Apogee Therapeutics Announces Positive Interim Results from Phase 1b Trial of Zumilokibart (APG777), its Potentially Best-in-Class Anti-IL-13 Antibody, in Patients with Mild-to-Moderate Asthma and Highlights 2026 Anticipated Milestones and Outlook

Rhea-AI Summary

Apogee Therapeutics (NASDAQ: APGE) reported positive interim Phase 1b results for zumilokibart (APG777) in 19 adults with mild-to-moderate asthma, showing a maximum mean FeNO reduction of 45 ppb (60% from baseline) after one 720 mg dose and durable FeNO suppression through 16 weeks (and through 32 weeks for patients with follow-up).

Zumilokibart was well tolerated with no Grade 3+ TEAEs, no conjunctivitis, injection-site reactions, or ADAs. Company highlights expected 2026 milestones: APEX Part A 52-week data in Q1 2026, Part B 16-week induction data in Q2 2026 (Part B enrolled 347 patients), potential Phase 3 start in 2H 2026, and a potential commercial launch in 2029. Cash of $913 million provides runway into 2H 2028.

Positive

• FeNO reduction of 45 ppb (60% decrease) after single 720 mg dose
• Durable FeNO suppression through 16 weeks (and through 32 weeks for available patients)
• Favorable safety: no Grade 3+ TEAEs, no conjunctivitis, injection-site reactions, or ADAs
• Phase 2 APEX Part B enrollment 347 patients (exceeded target)
• Cash position of $913 million with runway into 2H 2028
• APG279 Phase 1b upsized to ~80 patients with 2H 2026 readout on track

Negative

• Phase 1b interim dataset is small: only 19 patients
• Primary reported effect is biomarker-based (FeNO) rather than clinical exacerbation endpoints
• Planned Phase 3 start in 2H 2026 and 2029 launch remain contingent on future readouts

Key Figures

Asthma Phase 1b sample 19 adult patients Zumilokibart Phase 1b trial in mild-to-moderate asthma

Single dose level 720 mg Single dose of zumilokibart or placebo on day 1

FeNO baseline threshold ≥25 ppb Entry criterion for enriched Type 2 inflammation asthma population

FeNO reduction 45 ppb (60%) Maximum absolute mean FeNO reduction after a single dose

APEX Part B enrollment 347 patients Phase 2 APEX Part B atopic dermatitis trial enrollment total

APG279 Phase 1b size approximately 80 patients Expanded APG279 Phase 1b trial in atopic dermatitis

Total cash $913 million Pro forma as of September 30, 2025; runway into 2H 2028

Equity financing proceeds $324.3 million Proceeds before expenses from October 2025 equity financing

Market Reality Check

$78.25 Last Close

Volume Volume 1,159,915 is about 16% above the 20-day average of 998,859, indicating elevated interest into this data update. normal

Technical Shares at $77.51 are trading above the 200-day MA of $46.52 and sit 4.3% below the 52-week high of $80.99.

Peers on Argus

APGE is up 2.28% while close peers show mixed moves: ARQT +4.03%, AGIO +1.03%, IBRX +1.46%, but GLPG -0.37% and TVTX -5.15%. With no peers in the momentum scanner and no same-day peer headlines, today’s move appears more company-specific to APGE’s asthma data and 2026 outlook.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 10	Earnings & pipeline	Positive	+3.8%	Q3 results, four planned 2026 readouts, strong cash position highlighted.
Nov 10	Clinical trial data	Positive	+3.8%	Positive interim Phase 1 APG333 data with long half‑life and biomarker effect.
Nov 03	Conference participation	Neutral	-4.0%	Announcement of multiple investor conference appearances and webcasts.
Oct 10	Equity offering close	Negative	+2.9%	Closing of $345M underwritten offering and full exercise of over‑allotment.
Oct 08	Equity offering price	Negative	+18.9%	Pricing of $300M underwritten offering of stock and pre‑funded warrants.

Pattern Detected

Recent news often saw positive price reactions, including to clinical updates and even capital raises, though conference participation drew a negative move.

Recent Company History

Over the last few months, Apogee highlighted steady clinical and financing progress. On Oct 8–10, 2025, it priced and closed sizable equity offerings, raising about $300M–$345M. A Nov 10, 2025 earnings and pipeline update reiterated plans for four 2026 readouts and reported pro forma cash of $913M. The same day, positive interim Phase 1 data for APG333 showed a ~55‑day half‑life and durable biomarker suppression, supporting infrequent dosing. Today’s APG777 asthma data and 2026 milestones build directly on that strategy of long-acting I&I biologics and robust funding.

Market Pulse Summary

This announcement details positive interim Phase 1b data for zumilokibart in asthma, including a 60% FeNO reduction and durable effects to 16–32 weeks, and outlines multiple 2026 readouts across asthma and atopic dermatitis. Recent history shows Apogee pairing clinical progress with substantial financings, resulting in pro forma cash of $913 million. Investors may focus on upcoming APEX and APG279 data, the planned Phase 3 start, and how long-interval dosing could differentiate assets in large I&I markets.

Key Terms

FeNO medical

"demonstrated rapid and durable suppression of FeNO (key biomarker of Type 2 inflammation)"

FeNO (fractional exhaled nitric oxide) is a breath test that measures the level of nitric oxide gas produced in the lungs, used as a sign of airway inflammation often linked to asthma. It matters to investors because FeNO levels are used in clinical decisions, regulatory studies and to gauge the effectiveness of respiratory drugs and diagnostic devices, so changes in FeNO-related data or approvals can affect sales, trial outcomes and market value—like a fever reading for lung inflammation.

Type 2 inflammation medical

"FeNO (key biomarker of Type 2 inflammation) through 16 weeks for all patients"

An immune response driven by a specific set of cells and signaling molecules that causes allergic-type inflammation in tissues such as the lungs, skin and sinuses; think of it as the body’s alarm system stuck in the “allergy” mode. It matters to investors because drugs that reduce or block this pathway can treat common, chronic conditions (asthma, eczema, chronic sinusitis) and represent large, targeted markets with potential for premium-priced, specialty medicines.

IL-13 medical

"zumilokibart is a novel, half-life extended anti-IL-13 antibody"

IL-13 is a small signaling protein produced by the immune system that plays a key role in allergic inflammation and certain lung and fibrotic diseases; think of it as a radio message that tells cells to make mucus, narrow airways, or lay down scar tissue. For investors, IL-13 matters because therapies that block or measure it can change patient outcomes and determine the success of clinical trials, regulatory approvals, and the value of companies developing targeted drugs.

FEV1 medical

"Positive trends observed in forced expiratory volume in one second (FEV1)"

FEV1 stands for forced expiratory volume in one second, a medical measurement of how much air a person can forcibly exhale in one second during a breathing test. Think of it like timing how quickly someone can blow out a candle — it gives a clear snapshot of lung strength and airflow. Investors watch FEV1 because changes in this measure are used to judge whether respiratory drugs or devices work, which affects regulatory approval, market potential, and sales forecasts.

atopic dermatitis medical

"Zumilokibart in atopic dermatitis (AD) advancing in Phase 2 APEX trials"

A chronic inflammatory skin condition, often called eczema, that causes dry, itchy, red patches and recurring flare-ups; think of it as a persistent rash that can come and go over a person’s life. It matters to investors because its chronic nature and large patient population create steady demand for treatments, influence drug development and approval decisions, affect healthcare costs and reimbursement, and can drive revenue and valuation shifts for companies working on therapies and diagnostics.

Phase 1b medical

"Phase 1b interim results of zumilokibart (APG777) in asthma demonstrated rapid"

"Phase 1b" is an early stage in testing a new medical treatment or vaccine, where it is given to a small group of people to evaluate its safety and determine the right dose. For investors, this phase signals progress in development, indicating the treatment is advancing through initial safety checks, which can influence expectations for future success and potential market impact.

Phase 2 medical

"Zumilokibart in atopic dermatitis (AD) advancing in Phase 2 APEX trials"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

Rule 10b5-1 regulatory

"trading plan adopted on August 13, 2025"

Rule 10b5-1 is a regulation that allows company insiders to buy or sell their shares at predetermined times, even if they have access to non-public information. It acts like setting a schedule in advance for transactions, helping prevent accusations of unfair trading. This rule provides a way for insiders to plan trades transparently, giving investors confidence that these transactions are not based on hidden information.

AI-generated analysis. Not financial advice.

Phase 1b interim results of zumilokibart (APG777) in asthma demonstrated rapid and durable suppression of FeNO (key biomarker of Type 2 inflammation) through 16 weeks for all patients
- Suppression of FeNO through 32 weeks for patients with available follow up
 - Results reinforce continued development in asthma testing every 3- or 6-month dosing

Successful expansion of zumilokibart beyond dermatology confirms its pipeline-in-a-product potential across I&I indications

Zumilokibart in atopic dermatitis (AD) advancing in Phase 2 APEX trials with goal of Phase 3 initiation by end of 2026:
- Part A maintenance (52-week) data readout expected in Q1 2026 with potential to establish best-in-class every 3- or 6-month dosing profile
- Part B enrollment completed ahead of schedule and exceeded enrollment target with a total of 347 patients; 16-week induction data readout on track for Q2 2026

Serial innovation in AD advances with APG279 Phase 1b expanded to approximately 80 patients with readout on track for 2H 2026 based on strong enrollment

Strong cash position of $913 million with runway into 2H 2028 supports advancement toward potential launch of zumilokibart in 2029

Management will host a conference call at 8:00 a.m. ET

SAN FRANCISCO and BOSTON, Jan. 06, 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 interim data from the Phase 1b trial of zumilokibart (APG777) in patients with mild-to-moderate asthma and highlighted upcoming 2026 milestones. The company recently received approval for the International Non-proprietary Name (INN) of zumilokibart for APG777. Zumilokibart is a novel, half-life extended anti-IL-13 antibody.

“2025 was a foundational year for Apogee, setting the stage for a potentially transformational 2026 as we plan to deliver multiple significant clinical data readouts for our monotherapy and combination programs and enter Phase 3 development,” said Michael Henderson, M.D., Chief Executive Officer of Apogee. “With today’s positive readout in patients with mild-to-moderate asthma, we are excited to advance zumilokibart in asthma and seek to further derisk its pipeline-in-a-product potential. We look forward to reporting three clinical readouts for atopic dermatitis in 2026, which we expect to further solidify the potential for our portfolio of best-in-class monotherapy and combination treatments. Apogee is well capitalized and positioned to execute on its strategic vision of transforming the standard of care for people living with I&I conditions.”

Zumilokibart (APG777) Phase 1b Positive Interim Results in Mild-to-Moderate Asthma

Today, the company announced interim results from its Phase 1b double-blind, placebo-controlled trial evaluating the safety and tolerability of zumilokibart in 19 adult patients with mild-to-moderate asthma and a fractional exhaled nitric oxide (FeNO) baseline greater or equal to 25 parts per billion (ppb) which represents an enriched Type 2 inflammation population. The trial also evaluated FeNO suppression, a key biomarker of Type 2 inflammation. Participants received a single dose of 720 mg of zumilokibart or placebo on day 1.

In the trial, zumilokibart demonstrated:

• Favorable safety profile; zumilokibart was well-tolerated in patients with mild-to-moderate asthma.
  • The only treatment-emergent adverse event (TEAE) observed in more than one patient was gastroesophageal reflux disease (GERD; 2 patients). There were no Grade 3 or higher TEAEs or serious adverse events.
  • No conjunctivitis, injection site reactions, or anti-drug antibodies (ADAs) were observed.
• Robust and durable suppression of FeNO, a biomarker of Type 2 inflammation that has shown the strongest correlation with exacerbations in asthma, following a single dose.
  • Maximum absolute mean FeNO reduction of 45 ppb (60% decrease from baseline) after single dose.
  • Durable FeNO suppression through 16 weeks for all patients.
  • Suppression of FeNO through 32 weeks for patients with available follow up, supporting potential for 3- or 6-month dosing.
• Positive trends observed in forced expiratory volume in one second (FEV1) and across Type 2 biomarkers for all available data. FEV1 is a pharmacodynamic measure of lung function. Further data from the study will be shared at upcoming medical conferences.
  
  

“This first dataset of zumilokibart in asthma is very promising and showcases the potential of this treatment to help a new patient population,” said Mario Castro, M.D., M.P.H. Chief of Pulmonary, Critical Care, and Sleep Medicine, University of Kansas. “We need new treatment options for these patients, especially those that are more convenient with the less frequent administration. These data, in particular the deep and durable FeNO suppression, highlight the promise of this drug for asthma patients with Type 2 inflammation, and I look forward to continued evaluation of zumilokibart in upcoming studies.”

“The results from this study further emphasize the versatility of zumilokibart across Type 2 inflammatory diseases, now spanning both dermatology and respiratory indications,” said Carl Dambkowski, M.D., Chief Medical Officer of Apogee. “With a favorable safety profile, as well as durable FeNO suppression, zumilokibart has the potential to serve as a foundational therapy – both as a monotherapy and in combination. Further, in patients in the APEX Phase 2 Part A trial with comorbid asthma or sinusitis, we saw improvement in asthma and sinusitis, as measured by improvements in ACQ-5 and SNOT-22, respectively, solidifying zumilokibart’s potential to broadly impact Type 2 inflammatory diseases. Based on these results, we look forward to advancing and sharing our plans later this year to further evaluate zumilokibart in the ASPIRE asthma trial. I would like to thank the patients and physicians for their support in the successful execution of this Phase 1b trial.”

Anticipated 2026 Key Milestones

Establish potential best-in-class profile for zumilokibart in future $50B+ atopic dermatitis market

• Phase 2 APEX Part A (52-week) maintenance data readout – expected Q1 2026
• Phase 2 APEX Part B (16-week) induction data readout – expected Q2 2026
  • The trial completed enrollment ahead of schedule and exceeded its target with a total of 347 patients, driven by strong interest from physicians and patients.
• Initiation of Phase 3 trial – expected 2H 2026 enabling potential launch in 2029

Execute on expansion indications for zumilokibart in treating I&I diseases beyond atopic dermatitis

• Reported positive interim data readout today of zumilokibart Phase 1b clinical trial in mild-to-moderate asthma in Type 2 inflammation patients
  • Multiple potential blockbuster expansions in dermatology, respiratory and GI with prioritization to start ASPIRE asthma trial.

Continue serial innovation in atopic dermatitis with novel combinations

• Phase 1b head-to-head clinical trial of APG279 (APG777+APG990) vs. DUPIXENT for moderate-to-severe AD readout remains on track – expected 2H 2026
  • Trial upsized from approximately 50 to 80 patients due to strong patient enrollment.
  • APG279 is Apogee’s first-in-class fixed dose combination targeting both IL-13 and OX40L.
    
    

With these readouts, Apogee expects to generate data across monotherapy and combination programs in 2026, setting the stage for potential initiation of Phase 3 trials and a potential 2029 launch of zumilokibart in AD, as well as continued expansion across the company’s portfolio. As of September 30, 2025, Apogee had total cash of $913 million (pro forma cash, cash equivalents, marketable securities, and long-term marketable securities includes $588.9M as of September 30, 2025, plus proceeds before expenses, of $324.3M from October 2025 equity financing) with cash runway into the second half of 2028.

Webcast Details
Apogee Therapeutics’ live webcast of the positive interim data results of zumilokibart Phase 1b trial in mild-to-moderate asthma will begin today at 8:00 a.m. ET. The live webcast can be accessed via this link or the Investors section on the Company’s website at https://investors.apogeetherapeutics.com/news-events/events. A replay of the webcast will be available following the call.

About Apogee
Apogee Therapeutics is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, including for the treatment of AD, asthma, EoE, COPD and other I&I indications. Apogee’s antibody programs are designed to overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), the company’s most advanced program, is being initially developed for the treatment of AD, which is the largest and one of the least penetrated I&I markets, as well as asthma. With four validated targets in its portfolio, Apogee is seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of expertise, the company believes it can deliver value and meaningful benefit to patients underserved by today’s standard of care. For more information, please visit https://apogeetherapeutics.com.

Forward Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding: the potential for zumilokibart (APG777) in asthma; Apogee’s plans for its current and future product candidates and programs; the anticipated timing of its clinical trials, including the APEX 52-week Part A in AD, APEX 16-week Part B in AD, APG279 Phase 1b head-to-head readout against DUPIXENT in AD, the potential Phase 3 trial of zumilokibart and the potential launch of zumilokibart; its planned clinical trial designs; its plans for current and future clinical trials; the potential clinical benefit and half-life, PK profile and dosing regimen, and treatment outcomes of zumilokibart and APG279; the potential to expand zumilokibart for other indications; Apogee’s other product candidates, including combination therapies, and any other potential programs; its planned business strategies; potential market sizes; and its expectations regarding the time period over which Apogee’s capital resources will be sufficient to fund its anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Apogee believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Apogee’s filings with the U.S. Securities and Exchange Commission (the SEC)), many of which are beyond the company’s control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of Apogee’s preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of Apogee’s clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in Apogee’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 3, 2025, Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, filed with the SEC on May 12, 2025, Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, filed with the SEC on August 11, 2025, Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025, filed with the SEC on November 10, 2025 and subsequent disclosure documents Apogee may file with the SEC. Apogee claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. Apogee expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.

Investor Contact:
Noel Kurdi
VP, Investor Relations
Apogee Therapeutics, Inc.
Noel.Kurdi@apogeetherapeutics.com

Media Contact:
Dan Budwick
1AB Media
dan@1abmedia.com

FAQ

What did Apogee (APGE) announce about zumilokibart Phase 1b in asthma on January 6, 2026?

Apogee announced positive interim Phase 1b results showing a 45 ppb (60%) FeNO reduction after one 720 mg dose and durable suppression through 16 weeks (and through 32 weeks for some patients).

How safe was zumilokibart in the APGE Phase 1b asthma trial?

Zumilokibart was reported as well tolerated with no Grade 3+ TEAEs, no conjunctivitis, injection-site reactions, or detectable anti-drug antibodies.

When will Apogee report key 2026 clinical readouts for APGE programs?

Apogee expects APEX Part A 52-week maintenance data in Q1 2026 and APEX Part B 16-week induction data in Q2 2026.

What is the enrollment and size milestone for Apogee’s APEX Part B trial (APGE)?

APEX Part B completed enrollment ahead of schedule and exceeded its target with 347 patients.

What cash runway did Apogee report and how long does it support APGE operations?

Apogee reported $913 million in pro forma cash, providing runway into the second half of 2028.

When does Apogee expect to initiate Phase 3 for zumilokibart and potential launch timelines (APGE)?

Apogee expects to initiate a Phase 3 trial in 2H 2026, enabling a potential commercial launch in 2029.