PresentationGood morning, and welcome to Apogee Therapeutics' Conference Call [Operator Instructions] Please be advised that this call is being recorded at the company's request. I will now turn the call over to Noel Kurdi, Vice President of Investor Relations at Apogee. Noel, you may begin.Noel KurdiVice President of Investor Relations Thank you, operator, and thank you all for joining us today. During this call, we'll be making forward-looking statements related to our current expectations and plans for t ...

SAN FRANCISCO and BOSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today announced it will report interim results from its Phase 1b trial of APG777 in patients with mild-to-moderate asthma on Tuesday, January 6, 2026. Following the announcement, the Company will host a conference call and webcast at ...

Core Insights - Apogee Therapeutics Inc. (NASDAQ:APGE) is highlighted as a strong investment opportunity due to its promising pipeline and analyst confidence, with a Buy rating reiterated by TD Cowen and Canaccord Genuity [1][2]. Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologic therapies for inflammatory and immunological diseases, particularly targeting conditions like atopic dermatitis, asthma, and COPD [4]. Pipeline Developments - The company reported that its antibody APG333 demonstrated a 55-day half-life in Phase 1 trials, indicating potential for quarterly or semi-annual dosing, which is a significant advantage in treatment frequency [2]. - APG333 has shown the ability to suppress key biomarkers for up to six months with a single dose, and it has been well-tolerated with mild side effects [2][3]. Market Position and Future Prospects - The positive results from APG333 trials affirm the company's potential for delivering durable activity, which may allow for less frequent dosing compared to existing treatments [3]. - The CEO of Apogee highlighted the potential for a dosing combination of APG777 and APG333 to address respiratory diseases more effectively than monotherapy [3]. Analyst Ratings and Price Targets - Canaccord Genuity set a price target of $89 for Apogee Therapeutics, citing its strong financial position and cash reserves from a recent equity raise, alongside a promising pipeline with key data readouts expected in 2026 [1].

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.

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. 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]

Core Viewpoint - Apogee Therapeutics Inc. (NASDAQ:APGE) is identified as a promising healthcare stock with significant upside potential, supported by a Buy rating from BTIG analyst Julian Harrison, who has set a price target of $115 [1][2]. Group 1: Company Overview - Apogee Therapeutics Inc. is a biotechnology company focused on developing treatments for chronic obstructive pulmonary disease (COPD), atopic dermatitis (AD), and other inflammatory and immunology indications [3]. Group 2: Clinical Developments - The optimistic rating is based on the company's promising clinical developments, particularly the potential of its drug APG777, which targets conditions such as asthma, atopic dermatitis, and eosinophilic esophagitis [2]. - The expected best-in-class features of APG777 and the narrowing timelines of clinical data are significant factors indicating considerable upside potential for the company [2]. Group 3: Ongoing Trials and Data - Ongoing data updates and trials, along with the anticipated confirmation of APG777's safety profile and efficacy, further reinforce the Buy rating for Apogee Therapeutics Inc. [3].

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]

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].

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].