Acquisition of Spyre and concurrent
oversubscribed $210 million private
investment positions the company to advance a leading inflammatory
bowel disease (IBD) portfolio
Spyre, the second spinout from Paragon
Therapeutics, is advancing a pipeline of product candidates, led by
SPY001 and SPY002, that are potentially best-in-class antibodies
targeting a4b7 and TL1A,
respectively, and which are expected to enter the clinic in
2024
Combined company expected to have
approximately $220 million in cash or
cash equivalents at close: expected to fund operations into
2026
Webcast, June 22,
2023 at 9 a.m. ET
AUSTIN,
Texas and WALTHAM, Mass., June 22,
2023 /PRNewswire/ -- Aeglea BioTherapeutics, Inc.
("Aeglea") (NASDAQ: AGLE), today announced it has completed the
acquisition of Spyre Therapeutics, Inc. ("Spyre"), a privately held
biotechnology company advancing a robust pipeline of antibody
therapeutics with the potential to transform the treatment of
inflammatory bowel disease (IBD). Concurrent with the acquisition
of Spyre, Aeglea entered into a definitive agreement for the sale
of Series A non-voting convertible preferred stock (the "Series A
preferred stock") in a private placement to a group of
institutional accredited investors led by Fairmount Funds
Management LLC ("Fairmount Funds"), with participation from
Fidelity Management & Research Company, Venrock Healthcare
Capital Partners, Commodore Capital, Deep Track Capital, Perceptive
Advisors, RTW Investments, Cormorant Asset Management, Driehaus
Capital Management, Ecor1 Capital, RA Capital Management, Surveyor
Capital (a Citadel company), and Wellington Management Company LLP,
as well as additional undisclosed institutional investors. The
private placement is expected to result in gross proceeds to Aeglea
of approximately $210 million before
deducting placement agent and other offering expenses. The proceeds
from the private placement are intended to be used to advance
Spyre's portfolio of potentially best-in-class IBD products through
multiple data milestones and are expected to fund operations into
2026.
Spyre is the second spinout of Paragon Therapeutics. Spyre was
founded to transform the treatment of IBD by pursuing potentially
best-in-class long-acting antibodies, rational therapeutic
combinations, and precision immunology approaches. Integrating
these strategic pillars with deep expertise in antibody engineering
and biologics development, Spyre aims to maximize the efficacy,
safety, and convenience of treatments for IBD.
IBD causes chronic inflammation of the digestive tract and can
lead to diarrhea, rectal bleeding, abdominal pain, fatigue and
weight loss. Symptoms can range from mild to life-threatening.
There are approximately 1.7 million IBD patients in the United States. and biologics are the
preferred modality for moderate-to-severe patients due to a
superior benefit-risk profile. The IBD global market, which
includes Crohn's disease and ulcerative colitis, is estimated to
surpass $29 billion by 2028,
representing a significant and growing opportunity.
Spyre is advancing a robust portfolio that harnesses both proven
and novel mechanisms of action for addressing IBD. The company's
two parallel lead programs—SPY001 and SPY002—target a4b7 and TL1A,
respectively, and build upon the validation of these targets by
existing commercial- and clinical-stage antibody therapeutics.
Spyre's lead programs are projected to enter clinical studies in
2024, with clinical data for SPY001 expected by YE2024.
"The concurrent launch of Spyre and acquisition by Aeglea will
provide immediate access to the public capital markets and the
opportunity to accelerate research and development efforts for our
broad pipeline of biologics," said Cameron
Turtle, DPhil, newly appointed Chief Operating Officer of
Aeglea. "A continued unmet need exists for novel therapeutics that
improve both efficacy and convenience for patients suffering from
inflammatory bowel disease. We appreciate the support of this
outstanding investor syndicate and their confidence in Spyre's
approach to develop transformative treatments for this chronic
condition."
"Our management and our Board of Directors thoroughly explored
numerous strategic alternatives and believe this acquisition of
Spyre provides a phenomenal outcome for our stockholders," said
Jonathan D. Alspaugh, President and
Chief Financial Officer, Aeglea. "Spyre's approach to therapeutics
development aims to transform the current treatment experience for
individuals living with IBD. The company is making rapid progress
advancing their two parallel lead programs into the clinic, and we
believe these programs will enable us to capture a sizable share of
the growing IBD market."
Management and Organization
The current Aeglea management team, including Jonathan D. Alspaugh, President & Chief
Financial Offer, and Cortney
Caudill, Chief Product Officer, will be expanded with the
appointment of Cameron Turtle,
DPhil, to Chief Operating Officer; Janet
Gunzner-Toste, Ph.D., to SVP, Operations; Andy Spencer, Ph.D., to SVP, Preclinical
R&D; and, Justin LaFountaine,
Ph.D., to VP, Corporate Development.
In conjunction with the transaction, Aeglea Board Members will
include:
- Russell Cox, Chairman of the
Board, CEO of Epirium Bio (current)
- Hunter Smith, CFO of Rhythm
Pharmaceuticals (current)
- Alison Lawton, Former President
and CEO of Kaleido Biosciences (current)
- Ivana Magovčević-Liebisch, President and CEO of Vigil
Neuroscience (current)
- Peter Harwin, Managing Member,
Fairmount Funds
- Tomas Kiselak, Managing Member,
Fairmount Funds
- Michael Henderson, Chief
Executive Officer of Apogee Therapeutics
About the Acquisition and Financing Transaction
The acquisition of Spyre was structured as a stock-for-stock
transaction pursuant to which all of Spyre's outstanding equity
interests were exchanged based on a fixed exchange ratio for
consideration as a combination of 13,013,636 shares of Aeglea
common stock and 364,889 shares of Series A preferred stock (or
364,889,000 shares) on an as-converted-to-common basis).
Concurrently with the acquisition of Spyre, Aeglea entered into a
definitive agreement for a PIPE investment with existing and new
investors to raise $210 million in
which the investors will be issued 721,452 shares of Series A
preferred stock (or 721,452,000 on an as-converted-to-common basis)
at a price of $291.08 per share (or
$0.29108 per share on an
as-converted-to-common basis). Subject to Aeglea stockholder
approval, each share of Series A preferred stock will automatically
convert into 1,000 shares of common stock, subject to certain
beneficial ownership limitations set by each holder. On a pro
forma basis and based upon the number of shares of Aeglea common
stock and preferred stock issued in the acquisition and the
concurrent financing, stockholders of Aeglea immediately prior to
the acquisition will own approximately 5.48% of Aeglea on an
as-converted basis immediately after these transactions. The
acquisition was approved by the Board of Directors of Aeglea and
the Board of Directors and stockholders of Spyre. The closings of
the transactions are not subject to the approval of Aeglea
stockholders. On an as-converted basis and after accounting for
these transactions, the total number of shares of Aeglea common
stock will be 1,193,629,561.
In connection with the transactions, a non-transferrable
contingent value right (a "CVR") will be distributed to Aeglea
stockholders of record as of the close of business on July 3, 2023, but will not be distributed to
holders of shares of common stock or preferred stock issued to
Spyre or the PIPE investors in the transaction. Holders of the CVR
will be entitled to receive certain stock and/or cash payments from
proceeds received by Aeglea, if any, related to the disposition or
monetization of its legacy assets for a period of one year
following the closing of the transaction.
Wedbush PacGrow is serving as lead financial advisor and
Houlihan Lokey Financial Advisors is serving as financial advisor
to the board of directors of Aeglea. Cooley LLP is serving as legal
counsel to Aeglea. Jefferies, TD Cowen, Stifel and Guggenheim
Securities are serving as the placement agents to Spyre, and
Gibson, Dunn & Crutcher LLP is serving as legal counsel to
Spyre.
Webcast Details
The company will host a webcast on June
22, 2023, at 9:00 a.m. ET to
discuss the proposed transaction as well as Spyre's approach and
pipeline assets. To access the call, please dial 1-412-317-0790
(International) or 1-877-870-4263 (toll-free) and provide the
conference ID 10180132. To access the live webcast, please go to
https://app.webinar.net/mLZ39Jr9l25. A replay of the webcast
presentation and associated slides will be temporarily archived on
the Investors & Media section of Aeglea's website following the
presentation.
About Aeglea BioTherapeutics
Aeglea BioTherapeutics is a clinical-stage biotechnology company
redefining the potential of human enzyme therapeutics to benefit
people with rare metabolic diseases with limited treatment options.
Aeglea has investigated pegtarviliase in a Phase 1/2 clinical trial
for the treatment of Classical Homocystinuria. Aeglea's other
clinical program, pegzilarginase, achieved the primary endpoint of
arginine reduction in the PEACE Phase 3 clinical trial. The
Marketing Authorization Application for pegzilarginase is currently
under review with the European Medicines Agency. Aeglea has also
developed a pipeline of engineered human enzymes that have been
explored in preclinical testing, the most advanced of which is for
the potential treatment of Cystinuria. For more information, please
visit http://aeglea.com. Follow Aeglea BioTherapeutics on social
media: @Aegleabio and LinkedIn.
About Spyre Therapeutics
Spyre Therapeutics is a biotechnology company advancing a robust
pipeline of antibody therapeutics with the potential to transform
the treatment of inflammatory bowel disease (IBD). Spyre combines
best-in-class antibody engineering, rational therapeutic
combinations, and precision immunology approaches to maximize
efficacy, safety, and convenience of treatments for IBD. Spun out
of Paragon Therapeutics in 2023, the company was founded by
Fairmount and is based in
Waltham, MA. Visit Spyre's website
at www.spyretx.com.
Follow Spyre Therapeutics on social media: @spyretx and
LinkedIn
About Paragon Therapeutics
Paragon Therapeutics, Inc. is a biotechnology company leveraging
cutting-edge science and technology to identify and propel
best-in-class biologics into the clinic for a range of human
diseases with high unmet needs. The company rapidly advances
therapies through a range of opportunities, from new company
creation and strategic partnerships to shaping programs in-house.
Founded by Fairmount in 2021 as a
joint venture with FairJourney Biologics, Paragon Therapeutics is
based in Waltham, Mass. For more
information, please visit www.paragontherapeutics.com.
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
Aeglea, Spyre, the concurrent financing and the acquisition of
Spyre by Aeglea (the "Transactions") and other matters. These
forward-looking statements include, but are not limited to, express
or implied statements relating to Aeglea's or Spyre's management
team's expectations, hopes, beliefs, intentions or strategies
regarding the future including, without limitation, statements
regarding: the Transactions, including the closing of the
concurrent financing, if any, and the expected effects, perceived
benefits or opportunities and related timing with respect thereto,
expectations regarding or plans for discovery, preclinical studies,
clinical trials and research and development programs; expectations
regarding the use of proceeds and the time period over which
Aeglea's capital resources will be sufficient to fund its
anticipated operations; and regarding the market and potential
opportunities for inflammatory bowel disease therapies." 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 Aeglea, Spyre or the Transactions will be
those that have been anticipated. These forward-looking statements
involve a number of risks, uncertainties (some of which are beyond
Aeglea'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," "Risk Factor Summary" and "Forward-Looking Statements" in
Aeglea's most recent Annual Report on Form 10-K filed with the
Securities and Exchange Commission (the "SEC") on March 2, 2023, as well as discussions of
potential risks, uncertainties, and other important factors
included in other filings by Aeglea from time to time, as well as
risk factors associated with companies, such as Spyre, that operate
in the biopharma industry. Should one or more of these risks or
uncertainties materialize, or should any of Aeglea's or 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 herein 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. Neither Aeglea nor Spyre undertakes or accepts
any duty to release publicly 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 Aeglea.
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SOURCE Aeglea BioTherapeutics, Inc.