forth therein will be achieved or that any of the contemplated
results of such forward-looking statements will be achieved. You
should not place undue reliance on forward-looking statements in
this press release, which speak only as of the date they are made
and are qualified in their entirety by reference to the cautionary
statements herein. Spyre does not undertake or accept any duty to
make any updates or revisions to any forward-looking statements.
This press release does not purport to summarize all of the
conditions, risks and other attributes of an investment in
Spyre.
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