Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immune (I&I) markets, including treatments for atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE) [2] - The company's lead program, APG777, targets atopic dermatitis, which is identified as the largest and least penetrated market within the I&I sector [2] - Apogee aims to achieve best-in-class efficacy and dosing through its antibody programs, which are designed to address the limitations of existing therapies by utilizing advanced antibody engineering [2] Upcoming Events - Management of Apogee Therapeutics will participate in a fireside chat at the Guggenheim SMID Cap Biotech Conference on February 5, 2025, at 1:00 p.m. E.T. [1] - A live and archived webcast of the event will be accessible on the company's website [1]

Core Insights - Apogee Therapeutics is advancing its pipeline with promising interim data for APG808 and APG777, indicating potential for innovative dosing regimens and significant market impact in inflammatory and immunology conditions [2][3][5] Group 1: APG808 Developments - APG808 Phase 1 trial results show it was well-tolerated with a half-life of approximately 55 days, suggesting a potential dosing regimen of every 2- to 3-months, significantly longer than current therapies [3][6] - The trial enrolled 32 healthy adult participants, demonstrating deep and sustained effects on pharmacodynamic markers for up to 3 months [3][6] - Apogee plans to evaluate APG808 in a Phase 1b trial for asthma, with data expected in the first half of 2025 [3][6] Group 2: APG777 Progress - APG777 has shown a half-life of 77 days in its Phase 1 trial, supporting a potential annual dosing schedule, which could disrupt the $50 billion atopic dermatitis market [6][5] - The ongoing Phase 2 trial of APG777 in atopic dermatitis is expected to report 16-week topline data in mid-2025, accelerated due to strong enrollment [6][5] - APG777 is also being developed for eosinophilic esophagitis and asthma, with plans for a Phase 1b trial in asthma in the first half of 2025 [6][5] Group 3: Combination Therapies - Apogee is pursuing first-in-class combination therapies, including APG777 with APG990 and APG333, targeting broader inflammatory pathways for enhanced efficacy [7][8][12] - The APG777 + APG990 combination is expected to enter a Phase 1b trial against DUPIXENT in 2025, with results anticipated in the second half of 2026 [9][8] - APG777 + APG333 is planned for a Phase 1 trial by the end of 2024, aiming to address Type 2 and Type 3 inflammation with potentially less frequent dosing [11][12]

Core Insights - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, including treatments for atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD) [1][5] - The company will host a virtual R&D Day on December 2, 2024, to discuss its advancements and future strategies in the I&I space [1] Company Overview - Apogee Therapeutics aims to provide differentiated efficacy and dosing in the I&I markets, targeting conditions such as AD, asthma, and COPD [1][5] - The company’s lead program, APG777, is being developed for AD, which is identified as the largest and least penetrated market in I&I [5] - Apogee's antibody programs are designed to address limitations of existing therapies by targeting established mechanisms of action and utilizing advanced antibody engineering [5] R&D Day Agenda - The agenda includes discussions on Apogee's vision for next-gen biotech, interim results from the APG808 Phase 1 clinical trial, and updates on APG777 [4] - Key opinion leaders will present on topics such as the need for new treatment opportunities in I&I conditions and the potential of IL-13 + OX40L combination therapy for AD [2][4] - The event will also cover commercial opportunities and strategies, concluding with a Q&A session [4] Featured Speakers - Notable speakers include Emma Guttman-Yassky, M.D., Ph.D., and David Singh, M.D., who will provide insights into the current landscape of I&I treatments [2][3]

Core Insights - Apogee Therapeutics, Inc. is hosting a virtual R&D Day on December 2, 2024, to discuss updates on its programs and the potential of its lead candidate APG777 in treating atopic dermatitis [1][2] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease [1][4] - The company aims to provide differentiated efficacy and dosing through advanced antibody engineering, targeting established mechanisms of action [4] Product Development - APG777 is highlighted as having best-in-class potential for treating atopic dermatitis, which is noted as the largest and least penetrated market within I&I [2][4] - The company is pursuing both monotherapies and combination therapies to achieve superior efficacy and dosing across its portfolio of four validated targets [4] Event Details - The R&D Day will feature presentations from management and guest speakers discussing the current treatment landscape and the need for new therapies in the I&I space [2][3]

(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]

PART I: FINANCIAL INFORMATION [Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) Apogee Therapeutics' unaudited interim financial statements reflect increased cash and marketable securities from a stock offering and a growing net loss due to higher R&D Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $307,299 | $118,316 | | Marketable securities (Current & Long-term) | $482,324 | $277,143 | | **Total Assets** | **$800,657** | **$401,404** | | **Liabilities & Equity** | | | | Total Liabilities | $27,018 | $21,491 | | Total Stockholders' Equity | $773,639 | $379,913 | Condensed Consolidated Statement of Operations Highlights (in thousands) | Item | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $33,206 | $13,946 | $61,922 | $22,401 | | General and administrative | $10,916 | $4,939 | $20,381 | $9,142 | | **Loss from operations** | **$(44,122)** | **$(18,885)** | **$(82,303)** | **$(31,543)** | | Interest income, net | $10,306 | $— | $16,393 | $133 | | **Net loss** | **$(33,816)** | **$(18,885)** | **$(65,910)** | **$(31,410)** | | **Net loss per share** | **$(0.60)** | **$(3.78)** | **$(1.24)** | **$(6.28)** | Condensed Consolidated Statement of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(60,936) | $(25,127) | | Net cash used in investing activities | $(200,451) | $— | | Net cash provided by financing activities | $450,370 | $(1,694) | - The company is a clinical-stage biotechnology firm focused on inflammatory and immunology (I&I) indications like atopic dermatitis (AD), asthma, and COPD, having funded operations through preferred unit and common stock sales without generating revenue[36](index=36&type=chunk)[44](index=44&type=chunk) - The company believes its existing cash, cash equivalents, and marketable securities of approximately **$789.6 million** as of June 30, 2024, are sufficient to fund operations through at least the next 12 months from the financial statement issuance date[46](index=46&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Apogee's business, pipeline advancements, financial results, and liquidity, noting a strengthened cash position and increased R&D expenses [Overview and Pipeline Update](index=44&type=section&id=MD%26A_Overview) Apogee advanced APG777 into Phase 2, APG808 into Phase 1, and plans APG990 for Phase 1, securing **$450.0 million** from a March 2024 offering - **APG777 (anti-IL-13):** Dosing commenced in a Phase 2 clinical trial for moderate-to-severe Atopic Dermatitis (AD) in May 2024, with topline 16-week data from Part A expected in the second half of 2025[165](index=165&type=chunk) - **APG808 (anti-IL-4Rα):** A Phase 1 trial was initiated in March 2024, with interim Phase 1 PK and safety data expected in Q4 2024 and initial proof-of-concept data in asthma anticipated in H1 2025[169](index=169&type=chunk) - **APG990 (anti-OX40L):** A development candidate was nominated in May 2024, and the company plans to initiate a Phase 1 clinical trial in healthy volunteers in Q3 2024[168](index=168&type=chunk) - **APG333 (anti-TSLP):** A development candidate is planned to be nominated by the end of 2024, with a Phase 1 trial expected to start in 2025[170](index=170&type=chunk) - In March 2024, the company completed a public offering, selling 7,790,321 shares of common stock for aggregate net proceeds of **$450.0 million**[173](index=173&type=chunk) [Results of Operations](index=59&type=section&id=MD%26A_Results_of_Operations) Operating expenses, especially R&D, significantly increased due to clinical advancements and personnel costs, while interest income rose sharply Comparison of Operating Results (in thousands) | Period | R&D Expense | G&A Expense | Loss from Operations | Net Loss | | :--- | :--- | :--- | :--- | :--- | | **Q2 2024** | $33,206 | $10,916 | $(44,122) | $(33,816) | | **Q2 2023** | $13,946 | $4,939 | $(18,885) | $(18,885) | | **H1 2024** | $61,922 | $20,381 | $(82,303) | $(65,910) | | **H1 2023** | $22,401 | $9,142 | $(31,543) | $(31,410) | R&D Expense Breakdown - Six Months Ended June 30 (in thousands) | Program/Category | 2024 | 2023 | | :--- | :--- | :--- | | APG777 | $14,094 | $11,773 | | APG808 | $6,172 | $— | | APG990 | $10,883 | $— | | Unallocated R&D Costs | $13,004 | $8,784 | | Personnel-related | $17,769 | $1,844 | | **Total R&D** | **$61,922** | **$22,401** | - The increase in R&D expenses for H1 2024 was driven by advancing the pipeline, including a **$2.0 million** milestone payment for APG808's first dosing in a Phase 1 trial and a **$1.0 million** milestone for APG990's development candidate nomination, with personnel-related R&D costs increasing by **$15.9 million** due to higher headcount and share-based compensation[227](index=227&type=chunk) - General and administrative expenses for H1 2024 increased by **$11.2 million** compared to H1 2023, primarily due to an **$8.2 million** increase in personnel costs and a **$3.2 million** increase in other expenses related to operational expansion and public company costs[228](index=228&type=chunk) [Liquidity and Capital Resources](index=65&type=section&id=MD%26A_Liquidity_and_Capital_Resources) As of June 30, 2024, the company held **$307.3 million** cash and **$482.3 million** marketable securities, sufficient to fund operations into Q1 2028 Cash Position and Recent Financing (in millions) | Item | Amount | | :--- | :--- | | Cash and cash equivalents (June 30, 2024) | $307.3 | | Marketable securities (June 30, 2024) | $482.3 | | Net proceeds from July 2023 IPO | $315.4 | | Net proceeds from March 2024 Offering | $450.0 | - Based on the current operating plan, the company estimates its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditure requirements into the first quarter of 2028[245](index=245&type=chunk)[273](index=273&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2024, was **$60.9 million**, primarily due to the net loss of **$65.9 million**, adjusted for non-cash items like equity-based compensation[233](index=233&type=chunk)[235](index=235&type=chunk) - Net cash provided by financing activities was **$450.4 million** for the six months ended June 30, 2024, mainly from the March 2024 public offering[238](index=238&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=70&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Apogee Therapeutics is exempt from providing market risk disclosures - The company is a smaller reporting company as defined in Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[256](index=256&type=chunk) [Controls and Procedures](index=72&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls were effective as of June 30, 2024, with no material changes to internal controls - Management concluded that as of June 30, 2024, the company's disclosure controls and procedures were effective at the reasonable assurance level[257](index=257&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls[258](index=258&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=73&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, and management anticipates no material adverse effects - The company is not currently a party to any material legal proceedings[261](index=261&type=chunk) [Risk Factors](index=73&type=section&id=Item%201A.%20Risk%20Factors) This section details substantial investment risks, including Apogee's limited operating history, lead program dependence, and need for additional capital - The company is a clinical-stage entity with a limited operating history, no approved products, and a history of significant losses, making it difficult to evaluate its future success[263](index=263&type=chunk)[266](index=266&type=chunk) - Substantial additional capital will be required to finance operations, and failure to raise capital when needed could force delays or elimination of development programs[263](index=263&type=chunk)[268](index=268&type=chunk) - The company is substantially dependent on the success of its most advanced programs, APG777, APG808, and APG990, which are still in clinical development and may not be successful[263](index=263&type=chunk)[295](index=295&type=chunk) - The company relies on third parties, such as Paragon for discovery and WuXi Biologics for manufacturing, and any failure by these parties to perform could negatively impact the business[263](index=263&type=chunk)[327](index=327&type=chunk)[336](index=336&type=chunk) - The company's ability to protect its patents and proprietary rights is uncertain, and it may face costly infringement claims[263](index=263&type=chunk)[359](index=359&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=126&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the use of **$315.4 million** net proceeds from the July 2023 IPO for clinical trials and R&D, with no material change - On July 18, 2023, the company completed its IPO, receiving net proceeds of approximately **$315.4 million**[447](index=447&type=chunk)[449](index=449&type=chunk) - The net proceeds are being used to fund clinical trials and manufacturing for APG777, APG808, and APG990, as well as other R&D activities and general corporate purposes[450](index=450&type=chunk)[452](index=452&type=chunk) - There has been no material change in the intended use of proceeds from the IPO as described in the prospectus[452](index=452&type=chunk) [Defaults Upon Senior Securities](index=128&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities are reported - No defaults upon senior securities are reported[453](index=453&type=chunk) [Mine Safety Disclosures](index=128&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable to the company[454](index=454&type=chunk) [Other Information](index=128&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading plans during Q2 2024 - During the three months ended June 30, 2024, none of the Company's directors or executive officers adopted, modified or terminated any trading plan under Rule 10b5-1(c)[455](index=455&type=chunk) [Exhibits](index=129&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including stock plan amendments, license agreements, and officer certifications - The report includes several exhibits, such as amendments to the 2023 Employee Stock Purchase Plan, license agreements with MIL 6T, LLC, and certifications by the CEO and CFO[458](index=458&type=chunk)

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]