Acquisition of Spyre's assets and concurrent
oversubscribed $210.0 million private
investment positions the company to advance a potentially
best-in-class inflammatory bowel disease (IBD) portfolio, including
α4b7 and TL1A programs
Sale of legacy pipeline candidate,
pegzilarginase, further streamlines operations and increases focus
on IBD strategy
$236.7 million
of cash and cash equivalents and restricted cash as of June 30, 2023
WALTHAM,
Mass., Aug. 11, 2023 /PRNewswire/ -- Aeglea
BioTherapeutics, Inc. ("Aeglea" or the "Company") (NASDAQ:AGLE), a
biotechnology company advancing a pipeline of antibody therapeutics
with the potential to transform the treatment of inflammatory bowel
disease ("IBD"), today announced second quarter 2023 financial
results and provided program and corporate updates.
"With the acquisition of Spyre Therapeutics and concurrent
financing, we are in a privileged position to create meaningful new
medicines for patients with IBD and build an industry-leading
development organization," said Cameron
Turtle, DPhil, Chief Operating Officer of Aeglea. "Our
pipeline of differentiated and potentially best-in-class IBD
programs, including a4b7 and TL1A, combined with a strategy to
investigate therapeutic combinations and precision medicine
approaches, offers the possibility to transform the treatment of
this chronic and debilitating disease."
"In parallel, we have made significant progress streamlining the
organization with the sale of pegzilarginase and pivoting our
operations and strategy around the new IBD assets," said
Jonathan Alspaugh, President and
Chief Financial Officer of Aeglea. "We are working to rapidly
advance our co-lead product candidates with an expectation of
initiating clinical studies for both SPY001 and SPY002 in
2024."
Recent Program and Corporate Updates
Corporate
- Completed the asset acquisition (the "Acquisition") of Spyre
Therapeutics, Inc. ("Spyre"), a privately held biotechnology
company with a pipeline of antibody therapeutics possessing the
potential to transform the treatment of IBD alongside its research
partner, Paragon Therapeutics, Inc. ("Paragon")
- Raised $210.0 million in gross
proceeds (before deducting approximately $12.7 million in placement fees and other
offering expenses) through a sale of Series A non-voting
convertible preferred stock (the "Series A Preferred Stock") in a
private placement to a group of investors.
IBD Portfolio
With the Acquisition, Aeglea shifted its focus to the
development of a potentially best-in-class IBD portfolio
including:
- SPY001 – a highly potent and selective anti-α4β7 monoclonal
antibody engineered with half-life extension technology and
formulated for high concentration, convenient 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. Data from a healthy volunteer study are
expected by the end of 2024.
- SPY002 – a highly potent and selective anti-TL1A monoclonal
antibody engineered with half-life extension technology. TL1A has
emerged as one of the most promising targets in IBD and
broader immunology indications.
-
- We expect to begin FIH studies of the SPY002 program in the
second half of 2024 with healthy volunteer data expected in the
first half of 2025.
Pegzilarginase
- Sold global rights to pegzilarginase in development
for Arginase 1 Deficiency to Immedica Pharma AB ("Immedica") for
$15.0 million upfront cash proceeds
and up to $100.0 million of
contingent milestone payments. The sale of pegzilarginase to
Immedica supersedes the previous license agreement between the
companies.
-
- Marketing Authorisation Application for pegzilarginase is under
review by the European Medicines Agency.
- The milestone payments are contingent on formal reimbursement
decisions by national authorities in key European markets and
pegzilarginase approval by the FDA, among other events.
- Net proceeds of the sale are to be distributed to holders of
contingent value rights ("CVR") pursuant to the terms of the CVR
Agreement dated July 7, 2023 by and
between the Company and a rights agent.
Second Quarter 2023 Financial Results
As of June 30, 2023, Aeglea had
available cash and cash equivalents and restricted cash of
$236.7 million, including the
$210.0 million in gross proceeds from
the private placement offering in June
2023.
Aeglea recognized development fee and royalty revenues of
$0.7 million in the second quarter of
2023, as a result of its license and supply agreement with Immedica
for the commercial rights to pegzilarginase in Europe and several countries in the
Middle East. The revenues recorded
in the second quarter of 2023 are related to drug supply and
royalties from an early access program in France. Aeglea recognized $0.6 million for the second quarter of 2022 in
development fee revenues.
Research and development expenses totaled $17.4 million for the second quarter of 2023 and
$15.4 million for the second quarter
of 2022. The increase was primarily related to restructuring costs
net of savings and an increase in reimbursable costs under the
Paragon Agreement (as described below).
General and administrative expenses totaled $12.1 million for the second quarter of 2023 and
$7.7 million for the second quarter
of 2022. This increase was primarily due to restructuring costs,
net of savings.
Acquired in-process research and development expenses totaled
$130.5 million for the second quarter
of 2023 and no expenses for the second quarter of 2022. As the
Spyre assets have no alternative use, the net assets acquired are
expensed in the period acquired.
Change in the fair value of forward contract liability expense
was $58.2 million for the second
quarter of 2023 and no expenses for the second quarter of 2022. The
stock consideration provided in the Acquisition was not issued
until July 7, 2023. Accordingly, the
Company recognized a forward contract liability to represent the
contractual obligation to issue stock as of June 30, 2023. The increase in expense represents
the change in fair value between June 22,
2023 (the Acquisition date) and June
30, 2023 for the redeemable Series A Preferred Stock.
Net loss totaled $217.1 million
and $22.3 million for the second
quarter of 2023 and 2022, respectively, which includes non-cash
stock compensation expense of $1.9
million and $2.0 million for
the second quarter of 2023 and 2022, respectively.
About Aeglea BioTherapeutics
In June 2023, Aeglea completed the
asset acquisition of Spyre and shifted its disease focus to IBD.
Aeglea is advancing a pipeline of antibody therapeutics with the
potential to transform the treatment of IBD. The approaches combine
novel antibody engineering, rational therapeutic combinations, and
precision immunology approaches to maximize efficacy, safety, and
convenience of treatments for IBD.
For more information, please visit http://aeglea.com.
Follow Aeglea BioTherapeutics on social
media: @aegleabio and LinkedIn.
About the Paragon Agreement
In May 2023, Spyre entered into an
antibody discovery option and license agreement with Paragon (the
"Paragon Agreement"). As part of the Paragon Agreement, Paragon
identifies, evaluates and develops antibodies directed against
certain mutually agreed therapeutic targets of interest to the
Company. The arrangement currently includes four selected targets:
α4β7, TL1A, IL-23, and an undisclosed fourth target. Subsequent to
the Acquisition, the Company has exercised its option for the α4β7
program and will be granted an exclusive license to develop,
manufacture and commercialize the antibody and products directed to
the target, and plans to exercise its option for the other programs
upon development candidate selection. From time to time, the
Company can choose to add additional targets to the arrangement by
mutual agreement with Paragon.
Safe Harbor / Forward Looking Statements
This press release contains "forward-looking" statements within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can be identified by words such as: "believe,"
"continue," "goal," "expect," "may," "intend," "potential," "will"
and similar references to future periods. These statements are
subject to numerous risks and uncertainties that could cause actual
results to differ materially from what the Company expects.
Examples of forward-looking statements include, among others,
statements the Company makes regarding any future payouts
under the CVR, its ability to achieve the expected benefits or
opportunities and related timing with respect to the Acquisition or
to monetize any of its legacy assets, its future results of
operations and financial position, its business strategy, its
potential growth opportunities, its preclinical and future clinical
development activities, the efficacy and safety profile of its
product candidates, the potential therapeutic benefits and economic
value of its product candidates, and the timing and results of
preclinical studies and clinical trials, and other statements that
are not historical fact. Actual results may differ materially from
those indicated by such forward-looking statements. Factors that
could cause actual results to differ include, but are not limited
to, risks that the Company may not obtain stockholder approval of
the conversion rights of the Series A Preferred Stock, the Company
may fail to achieve the expected benefits or opportunities and
related timing with respect to the Acquisition or to monetize any
of its legacy assets, the Company's existing cash resources may not
be sufficient to fund its future planned operations, the impact of
macroeconomic conditions, including inflation, increasing interest
rates and volatile market conditions, current or potential bank
failures, as well as global events, including the ongoing military
conflict in Ukraine and
geopolitical tensions in China on
the Company's operations, and the receipt and timing of potential
regulatory designations, approvals and commercialization of product
candidates. Additional risks and uncertainties regarding the
Company's business can be found in the section titled "Risk
Factors" in the Company's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2023 filed
with the United States Securities and Exchange Commission ("SEC"),
and future filings and reports that the Company makes from time to
time with the SEC. The information contained in this press release
is as of the date of this release, and the Company undertakes no
duty to update forward-looking statements contained in this press
release except as required by applicable laws.
Aeglea
BioTherapeutics, Inc.
Condensed
Consolidated Balance Sheets
|
|
(Unaudited, in
thousands, except share and per share amounts)
|
|
|
|
June 30,
|
|
December
31,
|
|
|
2023
|
|
2022
|
ASSETS
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
Cash and cash
equivalents
|
|
$
235,358
|
|
$
34,863
|
Marketable
securities
|
|
—
|
|
20,848
|
Development
receivables
|
|
1,646
|
|
375
|
Prepaid expenses and
other current assets
|
|
2,882
|
|
6,172
|
Total current
assets
|
|
239,886
|
|
62,258
|
Restricted
cash
|
|
1,317
|
|
1,553
|
Property and equipment,
net
|
|
—
|
|
3,220
|
Operating lease
right-of-use assets
|
|
2,316
|
|
3,430
|
Other non-current
assets
|
|
10
|
|
683
|
TOTAL ASSETS
|
|
$
243,529
|
|
$
71,144
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
Accounts
payable
|
|
$
2,854
|
|
$
677
|
Forward contract
liability
|
|
164,382
|
|
—
|
CVR
liability
|
|
10,500
|
|
—
|
Operating lease
liabilities
|
|
4,331
|
|
625
|
Deferred
revenue
|
|
930
|
|
517
|
Accrued and other
current liabilities
|
|
28,427
|
|
12,837
|
Related party accounts
payable
|
|
20,810
|
|
—
|
Total current
liabilities
|
|
232,234
|
|
14,656
|
Non-current CVR
liability
|
|
19,000
|
|
—
|
Non-current operating
lease liabilities
|
|
—
|
|
4,004
|
Deferred revenue, net
of current portion
|
|
2,341
|
|
2,179
|
TOTAL
LIABILITIES
|
|
253,575
|
|
20,839
|
Commitments and
Contingencies (Note 11)
|
|
|
|
|
Series A non-voting
convertible preferred stock, $0.0001 par value; 1,086,341 and no
shares authorized as of June 30, 2023 and December 31, 2022,
respectively; 721,452 and no shares issued and outstanding as of
June 30, 2023 and December 31, 2022, respectively
|
|
197,323
|
|
—
|
STOCKHOLDERS' (DEFICIT)
EQUITY
|
|
|
|
|
Preferred stock,
$0.0001 par value; 8,913,659 shares and 10,000,000 authorized as of
June 30, 2023 and December 31, 2022; no shares issued and
outstanding as of June 30, 2023 and December 31,
2022
|
|
—
|
|
—
|
Common stock, $0.0001
par value; 500,000,000 shares authorized as of June 30, 2023 and
December 31, 2022; 81,001,676 shares and 65,350,343 shares
issued and outstanding as of June 30, 2023 and December 31,
2022, respectively
|
|
6
|
|
6
|
Additional paid-in
capital
|
|
453,741
|
|
475,971
|
Accumulated other
comprehensive income (loss)
|
|
11
|
|
(48)
|
Accumulated
deficit
|
|
(661,127)
|
|
(425,624)
|
TOTAL STOCKHOLDERS'
(DEFICIT) EQUITY
|
|
(207,369)
|
|
50,305
|
TOTAL LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' (DEFICIT)
EQUITY
|
|
$
243,529
|
|
$
71,144
|
Aeglea
BioTherapeutics, Inc.
Condensed
Consolidated Statements of Operations
|
|
(Unaudited, in
thousands, except share and per share amounts)
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
June 30,
|
|
June 30,
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenue:
|
|
|
|
|
|
|
|
|
Development fee and
royalty
|
|
$
688
|
|
$
625
|
|
$
886
|
|
$
1,987
|
Total
revenue
|
|
688
|
|
625
|
|
886
|
|
1,987
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Research and
development
|
|
17,386
|
|
15,373
|
|
31,162
|
|
32,351
|
General and
administrative
|
|
12,062
|
|
7,675
|
|
17,290
|
|
16,500
|
Acquired in-process
research and development
|
|
130,486
|
|
—
|
|
130,486
|
|
—
|
Total operating
expenses
|
|
159,934
|
|
23,048
|
|
178,938
|
|
48,851
|
Loss from
operations
|
|
(159,246)
|
|
(22,423)
|
|
(178,052)
|
|
(46,864)
|
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Interest
income
|
|
350
|
|
104
|
|
770
|
|
139
|
Change in fair value
of forward contract liability
|
|
(58,170)
|
|
—
|
|
(58,170)
|
|
—
|
Other income
(expense), net
|
|
(8)
|
|
5
|
|
(80)
|
|
1
|
Total other (expense)
income
|
|
(57,828)
|
|
109
|
|
(57,480)
|
|
140
|
Loss before income tax
expense
|
|
(217,074)
|
|
(22,314)
|
|
(235,532)
|
|
(46,724)
|
Income tax (expense)
benefit
|
|
(7)
|
|
(9)
|
|
29
|
|
(35)
|
Net loss
|
|
$
(217,081)
|
|
$
(22,323)
|
|
$ (235,503)
|
|
$
(46,759)
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
|
$
(2.27)
|
|
$
(0.27)
|
|
$
(2.48)
|
|
$
(0.63)
|
Weighted-average common
shares outstanding, basic and diluted
|
|
95,565,118
|
|
82,209,032
|
|
94,917,487
|
|
73,650,146
|
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SOURCE Aeglea BioTherapeutics, Inc.