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Associated Press
12-05-2025
- Business
- Associated Press
Apogee Therapeutics Provides Business Update, Pipeline Progress and Reports First Quarter 2025 Financial Results
Phase 2 APEX trial of APG777 in atopic dermatitis advancing with interim Part A 16-week data expected in mid-2025 and Part B actively enrolling First patient dosed in Phase 1b trial of APG777 in mild-to-moderate asthma with readout expected in 1H 2026 APG279 on track to initiate Phase 1b head-to-head trial vs DUPIXENT in 2025 with readout expected in 2H 2026 Positive interim Phase 1b readout of APG808 in patients with mild-to-moderate asthma demonstrated rapid, robust and sustained suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma $681.4million cash, cash equivalents and marketable securities supports runway into Q1 2028 SAN FRANCISCO and WALTHAM, Mass., May 12, 2025 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage biotechnology company advancing novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD) and other I&I indications, today provided business updates, pipeline progress and reported first quarter 2025 financial results. '2025 is poised to be a transformational year for Apogee, and we are pleased with the strong execution in the first quarter as we continue to advance therapies with the goal of reshaping the standard of care for patients living with I&I diseases,' said Michael Henderson, M.D., Chief Executive Officer of Apogee. 'We have made significant progress in our Phase 2 APEX trial of APG777, which is actively enrolling Part B and on track for the interim 16-week readout from Part A mid-year. Momentum continues across our programs, driven by the initiation of our Phase 1b trial of APG777 in patients with mild-to-moderate asthma, today's announcement of positive interim clinical trial results from our Phase 1b trial of APG808 in patients with mild-to-moderate asthma, as well as the positive Phase 1 interim readout for APG990, which exceeded all trial objectives and unlocked the potential for dosing APG279 (APG777 + APG990) two- to four- times per year with a single 2 mL co-formulated injection. Following these encouraging results from APG990, we are advancing our first-in-class combination strategy with plans to initiate a head-to-head Phase 1b study of APG279 versus DUPIXENT in AD later this year. With a very strong cash position and multiple catalysts across our portfolio in the months ahead, we are looking forward to an exciting and productive 2025 and 2026.' New independent market research reinforces APG777's potential to become a market leader in the rapidly expanding AD biologic space: Apogee conducted third-party quantitative market research in April 2025 and asked US patients and physicians the likelihood that they would switch to APG777 from their current or previous biologic assuming APG777 had similar efficacy and overall results to DUPIXENT and an every 3-month, or quarterly, injection maintenance schedule. 'Based on the recent market research we commissioned, APG777's potential quarterly dosing is highly preferred by both physicians and patients to other available options. Physicians expressed strong interest in both initiating new-to-biologic patients to APG777 as well as switching patients already on biologics to APG777, assuming comparable efficacy and safety to current biologics,' said Jeff Hartness, Chief Commercial Officer of Apogee. 'The AD biologic market is expanding rapidly—with year-to-date growth of 23% in total prescriptions and 44% in new-to-brand prescriptions—and new entrants are accelerating the shift from topicals to biologics. We believe APG777 is well positioned to transform the AD treatment landscape and significantly improve the quality of life for patients living with moderate-to-severe AD.' Pipeline Highlights and Upcoming Milestones First Quarter 2025 Financial Results About Apogee Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. APG777, the company's most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today's standard of care. For more information, please visit Forward Looking Statements Certain statements in this press release may constitute 'forward-looking statements' within the meaning of the federal securities laws, including, but not limited to, statements regarding: Apogee's plans for its current and future product candidates and programs; the anticipated timing of the initiation of its clinical trials, including the Phase 1b trial of APG279 (the combination of APG777 and APG990) in AD, the Phase 2 trial of APG777 in EoE, and the Phase 1 trial of APG333 in healthy volunteers; the expected timing of and results from its clinical trials, including data from Part A and Part B of its Phase 2 trial of APG777 in AD, Phase 1b trial of APG279 in AD, Phase 1 trial of APG333 in healthy volunteers, Phase 1b trial of APG777 in asthma; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of APG777, APG279, APG990, APG333, APG808, Apogee's other product candidates, including combination therapies, and any other potential programs; its planned business strategies; its expected timing for future pipeline updates; and its expectations regarding the time period over which Apogee's capital resources will be sufficient to funds its anticipated operations. Words such as 'may,' 'might,' 'will,' 'objective,' 'intend,' 'should,' 'could,' 'can,' 'would,' 'expect,' 'believe,' 'design,' 'estimate,' 'predict,' 'potential,' 'develop,' 'plan' or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee's filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company's control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee's preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee's clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee's Annual Report on 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. Investor Contact: Noel Kurdi VP, Investor Relations Apogee Therapeutics, Inc. [email protected] Media Contact: Dan Budwick 1AB Media [email protected]
Winnipeg Free Press
01-05-2025
- Automotive
- Winnipeg Free Press
Tariff turmoil prompts cloudy forecasts from General Motors, Harley-Davidson for the year ahead
NEW YORK (AP) — Uncertainty continues to hang over the latest round of financial results and forecasts for companies both big and small as they try to navigate a global trade system severely shaken by a shift in U.S. policy. Roughly half of the companies in the S&P 500 have reported their latest quarterly financial results, but the focus has been on how they will adjust to tariffs and any change in consumers' behavior. Here's a look a what companies are saying about tariffs and the potential impact: General Motors General Motors trimmed one of its profit measures as the carmaker braces for the potential impact from auto tariffs. Auto companies like General Motors have operations spread out throughout North America, with auto parts and assembly steps often crossing multiple borders before a car is produced. The company said that it expects full-year adjusted earnings before interest and taxes in a range of $10 billion to $12.5 billion. That's down from a previous range of $13.7 billion to $15.7 billion. The revised guidance includes a current tariff exposure of $4 billion to $5 billion. President Donald Trump signed executive orders Tuesday to relax some of his 25% tariffs on automobiles and auto parts. Harley-Davidson Harley-Davidson withdrew its financial forecast for the year because of uncertainty over tariffs and the economy. The iconic motorcycle maker said it is focusing on productivity measures, supply chain management and cost controls to help deal with the impact from tariffs. The company gets just under 70% of its revenue from within the U.S., according to FactSet. That leaves a large chunk of its revenue exposed to retaliatory tariffs from other nations. Hershey Hershey reaffirmed its financial forecasts for the year, which include assessments for tariff expenses as they currently stand. The chocolate maker estimates the current tariff expenses to range from about $15 million to $20 million in the second quarter. Hershey and other chocolate makers are already dealing with cocoa supply issues that have helped push prices higher. More than 70% of the global cocoa supply comes from West Africa and the region has been dealing with stressed and damaged crops for years. Church & Dwight During Elections Get campaign news, insight, analysis and commentary delivered to your inbox during Canada's 2025 election. Church & Dwight slashed its financial forecasts for the year as it faces the impact from tariffs and a potential slowdown in consumer spending. The maker of Arm & Hammer and other household and personal care products now expects earnings to range from flat to 2% growth. It previously forecast earnings growth of up to 8%. It estimated that its tariff exposure over the next 12 months is about $190 million. The company hopes to reduce that exposure by up to 80% with several measures, including no longer sourcing Waterpik flossers from China for the U.S. market. It will also potentially shut down or sell some of its brands. ___ AP writer Michelle Chapman contributed to this report.
