Spyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Spyre Therapeutics (NASDAQ:SYRE) reported Q4 and full year 2024 results, highlighting positive interim data from its Phase 1 trial of SPY001. The company strengthened its position with a $230 million public offering and maintains $603.1 million in cash reserves, extending runway into H2 2028.
Key developments include planned Phase 2 platform trial initiation in ulcerative colitis by mid-2025, expansion into rheumatoid arthritis with SPY002, and multiple expected data readouts. Q4 2024 financial results showed R&D expenses of $50.5 million (up from $33.7M in Q4 2023), G&A expenses of $10.8 million (down from $14.1M), and a net loss of $56.3 million.
The company's pipeline focuses on three validated targets in IBD treatment, with potential for subcutaneous maintenance dosing as monotherapy or combinations. Interim results for SPY001 showed favorable safety profiles and extended half-life supporting potential Q6M maintenance dosing.
Spyre Therapeutics (NASDAQ:SYRE) ha riportato i risultati del quarto trimestre e dell'intero anno 2024, evidenziando dati positivi intermedi dal suo studio di Fase 1 su SPY001. L'azienda ha rafforzato la sua posizione con un offerta pubblica di $230 milioni e mantiene $603,1 milioni in riserve di liquidità, estendendo il suo margine fino al secondo semestre del 2028.
Tra i principali sviluppi, si prevede l'avvio di uno studio di Fase 2 per la colite ulcerosa entro metà 2025, l'espansione nella artrite reumatoide con SPY002 e molteplici letture di dati attese. I risultati finanziari del quarto trimestre 2024 hanno mostrato spese per R&S di $50,5 milioni (in aumento rispetto ai $33,7 milioni del quarto trimestre 2023), spese generali e amministrative di $10,8 milioni (in diminuzione rispetto ai $14,1 milioni), e una perdita netta di $56,3 milioni.
Il pipeline dell'azienda si concentra su tre target validati nel trattamento delle IBD, con potenziale per dosaggi di mantenimento sottocutanei come monoterapia o in combinazioni. I risultati intermedi per SPY001 hanno mostrato profili di sicurezza favorevoli e una vita media prolungata che supportano un potenziale dosaggio di mantenimento ogni sei mesi.
Spyre Therapeutics (NASDAQ:SYRE) informó los resultados del cuarto trimestre y del año completo 2024, destacando datos interinos positivos de su ensayo de Fase 1 de SPY001. La compañía fortaleció su posición con una oferta pública de $230 millones y mantiene $603.1 millones en reservas de efectivo, extendiendo su margen hasta la segunda mitad de 2028.
Los desarrollos clave incluyen la iniciación planificada de un ensayo de plataforma de Fase 2 en colitis ulcerosa para mediados de 2025, la expansión en artritis reumatoide con SPY002 y múltiples lecturas de datos esperadas. Los resultados financieros del cuarto trimestre de 2024 mostraron gastos de I+D de $50.5 millones (aumento desde $33.7M en el cuarto trimestre de 2023), gastos generales y administrativos de $10.8 millones (disminución desde $14.1M), y una pérdida neta de $56.3 millones.
El pipeline de la compañía se centra en tres objetivos validados en el tratamiento de IBD, con potencial para dosificación de mantenimiento subcutáneo como monoterapia o en combinaciones. Los resultados interinos de SPY001 mostraron perfiles de seguridad favorables y una vida media prolongada que respaldan una posible dosificación de mantenimiento cada seis meses.
Spyre Therapeutics (NASDAQ:SYRE)는 2024년 4분기 및 연간 실적을 보고하며 SPY001의 1상 시험에서 긍정적인 중간 데이터를 강조했습니다. 회사는 2억 3천만 달러의 공모를 통해 입지를 강화했으며, 6억 3백만 달러의 현금 보유고를 유지하여 2028년 하반기까지의 운영 자금을 연장했습니다.
주요 개발 사항으로는 2025년 중반까지 궤양성 대장염에 대한 2상 플랫폼 시험 개시 계획, SPY002를 통한 류마티스 관절염으로의 확장, 그리고 여러 예상 데이터 공개가 포함됩니다. 2024년 4분기 재무 결과는 연구개발 비용이 5천 50만 달러로 (2023년 4분기 3천 370만 달러에서 증가), 일반 관리 비용이 1천 80만 달러로 (1천 410만 달러에서 감소), 순손실이 5천 630만 달러로 나타났습니다.
회사의 파이프라인은 IBD 치료를 위한 세 가지 검증된 타겟에 중점을 두고 있으며, 단독 요법 또는 조합으로서 피하 유지 요법의 가능성이 있습니다. SPY001의 중간 결과는 긍정적인 안전성 프로필과 잠재적인 6개월 유지 요법을 지원하는 연장된 반감기를 보여주었습니다.
Spyre Therapeutics (NASDAQ:SYRE) a annoncé les résultats du quatrième trimestre et de l'année complète 2024, mettant en avant des données intermédiaires positives de son essai de Phase 1 sur SPY001. L'entreprise a renforcé sa position avec une offre publique de 230 millions de dollars et maintient 603,1 millions de dollars en réserves de liquidités, prolongeant ainsi sa trésorerie jusqu'au second semestre 2028.
Les développements clés comprennent le lancement prévu d'un essai de plateforme de Phase 2 pour la colite ulcéreuse d'ici mi-2025, l'expansion dans l'arthrite rhumatoïde avec SPY002, et plusieurs résultats de données attendus. Les résultats financiers du quatrième trimestre 2024 ont montré des dépenses de R&D de 50,5 millions de dollars (en hausse par rapport à 33,7 millions de dollars au quatrième trimestre 2023), des dépenses générales et administratives de 10,8 millions de dollars (en baisse par rapport à 14,1 millions de dollars), et une perte nette de 56,3 millions de dollars.
Le pipeline de l'entreprise se concentre sur trois cibles validées dans le traitement de l'IBD, avec un potentiel pour des doses de maintien sous-cutanées en monothérapie ou en combinaison. Les résultats intermédiaires pour SPY001 ont montré des profils de sécurité favorables et une demi-vie prolongée soutenant une posologie de maintien potentielle tous les six mois.
Spyre Therapeutics (NASDAQ:SYRE) berichtete über die Ergebnisse des 4. Quartals und des gesamten Jahres 2024 und hob positive Zwischenresultate aus seiner Phase-1-Studie zu SPY001 hervor. Das Unternehmen stärkte seine Position mit einem öffentlichen Angebot von 230 Millionen Dollar und hält 603,1 Millionen Dollar an Barreserven, wodurch die finanzielle Stabilität bis in die zweite Hälfte von 2028 verlängert wird.
Wichtige Entwicklungen umfassen die geplante Einleitung einer Phase-2-Plattformstudie zur ulcerativen Kolitis bis Mitte 2025, die Expansion in die rheumatoide Arthritis mit SPY002 und mehrere erwartete Datenveröffentlichungen. Die finanziellen Ergebnisse des 4. Quartals 2024 zeigten F&E-Ausgaben von 50,5 Millionen Dollar (ein Anstieg von 33,7 Millionen Dollar im 4. Quartal 2023), allgemeine und administrative Ausgaben von 10,8 Millionen Dollar (ein Rückgang von 14,1 Millionen Dollar) und einen Nettoverlust von 56,3 Millionen Dollar.
Die Pipeline des Unternehmens konzentriert sich auf drei validierte Ziele in der Behandlung von IBD, mit Potenzial für subkutane Erhaltungsdosen als Monotherapie oder in Kombinationen. Zwischenresultate für SPY001 zeigten günstige Sicherheitsprofile und eine verlängerte Halbwertszeit, die potenzielle Erhaltungsdosen alle sechs Monate unterstützen.
- Robust cash position of $603.1M extending runway to H2 2028
- Successful $230M public offering completed
- Positive interim Phase 1 data for SPY001 supporting Q6M dosing
- Pipeline expansion into RA market with SPY002
- Multiple near-term catalysts with Phase 1 readouts in 2025
- Increased R&D expenses to $50.5M in Q4 2024 vs $33.7M in Q4 2023
- Net loss of $56.3M in Q4 2024
Insights
Spyre Therapeutics reported Q4 2024 results highlighting an exceptionally strong balance sheet with
The company's Q4 net loss of
Spyre's differentiated approach in the competitive IBD space centers on engineered antibodies with extended half-lives enabling significantly less frequent dosing. Their lead candidate SPY001 demonstrated a 90+ day half-life in Phase 1 trials, potentially supporting semi-annual maintenance dosing compared to competitors requiring monthly or bi-monthly administration – a compelling advantage for chronic conditions requiring lifelong treatment.
The company's strategic expansion into rheumatoid arthritis with their anti-TL1A antibody (SPY002) targets a 1.5+ million patient market in the US alone, representing significant commercial potential beyond their core IBD focus. Their innovative Phase 2 platform trial design will evaluate both monotherapies and combinations, potentially establishing a new efficacy benchmark in ulcerative colitis.
With multiple clinical catalysts expected through 2025-2026 and inclusion in the Nasdaq Biotechnology Index enhancing institutional visibility, Spyre's current
Spyre's pipeline represents a scientifically sophisticated approach to inflammatory disease treatment through antibody engineering that extends half-life while maintaining potency. Their lead candidate SPY001 (anti-α4β7) demonstrated >90-day half-life in Phase 1 studies – a 3-4x improvement over vedolizumab's ~25-day half-life – potentially enabling semi-annual dosing versus the current 8-week standard.
The company's multi-target strategy addresses three clinically validated IBD pathways through complementary mechanisms:
- SPY001 blocks immune cell trafficking to the gut via α4β7 inhibition
- SPY002 inhibits TL1A signaling, reducing inflammatory cytokine production
- SPY003 targets IL-23, a key upstream regulator of multiple inflammatory pathways
Their combination approach is particularly noteworthy as it targets distinct but complementary inflammatory mechanisms, potentially addressing the heterogeneous nature of IBD where single-target approaches often show response rates below
The expansion into rheumatoid arthritis with SPY002 is strategically sound as TL1A inhibition has shown promise in RA models by blocking both TNF-dependent and independent inflammatory pathways. This represents a potential advantage over existing TNF inhibitors that leave significant unmet need.
From a development perspective, Spyre's platform trial design is highly efficient, enabling parallel evaluation of multiple agents and combinations while reducing operational complexity and costs. Their ambitious timeline of four Phase 2 readouts in 2026 appears achievable given the modular trial design.
The key technical innovation underpinning their pipeline – YTE half-life extension technology – has been clinically validated in approved products, reducing development risk while maintaining the potential for best-in-class convenience through dramatically extended dosing intervals.
Reported positive interim pharmacokinetic ("PK") and safety data in Phase 1 trial of SPY001 in November 2024 and strengthened the balance sheet with a
Continued execution towards expected milestones across portfolio, with interim Phase 1 data readouts for SPY002 and SPY003 on-track for the second quarter and second half of 2025, respectively
Remain on track for initiation of Phase 2 platform trial in ulcerative colitis ("UC") in mid-2025 with SPY001 (α4β7), followed by SPY002 (TL1A), SPY003 (IL-23), and combinations thereof, with initial monotherapy results expected in 2026
Announced indication expansion into rheumatoid arthritis ("RA") with SPY002, with expected Phase 2 trial initiation in mid-2025 and top-line results in 2026
"In 2024, we initiated first-in-human studies for three of our next-generation antibodies and delivered outstanding interim Phase 1 results for SPY001, which underscore our portfolio's potential to revolutionize the treatment of IBD. Looking ahead, we are progressing our suite of therapeutics into a groundbreaking Phase 2 platform study in ulcerative colitis, which is designed to test both monotherapies and combination therapies with the potential for unified quarterly subcutaneous dosing in maintenance," said Cameron Turtle, DPhil., Chief Executive Officer. "Additionally, the expansion of SPY002 into a Phase 2 rheumatoid arthritis trial this year represents a key step in addressing a pressing unmet need in a disease that affects millions across the globe. We are well-positioned and well-capitalized to deliver a series of value-inflecting catalysts, including three Phase 1 readouts expected in 2025 and four Phase 2 proof-of-concept readouts expected in 2026."
Development Pipeline Overview and Update
The Company's approach combines best-in-class antibody engineering, dose optimization, and rational therapeutic combinations with the goal of maximizing efficacy, safety, and convenience in the treatment of IBD and other immune-mediated diseases. IBD is a chronic condition characterized by inflammation within the gastrointestinal tract, including two main disorders: 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 an undisclosed target. All three validated targets offer the potential for safe and effective treatment of UC and CD, with infrequent, subcutaneous maintenance dosing as a monotherapy or in rational combinations. The Company is also planning to study its anti-TL1A program in additional indications outside IBD, beginning with RA.
SPY001 – a highly potent and selective investigational monoclonal antibody targeting α4β7, 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 2024, interim healthy volunteer data from a Phase 1 trial were presented, demonstrating a favorable safety profile, a meaningfully differentiated PK profile relative to vedolizumab with half-life estimates greater than 90 days supporting potential Q6M maintenance dosing, and complete occupancy of α4β7 receptors out to 12 weeks at a single dose of 300mg.
- Longer-term data from this Phase 1 trial will be presented at a medical meeting later this year. Based on these interim results, Spyre plans to advance SPY001 to a Phase 2 clinical trial in UC patients in mid-2025.
SPY002 – a program with 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.
- In January 2025, the Company announced its intent to study one of its anti-TL1A antibodies in RA, with Phase 2 trial initiation expected in mid-2025 and topline results in 2026. With class-leading potency and half-life established in preclinical studies, SPY002 has the potential to become the first-in-class and best-in-class anti-TL1A treatment for RA.
- In December 2024, the Company initiated first-in-human ("FIH") trials of both SPY002 candidates, with healthy volunteer interim data expected in the second quarter of 2025. If successful, the Company expects one or more SPY002 candidates would then advance to Phase 2 clinical trials.
- In October 2024, preclinical data for both SPY002 development candidates were presented at the United European Gastroenterology Week ("UEGW") Congress demonstrating superior or comparable in vitro potency to first-generation anti-TL1As, as well as a pharmacokinetic half-life of 24 days in non-human primates ("NHPs"), which represents a two to three-fold increase compared to these same first-generation anti-TL1As.
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 October 2024, preclinical data for SPY003 were presented for the first time at UEGW, demonstrating comparable potency to risankizumab, as well as a pharmacokinetic half-life of 30 days in NHPs, greater than three-fold compared to risankizumab. These data also demonstrated that SPY003 exhibits high selectivity and affinity for IL-23 and potently inhibits downstream cellular signaling.
- SPY003 remains on track to initiate a FIH trial in the first quarter of 2025, with healthy volunteer interim data expected in the second half of 2025.
Rational Combinations – the Company plans to investigate combinations of our proprietary antibodies in nonclinical studies and clinical trials in order to evaluate whether combination therapy can potentially lead to best-in-class efficacy in IBD, with less frequent dosing.
- In February 2025, new preclinical data for SPY120 were presented at the 20th Congress of the European Crohn's and Colitis Organisation, demonstrating that the combined inhibition of TL1A and α4β7 is superior to either monotherapy in mouse models of colitis and that coadministration of SPY001 and SPY002 demonstrated no drug effects on PK in NHPs.
- In October 2024, preclinical data for SPY130 and SPY230 were presented at UEGW, demonstrating enhanced efficacy and pharmacodynamics with SPY003 in combination with SPY001 and with SPY002.
- The Company expects to initiate a Phase 2 clinical trial in 2025 that is intended to include each of its rational combinations, as well as all three of its lead monotherapy programs.
Recent Corporate Updates
- In December 2024, Spyre was added to the Nasdaq Biotechnology Index.
- In November 2024, the Company raised
in gross proceeds from a public offering of common stock with broad participation from both new and existing investors, extending cash runway into the second half of 2028.$230 million - In October 2024, the Company announced the appointment of Sheldon Sloan, M.D., M. Bioethics, as Chief Medical Officer. Dr. Sloan's 25+ years of experience in both large pharmaceutical and small biotech companies, featuring an extensive track record of program leadership in the field of Inflammation and Immunology, will be invaluable to guide the Company as it advances its potentially best-in-class IBD portfolio.
Fourth Quarter 2024 Financial Results
Cash Position: As of December 31, 2024, Spyre had cash, cash equivalents, and marketable securities 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 totaled
Net Loss: Net loss totaled
About Spyre Therapeutics
Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation inflammatory bowel disease (IBD) and other immune-mediated disease products by combining best-in-class antibody engineering, dose optimization, and rational therapeutic combinations. 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
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 | $ 89,423 | $ 188,893 | |
Marketable securities | 513,665 | 150,384 | |
Prepaid expenses and other current assets | 5,386 | 2,251 | |
Total current assets | 608,474 | 341,528 | |
Restricted cash | — | 322 | |
Other non-current assets | 10 | 9 | |
TOTAL ASSETS | $ 608,484 | $ 341,859 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
CURRENT LIABILITIES | |||
Accounts payable | $ 666 | $ 896 | |
CVR liability | 25,080 | 1,390 | |
Accrued and other current liabilities | 27,711 | 13,108 | |
Related party accounts payable | 603 | 16,584 | |
Total current liabilities | 54,060 | 31,978 | |
Non-current CVR liability | 36,620 | 41,310 | |
TOTAL LIABILITIES | 90,680 | 73,288 | |
Commitments and Contingencies | |||
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, | 13 | 10 | |
Additional paid-in capital | 1,334,223 | 763,191 | |
Accumulated other comprehensive income | 180 | 302 | |
Accumulated deficit | (972,432) | (764,414) | |
TOTAL STOCKHOLDERS' EQUITY | 517,804 | 184,016 | |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND | $ 608,484 | $ 341,859 | |
Spyre Therapeutics, Inc. | |||||||
Three Months Ended | Twelve Months Ended | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Revenue: | |||||||
Development fee and royalty | $ — | $ — | $ — | $ 886 | |||
Total revenue | — | — | — | 886 | |||
Operating expenses: | |||||||
Research and development (1) | 50,482 | 33,682 | 162,790 | 89,504 | |||
General and administrative | 10,771 | 14,072 | 45,776 | 39,946 | |||
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 | 61,253 | 45,914 | 208,566 | 243,189 | |||
Loss from operations | (61,253) | (45,914) | (208,566) | (242,303) | |||
Other (expense) income: | |||||||
Interest income | 5,776 | 4,126 | 21,312 | 6,147 | |||
Change in fair value of forward contract liability | — | — | — | (83,530) | |||
Other (expense) income, net | (818) | (21,392) | (20,713) | (19,130) | |||
Total other (expense) income | 4,958 | (17,266) | 599 | (96,513) | |||
Loss before income tax expense | (56,295) | (63,180) | (207,967) | (338,816) | |||
Income tax (expense) benefit | (1) | — | (51) | 26 | |||
Net loss | $ (56,296) | $ (63,180) | $ (208,018) | $ (338,790) | |||
Net loss per share, basic and diluted, Series A Preferred Stock | $ (32.28) | $ (49.17) | $ (127.21) | $ (550.28) | |||
Weighted-average Series A non-voting convertible preferred | 346,045 | 860,495 | 374,387 | 434,612 | |||
Net loss per share, basic and diluted, Series B Preferred Stock | $ (32.28) | $ (49.18) | $ (127.21) | $ (550.29) | |||
Weighted-average Series B non-voting convertible preferred | 16,667 | 34,239 | 85,208 | 8,630 | |||
Net loss per share, basic and diluted, common | $ (0.81) | $ (1.23) | $ (3.18) | $ (13.76) | |||
Weighted-average common shares outstanding, basic and diluted | 55,259,227 | 15,607,898 | 47,027,638 | 6,897,065 |
(1) | Includes |
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SOURCE Spyre Therapeutics, Inc.