Form 8-K
8-K — Apogee Therapeutics, Inc.
Accession: 0001104659-26-066572
Filed: 2026-05-27
Period: 2026-05-27
CIK: 0001974640
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Regulation FD Disclosure
Item: Other Events
Item: Financial Statements and Exhibits
Documents
8-K — tm2615568d1_8k.htm (Primary)
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EX-99.2 — EXHIBIT 99.2 (tm2615568d1_ex99-2.htm)
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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):
May 27, 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 May 27, 2026, Apogee Therapeutics, Inc. (the “Company”)
issued a press release and made publicly available a data presentation announcing positive 16-week induction dose optimization results
from Part B 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, Wednesday, May 27,
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 (this “Report”) and are
incorporated by reference herein. The exhibits furnished under Item 7.01 of this Report 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 May 27, 2026, the Company announced positive 16-week induction
dose optimization results from Part B of the Phase 2 APEX clinical trial of zumilokibart in patients with moderate-to-severe AD.
Zumilokibart Phase 2 Part B Key 16-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, and in March 2026, it announced the APEX Phase 2 Part A 52-week maintenance results.
In the Part B portion of the trial, 346 adult patients were dosed
after being randomized 1:1:1:1 to high-, mid- or low-dose zumilokibart versus placebo. The primary endpoint is the proportion of patients
who achieve an Eczema Area and Severity Index (“EASI”) percent score reduction of at least 75 (“EASI-75”) at Week
16. Secondary endpoints include Validated Investigator’s Global Assessment (“IGA”) 0/1, EASI-90, Itch Numeric Rating
Scale (“I-NRS ≥4”), EASI-100, and Very Low Disease Activity (vLDA; EASI-90 + I-NRS 0/1) at Week 16.
The trial met its primary endpoint. EASI-75 scores at Week 16 were
as follows:
· High-dose: 61.6% achieved EASI-75 (p<0.001 vs placebo)
· Mid-dose: 65.9% achieved EASI-75 (p<0.001 vs placebo)
· Low-dose: 50.5% achieved EASI-75 (p<0.001 vs placebo)
· Placebo: 23.4% achieved EASI-75
Mid-dose zumilokibart met key secondary endpoints at Week 16 as follows:
· IGA 0/1 response in 46.0% of patients, compared to 10.9% in the placebo arm
(p<0.001)
· EASI-90 response in 47.4% of patients, compared to 9.3% in the placebo arm
(p<0.001)
· I-NRS ≥4 reduction from baseline in 50.5% of patients, compared to 13.9%
in placebo arm (p <0.001)
· EASI-100 response in 16.5% of patients, compared to 3.4% in the placebo arm
(p<0.01)
· vLDA response in 20.6% of patients, compared to 4.5% in the placebo arm (p<0.01)
Zumilokibart was well tolerated, with a safety profile generally consistent
with other agents in the class.
· The most common treatment-emergent adverse events in zumilokibart-treated
patients were nasopharyngitis, headache, and noninfective conjunctivitis.
· For the planned Phase 3 dose (the mid-dose from Phase 2), the pooled conjunctivitis
rate (all conjunctivitis preferred terms) was 10.6%, compared to 15.1% for the low-dose and 20.7% for the high-dose.
Based on results from the APEX clinical program, Apogee plans to initiate
Phase 3 trials of zumilokibart for moderate-to-severe AD with the mid-dose in the second half of 2026, pending regulatory interactions.
Zumilokibart ADventure Phase 3 Trials in AD
The ADventure 1 and ADventure 2 trials are randomized,
placebo-controlled, replicate Phase 3 monotherapy trials evaluating zumilokibart in patients with moderate-to-severe AD (EASI ≥16,
vIGA ≥3, BSA ≥10%). Each study is expected to enroll approximately 400 patients and includes a 16-week induction period followed
by maintenance through Week 52. In maintenance, patients will receive dosing every three or six months. The co-primary endpoint is EASI-75
and IGA 0/1 at Week 16, with additional assessment at Week 52.
The ADventure TCS Phase 3 trial will evaluate
zumilokibart in combination with background topical corticosteroids (“TCS”) in patients with moderate-to-severe AD (EASI ≥16,
vIGA ≥3, BSA ≥10%). The randomized, placebo-controlled study is expected to enroll approximately 400 patients and includes a 16-week
induction period and maintenance through Week 52. The co-primary endpoint is EASI-75 and IGA 0/1 at Week 16, with longer-term outcomes
assessed at Week 52.
Zumilokibart ASPIRE Phase 2b trial in Asthma
The ASPIRE Phase 2b trial is a randomized, placebo-controlled
study evaluating multiple dosing regimens of zumilokibart in patients with moderate-to-severe asthma with elevated Type 2 biomarkers and
a history of exacerbations. The study is designed to be potentially registrational and is expected to enroll approximately 500 patients
randomized across dosing intervals of every three, six, or twelve months, or placebo. The primary endpoint is annualized exacerbation
rate at Week 52, with additional assessments of lung function and symptoms.
Zumilokibart ELEVATE Phase 2a trial in Eosinophilic
Esophagitis (“EoE”)
The ELEVATE Phase 2a trial is an open-label, proof-of-concept
study evaluating zumilokibart in patients with EoE. The study is expected to enroll approximately 30 to 50 patients and will assess dosing
every three or six months. The primary endpoint is histologic response, including reductions in eosinophil counts, with additional evaluation
of endoscopic findings and patient-reported outcomes.
Anticipated Program Milestones
The Company described expected program readouts and milestones through
2028.
Zumilokibart for the Treatment of AD
· Initiation of Phase 3 ADventure 1 and ADventure 2 monotherapy (16-week) clinical
trials expected 2H 2026
· Initiation of Phase 3 ADventure TCS combination (16-week) clinical trial
expected 2H 2026
· Phase 2 APEX Part B (52-week) maintenance data expected 1H 2027
· Phase 2 APEX Part A 2-year follow-up data expected 2H 2027
· Phase 3 ADventure 1 and ADventure 2 monotherapy (16-week) data readout expected
1H 2028
· Phase 3 ADventure TCS combination (16-week) data readout expected 2H 2028
· Launch anticipated in 2029
Zumilokibart for the Treatment of Asthma
· Initiation of Phase 2b ASPIRE trial expected 1H 2027
Zumilokibart for the Treatment of EoE
· Initiation of Phase 2a ELEVATE trial expected 2H 2026
· Phase 2a ELEVATE data readout expected 2H 2027
· Phase 2a ELEVATE long-term follow-up data expected 2H 2028
Additional Programs
· Phase 1b head-to-head clinical trial of APG279 (IL-13 + OX40L) vs. DUPIXENT
for moderate to severe AD data readout expected 2H 2026
· Announce further clinical plans for APG273 (zumilokibart+APG333) in 2H 2026
· Announce additional pipeline program in 1H 2027
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this Report may constitute “forward-looking
statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding the Company’s
expectations regarding: the Company’s plans for its current and future product candidates, programs, and clinical trials, including
expansion of zumilokibart into additional indications, and announcement plans for APG273 and an additional pipeline program; the anticipated
timing of initiation of the Company’s clinical trials, including the Phase 2b trial of zumilokibart in asthma, the Phase 2a trial
of zumilokibart in eosinophilic esophagitis (EoE), and the Phase 3 ADventure program for zumilokibart in AD; the expected timing of results
from the Company’s clinical trials, including the 52-week readout from Part B and the two-year follow-up from Part A of
its Phase 2 trial of zumilokibart in AD, 16-week readouts from the Phase 3 ADventure program, the data readouts for the Phase 2a ELEVATE
program, and the Phase 1b readout for APG279 vs. DUPIXENT; the potential for the ASPIRE Phase 2b trial to support a registrational pathway;
additional program milestones; the expectation that the APEX Phase 2 Part B 16-week results will support commencement of a Phase
3 trial in zumilokibart; the Company’s planned clinical trial designs, including anticipated enrollment and dosing regimens; the Company's
dose selection choices or regulatory feedback on its chosen dose, given the dose-optimization nature of Part B and the Phase 3 dose
selection decision; the potential clinical benefit, dosing regimen, safety and efficacy profiles and treatment outcomes of zumilokibart;
the planned 2029 launch timeline for zumilokibart in AD; its planned business strategies; and expected timing for future pipeline updates,
regulatory decisions and interactions, and potential commercialization. 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 the Company 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 Report.
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 the Company’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 the Company’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing,
completion and outcome of the Company’s clinical trials; the unpredictable relationship between preclinical study results and clinical
study results; the applicability of clinical study results to actual outcomes; the timing or likelihood of regulatory filings and approvals;
liquidity and capital resources; and other risks and uncertainties identified in the Company’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 the Company may file with
the SEC. The Company claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking
statements. The Company 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.
EXHIBIT INDEX
Exhibit
No.
Description
99.1
Data Press
Release, dated May 27, 2026
99.2
Data Presentation,
dated May 27, 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: May 27, 2026
By:
/s/ Michael Henderson, M.D.
Michael Henderson, M.D.
Chief Executive Officer
EX-99.1 — EXHIBIT 99.1
EX-99.1
Filename: tm2615568d1_ex99-1.htm · Sequence: 2
Exhibit 99.1
Apogee Therapeutics Announces Positive 16-Week
Part B Induction Dose Optimization Results from Phase 2 APEX Trial of Zumilokibart in Moderate-to-Severe Atopic Dermatitis
APEX Part B met all primary and secondary
endpoints with high statistical significance; mid-dose zumilokibart planned to advance into Phase 3 trials in moderate-to-severe atopic
dermatitis (AD) in 2H 2026
Zumilokibart was well tolerated with a safety
profile consistent with other agents in class
Strategic financing collaboration with Blackstone
Life Sciences announced today expected to provide funding through commercialization of zumilokibart in AD, asthma, and EoE
Results support pipeline-in-a-product potential
for zumilokibart with asthma and eosinophilic esophagitis (EoE) trial plans shared today
Management to host conference call today at
8:00 a.m. ET
SAN FRANCISCO and BOSTON, May 27, 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 16-week data
from Part B 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 AD. The trial met its primary and secondary endpoints with high statistical significance including 65.9% of patients
treated with mid-dose zumilokibart achieving EASI-75 (41.9% placebo adjusted). Based on these dose optimization results and subject to
regulatory interactions, Apogee plans to move forward with the mid-dose, which achieved the best clinical activity of the three doses
tested and was well-tolerated, in its Phase 3 trials.
"We are thrilled by the strength and consistency
that zumilokibart demonstrated across all endpoints from today's APEX Part B induction results, which we believe could
set a new standard of care for patients. Today’s results help clear our path to advance zumilokibart into the Phase
3 trials planned for the second half of this year and we look forward to engaging with regulatory agencies.” said Michael
Henderson, M.D., Chief Executive Officer of Apogee. "Zumilokibart has the potential to move the bar on disease
control and dosing based on both today's data as well as the robust APEX Part A maintenance results that showed continued improvement
in efficacy over 52 weeks with every 3- and 6- month dosing. Beyond AD, we are excited to develop zumilokibart's pipeline-in-a-product
potential and plan to commence Phase 2 studies in EoE in the second half of 2026 and asthma in the first half of 2027."
“Patients with atopic dermatitis and their
physicians want therapies that provide durable and deeper disease control with less frequent dosing. The APEX Part B results align
extremely well with these patient-centric goals, particularly the achievement of very low disease activity, or vLDA, with
simultaneous robust improvement in lesion and itch benefit in more than one fifth of mid-dose patients, which are results not seen with
any biologic to date,” said Ruth Ann Vleugels, MD, MPH, MBA, Heidi and Scott C. Schuster Distinguished Chair in Dermatology and
Director, Atopic Dermatitis Program at Mass General Brigham and Professor of Dermatology, Harvard Medical School. “The Part B
induction data demonstrated that zumilokibart delivered robust efficacy within the first 16 weeks with significantly fewer injections
versus the current standard-of-care. Together with Part A data demonstrating that zumilokibart can be dosed every 3 to 6 months in
maintenance with continuous and even enhanced efficacy, we are seeing a strong clinical profile that offers what dermatologists are looking
for in clinical practice for our patients.”
APEX Phase 2 Part B 16-Week Results
The Phase 2 APEX clinical trial is a randomized,
placebo-controlled study evaluating zumilokibart in patients with moderate-to-severe AD. In Part B, 346 adult patients were dosed
after being randomized 1:1:1:1 to high-, mid- or low-dose zumilokibart versus placebo. The primary endpoint is the proportion
of patients who achieve an Eczema Area and Severity Index (EASI) percent score reduction of at least 75 (EASI-75) at Week 16. Secondary
endpoints include Validated Investigator’s Global Assessment (IGA) 0/1, EASI-90, Itch Numeric Rating Scale (I-NRS ≥4), EASI-100,
and Very Low Disease Activity (vLDA; EASI-90 + I-NRS 0/1) at Week 16.
● The trial met its primary endpoint, with mid- and high-doses of zumilokibart demonstrating comparable
efficacy and both doses outperforming low dose and placebo with EASI-75 scores at Week 16:
o High dose: 61.6% achieved EASI-75 (p<0.001 vs placebo)
o Mid dose: 65.9% achieved EASI-75 (p<0.001 vs placebo)
o Low dose: 50.5% achieved EASI-75 (p<0.001 vs placebo)
o Placebo: 23.4% achieved EASI-75
● Mid-dose zumilokibart met key secondary endpoints at Week 16:
o IGA 0/1 response in 46.0% of patients, compared to 10.9% in the placebo arm (p<0.001)
o EASI-90 response in 47.4% of patients, compared to 9.3% in the placebo arm (p<0.001)
o I-NRS ≥4 reduction from baseline in 50.5% of patients, compared to 13.9% in placebo arm (p <0.001)
o EASI-100 response in 16.5% of patients, compared to 3.4% in the placebo arm (p<0.01)
o vLDA response in 20.6% of patients, compared to 4.5% in the placebo arm (p<0.01)
● Zumilokibart was well tolerated, with a safety profile generally consistent with other agents in the class.
o The most common treatment-emergent adverse events (TEAEs) in zumilokibart-treated patients were nasopharyngitis,
headache, and noninfective conjunctivitis.
o For the planned Phase 3 dose (mid dose), the pooled conjunctivitis rate (all conjunctivitis preferred
terms) was 10.6%, compared to 15.1% for the low dose and 20.7% for the high dose.
“The APEX Part B results demonstrated
meaningful improvements across all lesional and itch endpoints, achieved with just four dosing days during induction versus nine with
the current standard-of-care,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “Importantly, these results underscore
the potential for a significant reduction in treatment burden for patients while delivering robust clinical activity. We are grateful
to the patients and investigators whose participation made this study possible.”
“In the APEX Phase 2 Part B study,
the improvements in both skin outcomes and itch in the induction period are particularly encouraging given the replicability from prior
studies” said Jonathan I. Silverberg, M.D., Ph.D., MPH, Professor of Dermatology at The George Washington University School of Medicine
and Health Sciences. "These findings suggest the potential for sustained disease control with less frequent dosing, an important
goal in managing this chronic condition.”
Based on results from the APEX clinical program,
Apogee plans to initiate Phase 3 trials of zumilokibart for moderate-to-severe atopic dermatitis in the second half of 2026, pending regulatory
interactions. Apogee has also disclosed planned trial designs for its asthma and eosinophilic esophagitis (EoE) programs, further supporting
zumilokibart’s potential as a pipeline-in-a-product opportunity across multiple I&I diseases.
About the ADventure Phase 3 trials in AD
The ADventure 1 and ADventure 2 trials are randomized,
placebo-controlled, replicate Phase 3 monotherapy trials evaluating zumilokibart in patients with moderate-to-severe atopic dermatitis
(EASI ≥16, vIGA ≥3, BSA ≥10%). Each study is expected to enroll approximately 400 patients and includes a 16-week induction period
followed by maintenance through Week 52. In maintenance, patients will receive dosing every three or six months. The co-primary endpoint
is EASI-75 and IGA 0/1 at Week 16, with additional assessment at Week 52.
The ADventure TCS Phase 3 trial will evaluate
zumilokibart in combination with background topical corticosteroids in patients with moderate-to-severe atopic dermatitis (EASI ≥16,
vIGA ≥3, BSA ≥10%). The randomized, placebo-controlled study is expected to enroll approximately 400 patients and includes a 16-week
induction period and maintenance through Week 52. The co-primary endpoint is EASI-75 and IGA 0/1 at Week 16, with longer-term outcomes
assessed at Week 52.
About the ASPIRE Phase 2b trial in Asthma
The ASPIRE Phase 2b trial is a randomized, placebo-controlled
study evaluating multiple dosing regimens of zumilokibart in patients with moderate-to-severe asthma with elevated Type 2 biomarkers and
a history of exacerbations. The study is designed to be potentially registrational and is expected to enroll approximately 500 patients
randomized across dosing intervals of every three, six, or twelve months, or placebo. The primary endpoint is annualized exacerbation
rate at Week 52, with additional assessments of lung function and symptoms.
About the ELEVATE Phase 2a trial in Eosinophilic
Esophagitis (EoE)
The ELEVATE Phase 2a trial is an open-label, proof-of-concept
study evaluating zumilokibart in patients with EoE. The study is expected to enroll approximately 30 to 50 patients and will assess dosing
every three or six months. The primary endpoint is histologic response, including reductions in eosinophil counts, with additional evaluation
of endoscopic findings and patient-reported outcomes.
Webcast Details
Apogee Therapeutics’ live webcast of the
APEX Phase 2 Part B 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 Part A 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 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 expectations regarding: Apogee’s plans for its current and future product candidates, programs, and clinical
trials, including expansion of zumilokibart into additional indications; the anticipated timing of initiation of its clinical trials,
including the Phase 2b trial of zumilokibart in asthma, the Phase 2a trial of zumilokibart in eosinophilic esophagitis (EoE), and the
Phase 3 ADventure program for zumilokibart in AD; the expected timing of results from its clinical trials, including the 52-week readout
from Part B and the 2-year follow-up from Part A of our Phase 2 trial of zumilokibart in AD, and 16-week readouts from the Phase
3 ADventure program; the expectation that the APEX Phase 2 Part B 16-week results will support commencement of a Phase 3 trial in
zumilokibart; its planned clinical trial designs, including anticipated enrollment and dosing regimens; the potential clinical benefit,
dosing regimen, safety and efficacy profiles and treatment outcomes of zumilokibart, including its potential to be a best-in-class therapy
and new standard of care in AD, and any other product candidates, including combination therapies; its planned 2029 launch timeline for
zumilokibart in AD; the pipeline-in-a-product potential for zumilokibart; and its planned business strategies; expected timing for future
pipeline updates, regulatory decisions, BLA filing for zumilokibart in AD, and potential commercialization; its expectations regarding
the time period over which Apogee’s capital resources will be sufficient to fund its anticipated operations; and estimates of market
size. 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 Apogee 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 Apogee’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 applicability of clinical study results to actual outcomes; 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 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
EX-99.2 — EXHIBIT 99.2
EX-99.2
Filename: tm2615568d1_ex99-2.htm · Sequence: 3
Exhibit 99.2
May 27, 2026
APEX Part B
16-week data
2
© Apogee Therapeutics, Inc.
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, programs, and
clinical trials, including expansion of zumilokibart into additional indications, and announcement plans for APG273 and an additional pipeline program; the anticipated timing of initiation of our clinical trials, including the
Phase 2b trial of zumilokibart in asthma, the Phase 2a trial of zumilokibart in eosinophilic esophagitis (EoE), and the Phase 3 ADventure program for zumilokibart in AD; the expected timing of results from our clinical
trials, including the 52-week readout from Part B and the 2-year follow-up from Part A of our Phase 2 trial of zumilokibart in AD, 16-week readouts from the Phase 3 ADventure program, the data readouts for the Phase
2a ELEVATE program, and the Phase 1b readout for APG279 vs. DUPIXENT; the timing of other program catalysts; the expectation that the APEX Phase 2 Part B 16-week results will support commencement of a
Phase 3 trial in zumilokibart; the potential for dose ranging trials in AD, asthma and EoE to enable a straight to Phase 3 approach; our planned clinical trial designs, including anticipated enrollment and dosing
regimens; the potential clinical benefit, dosing regimen, safety and efficacy profiles and treatment outcomes of zumilokibart, including its potential to be a best-in-class therapy, new standard of care and biologic of
choice in AD; the planned 2029 launch timeline for zumilokibart in AD; the pipeline-in-a-product potential for zumilokibart; our planned business strategies; expected timing for future pipeline updates, regulatory
decisions, the BLA filing for zumilokibart in AD, and potential commercialization; our expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations; our future
funding needs, which do not include the need for equity financing; and estimates of market size. 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. The data included in this presentation may be subject to change following the availability of additional data or following a more
comprehensive review of the data. 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, 2025, filed with the U.S. Securities and Exchange Commission (the SEC) on March 2, 2026 and subsequent disclosure
documents we have filed and 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. 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, we have not
independently verified, and make 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 the cross-study comparisons are directional and may not be directly comparable.
Disclaimers and Forward-looking statements
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, Dermatology
Amol Kamboj, MD, SVP, Head of Clinical
Development, Respiratory & GI
APEX Phase 2 Part B 16-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
Treatment Gaps 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
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.
Zumilokibart has a
potentially best-in-class
profile in AD
Zumilokibart on track for
planned 2029 launch
Atopic dermatitis (AD) is
growing rapidly and could
be the largest I&I market
• AD market is projected to
reach $50B+
• Asthma and EoE prioritized
first among numerous
possible zumilokibart
expansions
© Apogee Therapeutics, Inc.
• Week 16 clinical activity is
robust across all lesional
and itch endpoints
• Previously demonstrated
continuous clinical activity
improvement through
week 52
• Could be the first product in
AD with both every 3- and
6-month dosing
• Anticipated initiation of
ADventure Phase 3 program
in 2H 2026 supports planned
2029 launch
• Strategic financing with
Blackstone provides path to
commercialization without
need for future equity
financing
6
© Apogee Therapeutics, Inc.
APEX PART B
ENDPOINT
(WEEK 16) MID DOSE PLACEBO SIGNIFICANCE
EASI-75
(primary) 65.9% 23.4% p<0.001
IGA 0/1 46.0% 10.9% p<0.001
EASI-90 47.4% 9.3% p<0.001
I-NRS4 50.5% 13.9% p<0.001
EASI-100 16.5% 3.4% p<0.01
Positive APEX Part B data supports planned Phase 3 initiation in 2H 2026
Zumilokibart
• Zumilokibart mid and high doses
demonstrated similar clinical activity
- Low dose showed relatively lower
clinical activity, as expected
• Mid dose planned for Phase 3 on basis of
compelling profile:
- Significant itch & lesion reduction in
the first 2 weeks1
- Well-tolerated with safety profile
consistent with class, including 10.6%
rate of conjunctivitis (all PTs2
)
- Only 4 dosing days in induction
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 trials have been conducted. 1
Itch NRS percent change from baseline for zumilokibart vs. placebo statistically significant at Week 2 (p<0.05). EASI percent change from baseline for zumilokibart vs placebo
statistically significant at Week 1 (p<0.01) and Week 2 (p<0.001). 2Pooled conjunctivitis rate includes the following preferred terms: noninfective conjunctivitis, conjunctivitis, conjunctivitis allergic, conjunctivitis
bacterial and conjunctivitis viral. IGA = Validated Investigator Global Assessment. EASI = Eczema Area and Severity Index. I-NRS4 = Percentage of patients achieving at least a 4-point reduction from baseline
on the Itch Numeric Rating Scale among patients with a baseline peak score of at least 4.
Zumilokibart has the potential to set a new standard for disease control
and dosing convenience for biologics in atopic dermatitis
7
© Apogee Therapeutics, Inc.
APEX PART B
0 2 4 6 8 10 12 24
0
30
40
50
60
70
80
90
Amlitelimab (24-week)
Part B
Part A
Apogee has the potential to transform
the future $50B atopic dermatitis market Efficacy (EASI-75 at Week 16, %)
NOTE: Positioning of Apogee programs is illustrative and based on APEX Phase 2 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 (non-responder imputation 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 (Ph2b Q12W regimen; non-responder imputation for missing values).
100
Zumilokibart
Dosing Interval (weeks)
Rezpegaldesleukin
8
© Apogee Therapeutics, Inc.
65.9
23.4
49.5
12.7
46.0
10.9
34.6
6.8
47.4
9.3
31.8
6.0
50.5
13.9
38.4
10.9
16.5
3.4 5.6
20
40
60
80
Response at Week 16 (%)
0
Zumilokibart APEX Part B demonstrated a competitive profile at Week 16
Zumilokibart Mid dose (N=85)
(Planned Phase 3 dose)
Placebo (N=88) DUPIXENT (N=521) Placebo (N=521)
EASI-75 IGA 0/1 EASI-90
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. Missing data was imputed with Markov Chain Monte Carlo Multiple Imputation (MCMC-MI). Data collected after the initiation of rescue medication or drug discontinuation will be set to missing for continuous
variables before MCMC-MI. A patient will be counted as a non-responder for the dichotomous variables for timepoints after rescue medication use or treatment discontinuation due to lack of efficacy. Statistical treatment of missing data varies across
studies shown. IGA = Investigator Global Assessment. Zumilokibart assessed Validated Investigator Global Assessment (vIGA 0/1). EASI = Eczema Area and Severity Index. I-NRS4 = % of patients achieving at least a 4-point reduction from
baseline on the Itch Numeric Rating Scale. 1 For I-NRS4, N = 77 for zumilokibart and N = 84 for placebo.
SOURCE: For all endpoints except I-NRS4 and EASI-100, DUPIXENT values are an average of Ph3 SOLO-1&2 and Ph2b (300 mg Q2W regimen; non-responder imputation for missing values); for I-NRS4, values are an average of Ph3 SOLO 1&2;
for EASI-100, value is from Level Up, a head-to-head study vs. RINVOQ (300 mg Q2W regimen; non-responder imputation incorporating multiple imputation for missing data due to COVID-19). No placebo-controlled DUPIXENT monotherapy
studies have measured EASI-100.
Δ = 41.9
Δ = 34.8 Δ = 37.8 Δ = 36.8
Δ = 25.8
Δ = 27.8
Zumilokibart has shown continuous improvement across endpoints after Week 16
with just 2-4 dosing days per year (vs. 26 dosing days for DUPIXENT with no improvement after Week 16)
Δ = 36.7
Δ = 27.5
I-NRS41
Δ = 12.9
EASI-100
APEX PART B
APEX Phase 2
Part B 16-week Results
Carl Dambkowski, MD
Chief Medical Officer
10
© Apogee Therapeutics, Inc.
APEX Part B 16-week topline data is available for all patients
Part B enrolled moderate-to-severe AD patients (EASI ≥16, vIGA ≥3, BSA ≥10%)
APEX PART B
Primary analysis method:
• Missing data was imputed with Markov Chain Monte Carlo Multiple Imputation (MCMC-MI)
• Rescue medication use or treatment discontinuation due to lack of efficacy was imputed
as non response for all subsequent time points2
Every 3 months (Q12W)
Every 6 months (Q24W)
Maintenance
LTE or 52-week
follow-up period
W16 Primary
Endpoint (EASI-75) W52 Endpoint
1:1:1:1
Induction
High dose
Mid dose
(Part A dose)
Low dose
N ~ 346 Placebo 1
Planned
Phase 3
dose
NOTE: 1 347 patients were randomized but one patient was not dosed; 346 indicates the total number of patients dosed and represents the mITT population. 2 Data collected after the initiation of rescue medication or drug
discontinuation will be set to missing for continuous variables (e.g. percent change from baseline in EASI score) before MCMC-MI. A patient will be counted as a non-responder for the dichotomous variables (e.g.,. EASI-75) for
timepoints after rescue medication use or treatment discontinuation due to lack of efficacy. Primary analysis method unless otherwise specified.
11
© Apogee Therapeutics, Inc.
NOTE: 1 Based on projected number of injections and dosing days with planned commercial presentation.
SOURCE: DUPIXENT USPI.
Zumilokibart could substantially decrease injections for patients
ZUMILOKIBART
DUPIXENT
9 dosing days
INDUCTION MAINTENANCE
W0 W2 W4 W12
Zumilokibart
4 dosing days
2-4
26
12
© Apogee Therapeutics, Inc.
Baseline characteristics and demographics were
generally well-balanced and in line with expectations
APEX PART B
Zumilokibart
NOTE: vIGA = Validated Investigator Global Assessment. EASI = Eczema Area and Severity Index. BSA = Body Surface Area. I-NRS = Itch Numeric Rating Scale.
Planned Phase 3 dose
Characteristic Low dose
(N=86)
Mid dose
(N=85)
High dose
(N=87)
Placebo
(N=88)
Age, mean (SD), Y 36.4 (14.6) 39.9 (16.4) 39.9 (14.5) 35.9 (15.9)
Female, n (percent) 41 (47.7) 45 (52.9) 37 (42.5) 47 (53.4)
Weight, mean (SD), kg 76.0 (18.2) 76.4 (17.5) 82.0 (23.6) 80.1 (18.2)
Duration of AD from diagnosis, mean (SD), Y 25.9 (14.5) 26.5 (16.3) 28.7 (17.1) 24.2 (15.8)
Race, n (percent)
White 61 (70.9) 59 (69.4) 65 (74.7) 56 (63.6)
Black or African American 7 (8.1) 8 (9.4) 8 (9.2) 13 (14.8)
Asian 11 (12.8) 11 (12.9) 7 (8.0) 10 (11.4)
Other/unknown 7 (8.1) 7 (8.2) 7 (8.0) 9 (10.2)
Baseline disease characteristics
EASI, mean (SD) 26.0 (10.5) 26.0 (10.8) 26.4 (10.2) 27.6 (10.6)
vIGA (4), n (percent) 31 (36.0) 31 (36.5) 33 (37.9) 33 (37.5)
Weekly mean I-NRS, (SD) 6.7 (1.9) 7.0 (1.6) 6.8 (2.0) 6.7 (1.7)
BSA affected, mean (SD) 38.6 (18.9) 40.0 (20.8) 39.0 (19.3) 42.6 (21.6)
13
© Apogee Therapeutics, Inc.
Zumilokibart was well tolerated
Zumilokibart
NOTE: TEAE = treatment-emergent adverse event. PT = preferred term. ADA = anti-drug antibody. Pooled conjunctivitis rate includes the following preferred terms: noninfective conjunctivitis, conjunctivitis, conjunctivitis allergic,
conjunctivitis bacterial and conjunctivitis viral.
APEX PART B
• Pooled conjunctivitis rate (all PTs) of 10.6% for planned Phase 3 dose; pooled rate was 15.1% for low dose and 20.7% for high dose
• No effect of ADAs on PK, clinical activity, or safety
Planned Phase 3 dose n (%) Low dose Mid dose High dose Placebo
Safety summary through Week 16 (N=86) (N=85) (N=87) (N=88)
Patients reporting ≥1 TEAE 65 (75.6) 51 (60.0) 59 (67.8) 59 (67.0)
Patients reporting ≥1 serious TEAE 2 (2.3) 1 (1.2) 3 (3.4) 2 (2.3)
Patients who discontinued due to TEAE 1 (1.2) 2 (2.4) 3 (3.4) 2 (2.3)
Most frequent TEAEs by PT through Week 16 (≥5%)
Nasopharyngitis 22 (25.6) 12 (14.1) 10 (11.5) 19 (21.6)
Headache 7 (8.1) 6 (7.1) 6 (6.9) 3 (3.4)
Noninfective conjunctivitis 4 (4.7) 5 (5.9) 10 (11.5) 0 (0.0)
Upper respiratory tract infection 5 (5.8) 6 (7.1) 5 (5.7) 3 (3.4)
Dermatitis atopic 7 (8.1) 2 (2.4) 5 (5.7) 5 (5.7)
Urinary tract infection 1 (1.2) 5 (5.9) 0 (0.0) 1 (1.1)
14
© Apogee Therapeutics, Inc.
APEX PART B
EASI-75 Response
61.6
35.6
52.6
59.7 65.9
50.5
6.9
17.9
25.2
23.4
0 1 2 4 8 12 16
0
20
40
60
80
EASI
Week
-75 Response (%)
12.2
1.2
High dose (N=87)
Mid dose (N=85)
(Planned Phase 3 dose)
Low dose (N=86)
Placebo (N=88)
APEX Part B met primary endpoint with EASI-75 response in 65.9% of patients
NOTE: *p<0.05, **p<0.01, ***p<0.001 (vs placebo). EASI = Eczema Area and Severity Index.
Significance
achieved for
all treatment
arms by
Week 2
** **
***
***
***
***
***
***
***
*
***
***
**
*
***
15
© Apogee Therapeutics, Inc.
Treatment with zumilokibart reduced lesions as early as Week 1
-69.3
-51.2
-67.0 -70.6
-61.0
-34.9
1 2 4 8 12 16
-80
-60
-40
-20
0 Week
Percent Change from Baseline
(LS Mean)
-17.0
-7.3
-32.5
-14.0
-21.0
-63.3
-30.8
-36.3
High dose (N=87)
Mid dose (N=85) (Planned Phase 3 dose)
Low dose (N=86)
Placebo (N=88)
APEX PART B
Eczema Area and Severity Index Score
**
***
***
**
***
***
***
***
***
***
***
***
***
***
***
***
NOTE: *p<0.05, **p<0.01, ***p<0.001 (vs placebo). LS = Least squares.
16
© Apogee Therapeutics, Inc.
APEX PART B
IGA 0/1 with a Reduction of ≥2 Points from Baseline
33.4
7.1
30.2
36.9
46.0
27.6
5.7 5.9
10.9
0 1 2 4 8 12 16
0
10
20
30
40
50
IGA 0/1 Response (%)
1.1 Week
13.3
1.1
High dose (N=87)
Mid dose (N=85) (Planned Phase 3 dose)
Low dose (N=86)
Placebo (N=88)
Zumilokibart treatment led to IGA 0/1 response in 46.0% of patients
NOTE: *p<0.05, **p<0.01, ***p<0.001 (vs placebo). Validated Investigator Global Assessment (vIGA 0/1) was used in APEX.
*
*
**
**
**
***
***
**
***
***
**
***
***
17
© Apogee Therapeutics, Inc.
APEX PART B
EASI-90 Response
35.8
5.9
16.5
32.0
36.7
47.4
28.2
7.1 6.8
9.3
0 1 2 4 8 12 16
0
10
20
30
40
50
EASI
Week
-90 Response (%)
High dose (N=87)
Mid dose (N=85) (Planned Phase 3 dose)
Low dose (N=86)
Placebo (N=88)
Zumilokibart treatment led to EASI-90 response in 47.4% of patients
NOTE: *p<0.05, **p<0.01, ***p<0.001 (vs placebo). EASI = Eczema Area and Severity Index.
*
**
**
***
**
***
***
**
***
***
**
***
***
18
© Apogee Therapeutics, Inc.
APEX PART B
I-NRS4 Response
43.4
36.2
49.7
50.5
35.7
4.8
8.6
16.3
21.4
13.9
0 2 4 8 12 16
0
10
20
30
40
50
60
I-Week NRS4 Response (%)
9.2
19.8
Zumilokibart treatment led to I-NRS4 response in 50.5% of patients
NOTE: *p<0.05, **p<0.01, ***p<0.001 (vs placebo).
I-NRS4 = Percentage of patients achieving at least a 4-point reduction from baseline on the Itch Numeric Rating Scale among patients with a baseline peak score of at least 4.
*
*
**
***
**
***
***
***
**
19
© Apogee Therapeutics, Inc.
65.9
23.4
49.5
12.7
53.0
15.3
42.8
29.6 29.1
12.1
0
20
40
60
10
30
50
70
EASI-75 Response at Week 16 (%)
N=85 N=88 N=521 N=521 N=639 N=339 N=1142 N=586
Zumilokibart demonstrated competitive EASI-75 response
APEX PART B
Δ = 41.91
p < 0.001
Δ = 36.8 Δ = 37.7
PBO PBO PBO PBO PBO
Zumilokibart
(Mid dose)
+TCS
N=1192 N=398
Δ = 13.2
Δ = 17.0
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. Statistical treatment of missing data varies across studies shown. 1 Calculation of difference between zumilokibart and placebo is based on Cochran–Mantel–Haenszel (CMH) analysis adjusted by
randomization stratification factors.
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 (non-responder imputation for missing values) and Ph2b
(sensitivity analysis 3: NRI for rescue medication use and LOCF for other missing values); 250mg Q2W regimen). NEMLUVIO+TCS (average of Ph3 ARCADIA1&2; 30 mg Q4W regimen; non-responder imputation for missing data). ADBRY
(average of Ph3 ECZTRA1&2; 300 mg Q2W regimen; non-responder imputation for missing values).
20
© Apogee Therapeutics, Inc.
46.0
10.9
34.6
6.8
37.0
10.4
36.7
25.3
19.0
9.0
0
10
20
30
40
50
IGA 0/1 Response at Week 16 (%)
N=85 N=88 N=521 N=521 N=639 N=339 N=1142 N=586
Zumilokibart demonstrated competitive IGA 0/1 response
Δ = 34.81
p < 0.001
Δ = 27.8 Δ = 26.6
Δ = 11.4
PBO PBO PBO PBO PBO
Zumilokibart
(Mid dose)
+TCS
N=1192 N=398
Δ = 10.0
APEX PART B
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. Statistical treatment of missing data varies across studies shown. 1 Calculation of difference between zumilokibart and placebo is based on Cochran–Mantel–Haenszel (CMH) analysis adjusted by
randomization stratification factors. Zumilokibart assessed vIGA 0/1 while DUPIXENT, EBGLYSS, NEMLUVIO+TCS, and ADBRY assessed IGA 0/1.
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 (non-responder imputation for missing values) and Ph2b
(sensitivity analysis 3: NRI for rescue medication use and LOCF for other missing values); 250mg Q2W regimen). NEMLUVIO+TCS (average of Ph3 ARCADIA1&2; 30 mg Q4W regimen; non-responder imputation for missing data). ADBRY
(average of Ph3 ECZTRA1&2; 300 mg Q2W regimen; non-responder imputation for missing values).
21
© Apogee Therapeutics, Inc.
47.4
9.3
31.8
6.0
34.5
9.3
25.8
17.9 16.4
4.8
0
10
20
30
40
50
EASI-90 Response at Week 16 (%)
N=85 N=88 N=521 N=521 N=1142 N=586
Zumilokibart demonstrated competitive EASI-90 response
Δ = 37.81
p < 0.001
Δ = 25.2
Δ = 25.8
Δ = 7.9
PBO PBO PBO PBO PBO
Zumilokibart
(Mid dose)
+TCS
N=1192 N=398
Δ = 11.6
APEX PART B
N=564 N=287
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. Statistical treatment of missing data varies across studies shown. 1 Calculation of difference between zumilokibart and placebo is based on Cochran–Mantel–Haenszel (CMH) analysis adjusted by
randomization stratification factors.
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; 250mg Q2W regimen; non-responder imputation for missing
values). NEMLUVIO+TCS (average of Ph3 ARCADIA1&2; 30 mg Q4W regimen; non-responder imputation for missing data). ADBRY (average of Ph3 ECZTRA1&2; 300 mg Q2W regimen; non-responder imputation for missing values).
22
© Apogee Therapeutics, Inc.
50.5
13.9
38.4
10.9
42.9
12.3
41.9
17.9
22.5
9.9
0
10
20
30
40
50
60
I-NRS4 Response at Week 16 (%)
N=77 N=84
Zumilokibart demonstrated competitive I-NRS4 response
Δ = 36.71
p < 0.001
Δ = 30.6
Δ = 27.5
Δ = 24.0
PBO PBO PBO PBO PBO
Zumilokibart
(Mid dose)
+TCS
Δ = 12.6
APEX PART B
N=438 N=433 N=497 N=252 N=1142 N=586 N=1169 N=394
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. Statistical treatment of missing data varies across studies shown. 1 Calculation of difference between zumilokibart and placebo is based on Cochran–Mantel–Haenszel (CMH) analysis adjusted by
randomization stratification factors. I-NRS4 = Percentage of patients achieving at least a 4-point reduction from baseline on the Itch Numeric Rating Scale among patients with a baseline peak score of at least 4 on the Itch Numeric Rating Scale.
SOURCE: DUPIXENT (average of Ph3 SOLO-1&2, 300 mg Q2W regimen; non-responder imputation for missing values). EBGLYSS (average of Ph3 ADVOCATE-1&2; 250mg Q2W regimen; non-responder imputation for missing values).
NEMLUVIO+TCS (average of Ph3 ARCADIA1&2; 30 mg Q4W regimen; non-responder imputation for missing data). ADBRY (average of Ph3 ECZTRA1&2; 300 mg Q2W regimen; non-responder imputation for missing values).
23
© Apogee Therapeutics, Inc.
Zumilokibart treatment led to EASI-100 response of 16.5%
and vLDA response of 20.6%
APEX PART B
Completely clear skin (EASI-100)1 Very Low Disease Activity (EASI-90 + I-NRS 0/1)2
16.5
3.4
5.6
14.8
0
10
20
EASI-100 Response at Week 16 (%)
Δ = 12.93
p < 0.01
20.6
4.5
8.9
19.9
0
5
10
15
20
25
vLDA at Week 16 (%)
Δ = 16.73
p < 0.01
N=462 N=458 N=462 N=458
Zumilokibart
(Mid dose)
N=85 N=88
Zumilokibart
(Mid dose)
N=63 N=66
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. Statistical treatment of missing data varies across studies shown. 1Non-responder imputation (NRI) analysis. 2As observed analysis. 3Calculation of difference between zumilokibart and placebo is based
on Cochran–Mantel–Haenszel (CMH) analysis adjusted by randomization stratification factors.
SOURCE: DUPIXENT LEVEL UP (Silverberg J et al. BJD 2025; 300 mg Q2W regimen; non-responder imputation incorporating multiple imputation for missing data due to COVID-19). RINVOQ LEVEL UP (Silverberg J et al. BJD 2025; 15 mg
QD or 30mg QD regimen; non-responder imputation incorporating multiple imputation for missing data due to COVID-19).
Treatment Gaps in Atopic
Dermatitis
Ruth Ann Vleugels, MD, MPH, MBA
Heidi and Scott C. Schuster Distinguished Chair in Dermatology
Director, Atopic Dermatitis Program
Mass General Brigham Department of Dermatology
Professor of Dermatology, Harvard Medical School
25
Atopic dermatitis is a severe, systemic disease that
profoundly impacts patient quality of life
1) Primary Care Dermatology Society . 2) Bridgman et al., 2018. Ann Allergy Asthma Immunol. 3) Irish Skin Foundation.
Loss of
sleep
Hospitalizations
Growth
restriction Depression
Work
sick leave
Reduced
physical activity
26
Available treatment options for AD enable
disease control, but have limitations
Therapy Target Early disease control Limitations
Dupilumab IL-4Ra
• Moderate onset of action for itch
and lesion benefit
• Dosing frequency (every 2 weeks)
Lebrikizumab IL-13
• Moderate onset of action for itch
and lesion benefit
• Dosing frequency (every 4 weeks)
Nemolizumab IL-31 • Rapid and substantial itch relief • Limited improvement in rash
Upadacitinib/
Abrocitinib JAK
• Rapid onset of action with
substantial lesion benefit and
itch relief
• Safety liabilities (boxed warning)
• Dosing frequency (daily)
1) Dupixent USPI, 2) Ebglyss USPI, 3) Nemluvio USPI, 4) Rinvoq USPI
27
Patients continue to look for improved treatments1
Key areas for improved treatment options patients cite as important include
Robust efficacy without safety
liabilities Freedom from injection burden
• Zumilokibart efficacy is
numerically similar to JAK-inhibitors at Week 16, including
on deepest endpoints: Very Low
Disease Activity (vLDA) and EASI-100 (completely clear skin)
• Responses improved on
zumilokibart after Week 16 in
previous studies, including >40%
of patients achieving completely
clear skin on every 3-month
dosing at Week 52
• Zumilokibart offers low injection
burden, with just 4 dosing days in
induction
• Zumilokibart demonstrated
maintenance of responses with
just 2-4 dosing days per year, a
significant reduction from current
standard of care
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.
28
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 safe and give patients freedom from disease burden
• Zumilokibart was well-tolerated with a safety profile generally in line with the IL-4/13 class
• Moreover, zumilokibart data presented today demonstrated efficacy numerically similar to that
of JAK inhibitors and itch data numerically similar to nemolizumab
• From previously presented data, zumilokibart showed improved responses over time with as
infrequent dosing as every 3- to 6-months, providing patients freedom from their disease burden
long-term
• Together, zumilokibart data support its potential to become the biologic of choice for patients
with moderate-to-severe atopic dermatitis
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
Amol Kamboj, MD
SVP, Head of Clinical
Development
30
© Apogee Therapeutics, Inc.
ZUMILOKIBART
Zumilokibart Phase 3 program expected to initiate in 2H 2026
NOTE: For illustrative purposes only. Trial designs subject to clinical and regulatory alignment.
Zumilokibart replicate Phase 3 monotherapy studies in moderate-to-severe atopic dermatitis patients
Trial design
• Patient population:
EASI ≥16, vIGA ≥3, BSA
≥10%
• Co-primary endpoint:
EASI-75 and IGA 0/1
• Trial geography: similar
to APEX Part B
Every 3 months (Q12W)
Maintenance
W16
Co-primary endpoint W52 Endpoint
Induction
N ~ 400
per trial
Zumilokibart
(Mid dose)
Placebo Placebo
Every 6 months (Q24W)
ADventure Phase 3 development program could enable zumilokibart launch in 2029
31
© Apogee Therapeutics, Inc.
ZUMILOKIBART
Zumilokibart Phase 3 program expected to initiate in 2H 2026
NOTE: For illustrative purposes only. Trial designs subject to clinical and regulatory alignment.
Zumilokibart Phase 3 TCS combination study in moderate-to-severe atopic dermatitis patients
Trial design
• Patient population:
EASI ≥16, vIGA ≥3, BSA
≥10%
• Co-primary endpoint:
EASI-75 and IGA 0/1
• Trial geography: similar
to APEX Part B
Maintenance
W16
Co-primary endpoint W52 Endpoint
Induction
N ~ 400
Zumilokibart
Mid dose + TCS
Placebo + TCS
ADventure Phase 3 development program could enable zumilokibart launch in 2029
Every 3 months (Q12W)
32
© Apogee Therapeutics, Inc.
Dose-ranging trials in AD, asthma, and EoE could enable efficient path
to registration for multiple additional blockbuster expansion indications
ZUMILOKIBART
NOTE: Phase 3 and launch plans subject to clinical and regulatory outcomes. COPD = Chronic Obstructive Pulmonary Disease. CRSwNP = Chronic Rhinosinusitis with Nasal Polyps. PN =Prurigo Nodularis.
Respiratory
ASPIRE Asthma
Phase 2
Dermatology
APEX AD
Phase 2 Part B
Gastroenterology
ELEVATE EoE
Phase 2
Phase 3 dose
Optimized dose in each therapeutic area could enable straight to Phase 3
approach for additional expansions (e.g., COPD, CRSwNP, PN)
33
© Apogee Therapeutics, Inc.
ZUMILOKIBART
Zumilokibart ASPIRE Phase 2b in asthma
expected to initiate in 1H 2027
NOTE: For illustrative purposes only. Trial designs subject to clinical and regulatory alignment.
Zumilokibart Phase 2b in moderate-to-severe asthma patients
W52 Primary endpoint:
Annualized exacerbation rate
Patient population:
▪ Elevated Type 2
biomarkers
▪ Exacerbation history
in prior year
Objectives
• Demonstrate reduction in
exacerbations
• Improve lung function and
symptoms
• Select dose for further
development
• Designed to be potentially
registrational
Every 3-month dosing (Q12W)
Every 6-month dosing (Q24W)
Placebo
Every 12-month dosing (Q48W)
N ~ 500
34
© Apogee Therapeutics, Inc.
NOTE: POC = proof of concept. For illustrative purposes only. Trial designs subject to clinical and regulatory alignment.
Induction Maintenance
Primary Endpoint:
Histology
W52
Endpoint
N
~30-50
Every 3-months
(Q12W)
Zumilokibart
induction
Every 6-months
(Q24W)
ZUMILOKIBART
Zumilokibart ELEVATE Phase 2a in eosinophilic
esophagitis expected to initiate 2H 2026
Zumilokibart Phase 2a proof-of-concept open-label design
Objectives
• Demonstrate rapid and early
proof of concept for zumilokibart
in EoE by evaluating:
• Histology
(eosinophil counts)
• Endoscopy
• Patient reported outcomes
• Enable 2H 2027 readout
35
© Apogee Therapeutics, Inc.
ZUMILOKIBART
Zumilokibart could transform the treatment paradigm
in multiple expansion indications beyond AD
Zumilokibart could become the first long-acting
biologic approved for both AD and asthma
Zumilokibart could be dosed 2-4 times per year in EoE
versus weekly dosing for the only approved biologic
0 2 12
30
40
50
60
70
Reduction in annual asthma
exacerbations (%, labeled population)
Dosing Interval (weeks)
Zumilokibart
AD, asthma, and EoE are the three largest Th2 indications and account for >75% of DUPIXENT’s gross sales1,2
52 0 1 12
30
40
50
60
70
Esophageal histologic remission
at Week 24
Dosing Interval (weeks)
Zumilokibart
24
NOTE: Positioning of zumilokibart is illustrative and based on Phase 2 results in AD and Phase 1b interim results in asthma for zumilokibart only and illustrates what we believe we can potentially achieve. Only DUPIXENT is 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. 1 Largest indications based on WW gross sales in 2025. 2 IQVIA (March 2025).
SOURCE: DUPIXENT asthma Phase 3 data (QUEST) from HCP website for 300mg Q2W in labeled population (EOS ≥150 cells/μL). DUPIXENT EoE Phase 3 data from USPI for 300mg QW (average of Part A and Part B).
Building a Leading
I&I Company
Michael Henderson, MD
Chief Executive Officer
37
© Apogee Therapeutics, Inc.
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.
Apogee has the potential to become a leader in a future $50B+ market
$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
$0
$5
$10
$15
$20
$25
Psoriasis
Atopic
dermatitis
Other biologics
Year of zumilokibart
planned launch (2029)
Amlitelimab
New agents EBGLYSS and NEMLUVIO
each projected to eclipse $1B in 2026
(2nd full year of launches)
ZUMILOKIBART
38
© Apogee Therapeutics, Inc.
Zumilokibart has demonstrated a potentially best-in-class profile in AD
Robust lesion and itch control
that improves over time
Week 161 Week 522,3
EASI-75 66% 88%
IGA 0/1 46% 72%
EASI-90 47% 75%
I-NRS4 51% 78%
EASI-100 17% 41%
Transformative
Dosing
2-4
Zumilokibart
dosing days per year
26
DUPIXENT
dosing days per year
ZUMILOKIBART
NOTE: Data are derived from Part A and Part B, with differences patient populations. As a result, cross-trial comparisons cannot be made, and no head-to-head trials have been conducted. IGA = Validated
Investigator Global Assessment. EASI = Eczema Area and Severity Index. I-NRS4 = % of patients achieving at least a 4-point reduction from baseline on the Itch Numeric Rating Scale. Maintenance dosing
intervals are as per label or published data.
SOURCE: 1 ZUMILOKIBART APEX Part B Mid Dose (MCMC-MI / NRI). 2 ZUMILOKIBART Guttman-Yassky et al, AAD 2026 (Q12W cohort, as observed analysis). 3
Itch-NRS data is at Week 48.
39
© Apogee Therapeutics, Inc.
ROYALTY FINANCING
Blackstone collaboration expected to provide path to commercialization
for zumilokibart without need for future equity financing
$500M
$800M
$1.3B
Future Senior
Debt Option1
Synthetic
Royalty
Current
Cash2
3
• Up to $1.3B in flexible, low-cost of capital funding customized for
Apogee’s future needs
- Largest royalty financing for a pre-Phase 3 program
• Max royalty rate of 6.25% on up to $5B of WW annual zumilokibart sales;
blended rate scales down with sales:
- 3.4% at $10B net sales
- 1.7% at $20B net sales
• Buy-back option in the event of a change of control
NOTE: 1 At mutual consent. 2As of March 31, 2026, Apogee had cash, cash equivalents and marketable securities of $1.3B. 3$150M of the $400M approval funding is at Apogee option. If only $250M of $400M available approval funding is drawn,
approval tranche drops to 1.5625% on <$5B, 0% above $5B.
Pre-approval
($400M)
Approval
(Up to $400M3
)
Tiered royalty rate
on annual net sales:
<$5B 3.75% 2.5%
$5B-$8B 1% 0%
+
40
© Apogee Therapeutics, Inc.
2026 2027 2028
1H: Ph2 Part B 52-week
2H: Ph2 Part A 2-year
2H: Ph3 mono 1&2 initiations
2H: Ph3 TCS initiation
1H: Ph3 mono 1&2 readouts
2H: Ph3 TCS readout
1H: Asthma Ph2b initiation
2H: EoE Ph2a initiation 2H: EoE Ph2a
preliminary readout
2H: EoE Ph2a
long-term follow-up
2H: APG279 (IL-13+OX40L) AD
Ph1b readout vs. DUPIXENT
2H: APG273 (IL-13+TSLP) trial
plans announced
1H: Additional pipeline
program disclosed
Multiple expected value-creating catalysts through 2028
CORPORATE
Zumilokibart
in AD
Zumilokibart
Pipeline-in-a-product
Serial
innovation
Ph3
Apogee /ˈapəjē/ noun
The highest point in the development of
something; a climax or culmination
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May 27, 2026
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May 27, 2026
Entity File Number
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Apogee
Therapeutics, Inc.
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Entity Tax Identification Number
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Entity Incorporation, State or Country Code
DE
Entity Address, Address Line One
221
Crescent Street
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Building 17
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Suite 102b
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Waltham
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MA
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