Interim Phase 1 results for APG990, a novel half-life extended OX40L antibody, exceeded trial objectives and demonstrated an approximately 60-day half-life APG279 (APG777 + APG990) Phase 1b head-to-head study vs. DUPIXENT supported by successful completion of preclinical combination toxicology studies and positive APG990 interim Phase 1 results; trial planned to initiate this year with readout expected in second half of 2026 Webcast to be held today at 8:30 a.m. ET SAN FRANCISCO and BOSTON, March 03, 2025 ( ...

Company Overview - 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, chronic obstructive pulmonary disease, and eosinophilic esophagitis [3] - The company's lead program, APG777, targets atopic dermatitis, which is identified as the largest and least penetrated market in the inflammatory and immunology sector [3] - Apogee aims to achieve best-in-class efficacy and dosing through its antibody programs, which are designed to overcome limitations of existing therapies by utilizing advanced antibody engineering [3] Upcoming Events - Apogee Therapeutics will participate in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, at 2:30 p.m. ET [2] - The company will also be present at the Leerink Global Healthcare Conference on March 11, 2025, at 8:40 a.m. ET [2] - A live and archived webcast of these events will be available on the company's website [2]

Core Insights - Apogee Therapeutics has successfully completed enrollment for Part A of the Phase 2 APEX clinical trial of APG777, exceeding the target with 123 patients enrolled ahead of schedule [1][3] - The first patient has been dosed in Part B of the trial, which focuses on moderate-to-severe atopic dermatitis (AD) [2][3] - APG777 is designed to provide improved dosing and efficacy compared to existing therapies, with a potential reduction in injection frequency [3][4] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology (I&I) markets, including treatments for AD, asthma, and chronic obstructive pulmonary disease (COPD) [2][7] - The company aims to address the limitations of current therapies by utilizing advanced antibody engineering to optimize drug properties [7] Clinical Trial Details - The APEX trial is a Phase 2 randomized, placebo-controlled study evaluating APG777, a monoclonal antibody targeting IL-13, a key cytokine in inflammation [3][4] - Part A of the trial randomized 123 patients in a 2:1 ratio to receive either APG777 or placebo, with a primary endpoint focused on the mean percentage change in EASI score from baseline at week 16 [3][4] - Part B will involve approximately 280 patients randomized to different dosing regimens of APG777 versus placebo [3][4] Future Development Plans - Apogee plans to advance APG777 into additional clinical trials, including a Phase 1b trial in asthma and a Phase 2 trial in eosinophilic esophagitis (EoE) [4][5] - The company is also exploring combination therapies with other investigational drugs to enhance efficacy and safety for I&I conditions [4][5] Product Profile - APG777 is a subcutaneous monoclonal antibody with a half-life of 77 days, demonstrating sustained efficacy in inhibiting IL-13 signaling [5] - The drug is positioned to potentially serve a large patient population, with an estimated 82 million people worldwide suffering from moderate-to-severe AD [5]

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]

[Company Information](index=1&type=section&id=Company%20Information) Provides essential details about Apogee Therapeutics, Inc., including its registration, headquarters, and filing status [Registrant Details](index=1&type=section&id=Registrant%20Details) Apogee Therapeutics, Inc., a Delaware corporation headquartered in Waltham, Massachusetts, filed its 10-Q quarterly report for the period ended September 30, 2024 - Apogee Therapeutics, Inc. is a Delaware corporation, headquartered in Waltham, Massachusetts, and has filed its 10-Q quarterly report for the period ended September 30, 2024[1](index=1&type=chunk) [Filing Status](index=1&type=section&id=Filing%20Status) The company is designated as a non-accelerated filer, smaller reporting company, and emerging growth company - The company is marked as a **Non-accelerated filer**, a **Smaller reporting company**, and an **Emerging growth company**[3](index=3&type=chunk) - The company has filed all required reports in the past 12 months and all required interactive data files[2](index=2&type=chunk) [Common Stock Information](index=1&type=section&id=Common%20Stock%20Information) As of November 5, 2024, the company had 58,513,198 shares of common stock outstanding, with a par value of $0.00001 per share - As of November 5, 2024, the company had **58,513,198 shares of common stock outstanding**, including **45,026,556 shares of voting common stock** and **13,486,642 shares of non-voting common stock**[3](index=3&type=chunk) Common Stock Information | Metric | Quantity | | :--- | :--- | | Total Common Stock Outstanding (as of November 5, 2024) | 58,513,198 | | Voting Common Stock | 45,026,556 | | Non-Voting Common Stock | 13,486,642 | | Par Value | $0.00001/share | [SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section cautions investors about forward-looking statements, which are subject to significant risks and uncertainties [Forward-Looking Statements Disclaimer](index=3&type=section&id=Forward-Looking%20Statements%20Disclaimer) This quarterly report contains forward-looking statements based on current expectations, subject to significant risks and uncertainties - This quarterly report contains "forward-looking statements" based on current expectations, estimates, forecasts, and assumptions, and are subject to significant risks and uncertainties[7](index=7&type=chunk) - Forward-looking statements reflect the company's current views on future events, and investors should not place undue reliance on these statements given the significant risks and uncertainties[7](index=7&type=chunk) [Key Risks and Uncertainties](index=3&type=section&id=Key%20Risks%20and%20Uncertainties) Risks include development plans, funding, clinical trials, third-party reliance, regulatory approvals, and intellectual property protection - Key risks include the company's plans for developing and commercializing programs for inflammatory and immune diseases such as atopic dermatitis, asthma, and chronic obstructive pulmonary disease[8](index=8&type=chunk) - The company's ability to obtain operating capital, including funds required to complete program development and commercialization, and the timing and focus of ongoing and future clinical trials[8](index=8&type=chunk) - The company's continued reliance on third parties for preclinical studies, clinical trials, and manufacturing of product candidates, and the ability to obtain and maintain regulatory approvals[8](index=8&type=chunk) [PART I FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) Presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section presents the company's unaudited condensed consolidated financial statements and related notes [Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20September%2030,%202024%20and%20December%2031,%202023) The balance sheet shows significant growth in total assets and stockholders' equity, driven by increased marketable securities Condensed Consolidated Balance Sheets (in thousands of dollars) | Metric | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $118,780 | $118,316 | | Marketable securities | $407,269 | $277,143 | | Long-term marketable securities | $227,746 | $— | | Total assets | $776,286 | $401,404 | | **Liabilities and Stockholders' Equity** | | | | Total liabilities | $41,884 | $21,491 | | Total stockholders' equity | $734,402 | $379,913 | - As of September 30, 2024, the company's total assets increased to **$776.3 million**, a **93.4% increase** from **$401.4 million** as of December 31, 2023, primarily due to a significant increase in marketable securities and long-term marketable securities[15](index=15&type=chunk) - Total stockholders' equity increased from **$379.9 million** as of December 31, 2023, to **$734.4 million** as of September 30, 2024, a **93.3% increase**, primarily reflecting additional paid-in capital[15](index=15&type=chunk) [Condensed Consolidated Statement of Operations for the Three and Nine Months Ended September 30, 2024 and 2023](index=6&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations%20for%20the%20Three%20and%20Nine%20Months%20Ended%20September%2030,%202024%20and%202023) The statement of operations reflects increased net losses due to substantial growth in research and development and general and administrative expenses Condensed Consolidated Statement of Operations (in thousands of dollars, except per share data) | Metric | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $45,714 | $17,069 | $107,636 | $39,470 | | General and administrative expenses | $12,972 | $7,236 | $33,353 | $16,378 | | Total operating expenses | $58,686 | $24,305 | $140,989 | $55,848 | | Operating loss | $(58,686) | $(24,305) | $(140,989) | $(55,848) | | Net interest income | $9,668 | $3,465 | $26,061 | $3,598 | | Net loss | $(49,018) | $(20,840) | $(114,928) | $(52,250) | | Net loss per share (basic and diluted) | $(0.86) | $(0.51) | $(2.11) | $(3.04) | - For the three months ended September 30, 2024, net loss was **$49.0 million**, a **135.2% increase** from **$20.8 million** in the prior-year period[18](index=18&type=chunk) - For the nine months ended September 30, 2024, net loss was **$114.9 million**, a **119.9% increase** from **$52.3 million** in the prior-year period, primarily due to a significant increase in research and development and general and administrative expenses[18](index=18&type=chunk) [Condensed Consolidated Statement of Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023](index=7&type=section&id=Condensed%20Consolidated%20Statement%20of%20Comprehensive%20Loss%20for%20the%20Three%20and%20Nine%20Months%20Ended%20September%2030,%202024%20and%202023) The comprehensive loss statement indicates a significant increase in total comprehensive loss, primarily driven by the expanded net loss Condensed Consolidated Statement of Comprehensive Loss (in thousands of dollars) | Metric | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Net loss | $(49,018) | $(20,840) | $(114,928) | $(52,250) | | Change in unrealized gain on marketable securities (net of tax) | $3,559 | $135 | $2,941 | $135 | | Comprehensive loss | $(45,459) | $(20,705) | $(111,987) | $(52,115) | - For the nine months ended September 30, 2024, comprehensive loss was **$112.0 million**, a **114.9% increase** from **$52.1 million** in the prior-year period, primarily impacted by the increased net loss[22](index=22&type=chunk) [Condensed Consolidated Statement of Stockholders' Equity for the Three and Nine Months Ended September 30, 2024 and 2023](index=8&type=section&id=Condensed%20Consolidated%20Statement%20of%20Stockholders'%20Equity%20for%20the%20Three%20and%20Nine%20Months%20Ended%20September%2030,%202024%20and%202023) The statement of stockholders' equity shows a substantial increase in additional paid-in capital and accumulated deficit Condensed Consolidated Statement of Stockholders' Equity (in thousands of dollars, except shares data) | Metric | Balance as of December 31, 2023 | Balance as of September 30, 2024 | | :--- | :--- | :--- | | Common stock shares | 48,338,769 | 56,899,295 | | Additional paid-in capital | $503,354 | $969,829 | | Accumulated deficit | $(123,770) | $(238,698) | | Total stockholders' equity | $379,913 | $734,402 | - As of September 30, 2024, additional paid-in capital increased to **$969.8 million**, an increase of **$466.5 million** from December 31, 2023, primarily from the common stock offering in March 2024[26](index=26&type=chunk) - As of September 30, 2024, the accumulated deficit increased to **$238.7 million**, an increase of **$114.9 million** from December 31, 2023, reflecting the net loss during the reporting period[26](index=26&type=chunk) [Condensed Consolidated Statement of Preferred Units and Stockholders' Equity/Members' Deficit for the Three and Nine Months Ended September 30, 2024 and 2023](index=9&type=section&id=Condensed%20Consolidated%20Statement%20of%20Preferred%20Units%20and%20Stockholders'%20Equity/Members'%20Deficit%20for%20the%20Three%20and%20Nine%20Months%20Ended%20September%2030,%202024%20and%202023) This statement details the conversion of preferred units to common stock following the 2023 IPO, eliminating outstanding preferred units - As of September 30, 2023, all preferred units were converted into common stock in the July 2023 IPO, thus no preferred units are outstanding[29](index=29&type=chunk) - The 2023 IPO of common stock generated **$315.4 million** in additional paid-in capital (net of offering costs)[29](index=29&type=chunk) [Condensed Consolidated Statement of Cash Flows for the Nine Months Ended September 30, 2024 and 2023](index=10&type=section&id=Condensed%20Consolidated%20Statement%20of%20Cash%20Flows%20for%20the%20Nine%20Months%20Ended%20September%2030,%202024%20and%202023) The cash flow statement highlights increased net cash outflows from operating and investing activities, offset by significant financing inflows Condensed Consolidated Statement of Cash Flows (in thousands of dollars) | Metric | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(103,460) | $(45,007) | | Net cash used in investing activities | $(346,829) | $(234,218) | | Net cash provided by financing activities | $450,753 | $315,604 | | Net increase in cash, cash equivalents, and restricted cash | $464 | $36,379 | | Cash, cash equivalents, and restricted cash at end of period | $119,074 | $188,269 | - For the nine months ended September 30, 2024, net cash used in operating activities was **$103.5 million**, a significant increase from **$45.0 million** in the prior-year period, primarily due to the expanded net loss[32](index=32&type=chunk) - Net cash provided by financing activities was **$450.8 million**, primarily from the March 2024 common stock offering, compared to **$315.6 million** in the prior-year period, mainly from the IPO[32](index=32&type=chunk) [Notes to the Unaudited Interim Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Unaudited%20Interim%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations and disclosures supporting the unaudited interim condensed consolidated financial statements [1. Nature of the Business](index=11&type=section&id=1.%20Nature%20of%20the%20Business) Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immune diseases - Apogee Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel biologics with differentiated efficacy and delivery potential, primarily targeting inflammatory and immune (I&I) markets such as atopic dermatitis (AD), asthma, and chronic obstructive pulmonary disease (COPD)[34](index=34&type=chunk) - The company completed a reorganization and initial public offering (IPO) in July 2023, with net cash proceeds of **$315.4 million**, and a follow-on public offering in March 2024, with net proceeds of **$450.0 million**[38](index=38&type=chunk)[40](index=40&type=chunk) - As of September 30, 2024, the company had an accumulated deficit of **$238.7 million** and a net loss of **$114.9 million**; it expects existing cash, cash equivalents, and marketable securities (totaling **$753.8 million**) to fund operations and capital requirements for at least the next 12 months[43](index=43&type=chunk) [2. Summary of Significant Accounting Policies](index=12&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) Outlines the key accounting principles and methods used in preparing the condensed consolidated financial statements - The company's condensed consolidated financial statements are prepared in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and include all normal and recurring adjustments[47](index=47&type=chunk) - The company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents[61](index=61&type=chunk) - The company's investments in marketable securities are classified as available-for-sale securities and reported at fair value based on quoted market prices for similar securities in active markets[62](index=62&type=chunk) - Research and development costs are expensed as incurred, including salaries, overhead, contract services, and other related costs[57](index=57&type=chunk) [3. Marketable Securities](index=18&type=section&id=3.%20Marketable%20Securities) Details the company's marketable securities portfolio, which significantly increased, primarily in US Treasury bills and government agency bonds Marketable Securities Portfolio (in thousands of dollars) | Category | Fair Value as of September 30, 2024 | Fair Value as of December 31, 2023 | | :--- | :--- | :--- | | U.S. Treasury bills | $266,125 | $123,974 | | U.S. government agency issued bonds | $258,164 | $153,169 | | Commercial paper | $30,315 | $— | | Corporate bonds | $80,411 | $— | | Total marketable securities | $635,015 | $277,143 | - As of September 30, 2024, the company's total marketable securities were **$635.0 million**, a significant increase from **$277.1 million** as of December 31, 2023, primarily invested in U.S. Treasury bills, U.S. government agency bonds, commercial paper, and corporate bonds[82](index=82&type=chunk) - As of September 30, 2024, the company's marketable securities had a net unrealized gain of **$3.279 million** and unrealized losses of **$9 thousand**[82](index=82&type=chunk) [4. Fair Value Measurements](index=18&type=section&id=4.%20Fair%20Value%20Measurements) Presents the fair value hierarchy for financial assets, primarily categorized within Level 1 and Level 2 inputs Fair Value Measurements (in thousands of dollars) as of September 30, 2024 | Category | Level 1 | Level 2 | Level 3 | Total | | :--- | :--- | :--- | :--- | :--- | | Cash equivalents: Money market funds | $111,924 | $— | $— | $111,924 | | Marketable securities: U.S. Treasury bills | $266,125 | $— | $— | $266,125 | | Marketable securities: U.S. government agency issued bonds | $— | $258,164 | $— | $258,164 | | Marketable securities: Commercial paper | $— | $30,315 | $— | $30,315 | | Marketable securities: Corporate bonds | $— | $80,411 | $— | $80,411 | | Total | $378,049 | $368,890 | $— | $746,939 | - As of September 30, 2024, the total fair value of the company's financial assets was **$746.9 million**, primarily distributed across Level 1 (**$378.0 million**) and Level 2 (**$368.9 million**), indicating valuation based on observable market inputs[84](index=84&type=chunk) [5. Prepaids and Other Assets](index=19&type=section&id=5.%20Prepaids%20and%20Other%20Assets) Shows a substantial increase in prepaids and other current assets, driven by higher interest receivables and prepaid expenses Prepaids and Other Current Assets (in thousands of dollars) | Category | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Prepaid expenses | $3,265 | $1,736 | | Interest receivable | $4,773 | $1,214 | | Other current assets | $396 | $— | | Total | $8,434 | $2,950 | - As of September 30, 2024, prepaids and other current assets increased to **$8.4 million**, a **185.9% increase** from **$2.95 million** as of December 31, 2023, driven by increased interest receivable and prepaid expenses[85](index=85&type=chunk) [6. Property and Equipment, net](index=19&type=section&id=6.%20Property%20and%20Equipment,%20net) Details the increase in net property and equipment, primarily due to additions in laboratory equipment and leasehold improvements Property and Equipment, net (in thousands of dollars) | Category | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Laboratory equipment | $1,285 | $377 | | Leasehold improvements | $245 | $— | | Less: Accumulated depreciation | $(113) | $— | | Total | $1,417 | $377 | - As of September 30, 2024, net property and equipment increased to **$1.417 million**, a **275.9% increase** from **$377 thousand** as of December 31, 2023, primarily due to additions in laboratory equipment and leasehold improvements[86](index=86&type=chunk) [7. Accrued Expenses](index=20&type=section&id=7.%20Accrued%20Expenses) Accrued expenses increased significantly, mainly due to higher accrued manufacturing costs and employee compensation Accrued Expenses (in thousands of dollars) | Category | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Accrued external R&D expenses | $5,242 | $6,685 | | Accrued manufacturing expenses | $13,676 | $9,219 | | Accrued employee compensation | $6,917 | $167 | | Total | $27,528 | $17,314 | - As of September 30, 2024, total accrued expenses were **$27.5 million**, a **59.0% increase** from **$17.3 million** as of December 31, 2023, driven by increases in accrued manufacturing expenses and accrued employee compensation[87](index=87&type=chunk) [8. Other Significant Agreements](index=20&type=section&id=8.%20Other%20Significant%20Agreements) Describes key agreements, including option and license agreements with Paragon Therapeutics and a master services agreement with WuXi Biologics - The company entered into option and license agreements with Paragon Therapeutics, with related R&D expenses of **$11.125 million** for the nine months ended September 30, 2024, a decrease from **$21.083 million** in the prior-year period[88](index=88&type=chunk) - The company has exercised options for IL-13, IL-4Rα, OX40L, and TSLP targets and entered into corresponding exclusive worldwide license agreements[37](index=37&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) - The company paid **$5.0 million** in milestone payments for the APG808 and APG990 programs in 2024 and expects to pay a **$3.0 million** milestone payment for the TSLP program in the fourth quarter of 2024[102](index=102&type=chunk)[145](index=145&type=chunk) - The company entered into a Biologics Master Services Agreement with WuXi Biologics, with related R&D expenses of **$27.9 million** for the nine months ended September 30, 2024, a significant increase from **$9.6 million** in the prior-year period[108](index=108&type=chunk) [9. Commitments and Contingencies](index=23&type=section&id=9.%20Commitments%20and%20Contingencies) Discusses the company's outsourcing of drug manufacturing and the absence of significant legal proceedings or claims - The company outsources the manufacturing, storage, distribution, and quality testing of all preclinical and clinical drug products to third-party manufacturers[112](index=112&type=chunk) - The company enters into standard indemnification agreements in the ordinary course of business, but as of September 30, 2024, no litigation or claims related to these agreements have occurred[113](index=113&type=chunk) - The company is not currently involved in any material legal proceedings that could have a significant adverse effect on its operating results, financial condition, or cash flows[114](index=114&type=chunk) [10. Preferred Shares](index=24&type=section&id=10.%20Preferred%20Shares) Explains the conversion of all preferred units into common stock during the 2023 IPO, resulting in no outstanding preferred shares - As of June 30, 2023, the company had **65,089,212 preferred units** (Series A and Series B) authorized, issued, and outstanding[115](index=115&type=chunk) - All issued preferred units were converted into common stock during the July 2023 IPO, and as of September 30, 2024, the company has no preferred units outstanding[115](index=115&type=chunk) - The company received total proceeds of **$20.0 million** from Series A preferred unit agreements and **$149.0 million** from Series B preferred unit agreements prior to the IPO[116](index=116&type=chunk)[118](index=118&type=chunk) [11. Common Stock](index=24&type=section&id=11.%20Common%20Stock) Provides details on authorized and outstanding common stock, including a recent at-the-market facility for potential future sales - The company has authorized the issuance of **400 million shares** of common stock with a par value of **$0.00001 per share**[120](index=120&type=chunk) Common Stock Issuance and Outstanding Status | Metric | September 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Number of common shares issued | 58,509,583 | 50,655,671 | | Number of common shares outstanding | 56,899,295 | 48,338,769 | | Number of unvested restricted common shares | 1,610,288 | 2,316,902 | - In August 2024, the company entered into an at-the-market sales agreement with Jefferies LLC to sell common stock with an aggregate offering price of up to **$300.0 million**, but no sales had occurred as of September 30, 2024[121](index=121&type=chunk)[122](index=122&type=chunk) [12. Equity-Based Compensation](index=25&type=section&id=12.%20Equity-Based%20Compensation) Details the company's equity-based compensation expenses and the remaining unrecognized compensation cost Equity-Based Compensation Expense (in thousands of dollars) | Category | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development expenses | $2,464 | $417 | $6,548 | $755 | | General and administrative expenses | $3,375 | $1,088 | $9,175 | $3,137 | | Total | $5,839 | $1,505 | $15,723 | $3,892 | - As of September 30, 2024, total unrecognized compensation expense related to stock options, unvested restricted stock, and the employee stock purchase plan was **$71.3 million**, expected to be recognized over a weighted-average period of approximately **2.7 years**[137](index=137&type=chunk) - The company uses the Black-Scholes option pricing model to estimate the fair value of stock options and grants restricted common stock, restricted stock units, and stock options under its 2023 Equity Incentive Plan[132](index=132&type=chunk)[133](index=133&type=chunk) [13. Related Parties](index=28&type=section&id=13.%20Related%20Parties) Identifies Paragon Therapeutics as a related party and details the associated research and development expenses and payables - Paragon Therapeutics is a related party of the company; for the nine months ended September 30, 2024, the company recognized **$11.125 million** in R&D expenses for services provided by Paragon, a decrease from **$21.083 million** in the prior-year period[139](index=139&type=chunk) - As of September 30, 2024, amounts payable to Paragon were **$0.5 million**, compared to **$5.2 million** as of December 31, 2023[139](index=139&type=chunk) [14. Net Loss Per Share](index=28&type=section&id=14.%20Net%20Loss%20Per%20Share) Explains the calculation of net loss per share, which decreased despite increased net loss due to a higher weighted-average share count Net Loss Per Share (in thousands of dollars, except per share data) | Metric | Three Months Ended September 30, 2024 | Three Months Ended September 30, 2023 | Nine Months Ended September 30, 2024 | Nine Months Ended September 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Net loss attributable to common stockholders | $(49,018) | $(20,840) | $(114,928) | $(52,250) | | Weighted-average common shares outstanding (basic and diluted) | 56,795,544 | 41,231,379 | 54,508,496 | 17,209,842 | | Net loss per common share (basic and diluted) | $(0.86) | $(0.51) | $(2.11) | $(3.04) | - For the nine months ended September 30, 2024, net loss per share was **$2.11**, a decrease from **$3.04** in the prior-year period, despite an increase in total net loss, due to a significant increase in weighted-average common shares outstanding[140](index=140&type=chunk) - Due to the company's net loss position, potentially dilutive securities (such as stock options, unvested restricted common stock, and restricted stock units) are excluded from the calculation of diluted net loss per share as they are anti-dilutive[140](index=140&type=chunk) [15. Operating Leases](index=28&type=section&id=15.%20Operating%20Leases) Outlines the company's operating lease liabilities and expenses, stemming from recent laboratory and office space agreements - As of September 30, 2024, the company had current operating lease liabilities of **$2.9 million** and non-current operating lease liabilities of **$9.3 million**[143](index=143&type=chunk) - For the nine months ended September 30, 2024, the company's lease expense was **$1.3 million**[143](index=143&type=chunk) - The company entered into laboratory and office space lease agreements in November 2023 and September 2024, with lease terms of **2.2 years** and **5 years**, respectively[141](index=141&type=chunk)[142](index=142&type=chunk) [16. Subsequent Events](index=29&type=section&id=16.%20Subsequent%20Events) Discloses a post-period event regarding the finalization of a TSLP license agreement and an anticipated milestone payment - In October 2024, the company finalized the development candidate nomination under the TSLP license agreement, with an anticipated **$3.0 million** milestone payment to Paragon in the fourth quarter of 2024[145](index=145&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, and future outlook, emphasizing R&D investments and liquidity [Overview](index=30&type=section&id=Overview) Apogee Therapeutics is a clinical-stage biotech company developing novel biologics for inflammatory and immune diseases - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for the treatment of atopic dermatitis (AD), asthma, chronic obstructive pulmonary disease (COPD), and other inflammatory and immune (I&I) indications[148](index=148&type=chunk) - The company's pipeline includes four antibody programs: APG777 (anti-IL13 antibody), APG808 (anti-IL4Rα antibody), APG990 (anti-OX40L antibody), and APG333 (anti-TSLP antibody), designed to optimize half-life and other properties through advanced antibody engineering[149](index=149&type=chunk)[150](index=150&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) - APG777 initiated a Phase II clinical trial for moderate-to-severe AD patients in May 2024, with Part A 16-week topline data expected in the second half of 2025; APG808 and APG990 have entered Phase I clinical trials, and the development candidate for APG333 was nominated in October 2024[151](index=151&type=chunk)[153](index=153&type=chunk)[154](index=154&type=chunk)[155](index=155&type=chunk) [Funding and Capital Resources](index=32&type=section&id=Funding%20and%20Capital%20Resources) The company primarily funds operations through equity offerings and expects existing capital to support operations until Q1 2028 - Since its inception in 2022, the company has primarily funded operations through the issuance of preferred units (total proceeds of **$169.0 million**) and the sale of common stock (2023 IPO net proceeds of **$315.4 million**, March 2024 public offering net proceeds of **$450.0 million**)[156](index=156&type=chunk) - As of September 30, 2024, the company had an accumulated deficit of **$238.7 million** and a net loss of **$114.9 million** for the nine months ended September 30, 2024[157](index=157&type=chunk) - The company expects its existing cash and cash equivalents, marketable securities, and long-term marketable securities (totaling **$753.8 million**) to be sufficient to fund operating expenses and capital requirements through the first quarter of 2028[161](index=161&type=chunk) [Reorganization](index=33&type=section&id=Reorganization) Details the 2023 reorganization where Apogee Therapeutics, Inc. became the parent company of Apogee Therapeutics, LLC - Apogee Therapeutics, Inc. was formed in June 2023 and completed a reorganization in July 2023, becoming the parent and holding company of Apogee Therapeutics, LLC[162](index=162&type=chunk) - The reorganization involved the conversion of Apogee Therapeutics, LLC's Series A preferred units, Series B preferred units, common units, and incentive units into common stock or non-voting common stock of Apogee Therapeutics, Inc.[162](index=162&type=chunk)[164](index=164&type=chunk) [Collaboration, License and Services Agreements](index=33&type=section&id=Collaboration,%20License%20and%20Services%20Agreements) Describes the company's strategic agreements with third parties for drug discovery, development, and manufacturing [Paragon Option Agreements](index=33&type=section&id=Paragon%20Option%20Agreements) Outlines the company's option agreements with Paragon Therapeutics for exclusive global licenses to antibody programs - The company entered into 2022 and 2023 option agreements with Paragon Therapeutics, where Paragon is responsible for identifying, evaluating, and developing antibodies targeting IL-13, IL-4Rα, OX40L, and TSLP[163](index=163&type=chunk)[167](index=167&type=chunk) - The company holds exclusive options to obtain exclusive worldwide licenses to intellectual property generated by Paragon under the applicable research programs[163](index=163&type=chunk)[167](index=167&type=chunk) - The company paid a **$2.0 million** non-refundable fee for the TSLP research program to Paragon in the first quarter of 2024[169](index=169&type=chunk) [Paragon License Agreements](index=35&type=section&id=Paragon%20License%20Agreements) Details the exclusive global license agreements with Paragon for IL-13, IL-4Rα, OX40L, and TSLP programs, including milestone payments - The company has exercised options for the IL-13, IL-4Rα, OX40L, and TSLP research programs and entered into corresponding exclusive worldwide license agreements with Paragon[172](index=172&type=chunk) - The company is obligated to pay Paragon milestone payments and low single-digit percentage royalties on net sales[173](index=173&type=chunk)[175](index=175&type=chunk) - **$5.0 million** in milestone payments for the APG808 and APG990 programs were paid in 2024, and a **$3.0 million** milestone payment for the TSLP program is expected in the fourth quarter of 2024[174](index=174&type=chunk) [Biologics Master Services Agreement — WuXi Biologics (Hong Kong) Limited](index=35&type=section&id=Biologics%20Master%20Services%20Agreement%20—%20WuXi%20Biologics%20(Hong%20Kong)%20Limited) Describes the master services agreement with WuXi Biologics for development, GMP manufacturing, and testing of antibody programs - The company entered into a Biologics Master Services Agreement with WuXi Biologics, which was assigned to the company in the second quarter of 2023, covering development activities and GMP manufacturing and testing for APG777, APG808, APG990, and APG333 programs[176](index=176&type=chunk) - The agreement terminates on June 20, 2027, or upon completion of all work orders executed prior to that date[178](index=178&type=chunk) [Cell Line License Agreement — WuXi Biologics (Hong Kong) Limited](index=36&type=section&id=Cell%20Line%20License%20Agreement%20—%20WuXi%20Biologics%20(Hong%20Kong)%20Limited) Details the non-exclusive, global cell line technology license from WuXi Biologics for manufacturing components of antibody programs - The company obtained a non-exclusive, worldwide, sublicensable license to cell line technology from WuXi Biologics for the manufacture of components for APG777, APG808, APG990, and APG333 programs[179](index=179&type=chunk) - The company paid a **$150 thousand** non-refundable license fee and is obligated to pay low single-digit percentage royalties on worldwide net sales when commercial supply is manufactured by a third party[180](index=180&type=chunk) [Overview of Financial Results](index=36&type=section&id=Overview%20of%20Financial%20Results) Provides a summary of the company's financial performance, including revenue, operating expenses, and other income [Revenue](index=36&type=section&id=Revenue) The company has not generated revenue from product sales and anticipates no such revenue in the near future - The company has not generated any revenue from product sales since its inception and does not expect to do so for the next several years[183](index=183&type=chunk) - Future revenue generation will depend on successful product development, regulatory approvals, or entering into collaboration or license agreements with third parties[183](index=183&type=chunk) [Operating Expenses](index=36&type=section&id=Operating%20Expenses) Discusses the components of operating expenses, including research and development and general and administrative costs [Research and Development](index=36&type=section&id=Research%20and%20Development) Research and development expenses, primarily for third-party research and manufacturing, are expected to increase significantly - Research and development expenses primarily include third-party research (such as Paragon), acquired in-process research and development with no alternative future use, manufacturing process development, and personnel-related expenses[185](index=185&type=chunk)[186](index=186&type=chunk) - Research and development costs are expensed as incurred and are expected to increase significantly in the future to support clinical development and manufacturing investments for existing and future programs[188](index=188&type=chunk)[190](index=190&type=chunk) [General and Administrative](index=37&type=section&id=General%20and%20Administrative) General and administrative expenses, mainly personnel-related, are projected to rise with increased R&D and public company operations - General and administrative expenses primarily include salaries, bonuses, and equity-based compensation for personnel in executive, finance, operations, human resources, business development, and commercial functions[192](index=192&type=chunk) - General and administrative expenses are expected to increase significantly in the future to support the growth of R&D activities, potential commercialization, and the costs of operating as a public company[195](index=195&type=chunk) [Other Income (Expense), Net](index=38&type=section&id=Other%20Income%20(Expense),%20Net) Net other income primarily consists of interest income from cash, cash equivalents, and marketable securities - Net other income primarily consists of interest income generated from cash, cash equivalents, and marketable securities, as well as amortization of investment discounts[196](index=196&type=chunk) [Income Taxes](index=38&type=section&id=Income%20Taxes) The company has not recognized income tax benefits due to accumulated net losses and a full valuation allowance on deferred tax assets - The company has not recognized income tax benefits for net losses or R&D tax credits since inception because, based on available evidence, it is more likely than not that deferred tax assets will not be realized, and a full valuation allowance has been provided[197](index=197&type=chunk) Tax Carryforwards as of December 31, 2023 (in millions of dollars) | Category | Amount | Carryforward Period | Usage Limitations | | :--- | :--- | :--- | :--- | | U.S. Federal Net Operating Loss (NOL) | $23.6 | Indefinite | 80% of taxable income annually | | State Net Operating Loss (NOL) | $6.5 | Expiring starting 2043 | None | | U.S. Federal R&D Tax Credit | $2.7 | Expiring starting 2042 | None | | California R&D Tax Credit | $0.7 | Indefinite | None | [Comparison of the Three Months Ended September 30, 2024 and 2023](index=38&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20September%2030,%202024%20and%202023) Compares the company's financial performance for the three months ended September 30, 2024, and 2023 Financial Performance Comparison (Three Months Ended September 30, in thousands of dollars) | Metric | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development expenses | $45,714 | $17,069 | +$28,645 | | General and administrative expenses | $12,972 | $7,236 | +$5,736 | | Total operating expenses | $58,686 | $24,305 | +$34,381 | | Operating loss | $(58,686) | $(24,305) | $(34,381) | | Interest income | $9,668 | $3,465 | +$6,203 | | Net loss | $(49,018) | $(20,840) | $(28,178) | [Research and Development Expense](index=39&type=section&id=Research%20and%20Development%20Expense) Research and development expenses significantly increased due to advanced clinical development and trial progression for key programs - For the three months ended September 30, 2024, R&D expenses increased to **$45.7 million**, a **$28.6 million (167.8%) increase** from the prior-year period, primarily due to further development and clinical trial advancement of APG777, APG808, APG990, and APG333 programs[201](index=201&type=chunk)[202](index=202&type=chunk) Research and Development Expenses by Program (Three Months Ended September 30, in thousands of dollars) | Program/Category | 2024 | 2023 | | :--- | :--- | :--- | | APG777 | $14,928 | $5,369 | | APG808 | $2,093 | $— | | APG990 | $4,694 | $— | | Unallocated external discovery-related costs and other | $11,979 | $8,698 | | Personnel-related expenses (including equity-based compensation) | $12,020 | $3,002 | | Total | $45,714 | $17,069 | [General and Administrative Expense](index=39&type=section&id=General%20and%20Administrative%20Expense) General and administrative expenses rose substantially, driven by increased personnel costs and other operational expenses - For the three months ended September 30, 2024, G&A expenses increased to **$13.0 million**, a **$5.7 million (79.3%) increase** from the prior-year period, primarily due to a **$3.7 million increase** in personnel costs (including equity-based compensation) and a **$2.0 million increase** in IT-related costs, D&O insurance, and other employee-related expenses[203](index=203&type=chunk) General and Administrative Expenses (Three Months Ended September 30, in thousands of dollars) | Category | 2024 | 2023 | | :--- | :--- | :--- | | Personnel-related expenses (including equity-based compensation) | $7,195 | $3,483 | | Legal and professional fees | $2,031 | $2,022 | | Other | $3,746 | $1,731 | | Total | $12,972 | $7,236 | [Other Income, Net](index=40&type=section&id=Other%20Income,%20Net) Net other income saw a substantial increase, primarily from interest earned on cash, cash equivalents, and marketable securities - For the three months ended September 30, 2024, net interest income increased to **$9.7 million**, a **$6.2 million increase** from the prior-year period, primarily from interest income on cash, cash equivalents, and marketable securities[204](index=204&type=chunk) [Comparison of the Nine Months Ended September 30, 2024 and 2023](index=40&type=section&id=Comparison%20of%20the%20Nine%20Months%20Ended%20September%2030,%202024%20and%202023) Compares the company's financial performance for the nine months ended September 30, 2024, and 2023 Financial Performance Comparison (Nine Months Ended September 30, in thousands of dollars) | Metric | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development expenses | $107,636 | $39,470 | +$68,166 | | General and administrative expenses | $33,353 | $16,378 | +$16,975 | | Total operating expenses | $140,989 | $55,848 | +$85,141 | | Operating loss | $(140,989) | $(55,848) | $(85,141) | | Interest income | $26,061 | $3,598 | +$22,463 | | Net loss | $(114,928) | $(52,250) | $(62,678) | [Research and Development Expense](index=40&type=section&id=Research%20and%20Development%20Expense) Research and development expenses surged due to the accelerated development and clinical trial activities for the company's pipeline programs - For the nine months ended September 30, 2024, R&D expenses increased to **$107.6 million**, a **$68.2 million (172.7%) increase** from the prior-year period, primarily due to further development and clinical trial advancement of APG777, APG808, APG990, and APG333 programs[208](index=208&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk) Research and Development Expenses by Program (Nine Months Ended September 30, in thousands of dollars) | Program/Category | 2024 | 2023 | | :--- | :--- | :--- | | APG777 | $29,022 | $17,663 | | APG808 | $8,265 | $— | | APG990 | $15,577 | $— | | Unallocated external discovery-related costs and other | $24,983 | $16,961 | | Personnel-related expenses (including equity-based compensation) | $29,789 | $4,846 | | Total | $107,636 | $39,470 | [General and Administrative Expense](index=41&type=section&id=General%20and%20Administrative%20Expense) General and administrative expenses increased significantly, primarily due to higher personnel costs and public company operational expenses - For the nine months ended September 30, 2024, G&A expenses increased to **$33.4 million**, a **$17.0 million (103.6%) increase** from the prior-year period, primarily due to a **$12.0 million increase** in personnel costs (including equity-based compensation) and a **$5.3 million increase** in IT-related costs, D&O insurance, and other employee-related expenses[211](index=211&type=chunk) General and Administrative Expenses (Nine Months Ended September 30, in thousands of dollars) | Category | 2024 | 2023 | | :--- | :--- | :--- | | Personnel-related expenses (including equity-based compensation) | $19,627 | $7,669 | | Legal and professional fees | $5,208 | $5,446 | | Other | $8,518 | $3,263 | | Total | $33,353 | $16,378 | [Other Income, Net](index=41&type=section&id=Other%20Income,%20Net) Net other income experienced a substantial increase, mainly from interest income generated by the company's cash and investment holdings - For the nine months ended September 30, 2024, net interest income increased to **$26.1 million**, a **$22.5 million increase** from the prior-year period, primarily from interest income on cash, cash equivalents, and marketable securities[212](index=212&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's sources of liquidity, cash flow activities, and future funding requirements to support its operations [Sources of Liquidity](index=41&type=section&id=Sources%20of%20Liquidity) The company's liquidity primarily stems from equity offerings, including its 2023 IPO and a 2024 public offering - The company has primarily obtained funding through the issuance of preferred units (total proceeds of **$169.0 million**), the July 2023 IPO (net proceeds of **$315.4 million**), and the March 2024 public offering (net proceeds of **$450.0 million**)[213](index=213&type=chunk)[214](index=214&type=chunk) Liquidity Position (as of September 30, 2024, in millions of dollars) | Category | Amount | | :--- | :--- | | Cash and cash equivalents | $118.8 | | Marketable securities | $407.3 | | Long-term marketable securities | $227.7 | | Total | $753.8 | - In August 2024, the company established an at-the-market sales agreement (ATM Facility) to sell common stock with an aggregate offering price of up to **$300.0 million**, but no sales had occurred as of September 30, 2024[215](index=215&type=chunk) [Cash Flows](index=42&type=section&id=Cash%20Flows) Provides a summary of cash flows from operating, investing, and financing activities for the nine months ended September 30 Cash Flow Summary (Nine Months Ended September 30, in thousands of dollars) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(103,460) | $(45,007) | | Net cash used in investing activities | $(346,829) | $(234,218) | | Net cash provided by financing activities | $450,753 | $315,604 | | Net increase in cash, cash equivalents, and restricted cash | $464 | $36,379 | - For the nine months ended September 30, 2024, net cash used in operating activities was **$103.5 million**, primarily due to a net loss of **$114.9 million** and amortization of marketable securities discounts of **$9.3 million**[218](index=218&type=chunk) - Net cash used in investing activities was **$346.8 million**, primarily for the purchase of marketable securities totaling **$588.9 million**, partially offset by maturities of marketable securities totaling **$243.2 million**[220](index=220&type=chunk) [Future Funding Requirements](index=42&type=section&id=Future%20Funding%20Requirements) The company anticipates significant future capital needs for development and commercialization, potentially requiring additional financing - The company has not generated revenue from product sales and expects significantly increased expenses in preclinical and clinical development, regulatory approvals, and potential commercialization[223](index=223&type=chunk) - The company will require substantial additional funding to support its business objectives, potentially raised through equity, debt financing, or collaborations with other companies[224](index=224&type=chunk)[225](index=225&type=chunk)[227](index=227&type=chunk) - The company estimates that its existing cash, cash equivalents, and marketable securities (totaling **$753.8 million** as of September 30, 2024) will be sufficient to fund operating expenses and capital requirements through the first quarter of 2028, though this estimate may not be accurate[228](index=228&type=chunk)[229](index=229&type=chunk) [Contractual Obligations and Other Commitments](index=44&type=section&id=Contractual%20Obligations%20and%20Other%20Commitments) Outlines the company's contractual obligations, including intellectual property license payments and the absence of minimum purchase commitments - The company's contracts with contract research organizations (CROs), contract manufacturing organizations (CMOs), and other third parties do not contain minimum purchase commitments and allow for termination with advance written notice, subject to payment for services rendered and non-cancelable obligations[230](index=230&type=chunk) - As of September 30, 2024, the company had incurred **$9.0 million** in potential milestone payments under intellectual property license agreements and is obligated to pay royalties on net product sales[231](index=231&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=44&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Highlights the critical accounting policies and significant management judgments and estimates used in preparing the financial statements - The preparation of the company's financial statements relies on management's significant judgments and estimates regarding research and development expenses, asset acquisitions (including acquired in-process research and development), and equity-based compensation[233](index=233&type=chunk)[234](index=234&type=chunk) - No significant changes have occurred in critical accounting policies compared to those disclosed in the company's 2023 10-K annual report[234](index=234&type=chunk) [JOBS Act Transition Period and Smaller Reporting Company Status](index=44&type=section&id=JOBS%20Act%20Transition%20Period%20and%20Smaller%20Reporting%20Company%20Status) Discusses the company's status as an "emerging growth company" and "smaller reporting company" and the implications for its disclosure requirements - As an "emerging growth company" and "smaller reporting company," the company can take advantage of simplified disclosure requirements and an extended transition period for new accounting standards provided by the JOBS Act[235](index=235&type=chunk)[238](index=238&type=chunk) - The company has elected to use the extended transition period for complying with new or revised accounting standards[235](index=235&type=chunk) - Based on the market value of its common stock as of June 30, 2024, the company expects to become a "large accelerated filer" on December 31, 2024, at which point it will no longer qualify as an emerging growth company or smaller reporting company and will be subject to Section 404(b) of the Sarbanes-Oxley Act[239](index=239&type=chunk) [Recently Issued Accounting Pronouncements](index=45&type=section&id=Recently%20Issued%20Accounting%20Pronouncements) States that recently issued accounting pronouncements are not expected to have a material impact on the consolidated financial statements - The company has reviewed all recently issued accounting pronouncements and determined that, other than those disclosed in Note 2, they are not expected to have a material impact on its consolidated financial statements[240](index=240&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company, as a smaller reporting company, is not required to provide quantitative and qualitative disclosures about market risk for this reporting period - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk for this reporting period[241](index=241&type=chunk) [Item 4. Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management assessed the effectiveness of disclosure controls and procedures as of September 30, 2024, concluding they are effective at a reasonable assurance level, with no material changes to internal control over financial reporting this quarter [Evaluation of Disclosure Controls and Procedures](index=45&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management assessed the effectiveness of disclosure controls and procedures as of September 30, 2024, concluding they are effective at a reasonable assurance level - The company's management evaluated the effectiveness of disclosure controls and procedures as of September 30, 2024, and concluded they are effective at a reasonable assurance level[242](index=242&type=chunk) - Disclosure controls and procedures are designed to ensure that information required to be disclosed in reports filed by the company under the Exchange Act is recorded, processed, summarized, and reported in a timely manner[242](index=242&type=chunk) [Changes in Internal Control over Financial Reporting](index=46&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes occurred in the company's internal control over financial reporting during the quarter ended September 30, 2024 - No material changes in the company's internal control over financial reporting occurred during the quarter ended September 30, 2024, that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting[244](index=244&type=chunk) [PART II OTHER INFORMATION](index=47&type=section&id=PART%20II%20OTHER%20INFORMATION) Contains additional information not covered in the financial statements, including legal proceedings, risk factors, and equity sales [Item 1. Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings that could significantly impact its financial results - The company is not currently involved in any material legal proceedings that could have a significant adverse effect on its operating results, financial condition, or cash flows[247](index=247&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) Investing in the company's common stock involves high risks, including limited operating history, funding needs, competition, and regulatory uncertainties [Risk Factor Summary](index=47&type=section&id=Risk%20Factor%20Summary) Summarizes key risks such as limited operating history, funding requirements, intense competition, and reliance on third parties - The company is a clinical-stage biotechnology company with a limited operating history, no approved commercial products, and has incurred continuous losses, requiring substantial additional capital in the future[250](index=250&type=chunk) - The company faces intense competition, and its key programs APG777, APG808, APG990, and APG333 may fail or be delayed, with its development approach not yet fully validated[250](index=250&type=chunk) - The company is highly dependent on third parties for preclinical studies, clinical trials, and product manufacturing, faces uncertainties in intellectual property protection, and a lengthy and unpredictable regulatory approval process[250](index=250&type=chunk) [Risks Related to Our Limited Operating History, Financial Position and Capital Requirements](index=48&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History,%20Financial%20Position%20and%20Capital%20Requirements) Risks include limited operating history, significant accumulated deficits, and the ongoing need for substantial additional capital to fund operations - As a clinical-stage biotechnology company, the company has a limited operating history and no approved commercial products, making it difficult to evaluate its current business and future success potential[252](index=252&type=chunk) - The company has incurred significant operating losses since its inception, with an accumulated deficit of **$238.7 million** as of September 30, 2024, and expects to continue incurring significant losses in the future[260](index=260&type=chunk)[261](index=261&type=chunk) - The company will require substantial additional capital in the future to fund operations, including clinical trials and commercialization, and failure to raise funds timely or on acceptable terms may force it to delay, scale back, or cancel one or more development programs[254](index=254&type=chunk)[259](index=259&type=chunk) [Risks Related to Discovery, Development and Commercialization](index=50&type=section&id=Risks%20Related%20to%20Discovery,%20Development%20and%20Commercialization) Risks involve intense competition, potential development failures or delays, and the uncertainty of clinical trial outcomes for pipeline programs - The company faces intense competition from multinational biopharmaceutical companies with greater financial resources, R&D, and commercialization expertise[267](index=267&type=chunk) - The company's programs are in clinical and preclinical development and may fail or encounter delays during development, severely impacting their commercial viability[271](index=271&type=chunk) - The company's future success heavily relies on the success of its most advanced programs, APG777, APG808, APG990, and APG333, whose clinical trials may not succeed, particularly as their extended half-life assumptions are not yet fully validated in humans[276](index=276&type=chunk) - The preclinical and clinical development process is lengthy, expensive, and uncertain, and results from early studies and trials may not predict future clinical trial success[284](index=284&type=chunk) [Risks Related to Our Reliance on Third Parties](index=57&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) Risks include dependence on third-party collaborations, contract research organizations, and contract manufacturing organizations, including foreign suppliers - The company relies on collaborations and license arrangements with third parties, particularly with related party Paragon, and its business could be negatively affected if these collaborations are not maintained or are unsuccessful[305](index=305&type=chunk)[306](index=306&type=chunk) - The company relies on third parties (such as CROs, CMOs) for preclinical studies and clinical trials, and if these third parties fail to perform their contractual obligations correctly or on time, it could lead to delays in regulatory approval or inability to commercialize[310](index=310&type=chunk)[311](index=311&type=chunk) - The company currently relies on and may continue to rely on foreign CROs and CMOs (including WuXi Biologics), which may be affected by U.S. legislation, sanctions, trade restrictions, and foreign regulatory requirements, increasing costs or reducing supply[312](index=312&type=chunk)[313](index=313&type=chunk) [Risks Related to Our Business and Operations](index=59&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Operations) Risks include managing organizational growth, attracting talent, IT system failures, data security breaches, and adverse legislative changes - The company expects its organizational size to grow significantly and may encounter difficulties in managing growth, attracting, and retaining highly qualified personnel[316](index=316&type=chunk)[317](index=317&type=chunk) - The company's internal information technology systems or those of its third-party service providers may fail or suffer security breaches, leading to data loss, increased costs, reputational damage, and operational disruptions[321](index=321&type=chunk)[322](index=322&type=chunk)[324](index=324&type=chunk) - The company is subject to stringent and evolving privacy, data protection, and data security laws and regulations, and failure to comply could result in government enforcement actions, fines, and reputational harm[330](index=330&type=chunk) - The company may face adverse legislative or regulatory tax changes, such as the Inflation Reduction Act and R&D expense amortization requirements, which could negatively impact its financial condition[332](index=332&type=chunk) [Risks Related to Intellectual Property](index=62&type=section&id=Risks%20Related%20to%20Intellectual%20Property) Risks involve the uncertainty of protecting intellectual property, potential infringement claims, and the impact of changes in patent law - The company's ability to protect its patents and other proprietary rights is uncertain, potentially leading to a loss of competitive advantage, as its intellectual property portfolio is still early-stage and it does not yet own any issued patents[335](index=335&type=chunk)[337](index=337&type=chunk) - The company may face patent infringement claims or need to initiate litigation to protect its intellectual property, which could result in substantial costs and liabilities and prevent commercialization of its potential products[347](index=347&type=chunk) - Changes in patent law in the U.S. and other jurisdictions, including the Leahy-Smith America Invents Act and recent court decisions (e.g., Amgen, Inc. v. Sanofi), may weaken patent value and scope of protection[355](index=355&type=chunk)[357](index=357&type=chunk) - Geopolitical actions, such as government actions related to Russia's invasion of Ukraine, may increase uncertainty and costs in patent application and maintenance, leading to partial or complete loss of patent rights[358](index=358&type=chunk) [Risks Related to Government Regulation](index=68&type=section&id=Risks%20Related%20to%20Government%20Regulation) Risks include lengthy and unpredictable regulatory approval processes, competition from biosimilars, and ongoing compliance obligations - The approval process by the FDA and other comparable foreign regulatory agencies is lengthy, time-consuming, and unpredictable, and the company may fail to obtain or experience delays in obtaining required regulatory approvals, severely impacting its ability to generate revenue[368](index=368&type=chunk)[369](index=369&type=chunk) - The biologics the company intends to seek approval for may face biosimilar competition earlier than anticipated, which could shorten exclusivity periods[374](index=374&type=chunk)[375](index=375&type=chunk) - Even if regulatory approval is obtained, the company will remain subject to extensive ongoing regulatory obligations and scrutiny, potentially leading to additional significant expenses and penalties for non-compliance[376](index=376&type=chunk)[377](index=377&type=chunk) - The company's business operations and arrangements with healthcare professionals, third-party payors, and others will be subject to applicable healthcare regulatory laws, and failure to comply could result in fines and penalties[379](index=379&type=chunk)[380](index=380&type=chunk) [Risks Related to Our Common Stock](index=71&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) Risks include stock price volatility, significant influence by major shareholders, dual-class stock structure, and changes in reporting status - The company's quarterly and annual operating results may fluctuate significantly or fall below investor or securities analyst expectations, leading to stock price volatility or decline[386](index=386&type=chunk)[387](index=387&type=chunk) - The company's principal stockholders and management hold a significant amount of its common stock, enabling them to exert substantial influence over matters requiring stockholder approval[390](index=390&type=chunk) - The company's dual-class common stock structure may limit stockholders' influence over company affairs and could limit their visibility into certain transactions[402](index=402&type=chunk) - The company's simplified disclosure requirements as an "emerging growth company" and "smaller reporting company" may reduce the attractiveness of its common stock to investors, and losing these qualifications by December 31, 2024, is expected to increase compliance costs[393](index=393&type=chunk)[396](index=396&type=chunk) [General Risk Factors](index=74&type=section&id=General%20Risk%20Factors) General risks include product liability, litigation costs, increased public company expenses, and adverse macroeconomic conditions - The company faces product liability and professional indemnity risks, which could result in costly claims, and product liability insurance may not cover all damages[403](index=403&type=chunk) - Litigation costs and outcomes could have a significant adverse effect on the company's business[404](index=404&type=chunk)[405](index=405&type=chunk) - The company will continue to incur increased costs as a public company, and management will devote substantial time to new compliance initiatives and corporate governance practices[407](index=407&type=chunk) - Macroeconomic conditions such as economic downturns, inflation, rising interest rates, natural disasters, public health crises (e.g., COVID-19 pandemic), political crises, and geopolitical events (e.g., Russia-Ukraine conflict, Israel-Hamas conflict) could have a significant adverse impact on the company's operating results and financial condition[412](index=412&type=chunk)[413](index=413&type=chunk) [Item 2. Unregistered Sales of Equity Sec

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]