Announced corporate name change to Spyre
Therapeutics; appointment of Cameron
Turtle, DPhil, as Chief Executive Officer; and began trading
on Nasdaq under the symbol "SYRE"
SPY001, an anti-α4β7 antibody
engineered for infrequent, subcutaneous dosing, demonstrated an
updated half-life of 22 days, a greater than three-fold increase
relative to vedolizumab in non-human primate pharmacokinetic data
recently presented at ECCO; remains on track to begin
first-in-human studies in the first half of 2024, with interim
proof-of-concept data expected year-end 2024
SPY002, an anti-TL1A antibody designed for
enhanced potency to both TL1A monomers and trimers, and extended
half-life compared to existing molecules, remains on track to begin
first-in-human studies in the second half of 2024
Raised $180
million in private placement equity financing with
participation from new and existing investors
$340
million of cash, cash equivalents, marketable
securities, and restricted cash as of December 31, 2023, with
expected runway into the second half of 2026, through multiple
clinical readouts
WALTHAM,
Mass., Feb. 29, 2024 /PRNewswire/ -- Spyre
Therapeutics, Inc. ("Spyre" or the "Company") (NASDAQ:SYRE), a
biotechnology company advancing a pipeline of investigational
antibody therapeutics with the potential to transform the treatment
of inflammatory bowel disease ("IBD"), today announced its fourth
quarter and full year 2023 financial results and provided program
and corporate updates.
"In 2023, we built the foundation required to advance our
mission of creating IBD therapies that provide meaningful
improvements in both efficacy and convenience compared to today's
standard of care. Beginning with a highly unique portfolio of three
promising drug candidates to what we consider the most critical
targets in IBD, including α4β7, TL1A, and IL-23, we capitalized the
company with nearly $400 million from
top-tier investors while also attracting a talented and passionate
management team and Board of Directors," said Cameron Turtle, DPhil., Chief Executive Officer.
"As we look forward to 2024, our ambitions will come into focus as
we enter clinical studies across multiple programs and begin to
demonstrate potential best-in-class properties of our
investigational medicines. We anticipate initiating Phase 2
evaluation of rational therapeutic combinations in IBD patients in
2025."
Development Pipeline Overview and Update
The Company's approach combines best-in-class antibody
engineering, rational therapeutic combinations, and precision
immunology with the goal of maximizing efficacy, safety, and
convenience of its IBD treatments under development. IBD is a
chronic condition characterized by inflammation within the
gastrointestinal tract, including two main disorders: ulcerative
colitis ("UC") and Crohn's disease ("CD"). In the United States, it is estimated that
approximately 2.4 million individuals are diagnosed with IBD.
The Company has four programs in preclinical development, three
of which are targets in IBD validated by third parties. The
fourth program is a novel, undisclosed target. The Company is
also researching rational combinations of its therapeutic antibody
product candidates to target IBD. All three validated targets offer
the potential for effective and safe treatment of UC and CD as a
monotherapy or in combination, with the potential advantage of
infrequent subcutaneous dosing.
SPY001 – a highly potent and selective investigational
anti-α4β7 monoclonal antibody engineered with half-life extension
technology and formulated for high concentration and subcutaneous,
infrequent dosing.
- In the third quarter of 2023, the Company selected the SPY001
development candidate, which is currently progressing through
IND-enabling studies and is expected to enter first-in-human
("FIH") studies in the first half of 2024.
- In February 2024, expanded
preclinical data for SPY001 was presented at the 19th Annual
Congress of the European Crohn's and Colitis Organisation (ECCO),
including head-to-head non-human primate pharmacokinetic data
showing an updated half-life of 22 days, a greater than three-fold
increase relative to vedolizumab. This data further supports our
target human half-life for SPY001 of more than 35 days predicted by
allometric scaling.
- Interim data from a healthy volunteer study are expected by the
end of 2024. The Company expects pharmacokinetic data to
demonstrate proof of concept for SPY001 to potentially be dosed
subcutaneously in an every-eight-week or every-twelve-week dosing
interval.
SPY002 – a highly potent, selective, half-life
extended, anti-TL1A investigational monoclonal antibody with
potential best-in-class subnanomolar binding affinity for both the
monomer and trimer forms of the target. The Company believes TL1A
has emerged as one of the most promising targets in IBD and broader
immunology indications.
- The Company has nominated two lead SPY002 development
candidates and exercised its option to exclusively license related
intellectual property rights under its agreement with Paragon
Therapeutics. The Company's lead candidates bind both TL1A monomers
and trimers and have in vitro subnanomolar potency and
pharmacokinetic half-lives that potentially exceed all
clinical-stage TL1A antibodies.
- In February 2024, preclinical
data for a lead SPY002 development candidate was presented at the
19th Annual ECCO Congress demonstrating subnanomolar binding
affinity and potency, as well as a pharmacokinetic half-life of 24
days in non-human primates, which represents a two to three-fold
increase compared to clinical-stage anti-TL1As.
- The Company expects to begin FIH studies of one or both SPY002
candidates in the second half of 2024 with healthy volunteer
interim data expected in the first half of 2025. If successful, one
SPY002 candidate would then advance into additional clinical
development.
SPY003 – a highly potent and selective investigational
monoclonal antibody 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
common to IL-12 and IL-23.
- The Company expects to nominate a development candidate in
mid-2024 and move into IND-enabling studies in the second half of
2024.
Recent Corporate Updates
- In February 2024, the Company
announced the appointment of Mark C.
McKenna, former Chairman, President and CEO of Prometheus
Biosciences, Inc., to its Board of Directors. Mr. McKenna's track
record of corporate leadership, product development, and value
creation will be instrumental to guide the Company as it advances
its potentially best-in-class IBD portfolio.
- In December 2023, the Company
announced $180 million in gross
proceeds from a private placement equity financing with broad
participation from both new and existing investors, extending cash
runway into the second half of 2026.
- In November 2023, the Company
announced its name change to Spyre Therapeutics and the appointment
of Cameron Turtle as Chief Executive
Officer and also a member of the Company's Board of Directors. The
Company also announced the appointments of industry veterans
Jeffrey Albers and Laurie Stelzer to its Board of Directors.
- In November 2023, the Company
held a Special Meeting of Stockholders wherein all four proposals
were approved, including the conversion of the Company's Series A
Preferred Stock to common stock and an increase to the Company's
authorized shares.
Fourth Quarter 2023 Financial
Results
Cash Position: As of December 31, 2023, Spyre
had available cash and cash equivalents, marketable securities, and
restricted cash of $339.6
million. Net cash used in operating activities
was $31.0 million for the fourth
quarter of 2023. In December
2023, the Company raised $180.0
million in gross proceeds, before deducting $10.9 million in placement agent fees and other
offering costs, from a private placement of equity securities.
Research and Development (R&D) expenses: R&D
expenses totaled $33.7 million for
the fourth quarter of 2023 and $14.3
million for the fourth quarter of 2022. The increase was
primarily related to increases in preclinical development and
manufacturing expenses for the Company's IBD pipeline including
expenses related to the annual equity grant under our agreement
with Paragon, partially offset by a decrease in expenses associated
with the Company's legacy rare disease pipeline.
General and Administrative (G&A)
expenses: G&A expenses totaled $14.1 million for the fourth quarter of 2023 and
$5.1 million for the fourth quarter
of 2022. This increase was primarily due to an increase in stock
compensation expense, as well as legal and other professional
service fees related to the Spyre acquisition.
Gain on Sale of In-Process Research & Development
Asset: During the fourth quarter of 2023, the Company
recognized an additional $1.8 million
gain on the sale of the global rights of pegzilarginase driven by
the receipt of a cash reimbursement from Immedica for a previous
expenditure.
Other (expense) income: Other (expense) income for
the fourth quarter totaled $17.3
million expense primarily driven by an increase in the
Company's CVR liability related to the increased likelihood of
certain milestone payments related to pegzilarginase reimbursement
in European markets, partially offset by interest earned on the
Company's cash and marketable securities.
Net Loss: Net loss totaled $63.2
million and $18.8 million for
the fourth quarters of 2023 and 2022, respectively, which includes
non-cash stock compensation expense of $17.3
million and $1.4 million for
the fourth quarters of 2023 and 2022, respectively.
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. Spyre's pipeline
includes investigational extended half-life antibodies targeting
α4β7, TL1A, and IL-23.
For more information, please visit http://spyre.com.
Follow Spyre Therapeutics on social media: @spyretx and
LinkedIn.
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. All statements contained in this
press release, other than statements of historical fact are
forward-looking statements. These forward-looking statements
include statements regarding the Company's future results of
operations and financial position, business strategy, including the
Company's potential success of developing therapeutics for IBD, the
sufficiency of the Company's funding to support the development of
its assets, the length of time that the Company believes its
existing cash resources will fund its operations, its market size,
its potential growth opportunities, its preclinical and future
clinical development activities, including the expected timing of
nomination of development candidates and submission of
investigational new drug applications, the efficacy and safety
profile of its product candidates, the potential therapeutic
benefits and economic value of its product candidates, the timing
and results of preclinical studies and clinical trials, including
the commencement of FIH studies, the timing of data and
whether the data demonstrates proof of concept, and the Company's
planned regulatory activities including filing of INDs to support
development and potential commercialization of product candidates.
The words "believe," "may," "will," "potentially," "estimate,"
"continue," "anticipate," "predict," "target," "intend," "could,"
"would," "should," "project," "plan," "expect," the negatives of
these terms, and similar expressions that convey uncertainty of
future events or outcomes are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words.
These forward-looking statements are subject to a number of
risks, uncertainties and assumptions, including the expected
or potential impact of macroeconomic conditions, including
inflationary pressures, rising interest rates, general economic
slowdown or a recession, changes in monetary policy, the prospect
of a shutdown of the U.S. federal government, volatile market
conditions, financial institution instability, as well as
geopolitical instability, including the ongoing military conflict
in Ukraine, conflict in
Israel and surrounding areas, and
geopolitical tensions in China on
the Company's operations, the potential impacts of the BIOSECURE
Act bill if passed into law and those risks described in the
Company's Quarterly Reports on Form 10-Q, Annual Reports on Form
10-K, as well as in other filings and reports that the Company
makes from time to time with the Securities and Exchange
Commission. Moreover, the Company operates in a very competitive
and rapidly changing environment, and new risks emerge from time to
time. It is not possible for the Company's management to predict
all risks, nor can the Company assess the impact of all factors on
the business or the extent to which any factor, or combination of
factors, may cause actual results to differ materially from those
contained in any forward-looking statements it may make. In light
of these risks, uncertainties, and assumptions, the forward-looking
events and circumstances discussed in this press release may not
occur and actual results could differ materially and adversely from
those anticipated or implied in the forward-looking statements.
You should not rely upon forward-looking statements as
predictions of future events. Although the Company believes that
the expectations reflected in the forward-looking statements are
reasonable, the Company cannot guarantee that the future results,
levels of activity, performance or events and circumstances
reflected in the forward-looking statements will be achieved or
occur. The Company undertakes no obligation to update publicly any
forward-looking statement for any reason after the date of this
press release to conform these statements to actual results, to
reflect changes in the Company's expectations, or otherwise, except
as required by law. You should read press release with the
understanding that the Company's actual results, levels of
activity, performance, events, outcomes, and the timing of results
and outcomes, and other circumstances may be materially different
from what the Company expects.
Spyre Therapeutics,
Inc. Consolidated Balance Sheets (Unaudited, in
thousands, except share and per share amounts)
|
|
|
December 31,
2023
|
|
December 31,
2022
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$
188,893
|
|
$
34,863
|
Marketable
securities
|
150,384
|
|
20,848
|
Development
receivables
|
—
|
|
375
|
Prepaid expenses and
other current assets
|
2,251
|
|
6,172
|
Total current
assets
|
341,528
|
|
62,258
|
Restricted
cash
|
322
|
|
1,553
|
Property and equipment,
net
|
—
|
|
3,220
|
Operating lease
right-of-use assets
|
—
|
|
3,430
|
Other non-current
assets
|
9
|
|
683
|
TOTAL ASSETS
|
$
341,859
|
|
$
71,144
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts
payable
|
$
896
|
|
$
677
|
CVR
liability
|
1,390
|
|
—
|
Operating lease
liabilities
|
—
|
|
625
|
Deferred
revenue
|
—
|
|
517
|
Accrued and other
current liabilities
|
13,108
|
|
12,837
|
Related party accounts
payable and other current liabilities
|
16,584
|
|
—
|
Total current
liabilities
|
31,978
|
|
14,656
|
Non-current CVR
liability
|
41,310
|
|
—
|
Non-current operating
lease liabilities
|
—
|
|
4,004
|
Deferred revenue, net
of current portion
|
—
|
|
2,179
|
Other non-current
liabilities
|
—
|
|
—
|
TOTAL
LIABILITIES
|
73,288
|
|
20,839
|
Commitments and
Contingencies
|
|
|
|
Series B non-voting
convertible preferred stock, $0.0001 par value; 150,000 and no
shares authorized as of December 31, 2023 and December 31, 2022,
respectively;
150,000 and no shares issued and outstanding as of December 31,
2023 and December
31, 2022, respectively.
|
84,555
|
|
—
|
STOCKHOLDERS'
EQUITY
|
|
|
|
Series A non-voting
convertible preferred stock, $0.0001 par value; 1,086,341 and
no
shares authorized as of December 31, 2023 and December 31, 2022,
respectively;
437,037 and no shares issued and outstanding as of December 31,
2023 and
December 31, 2022, respectively.
|
184,927
|
|
—
|
Preferred stock,
$0.0001 par value; 8,763,659 shares and 10,000,000 authorized
as
of December 31, 2023 and December 31, 2022, respectively; no shares
issued and
outstanding as of December 31, 2023 and December 31,
2022.
|
—
|
|
—
|
Common stock, $0.0001
par value; 400,000,000 and 20,000,000 shares authorized as
of December 31, 2023 and December 31, 2022, respectively;
36,057,109 shares and
2,614,014 shares issued and outstanding as of December 31, 2023 and
December
31, 2022, respectively.
|
10
|
|
6
|
Additional paid-in
capital
|
763,191
|
|
475,971
|
Accumulated other
comprehensive income (loss)
|
302
|
|
(48)
|
Accumulated
deficit
|
(764,414)
|
|
(425,624)
|
TOTAL STOCKHOLDERS'
EQUITY
|
184,016
|
|
50,305
|
TOTAL LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY
|
341,859
|
|
71,144
|
Spyre Therapeutics,
Inc. Consolidated Statements of
Operations (Unaudited, in thousands, except share and per
share amounts)
|
|
|
Three Months
Ended
December 31,
|
|
Twelve Months
Ended
December 31,
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
Revenue:
|
|
|
|
|
|
|
|
Development fee and
royalty
|
$
—
|
|
$
168
|
|
$
886
|
|
$
2,329
|
Total
revenue
|
—
|
|
168
|
|
886
|
|
2,329
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development (1)
|
33,682
|
|
14,251
|
|
89,504
|
|
58,579
|
General and
administrative
|
14,072
|
|
5,079
|
|
39,946
|
|
28,531
|
Acquired in-process
research and development
|
—
|
|
—
|
|
130,188
|
|
—
|
Gain on sale of
in-process research and development asset
|
(1,840)
|
|
—
|
|
(16,449)
|
|
—
|
Total operating
expenses
|
45,914
|
|
19,330
|
|
243,189
|
|
87,110
|
Loss from
operations
|
(45,914)
|
|
(19,162)
|
|
(242,303)
|
|
(84,781)
|
|
|
|
|
|
|
|
|
Other (expense)
income:
|
|
|
|
|
|
|
|
Interest
income
|
4,126
|
|
410
|
|
6,147
|
|
837
|
Change in fair value of
forward contract liability
|
—
|
|
—
|
|
(83,530)
|
|
—
|
Other expense,
net
|
(21,392)
|
|
(32)
|
|
(19,130)
|
|
(7)
|
Total other (expense)
income
|
(17,266)
|
|
378
|
|
(96,513)
|
|
830
|
Loss before income tax
expense
|
(63,180)
|
|
(18,784)
|
|
(338,816)
|
|
(83,951)
|
Income tax (expense)
benefit
|
—
|
|
(38)
|
|
26
|
|
136
|
Net loss
|
$ (63,180)
|
|
$ (18,822)
|
|
$
(338,790)
|
|
$ (83,815)
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(4.05)
|
|
$
(5.00)
|
|
$
(49.12)
|
|
$
(24.86)
|
Weighted-average common
shares outstanding, basic and
diluted
|
15,607,898
|
|
3,764,608
|
|
6,897,065
|
|
3,371,231
|
|
|
(1)
|
Includes $27.7 million
and $48.5 million in related party expenses for the three and
twelve months ended December 31, 2023, respectively and no
related party expenses for the three and twelve months ended
December 31, 2022.
|
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SOURCE Spyre Therapeutics, Inc.