Introduction Justine Koenigsberg, Vice President, Investor Relations Kymera Therapeutics Fourth Quarter & Full Year 2024 Quarterly Results Call February 27, 2025 Agenda Key Highlights & Business Update Nello Mainolfi, PhD, Founder, President and Chief Executive Officer Clinical Update Jared Gollob, MD, Chief Medical Officer Financial Review Bruce Jacobs, CFA, MBA, Chief Financial Officer Question and Answer Session Forward Looking Statements This presentation contains forward-looking statements within the m ...

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4FRONT-1 Phase 3 expected data readout accelerated from H2 2027 to H1 20274FRONT-2 Phase 3 trial initiated ahead of schedule Streamlined late-stage clinical and pre-commercial organization aligns with focused pipeline shift, as announced in January 2025 EMERYVILLE, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigm ...

NEW YORK, July 02, 2025 (GLOBE NEWSWIRE) -- Wolf Haldenstein Adler Freeman & Herz LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Southern District of New York on behalf of investors who purchased or otherwise acquired Sarepta Therapeutics, Inc. (“Sarepta” or the “Company”) (NASDAQ: SRPT) securities between June 22, 2023 and June 24, 2025, inclusive (the “Class Period”). Investors who purchased or otherwise acquired shares of Sarepta should contact the Firm prior ...

Core Insights - The Zacks Medical - Outpatient and Home Healthcare industry is experiencing a significant shift towards digital healthcare, driven by rising demand for telemedicine and AI-powered services, particularly due to an aging global population and increasing healthcare costs [1][4][9]. Industry Overview - The industry includes companies providing outpatient care and home healthcare services, utilizing advanced medical technologies for diagnosis and treatment. The sector has shown steady growth post-pandemic, supported by innovation and the shift towards value-based care models [3][6]. - The global home healthcare market was valued at $390.24 billion in 2023, with an expected CAGR of approximately 7.9% from 2024 to 2030 [1]. Major Trends - **Aging Population**: The growing elderly population is a primary driver for home healthcare services, increasing the demand for chronic disease management and rehabilitation [4]. - **Cost Effectiveness**: Outpatient clinics offer cost-effective care, supported by financial incentives from health plans and government programs [5]. - **AI Integration**: AI is enhancing healthcare delivery, with outpatient companies utilizing automated systems for better patient outcomes and efficiency [7]. - **Technological Advancements**: Virtual assistants and chatbots are becoming integral in patient care, aiding in appointment scheduling and medication compliance [8]. Challenges - **Staffing Shortages**: The U.S. healthcare sector faces significant staffing shortages, particularly among home health aides, exacerbated by high burnout rates [10]. - **Tariff Impact**: New U.S. tariffs have increased costs for imported medical supplies, straining home healthcare providers and leading to operational challenges [11]. Market Performance - The industry has outperformed its sector but underperformed compared to the S&P 500, gaining 6.8% over the past year versus the S&P 500's 12.1% gain [14]. - The industry is currently trading at a forward P/E of 19.8X, lower than the S&P 500's 22.3X [18]. Notable Companies - **Quest Diagnostics**: Expected revenue growth of 9.2% for 2025, with a strong return on equity (ROE) of 15.1% [22][23]. - **Encompass Health**: Anticipated revenue growth of 9.5% for 2025, with an ROE of 17.6% [25][26]. - **The Pennant Group**: Projected revenue growth of 23.3% for 2025, with an ROE of 10.7% [29][30]. - **DaVita**: Expected revenue growth of 5.2% for 2025, with a notably high ROE of 176.1% [33][34].

Industry Overview - The biotech industry has shown resilience amid global trade tensions, with ongoing geopolitical issues presenting challenges, yet the demand for innovative medical treatments remains strong [1] - Strategic collaborations and acquisitions are increasingly common as large pharma and biotech companies seek to expand their product portfolios and pipelines, particularly in the context of AI-driven drug discovery [2][9] - The Zacks Biomedical and Genetics industry is currently ranked 86, placing it in the top 35% of over 246 Zacks industries, indicating a decent outlook driven by consistent demand for medical advancements [15] Market Trends - The focus on high-profile drug performance and innovative pipeline development is critical, with significant R&D expenditures required to create breakthrough treatments [6] - Successful commercialization is essential for drug uptake, often leading smaller biotech firms to collaborate with larger companies for shared sales or royalties [7] - The recent emphasis on AI technology for drug discovery is expected to attract further investment into the biotech sector [11] Company Performance - Exelixis, Inc. (EXEL) is positioned well with its lead drug, Cabometyx, which is gaining traction in the oncology market, and its shares have surged 31% year to date [35][36] - Verona Pharma (VRNA) has seen a 94.8% increase in shares year to date, driven by the uptake of its drug Ohtuvayre for COPD, with further growth anticipated [24] - Alkermes (ALKS) is benefiting from strong sales of its proprietary drugs and has a Zacks Rank of 1, with EPS estimates for 2025 rising to $1.79 [26][27] - Immunocore Holdings (IMCR) focuses on TCR bispecific immunotherapies and has gained 11.4% year to date, with ongoing studies expected to enhance its market position [30][32] - Kiniska Pharmaceuticals (KNSA) is experiencing growth with its FDA-approved drug Arcalyst and has seen a 37.7% increase in shares [39][40]

Financial Position & Pipeline - Cytokinetics had approximately $1.1 billion in cash, cash equivalents, and investments as of March 31, 2025[9] - Cytokinetics has further access to capital, including up to $275 million in term loan facilities with Royalty Pharma[176] - Royalty Pharma has the option to invest up to $150 million in a Phase 3 trial of CK-586 in exchange for an additional 3.5% revenue participation interest in worldwide net sales of CK-586[9, 176] - 2025 GAAP operating expense is guided to be between $670 million and $710 million, including $110 million to $120 million in stock-based compensation[178] Aficamten Program - The U S PDUFA date for aficamten is December 26, 2025, with China NDA and EU MAA on file[8, 92, 181] - Positive topline results from MAPLE-HCM demonstrated superiority of aficamten to metoprolol in patients with obstructive HCM[96, 99, 181] - SEQUOIA-HCM pivotal Phase 3 trial enrolled 282 patients with oHCM treated with standard of care[42] - SEQUOIA-HCM showed a statistically significant improvement in exercise capacity compared to placebo, with a least squares mean difference of 1 74 mL/kg/min (p=0 000002)[46, 47] - In the SEQUOIA-HCM CMR sub-study, aficamten was associated with a significant improvement in Left Ventricular Mass Index (LVMI) of -15 4 g/m2 (p=0 001)[62, 63] Omecamtiv Mecarbil Program - COMET-HF is a Phase 3 confirmatory clinical trial for omecamtiv mecarbil[128, 181] - The COMET-HF trial is targeting a patient population of approximately 840,000 high-risk heart failure patients with EF<30% in the US[21, 133] CK-586 Program - AMBER-HFpEF is a Phase 2 clinical trial evaluating CK-586 in HFpEF patients with LVEF ≥ 60%[163, 166] - Approximately 84% of HFpEF patients will die within five years of initial hospitalization[143, 144]

PLA Code issuance by the American Medical Association CPT editorial panel marks a meaningful step toward attaining health insurance reimbursement and expanded patient access for inFoods® IBSinFoods® IBS provides personalized identification of food triggers to substantially improve IBS-related symptoms like bloating, abdominal pain, diarrhea, and constipation IRVINE, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA), a global biomedical company focused on innovative gastroenterology di ...

TORONTO, July 02, 2025 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the "Company" or "PharmaTher") (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company focused on the development and commercialization of ketamine-based pharmaceuticals, is pleased to provide a corporate update to its shareholders, outlining a clear strategy to become the global leader in unlocking the pharmaceutical potential of ketamine. The Company has reached a pivotal stage in its growth, marked by a defined regulatory timelin ...

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