UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 6, 2026
Apogee Therapeutics, Inc.
(Exact Name of Registrant as Specified in Its Charter)
| Delaware | 001-41740 | 93-4958665 |
| (State
of Incorporation or Organization) |
(Commission File Number) | (I.R.S.
Employer Identification No.) |
221 Crescent Street, Building 17, Suite 102b,
Waltham, MA, 02453
(Address of Principal Executive Offices, including Zip Code)
(650) 394-5230
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) |
Name of each exchange on which registered |
||
| Common Stock, par value $0.00001 per share | APGE | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 7.01 | Regulation FD Disclosure. |
On January 6, 2026, Apogee Therapeutics, Inc. (the “Company”) issued a press release and made publicly available a data presentation announcing positive interim data from the Phase 1b clinical trial of zumilokibart (APG777), its potentially best-in-class anti-IL-13 antibody, in patients with mild-to-moderate asthma and highlighted upcoming 2026 milestones. The Company will host a conference call and webcast today, Tuesday, January 6, 2026, at 8:00 a.m., Eastern Time, to discuss the data results.
Copies of the press release and the data presentation are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are incorporated by reference herein. The exhibits furnished under Item 7.01 of this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
| Item 8.01 | Other Events. |
On January 6, 2026, the Company announced positive interim data from the Phase 1b clinical trial of zumilokibart (APG777) in patients with mild-to-moderate asthma and highlighted upcoming 2026 milestones. The Company recently received approval for the International Non-proprietary Name (INN) of zumilokibart for APG777. Zumilokibart is a novel, half-life extended anti IL-13 antibody.
Zumilokibart (APG777) Phase 1b Positive Interim Results
The Phase 1b clinical trial is a double-blind, placebo-controlled trial evaluating the safety and tolerability of zumilokibart in patients with mild-to-moderate asthma. The trial is designed to also evaluate fractional exhaled nitric oxide (“FeNO”) suppression, a key biomarker of Type 2 inflammation.
The trial enrolled 31 adult patients who were randomized 3:1 to zumilokibart versus placebo and participants received a single dose of 720 mg of zumilokibart or placebo on day 1. 19 of the patients with mild-to-moderate asthma had a FeNO baseline ≥25 ppb, representative of asthma with Type 2 inflammation, and as a result met the pre-specified criteria for the analysis population.
In the trial, zumilokibart demonstrated:
| • | A favorable safety profile; zumilokibart was well-tolerated in all patients. |
| o | In the 19 patients analysis population, the only treatment-emergent adverse event (“TEAE”) observed in more than one patient was gastroesophageal reflux disease (“GERD”; 2 patients). There were no Grade 3 or higher TEAEs or serious adverse events and no conjunctivitis, injection site reactions, or anti-drug antibodies (ADAs) were observed. |
| o | In the full safety population (N=31) that were on treatment (N=23), TEAEs occurring in more than one patient on zumilokibart were upper respiratory tract infection (N=3), nasopharyngitis (N=2), GERD (N=2), and arthralgia (N=2); there were no Grade 3 or higher TEAEs or serious adverse events. |
| • | Robust and durable suppression of FeNO, a biomarker of Type 2 inflammation that has shown the strongest correlation with exacerbations in asthma, following a single dose in the analysis population. |
| o | Maximum absolute mean FeNO reduction of 45 ppb (60% decrease from baseline) after a single dose. |
| o | Durable FeNO suppression through 16 weeks for all patients in the analysis population. |
| o | Suppression of FeNO through 32 weeks for those patients in the analysis population with available follow up at the time of the data cut (N=3), supporting the potential for 3- or 6- month dosing. |
| • | Positive trends observed in forced expiratory volume in one second (“FEV1”) and across Type 2 biomarkers for all available data in the analysis population. FEV1 is a pharmacodynamic measure of lung function. Further data from the study will be shared at upcoming medical conferences. |
The Company also reported that it observed improvement in asthma and sinusitis, as measured by improvements in ACQ-5 and SNOT-22 in patients with comorbid asthma or sinusitis, in the APEX Phase 2 Part A trial of zumilokibart in moderate to severe atopic dermatitis ("AD").
Anticipated 2026 Key Milestones
The Company described additional expected data readouts and milestones for 2026:
| • | Zumilokibart (APG777) Phase 2 APEX Part A (52-week) maintenance data readout – expected Q1 2026 |
| • | Zumilokibart (APG777) Phase 2 APEX Part B (16-week) induction data readout – expected Q2 2026 |
| o | The trial completed enrollment ahead of schedule and exceeded its target with a total of 347 patients, driven by strong interest from physicians and patients. |
| • | Initiation of zumilokibart (APG777) Phase 3 trial in AD – expected 2H 2026 enabling potential launch in 2029 |
| • | Phase 1b head-to-head clinical trial of APG279 (APG777+APG990) vs. DUPIXENT for moderate-to-severe AD readout remains on track – expected 2H 2026 |
| o | Trial upsized from approximately 50 to 80 patients due to strong patient enrollment. |
The Company confirmed that it believes it has cash runway into the second half of 2028.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this Current Report on Form 8-K may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: the potential for zumilokibart (APG777) in asthma; Apogee’s plans for its current and future product candidates and programs; the anticipated timing of its clinical trials, including the APEX 52-week Part A in AD, APEX 16-week Part B in AD, APG279 Phase 1b head-to-head readout against DUPIXENT in AD, the potential Phase 3 trial of zumilokibart and the potential launch of zumilokibart; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of zumilokibart and APG279; the potential to expand zumilokibart for other indications; Apogee’s other product candidates, including combination therapies, and any other potential programs; its planned business strategies; potential market sizes; and its expectations regarding the time period over which Apogee’s capital resources will be sufficient to fund its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the “SEC”)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, filed with the SEC on May 12, 2025, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, filed with the SEC on August 11, 2025, Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed with the SEC on November 10, 2025 and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits. The following exhibit is being furnished herewith:
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Data Press Release, dated January 6, 2026 | |
| 99.2 | Data Presentation, dated January 6, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Apogee Therapeutics, Inc. | ||
| Date: January 6, 2026 | By: | /s/ Michael Henderson, M.D. |
| Michael Henderson, M.D. | ||
| Chief Executive Officer | ||
Exhibit 99.1

Apogee Therapeutics Announces Positive Interim Results from Phase 1b Trial of Zumilokibart (APG777), its Potentially Best-in-Class Anti-IL-13 Antibody, in Patients with Mild-to-Moderate Asthma and Highlights 2026 Anticipated Milestones and Outlook
Phase 1b interim results of zumilokibart (APG777) in asthma demonstrated rapid and durable suppression of FeNO (key biomarker of Type 2 inflammation) through 16 weeks for all patients
| - Suppression of FeNO through 32 weeks for patients with available follow up |
| - Results reinforce continued development in asthma testing every 3- or 6- month dosing |
Successful expansion of zumilokibart beyond dermatology confirms its pipeline-in-a-product potential across I&I indications
Zumilokibart in atopic dermatitis (AD) advancing in Phase 2 APEX trials with goal of Phase 3 initiation by end of 2026:
| - Part A maintenance (52-week) data readout expected in Q1 2026 with potential to establish best-in-class every 3- or 6-month dosing profile |
| - Part B enrollment completed ahead of schedule and exceeded enrollment target with a total of 347 patients; 16-week induction data readout on track for Q2 2026 |
Serial innovation in AD advances with APG279 Phase 1b expanded to approximately 80 patients with readout on track for 2H 2026 based on strong enrollment
Strong cash position of $913 million with runway into 2H 2028 supports advancement toward potential launch of zumilokibart in 2029
Management will host a conference call at 8:00 a.m. ET
San Francisco and Boston, January 6, 2026 – Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today announced positive interim data from the Phase 1b trial of zumilokibart (APG777) in patients with mild-to-moderate asthma and highlighted upcoming 2026 milestones. The company recently received approval for the International Non-proprietary Name (INN) of zumilokibart for APG777. Zumilokibart is a novel, half-life extended anti-IL-13 antibody.
“2025 was a foundational year for Apogee, setting the stage for a potentially transformational 2026 as we plan to deliver multiple significant clinical data readouts for our monotherapy and combination programs and enter Phase 3 development,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “With today’s positive readout in patients with mild-to-moderate asthma, we are excited to advance zumilokibart in asthma and seek to further derisk its pipeline-in-a-product potential. We look forward to reporting three clinical readouts for atopic dermatitis in 2026, which we expect to further solidify the potential for our portfolio of best-in-class monotherapy and combination treatments. Apogee is well capitalized and positioned to execute on its strategic vision of transforming the standard of care for people living with I&I conditions.”

Zumilokibart (APG777) Phase 1b Positive Interim Results in Mild-to-Moderate Asthma
Today, the company announced interim results from its Phase 1b double-blind, placebo-controlled trial evaluating the safety and tolerability of zumilokibart in 19 adult patients with mild-to-moderate asthma and a fractional exhaled nitric oxide (FeNO) baseline greater or equal to 25 parts per billion (ppb) which represents an enriched Type 2 inflammation population. The trial also evaluated FeNO suppression, a key biomarker of Type 2 inflammation. Participants received a single dose of 720 mg of zumilokibart or placebo on day 1.
In the trial, zumilokibart demonstrated:
| · | Favorable safety profile; zumilokibart was well-tolerated in patients with mild-to-moderate asthma. |
| o | The only treatment-emergent adverse event (TEAE) observed in more than one patient was gastroesophageal reflux disease (GERD; 2 patients). There were no Grade 3 or higher TEAEs or serious adverse events. | |
| o | No conjunctivitis, injection site reactions, or anti-drug antibodies (ADAs) were observed. |
| · | Robust and durable suppression of FeNO, a biomarker of Type 2 inflammation that has shown the strongest correlation with exacerbations in asthma, following a single dose. |
| o | Maximum absolute mean FeNO reduction of 45 ppb (60% decrease from baseline) after single dose. | |
| o | Durable FeNO suppression through 16 weeks for all patients. | |
| o | Suppression of FeNO through 32 weeks for patients with available follow up, supporting potential for 3- or 6- month dosing. |
| · | Positive trends observed in forced expiratory volume in one second (FEV1) and across Type 2 biomarkers for all available data. FEV1 is a pharmacodynamic measure of lung function. Further data from the study will be shared at upcoming medical conferences. |
“This first dataset of zumilokibart in asthma is very promising and showcases the potential of this treatment to help a new patient population,” said Mario Castro, M.D., M.P.H. Chief of Pulmonary, Critical Care, and Sleep Medicine, University of Kansas. “We need new treatment options for these patients, especially those that are more convenient with the less frequent administration. These data, in particular the deep and durable FeNO suppression, highlight the promise of this drug for asthma patients with Type 2 inflammation, and I look forward to continued evaluation of zumilokibart in upcoming studies.”
“The results from this study further emphasize the versatility of zumilokibart across Type 2 inflammatory diseases, now spanning both dermatology and respiratory indications,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “With a favorable safety profile, as well as durable FeNO suppression, zumilokibart has the potential to serve as a foundational therapy – both as a monotherapy and in combination. Further, in patients in the APEX Phase 2 Part A trial with comorbid asthma or sinusitis, we saw improvement in asthma and sinusitis, as measured by improvements in ACQ-5 and SNOT-22, respectively, solidifying zumilokibart’s potential to broadly impact Type 2 inflammatory diseases. Based on these results, we look forward to advancing and sharing our plans later this year to further evaluate zumilokibart in the ASPIRE asthma trial. I would like to thank the patients and physicians for their support in the successful execution of this Phase 1b trial.”

Anticipated 2026 Key Milestones
Establish potential best-in-class profile for zumilokibart in future $50B+ atopic dermatitis market
| · | Phase 2 APEX Part A (52-week) maintenance data readout – expected Q1 2026 | |
| · | Phase 2 APEX Part B (16-week) induction data readout – expected Q2 2026 |
| o | The trial completed enrollment ahead of schedule and exceeded its target with a total of 347 patients, driven by strong interest from physicians and patients. |
| · | Initiation of Phase 3 trial – expected 2H 2026 enabling potential launch in 2029 |
Execute on expansion indications for zumilokibart in treating I&I diseases beyond atopic dermatitis
| · | Reported positive interim data readout today of zumilokibart Phase 1b clinical trial in mild-to-moderate asthma in Type 2 inflammation patients |
| o | Multiple potential blockbuster expansions in dermatology, respiratory and GI with prioritization to start ASPIRE asthma trial. |
Continue serial innovation in atopic dermatitis with novel combinations
| · | Phase 1b head-to-head clinical trial of APG279 (APG777+APG990) vs. DUPIXENT for moderate-to-severe AD readout remains on track – expected 2H 2026 |
| o | Trial upsized from approximately 50 to 80 patients due to strong patient enrollment. | |
| o | APG279 is Apogee’s first-in-class fixed dose combination targeting both IL-13 and OX40L. |
With these readouts, Apogee expects to generate data across monotherapy and combination programs in 2026, setting the stage for potential initiation of Phase 3 trials and a potential 2029 launch of zumilokibart in AD, as well as continued expansion across the company’s portfolio. As of September 30, 2025, Apogee had total cash of $913 million (pro forma cash, cash equivalents, marketable securities, and long-term marketable securities includes $588.9M as of September 30, 2025, plus proceeds before expenses, of $324.3M from October 2025 equity financing) with cash runway into the second half of 2028.
Webcast Details
Apogee Therapeutics’ live webcast of the positive interim data results of zumilokibart Phase 1b trial in mild-to-moderate asthma will begin today at 8:00 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company’s website at https://investors.apogeetherapeutics.com/news-events/events. A replay of the webcast will be available following the call.
About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’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. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com.

Forward Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: the potential for zumilokibart (APG777) in asthma; Apogee’s plans for its current and future product candidates and programs; the anticipated timing of its clinical trials, including the APEX 52-week Part A in AD, APEX 16-week Part B in AD, APG279 Phase 1b head-to-head readout against DUPIXENT in AD, the potential Phase 3 trial of zumilokibart and the potential launch of zumilokibart; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of zumilokibart and APG279; the potential to expand zumilokibart for other indications; Apogee’s other product candidates, including combination therapies, and any other potential programs; its planned business strategies; potential market sizes; and its expectations regarding the time period over which Apogee’s capital resources will be sufficient to fund its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, filed with the SEC on May 12, 2025, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, filed with the SEC on August 11, 2025, Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed with the SEC on November 10, 2025 and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
Noel.Kurdi@apogeetherapeutics.com
Media Contact:
Dan Budwick
1AB Media
dan@1abmedia.com
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Title text 2 January 6, 2026 Zumilokibart (APG777) Asthma Phase 1b Interim Results |
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© Apogee Therapeutics, Inc 2 This presentation contains certain "forward-looking statements" within the meaning of applicable securities laws. Other than statements of historical facts, all statements included in this presentation are forward-looking statements, including statements about the potential for zumilokibart (APG777) in asthma; Apogee's plans for its current and future product candidates and programs; the anticipated timing of its clinical trials, including the APEX 52-week Part A in AD, APEX 16-week Part B in AD, APG279 Phase 1b head-to-head readout against DUPIXENT in AD, the potential Phase 3 trial of zumilokibart and the potential launch of zumilokibart; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of zumilokibart and APG279; the potential to expand zumilokibart for other indications; Apogee's other product candidates, including combination therapies, and any other potential programs; its planned business strategies; potential market sizes; and its expectations regarding the time period over which Apogee's capital resources will be sufficient to fund its anticipated operations.Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, filed with the SEC on August 11, 2025, Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed with the SEC on November 10, 2025 . In some cases, you can identify forward-looking statements by terms such as “anticipate,” “believe,” “can,” “could,” “design,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “predict,” “suggest,” “target,” “will,” “would,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. The forward-looking statements are based on our beliefs, assumptions and expectations of future performance, taking into account the information currently available to us. These statements are only predictions based upon our current expectations and projections about future events. Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking statements, including those risks described in “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 3, 2025, our Quarterly Report on Form 10-Q for the three months ended March 31, 2025, to be filed with the SEC on May 12, 2025, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, filed with the SEC on August 11, 2025, Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed with the SEC on November 10, 2025, and subsequent disclosure documents we may file with the SEC. Although we have attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. This presentation concerns a drug candidate that is under clinical investigation, and which has not yet been approved by the U.S. Food and Drug Administration. It is currently limited by federal law to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated. The assumptions used in the preparation of this presentation, although considered reasonable by us at the time of preparation, may prove to be incorrect. You are cautioned that the information is based on assumptions as to many factors and that actual results may vary from the results projected, and such variations may be material. Accordingly, you should not place undue reliance on any forward-looking statements contained herein or rely on them as predictions of future events. All forward-looking statements in this presentation apply only as of the date made and are expressly qualified by the cautionary statements included in this presentation. We do not undertake to update any forward-looking statements, except in accordance with applicable securities laws. The trademarks, trade names and service marks appearing in this presentation are the property of their respective owners. Certain information contained in this presentation relate to or are based on studies, publications and other data obtained from third-party sources as well as our own internal estimates and research. While we believe these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. Disclaimers and Forward-looking Statements |
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© Apogee Therapeutics, Inc 3 Agenda Introduction Michael Henderson, MD Chief Executive Officer Carl Dambkowski, MD Chief Medical Officer Invited KOL: Mario Castro, MD, MPH University of Kansas School of Medicine Michael Henderson, MD, CEO Carl Dambkowski, MD, CMO Jane Pritchett Henderson, CFO Jeff Hartness, CCO Invited KOL: Mario Castro, MD, MPH Zumilokibart (APG777) Asthma Phase 1b Results IL-13 inhibition in asthma Closing remarks Analyst Q&A Michael Henderson, MD Chief Executive Officer |
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Introduction Michael Henderson, MD Chief Executive Officer |
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© Apogee Therapeutics, Inc. Q1 NOTE: 1APG279 is a combination of APG777 and APG990. APG279 will be co-administered in the proof-of-concept Phase 1b trial; coformulation planned for future clinical studies and commercialization. FeNO = fractional exhaled nitric oxide. © Apogee Therapeutics, Inc. 5 2026 could be a transformational year for Apogee Zumilokibart (APG777) Asthma Phase 1b positive data UPDATE: Robust effect on FeNO comparable to DUPIXENT; sustained FeNO suppression after a single dose for 16 weeks, with continued FeNO suppression through 32 weeks for patients with available follow-up Zumilokibart AD Phase 2: Part A (52-week readout) Q2 Zumilokibart AD Phase 2: Part B (16-week readout) UPDATE: Part B enrollment complete and on track for Q2 2026 readout; overenrolled (N=347) due to strong interest from physicians and patients 2H APG279 AD Phase 1b POC readout (vs DUPIXENT)1 UPDATE: On track for 2H 2026 readout with expanded enrollment (N ~80) due to strong interest from physicians and patients Zumilokibart AD Phase 3 initiation Expected Key 2026 Milestones: |
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© Apogee Therapeutics, Inc 6 Zumilokibart (APG777) targets IL -13, the core driver of multiple I&I diseases Atopic dermatitis • Part A 16 -week data demonstrated potentially best -in -class profile • Patients in Part A with comorbid asthma or sinusitis saw improvement based on ACQ -5 and SNOT -22 Expansion indications • 8+ potential additional expansions (e.g., EoE, COPD, CRSwNP, PN) • Asthma Phase 1b: Depth and durability of response support continued expansion to asthma with potential every 3 - or 6 -month dosing UPDATE 6 |
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7 © Apogee Therapeutics, Inc. Apogee is entering late-stage development in the two largest I&I markets Projected growth for key I&I markets (2023-2030) NOTE: Market growth is in terms of global annual revenue. IBD = Inflammatory bowel disease; RA = Rheumatoid arthritis; PsO = Psoriasis; COPD = Chronic obstructive pulmonary disease; AD = Atopic dermatitis. SOURCE: Academic journals, disease foundations, WHO, CDC, census data, EvaluatePharma, analyst research. Projected sales growth based on Evaluate Pharma figures as of 1/2/2026. Projected sales growth (% CAGR, 2023-30) Estimated WW population size PsO COPD Asthma 2.6M 13.5M 26.9M 59.6M 65.5M 81.6M US biologics penetration AD 0% 60% Clinical PoC for zumilokibart (APG777) -4.5 -10 0 10 20 +7.4 +5.6 +4.8 +3.3 +15.6 IBD RA |
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Zumilokibart (APG777) Asthma Phase 1b Interim Results Carl Dambkowski, MD Chief Medical Officer |
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© Apogee Therapeutics, Inc 9 GOAL Confirm safety of zumilokibart as monotherapy in an asthma patient population Single dose of 720mg was well-tolerated Demonstrate activity of zumilokibart via maximum mean FeNO reduction in line with standard of care GOAL Show sustained suppression of FeNO supporting every 3- month dosing or less frequent Sustained FeNO suppression after a single dose for 16 weeks (limit of follow-up available for all patients)2 Suppression was sustained through 32 weeks for patients with available follow-up GOAL ZUMILOKIBART (APG777) PHASE 1B Zumilokibart Phase 1b interim data achieved or exceeded trial objectives NOTE: 1 Maximum mean change from baseline and maximum mean percent change from baseline in FeNO through 16-weeks (limit of available follow-up for all patients). 2 Data available for all patients to 16 weeks, 14 patients to 20 weeks, 6 patients to 24 weeks, 5 patients to 28 weeks, and 3 patients to 32 weeks. FeNO = fractional exhaled nitric oxide. Ppb = parts per billion. Robust FeNO reduction after a single dose (maximum mean)1: • 45 ppb reduction from baseline • 60 percent reduction from baseline RESULT RESULT RESULT |
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© Apogee Therapeutics, Inc 10 ZUMILOKIBART (APG777) PHASE 1B Zumilokibart Phase 1b was designed to address shortcomings of lebrikizumab asthma trials Zumilokibart Phase 1b data validates IL-13 inhibition in asthma with robust and sustained effect on FeNO Lebrikizumab asthma trials were underdosed relative to AD trials3,4 Zumilokibart Ph1b modeled exposure >3X higher vs. lebrikizumab pivotal asthma trials1,2 37.5 mg Q4W 125 mg Q4W 250mg Q2W 188 mg 625 mg 2,750 mg 4.4x Lebri asthma dose Lebri AD dose Modeled exposure 0 Weeks 12 Zumilokibart (720mg x1) Lebri (125mg Q4W) Optimized dosing Improved patient selection 29% Lebri ITT 46% Lebri FeNO ≥50, ≥ 1 exac % Reduction in AER vs placebo 125 mg Q4W regimen Patients with high T2 inflammation had greater benefit in lebrikizumab asthma trials5 Zumilokibart Ph1b enrolled T2 enriched population (baseline FeNO ≥ 25 ppb) NOTE: The above graphs are illustrative only with respect to plans for dosing of APG777 and does not present comparative data. N.S. = Not significant. FeNO = fractional exhaled nitric oxide. 1Solid blue line represents population PK (PPK) model predicted median concentrations of APG777 for Q3M or Q6M dosing regimen, shaded blue area represents 90% prediction interval (PI). 2 Based on Apogee modeled exposures for lebrikizumab 125mg Q4W dosing. SOURCE: 3 Hanania et al. Lancet, 2016. 4 EBGLYSS USPI. 5 Corren et al. J Allergy Clin Immunol Pract, 2024 (digitized). P < 0.001 N.S. |
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© Apogee Therapeutics, Inc 11 • Safety: Confirm safety of zumilokibart as monotherapy in asthma patients • FeNO (fractional exhaled nitric oxide): • Generally strongest correlation with asthma exacerbations of any biomarker2,3 • FDA has suggested FeNO is a potential surrogate marker of treatment response for asthma with Type 2 airway inflammation4 ZUMILOKIBART (APG777) PHASE 1B Zumilokibart Phase 1b in mild-to-moderate asthma patients focused on FeNO – a surrogate marker of treatment response in Type 2 asthma Design elements Double-blind, placebo-controlled, Single dose regimen in patients with asthma N = 19 (3:1 active:placebo) Key inclusion criteria1 • Mild-to-moderate asthma • FeNO ≥25 ppb Schematic: Primary objectives NOTE: 1 Zumilokibart Phase 1b in mild-to-moderate asthma enrolled a total of 31 patients; 19 patients met the pre-specified criteria for the analysis population (FeNO ≥25 ppb, representative of asthma with Type 2 inflammation). SOURCE: 2 Mansur AH, et al. Respiratory Medicine, 2018. 3 Kraft M, et al. Eur Respir J. 2021. 4 FDA Public Workshop: Biomarker-driven drug development for allergic diseases and asthma. February 22, 2024. 3:1 Zumilokibart 720mg (single dose) Placebo |
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© Apogee Therapeutics, Inc 12 ZUMILOKIBART (APG777) PHASE 1B Baseline characteristics are in line with expectations Demographics were generally well-balanced across cohorts Placebo N=5 Zumilokibart N=14 Age in years, mean (SD) 51.2 (8.2) 42.1 (13.3) Female 40.0% 42.9% White 80.0% 92.9% Weight in kg, mean (SD) 92.5 (16.2) 81.0 (12.8) Patients on daily ICS ± LABA 100.0% 78.6% Blood eosinophil count, mean (SD) 176 (108) 304 (205) FeNO in ppb, mean (SD) 57.2 (34.1) 66.9 (65.2) |
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© Apogee Therapeutics, Inc 13 n (%) Placebo N=5 Zumilokibart N=14 ≥1 TEAE 4 (80.0%) 7 (50.0%) ≥1 serious TEAE 0 0 ≥1 Grade 3 or 4 TEAE 0 0 ≥1 drug-related TEAE 0 0 ≥1 drug-related serious TEAE 0 0 ≥1 drug-related Grade 3 or 4 TEAE 0 0 Discontinued study due to TEAE 0 0 ZUMILOKIBART (APG777) PHASE 1B Zumilokibart was well-tolerated in mild-to-moderate asthma patients NOTE: TEAE = Treatment-Emergent Adverse Event. GERD = gastroesophageal reflux disease. ADA = anti-drug antibody. Data cut off date: November 28th, 2025. In full safety population (N=31) that were on treatment (N=23), TEAE occurring in >1 patient on zumilokibart were upper respiratory tract infection (N=3), nasopharyngitis (N=2), gastroesophageal reflux disease (N=2), and arthralgia (N=2); there were no Grade 3 or 4 AEs or SAEs. • No conjunctivitis or injection site reactions observed • Only TEAE occurring in >1 patient on zumilokibart was GERD (2 patients, 14.3%) • Safety profile is in line with expectations for therapies targeting IL-13 in asthma • No ADAs; PK in line with previous studies |
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© Apogee Therapeutics, Inc 14 ZUMILOKIBART (APG777) PHASE 1B Single dose of zumilokibart led to durable FeNO suppression -38 -45 -41 -43 -44 -41 -7 -11 -14 -15 -11 -13 -80 -60 -40 -20 0 0 4 8 12 16 FeNO, mean change from baseline ±SEM (ppb) Weeks NOTE: 1 One patient discontinued following the Week 12 visit (lost to follow-up). FeNO = fractional exhaled nitric oxide. FeNO mean absolute change from baseline Zumilokibart 720 mg (N=14)1 Placebo (N=5) -45 ppb maximum mean reduction |
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© Apogee Therapeutics, Inc 15 ZUMILOKIBART (APG777) PHASE 1B Single dose of zumilokibart led to durable FeNO suppression -51% -60% -51% -54% -57% -53% -11% -10% -19% -19% -17% -10% -80% -60% -40% -20% 0% 0 4 8 12 16 FeNO, mean percent change from baseline ±SEM (%) Weeks NOTE: 1 One patient discontinued following the Week 12 visit (lost to follow-up). FeNO = fractional exhaled nitric oxide. FeNO mean percent change from baseline -60 percent maximum mean reduction Zumilokibart 720 mg (N=14)1 Placebo (N=5) |
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© Apogee Therapeutics, Inc 16 -38 -45 -41 -43 -44 -41 -7 -11-14 -15 -11 -13 -40 -61 -54 -37 12 -4 4 -3 -100 -80 -60 -40 -20 0 20 0 4 8 12 16 20 24 28 32 FeNO, mean change from baseline ±SEM (ppb) Weeks -51% -60% -51% -54% -57% -53% -11% -10% -19% -19% -17% -10% -48% -56% -59% -76% 22% -16% 16% -12% -100% -80% -60% -40% -20% 0% 20% 0 4 8 12 16 20 24 28 32 FeNO, mean percent change from baseline ±SEM (%) Weeks ZUMILOKIBART (APG777) PHASE 1B For patients with available follow-up, FeNO suppression was maintained through 32-weeks following a single dose NOTE: 1 One patient discontinued following the Week 12 visit (lost to follow-up). 2 Error bars cannot be generated for placebo beyond Week 20 due to small N. FeNO = fractional exhaled nitric oxide. Zumilokibart 720 mg Complete follow-up (N=14) Incomplete follow-up 1 Placebo Complete follow-up (N=5) Incomplete follow-up2 Complete N=14 N=6 N=5 N=3 Follow 1 -up: Complete N=14 N=6 N=5 N=3 Follow 1 -up: 0 0 FeNO mean absolute change from baseline FeNO mean percent change from baseline |
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© Apogee Therapeutics, Inc 17 Single dose of zumilokibart achieved competitive FeNO reduction -16 -19 -38 -30 -10 -16 -37 -11 -32 -11 -16 -44 -50 -40 -30 -20 -10 0 VESTIGE APG808 GB-0895 Zumi Anti-IL-4Rα Anti-TSLP Anti-IL-13 BL FeNO (ppb)1 34 36 63 53 32 41 64 32 61 31 40 67 NOTE: Data are derived from different clinical trials conducted at different times, with differences in trial design and patient populations. As a result, cross-trial comparisons cannot be made, and no head-to-head clinical trials have been conducted. FeNO level reflects data from marketed dose, where available. Lunsekimig data is from D57 (week 8; week 12 data not available). Lebrikizumab data is for 125mg Q4W dose (highest tested dose in Phase 3 trials). BL = baseline. FeNO = fractional exhaled nitric oxide. SOURCE: 1 Baseline indicated refers to treatment group(s) only. 2Castro M, et al. NEJM, 2018. 3Rabe KF et al. NEJM, 2018 (digitized). 4Castro M, et al. Lancet Resp Med, 2025 (difference of baseline mean FeNO of 63.1 ppb and Week 12 mean FeNO of 25.3 ppb). 5Kamboj A, et al. ACAAI, 2025. 6Corren JC, et al. NEJM, 2019 (digitized). 7Menzies-Gow A, et al. NEJM, 2021 (digitized). 8Deykin A et al. ERS 2024 (straight average of 100mg Q4W, 200mg Q4W, and 300mg Q12W cohorts). 9Singh et al ERS 2025 (straight average of 100mg, 300mg, 600mg, and 1200mg cohorts, digitized). 10Deiteren A et al. ATS 2023 (digitized). 11Hanania NA, et al. Thorax, 2015 (125mg Q4W, weighted average of biomarker-high and biomarker low cohorts, digitized). 12Russell RJ, et al. Lancet Respir Med, 2018 (digitized). FeNO, mean change from baseline (ppb) ZUMILOKIBART (APG777) PHASE 1B FeNO mean absolute change from baseline at 12 weeks (ppb) |
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© Apogee Therapeutics, Inc 18 Zumilokibart achieved or exceeded trial objectives, derisking path forward in asthma and demonstrating expansion potential for zumilokibart Primary trial objectives Well tolerated with no Grade 3 or 4 AEs, no SAEs, no conjunctivitis and no ISRs Robust FeNO reduction in line with standard-of-care (i.e., DUPIXENT) Zumilokibart advancing in asthma; ASPIRE asthma trial plans to be announced later this year Sustained FeNO suppression after a single dose for 16 weeks, with continued FeNO suppression through 32 weeks for patients with available follow-up ZUMILOKIBART (APG777) PHASE 1B NOTE: AE = adverse event. SAE = serious adverse event. FeNO = fractional exhaled nitric oxide. FEV1 = Forced Expiratory Volume in 1 Second. TARC = Thymus and Activation-Regulated Chemokine. Supplemental endpoints Positive trends in Type 2 inflammatory biomarkers (e.g., TARC, eotaxin-3) for all available data Positive trends in FEV1 (a measure of lung function) for all available data |
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IL-13 in asthma Mario Castro, MD, MPH University of Kansas School of Medicine |
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IL-13 mRNA is elevated in asthma patient lung tissue vs. controls3 • IL-13 is a key cytokine driving Type 2 airway inflammation and is targeted by several approved biologics for asthma (e.g., dupilumab) • IL-13 drives core features of asthma, including mucus hypersecretion, airway hyperreactivity, and eosinophilic infiltration1,2 • IL-13 mRNA was shown to be elevated in lung biopsies in both atopic and non-atopic asthma patients compared to individuals without asthma3 IL-13 is a central mediator of asthma 1) Wills-Karp et al, Science 1998 10.1126/science.282.5397.2258. 2) Grunig et al, Science 1998 10.1126/science.282.5397.2261. 3) Humbert et al. JACI 1997 10.1016/s0091-6749(97)70028-9. |
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IL-13 drives the pathogenesis of asthma Boomer et al, Am J Respir Crit Care Med. 2024 10.1164/rccm.202307-1266OC. Muc5AC Healthy Nonsevere Severe Cilia-related genes Healthy Nonsevere Severe Red = Cilia + IL-13 Green = Muc5AC Control Severe asthma is associated with airway remodeling including increased mucin expression and loss of ciliated cells IL-13 stimulus drives mucin expression (green) and loss of ciliated cells (red) in ex vivo asthma model • Airway remodeling is the process resulting in structural changes within the airway, including epithelial thickening, subepithelial fibrosis, goblet cell metaplasia, and increased smooth muscle mass • Airway remodeling ultimately leads to chronic airflow obstruction and hyperresponsiveness |
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Lebrikizumab, an IL-13 inhibitor, reduced exacerbations in a Type 2-high population • Lebrikizumab resulted in a significant reduction in asthma exacerbations in a subset of asthma patients with a history of exacerbations and high Type 2 inflammatory biomarkers (baseline blood eosinophils of ≥300 cells/mL or FeNO ≥50 ppb greater) • These results suggest IL-13 inhibition is likely effective in asthma patients with a high type 2 phenotype Corren et al, J Allergy Clin Immunol. Pract. 2024 Pooled LAVOLTA-I & LAVOLTA-II (Lebrikizumab Phase 3 asthma trials) |
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Summary • IL-13 is a central mediator of asthma and is consistently elevated in the lungs of asthma patients relative to healthy controls • IL-13 drives the pathogenesis of asthma (e.g., airway remodeling), directly contributing to the hallmark signs of asthma including chronic airflow obstruction and hyperresponsiveness • Post-hoc subgroup analyses of lebrikizumab (αIL-13 antibody) phase 3 studies demonstrated significant reduction in asthma exacerbations in patients with high Type-2 inflammatory biomarker levels and history of exacerbation • The phase I zumilokibart interim data demonstrates significant and durable improvement in lung function and suppression of FeNO with a single dose, with an acceptable safety profile, as one would expect from IL-13 inhibition in an appropriately selected population |
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Closing remarks Michael Henderson, MD Chief Executive Officer |
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© Apogee Therapeutics, Inc 25 ZUMILOKIBART (APG777) Zumilokibart has potential to become a leading therapy in the $15B+ future asthma biologics market $0 $2 $4 $6 $8 $10 $12 $14 $16 Global Revenue, $B (estimated share for asthma) NOTE: Not shown CINQAIR, rocatinlimab. SOURCE: EvaluatePharma (2025-2028 sales are projections). 1Clarify Health claims analysis conducted Q2 2023 based on claims submitted between Jan 1, 2018 and June 30, 2022. • Global asthma biologics market is forecasted to grow to ~$16B by 2028 • DUPIXENT has leading market share (~30%) among asthma biologics: • Only biologic approved for both AD and asthma; ~30% overlap between AD and asthma patients1 • Projected to reach $5.3B in asthma in 2028 • Zumilokibart demonstrated robust and durable FeNO suppression with potential for every 3- or 6-month dosing 2015 Zumilokibart is the only long-acting biologic to demonstrate compelling activity in both AD and asthma, supporting a potential best-in-class profile across the two largest I&I indications 2028 Year |
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© Apogee Therapeutics, Inc 26 30 40 50 60 70 0 2 4 6 8 10 12 ZUMILOKIBART (APG777) Zumilokibart has the potential to be a differentiated drug for Type 2 inflammatory conditions including AD and asthma NOTE: Positioning of zumilokibart is illustrative and based on Phase 2 Part A results in AD and Phase 1b interim results in asthma for zumilokibart only and illustrates what we believe we can potentially achieve. Only DUPIXENT, TEZSPIRE, NUCALA, FASENRA, and EXDENSUR are approved in the US. Efficacy data are derived from different clinical trials conducted at different times, with differences in trial design and patient populations. As a result, cross-trial comparisons cannot be made, and no head-to-head clinical trials have been conducted. Maintenance dosing intervals are as per label or published data. For some agents, longer dosing intervals are currently being evaluated in ongoing clinical trial(s). SOURCE: FDA labels. DUPIXENT label indicates reductions in exacerbations were significant in those with eos ≥150. TEZSPIRE data from population without a biomarker requirement. NUCALA data from population with eos ≥150 at screening or ≥300 in prior year. FASENRA data from two Phase 3 trials in patients with eos ≥300. EXDENSUR data from two Phase 3 trials in patients with eos ≥150 at screening or ≥300 in prior year Zumilokibart could become a leading therapy in the $15B+ future asthma biologics market Dosing Interval (weeks) Labeled for AD and asthma Labeled for asthma only Reduction in asthma exacerbations (labeled population) 12+ Zumilokibart Clinical PoC in both asthma and AD |
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© Apogee Therapeutics, Inc 27 Multiple potential blockbuster expansions in dermatology, respiratory and GI with prioritization to start ASPIRE asthma trial ZUMILOKIBART (APG777) • Bullous Pemphigoid • Chronic Spontaneous Urticaria • Cold Inducible Urticaria • Prurigo Nodularis APEX AD Part A 52-week Q1 2026 expected readout APEX AD Part B 16-week Q2 2026 expected readout Atopic dermatitis Next steps: • Asthma • Allergic Rhinitis (perennial) • Chronic Obstructive Pulmonary Disease • Chronic Rhinosinusitis with Nasal Polyps • Eosinophilic esophagitis ASPIRE asthma trial Plans to be announced later this year Multiple potential expansions in respiratory and GI |
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2026 could be a transformational year for Apogee Apogee poised for sustained leadership in AD starting with potential zumilokibart launch in 2029 NOTE: 1 Pro forma cash, cash equivalents, marketable securities, and long-term marketable securities includes $588.9M as of September 30, 2025, plus proceeds before expenses, of $324.3M from October 2025 equity financing. 2 APG279 is a combination of APG777 (zumilokibart) and APG990. APG279 will be co-administered in the proof-of-concept Phase 1b trial; coformulation planned for future clinical studies and commercialization. Well-capitalized to deliver key milestones with $913M in cash1 and runway into 2H 2028 © Apogee Therapeutics, Inc. 28 Establishing potential best-in-class dosing for zumilokibart in future $50B+ atopic dermatitis market • Q1 2026: APEX Phase 2 Part A 52-week expected readout • Q2 2026: APEX Phase 2 Part B 16-week expected readout • 2H 2026: AD Phase 3 planned initiation Optimizing Phase 3 dose to advance zumilokibart into late-stage development • 2H 2026: AD Phase 1b POC expected readout (against DUPIXENT) Serial innovation in atopic dermatitis with first-in-class APG279 combination2 • Q1 2026: Asthma Phase 1b positive data Expanding zumilokibart beyond atopic dermatitis |
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Apogee /ˈapəjē/ noun The highest point in the development of something; a climax or culmination |