Spyre Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update
Spyre Therapeutics, Inc. reported its first-quarter 2024 financial results and provided corporate updates. The company is advancing its anti-α4β7 antibody, SPY001, and anti-TL1A antibody, SPY002, towards first-in-human studies. With $485 million in cash and expected runway until 2027, Spyre is on track to achieve significant milestones in 2024 and beyond.
Successful completion of the 28-day GLP toxicity study for SPY001 with a clean safety profile
Raised $180 million in private placement equity financing, ensuring a strong financial foundation
$485 million in cash, cash equivalents, marketable securities, and restricted cash as of March 31, 2024, with expected runway into 2027
SPY001 and SPY002 on track for first-in-human studies in 2024, with promising interim data expected by year-end
Increased R&D and G&A expenses contributing to a net loss of $43.9 million for the first quarter of 2024
Net cash used in operating activities was $28.5 million for the first quarter of 2024
Insights
Exploring the financial stability of Spyre Therapeutics, the cash reserves are noteworthy. A strong cash position of
However, an increase in R&D expenses from
The net loss widening from
The therapeutic prospect of SPY001, with a promising safety profile and an anticipated human half-life that could permit infrequent dosing, positions Spyre Therapeutics at the forefront of patient-centric IBD treatment development. This scientific advancement could be a differentiator, offering competitive advantage and patient adherence benefits, subject to clinical outcomes.
Moving to SPY002, the preclinical data showing enhanced potency and a significantly extended half-life speaks to a strategy aimed at best-in-class status. This approach, if clinically validated, could disrupt the current IBD treatment paradigm—potentially enhancing the company's market positioning and investor appeal.
The appointment of Mark C. McKenna to the Board of Directors, with his track record in product development, is a strategic move likely to aid in navigating the complex landscape of drug development and commercialization. It’s a subtle yet influential factor for long-term corporate guidance and value creation.
SPY001's completion of the 28-day GLP toxicity study is a foundational step for its FIH studies, with interim data expected by the end of 2024. This progression into clinical trials is pivotal for the validation of efficacy and safety in humans, a significant milestone for potential FDA approval and commercialization.
The therapeutic potential of targeting α4β7 and TL1A in IBD, alongside IL-23 for SPY003, aligns with emerging immunology research. These targets are integral to the pathophysiology of IBD and advancements here could lead to substantial improvements in therapeutic outcomes for UC and CD patients—a demographic with a high unmet medical need.
The multi-target approach and exploration of rational therapeutic combinations may offer Spyre Therapeutics a diverse and resilient development portfolio. It positions the company to potentially address various patient subpopulations within the IBD spectrum, which can be translated into a strategic advantage in a market that often demands personalized medicine solutions.
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
"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 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 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
Research and Development (R&D) expenses: R&D expenses totaled
General and Administrative (G&A) expenses: G&A expenses totaled
Other income (expense): Other income for the first quarter totaled
Net Loss: Net loss totaled
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
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. | |||
March 31, | December 31, | ||
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, | 253,405 | 84,555 | |
STOCKHOLDERS' (DEFICIT) EQUITY | |||
Series A non-voting convertible preferred stock, | 184,927 | 184,927 | |
Preferred stock, | — | — | |
Common stock, | 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. | |||
Three Months Ended | |||
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 |
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SOURCE Spyre Therapeutics, Inc.
FAQ
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