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Spyre Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

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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.

Positive
  • 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
Negative
  • 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 $603.1 million in cash and investments, providing runway into H2 2028 – a 3.5+ year operational window that significantly de-risks their development timeline through multiple clinical readouts.

The company's Q4 net loss of $56.3 million (improved from $63.2 million in Q4 2023) reflects disciplined spending despite increased R&D investment ($50.5 million vs. $33.7 million year-over-year) to advance their antibody pipeline. This burn rate of approximately $37.2 million quarterly appears well-managed relative to their substantial cash reserves.

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 $1.2 billion market cap appears to reflect early-stage risk while providing substantial upside potential if their differentiated antibody engineering approach demonstrates superior efficacy and convenience in upcoming trials.

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 50%. Preclinical data demonstrating superior efficacy with combinations versus monotherapy provides compelling scientific rationale.

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 $230 million public offering

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

$603 million of cash, cash equivalents, and marketable securities as of December 31, 2024, with expected runway into the second half of 2028

WALTHAM, Mass., Feb. 27, 2025 /PRNewswire/ -- Spyre Therapeutics, Inc. ("Spyre" or the "Company") (NASDAQ:SYRE), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, dose optimization, and rational therapeutic combinations to target improved efficacy and convenience in the treatment of inflammatory bowel disease ("IBD") and other immune-mediated diseases, today announced its fourth quarter and full year 2024 financial results and provided program and corporate updates.

"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 United States, it is estimated that approximately 2.4 million individuals are diagnosed with IBD. RA is a chronic inflammatory autoimmune condition that primarily affects the joints but also other parts of the body. It is characterized by pain, stiffness, and swelling of one or more joints and can progress from mild swelling of the joints in early stages to severe deformations of the feet, ankles, and hands in late/severe stages. RA affects more than 1.5 million individuals in the United States.

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 $230 million 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.
  • 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 $603.1 million. Net cash used in operating activities was $37.2 million for the fourth quarter of 2024. In November 2024, the Company raised $230 million in gross proceeds, before deducting $14.2 million in underwriting discounts, commissions, and other offering expenses, from a public offering of common stock.

Research and Development (R&D) expenses: R&D expenses totaled $50.5 million for the fourth quarter of 2024 and $33.7 million for the fourth quarter of 2023. The increase was primarily driven by nonclinical and clinical development, as well as manufacturing expenses, for the Company's pipeline candidates.

General and Administrative (G&A) expenses: G&A expenses totaled $10.8 million for the fourth quarter of 2024 and $14.1 million for the fourth quarter of 2023. The decrease was driven by higher stock compensation expense related to the Spyre acquisition in the fourth quarter of 2023.

Other income (expense): Other income totaled $5.0 million for the fourth quarter of 2024 primarily driven by interest earned on the Company's cash and marketable securities. For the fourth quarter of 2023, other expense totaled $17.3 million, primarily driven by an increase in the Company's CVR liability related to the increased likelihood of certain milestone payments related to pegzilarginase reimbursement in European markets, partially offset by interest earned on the Company's cash and marketable securities.

Net Loss: Net loss totaled $56.3 million and $63.2 million for the fourth quarters of 2024 and 2023, respectively, which includes non-cash stock compensation expense of $9.2 million and $17.3 million for the fourth quarters of 2024 and 2023, respectively.

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 U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical fact are forward-looking statements. These forward-looking statements include statements regarding the Company's future results of operations and financial position; its business strategy, including the Company's ability to successfully develop best-in-class and/or first-in-class therapeutics for IBD, RA, or other immune-mediated diseases that meaningfully improve both efficacy and convenience compared to today's standard of care; the SPY001 Phase 1 trial final data readouts not being consistent with or being different than the interim Phase 1 results; the sufficiency of the Company's funding to support the development of its assets, including expectations of cash runway extending into the second half of 2028; the length of time that the Company believes its existing cash resources will fund its operations; estimated market sizes and potential growth opportunities; its nonclinical and future clinical development activities; clinical trial designs and related regulatory feedback; further clinical evaluation of therapeutic combinations; the potential efficacy, tolerability, convenience, commercial viability and safety profile of its product candidates, including in combinations; the planned dosing regimen for SPY001 and our other product candidates, including the potential for a Q6M dosing profile; the potential therapeutic benefits and economic value of its product candidates as monotherapies or in combinations and their extended half-life; the timing for initiation of nonclinical studies and clinical trials, including the commencement of FIH and Phase 2 trials; and the planned expansion of SPY002 into RA, including timing thereof. The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "predict," "target," "intend," "could," "would," "should," "project," "plan," "expect," the negatives of these terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the expected or potential impact of macroeconomic conditions, including U.S. elections inflationary pressures, rising interest rates, general economic slowdown or a recession, changes in monetary policy, the prospect of a shutdown of the U.S. federal government, volatile market conditions, financial institution instability, as well as geopolitical instability, including the ongoing military conflict in Ukraine, conflict in Israel and surrounding areas, and geopolitical tensions in China on the Company's operations, the potential impacts of the BIOSECURE Act bill if passed into law and those risks described in the Company's Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, as well as in other filings and reports that the Company makes from time to time with the Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for the Company's management to predict all risks, nor can the Company assess the impact of all factors on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

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.
Consolidated Balance Sheets
(Unaudited, in thousands, except share and per share amounts)



December 31,
2024


December 31,
2023

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, $0.0001 par value; 150,000 shares
authorized, issued, and outstanding as of December 31, 2023.


84,555

STOCKHOLDERS' EQUITY




Series A non-voting convertible preferred stock, $0.0001 par value; 1,086,341 shares
authorized as of December 31, 2024 and December 31, 2023; 346,045 and 437,037
shares issued and outstanding as of December 31, 2024 and December 31, 2023,
respectively.

146,425


184,927

Series B non-voting convertible preferred stock, $0.0001 par value; 271,625 shares
authorized and 16,667 shares issued and outstanding as of December 31, 2024.

9,395


Preferred stock, $0.0001 par value; 8,642,034 shares and 8,763,659 shares
authorized as of December 31, 2024 and December 31, 2023, respectively; no shares
issued and outstanding as of December 31, 2024 and December 31, 2023.


Common stock, $0.0001 par value; 400,000,000 shares authorized as of
December 31, 2024 and December 31, 2023; 60,257,023 shares and 36,057,109
shares issued and outstanding as of December 31, 2024 and December 31, 2023,
respectively.

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
STOCKHOLDERS' EQUITY

$         608,484


$         341,859





 

Spyre Therapeutics, Inc.
Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share amounts)



Three Months Ended
December 31,


Twelve Months Ended
December 31,


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
stock outstanding, basic and diluted

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
stock outstanding, basic and diluted

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 $6.1 million and $41.2 million in related party expenses for the three and twelve months ended December 31, 2024, respectively, and $27.7 million and $48.5 million related party expenses for the three and twelve months ended December 31, 2023, respectively.

 

Spyre Therapeutics, Inc. (PRNewsfoto/Spyre Therapeutics, Inc.)

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/spyre-therapeutics-reports-fourth-quarter-and-full-year-2024-financial-results-and-provides-corporate-update-302385753.html

SOURCE Spyre Therapeutics, Inc.

FAQ

What were Spyre Therapeutics (SYRE) Q4 2024 financial results?

SYRE reported Q4 2024 R&D expenses of $50.5M, G&A expenses of $10.8M, and a net loss of $56.3M, with $603.1M in cash reserves as of December 31, 2024.

When will Spyre Therapeutics (SYRE) initiate its Phase 2 platform trial for ulcerative colitis?

SYRE plans to initiate the Phase 2 platform trial in ulcerative colitis in mid-2025, with initial monotherapy results expected in 2026.

What were the key findings from SPY001's Phase 1 trial in November 2024?

SPY001 showed favorable safety profile, extended PK profile with >90 days half-life supporting Q6M dosing, and complete α4β7 receptor occupancy at 12 weeks with 300mg dose.

How did the November 2024 public offering impact SYRE's cash runway?

The $230M public offering extended SYRE's cash runway into the second half of 2028.

What are the expected clinical trial milestones for SYRE in 2025?

SYRE expects interim Phase 1 data readouts for SPY002 in Q2 2025 and SPY003 in H2 2025, plus Phase 2 trial initiations in UC and RA by mid-2025.
Spyre Therapeutics

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