Spyre Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update
- Strong financial position with $340 million in cash, cash equivalents, marketable securities, and restricted cash as of December 31, 2023.
- Raised $180 million in private placement equity financing with participation from new and existing investors.
- SPY001 demonstrated an updated half-life of 22 days, a greater than three-fold increase relative to vedolizumab in non-human primate pharmacokinetic data.
- SPY002 remains on track to begin first-in-human studies in the second half of 2024.
- Company has four programs in preclinical development, three of which are targets in IBD validated by third parties.
- SPY003 continues preclinical development efforts targeting the p19 subunit of IL-23.
- Appointment of new CEO, Cameron Turtle, and addition of industry veterans to the Board of Directors.
- Net loss totaled $63.2 million for the fourth quarter of 2023, including non-cash stock compensation expense.
- Increase in R&D expenses for the fourth quarter of 2023 compared to the same period in 2022.
- Net loss increased significantly from $18.8 million in the fourth quarter of 2022 to $63.2 million in the fourth quarter of 2023.
Insights
The financial results announced by Spyre Therapeutics indicate a robust cash position with $339.6 million in cash and equivalents, providing the company a runway into the second half of 2026. This is a strong indicator of financial health and strategic fundraising ability, particularly the $180 million raised in private placement. Such capital raises are critical for biotechnology firms, which often operate at a loss while developing their drug pipelines. Investors typically scrutinize burn rates and cash runways and Spyre's current position may provide some confidence in its ability to reach multiple clinical readouts without the immediate need for additional financing.
However, the reported net loss of $63.2 million for the fourth quarter of 2023, compared to $18.8 million for the same period in the previous year, reflects significant increases in R&D and G&A expenses. This uptick is expected as the company ramps up preclinical development and prepares for first-in-human studies. The increase in R&D expenses, from $14.3 million to $33.7 million year-over-year, is particularly noteworthy as it underscores the company's investment in its IBD pipeline. While high R&D costs are common in the biotech industry, they must eventually be balanced by successful product development and commercialization to achieve long-term sustainability.
Spyre Therapeutics' focus on inflammatory bowel disease (IBD) represents a strategic targeting of a chronic condition affecting millions. The advancement of their pipeline, including SPY001, SPY002 and SPY003, with potential best-in-class properties, could significantly impact the IBD treatment market if clinical trials prove successful. The updated half-life data for SPY001 and SPY002, indicating less frequent dosing, could offer a competitive advantage in terms of patient convenience and adherence to treatment regimens, which is a valuable proposition in drug development.
The biotechnology sector pays close attention to preclinical and early clinical data, as these are early indicators of a drug's potential. Spyre's presentation of preclinical data at ECCO and the planned initiation of first-in-human studies in 2024 are pivotal steps that could influence the company's market valuation and partnership opportunities. The appointment of experienced executives to the Board of Directors, such as Mark C. McKenna and the leadership of Cameron Turtle as CEO, also adds credibility to Spyre's strategic direction and operational execution capabilities. These corporate updates can have a positive impact on investor perception and potentially attract further investment or strategic partnerships.
The preclinical data presented by Spyre Therapeutics for its investigational therapies, SPY001 and SPY002, indicates a significant improvement in pharmacokinetics over existing treatments like vedolizumab. The extended half-life of these antibodies could lead to reduced dosing frequency, which is a substantial advancement in the treatment of IBD. This could improve patient compliance and quality of life. The targeting of specific subunits, such as the p19 subunit of IL-23 in SPY003, is based on validated scientific research, as seen in the referenced SEQUENCE study, suggesting a potential for superior efficacy.
It is important to note that the transition from preclinical to clinical development is fraught with challenges and many compounds fail to translate early promise into clinical success. Therefore, while the preclinical data is promising and supports the rationale for the therapeutic approach, the true test will come with first-in-human studies and subsequent clinical trials. The company's commitment to initiating Phase 2 evaluations of therapeutic combinations in 2025 suggests a forward-thinking approach to IBD treatment, potentially addressing multiple pathways of the disease.
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
"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
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.
- 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 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
Research and Development (R&D) expenses: R&D expenses totaled
General and Administrative (G&A) expenses: G&A expenses totaled
Gain on Sale of In-Process Research & Development Asset: During the fourth quarter of 2023, the Company recognized an additional
Other (expense) income: Other (expense) income for the fourth 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. | |||
December 31, | December 31, | ||
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, | 84,555 | — | |
STOCKHOLDERS' EQUITY | |||
Series A non-voting convertible preferred stock, | 184,927 | — | |
Preferred stock, | — | — | |
Common stock, | 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 | 341,859 | 71,144 | |
Spyre Therapeutics, Inc. | |||||||
Three Months Ended | Twelve Months Ended | ||||||
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 | 15,607,898 | 3,764,608 | 6,897,065 | 3,371,231 | |||
(1) | Includes |
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SOURCE Spyre Therapeutics, Inc.
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