Spyre Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update
Initiated dosing in Phase 1 trial of SPY001, an anti-α4β7 antibody engineered for infrequent, subcutaneous maintenance dosing, with interim proof-of-concept data on track for year-end 2024
SPY002, an anti-TL1A antibody program 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 trials in the second half of 2024
Nominated a development candidate for SPY003, a highly potent anti-IL-23 antibody with an extended half-life compared to existing molecules, with expectations to begin a first-in-human trial in the first half of 2025
"Initiation of our Phase 1 trial of SPY001 represents an important transition of Spyre into a clinical-stage biotechnology company and sets the stage for an important year of catalysts to validate the promise of our portfolio. Specifically, by this time next year, we expect to have reported Phase 1 data from our α4β7 and TL1A programs and have an ongoing Phase 1 trial of our IL-23 program reporting data shortly thereafter," said
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 Company has four programs in nonclinical and clinical 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 maintenance dosing.
SPY001 – a highly potent and selective investigational anti-α4β7 monoclonal antibody engineered with half-life extension technology and formulated for high concentration to maximize induction exposure and potential remission rates, and to enable infrequent, subcutaneous maintenance dosing.
- In
June 2024 , the Company announced the initiation of dosing of healthy volunteers in its first-in-human ("FIH") trial of SPY001. The Phase 1 trial is a double blind, placebo-controlled trial expected to enroll approximately 48 healthy volunteers, consisting of at least four single-ascending dose (SAD) cohorts and two multi-ascending dose (MAD) cohorts. - Interim data from this Phase 1 trial 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 maintenance dosing interval.
- In
February 2024 , expanded preclinical data for SPY001 were presented at the 19th AnnualCongress of the European Crohn's and Colitis Organisation ("ECCO"), including comparable potency and selectivity to the vedolizumab epitope, as well as 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. These data further support our target human half-life for SPY001 of more than 35 days, predicted by allometric scaling.
SPY002 – a program with two highly potent, selective, half-life extended, anti-TL1A investigational monoclonal antibody candidates 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 which bind both TL1A monomers and trimers and have in vitro subnanomolar potency and pharmacokinetic half-lives that potentially exceed all clinical-stage TL1A antibodies.
- The Company expects to begin FIH trials of both SPY002 candidates in the second half of 2024 with healthy volunteer interim data expected in the first half of 2025. If successful, the Company expects one SPY002 candidate would then advance into further clinical development.
- In
February 2024 , preclinical data for a lead SPY002 development candidate were presented at the 19th AnnualECCO 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.
SPY003 – a highly potent and selective investigational monoclonal antibody targeting the p19 subunit of IL-23, engineered with half-life extension technology.
- The Company nominated its potential best-in-class development candidate in
June 2024 and expects to initiate IND-enabling studies in the second half of 2024. The Company expects to initiate FIH trials in the first half of 2025. - Data from the Phase 3 SEQUENCE trial of risankizumab versus ustekinumab in Crohn's disease, as well as recent data from the Phase 3 VIVID-1 trial of mirikizumab versus ustekinumab, validate the Company's targeting of the p19 subunit as it demonstrated superiority to targeting the p40 subunit common to IL-12 and IL-23.
Recent Corporate Updates
- In
May 2024 , the Company announced the appointment ofSandra Milligan , M.D., J.D. to its Board of Directors.Dr. Milligan's deep expertise in clinical development and regulatory affairs, including within IBD, will be invaluable to guide the Company as it advances its potentially best-in-class IBD portfolio.Jeffrey Albers was also appointed Chairman of the Board of Directors as successor toRussell Cox , whose Board term ended in May. - In
May 2024 , the Company's stockholders approved all proposals at the 2024 annual meeting of stockholders, including the conversion of the Company's Series B Preferred Stock to Common Stock.
Second Quarter 2024 Financial Results
Cash Position: As of
Research and Development (R&D) expenses: R&D expenses totaled
General and Administrative (G&A) expenses: G&A expenses totaled
Acquired in-process research and development expenses: Acquired in-process research and development totaled
Other income (expense): Other income totaled
Net Loss: Net loss totaled
About Spyre Therapeutics
Spyre Therapeutics is a clinical-stage biotechnology company that aims to create 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.
Safe Harbor / Forward Looking Statements
This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the
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
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. |
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Consolidated Balance Sheets |
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(Unaudited, in thousands, except share and per share amounts) |
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ASSETS |
|
|
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CURRENT ASSETS |
|
|
|
Cash and cash equivalents |
$ 45,144 |
|
$ 188,893 |
Marketable securities |
380,851 |
|
150,384 |
Prepaid expenses and other current assets |
9,741 |
|
2,251 |
Total current assets |
435,736 |
|
341,528 |
Restricted cash |
321 |
|
322 |
Other non-current assets |
10 |
|
9 |
TOTAL ASSETS |
$ 436,067 |
|
$ 341,859 |
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
CURRENT LIABILITIES |
|
|
|
Accounts payable |
$ 3,231 |
|
$ 896 |
CVR liability |
2,640 |
|
1,390 |
Accrued and other current liabilities |
5,683 |
|
13,108 |
Related party accounts payable and other current liabilities |
10,568 |
|
16,584 |
Total current liabilities |
22,122 |
|
31,978 |
Non-current CVR liability |
39,560 |
|
41,310 |
TOTAL LIABILITIES |
61,682 |
|
73,288 |
Commitments and Contingencies |
|
|
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Series B non-voting convertible preferred stock, |
— |
|
84,555 |
STOCKHOLDERS' EQUITY |
|
|
|
Series A non-voting convertible preferred stock, |
146,425 |
|
184,927 |
Series B non-voting convertible preferred stock, |
9,395 |
|
— |
Preferred stock, |
— |
|
— |
Common stock, |
12 |
|
10 |
Additional paid-in capital |
1,066,214 |
|
763,191 |
Accumulated other comprehensive (loss) income |
(553) |
|
302 |
Accumulated deficit |
(847,108) |
|
(764,414) |
TOTAL STOCKHOLDERS' EQUITY |
374,385 |
|
184,016 |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY |
$ 436,067 |
|
$ 341,859 |
Spyre Therapeutics, Inc. |
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Consolidated Statements of Operations |
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(Unaudited, in thousands, except share and per share amounts) |
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Three Months Ended
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Six Months Ended
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2024 |
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2023 |
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Revenue: |
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Development fee and royalty |
$ — |
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$ 688 |
|
$ — |
|
$ 886 |
Total revenue |
— |
|
688 |
|
— |
|
886 |
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|
|
|
|
|
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Operating expenses: |
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|
|
|
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Research and development (1) |
32,636 |
|
17,386 |
|
67,564 |
|
31,162 |
General and administrative |
11,511 |
|
12,062 |
|
24,357 |
|
17,290 |
Acquired in-process research and development |
— |
|
130,486 |
|
— |
|
130,486 |
Total operating expenses |
44,147 |
|
159,934 |
|
91,921 |
|
178,938 |
Loss from operations |
(44,147) |
|
(159,246) |
|
(91,921) |
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(178,052) |
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|
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Other income (expense): |
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|
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|
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|
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Interest income |
5,920 |
|
350 |
|
10,352 |
|
770 |
Change in fair value of forward contract liability |
— |
|
(58,170) |
|
— |
|
(58,170) |
Other expense, net |
(610) |
|
(8) |
|
(1,093) |
|
(80) |
Total other income (expense) |
5,310 |
|
(57,828) |
|
9,259 |
|
(57,480) |
Loss before income tax expense |
(38,837) |
|
(217,074) |
|
(82,662) |
|
(235,532) |
Income tax (expense) benefit |
— |
|
(7) |
|
(32) |
|
29 |
Net loss |
$ (38,837) |
|
$ (217,081) |
|
$ (82,694) |
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$ (235,503) |
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|
|
|
|
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Net loss per share, basic and diluted |
$ (0.86) |
|
$ (56.79) |
|
$ (2.02) |
|
$ (62.03) |
Weighted-average common shares outstanding, basic and diluted |
45,316,264 |
|
3,822,605 |
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40,914,463 |
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3,796,699 |
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(1) |
Includes $9.4 million and |
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