Announced positive topline induction data from Part A of the Phase 2 SKYLINE trial of SPY001, demonstrating best-in-class efficacy potential and a safety profile consistent with the a4ß7 class
Announced over-enrollment and acceleration of topline readout to the third quarter of 2026 of the rheumatoid arthritis (“RA”) sub-study of the Phase 2 SKYWAY basket trial
Remain on track for 6 proof-of-concept readouts in 2026 across the SKYLINE and SKYWAY Phase 2 trials
Further strengthened the balance sheet with
common stock
“With our first Phase 2 readout of the year supporting a potential best-in-class profile for SPY001 in IBD, we have begun to deliver on the promise of what we believe is one of the most ambitious and differentiated pipelines in our industry. This result opened the possibility that our monotherapies could become valuable products in IBD and further strengthened our conviction that our combination therapies have the potential to deliver paradigm-changing efficacy for the more than two million Americans suffering from IBD,” said
Development Pipeline Overview and Update
The Company is pioneering long-acting antibodies and antibody combinations to redefine the standard of care in IBD and rheumatic diseases. 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
Each of the Company's monotherapy programs in IBD target validated mechanisms with the potential for safe and effective treatment of UC and CD with infrequent dosing as a monotherapy or in rational combinations. The Company is also studying its anti-TL1A program as a monotherapy in indications outside IBD, including RA, PsA, and axSpA.
The Company has two ongoing Phase 2 clinical trials with proof-of-concept data readouts in 2026:
SKYLINE Phase 2 Platform Trial in IBD - in
- Part A: Open-label assessment of the safety and preliminary efficacy of a single dose level of each investigational monotherapy. Enrollment for Part A has completed, with SPY001 Part A topline induction data announced in
April 2026 , and topline data expected for SPY002 and SPY003 in mid-2026 and the third quarter of 2026, respectively. - Part B: Randomized and placebo-controlled assessment of the safety and efficacy of monotherapies and combinations, designed to provide dose-ranging data on monotherapies, proof-of-concept, and contribution of components for combinations, with induction data expected in 2027.
SKYLINE is currently enrolling participants into Part B of the trial.
SKYWAY Phase 2 Basket Trial in Rheumatic Diseases (RA, PsA, axSpA) - in
- RA sub-study: Double-blind, placebo-controlled safety and efficacy study of two dose levels of SPY072 at Week 12 with open-label follow-up through Week 36. This sub-study has completed enrollment ahead of schedule and topline proof-of-concept data are expected in the third quarter of 2026.
- PsA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16 with open-label follow-up through Week 40. Enrollment continues in this sub-study and topline proof-of-concept data are expected in the fourth quarter of 2026.
- axSpA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16 with open-label follow-up through Week 40. Enrollment continues in this sub-study and topline proof-of-concept data are expected in the fourth quarter of 2026.
The investigational therapies being studied in the SKYLINE and SKYWAY clinical trials include:
SPY001 – a highly potent and selective investigational monoclonal antibody targeting a4ß7, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing.
- In
April 2026 , topline induction results were presented for SPY001 from Part A of the SKYLINE trial in ulcerative colitis subjects. 43 subjects were dosed with SPY001 and 41 subjects completed the induction period. SPY001 was well tolerated with a safety profile consistent with the a4ß7 class. SPY001 achieved the primary endpoint, demonstrating a statistically significant reduction in the Robart’s Histopathology Index (RHI) score of 9.2 points (p<0.0001). The rates of key secondary endpoints of clinical remission and endoscopic improvement were clinically meaningful at 40% and 51%, respectively.
SPY002 and SPY072 – two highly potent and selective, investigational anti-TL1A monoclonal antibodies, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing. The Company believes TL1A has emerged as one of the most promising targets in IBD and broader immunology indications. SPY002 is being evaluated for the treatment of IBD in the SKYLINE study and SPY072 is being evaluated for the treatment of rheumatic diseases in the SKYWAY study.
- In
June 2025 , interim healthy volunteer data from two Phase 1 trials (one for SPY002 and one for SPY072) were presented, demonstrating favorable safety profiles, meaningfully differentiated PK profiles supporting potential Q3M or Q6M maintenance dosing, and complete suppression of free TL1A through up to 20 weeks at single 100mg doses. Longer-term data from these Phase 1 trials were presented at medical meetings in late 2025, providing further support for these potential best-in-class profiles. - Based on these interim results, SPY002 was advanced to the SKYLINE Phase 2 platform trial, and SPY072 was advanced to the SKYWAY Phase 2 basket trial.
SPY003 – a highly potent and selective investigational monoclonal antibody targeting the p19 subunit of IL-23, engineered with half-life extension technology and formulated at high concentration with the goal of maximizing efficacy and enabling infrequent, subcutaneous maintenance dosing.
- In
November 2025 , interim healthy volunteer data from a Phase 1 trial were disclosed, demonstrating that SPY003 exhibited a favorable safety profile and a meaningfully differentiated PK profile supporting potential Q3M or Q6M maintenance dosing. Additional data from this Phase 1 trial were presented at the 21stCongress of the European Crohn’s andColitis Organisation ("ECCO") inFebruary 2026 , providing further support for this potential best-in-class profile. - Based on these interim results, SPY003 was advanced to the SKYLINE Phase 2 platform trial.
Rational Combinations – the Company plans to investigate combinations of our proprietary antibodies in nonclinical studies and clinical trials in order to evaluate whether combinations can potentially lead to best-in-class efficacy in IBD, with less frequent dosing.
- In February and
May 2025 , preclinical data for SPY120 were presented at medical meetings, demonstrating that the combined inhibition of TL1A and a4ß7 is superior to either monotherapy in mouse models of colitis and that the PK profiles of SPY001 and SPY002 were similar in non-human primates whether dosed as monotherapy or in combination, while also demonstrating no drug effects on PK. - Preclinical data for SPY130 and SPY230 have demonstrated enhanced efficacy and pharmacodynamics with SPY003 in combination with SPY001 and with SPY002.
- The Company is enrolling each of its combinations in Part B of the SKYLINE trial.
First Quarter 2026 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
Gain on Sale of
Total Other (Expense) Income: Other expense totaled
Net Loss: Net loss totaled
About
For more information, please visit http://spyre.com.
Safe Harbor / Forward Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding: the Company's future results of operations and financial position; its ability to achieve the expected benefits or opportunities with respect to its product candidates, including their potential commercialization, the possibility that its monotherapies could become valuable assets in IBD and the potential paradigm-shifting efficacy of its combination therapies; its business strategy, including its ability to successfully develop best-in-class therapeutics for IBD, RA, PsA, axSpA and other immune-mediated diseases that meaningfully improve both efficacy and convenience compared to today's standard of care and the Company's ability to develop first-in-class therapeutics for RD; the potential consistency of the SPY001, SPY002, SPY072 and SPY003 Phase 1 trial and Phase 2 trial final data readouts with previously disclosed data for the Company's programs; expectations regarding the drug delivery of the Company's product candidates, including in the form of a subcutaneous injection; the length of time that the Company believes its existing cash resources will fund its operations, including the expectation of cash runway extending into the second half of 2029; estimated market sizes and potential growth opportunities; its nonclinical and future clinical development activities, including the Company's plans for and timing of cohort initiation and data readouts for the ongoing SKYWAY Phase 2 basket trial and SKYLINE Phase 2 platform trial, enrollment of clinical trials and, the inclusion of each rational combination in Part B of the SKYLINE Phase 2 platform trial and the number of data readouts expected to be delivered in 2026 and 2027; the potential efficacy, tolerability, convenience, commercial viability and safety profile of its product candidates, including in combinations; the planned dosing regimen for SPY001, SPY002, SPY072 and SPY003, and combinations thereof, including the potential for a Q3M or Q6M dosing profile and the potential for such dosing profile to be the leading product profile in IBD and RD; the potential therapeutic benefits and economic value of its product candidates as monotherapies or in combinations and their extended half-life; and Spyre’s business plans, milestones, and goals. The words "opportunity," "potential," “milestones,” “pipeline,” “strategy,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “might,” “plan,” “possible,” “predict,” “should,” “will,” “would,” and similar expressions (including the negatives of these terms) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs and involve a number of risks and uncertainties, many of which are beyond Spyre’s control, and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited, uncertainties and risks arising from regulatory feedback, including potential disagreement by regulatory authorities with the Company’s interpretation of data and the Company’s clinical trials for its product candidates; the potential for interim data not being delivered within expected time frames or final data not being consistent with or different than the interim data reported for the Company’s programs; the potential impact of
Contact Information:
Media Contact
josie@1abmedia.com
Investor Contact
eric.mcintyre@spyre.com
Consolidated Balance Sheets (Unaudited, in thousands, except share and per share amounts) | |||||||
2026 | 2025 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS | |||||||
| Cash and cash equivalents | $ | 97,185 | $ | 85,721 | |||
| Marketable securities | 644,282 | 670,812 | |||||
| Prepaid expenses and other current assets | 22,486 | 21,248 | |||||
| Total current assets | 763,953 | 777,781 | |||||
| TOTAL ASSETS | $ | 763,953 | $ | 777,781 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| CURRENT LIABILITIES | |||||||
| Accounts payable | $ | 5,692 | $ | 8,904 | |||
| CVR liability | 50,260 | 22,820 | |||||
| Accrued and other current liabilities | 29,160 | 26,947 | |||||
| Related party accounts payable | 50 | 14 | |||||
| Total current liabilities | 85,162 | 58,685 | |||||
| Non-current CVR liability | 6,690 | 3,860 | |||||
| Other non-current liabilities | 1,290 | — | |||||
| TOTAL LIABILITIES | 93,142 | 62,545 | |||||
| Commitments and Contingencies | |||||||
| STOCKHOLDERS’ EQUITY | |||||||
| Series A non-voting convertible preferred stock, | 146,425 | 146,425 | |||||
| Series B non-voting convertible preferred stock, | 9,395 | 9,395 | |||||
| Preferred stock, | — | — | |||||
| Common stock, | 15 | 15 | |||||
| Additional paid-in capital | 1,712,383 | 1,686,167 | |||||
| Accumulated other comprehensive (loss) income | (767 | ) | 869 | ||||
| Accumulated deficit | (1,196,640 | ) | (1,127,635 | ) | |||
| TOTAL STOCKHOLDERS’ EQUITY | 670,811 | 715,236 | |||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY | $ | 763,953 | $ | 777,781 | |||
Consolidated Statements of Operations (Unaudited, in thousands, except share and per share amounts) | |||||||
| Three Months Ended | |||||||
| 2026 | 2025 | ||||||
| Operating expenses: | |||||||
| Research and development (1) | 60,411 | 41,623 | |||||
| General and administrative (2) | 15,230 | 11,944 | |||||
| Gain on sale of in-process research and development asset | (30,000 | ) | — | ||||
| Total operating expenses | 45,641 | 53,567 | |||||
| Loss from operations | (45,641 | ) | (53,567 | ) | |||
| Other (expense) income: | |||||||
| Interest income | 6,995 | 6,493 | |||||
| Other (expense) income, net | (30,359 | ) | 2,286 | ||||
| Total other (expense) income | (23,364 | ) | 8,779 | ||||
| Loss before income tax expense | (69,005 | ) | (44,788 | ) | |||
| Income tax benefit | — | 15 | |||||
| Net loss | $ | (69,005 | ) | $ | (44,773 | ) | |
| Net loss per share, basic and diluted, Series A Preferred Stock | $ | (29.66 | ) | $ | (23.95 | ) | |
| Weighted-average Series A non-voting convertible preferred stock outstanding, basic and diluted | 346,045 | 346,045 | |||||
| Net loss per share, basic and diluted, Series B Preferred Stock | $ | (29.66 | ) | $ | (23.95 | ) | |
| Weighted-average Series B non-voting convertible preferred stock outstanding, basic and diluted | 16,667 | 16,667 | |||||
| Net loss per share, basic and diluted, common | $ | (0.74 | ) | $ | (0.60 | ) | |
| Weighted-average common stock outstanding, basic and diluted | 78,548,709 | 60,265,932 | |||||
(1) Includes
(2) Includes related party expenses of
