SPY001, an anti-α4β7 antibody
engineered for infrequent, subcutaneous dosing successfully
completed a 28-day GLP toxicity study and remains on track to begin
first-in-human studies in the second quarter 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 a March 2024
private placement equity financing with participation from new and
existing investors
$485 million
of cash, cash equivalents, marketable securities, and restricted
cash as of March 31, 2024, with expected runway well into
2027, through multiple clinical readouts
WALTHAM,
Mass., May 9, 2024 /PRNewswire/ -- Spyre
Therapeutics, Inc. ("Spyre" or the "Company") (NASDAQ:SYRE), a
development-stage biotechnology company advancing best-in-class
antibody engineering, rational therapeutic combinations, and
precision medicine approaches for the treatment of inflammatory
bowel disease ("IBD"), today announced its first quarter 2024
financial results and provided program and corporate updates.
"I am proud of Spyre's continued execution against our corporate
strategy this past quarter, further expanding our team and building
a strong financial foundation with the support of top-tier
investors. With a clean safety profile in SPY001's 28-day GLP
toxicity study, we remain on track towards initiating a
first-in-human study later this quarter and advancing our mission
of creating IBD therapies that provide meaningful improvements in
both efficacy and convenience," said Cameron Turtle, DPhil., Chief Executive Officer.
"We expect to report interim PK and safety data from our Phase 1
trial of SPY001 by the end of this year, setting up the first of
what we expect to be a string of important catalysts from year-end
2024 through 2025 across our lead programs. We also anticipate
initiating a 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.
- The 28-day GLP toxicity study in non-human primates ("NHPs")
has been completed, demonstrating a favorable safety profile with
the highest dose level evaluated as the
no-observed-adverse-effect-level ("NOAEL"). Chemistry,
manufacturing, and controls ("CMC") activities to enable the SPY001
first-in-human ("FIH") study are also complete, and SPY001 remains
on track to enter FIH studies in the second quarter 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. 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. The Company expects to initiate FIH studies in the first half
of 2025.
Recent Corporate Updates
- In March 2024, 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 well into 2027.
- 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.
First Quarter 2024 Financial Results
Cash Position: As of March 31, 2024, Spyre had
available cash and cash equivalents, marketable securities, and
restricted cash of $485.0
million. Net cash used in operating activities was
$28.5 million for the first quarter
of 2024. In March 2024, the Company
raised $180 million in gross
proceeds, before deducting $11.2
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 $34.9 million for
the first quarter of 2024 and $13.8
million for the first quarter of 2023. The increase was
driven by preclinical development and manufacturing expenses for
the Company's IBD pipeline, 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 $12.8 million for the first quarter of 2024 and
$5.2 million for the first quarter of
2023. This increase was primarily due to higher stock compensation
and professional services expenses.
Other income (expense): Other income for the first
quarter totaled $3.9 million
primarily driven by interest earned on the Company's cash and
marketable securities.
Net Loss: Net loss totaled $43.9
million and $18.4 million for
the first quarters of 2024 and 2023, respectively, which includes
non-cash stock compensation expense of $13.8
million and $1.7 million for
the first quarters of 2024 and 2023, 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, submission of investigational
new drug ("IND") applications and Phase 2 evaluation of therapeutic
combinations, 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)
|
|
March 31,
2024
|
|
December 31,
2023
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$
227,552
|
|
$
188,893
|
Marketable
securities
|
257,089
|
|
150,384
|
Prepaid expenses and
other current assets
|
2,632
|
|
2,251
|
Total current
assets
|
487,273
|
|
341,528
|
Restricted
cash
|
319
|
|
322
|
Other non-current
assets
|
10
|
|
9
|
TOTAL ASSETS
|
$
487,602
|
|
$
341,859
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts
payable
|
$
3,106
|
|
$
896
|
CVR
liability
|
2,590
|
|
1,390
|
Accrued and other
current liabilities
|
21,594
|
|
13,108
|
Related party accounts
payable and other current liabilities
|
15,528
|
|
16,584
|
Total current
liabilities
|
42,818
|
|
31,978
|
Non-current CVR
liability
|
39,110
|
|
41,310
|
TOTAL
LIABILITIES
|
81,928
|
|
73,288
|
Commitments and
Contingencies
|
|
|
|
Series B non-voting
convertible preferred stock, $0.0001 par value; 271,625 and
150,000
shares authorized as of March 31, 2024 and December 31,
2023, respectively; 271,625
and 150,000 shares issued and outstanding as of March 31, 2024
and December 31,
2023, respectively
|
253,405
|
|
84,555
|
STOCKHOLDERS' (DEFICIT)
EQUITY
|
|
|
|
Series A non-voting
convertible preferred stock, $0.0001 par value; 1,086,341
shares
authorized as of both March 31, 2024 and December 31, 2023; 437,037
shares issued
and outstanding as of March 31, 2024 and December 31, 2023,
respectively
|
184,927
|
|
184,927
|
Preferred stock,
$0.0001 par value; 8,642,034 shares and 8,763,659 authorized as
of
March 31, 2024 and December 31, 2023; no shares issued
and outstanding as of
March 31, 2024 and December 31, 2023
|
—
|
|
—
|
Common stock, $0.0001
par value; 400,000,000 shares authorized as of March 31,
2024 and December 31, 2023; 36,629,680 shares and 36,057,109
shares issued and
outstanding as of March 31, 2024 and December 31, 2023,
respectively
|
10
|
|
10
|
Additional paid-in
capital
|
775,966
|
|
763,191
|
Accumulated other
comprehensive (loss) income
|
(363)
|
|
302
|
Accumulated
deficit
|
(808,271)
|
|
(764,414)
|
TOTAL STOCKHOLDERS'
EQUITY
|
152,269
|
|
184,016
|
TOTAL LIABILITIES,
CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY
|
$
487,602
|
|
$
341,859
|
Spyre Therapeutics,
Inc. Consolidated Statements of
Operations (Unaudited, in thousands, except share and per
share amounts)
|
|
Three Months
Ended
March 31,
|
|
2024
|
|
2023
|
Revenue:
|
|
|
|
Development fee and
royalty
|
$
—
|
|
$
198
|
Total
revenue
|
—
|
|
198
|
|
|
|
|
Operating
expenses:
|
|
|
|
Research and
development (1)
|
34,928
|
|
13,776
|
General and
administrative
|
12,846
|
|
5,228
|
Total operating
expenses
|
47,774
|
|
19,004
|
Loss from
operations
|
(47,774)
|
|
(18,806)
|
|
|
|
|
Other income
(expense):
|
|
|
|
Interest
income
|
4,432
|
|
420
|
Other
expense
|
(483)
|
|
(72)
|
Total other income
(expense)
|
3,949
|
|
348
|
Loss before income tax
expense
|
(43,825)
|
|
(18,458)
|
Income tax (expense)
benefit
|
(32)
|
|
36
|
Net loss
|
$ (43,857)
|
|
$ (18,422)
|
|
|
|
|
Net loss per share,
basic and diluted
|
$
(1.20)
|
|
$
(4.89)
|
Weighted-average common
shares outstanding, basic and diluted
|
36,512,662
|
|
3,770,506
|
(1)
|
Includes $17.1 million
in related party expenses for the three months ended March 31,
2024, and no related party expenses for the three months ended
March 31, 2023.
|
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SOURCE Spyre Therapeutics, Inc.