Summary of Apogee Therapeutics Inc (APGE) Conference Call Company Overview - **Company**: Apogee Therapeutics Inc (APGE) - **Industry**: Pharmaceuticals and Biotechnology - **Focus**: Development of antibodies for atopic dermatitis and other inflammatory diseases Key Points and Arguments Product Development and Market Potential - Apogee is developing potentially best-in-class antibodies targeting atopic dermatitis, with a focus on long-acting IL-13 as a cornerstone asset [2][4] - The atopic dermatitis market is projected to be the largest in the inflammatory and immunology (I&I) sector, with significant unmet needs [5][11] - Upcoming phase two data is critical, with expectations to demonstrate efficacy comparable to existing treatments like Dupixent [3][7] Clinical Trial Insights - The company aims for a top-line efficacy score (EC 75) in the 45-50% range, which would position their drug as equivalent to lebrikizumab and Dupixent [8][12] - There is a strong emphasis on reducing dosing frequency from every two weeks to every three to six months, which is expected to enhance patient adherence [4][10] - Feedback from physicians indicates a high willingness to switch patients from Dupixent to Apogee's treatment if efficacy is demonstrated [9][11] Competitive Landscape - Apogee is entering a market with existing players like Dupixent, but believes there is a significant white space for new entrants [11][19] - The company is aware of potential biosimilar threats and aims to establish a strong market presence before these threats materialize [20] Regulatory Considerations - The FDA's guidance on combination therapies is vague, but Apogee plans to demonstrate that their combination therapy is superior to individual components [25][26] - The company is preparing for a factorial design study to compare their combination therapy against standard monotherapies [26][27] Financial and Market Dynamics - Estimated costs for Phase 3 trials are around $250,000 per patient, which reflects the high investment required for clinical development [30] - The company believes that the market for atopic dermatitis is large enough to support multiple successful products, even those that are not highly differentiated [18][19] Patient Adherence and Market Needs - Current adherence rates for Dupixent are around 73% in the first year, with a significant drop-off leading to cycling among treatments [35][39] - Payers are interested in long-acting therapies that can improve adherence and reduce overall healthcare costs associated with treatment cycling [40][41] Strategic Positioning - Apogee aims to position itself as a leading player in the I&I space, with a focus on developing a drug that can become the frontline treatment for atopic dermatitis [17][19] - The company is also exploring strategic partnerships or acquisitions to enhance its portfolio and market presence [71][73] Future Outlook - The upcoming data readout is expected to shift the company's risk profile from pre-data uncertainty to a more favorable position with a differentiated product offering [63][64] - There is a strong correlation between phase two and phase three success rates in atopic dermatitis, which provides confidence in the potential outcomes of their trials [67][69] Additional Important Insights - The competitive landscape is evolving, with new entrants and combination therapies being developed by other companies, such as Sanofi [48][52] - Apogee's strategy includes not only focusing on atopic dermatitis but also expanding into other indications like asthma and eosinophilic esophagitis [83][85] This summary encapsulates the critical insights from the conference call, highlighting Apogee Therapeutics' strategic direction, product development, and market positioning within the pharmaceutical industry.

Company Overview - Apogee Therapeutics, Inc. 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, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and other I&I indications [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 overcome limitations of existing therapies by utilizing advanced antibody engineering [2] Upcoming Events - Management of Apogee Therapeutics will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, at 10:30 a.m. E.T. [1] - A live and archived webcast of the event will be accessible on the company's website [1]

Summary of Conference Call for Apogee Therapeutics Inc (APGE) and Amelix Apogee Therapeutics Inc (APGE) Industry and Company Overview - Focus on developing treatments for atopic dermatitis, asthma, and eosinophilic esophagitis (EOE) with a pipeline that includes phase two trials for multiple indications [1][2][4] Core Points and Arguments - **Atopic Dermatitis Trials**: Aiming for a six-month endpoint with reduced dosing frequency, targeting a market similar to psoriasis [1][4] - **Head-to-Head Trials**: Plans to launch a trial against Dupixent, with results expected next year [2][6] - **Market Dynamics**: The atopic dermatitis market is described as "white space," with Dupixent being the primary competitor [4][14] - **Dosing Innovations**: Emphasis on improving dosing frequency to every three months or better, which is expected to enhance efficacy [5][6][12] - **Efficacy Measures**: Data indicates deep and sustained inhibition of type two inflammation, suggesting potential for longer dosing intervals [7][8] - **Market Potential**: The atopic dermatitis market could reach $50 billion, with significant patient preference for less frequent dosing [14][15] Additional Important Content - **Patient Feedback**: Over 80% of surveyed patients preferred a drug with less frequent dosing compared to Dupixent [14] - **Financial Position**: The company has a strong balance sheet with over $680 million, providing a runway into Q1 2028 [17] Amelix Industry and Company Overview - Focus on developing treatments for rare diseases, including post-bariatric hypoglycemia (PBH) and Wolfram syndrome, with a pipeline that includes Avexatide [19][20] Core Points and Arguments - **Lead Asset - Avexatide**: A GLP-1 receptor antagonist with breakthrough therapy designation for PBH, currently in phase three trials [20][36] - **Clinical Data**: Phase two trials showed significant reductions in hypoglycemic events, with a 53% reduction in level two and a 66% reduction in level three events [38][40] - **Unmet Need**: Approximately 160,000 people in the U.S. suffer from PBH, with no approved treatments available [37][42] Additional Important Content - **Wolfram Syndrome**: Positive phase two data showing stabilization or improvement in C peptide levels, indicating better beta cell function [28][31] - **FDA Discussions**: Ongoing discussions with the FDA regarding trial design and endpoints for potential approval [30][40] - **Patient Experience**: High patient satisfaction reported, with most rating the treatment highly due to improvements in energy and reduction of hypoglycemic events [44] This summary encapsulates the key points from the conference call, highlighting the strategic focus, clinical developments, and market potential for both Apogee Therapeutics and Amelix.

Core Insights - APG808 shows significant potential in treating asthma, with a maximal FeNO decrease from baseline of 53% and sustained reduction of 50% at 12 weeks, indicating robust efficacy [1][4] - The drug's optimized formulation and promising pharmacokinetic profile suggest the possibility of extending dosing intervals to every two months or longer, which could redefine treatment standards for asthma patients [1][2][4] - The Phase 1b trial demonstrated a favorable safety profile, with no severe adverse events reported, reinforcing the drug's potential as a best-in-class therapy [2][4] Company Overview - Apogee Therapeutics is a clinical-stage biotechnology company focused on developing novel biologics for inflammatory and immunology markets, including asthma, atopic dermatitis, and chronic obstructive pulmonary disease [1][6] - The company aims to overcome limitations of existing therapies by targeting established mechanisms of action and optimizing antibody properties for improved efficacy and dosing [6] Trial Details - The Phase 1b trial was a double-blind, placebo-controlled study involving 22 adult patients with mild-to-moderate asthma, assessing the safety, tolerability, and efficacy of APG808 [2][4] - Key biomarkers evaluated included fractional exhaled nitric oxide concentration (FeNO), TARC, and pSTAT6, with results indicating significant suppression of Type 2 inflammation markers [4][5] Market Context - Asthma affects approximately 40 million adults and 12 million children in major markets, with prevalence rates ranging from 5% to 8%, highlighting the substantial need for effective treatments [3][5]

Shares of Apogee Therapeutics Inc. (APGE) have gained 24.1% over the past four weeks to close the last trading session at $40.12, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $93.88 indicates a potential upside of 134%.The average comprises eight short-term price targets ranging from a low of $78 to a high of $116, with a standard deviation of $11.05. While the lowest estimat ...

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, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and other I&I indications [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 present at the Bank of America Health Care Conference on May 13, 2025, at 1:40 p.m. P.T. / 4:40 p.m. E.T. [1] - A live and archived webcast of the presentation will be accessible on the company's website [1]

[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

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)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 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) Delaware 93-4958665 (Sta ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark one) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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) Delaware 88-0588063 (State o ...