Apogee Therapeutics (Nasdaq: APGE) reports durable 52-week AD results for zumilokibart
Rhea-AI Filing Summary
Apogee Therapeutics reported positive 52-week maintenance results from Part A of its Phase 2 APEX trial of zumilokibart (APG777) in moderate-to-severe atopic dermatitis. At 3- and 6‑month dosing intervals, 75% and 85% of patients maintained EASI‑75, and 86% and 78% maintained vIGA 0/1, showing durable disease control with infrequent injections.
The 360 mg subcutaneous regimen produced deepening responses across lesion and itch endpoints in both initial 16‑week responders and the full treated population, with a safety profile generally in line with other agents in the class. APEX Part B, a 347‑patient, placebo‑controlled dose‑optimization study, is expected to deliver 16‑week data in the second quarter of 2026.
Based on these data and the anticipated Part B induction results, the company plans to start Phase 3 trials in the second half of 2026, targeting a potential commercial launch in 2029 in what it believes could be a $50 billion atopic dermatitis market.
Positive
- Zumilokibart shows strong 52-week durability with infrequent dosing, maintaining EASI-75 in 75% and 85% of patients and vIGA 0/1 in 86% and 78% at 3- and 6-month intervals, supporting advancement to Phase 3 and a potential 2029 launch in a large atopic dermatitis market.
Negative
- None.
Insights
Strong Phase 2 durability data support advancing zumilokibart toward Phase 3 in atopic dermatitis.
Apogee Therapeutics released 52‑week Phase 2 APEX Part A data for zumilokibart in moderate‑to‑severe atopic dermatitis. Every 3‑ and 6‑month 360 mg dosing maintained high response rates, with 75% and 85% of patients keeping EASI‑75 and 86% and 78% maintaining vIGA 0/1, respectively. Deepening responses across lesion and itch endpoints suggest continued benefit beyond the initial 16‑week induction.
The drug was described as well tolerated, with a safety profile generally consistent with other agents in its class, which is important for a chronic disease requiring long‑term control. Infrequent 3‑ or 6‑month dosing contrasts with up to 26 injections annually for current therapies, a potential convenience advantage if efficacy and safety hold in larger studies.
APEX Part B, a placebo‑controlled dose‑optimization trial in 347 patients, is expected to yield 16‑week data in the second quarter of 2026. The company plans to initiate Phase 3 trials in the second half of 2026, aiming for a potential commercial launch in 2029 in a stated $50 billion atopic dermatitis market. Actual outcomes will depend on confirming these results in Part B and Phase 3 and on regulatory decisions.
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| Item 7.01 | Regulation FD Disclosure. |
On March 23, 2026, Apogee Therapeutics, Inc. (the “Company”) issued a press release and made publicly available a data presentation announcing positive maintenance data from Part A of the Phase 2 APEX clinical trial of zumilokibart (APG777), its potentially best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (“AD”). The Company will host a conference call and webcast today, Monday, March 23, 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 March 23, 2026, the Company announced positive maintenance data from Part A of the Phase 2 APEX clinical trial of zumilokibart (APG777) in patients with moderate-to-severe AD.
Zumilokibart (APG777) Phase 2 Part A Key 52-Week Results
The APEX Phase 2 clinical trial is a randomized, placebo-controlled study evaluating zumilokibart in patients with moderate-to-severe AD. In July 2025, the Company announced the APEX Phase 2 Part A 16-week results.
The 52-week maintenance portion of the trial evaluated 360mg of zumilokibart administered at 3- and 6-month maintenance dosing intervals. Results focused on two analysis populations: the Week 16 zumilokibart responder population and the full 52-week zumilokibart-treated population. At Week 52, zumilokibart demonstrated durable maintenance of response among Week 16 responders, with deepening of efficacy across the full treated population for all lesion and itch endpoints.
Initial 52-week findings from the trial include:
| · | Eczema Area and Severity Index (“EASI”) 75 maintenance of response of 75% for 3-month dosing and 85% for 6-month dosing among the Week 16 responder population, and overall response of 88% for 3-month dosing and 81% for 6-month dosing among all patients; |
| · | Validated Investigator’s Global Assessment (“vIGA”) 0/1 maintenance of response of 86% for 3-month dosing and 78% for 6-month dosing among the Week 16 responder population, and overall response of 72% for 3-month dosing and 52% for 6-month dosing among all patients; |
| · | 77% reduction of Itch NRS for 3-month dosing and 67% reduction of Itch NRS for 6-month dosing among the Week 16 responder population, and overall response of 73% for 3-month dosing and 64% for 6-month dosing among all patients; |
| · | EASI 90 overall response of 75% for 3-month dosing and 48% for 6-month dosing, respectively, among all patients; |
| · | EASI 100 overall response of 41% for 3-month dosing and 19% for 6-month dosing, respectively, among all patients; |
| · | Observed deepening of response across all lesional and itch endpoints with both every 3- and 6-month dosing; and |
| · | Zumilokibart was well tolerated across the full 52-week study with a safety profile generally consistent with other agents in the class. |
| o | 71.4% of patients receiving at least one dose of zumilokibart experienced treatment-emergent adverse events (“TEAEs”). |
| o | Serious TEAEs were rare for patients receiving at least one dose of zumilokibart (0.8%). |
| o | Discontinuation rate was low due to TEAEs for patients receiving at least one dose of zumilokibart (3.4%). |
| o | Across the 52-week treatment period, the most common TEAEs (occurring in ≥5% of patients) were noninfective conjunctivitis (13.4%), upper respiratory tract infection (12.6%), nasopharyngitis (9.2%) and dermatitis atopic (5.0%). |
APEX Part B is a placebo-controlled dose optimization trial with 347 patients randomized 1:1:1:1 to high-, medium- or low-dose zumilokibart versus placebo. Part B 16-week data are expected in the second quarter of 2026. Based on today’s results and anticipated Part B induction data, subject to clinical and regulatory outcomes, the company plans to begin Phase 3 trials of zumilokibart in the second half of 2026 enabling a potential commercial launch in 2029 in what the Company believes could be a $50 billion AD market.
Anticipated 2026 Key Milestones
The Company described expected data readouts and milestones for 2026:
| · | Zumilokibart Phase 2 APEX Part B (16-week) induction data readout – expected Q2 2026 | |
| · | Initiation of zumilokibart 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 fully enrolled with 24-week readout remaining on track – expected 2H 2026 | |
| · | Announce further clinical trial plans for zumilokibart in asthma and eosinophilic esophagitis in 2H 2026 |
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits. The following exhibits are being furnished herewith:
EXHIBIT INDEX
Exhibit No. |
Description | |
| 99.1 | Data Press Release, dated March 23, 2026 | |
| 99.2 | Data Presentation, dated March 23, 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: March 23, 2026 | By: | /s/ Michael Henderson, M.D. |
| Michael Henderson, M.D. | ||
| Chief Executive Officer | ||
Exhibit 99.1
Apogee Therapeutics Announces Positive Phase 2 Part A 52-Week Data of Zumilokibart (APG777), Demonstrating Maintenance and Deepening of Responses with Every 3- and 6-Month Dosing in Moderate-to-Severe Atopic Dermatitis
APEX Part A data demonstrated durable maintenance of response at 52-weeks for every 3- and 6-months dosing, respectively, including:
- 75% and 85% patients maintained EASI-75
- 86% and 78% patients maintained vIGA 0/1
Deepening of response was observed across all lesional and itch endpoints with both every 3- and 6- month dosing among the full population of patients initially randomized to zumilokibart
Well tolerated across both dosing regimens, with safety profile generally in line with other agents in class
APEX Part B 16-week induction expected to readout 2Q 2026, supporting expected initiation of Phase 3 zumilokibart trials in moderate-to-severe atopic dermatitis starting in 2H 2026
Data to be presented during late-breaking oral presentation at 2026 American Academy of Dermatology Annual Meeting
Management to host conference call today at 8:00 a.m. ET to share further details
SAN FRANCISCO and BOSTON, March 23, 2026 (GLOBE NEWSWIRE) -- 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 52-week maintenance data from Part A of the Phase 2 APEX clinical trial of zumilokibart (APG777), a potential best-in-class anti-IL-13 antibody, in patients with moderate-to-severe atopic dermatitis (AD). The results demonstrated durable maintenance of response with both 3- and 6- month maintenance dosing regimens. Deepening of response for the full population across all lesional and itch endpoints was also observed, supporting zumilokibart’s potentially differentiated profile, including significantly less frequent dosing than current standard of care.
“Our 52-week Part A data mark a significant milestone for zumilokibart, with the potential to transform the treatment paradigm as the first 6-month dosed therapeutic for patients with AD” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “Importantly, we observed continued deepening of efficacy across all endpoints for both 3- and 6-month dosing through 52 weeks in the full zumilokibart treated population, not just 16-week responders, while standard of care treatments typically plateau. These Part A results reinforce the potentially best-in-class profile of zumilokibart, which achieved greater than 99% inhibition of IL-13, the offending cytokine in AD, leading to rapid, early itch and lesion relief that deepened over time. We look forward to further evaluation of zumilokibart in our Phase 3 trials expected to initiate later this year which, subject to regulatory approval, we expect will support a potential commercial launch in 2029.”
“While the treatment landscape for atopic dermatitis has improved in recent years, patients and physicians are still looking for therapies that provide durable disease control with less frequent dosing,” said Ruth Ann Vleugels, M.D., MPH, MBA, Heidi and Scott C. Schuster Distinguished Chair in Dermatology and Director, Atopic Dermatitis Program at Brigham and Women’s Hospital and Professor of Dermatology, Harvard Medical School. “Quarterly or even biannual dosing alone would be transformative for patients living with AD, and the durability and efficacy demonstrated in APEX Phase 2 Part A through one year makes the profile for zumilokibart even more compelling as a future go-to treatment for this disease.”
APEX Phase 2 Part A Key 52-Week Results
The 52-week maintenance portion of the trial evaluated 360mg of zumilokibart administered at 3- and 6-month maintenance dosing intervals. Results focused on two analysis populations: the Week 16 zumilokibart responder population and the full 52-week zumilokibart-treated population. At Week 52, zumilokibart demonstrated strong maintenance of response among Week 16 responders, with deepening of efficacy across the full treated population for all lesion and itch endpoints.
Zumilokibart demonstrated:
| · | Maintenance of Eczema Area and Severity Index percent score reductions of at least 75 (EASI-75) among Week 16 responder population by 75% and 85% of patients with every 3-month and 6-month dosing, respectively. |
| · | Validated Investigator’s Global Assessment (vIGA) 0/1 maintenance of response of 86% for 3-month dosing and 78% for 6-month dosing among Week 16 responder population. |
| · | Deepening of response was observed across all lesional and itch endpoints with every 3- and 6-month dosing. |
| · | Well tolerated across the full 52-week study with a safety profile generally consistent with other agents in the class. |
| o | Across the 52-week treatment period, the most common TEAEs were noninfective conjunctivitis, upper respiratory tract infection, and nasopharyngitis. |
“Consistent maintenance of response as well as deepening of responses over time were observed across key endpoints for both the 3- and 6-month dosing regimens, demonstrating a highly differentiated profile that could allow treatment to be administered as few as two times per year, compared with up to 26 injections annually for currently available therapies,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “The potential for only 2-4 dosing days per year in addition to robust efficacy and a safety profile consistent with other agents in the class, further supports zumilokibart’s potentially best-in-class profile. I would like to thank the patients and physicians for their contributions in the successful execution of this trial.”
“Because atopic dermatitis is a chronic disease, maintaining disease control over time is critically important,” said Emma Guttman-Yassky, M.D., Ph.D., Waldman Professor of Dermatology and Immunology and Health System Chair of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City. “These 52-week findings for the full population are particularly encouraging for patients who did not fully respond during the first 16 weeks of treatment, suggesting that responses to zumilokibart may continue to deepen over time. I look forward to seeing how these results translate in the upcoming Part B data and Phase 3 trial starting later this year.”
APEX Part B is a placebo-controlled dose optimization trial with 347 patients randomized 1:1:1:1 to high-, medium- or low-dose zumilokibart versus placebo. Part B 16-week data are expected in the second quarter of 2026. Based on today’s results and anticipated Part B induction data, subject to clinical and regulatory outcomes, the company plans to begin Phase 3 trials of zumilokibart in the second half of 2026 enabling a potential launch in 2029.
Today’s data will also be presented in a late-breaking oral presentation at the 2026 American Academy of Dermatology Annual Meeting. Details of the presentation are as follows:
Title: Zumilokibart (APG777) Provides Early and Sustained Improvements in the Signs and Symptoms of Atopic Dermatitis: Results from the Phase 2 APEX Part A Study (79278)
Date & time: March 28, 2026, at 10:00 AM
Location: Bellco Theatre, Colorado Convention Center, Denver
Webcast Details
Apogee Therapeutics’ live webcast of the APEX Phase 2 Part A results 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 zumilokibart
Zumilokibart (APG777) is a novel, subcutaneous extended half-life monoclonal antibody targeting IL-13 – a critical cytokine in inflammation and a primary driver of AD. In the APEX Phase 2 52-week trial, zumilokibart demonstrated potential to maintain and deepen clinical responses with as little as every 3- and 6-month dosing. AD is a chronic inflammatory skin disorder which can lead to sleep disturbance, psychological distress, elevated infection risk and chronic pain, all of which significantly impact quality of life. Today’s treatments are associated with many challenges, including frequent injection regimens that can lead to poor patient compliance. Zumilokibart has pipeline-in-a-product potential with proof-of-concept demonstrated in asthma, and with expansion plans to be announced in asthma, EoE, and other I&I indications.
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, Chronic Obstructive Pulmonary Disease (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, 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 and EoE. 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: Apogee’s plans for its current and future product candidates, programs, clinical trials and expansion indications; the anticipated timing of its current and future clinical trials and clinical trial results, including the APEX Phase 2 Part B 16-week readout and the expectation that it will support commencement of a Phase 3 trial in zumilokibart; its planned clinical trial designs; the potential clinical benefit, dosing regimen, safety, PK, PD and efficacy profiles and treatment outcomes of zumilokibart and any other product candidates, including combination therapies; its planned business strategies; and its expected timing for future pipeline updates, regulatory decisions and commercialization, including the planned commercial launch of zumilokibart in 2029. 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 or final 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 clinical trial results across different phases of clinical trials; the accuracy of cross-trial comparisons against products and product candidates in the same class; 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, 2025, filed with the SEC on March 2, 2026, and subsequent disclosure documents Apogee has filed and 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
| APEX Part A 52-week readout March 23, 2026 |
| 2 © Apogee Therapeutics, Inc. Disclaimers and Forward-looking statements Other than statements of historical facts, all statements included in this presentation are forward-looking statements, including statements about our plans for our current and future product candidates and programs; the anticipated timing of initiation of our clinical trials, including the Phase 3 trial of zumilokibart (APG777) in AD; the expected timing of results from our clinical trials, including the initial readout from Part B of our Phase 2 trial of zumilokibart in AD and the initial readout from our Phase 1b trial of APG279 in AD; planned clinical trial designs; our plans for current and future clinical trials and expansion indications; the potential launch timing of our product candidates, including zumilokibart in AD; the potential clinical benefit, treatment outcomes, dosing regimen, and safety of zumilokibart and our other product candidates, including combination therapies, and any other potential programs; our expected timing for future pipeline updates; our potential path to regulatory approval; our expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations, our cash runway, our planned business strategies; and estimates of market size. 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We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. This presentation concerns drug candidates that are under clinical investigation, and which have not yet been approved by the U.S. Food and Drug Administration. These are currently limited by federal law to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are 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. This presentation also uses estimates and other statistical data made by independent parties and us relating to the data and analysis about our industry. The data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk. 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. This presentation contains data based on cross-study comparisons and not based on any head-to-head clinical trials. Cross-study comparisons are inherently limited and may suggest misleading similarities and differences. The values shown in cross-study comparisons are directional and may not be directly comparable. |
| 3 © Apogee Therapeutics, Inc. Agenda Introduction Michael Henderson, MD Chief Executive Officer Carl Dambkowski, MD Chief Medical Officer Kristine Nograles, MD SVP, Head of Clinical Development & Medical Affairs APEX Phase 2 Part A 52-Week Results Zumilokibart Development Program Building a Leading I&I Company Analyst Q&A Michael Henderson, MD Chief Executive Officer Michael Henderson, MD, CEO Carl Dambkowski, MD, CMO Jane Pritchett Henderson, CFO Jeff Hartness, CCO Invited KOL: Ruth Ann Vleugels, MD, MPH, MBA Unmet Need in Atopic Dermatitis Invited KOL: Ruth Ann Vleugels, MD, MPH, MBA Mass General Brigham, Harvard Medical School |
| Introduction Michael Henderson, MD Chief Executive Officer |
| 5 © Apogee Therapeutics, Inc. Building a leading I&I company to address Type 2 inflammatory conditions Atopic dermatitis (AD) is growing rapidly and could be the largest I&I market • AD market is projected to reach $50B+ • New entrants with limited differentiation are quickly becoming blockbusters © Apogee Therapeutics, Inc. 5 Zumilokibart is a potentially best-in-class antibody targeting IL-13, the primary driver of AD and other Type 2 inflammatory diseases • Zumilokibart’s prior 16-week induction data showed rapid reduction in itch and lesions • 52-week results now demonstrate zumilokibart maintains those responses and could be the first every 6-month dosed drug in dermatology, if approved • Both every 3- and 6-month dosing led to deepening across all endpoints, in contrast to DUPIXENT NOTE: Future $50B AD market size based on EvaluatePharma and company projections. Actual market size may differ materially.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. |
| 6 © Apogee Therapeutics, Inc. APEX PART A Data support planned zumilokibart Phase 3 initiation in 2H 2026 with every 3- and every 6-month dosing regimens Durable maintenance of response at 52 weeks Maintenance of EASI-75: • 75% every 3-month dosing • 85% every 6-month dosing Maintenance of IGA 0/1: • 86% every 3-month dosing • 78% every 6-month dosing Deepening responses through Week 52 • Deepening of response seen across all lesional and itch endpoints tested for both every 3- and 6-month dosing • Up to 36 percentage points of deepening on the most stringent endpoints (IGA 0/1, EASI-90, EASI-100) Well-tolerated safety profile consistent with class • Both maintenance regimens well-tolerated • Safety profile generally in line with class APEX 52-week data demonstrated a potentially best-in-class profile with both every 3-month and every 6-month dosing NOTE: Safety 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. IGA = Investigator Global Assessment. EASI = Eczema Area and Severity Index. Phase 3 plans subject to regulatory outcomes. Zumilokibart assessed Validated Investigator Global Assessment (vIGA) during APEX Part A. |
| 7 © Apogee Therapeutics, Inc. 0 2 4 6 8 10 12 24 0 30 40 50 60 70 80 90 Amlitelimab (24-week) Apogee has the potential to transform the future $50B atopic dermatitis market Efficacy (EASI-75 at Week 16, %) APEX PART A NOTE: Positioning of Apogee programs is illustrative and based on Phase 2 Part A results for zumilokibart only and illustrates what we believe we can potentially achieve. Only DUPIXENT, ADBRY, and EBGLYSS 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. Future $50B AD market size based on EvaluatePharma and company projections. 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). All efficacy data shown based on non-responder imputation for rescue medication (topical or systemic) use (i.e., data subsequent to the use of rescue medication categorized as non-response). Statistical treatment of missing data varies across studies shown. SOURCE: DUPIXENT (average of Ph3 SOLO-1&2 and Ph2b; 300 mg Q2W regimen; non-responder imputation for missing values). EBGLYSS (average of Ph3 ADVOCATE-1&2 (multiple imputation (MCMC-MI) for missing values) and Ph2b (sensitivity analysis 3: NRI for rescue medication use and LOCF for other missing values); 250mg Q2W regimen). ADBRY (average of Ph3 ECZTRA1&2; 300 mg Q2W regimen; non-responder imputation for missing values). AMLITELIMAB Sanofi press release (average of COAST-1 and COAST-2, 250mg Q4W + 500mg loading dose; non-responder imputation for missing values). REZPEGALDESLEUKIN Nektar press release (non-responder imputation for missing values). 100 Zumilokibart (APEX Part A) Dosing Interval (weeks) Rezpegaldesleukin |
| APEX Part A 52-week results Carl Dambkowski, MD Chief Medical Officer |
| 9 © Apogee Therapeutics, Inc. APEX Part A study design APEX Part A schematic APEX PART A Induction Maintenance Week 0 Week 16 Week 52 720mg W0, W2, 360mg W4, W12 Every 3 months (360mg Q12W) Every 6 months (360mg Q24W) 1:1 Placebo Placebo crossover to zumilokibart crossover dose6 Efficacy analysis populations Rerandomized and double-blind with placebo-matched injections for dose masking Maintenance of response Zumilokibart responders at Week 161,4 52-week efficacy All patients initially randomized to zumilokibart2,5 NOTE: 1 Patients randomized to zumilokibart in induction that achieved a response at Week 16 (e.g., EASI-75) and received >1 dose of zumilokibart during maintenance. 2 Week 0-16 data: All patients randomized to zumilokibart in induction and received >1 dose of study drug in induction; Week 16-52 data: all patients randomized to zumilokibart in induction and received >1 dose of study drug in maintenance. 3 Patients randomized to placebo in induction and received >1 dose of zumilokibart in maintenance. 4 Evaluation method was Markov Chain Monte Carlo Multiple Imputation (MCMC-MI). Systemic rescue medication use or treatment discontinuation due to lack of efficacy was imputed as non-responder for all subsequent time points. Patients who received topical rescue medication or discontinued treatment for any other reasons had values set to missing subsequent to this time through to Week 52. 5 Efficacy data was evaluated as-observed without imputation for missing data or rescue medication use. 6 Placebo crossover zumilokibart dose regimen was: 720mg at W16; 360mg at W20, W24, W36, W48. Placebo crossover efficacy (appendix) Patients crossing over from placebo to zumilokibart treatment3,5 |
| 10 © Apogee Therapeutics, Inc. Baseline characteristics and demographics were in line with expectations APEX PART A Baseline demographics and disease characteristics of all patients treated with zumilokibart Characteristic Study mITT population (all patients receiving ≥1 dose of zumilokibart; N=119) NOTE: Baseline refers to week 0 of the study. vIGA = Validated Investigator Global Assessment. EASI = Eczema Area and Severity Index. BSA = Body Surface Area. I-NRS = Itch Numeric Rating Scale. SD = standard deviation. Age, mean (SD), Y 37.9 (14.9) Female, n (percent) 58 (48.7) Weight, mean (SD), kg 83.4 (20.9) Duration of AD from diagnosis, mean (SD), Y 24.3 (14.4) Race, n (percent) White 82 (68.9) Black or African American 17 (14.3) Asian 16 (13.4) Other 3 (2.5) Baseline disease characteristics EASI, mean (SD) 25.3 (10.8) vIGA (4), n (percent) 40 (33.6) Weekly mean I-NRS, (SD) 6.5 (2.0) BSA affected, mean (SD) 36.0 (22.5) |
| 11 © Apogee Therapeutics, Inc. APEX PART A Zumilokibart was well-tolerated across the full 52-week treatment period NOTE: Safety 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. TEAE = treatment-emergent adverse event. PT = preferred term. ADA = anti-drug antibody. Pooled conjunctivitis rate of 20.2% includes the following preferred terms: noninfective conjunctivitis, conjunctivitis allergic, conjunctivitis bacterial and conjunctivitis viral. • Pooled conjunctivitis rate (all PTs) of 20.2% with <1% discontinuations for full 52-week treatment period, generally in line with the IL-4Rα/13 class • No effect of ADAs on PK, efficacy, or safety n (%) Study mITT population Safety summary for Week 0 to 52 (all patients receiving ≥1 dose of zumilokibart; N=119) Patients reporting ≥1 TEAE 85 (71.4) Patients reporting ≥1 serious TEAE 1 (0.8) Patients who discontinued due to TEAE 4 (3.4) Most frequent TEAEs by PT for Week 0 to 52 (≥5%) Noninfective conjunctivitis 16 (13.4) Upper respiratory tract infection 15 (12.6) Nasopharyngitis 11 (9.2) Dermatitis atopic 6 (5.0) |
| 12 © Apogee Therapeutics, Inc. NOTE: Safety 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. 1 Conjunctivitis rate shown is the combined rate for all reported conjunctivitis-related MedDRA preferred terms including allergic conjunctivitis, atopic keratoconjunctivitis, bacterial conjunctivitis, conjunctivitis, noninfective conjunctivitis, and viral conjunctivitis. 2 Conjunctivitis rate shown for zumilokibart includes all conjunctivitis-related preferred terms for study mITT population (all patients receiving ≥1 dose of zumilokibart; N=119). 3 Actual rate for all conjunctivitis-related preferred terms for DUPIXENT and EBGLYSS studies shown may differ due to missing and/or not reported data. SOURCE: 4 DUPIXENT USPI. 5 APEX Phase 2 Part A. 6 Blauvelt A et al. Lancet 2017. 7 Blauvelt A et al. Br J Dermatol 2023. 8 Warren R.B. et al BJD 2025. CONJUNCTIVITIS APEX Part A conjunctivitis rate was comparable to DUPIXENT and EBGLYSS studies 0 10 20 30 40 Conjunctivitis rate (%) APEX Zumi2,5 CHRONOS QW3,6 CHRONOS Q2W3,6 ADvocate Lebri3,7,8 ADvantage Lebri3,9 20.2% 19.4% 13.6% 14.2% 16% reported in DUPIXENT USPI 30.0% (avg. of QW and Q2W)4 Conjunctivitis rate for 52-week studies including all reported preferred terms (%)1 APEX Part A2,5 Every 3 or 6 months (Q12W/Q24W) Zumilokibart CHRONOS3,6 Weekly (QW) CHRONOS3,6 Biweekly (Q2W) ADvocate3,7 Biweekly/Monthly (Q2W/Q4W) ADvantage3,8 Biweekly (Q2W) |
| Zumilokibart achieved durable maintenance of Week 16 responses |
| 14 © Apogee Therapeutics, Inc. Patients who achieved a response at Week 16 were assessed for maintenance of response at Week 52 APEX Part A schematic APEX PART A | MAINTENANCE OF RESPONSE 720mg W0, W2, 360mg W4, W12 Induction Every 3 months (360mg Q12W) Every 6 months (360mg Q24W) Maintenance Week 0 Week 16 Week 52 Zumilokibart responders at Week 16 1:1 Rerandomized and double-blind with placebo-matched injections for dose masking NOTE: Zumilokibart responders at Week 16 refers to patients randomized to zumilokibart in induction who achieved a response at Week 16 (e.g., EASI-75) and received ≥1 dose of zumilokibart during maintenance. Unless otherwise specified, maintenance of response was evaluated with Markov Chain Monte Carlo Multiple Imputation (MCMC-MI). Systemic rescue medication use or treatment discontinuation due to lack of efficacy was imputed as non-responder for all subsequent time points. Patients who received topical rescue medication or discontinued treatment for any other reasons had values set to missing subsequent to this time through to Week 52. |
| 15 © Apogee Therapeutics, Inc. Zumilokibart demonstrated 75-85% maintenance of EASI-75 response APEX PART A | MAINTENANCE OF RESPONSE Maintenance of EASI-75 response among patients with EASI-75 at Week 16 (%) 16 20 24 28 32 36 40 44 48 52 0 20 40 60 80 100 Week Every 6 months (Q24W, N=24) Every 3 months (Q12W, N=26) Zumilokibart: 0 20 40 60 80 100 Patients with EASI-75 at Week 52 among patients with EASI-75 at Week 16 (%) 85% 75% 72% 82% 78% Every 6 months (Q24W) Zumilokibart Monthly (Q4W) Biweekly (Q2W) Weekly / Biweekly (QW/Q2W) NOTE: For illustrative purposes only. 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. All efficacy data shown based on non-responder imputation for systemic rescue medication use or treatment discontinuation due to lack of efficacy. Statistical treatment of missing data varies across studies shown. SOURCE: DUPIXENT Worm, M JAMA Dermatology 2019 (SOLO-CONTINUE). EBGLYSS Blauvelt A et al. Br J Dermatology 2023 (ADvocate 1/2). 75% 85% Every 3 months (Q12W) |
| 16 © Apogee Therapeutics, Inc. Zumilokibart demonstrated 78-86% maintenance of IGA 0/1 response APEX PART A | MAINTENANCE OF RESPONSE NOTE: For illustrative purposes only. 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. All efficacy data shown based on non-responder imputation for systemic rescue medication use or treatment discontinuation due to lack of efficacy. Statistical treatment of missing data varies across studies shown. Zumilokibart assessed vIGA 0/1 while DUPIXENT and EBGLYSS studies shown assessed IGA 0/1. SOURCE: DUPIXENT Worm, M JAMA Dermatology 2019 (SOLO-CONTINUE). EBGLYSS Blauvelt A et al. Br J Dermatology 2023 (ADvocate 1/2). Maintenance of IGA 0/1 response among patients with IGA 0/1 at Week 16 (%) 16 20 24 28 32 36 40 44 48 52 0 20 40 60 80 100 Week Every 6 months (Q24W, N=14) Every 3 months (Q12W, N=11) Zumilokibart: 0 20 40 60 80 100 Patients with IGA 0/1 at Week 52 among patients with IGA 0/1 at Week 16 (%) 78% 86% 54% 77% 71% Every 6 months (Q24W) Zumilokibart Monthly (Q4W) Biweekly (Q2W) Weekly / Biweekly (QW/Q2W) Every 3 months (Q12W) 86% 78% |
| 17 © Apogee Therapeutics, Inc. Zumilokibart demonstrated 82-88% reduction in EASI and 67-77% reduction in Itch NRS score among EASI-75 responders APEX PART A | MAINTENANCE OF RESPONSE %CFBL EASI among EASI-75 responders (%) NOTE: For %CFBL EASI, missing data was imputed with Markov Chain Monte Carlo Multiple Imputation (MCMC-MI). Patients who received rescue medication or discontinued treatment had values set to missing subsequent to this time through to Week 52. For %CFBL I-NRS, data was evaluated as-observed without imputation for missing data or rescue medication use. Specified N for I-NRS data is based on patients per arm at Week 16. 16 20 24 28 32 36 40 44 48 52 -100 -80 -60 -40 -20 0 Week Percent Change from Baseline (LS Mean) Every 6 months (Q24W, N=24) Every 3 months (Q12W, N=26) %CFBL I-NRS among EASI-75 responders (%) -77% -67% Itch worsens Itch improves Zumilokibart: 16 20 24 28 32 36 40 44 48 52 -100 -80 -60 -40 -20 0 Week Percent Change from Baseline (LS Mean) Every 6 months (Q24W, N=24) Every 3 months (Q12W, N=26) -82% -88% Lesions worsen Lesions improve Zumilokibart: |
| Zumilokibart led to deepening responses over 52 weeks |
| 19 © Apogee Therapeutics, Inc. Responses over 52 weeks were assessed for all patients who were initially randomized to zumilokibart APEX Part A schematic APEX PART A | OVERALL RESPONSE THROUGH WEEK 52 720mg W0, W2, 360mg W4, W12 Induction Every 3 months (360mg Q12W) Every 6 months (360mg Q24W) Maintenance Week 0 Week 16 Week 52 1:1 Rerandomized and double-blind with placebo-matched injections for dose masking All patients initially randomized to zumilokibart NOTE: Week 0-16 data: All patients randomized to zumilokibart in induction and received >1 dose of study drug in induction; Week 16-52 data: all patients randomized to zumilokibart in induction and received ≥1 dose of study drug in maintenance. Efficacy data was evaluated as-observed without imputation for missing data or rescue medication use. N=82 patients were randomized to zumilokibart for induction (Week 0-16), of which N=70 received ≥1 dose of study drug during maintenance period (16-52 weeks). |
| 20 © Apogee Therapeutics, Inc. Zumilokibart achieves >99% IL-13 inhibition and demonstrates deepening of response on all endpoints SOURCE: DUPIXENT USPI. NOTE: 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. Zumilokibart assessed vIGA 0/1 while DUPIXENT studies shown assessed IGA 0/1. APEX PART A | OVERALL RESPONSE THROUGH WEEK 52 IGA 0/1 response for DUPIXENT + TCS (from label): o Week 16: 39% o Week 52: 36% IGA 0/1 response for zumilokibart (monotherapy): o Week 16: 37% o Week 52: 52-72% IL-13 IL-13RA1 IL-4Rα DUPIXENT Zumilokibart IL-13RA1 IL-4Rα Zumilokibart neutralizes nearly all IL-13 and demonstrates deepening responses IL-4Rα inhibition does not reduce IL-13 or show deepening of response Both every 3- and 6-month dosing deepen across all endpoints tested |
| 21 © Apogee Therapeutics, Inc. Zumilokibart IGA 0/1 responses deepened by 14-35 percentage points APEX PART A | OVERALL RESPONSE THROUGH WEEK 52 IGA 0/1 with a Reduction of ≥2 Points from Baseline (%) 0 4 8 12 16 20 24 28 32 36 40 44 48 52 0 20 40 60 80 100 Week Induction (N=82) Every 6 months (Q24W, N=34) Every 3 months (Q12W, N=36) 0 20 40 60 80 100 IGA 0/1 Response at Week 52 (%) 52% 72% N.R. N.R. 56% 64% 72% 52% Zumilokibart Re-randomization to maintenance interval Every 6 months (Q24W) Every 3 months (Q12W) Zumilokibart 30mg Daily (QD) 15mg Daily (QD) Biweekly / Monthly Weekly / Biweekly NOTE: For illustrative purposes only. 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. Efficacy data shown for zumilokibart and RINVOQ was evaluated as-observed without imputation for missing data or rescue medication use. Specified N is based on patients per arm at Week 16. Deepening of response was evaluated as observed based on the change in response rate from Week 16 (induction mITT population) to Week 52 (maintenance mITT population) for Q12W or Q24W cohorts. SOURCE: RINVOQ Simpson et al Jama Dermatol 2022 (Measure Up 1/2, average across both trials; observed case (OC) analysis). |
| 22 © Apogee Therapeutics, Inc. Zumilokibart Itch-NRS reduction deepened by 13-22 percentage points APEX PART A | OVERALL RESPONSE THROUGH WEEK 52 %CFBL I-NRS (LS mean) 0 4 8 12 16 20 24 28 32 36 40 44 48 52 0 -80 -60 -40 -20 -100 Week Induction (N=82) Every 6 months (Q24W, N=34) Every 3 months (Q12W, N=36) Zumilokibart -100 -80 -60 -40 -20 0 %CFBL I-NRS at Week 48 (LS Mean) -64% -73% N.R. N.R. -59% -64% Zumilokibart Week 52 Every 6 months (Q24W) Every 3 months (Q12W) 30mg Daily (QD) 15mg Daily (QD) Biweekly / Monthly Weekly / Biweekly -73% -64% Re-randomization to maintenance interval NOTE: For illustrative purposes only. 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. Efficacy data shown for zumilokibart and RINVOQ was evaluated as-observed without imputation for missing data or rescue medication use. Specified N is based on patients per arm at Week 16. Deepening of response was evaluated as observed based on the change in response rate from Week 16 (induction mITT population) to Week 48 (maintenance mITT population) for Q12W or Q24W cohorts. SOURCE: RINVOQ Simpson et al Jama Dermatol 2022 (Measure Up 1/2, average across both trials; observed case (OC) analysis). |
| 23 © Apogee Therapeutics, Inc. Zumilokibart EASI-75 responses deepened by 6-13 percentage points APEX PART A | OVERALL RESPONSE THROUGH WEEK 52 EASI-75 Response (%) 0 4 8 12 16 20 24 28 32 36 40 44 48 52 0 20 40 60 80 100 Week Induction (N=82) Every 6 months (Q24W, N=34) Every 3 months (Q12W, N=36) 0 20 40 60 80 100 EASI-75 Response at Week 52 (%) 81% 88% N.R. N.R. 81% 88% 85% 81% Zumilokibart Re-randomization to maintenance interval Every 6 months (Q24W) Every 3 months (Q12W) Zumilokibart 30mg Daily (QD) 15mg Daily (QD) Biweekly / Monthly Weekly / Biweekly NOTE: For illustrative purposes only. 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. Efficacy data shown for zumilokibart and RINVOQ was evaluated as-observed without imputation for missing data or rescue medication use. Specified N is based on patients per arm at Week 16. Deepening of response was evaluated as observed based on the change in response rate from Week 16 (induction mITT population) to Week 52 (maintenance mITT population) for Q12W or Q24W cohorts. SOURCE: RINVOQ Simpson et al Jama Dermatol 2022 (Measure Up 1/2, average across both trials; observed case (OC) analysis). |
| 24 © Apogee Therapeutics, Inc. Zumilokibart EASI-90 responses deepened by 10-36 percentage points APEX PART A | OVERALL RESPONSE THROUGH WEEK 52 EASI-90 Response (%) 0 4 8 12 16 20 24 28 32 36 40 44 48 52 0 20 40 60 80 100 Week Induction (N=82) Every 6 months (Q24W, N=34) Every 3 months (Q12W, N=36) 0 20 40 60 80 100 EASI-90 Response at Week 52 (%) 48% 75% N.R. N.R. 62% 75% 72% 48% Zumilokibart Re-randomization to maintenance interval Every 6 months (Q24W) Every 3 months (Q12W) Zumilokibart 30mg Daily (QD) 15mg Daily (QD) Biweekly / Monthly Weekly / Biweekly NOTE: For illustrative purposes only. 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. Efficacy data shown for zumilokibart and RINVOQ was evaluated as-observed without imputation for missing data or rescue medication use. Specified N is based on patients per arm at Week 16. Deepening of response was evaluated as observed based on the change in response rate from Week 16 (induction mITT population) to Week 52 (maintenance mITT population) for Q12W or Q24W cohorts. SOURCE: RINVOQ Simpson et al Jama Dermatol 2022 (Measure Up 1/2, average across both trials; observed case (OC) analysis). |
| 25 © Apogee Therapeutics, Inc. Zumilokibart EASI-100 responses deepened by 11-33 percentage points APEX PART A | OVERALL RESPONSE THROUGH WEEK 52 EASI-100 Response (%) 0 4 8 12 16 20 24 28 32 36 40 44 48 52 0 20 40 60 80 100 Week Induction (N=82) Every 6 months (Q24W, N=34) Every 3 months (Q12W, N=36) 0 20 40 60 80 100 EASI-100 Response at Week 52 (%) 19% 41% N.R. N.R. 28% 41% 36% 19% Zumilokibart Re-randomization to maintenance interval Every 6 months (Q24W) Every 3 months (Q12W) Zumilokibart 30mg Daily (QD) 15mg Daily (QD) Biweekly / Monthly Weekly / Biweekly NOTE: For illustrative purposes only. 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. Efficacy data shown for zumilokibart and RINVOQ was evaluated as-observed without imputation for missing data or rescue medication use. Specified N is based on patients per arm at Week 16. Deepening of response was evaluated as observed based on the change in response rate from Week 16 (induction mITT population) to Week 52 (maintenance mITT population) for Q12W or Q24W cohorts. SOURCE: RINVOQ Simpson et al Jama Dermatol 2022 (Measure Up 1/2, average across both trials; observed case (OC) analysis). |
| Unmet Need in Atopic Dermatitis Ruth Ann Vleugels, MD, MPH, MBA Heidi and Scott C. Schuster Distinguished Chair in Dermatology Director, Atopic Dermatitis Program Brigham & Women’s Hospital Department of Dermatology Professor of Dermatology, Harvard Medical School |
| 27 Atopic dermatitis is a severe, systemic disease 1) Primary Care Dermatology Society |
| 28 Atopic dermatitis has a profound impact on patient quality of life Children Adults Healthcare system 1) Bridgman et al., 2018. Ann Allergy Asthma Immunol. 2) Irish Skin Foundation. Loss of sleep Absence from school Growth restriction Depression Work sick leave Reduced physical activity Hospitalizations Annual cost burden Specialist consultations |
| 29 Approval of new therapies has improved AD care Pre-2017 2017 2020 2023 2026 Dupilumab (IL-4Ra) Year of AD approval Tralokinumab (IL-13) Lebrikizumab (IL-13) Nemolizumab (IL-31) Topicals Biologics Oral JAK inhibitors Hydrocortisone & other TCS Roflumilast (PDE4) Ruxolitinib (JAK) Upadacitinib Abrocitinib 1) Symons et al., Journal of Drugs in Dermatology 2025 |
| 30 Despite multiple available treatment options for AD, unmet need remains significant Therapy Target Strengths Limitations Dupilumab IL-4Ra • Significant lesion benefit • Well tolerated • Dosing frequency (every 2 weeks) Lebrikizumab IL-13 • Significant lesion benefit • Well tolerated • Dosing frequency (every 4 weeks) Nemolizumab IL-31 • Rapid and substantial itch relief • Well tolerated • Limited improvement in rash Upadacitinib/ Abrocitinib JAK • Rapid onset of action with substantial lesion benefit and itch relief • Oral route of administration • Safety liabilities (boxed warning) • Dosing frequency (daily) 1) Dupixent USPI, 2) Ebglyss USPI, 3) Nemluvio USPI, 4) Rinvoq USPI |
| 31 Zumilokibart could address several unmet needs in AD1 • Although newer therapies have greatly improved the lives of patients with AD, substantial unmet need still exists for therapies that are both safe and effective as well as have the ability to reduce injection burden • Zumilokibart demonstrated strong clinical response at week 16 and responses were maintained with every 3-month and every 6-month dosing • Deep responses on skin and itch were achieved in a substantial proportion of patients by week 52, including on EASI-100, which represents completely clear skin • Zumilokibart was well-tolerated across both dosing regimens with a safety profile generally in line with the IL-4/13 class • Zumilokibart has the potential to improve the lives of patients with AD by providing long-term disease control with only 2-4 maintenance injections per year 1) Safety and 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. |
| Zumilokibart Development Program Kristine Nograles, MD SVP, Clinical Development & Medical Affairs |
| 33 © Apogee Therapeutics, Inc. Zumilokibart Part B trial design Mod-Sev AD: EASI ≥16, vIGA ≥3, BSA ≥10%, up to 20% biologic experienced Induction Maintenance Enrollment complete W16 Primary Endpoint: EASI-75 N = 347 1:1:1:1 NOTE: Phase 3 and launch plans subject to clinical and regulatory outcomes. EASI = Eczema Area and Severity Index. vIGA = validated Investigator Global Assessment for Atopic Dermatitis. BSA = body surface area. LTE = long term extension. Modeled exposure vs. EBGLYSS Placebo Every 3 months (Q12W) High dose ~90-100% greater Every 6 months (Q24W) Mid dose (Part A dose) ~30-40% greater Low dose ~40-50% less LTE or 52-week follow-up period W52 Endpoint Week 16 readout expected in Q2 2026 to support Phase 3 dose selection Phase 3 studies expected to initiate in 2H 2026 Zumilokibart launch planned in 2029 ZUMILOKIBART Part B has completed enrollment; planned Q2 2026 readout potentially enables Phase 3 initiation in 2026 |
| 34 © Apogee Therapeutics, Inc. Beyond zumilokibart in AD, ASPIRE and ELEVATE dose-ranging trials could enable Phase 3 for multiple blockbuster indication expansions ZUMILOKIBART • Allergic Rhinitis (perennial) • COPD • CRSwNP Respiratory ASPIRE Asthma Phase 2 Plans TBA this year • BP • CSU • Cold Inducible Urticaria • Prurigo Nodularis Dermatology APEX AD Part B 16-week Q2 2026 expected readout • EGID (non-EoE) Gastroenterology ELEVATE EoE Phase 2 Plans TBA this year Dose Optimized dose in each TA could enable straight to Phase 3 approach for add’l expansions -ranging trial Expansion potential NOTE: 1Cendakimab positive Phase 3 in EoE (Dellon SE et al NEJM Evid 2025). Phase 3 and launch plans subject to clinical and regulatory outcomes. BP =Bullous Pemphigoid. CSU = Chronic Spontaneous Urticaria. COPD = Chronic Obstructive Pulmonary Disease. CRSwNP = Chronic Rhinosinusitis with Nasal Polyps. EGID = Eosinophilic Gastrointestinal Disorders. TA PoC achieved Positive Phase 2 Part A data for zumilokibart in AD Positive Phase 1b data for zumilokibart in asthma Positive Phase 3 data for IL-13 inhibition in EoE1 |
| Building a Leading I&I Company Michael Henderson, MD Chief Executive Officer |
| 36 © Apogee Therapeutics, Inc. Zumilokibart could be the next clearly differentiated first line product to launch in AD Robust Lesion and Itch Control that Deepens Rapid Itch Relief in 48 Hours NOTE: For illustrative purposes only. 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. Zumilokibart data shown based on as-observed analysis without imputation for missing data. Expected launch subject to clinical outcomes and regulatory approval. I-NRS = itch numerical rating scale. TCS = topical corticosteroids. SOURCE: 1 Placebo-adjusted I-NRS Percent Reduction From Baseline (LS mean, 48h). 2 ZUMILOKIBART APEX Part A (as observed). 3 DUPIXENT Silverberg et al. J. Am. Acad. Dermatol. 2020. (SOLO 1&2; digitized pooled data for 300mg Q2W vs placebo). 4 EBGLYSS Yosipovitch et al. BJD. 2024. (ADvocate 1&2, straight average of both trials based on digitized data for 250mg Q2W vs placebo). 5 NEMLUVIO Silverberg et al. J. EADV 2021 (Ph2b; digitized data for 30 mg Q4W vs placebo). 6ZUMILOKIBART APEX Part A Q12W cohort (as observed analysis); Itch-NRS data is at Week 48. Week 526 EASI-75 88% IGA 0/1 72% EASI-90 75% EASI-100 41% Itch-NRS -73% Transformative Dosing 2-4 Zumilokibart dosing days per year 26 DUPIXENT dosing days per year 0 10 20 Itch Reduction from Baseline at 48h1 (%) 14% 7% 4% 16% Zumilokibart11,2 DUPIXENT3 EBGLYSS4 NEMLUVIO + TCS5 |
| 37 © Apogee Therapeutics, Inc. $0 $5 $10 $15 $20 $25 Global Revenue, $B (estimated share for indication) Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7 Year 8 Year 9 Year 10 Year 11 Year 12 Year 13 Year 14 Year 15 Year 16 Year 17 Year 18 Year 19 Year 20 Years After First Biologic Launch SOURCE: EvaluatePharma NOTE: Year 1 for DUPIXENT in AD is 2017 and for Biologics in PsO is 2004 (i.e., ENBREL approval). Other includes SILIQ, ILLUMYA, and CIMZIA, which all launched prior to SKYRIZI. Future $50B AD market size based on EvaluatePharma and company projections. Actual market size may differ materially. Expected 2029 launch subject to clinical outcomes and regulatory approval. $0 $5 $10 $15 $20 $25 Psoriasis Atopic dermatitis Other biologics Year of zumilokibart planned launch (2029) Amlitelimab Apogee has the potential to become a leader in a future $50B+ market New agents EBGLYSS and NEMLUVIO each projected to eclipse $1B in 2026 (2nd full year of launches) |
| 2026 is becoming a transformational year for Apogee Apogee poised for sustained leadership in AD starting with potential zumilokibart launch in 2029 NOTE: 1 Cash, cash equivalents and marketable securities were $902.9 million as of December 31, 2025. 2 APG279 is a combination of zumilokibart and APG990. APG279 is co-administered in the proof-of-concept Phase 1b trial; coformulation planned for future clinical studies and commercialization. Future $50B AD market size based on EvaluatePharma and company projections. Actual market size may differ materially. AD Phase 3 planned initiation is subject to positive Part B clinical results and regulatory alignment. Expected 2029 launch subject to clinical outcomes and regulatory approval. Well-capitalized to deliver key milestones with $903M in cash1 and runway into 2H 2028 © Apogee Therapeutics, Inc. 38 Demonstrated potential best-in-class dosing for zumilokibart in a potential future $50B+ AD market • Q1 2026: APEX Phase 2 Part A 52-week positive data • 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 Ph1b expected readout (vs DUPIXENT; fully enrolled) Serial innovation in atopic dermatitis with first-in-class APG279 combination2 Expanding zumilokibart beyond atopic dermatitis • Q1 2026: Asthma Phase 1b positive data • 2H 2026: Expect to announce clinical trial plans in asthma and EoE |
| Apogee /ˈapəjē/ noun The highest point in the development of something; a climax or culmination |
| 40 © Apogee Therapeutics, Inc. Induction (N=82) Every 6 months (Q24W, N=34)1 Every 3 months (Q12W, N=36)1 Placebo crossover (N=37)2 -91% -86% 0 4 8 12 16 20 24 28 32 36 40 44 48 52 -100 -80 -60 -40 -20 0 Week Percent Change from Baseline (LS Mean) Re-randomization Patients crossing over to zumilokibart achieved responses by week 52 similar to those of patients that received zumilokibart in induction NOTE: Efficacy data shown was evaluated as-observed without imputation for missing data or rescue medication use. Specified N is based on patients per arm at Week 16, except for “Induction (N=82)” that is based on Week 0. Induction dose regimen was: 720mg at W0 and W2; 360mg at W4 and W12. Placebo crossover dose regimen was: 720mg at W16; 360mg at W20, W24, W36, W48. 1 Week 0-16 data: All patients randomized to zumilokibart in induction and received >1 dose of study drug in induction; Week 16-52 data: all patients randomized to zumilokibart in induction and received >1 dose of study drug in maintenance. 2 Week 0-16 data: All patients randomized to placebo in induction; Week 16-52 data: all patients randomized to placebo in induction and received >1 dose of study drug in maintenance. APEX PART A | PLACEBO CROSSOVER TO ZUMILOKIBART Zumilokibart -85% Eczema Area and Severity Index Score (percent change from baseline) |
FAQ
What did Apogee Therapeutics (APGE) report from the Phase 2 APEX Part A trial?
How effective was zumilokibart in maintaining atopic dermatitis responses?
What dosing schedule was tested for zumilokibart in the APEX Part A study?
What are the next clinical milestones for Apogee Therapeutics’ zumilokibart program?
When could zumilokibart potentially reach the atopic dermatitis market?
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