Apogee Therapeutics, Inc.

Apogee Therapeutics, Inc. is a clinical stage biotechnology company advancing optimized, novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (I&I) markets, including for the treatment of atopic dermatitis (AD), asthma, eosinophilic esophagitis (EoE), chronic obstructive pulmonary disease (COPD), and other I&I indications. The company's antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. The pipeline comprises multiple antibody programs being developed initially for the treatment of I&I indications as monotherapies and combinations, including zumilokibart (APG777), APG279 (zumilokibart + APG990), APG273 (zumilokibart + APG333), and APG808.

The company faces competition from major pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions. Key competitive factors affecting the success of all product candidates that are developed, if approved, are likely to be efficacy, safety, convenience, presentation, price, the level of generic competition, and the availability of reimbursement from government and other third-party payors. Competitors may also obtain FDA or other regulatory approval for their products more rapidly, which could result in competitors establishing a strong market position before Apogee is able to enter the market. Specifically, there are several companies developing or marketing treatments that may be approved for the same indications and/or disease as Apogee's product candidates, including approved products for moderate-to-severe AD such as dupilumab (DUPIXENT), lebrikizumab (EBGLYSS), tralokinumab-ldrm (ADBRY), and nemolizumab (NEMLUVIO), as well as approved treatments for asthma, EoE, and COPD.

Apogee has not generated any revenue from product sales and does not expect to generate any revenue from the sale of products for several years, if at all. The company's operating expenses consist of research and development expenses and general and administrative expenses. Research and development expenses consist primarily of costs incurred in connection with the development and research of its programs, including the cost of developing and validating manufacturing processes, expenses incurred under agreements with clinical trial sites and clinical research organizations, costs related to production of clinical supplies, and personnel-related expenses. General and administrative expenses consist primarily of personnel-related expenses for individuals in executive, finance, legal, IT, operations, human resources, business development, commercial, and other administrative functions, as well as legal fees, professional fees, insurance costs, and recruiting costs.

Zumilokibart (APG777) is a subcutaneous extended half-life monoclonal antibody targeting IL-13. In March 2024, positive interim safety and PK data from a Phase 1 trial in healthy volunteers demonstrated a potential best-in-class PK profile, including a half-life of 77 days ¹, supporting the potential for every three- to six-month maintenance dosing in AD. The APEX Phase 2 trial in patients with moderate-to-severe AD met its primary endpoint in Part A, with zumilokibart showing a least squares mean percent change from baseline at Week 16 with an EASI reduction of 71.0% ² compared to placebo of 33.8% ³ (p < 0.001). Part B of the APEX trial completed enrollment ahead of schedule with a total of 347 patients ⁴. APG808 is a subcutaneous extended half-life mAb targeting IL-4Rα, which demonstrated a half-life of approximately 55 days ⁵ at projected, clinically relevant steady state exposures. APG990 is a subcutaneous extended half-life mAb targeting OX40L, with PK data showing a half-life of approximately 60 days ⁶ across doses tested. APG333 is a fully-human mAb against TSLP, which demonstrated a half-life of approximately 55 days ⁷.

In October 2025, Apogee issued and sold an aggregate of 8,048,782 shares of common stock ⁸ (inclusive of 1,097,561 shares of common stock pursuant to the exercise in full of the underwriters' option to purchase additional shares) at a public offering price of $41.00 per share ⁹, and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to 365,853 shares of common stock ¹⁰ at a public offering price of $40.99999 per pre-funded warrant ¹¹. The aggregate net proceeds from the offering were $324.1 million ¹² after deducting underwriting discounts and commissions, and estimated offering expenses. During the year ended December 31, 2025, Apogee sold 1,175,701 shares of common stock ¹³ under its at-the-market offering program for gross proceeds of $67.6 million ¹⁴, less commissions and other offering expenses of $2.0 million ¹⁵. In March 2025, the company entered into a Master Services Agreement with Samsung Biologics Co., Ltd., made effective as of February 28, 2025, for the manufacture and supply of zumilokibart drug substance for clinical development and commercial sale, if approved.

Apogee has incurred significant net losses in each period since commencing operations in February 2022. The company generated net losses of $255.8 million ¹⁶ and $182.1 million ¹⁷ for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, the company had an accumulated deficit of $561.8 million ¹⁸. Total operating expenses for the year ended December 31, 2025 were $285.6 million ¹⁹, compared to $216.9 million ²⁰ for the year ended December 31, 2024. Research and development expenses were $214.7 million ²¹ for 2025, compared to $167.9 million ²² for 2024. General and administrative expenses were $70.9 million ²³ for 2025, compared to $49.0 million ²⁴ for 2024. Interest income was $30.0 million ²⁵ for 2025, compared to $34.7 million ²⁶ for 2024.

Based on its current operating plan, Apogee estimates that its existing cash, cash equivalents, and marketable securities will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the second half of 2028 ²⁷.

A primary growth vector is the advancement of zumilokibart (APG777) targeting IL-13 through clinical development, regulatory filings, approval, and launch for AD. Subject to positive results and regulatory alignment with the FDA, the company plans to initiate a Phase 3 trial in AD in the second half of 2026 ²⁸, enabling a potential launch of zumilokibart for the treatment of AD in 2029 ²⁹. The company expects to report Part A maintenance data from the APEX Phase 2 trial in March 2026 ³⁰ and expects to report 16-week topline induction data from Part B in the second quarter of 2026 ³¹. Another growth vector is the advancement of APG279 for the dual inhibition of OX40L and IL-13. In July 2025, Apogee commenced dosing in the Phase 1b trial of APG279 against DUPIXENT in patients with moderate-to-severe AD, which was upsized from approximately 50 to 80 patients ³² due to strong patient enrollment, with a data readout expected in the second half of 2026 ³³.

Apogee expects to continue to incur significantly increased expenses for the foreseeable future as it continues to operate its business. The company expects research and development expenses to increase substantially as it continues to invest in research and development activities for its programs, including investments in clinical trials and manufacturing. General and administrative expenses are also expected to increase substantially as the company increases headcount to support expected growth in research and development activities and the potential commercialization of product candidates, if approved.

Apogee does not own or operate any manufacturing facilities and outsources all preclinical and clinical drug supply development, manufacturing, storage, distribution, and testing to third-party manufacturers and facilities. The company has successfully manufactured zumilokibart drug substance at commercial scale for clinical trial use and has successfully manufactured zumilokibart drug product at clinical scale with acceptable yields for near-term, planned clinical trials. Apogee currently has two sources for its preclinical and clinical supply of zumilokibart drug substance and drug product and has entered into an agreement for the commercial supply of zumilokibart drug substance should the product candidate eventually receive regulatory approval. The company has a sole source relationship for its preclinical and clinical supply of APG990, APG333, and APG808 drug substance and drug product. As of December 31, 2025, Apogee had 261 full-time employees ³⁴, 57 of whom have Ph.D. or M.D. degrees ³⁵, and 191 employees engaged in research and development ³⁶.

Apogee's capital allocation strategy focuses on funding its clinical trials, manufacturing, and research and development activities. The company has raised capital through the issuance of preferred units, its initial public offering, follow-on offerings, and its at-the-market offering program. As of December 31, 2025, $187.5 million ³⁷ remained available for sale under the Sale Agreement for the ATM Facility. The company does not anticipate declaring or paying any dividends on its capital stock for the foreseeable future.

The global macroeconomic environment is uncertain and could be negatively affected by financial market volatility and uncertainty, inflation, interest rate fluctuations, changing tariff policies and trade restrictions, uncertainty with respect to the federal budget and debt ceiling, instability in the global banking system, cybersecurity events, the impact of war or military conflict, and public health pandemics. Since February 2025, the United States government has imposed various tariffs on imports from most countries, including tariffs on imports from China and South Korea. In September 2025, President Trump announced plans to impose 100% tariffs ³⁸ on imported branded or patented pharmaceuticals, unless the importing company is building U.S. manufacturing capacity. The company continues to take risk mitigation measures to reduce supply chain risk in the event that WuXi Biologics, Samsung Biologics, or one of its other manufacturers or supply chain vendors is impacted, including by continuing to identify and select additional source suppliers, including those based in the U.S. and EU.

Apogee is a clinical stage biotechnology company with a limited operating history and no products approved for commercial sale, making it difficult to evaluate its likelihood of success. The company has incurred significant net losses since inception, with net losses of $255.8 million ³⁹ and $182.1 million ⁴⁰ for the years ended December 31, 2025 and 2024, respectively, and an accumulated deficit of $561.8 million ⁴¹ as of December 31, 2025. The company expects to continue to incur significant losses for the foreseeable future and may never achieve profitability. Apogee will require substantial additional capital to finance its operations, and if unable to raise such capital when needed, may be forced to delay, reduce, or eliminate one or more of its development programs. The company is substantially dependent on the success of its product candidates, zumilokibart, APG279, APG273, APG990, APG333, and APG808, and its ongoing and anticipated clinical trials may not be successful. The company faces significant competition from entities that have developed or may develop programs for the diseases addressed by its product candidates, including approved products for AD, asthma, EoE, and COPD, as well as numerous product candidates in clinical development. The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming, and inherently unpredictable, and if Apogee is not able to obtain required regulatory approvals, it will not be able to commercialize its product candidates.

Management's message emphasizes the company's goal to become a leader in developing and commercializing novel therapies for I&I indications, with antibody programs designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. The key strategic priorities emphasized for the period ahead include advancing zumilokibart targeting IL-13 through clinical development, regulatory filings, approval, and launch for AD; advancing APG279 for the dual inhibition of OX40L and IL-13; advancing APG273 for the dual inhibition of TSLP and IL-13; maximizing the potential of programs through indication expansion beyond AD, including asthma, EoE, and COPD; and expanding existing and evaluating new collaborations to broaden the impact for patients living with I&I indications. Management's forward-looking statements include the expectation to report Part A maintenance data from the APEX Phase 2 trial in March 2026 ⁴², to report 16-week topline induction data from Part B in the second quarter of 2026 ⁴³, to initiate a Phase 3 trial in AD in the second half of 2026 ⁴⁴ enabling a potential launch in 2029 ⁴⁵, and that existing cash, cash equivalents, and marketable securities will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2028 ⁴⁶.