PresentationI will now turn the call over to Noel Kurdi, Vice President of Investor Relations at Apogee. Noel, you may begin.Good morning, and welcome to the Apogee Therapeutics conference call. [Operator Instructions] Please be advised that this call is being recorded at the company's request.Noel KurdiVice President of Investor Relations Thank you, operator, and thank you all for joining us today. During this call, we will be making forward-looking statements related to our current expectations and plans ...

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SAN FRANCISCO and BOSTON, March 23, 2026 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with the potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today announced that it has commenced an underwritten public offering of $300 million of shares of its common stock. In addition, Apogee expects to grant the underwriters a 30-day option to purchase up to an additional $45 millio ...

Durable Efficacy Across Extended Dosing IntervalsThe data revealed that zumilokibart demonstrated durable maintenance of response with both 3- and 6-month dosing regimens, with 75% and 85% of patients maintaining EASI-75, respectively.Deepening of response was observed across all lesional and itch endpoints with both every 3- and 6- month dosing among the full population of patients initially randomized to zumilokibart Well tolerated across both dosing regimens, with a safety profile generally in line with ...

Apogee Therapeutics Conference Call Summary Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Focus**: Development of treatments for atopic dermatitis and type two inflammation Industry Context - **Market Size**: Atopic dermatitis is projected to become the largest I&I market, potentially exceeding $50 billion [4][32] - **Current Treatments**: Limited options exist, with even modestly differentiated products achieving blockbuster status [4] Key Points from the Call Clinical Development and Results - **Drug**: Zumilokibart (Zumi) - **Study**: APECS Part A 52-week maintenance results - **Efficacy**: - 75% maintenance of EASI-75 response with 3-month dosing - 85% maintenance of EASI-75 response with 6-month dosing - 86% maintenance of IGA 0/1 response with 3-month dosing - 78% maintenance of IGA 0/1 response with 6-month dosing [5][12] - **Deepening Responses**: Observed across all endpoints tested, contrasting with Dupixent, which plateaued after week 16 [6][15] - **Safety Profile**: Well-tolerated with adverse events consistent with the IL-13 class, including a 20.2% rate of non-infective conjunctivitis [11][25] Market Opportunity - **Unmet Need**: Significant quality-of-life impact for patients with atopic dermatitis, including sleep loss and mood disorders [21][22] - **Dosing Advantage**: Zumi offers a reduced injection burden (2-4 times per year) compared to standard care (26 times per year) [31][32] - **Potential Launch**: Planned for 2029, with expectations of becoming a first-line treatment option [29][32] Future Directions - **Phase III Trials**: On track to initiate in the second half of the year, with part B results expected in Q2 2026 [29][33] - **Expansion Potential**: Zumi's application may extend to asthma and eosinophilic esophagitis, with positive phase I-B asthma data already disclosed [29] Competitive Landscape - **Comparison with Other Treatments**: Zumi's efficacy and safety profile position it favorably against existing treatments like Dupixent and JAK inhibitors [72] - **Market Penetration**: Atopic dermatitis remains underpenetrated, with new entrants quickly achieving blockbuster status [32] Conclusion - **Strategic Vision**: Apogee aims to establish itself as a leader in the I&I market by delivering innovative treatments that address significant unmet needs in atopic dermatitis [32][34]

Core Insights - The APEX Phase 2 trial results for zumilokibart (APG777) indicate durable maintenance of response in patients with moderate-to-severe atopic dermatitis (AD) over 52 weeks, with significant efficacy observed in both 3- and 6-month dosing regimens [2][3][4] - Zumilokibart demonstrated a potentially best-in-class profile, achieving over 99% inhibition of IL-13, leading to rapid and sustained relief of itch and lesions [3][8] - The company plans to initiate Phase 3 trials in the second half of 2026, with a potential commercial launch of zumilokibart anticipated in 2029 [3][4][9] Clinical Trial Results - In the 52-week maintenance portion of the APEX trial, 75% and 85% of patients maintained Eczema Area and Severity Index (EASI-75) scores with 3- and 6-month dosing, respectively [5][9] - The validated Investigator's Global Assessment (vIGA) 0/1 maintenance of response was 86% for 3-month dosing and 78% for 6-month dosing among Week 16 responders [9] - Deepening of response was observed across all lesional and itch endpoints for both dosing regimens, indicating a highly differentiated treatment profile [6][9] Future Developments - APEX Part B, a placebo-controlled dose optimization trial, is set to read out 16-week data in the second quarter of 2026, which will support the initiation of Phase 3 trials [4][6] - The upcoming Phase 3 trials are expected to further evaluate the efficacy and safety of zumilokibart, with results from Part B anticipated to influence clinical and regulatory outcomes [4][6][9] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including AD, asthma, and eosinophilic esophagitis (EoE) [2][9] - The company aims to address the challenges of existing therapies by providing treatments with less frequent dosing and improved patient compliance [8][10] - Zumilokibart is positioned as a potential game-changer in the treatment of AD, with plans for expansion into other indications based on its promising profile [8][10]

Core Insights - Apogee Therapeutics Inc. (NASDAQ:APGE) is identified as one of the 10 most shorted biotech stocks to consider for investment according to hedge funds [1] - Wedbush has raised its price target for Apogee from $90 to $95, maintaining an Outperform rating, indicating a potential upside of 30% from current levels [1] Financial Performance - For FY25, Apogee reported a net loss of $255.8 million, an increase from a net loss of $182.1 million in the previous year [3] - The company has a cash runway extending into the second half of 2028, positioning it well for future developments [3] Clinical Developments - Apogee reaffirmed its guidance on the 52-week Phase 2 APEX study data, with induction data for the dose-ranging trial expected in Q2 2026 [2] - The Phase 3 trials are anticipated to commence in the second half of the year, with further developments expected from APG279 [2] - Significant progress has been made in the pipeline, including positive results from the APEX Phase 2 Part A trial and proof-of-concept data from a Phase 1b trial in asthma [3] Product Pipeline - Apogee is focused on developing biologics for inflammatory and immune diseases, including atopic dermatitis, asthma, and eosinophilic esophagitis [4][5] - The existing pipeline includes multiple candidates such as APG777, APG279, APG990, APG333, and APG808, all at various stages of clinical trials [5]

Apogee Therapeutics FY Conference Summary Company Overview - **Company**: Apogee Therapeutics (NasdaqGM:APGE) - **Event**: FY Conference held on March 03, 2026 - **Key Speakers**: Michael Henderson (CEO), Carl Dambkowski (Chief Medical Officer), Jeff Hartness (Chief Commercial Officer), Jane Pritchett Henderson (Chief Financial Officer) Core Industry Insights - **Industry Focus**: Biopharmaceuticals, specifically treatments for atopic dermatitis and related Type 2 inflammation - **Market Size**: The atopic dermatitis market is projected to be around $50 billion, with competitors like Dupixent, Nemluvio, and Ebglyss showing significant growth [60] Key Points and Arguments 1. **Upcoming Data Updates**: Apogee is set to release maintenance data for zumilokibart, which aims to improve dosing frequency for atopic dermatitis patients from every two weeks to every three to six months, enhancing patient adherence [3][5][17] 2. **Part A Results**: The company previously reported promising results for zumilokibart, showing comparable efficacy to Dupixent and Ebglyss in lesion reduction and rapid itch relief [4][6] 3. **Dosing Strategy**: Apogee plans to pursue both quarterly and semi-annual dosing regimens in Phase III trials, based on market research indicating that both options could significantly increase market share [10][12] 4. **Efficacy Metrics**: The company aims to demonstrate that a significant percentage of patients maintain their response to treatment over 52 weeks, comparing their results against established benchmarks from competitors [6][9] 5. **Safety Profile**: Concerns regarding safety, particularly conjunctivitis, are acknowledged, but Apogee believes their product will have a favorable safety profile compared to existing treatments [32][33] 6. **Head-to-Head Study**: Apogee is conducting a head-to-head study against Dupixent to establish zumilokibart as a frontline treatment option, with expectations of needing to demonstrate an 8-10 point efficacy advantage [49][52] 7. **Pipeline Expansion**: The company is also exploring additional indications, including asthma and eosinophilic esophagitis (EoE), with plans to announce trial designs later this year [61][66] Additional Important Insights - **Market Research Findings**: Physicians and patients express a strong preference for less frequent dosing, which could transform the market dynamics for atopic dermatitis treatments [11][12] - **Placebo Rates**: Apogee is implementing strategies to manage placebo rates in clinical trials, particularly by increasing the size of the placebo arm in Part B of their studies [42][44] - **Investor Perspective**: The management team emphasizes the potential for significant growth and value creation as the company transitions from Phase II to Phase III, with a clear path to becoming a market leader in the immunology and inflammation sector [69][70] This summary encapsulates the critical insights and strategic directions discussed during the conference, highlighting Apogee Therapeutics' innovative approach to addressing unmet needs in the biopharmaceutical landscape.

Core Insights - Apogee Therapeutics is advancing its clinical pipeline, particularly zumilokibart (APG777), with significant milestones expected in atopic dermatitis (AD) and other indications [1][2][3] Pipeline Progress - APEX Phase 2 Part A 52-week data for zumilokibart is expected this month, while Part B 16-week data is anticipated in Q2 2026 [1][3] - Phase 3 trial initiation for zumilokibart in AD is targeted for the second half of 2026 [1][3] - Positive interim results from the Phase 1b trial in asthma support the potential for zumilokibart in multiple indications, with further details to be shared later this year [1][3] Financial Position - As of December 31, 2025, the company reported a strong cash position of $902.9 million, up from $731.1 million in 2024, providing a runway into the second half of 2028 [7] - Research and development (R&D) expenses increased to $214.7 million in 2025 from $167.9 million in 2024, driven by pipeline advancement and personnel-related costs [7] - General and administrative (G&A) expenses rose to $70.9 million in 2025 from $49.0 million in 2024, reflecting increased headcount and equity-based compensation [7] Market Strategy - The company aims to position zumilokibart as a "pipeline-in-a-product," with plans to expand its indications to asthma and eosinophilic esophagitis (EoE) [2][3] - A head-to-head trial of APG279 (zumilokibart + APG990) against DUPIXENT is ongoing, with interim data expected in the second half of 2026 [1][3]

Company Overview - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on advancing novel biologics for inflammatory and immune (I&I) markets, including treatments for Atopic Dermatitis (AD), asthma, Eosinophilic Esophagitis (EoE), and Chronic Obstructive Pulmonary Disease (COPD) [3] - The company's lead program, Zumilokibart (APG777), is being developed primarily for AD, which is identified as the largest and least penetrated market within I&I [3] - Apogee aims to achieve best-in-class efficacy and dosing through its antibody programs, which target established mechanisms of action and utilize advanced antibody engineering [3] Upcoming Events - Management will participate in a fireside chat at the TD Cowen 46th Annual Health Care Conference on March 3, 2026, at 9:10 a.m. E.T. [1] - The company will also attend the UBS Biotech Summit Miami on March 9, 2026, and the Jefferies Biotech on the Beach Summit on March 10, 2026 [1] Investor Relations - For investor inquiries, Noel Kurdi serves as the VP of Investor Relations at Apogee Therapeutics [4] - Media inquiries can be directed to Dan Budwick at 1AB [4]