Summary of Apogee Therapeutics Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Industry**: Biotechnology, specifically focused on treatments for atopic dermatitis and asthma - **Key Product**: Zumilokibart, targeting type two inflammation Core Insights and Arguments 1. **Company Vision and Progress**: Apogee was founded to provide better treatment options for patients with atopic dermatitis and related conditions. The company is transitioning from a dosing schedule of every 2-4 weeks to potentially every 3-6 months without sacrificing efficacy, aiming to prove this in upcoming studies [2][3][10]. 2. **Phase 1b Asthma Data**: The company reported a 60% reduction in FeNO (Fractional Exhaled Nitric Oxide) from baseline in a study of 19 mild to moderate asthma patients, indicating competitive efficacy compared to other approved agents [5][6]. 3. **Market Opportunity**: There is a 30% overlap between atopic dermatitis and asthma patients, which allows Apogee to expand its market reach into allergist and pulmonologist offices, potentially increasing revenue [7][8]. 4. **Efficacy and Safety**: Apogee aims to demonstrate rapid itch relief and lesional benefits comparable to existing treatments like Dupixent. The company is also focused on maintaining a favorable safety profile, particularly concerning conjunctivitis rates, which are common in this treatment class [10][18][19]. 5. **Phase 3 Studies**: The company is preparing to initiate Phase 3 studies to confirm dosing and efficacy, with expectations of replicating positive results from earlier trials [13][35]. Additional Important Points 1. **Dosing Flexibility**: Apogee's formulation allows for flexible dosing without compromising efficacy, which could lead to better patient adherence and outcomes [36][39]. 2. **Financial Position**: The company has over $900 million in cash, providing a runway into the second half of 2028, which supports ongoing clinical trials and potential product launch [70][71]. 3. **Launch Timeline**: Apogee plans to launch Zumilokibart in 2029, positioning itself as a first-line treatment in the atopic dermatitis market, directly competing with Dupixent [66][67]. 4. **Combination Therapies**: The company is exploring combination therapies with its lead product, Zumilokibart, and other agents, aiming to enhance treatment efficacy for patients who may not respond adequately to monotherapy [54][57]. Conclusion Apogee Therapeutics is positioned to make significant advancements in the treatment of atopic dermatitis and asthma with its innovative product, Zumilokibart. The company is focused on proving its efficacy and safety through ongoing clinical trials while preparing for a strategic market entry in 2029.

Title text 2 Zumilokibart (APG777) Asthma Phase 1b Interim Results January 6, 2026 Disclaimers and Forward-looking Statements This presentation contains certain "forward-looking statements" within the meaning of applicable securities laws. Other than statements of historical facts, all statements included in this presentation are forward-looking statements, including statements about the potential for zumilokibart (APG777) in asthma; Apogee's plans for its current and future product candidates and programs; ...

Core Insights - Apogee Therapeutics announced positive interim results from the Phase 1b trial of zumilokibart (APG777) in patients with mild-to-moderate asthma, demonstrating rapid and durable suppression of FeNO, a key biomarker of Type 2 inflammation [3][5][6] - The company aims to advance zumilokibart in asthma and atopic dermatitis, with significant milestones expected in 2026, including the initiation of Phase 3 trials [4][8] Phase 1b Trial Results - The Phase 1b trial involved 19 adult patients with mild-to-moderate asthma, showing a maximum absolute mean FeNO reduction of 45 ppb, representing a 60% decrease from baseline after a single dose of 720 mg of zumilokibart [5][6] - The treatment exhibited a favorable safety profile, with no serious adverse events reported and only two patients experiencing gastroesophageal reflux disease [6][7] Future Development Plans - Zumilokibart is advancing in Phase 2 APEX trials for atopic dermatitis, with Part A maintenance data readout expected in Q1 2026 and Part B induction data readout on track for Q2 2026 [8][10] - The company has a strong cash position of $913 million, providing a runway into the second half of 2028, supporting the potential launch of zumilokibart in 2029 [8][10] Market Potential - Apogee aims to establish a best-in-class profile for zumilokibart in the atopic dermatitis market, projected to exceed $50 billion, while also expanding its indications for other inflammatory and immunology diseases [8][10] - The company is focused on serial innovation in atopic dermatitis and plans to report multiple clinical data readouts in 2026, setting the stage for potential Phase 3 trial initiation [4][8]

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]

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]

Core Insights - Apogee Therapeutics reported positive results from the 16-week Phase 2 Part A APEX trial for APG777, an anti-IL-13 antibody, which met all primary and key secondary endpoints for moderate-to-severe atopic dermatitis [1][2][3] - The company is advancing its pipeline with ongoing trials, including a Phase 1b head-to-head study of APG279 against DUPIXENT, with results expected in the second half of 2026 [1][2][3] - Apogee has a strong cash position of $621.2 million, which is projected to support operations into Q1 2028 [1][6][8] Pipeline Progress - APG777 demonstrated a 71.0% reduction in the Eczema Area and Severity Index (EASI) from baseline compared to 33.8% for placebo (p < 0.001) in the APEX Part A trial [3][4] - The APEX Part A maintenance phase is testing dosing every 3- and 6-months, potentially allowing for 2-4 injections per year versus 26 for standard care [3][7] - The readout for APEX Part B has been accelerated to mid-2026 due to strong enrollment [1][2][3] Financial Performance - Research and development expenses increased to $55.7 million for Q2 2025, up from $33.2 million in Q2 2024, primarily due to the development of APG777 [6][8] - General and administrative expenses rose to $17.5 million in Q2 2025 from $10.9 million in Q2 2024, driven by increased personnel-related costs [6][8] - The net loss for Q2 2025 was $66.1 million, compared to a net loss of $33.8 million in Q2 2024, reflecting higher operating expenses [8][15]

Core Insights - Apogee Therapeutics announced positive results from the Phase 2 APEX clinical trial of APG777, demonstrating significant efficacy in treating moderate-to-severe atopic dermatitis [2][3][4] Group 1: Trial Results - APEX Part A met all primary and key secondary endpoints, achieving a 71.0% decrease in Eczema Area Severity Index (EASI) from baseline at Week 16 [1][9] - APG777 showed an EASI-75 response rate of 66.9%, which is the highest reported for any biologic in a global study, with a placebo-adjusted rate of 42.5% [1][3][9] - The trial included 123 adult patients, randomized 2:1 to receive APG777 or placebo, with a dosing regimen of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12 [4][9] Group 2: Safety and Tolerability - APG777 was well tolerated, with a safety profile consistent with other agents in its class, and serious treatment-emergent adverse events (TEAEs) were rare at 1.2% compared to 2.4% in the placebo group [1][9] - The discontinuation rate due to adverse events was low at 2.4% for APG777-exposed patients [9] Group 3: Future Developments - APEX Part B is set to test higher doses of APG777, with readout expected in mid-2026, and the initiation of a Phase 3 trial planned for 2026 [1][3][6] - The company is also conducting a Phase 1b head-to-head trial of APG279 against DUPIXENT, with results anticipated in the second half of 2026 [1][3]

Core Insights - APG777 has shown significant efficacy in treating moderate-to-severe atopic dermatitis, achieving a 71.0% reduction in EASI from baseline at Week 16, surpassing the placebo group which had a 33.8% reduction [1][9] - The drug demonstrated an EASI-75 response rate of 66.9%, the highest for any biologic in a global study, with a placebo-adjusted rate of 42.5% [1][3][9] - A favorable safety profile was observed, with serious treatment-emergent adverse events being rare at 1.2% compared to 2.4% in the placebo group [9] Clinical Trial Results - The Phase 2 APEX trial Part A enrolled 123 adult patients, randomized 2:1 to receive APG777 or placebo, with a dosing regimen of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12 [4][9] - Key secondary endpoints included EASI-90 and Validated Investigator Global Assessment (IGA) 0/1, with EASI-90 achieving 33.9% compared to 14.7% in placebo (p < 0.05) and vIGA 0/1 at 34.9% compared to 17.3% in placebo (p < 0.05) [9] - Rapid onset of itch relief was noted, with a 50.7% reduction in Itch NRS from baseline by Week 1 compared to 23.2% in the placebo group (p < 0.01) [9] Future Developments - APEX Part B is set to test higher doses of APG777, with results expected in mid-2026, while the maintenance phase readout from Part A is anticipated in the first half of 2026 [1][6] - The company is also conducting a Phase 1b trial of APG279, a combination therapy, with readout expected in the second half of 2026 [2][3] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including atopic dermatitis [2][8] - The company aims to optimize efficacy and dosing through advanced antibody engineering, targeting well-established mechanisms of action [8][10]

Pipeline and Clinical Development - Apogee plans to transform the standard-of-care for I&I diseases with novel antibodies and combination approaches [6] - APG777 Phase 2 Part A is fully enrolled, with a readout expected in mid-2025, potentially demonstrating best-in-class efficacy [8, 33] - APG279, a combination of APG777 and APG990, is expected to initiate a Phase 1b trial against DUPIXENT in 2025, with a readout expected in 2H 2026 [6, 19] - APG777+APG333 clinical planning is underway for asthma and COPD [19] - Apogee has 7 clinical trial readouts expected over the next 2 years [105] Financial Position - Apogee has $681 million in total cash, providing an expected runway into Q1 2028 [7, 105] Market Opportunity - The atopic dermatitis (AD) market is projected to be a future $50B+ market [7, 17, 25, 90] - Mature I&I markets have consistently achieved high biologics penetration, approximately 25-60% after 15-20 years [9] - In 2024, the worldwide market size for IBD was $24B, RA was $24B, PsO was $29B [10] APG777 Potential - APG777 has the potential for annual dosing due to its optimized PK profile and 77-day half-life [8, 30, 31] - APG777 Phase 2 induction exposures are designed to exceed EBGLYSS for potentially greater efficacy [35] - APG777 could substantially decrease annual injections for patients, potentially requiring only 2-4 injections compared to EBGLYSS (13-26) and DUPIXENT (26) [45, 46]

Core Insights - Apogee Therapeutics, Inc. released interim Phase 1 results for APG990, demonstrating a half-life of approximately 60 days, indicating potential for extended dosing intervals [1][5] - The company plans to submit an Investigational New Drug application for APG279, targeting moderate-to-severe atopic dermatitis, with a Phase 1b trial expected to start in 2025 [2] - As of December 31, 2024, the company reported cash and equivalents of $731.1 million, sufficient to fund operations into Q1 2028 [3] Group 1: APG990 Development - APG990 showed a potential best-in-class pharmacokinetic profile with a half-life of approximately 60 days, supporting maintenance dosing every three to six months [5] - The drug was well tolerated across all cohorts, with the most common treatment-emergent adverse event being headache, affecting 53% of participants [5] - No severe adverse events or study discontinuations were reported, and there were no cases of pyrexia or chills [5] Group 2: Future Plans and Financials - The company intends to initiate a Phase 1b clinical trial for APG279 against Dupixent in 2025, with data anticipated in the second half of 2026 [2] - Apogee's financial position is strong, with sufficient cash reserves to support operations until early 2028 [3] - Following the release of positive data, APGE stock increased by 7.14% to $33.68 [3]