(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 WASHINGTON, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41740 Apogee Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other juri ...

Company Overview - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, targeting conditions such as atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) [3] - The company aims to address limitations of existing therapies by utilizing advanced antibody engineering to optimize efficacy and dosing [3] Product Pipeline - Apogee's most advanced program, APG777, is being developed for the treatment of atopic dermatitis, which is identified as the largest and least penetrated market within I&I [3] - The company has four validated targets in its portfolio and is pursuing both monotherapies and combination therapies to achieve best-in-class efficacy [3] Upcoming Events - Apogee Therapeutics will participate in several investor conferences, including: - Guggenheim Inaugural Healthcare Innovation Conference on November 12, 2024, at 3:00 p.m. ET - Stifel 2024 Healthcare Conference on November 18, 2024, at 10:20 a.m. ET - Jefferies London Healthcare Conference on November 20, 2024, at 3:30 a.m. GMT / 10:30 a.m. ET - A live and archived webcast of these events will be available on the company's website [2]

Core Insights - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including treatments for atopic dermatitis, asthma, and chronic obstructive pulmonary disease [1][3] - The company will present data from its ongoing Phase 1 clinical trial of APG777, an anti-IL-13 antibody, at the ACAAI 2024 Annual Scientific Meeting [1][2] Company Overview - Apogee Therapeutics aims to address limitations of existing therapies by utilizing advanced antibody engineering to optimize half-life and efficacy [3] - The company is initially developing APG777 for atopic dermatitis, which is identified as a large and under-penetrated market within the inflammatory and immunology sector [3] - Apogee has a portfolio with four validated targets and seeks to achieve best-in-class efficacy through both monotherapies and combinations of its novel antibodies [3]

Core Insights - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, targeting conditions such as atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) [2] Company Overview - Apogee Therapeutics aims to provide differentiated efficacy and dosing in the I&I markets, with a particular focus on AD, which is noted as the largest and least penetrated market in this sector [2] - The company is advancing its antibody programs to address limitations of existing therapies by targeting established mechanisms of action and utilizing advanced antibody engineering to enhance properties like half-life [2] - APG777 is the most advanced program of the company, initially developed for the treatment of AD [2] - Apogee has four validated targets in its portfolio and is pursuing best-in-class efficacy through both monotherapies and combinations of its novel antibodies [2] - The company believes its broad pipeline and expertise can deliver significant value and benefits to patients who are underserved by current standard care [2]

Table of Contents For the transition period from to Commission File Number: 001-41740 Apogee Therapeutics, Inc. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Indicate by check mark whether the registrant (1) has filed all reports required ...

Core Insights - NewAmsterdam Pharma Company N.V. has appointed Mark C. McKenna and Wouter Joustra as temporary non-executive directors to its Board of Directors, filling vacant positions until the next annual general meeting [1][2] - The company announced the departure of Sander Slootweg from its Board of Directors, effective July 16, 2024 [1] Company Overview - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C) [6] - The company aims to address unmet needs for safe, well-tolerated, and convenient LDL-lowering therapies, particularly through its ongoing Phase 3 studies of obicetrapib, a CETP inhibitor [6] Leadership Experience - Mark C. McKenna brings over 20 years of pharmaceutical industry experience, having held leadership roles in various companies, including Prometheus Biosciences, which was acquired by Merck for approximately $10.8 billion in June 2023 [2][3] - Wouter Joustra has extensive experience in capital markets and life sciences investments, currently serving as a General Partner at Forbion, a global life sciences venture capital firm [3][4] Strategic Importance - The appointments of McKenna and Joustra are seen as strategic moves as NewAmsterdam approaches pivotal Phase 3 data readouts from multiple ongoing clinical trials [2] - Both new board members express confidence in the company's potential to impact the CVD treatment landscape significantly [3][5]

Company Overview - Apogee Therapeutics Inc (NASDAQ: APGE) is a biotechnology company focused on developing innovative therapies for chronic and prevalent conditions such as atopic dermatitis (AD) and asthma [1][3] - The company's lead clinical candidate, APG777, is a Phase 1 SQ monoclonal antibody targeting IL13, with dosing frequency of every three to six months, potentially offering a significant improvement over existing treatments like Dupixent [1][3] - Apogee is also developing APG808, a novel SQ half-life extended mAb targeting IL-4Rα, for type 2 allergic diseases like asthma and COPD, aiming to compete in Dupixent's market [3] Clinical Progress - APG777 has advanced to a Phase 2 clinical trial (NCT06395948) in patients with moderate-to-severe atopic dermatitis, with proof-of-concept data expected in 2H 2025 [3] - The company anticipates initiating a Phase 2 clinical trial for APG777 in asthma next year, targeting two large markets: AD (projected to reach over $18 billion by 2032) and asthma (currently valued at near $25 billion) [3] - APG777's extended-release mechanism could differentiate it from existing drugs like Dupixent, with clinical risks slightly reduced due to its validated MOA [5] Financial Health - As of March 31, Apogee has $485 457 million in cash and cash equivalents and $330 739 million in marketable securities, with no major liabilities [4] - Q1 R&D and G&A expenses totaled $28 716 million and $9 465 million, respectively, with a cash runway estimated to extend into 2028 based on current liquid assets and operating expenses [4] - The company raised $420 million in capital at $62/share in March, a strategic move given the high costs associated with advancing clinical candidates into late-stage trials [2][5] Market and Competitive Landscape - The AD and asthma markets are substantial, with AD projected to grow to over $18 billion by 2032 and asthma currently valued at near $25 billion [3] - APG777 and APG808 aim to compete with Dupixent, which has a speculated peak annual revenue of over $20 billion following its success in COPD [3] - Historical examples like Humira and Enbrel in rheumatoid arthritis, and Aimovig in migraine, demonstrate the market preference for less frequent dosing, which could benefit APG777 if it demonstrates non-inferiority to Dupixent [3] Investment Considerations - APGE stock has declined by 34% since March, while the S&P 500 Index has risen by 7 7%, potentially due to a lack of major catalysts and a weaker biotech sector [1][3] - The company's progress with APG777 and APG808, combined with its strong financial position, suggests potential for long-term growth, though significant operating cost increases are expected as clinical trials advance [4][5] - APGE is recommended as a high-risk/high-reward stock, suitable for a barbell portfolio strategy with 10% allocation to such stocks, allowing investors to benefit from upside potential while mitigating risk [7]

SAN FRANCISCO and WALTHAM, Mass., May 28, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (NASDAQ:APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease (COPD) and other inflammatory and immunology (I&I) indications, today announced that Lisa Bollinger, MD, has been appointed to the company's board of directors. Dr. Bollinger most recently served as Vice President, Regulatory Affairs, Global Regulatory ...

SAN FRANCISCO and WALTHAM, Mass., May 23, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (NASDAQ:APGE), a clinical-stage biotechnology company advancing differentiated biologics for the treatment of atopic dermatitis, COPD, asthma and other inflammatory and immunology indications, today announced that members of management will participate at the following upcoming investor conferences: Jefferies Global Healthcare Conference Date: Thursday, June 6, 2024Time: 8:30 a.m. ET Goldman Sachs 45th Annual Global ...

Interim clinical data from APG777 Phase 1 healthy volunteers study exceeded all trial objectives and achieved a half-life of approximately 75 days with a potentially best-in-class profile 16-week proof-of-concept data from Part A of the Phase 2 trial expected in 2H 2025 Pipeline-in-a-product potential with a Phase 2 in asthma expected to initiate in 2025 and plans for additional indication expansion SAN FRANCISCO and WALTHAM, Mass., May 15, 2024 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (NASDAQ:APGE), a ...