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Apogee Therapeutics (NasdaqGM:APGE) Conference Transcript
2025-11-13 18:30
Summary of Apogee Therapeutics Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Date**: November 13, 2025 - **Key Speakers**: Michael Henderson (CEO), Carl Dambkowski (CMO), Jeff Hartness (CCO), Jane Pritchett Henderson (CFO) Key Industry and Company Insights Asthma Data and APG777 - **APG777 Phase 1 Readout**: Expected in Q1 2026, focusing on asthma data [2][4] - **Comparison with Ebglyss**: Ebglyss failed due to underdosing (20% of effective dose) and lack of targeting type 2 disease [2][3] - **Targeting Type 2 Disease**: Apogee aims to enroll high FeNO patients, expecting a change in FeNO similar to Dupixent (15-20 parts per billion) [3][4] - **Loading Dose**: APG777 will use a loading dose of 720 mg, compared to Ebglyss's 500 mg [5][7] Future Plans in Asthma - **Expansion Plans**: If successful, Apogee plans to initiate Phase 2B studies in asthma and EoE, contingent on atopic dermatitis data [8][9] - **Overlap with Atopic Dermatitis**: Approximately 30% overlap between atopic dermatitis and asthma patients [9] Atopic Dermatitis Phase 2 Program - **Part A Results**: Positive results reported, with 52-week maintenance data expected in Q1 2026 [10][11] - **Success Metrics**: Aiming for maintenance of EC75 response at week 52, with a benchmark of 72% for Dupixent [11][12] - **Dosing Strategy**: Plans for every three-month and six-month dosing regimens, with data expected to inform Phase 3 studies [12][13] Mechanistic Insights - **Differentiation from Competitors**: APG777 targets IL-13 and IL-4 receptors, potentially leading to better durability of response compared to competitors [16][17] Part B Study Design - **Dose Optimization**: Part B will explore three doses versus placebo, aiming to fully understand the dose-response curve [19][20] - **Market Research**: Positive feedback from physicians, with 60% preferring APG777 over competitors [37][38] Market Positioning - **Market Disruption Potential**: Ebglyss and Nemluvio are currently strong competitors, but Apogee believes it can capture significant market share [38][39] - **Combination Therapy**: Plans to explore combinations with APG990, aiming for additive efficacy [32][33] Financial Position - **Cash Reserves**: Apogee has $913 million in cash, providing a runway into the second half of 2028 [30] Timeline for Future Trials - **Phase 3 Trials**: Expected to start next year, with a potential market launch in 2029 [27] Additional Insights - **Conjunctivitis Rates**: Lower rates observed in higher exposure groups, aligning with Dupixent's data [26] - **Combination with TSLP**: Future plans to explore combinations with TSLP based on upcoming data [41][44] Conclusion Apogee Therapeutics is positioned to make significant advancements in the treatment of asthma and atopic dermatitis with its APG777 product. The company is focused on differentiating its therapies through targeted dosing and mechanistic advantages, while also preparing for future market competition and expansion into additional indications.
Apogee Therapeutics Provides Pipeline Progress and Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-10 12:10
Core Insights - Apogee Therapeutics is positioned for significant advancements in 2026 with four key clinical data readouts expected, including results for APG777 in atopic dermatitis (AD) and APG279 in a head-to-head trial against DUPIXENT [1][2][3] Pipeline Progress - The company anticipates readouts for APG777 in asthma and AD, with Phase 1b data in asthma expected in Q1 2026, APEX 52-week Part A data in AD in Q1 2026, and APEX 16-week Part B data in AD in Q2 2026 [1][3] - Interim results for APG333 showed a half-life of approximately 55 days and significant biomarker suppression for 6 months after a single dose, supporting potential quarterly dosing [1][7] - APG777 demonstrated a 71.0% reduction in EASI from baseline compared to 33.8% for placebo in APEX Part A, meeting its primary endpoint [3][4] Financial Overview - Apogee completed a $345 million public offering, resulting in a pro forma cash position of $913 million as of September 30, 2025, which supports operations into the second half of 2028 [1][7] - Research and development expenses for Q3 2025 were $54.2 million, up from $45.7 million in Q3 2024, driven by pipeline advancements and increased personnel costs [7][12] - The net loss for Q3 2025 was $65.0 million, compared to a net loss of $49.0 million in Q3 2024, reflecting higher operating expenses [7][13]
Apogee Therapeutics to Participate in Upcoming Conferences
Globenewswire· 2025-11-03 12:30
Core Insights - Apogee Therapeutics, Inc. is actively participating in several upcoming investor conferences, showcasing its commitment to engaging with the investment community [1][2][3] Conference Participation - Apogee will participate in the Guggenheim 2 Annual Healthcare Innovation Conference on November 11, 2025, at 1:30 p.m. ET [2] - The company will also be present at the Stifel 2025 Healthcare Conference on November 12, 2025, at 11:20 a.m. ET [2] - Additionally, Apogee will take part in the TD Cowen Immunology and Inflammation Virtual Summit on November 13, 2025, at 12:30 p.m. ET [2] - The Jefferies London Healthcare Conference is scheduled for November 19, 2025, at 3:00 p.m. GMT / 10:00 a.m. ET [2] - The Citi 2025 Global Healthcare Conference will occur on December 3, 2025, at 9:45 a.m. ET [3] - A live and archived webcast of these events will be available on the Apogee Therapeutics website [3] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing optimized, novel biologics for major inflammatory and immunology (I&I) markets [4] - The company targets conditions such as Atopic Dermatitis (AD), asthma, Eosinophilic Esophagitis (EoE), and Chronic Obstructive Pulmonary Disease (COPD) [4] - Apogee's lead program, APG777, is primarily aimed at treating AD, which is identified as a significant and under-penetrated market [4] - The company has four validated targets in its portfolio and aims to achieve best-in-class profiles through both monotherapies and combinations of its novel antibodies [4] - Apogee believes its broad pipeline and expertise can provide substantial value and benefits to patients who are underserved by current treatment options [4]
BTIG Maintains a Buy on Apogee Therapeutics (APGE)
Yahoo Finance· 2025-10-18 01:55
Apogee Therapeutics Inc. (NASDAQ:APGE) is one of the best healthcare stocks with the highest upside. BTIG analyst Julian Harrison maintained a Buy rating on Apogee Therapeutics Inc. (NASDAQ:APGE) on October 10, keeping the associated price target at $115. 10 Best Biotech Stocks To Buy Under $20 The analyst based the optimistic rating on the company’s promising clinical developments, along with the potential of its APG777, especially to treat asthma, atopic dermatitis, and eosinophilic esophagitis. Accor ...
Apogee Therapeutics, Inc. Announces Closing of Public Offering and Full Exercise of the Underwriters' Option to Purchase Additional Shares for Gross Proceeds of $345 Million
Globenewswire· 2025-10-10 20:01
Core Insights - Apogee Therapeutics, Inc. has successfully closed a public offering of 8,048,782 shares of common stock, raising approximately $345 million before expenses [1] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing optimized, novel biologics for the inflammatory and immunology markets, targeting conditions such as Atopic Dermatitis, asthma, Eosinophilic Esophagitis, and Chronic Obstructive Pulmonary Disease [5] - The company's lead program, APG777, is aimed at treating Atopic Dermatitis, which is identified as a significant and under-penetrated market [5] - Apogee's antibody programs are designed to enhance existing therapies by targeting established mechanisms of action and utilizing advanced antibody engineering to improve properties like half-life [5]
Apogee Therapeutics, Inc. Announces Pricing of $300 Million Underwritten Public Offering
Globenewswire· 2025-10-09 01:52
Core Viewpoint - Apogee Therapeutics, Inc. has announced a public offering of 6,951,221 shares of common stock priced at $41.00 per share, aiming to raise approximately $300 million before expenses [1]. Group 1: Offering Details - The offering includes pre-funded warrants for certain investors to purchase up to 365,853 shares at a price of $40.99999 per warrant, with an exercise price of $0.00001 per share [1]. - The offering is expected to close on October 10, 2025, subject to customary closing conditions [1]. - Underwriters have an option to purchase an additional 1,097,561 shares at the public offering price within 30 days [1]. Group 2: Underwriters - Jefferies, BofA Securities, Guggenheim Securities, and TD Cowen are acting as joint book-running managers for the offering, while BTIG serves as a passive bookrunner [2]. Group 3: Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including treatments for Atopic Dermatitis, asthma, Eosinophilic Esophagitis, and Chronic Obstructive Pulmonary Disease [5]. - The company's lead program, APG777, targets Atopic Dermatitis, which is noted as a large and under-penetrated market [5]. - Apogee aims to achieve best-in-class profiles through its antibody programs by addressing limitations of existing therapies and optimizing properties such as half-life [5].
Apogee Therapeutics, Inc. Announces Proposed Underwritten Public Offering
Globenewswire· 2025-10-08 20:01
Core Viewpoint - Apogee Therapeutics, Inc. has initiated an underwritten public offering of its common stock and pre-funded warrants, with the intention to utilize the proceeds for various research and development activities, including clinical trials and manufacturing [1][2]. Group 1: Offering Details - The public offering includes a 30-day option for underwriters to purchase an additional 15% of shares at the public offering price [1]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to fund preclinical studies, clinical trials, manufacturing, and commercial readiness activities for the company's antibody programs [2]. - Additional uses include research and development activities, capital expenditures, working capital, and general corporate purposes [2]. Group 3: Company Overview - Apogee Therapeutics is focused on developing novel biologics for inflammatory and immunology markets, targeting conditions such as Atopic Dermatitis, asthma, and Chronic Obstructive Pulmonary Disease [6]. - The company's lead program, APG777, is aimed at treating Atopic Dermatitis, which is identified as a significant and under-penetrated market [6]. - Apogee's antibody programs are designed to enhance existing therapies by targeting established mechanisms and optimizing properties through advanced engineering [6].
RBC Capital Initiates Coverage of Apogee Therapeutics (APGE) With an Outperform Rating
Yahoo Finance· 2025-09-30 08:00
Apogee Therapeutics Inc. (NASDAQ:APGE) is one of the best strong buy stocks to invest in according to Wall Street. On September 25, RBC Capital initiated coverage of Apogee Therapeutics Inc. (NASDAQ:APGE) with an Outperform rating and a $60 price target. Is Exact Sciences Corporation (NASDAQ:EXAS) the Gene Therapy Stock with the Greatest Potential? The firm expressed optimistic sentiments regarding the company’s potential to deliver clinically differentiated biologics, telling investors in a research not ...
BofA Raises Apogee Therapeutics (APGE) PT to $87 Following Positive Phase 2 APEX Trial Results for Atopic Dermatitis
Yahoo Finance· 2025-09-15 13:09
Company Overview - Apogee Therapeutics Inc. (NASDAQ:APGE) is a clinical-stage biotechnology company focused on developing novel biologics for treating atopic dermatitis, asthma, eosinophilic esophagitis, chronic obstructive pulmonary disease, and other inflammatory and immunology indications [4] Financial Performance - As of the end of Q2 2025, Apogee Therapeutics reported a strong cash position of $621.2 million in cash, cash equivalents, and marketable securities, which is expected to support operations into Q1 2028 [2] Recent Developments - BofA analyst Tim Anderson raised the price target for Apogee Therapeutics to $87 from $78, maintaining a Buy rating, following positive changes in estimates after the Q2 2025 results [1] - The company announced positive topline data from Part A of its Phase 2 APEX trial for APG777, a potential best-in-class treatment for moderate-to-severe atopic dermatitis, achieving a 71% reduction in the Eczema Area and Severity Index from baseline, compared to 33.8% for placebo [3]
Apogee Therapeutics Announces Late-Breaker Presentation of 16-Week Data from Phase 2 APEX Trial of APG777 for Moderate-to-Severe Atopic Dermatitis at the Upcoming European Academy of Dermatology and Venereology (EADV) 2025 Congress
Globenewswire· 2025-09-11 11:30
Core Insights - Apogee Therapeutics, Inc. announced that data from the Phase 2 APEX trial of APG777 for moderate-to-severe atopic dermatitis will be presented at the EADV Congress 2025 in Paris, highlighting its potential as a best-in-class treatment [1][2] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease [4][5] - The company aims to create best-in-class profiles through advanced antibody engineering and targeting established mechanisms of action [4][5] Clinical Trial Highlights - The APEX trial demonstrated that APG777 met both primary and secondary endpoints, reinforcing its potential as a leading treatment option for moderate-to-severe atopic dermatitis [2] - APG777 is notable for being the only biologic tested with maintenance dosing every 3 and 6 months [2] - The combination of APG777 with APG990, which targets OX40L, is expected to broaden the treatment scope for various inflammatory conditions [2] Presentation Details at EADV Congress 2025 - A late-breaker oral presentation titled "APG777, a Novel, Half-Life Extended Anti-IL-13 Antibody, Demonstrates Safety and Efficacy in Moderate-to-Severe Atopic Dermatitis: 16-Week Results from the Phase 2 APEX Study" will be presented by Dr. Emma Guttman-Yassky on September 19, 2025 [3] - Multiple poster presentations will also be featured, including studies on APG777 and APG990, showcasing their safety profiles and efficacy [3]