Core Insights - Spyre Therapeutics reported positive interim pharmacokinetic and safety data for SPY001 in a Phase 1 trial and raised $230 million through a public offering to strengthen its balance sheet [1][12] - The company is on track for multiple milestones, including interim Phase 1 data readouts for SPY002 and SPY003 expected in 2025, and the initiation of a Phase 2 trial for SPY001 in ulcerative colitis planned for mid-2025 [1][2] - The company aims to expand SPY002 into rheumatoid arthritis with a Phase 2 trial initiation also expected in mid-2025 [1][11] Financial Overview - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities totaling $603 million, providing a financial runway into the second half of 2028 [1][12] - Research and development expenses for Q4 2024 were $50.5 million, an increase from $33.7 million in Q4 2023, driven by clinical development and manufacturing costs [13] - General and administrative expenses decreased to $10.8 million in Q4 2024 from $14.1 million in Q4 2023, attributed to higher stock compensation expenses in the previous year [14] Development Pipeline - The company has four programs in development, with three targeting inflammatory bowel disease (IBD) and one undisclosed target [4] - SPY001 is a monoclonal antibody targeting α4β7, showing a favorable safety profile and a half-life greater than 90 days, supporting potential Q6M maintenance dosing [5][6] - SPY002 and SPY003 are also being developed with half-life extension technology, aiming for infrequent subcutaneous maintenance dosing [6][7] Recent Corporate Updates - The company initiated first-in-human trials for SPY002 in December 2024, with interim data expected in Q2 2025 [11] - SPY003 is on track to begin its first-in-human trial in Q1 2025, with interim data anticipated in the second half of 2025 [11] - Spyre was added to the Nasdaq Biotechnology Index in December 2024, reflecting its growing presence in the biotech sector [11]

Revenue Recognition - The company recognized revenue of $0.9 million for the year ended December 31, 2023, compared to $2.3 million for the previous year, primarily from the PEACE Phase 3 trial and early access programs [443]. - The company has not generated any revenue from commercial product sales and future revenues depend on successful development and regulatory approval of product candidates [441]. - For the year ended December 31, 2024, total revenue was $0, a decrease of $886,000 or 100% compared to $886,000 in 2023 [481]. - The company did not recognize any revenue in connection with the Immedica Agreement for the year ended December 31, 2024, compared to $0.9 million in 2023 [482]. - Total revenue for 2024 was $886,000, a significant decrease from $2,329,000 in 2023, representing a decline of approximately 62% [537]. Expenses and Losses - Research and development expenses for the year ended December 31, 2023, included restructuring expenses of $6.4 million, with $5.3 million paid during the year [456]. - The company experienced an approximate 83% reduction in headcount by June 30, 2023, as part of a restructuring plan initiated in response to inconclusive interim trial results [454]. - An impairment loss of $0.9 million was recognized related to the operating lease right-of-use asset and $1.7 million for leasehold improvements after abandoning the leased office space in Austin, Texas [458]. - Research and development expenses increased by $73.3 million, or 82%, to $162.8 million for the year ended December 31, 2024, from $89.5 million in 2023 [483]. - General and administrative expenses rose by $5.8 million, or 15%, to $45.8 million for the year ended December 31, 2024, compared to $39.9 million in 2023 [481]. - The net loss for the year ended December 31, 2024, was $208.0 million, a decrease of $130.8 million from a net loss of $338.8 million in 2023 [481]. - The net loss for 2024 was $208,018,000, compared to a net loss of $338,790,000 in 2023, indicating an improvement of approximately 39% [539]. - The company reported a total comprehensive loss of $208,140,000 for 2024, down from $338,440,000 in 2023, showing a decrease of approximately 38% [539]. Financing and Cash Flow - The company completed the sale of global rights to pegzilarginase to Immedica for $15.0 million in upfront cash and up to $100.0 million in contingent milestone payments [445]. - Cash used in operating activities was $157.4 million in 2024, compared to $99.9 million in 2023 [502][503]. - Cash provided by financing activities was $410.9 million in 2024, up from $361.1 million in 2023 [506][507]. - The company anticipates needing additional financing in the future to fund further research and development [493]. - The Company raised approximately $1.3 billion in gross proceeds from various financing activities since inception [566]. - The Company completed a public offering of 8,366,250 shares of common stock at a price of $27.50 per share in November 2024, resulting in net proceeds of approximately $215.9 million [564]. Assets and Liabilities - As of December 31, 2024, the company had an accumulated deficit of $972.4 million [492]. - The company held $603.1 million in cash, cash equivalents, marketable securities, and restricted cash as of December 31, 2024 [513]. - As of December 31, 2024, total assets increased to $608.5 million from $341.9 million in 2023, representing a growth of approximately 78% [534]. - The total liabilities increased to $90.7 million in 2024 from $73.3 million in 2023, reflecting a rise of about 24% [534]. - The CVR liability as of December 31, 2024, was recorded at $61.7 million, with an increase of $19.0 million for the year, primarily due to changes in fair value [529]. - The accumulated deficit grew to $972.4 million in 2024 from $764.4 million in 2023, indicating an increase of approximately 27% [534]. - The total stockholders' equity rose to $517.8 million in 2024, up from $184.0 million in 2023, representing a growth of about 181% [534]. Internal Controls and Compliance - The Company reported a material weakness in internal control over financial reporting as of December 31, 2024, related to the evaluation of Series A and Series B Preferred Stock [520]. - The Company’s management is responsible for maintaining effective internal control over financial reporting, which was found to be ineffective in certain respects as of December 31, 2024 [520]. Research and Development - The company plans to investigate combination therapies of its proprietary antibodies to enhance efficacy in treating immune-mediated diseases [438]. - External research and development expenses increased to $140.7 million in 2024 from $72.7 million in 2023, a rise of 93% [484]. - Internal research and development expenses rose to $22.1 million in 2024 from $16.8 million in 2023, an increase of 31% [485]. - The increase in research and development expenses was primarily driven by a $43.4 million increase in manufacturing costs and a $34.0 million increase in nonclinical and clinical development [483]. Marketable Securities - The estimated fair value of total marketable securities increased to $513.67 million in 2024 from $150.38 million in 2023 [632]. - The company reported net unrealized losses on marketable securities of $0.1 million for the year ended December 31, 2024, compared to net unrealized gains of $0.3 million in 2023 [631]. - The total unrealized losses on marketable securities as of December 31, 2024, were $493,000, with significant losses attributed to U.S. government treasury securities [630]. - The company classified all marketable securities as current assets, allowing for potential sales before maturity [633].

Company Overview - Spyre Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing advanced antibody engineering and therapeutic combinations for treating Inflammatory Bowel Disease (IBD) and other immune-mediated diseases [3]. Upcoming Events - The company will participate in the TD Cowen 45th Annual Healthcare Conference on March 4, 2025, at 3:10 PM ET, featuring a fireside chat and one-on-one meetings [1]. - Additionally, Spyre Therapeutics will attend the Jefferies Biotech on the Beach Summit on March 11, 2025, which will consist of one-on-one meetings [2]. Product Pipeline - Spyre's pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23, aimed at addressing IBD and other immune-mediated diseases [3].

Core Insights - Spyre Therapeutics, Inc. presented preclinical findings at the 20th Congress of the European Crohn's and Colitis Organisation (ECCO) indicating that the combined inhibition of α4β7 integrin and TL1A cytokine is more effective than either treatment alone in mouse models of colitis [1][2] - The pharmacokinetic profiles of the antibodies SPY001 and SPY002 showed no drug-drug effects when administered together in non-human primates, suggesting potential for less frequent dosing in humans [2] Company Overview - Spyre Therapeutics is focused on developing next-generation therapies for inflammatory bowel disease (IBD) and other immune-mediated diseases through advanced antibody engineering and rational therapeutic combinations [3] - The company's pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23, with ongoing research into their efficacy and dosing regimens [3]

Core Viewpoint - Spyre Therapeutics (SYRE) has shown a 0.9% increase in share price over the past four weeks, closing at $22.65, with analysts projecting a potential upside of 158.9% based on a mean price target of $58.63 [1][12]. Price Targets - The average price target consists of eight estimates ranging from a low of $40 to a high of $71, with a standard deviation of $12.36, indicating variability among analysts [2]. - The lowest estimate suggests a 76.6% increase from the current price, while the highest estimate indicates a 213.5% upside [2]. Analyst Sentiment - There is strong agreement among analysts regarding SYRE's ability to exceed previous earnings predictions, which supports the expectation of a stock price increase [4][9]. - Over the last 30 days, the Zacks Consensus Estimate for the current year has risen by 2%, with one estimate increasing and no negative revisions [10]. Zacks Rank - SYRE holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting a strong potential for upside in the near term [11].

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud and unlawful business practices involving Spyre Therapeutics, Inc. following the company's disclosure of issues with its financial statements [1][2]. Financial Reporting Issues - On November 18, 2024, Spyre announced that its previously issued audited financial statements for the year ending December 31, 2023, and interim periods should no longer be relied upon due to a misapplication of Generally Accepted Accounting Principles [2]. - The misapplication involved the exclusion of Series A and Series B non-voting convertible preferred stock in the calculation of basic and diluted net loss per share, along with a finding of material weakness in internal control over financial reporting [2]. - Spyre plans to amend its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q for the affected periods to correct the net loss per share figures [2]. Stock Market Reaction - Following the announcement of the financial reporting issues, Spyre's stock price experienced a significant decline during intraday trading on November 19, 2024 [2]. Legal Context - Pomerantz LLP is recognized for its expertise in corporate, securities, and antitrust class litigation, having a long history of fighting for victims of securities fraud and corporate misconduct [3].

Core Insights - Spyre Therapeutics is advancing its clinical pipeline with multiple antibody candidates targeting inflammatory bowel disease (IBD) and rheumatoid arthritis (RA), with significant milestones expected in 2025 and 2026 [2][3][11] Clinical Development - Phase 1 interim results for SPY002 and SPY003 are anticipated in 2Q2025 and 2H2025 respectively [1][6] - A Phase 2 platform trial for ulcerative colitis (UC) is set to begin in mid-2025, involving SPY001, SPY002, SPY003, and their combinations, with initial results expected in 2026 [1][11] - The SPY002 program is expanding into RA, with a Phase 2 trial expected to start in mid-2025 and topline results projected for 2026 [1][3][11] Financial Position - The company reported a strong balance sheet with over $600 million in cash, cash equivalents, and marketable securities as of December 31, 2024, providing operational runway into the second half of 2028 [2][8] Product Pipeline - SPY001 is a highly potent anti-α4β7 monoclonal antibody with a half-life exceeding 90 days, supporting potential quarterly to semi-annual dosing [6][11] - SPY002 consists of two extended half-life anti-TL1A antibodies, with Phase 1 studies initiated in Q4 2024 [6][11] - SPY003 targets the p19 subunit of IL-23, with Phase 1 initiation on track for Q1 2025 [6][11] Market Opportunity - The expansion into RA addresses a significant unmet need for effective treatments, with evidence supporting the efficacy of anti-TL1A in RA [3][11]

WALTHAM, Mass., Dec. 18, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. (NASDAQ: SYRE), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of Inflammatory Bowel Disease ("IBD"), today announced Spyre has been added to the Nasdaq Biotechnology Index (Nasdaq: NBI), effective prior to market open, Monday, December 23, 2024. The NBI is designed to tra ...

NEW YORK, Dec. 03, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Spyre Therapeutics, Inc. (“Spyre” or the “Company”) (NASDAQ:SYRE) on behalf of Spyre stockholders. Our investigation concerns whether Spyre has violated the federal securities laws and/or engaged in other unlawful business practices. Click here to participate in the action. On November 18, 2024, Spyre disclosed in a filing with the U.S. Secur ...

Spyre is concurrently advancing two anti-TL1A molecules into first-in-human studiesPreclinical data for both SPY002 molecules demonstrate picomolar potency and potential for quarterly or twice-yearly dosing, suggesting opportunity for improved efficacy and convenience over first-generation anti-TL1As which are dosed every two to four weeksInterim pharmacokinetic, pharmacodynamic, and safety data from healthy volunteers for both SPY002 molecules anticipated in the second quarter of 2025Spyre expects to intro ...