Core Insights - Apogee is preparing for a transformative year in 2026 with significant clinical readouts planned, including data points for their LEAP program and asthma studies [5] Group 1: Clinical Developments - In Q1 2026, Apogee will present data for their LEAP program (777) in atopic dermatitis (AD) and maintenance data, along with asthma data for the same compound [5] - Q2 2026 will feature Part B of Phase II trials, focusing on the dose response curve for 777 in AD [5] - The second half of 2026 will see a combination trial of IL-13 and OX40 ligand, with a Phase Ib trial ongoing against DUPI [5]

Apogee Therapeutics (NasdaqGM:APGE) FY 2025 Conference December 03, 2025 09:45 AM ET Company ParticipantsJeff Hartness - CCOJane Pritchett Henderson - CFOGeoff Meacham - Managing DirectorGeoff MeachamIt's the second day of the Citi Global Healthcare Conference. I'm Geoff Meacham. I'm the Senior Biopharma Analyst. My team here too, Nishant, Ross, Mary Kate. We're thrilled to have Apogee with us. We have Jane Henderson, CFO. We have Geoff Hartness, CCO. Guys, thanks for joining us. Good to see you.Jane Pritch ...

Financial Data and Key Metrics Changes - The company anticipates 2026 to be a transformative year with important clinical readouts, including data points for their lead program 777 in atopic dermatitis (AD) and asthma [5][6] - The market for atopic dermatitis is expected to grow at approximately 25% annually, indicating a significant opportunity for the company [40][58] Business Line Data and Key Metrics Changes - The company is focusing on the biologic penetration in the AD space, which is currently around 10%, significantly lower than other inflammatory diseases, presenting a large opportunity for growth [11][30] - The company plans to test both lower and higher doses in their Part B trial to optimize dosing strategies for their product 777 [14][35] Market Data and Key Metrics Changes - The asthma market is also underpenetrated, with significant growth potential, and the company expects to leverage its existing presence in allergist offices to expand into this market [40][47] - The company is looking to achieve a FeNO reduction of 15-20 parts per billion in their asthma trials, which would be competitive with existing treatments [37][45] Company Strategy and Development Direction - The company aims to be a serial innovator in atopic dermatitis, focusing on establishing a strong foundation before expanding into other indications [53][56] - The strategy includes launching with monotherapy and following up with combination therapies to address broader patient populations [42][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the product profile of 777, highlighting its preferred status among physicians and patients, which is expected to facilitate favorable payer access [60][61] - The company believes that the AD market needs new options, as many patients do not achieve satisfactory results with existing treatments, indicating a strong demand for their product [59][62] Other Important Information - The company is preparing for a phase 3 trial by the end of 2026, with plans to include biologic experienced patients to better understand the market dynamics [32][35] - The company is also exploring combination therapies to enhance efficacy and address diverse drivers of diseases like asthma and COPD [42][46] Q&A Session Summary Question: What are the opportunities for differentiation in the Part B study? - The company aims to replicate strong data from Part A and test a dose-response curve to optimize dosing strategies [13][14] Question: What challenges exist in moving to less frequent dosing? - The company has confidence in their pharmacokinetic modeling and plans to adjust dosing based on efficacy observed in trials [19][20] Question: How does the company plan to secure payer access? - The company believes that strong physician preference and patient need for new options will facilitate favorable access with payers [60][61] Question: What is the expected market landscape by the time 777 launches? - The market is expected to continue growing, with new-to-brand prescriptions increasing significantly, indicating a robust opportunity for the company [57][58]

Summary of Apogee Therapeutics Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Event**: 2025 Conference on November 19, 2025 - **Focus**: Discussion on the company's pipeline, particularly in atopic dermatitis and asthma Key Points Industry and Product Development - **Atopic Dermatitis**: Apogee's lead drug shows promising proof of concept data, demonstrating rapid itch relief within 48 hours and effectiveness on lesions [6][51] - **Clinical Trials**: Four clinical readouts are expected in the upcoming year, with the potential to establish the drug as a frontline treatment for atopic dermatitis, administered every three to six months [6][7] - **Combination Therapy**: The company is developing a combination therapy targeting IL-13 and OX40 Ligand, aiming for an 8-10 point improvement in efficacy compared to Dupixent [7][17] Financial Position - **Balance Sheet**: Apogee has a strong balance sheet, allowing for appropriate growth and investment in its pipeline [9] Regulatory and Market Strategy - **Regulatory Requirements**: The company acknowledges the need to demonstrate that their combination therapy is superior to individual agents for regulatory approval [24][26] - **Market Penetration**: Currently, there is only 10% penetration in the biologically eligible atopic dermatitis market, indicating significant growth potential as new treatments enter the market [51] Competitive Landscape - **Comparison with Competitors**: Apogee's strategy includes learning from competitors like Pfizer and Vertex, focusing on long-acting antibodies and combination therapies to address unmet needs in the market [15][41] - **Emerging Therapies**: The company is monitoring other emerging therapies in the market, such as those from UCB, which may provide insights into potential additive benefits from different targets [35][39] Clinical Efficacy and Endpoints - **Efficacy Goals**: The company aims for an 8-10% improvement across various endpoints in their clinical trials, which is considered meaningful by both physicians and payers [61][66] - **Long-term Efficacy**: There is a focus on demonstrating sustained efficacy over time, with plans to assess the durability of response after treatment cessation [105][106] Respiratory Portfolio - **Broader Strategy**: Apogee is positioning itself as a type 2 inflammatory company, with plans to expand into asthma and COPD treatments [110] - **Potential for Combination Therapies**: The company is optimistic about the potential for its respiratory portfolio to improve upon existing monotherapies, particularly with quarterly dosing options [118][120] Conclusion - **Future Outlook**: Apogee Therapeutics is poised for a significant year in 2026, with multiple clinical readouts and a strong focus on innovative therapies for atopic dermatitis and asthma, backed by a solid financial position and strategic market insights [6][9][51]

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.

Summary of Apogee Therapeutics Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Focus**: Development of potentially best-in-class antibodies for atopic dermatitis and asthma, with a busy pipeline ahead [1][2] Key Points on Atopic Dermatitis - **Market Potential**: The atopic dermatitis market is large, with Dupixent continuing to grow despite new entrants like Ebglyss and Nemluvio, which are annualizing at approximately $650 million and $500 million respectively [3][4] - **Biologic Penetration**: Current biologic penetration in the atopic dermatitis space is around 10%, indicating significant growth potential [4] - **Triple 7 and Combination Approach**: Apogee aims to position its drug, Triple 7, and its combination approach (279) as frontline treatments for atopic dermatitis, with phase three trials expected to start by the end of next year [2][6] Clinical Data Highlights - **Phase 2 Trial Results**: The phase 2 trial showed promising results with a placebo-adjusted EASI-75 of 42.5%, indicating strong efficacy compared to existing treatments [7][8] - **Rapid Itch Relief**: Significant itch relief was observed as early as 48 hours post-treatment, comparable to Nemluvio [8][10] - **Safety Profile**: Conjunctivitis rates were similar to those seen with Dupixent, but no discontinuations due to this side effect were reported [11][12] Future Developments - **Upcoming Data**: Maintenance data for dosing every three and six months is expected in Q1 of next year, which will be crucial for regulatory discussions [14][15] - **Combination Studies**: A study combining Triple 7 with OX40 ligands (279) is currently enrolling, aiming to replicate JAK-like efficacy without associated safety issues [22][24] Asthma Pipeline - **Asthma Focus**: Apogee is prioritizing asthma due to the overlap with atopic dermatitis patients, with proof of concept studies expected in Q1 [28][30] - **Dosing Strategy**: A single dose of 720 mg is planned to evaluate efficacy against Dupixent, particularly in reducing FeNO levels [29][30] Financial Position - **Cash Reserves**: Apogee has over $900 million in cash, providing a runway into the second half of 2028, covering phase three top-line data [33] Conclusion - Apogee Therapeutics is positioned to make significant strides in the atopic dermatitis and asthma markets with a robust pipeline and promising clinical data. The company is focused on establishing its products as frontline therapies while maintaining a strong financial position to support ongoing and future clinical trials.

Summary of Apogee Therapeutics FY Conference Call Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Industry**: Biopharmaceuticals, specifically focusing on antibody development for various indications including atopic dermatitis, asthma, and other conditions Core Strategy and Differentiation - Apogee is focused on developing best-in-class antibodies targeting large markets, with a lead program being a fully optimized IL-13 antibody for atopic dermatitis [4][5] - The company aims to improve dosing and efficacy through both monotherapies and combination approaches, with a goal of three to six-month dosing and optimized efficacy [5][6] - Apogee plans to initiate phase three trials next year, positioning itself ahead of competitors in the market [7][8] Market Dynamics and Competitive Landscape - The atopic dermatitis biologic market is growing at over 25% annually, with new-to-brand prescriptions increasing by 49% year-over-year [10][11] - Current biologic penetration in atopic dermatitis is only about 10%, indicating significant growth potential compared to other conditions like plaque psoriasis (25-30% penetration) and inflammatory bowel disease (60% penetration) [11] - Recent launches of competitors like Nemluvio and Ebglyss have shown promising sales, with Nemluvio annualizing at $500 million and Ebglyss at $650 million in their first year [10] Payer Environment and Access - Payers are providing first-line access to new biologics, with Nemluvio and Ebglyss achieving 80% and 90% coverage, respectively [13][14] - Apogee anticipates that its product will be preferred by both physicians and patients, driving prescription volume and payer access [14] Clinical Data and Product Development - Apogee's lead asset, APG 777, has shown promising phase 2a data, with a higher response rate (EASI 75) compared to competitors [16][17] - The company is exploring both three-month and six-month dosing regimens, with plans to gather data to inform phase three trials starting in the second half of 2026 [22][23] - The company is also investigating the efficacy of APG 777 in asthma, with a focus on FeNO as a biomarker for response [27][28] Combination Therapies and Future Directions - Apogee is developing combination therapies with TSLP and OX40L, aiming for co-formulation to enhance dosing frequency and efficacy [31][32] - The company is cautious about the crowded landscape for TSLP therapies and is focusing on combination approaches rather than monotherapy [30][31] - Apogee's strategy includes running active comparator studies to establish its products as frontline therapies [36][37] Conclusion - Apogee Therapeutics is positioned for a busy 2026 with multiple catalysts on the horizon, including phase three trials and potential product launches [40]

Company Overview - Apogee Therapeutics Inc. (APGE) is part of the Medical group, which consists of 951 companies and currently ranks 4 within the Zacks Sector Rank [2] - The company is classified under the Medical - Biomedical and Genetics industry, which includes 469 companies and is ranked 78 in the Zacks Industry Rank [6] Performance Metrics - Year-to-date, Apogee Therapeutics has returned approximately 25.3%, significantly outperforming the Medical sector's average return of 2.1% [4] - The Zacks Consensus Estimate for APGE's full-year earnings has increased by 0.2% over the past quarter, indicating improved analyst sentiment and a stronger earnings outlook [4] Comparison with Peers - Aveanna Healthcare (AVAH), another stock in the Medical sector, has shown a year-to-date return of 95.8% and has a Zacks Rank of 2 (Buy) [5] - The Medical - Outpatient and Home Healthcare industry, to which Aveanna belongs, is currently ranked 65 and has returned +6.8% this year [7] - In contrast, stocks in the Medical - Biomedical and Genetics industry, including Apogee, have gained an average of 12.8% this year, indicating that APGE is performing better than its industry peers [6]

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 announced positive interim Phase 1 results for APG333, demonstrating a half-life of approximately 55 days and suppression of key biomarkers for 6 months after a single dose, supporting potential 3- and 6-month dosing regimens [1][2][5] - APG333 was well tolerated across all cohorts with doses up to 1,000 mg, with the most common treatment-emergent adverse events being headache and upper respiratory tract infection [5][6] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing optimized, novel biologics for inflammatory and immunology (I&I) markets, including treatments for Atopic Dermatitis, asthma, and Chronic Obstructive Pulmonary Disease [5][6] - The company aims to achieve best-in-class profiles through its antibody programs by targeting established mechanisms of action and utilizing advanced antibody engineering [6] Clinical Trial Details - The Phase 1 clinical trial for APG333 was a double-blind, placebo-controlled study involving 32 healthy adults across four cohorts, evaluating safety, tolerability, and pharmacokinetics [2][3] - Results indicate that APG333's pharmacokinetic profile supports potential dosing two to four times a year, which is a significant improvement over current standard treatments [3][5] Future Development - The positive results from APG333 support the development of a co-formulation with APG777, potentially allowing for quarterly or less frequent dosing to address respiratory diseases more effectively [1][2][3] - The combination of APG777 and APG333 is expected to suppress complementary pathways involved in obstructive airway disease, expanding treatment options for patients [3][5]