STOCK TITAN

Apogee Therapeutics Provides Pipeline Progress and Reports First Quarter 2026 Financial Results

Rhea-AI Impact
(High)
Rhea-AI Sentiment
(Positive)
Tags

Apogee Therapeutics (Nasdaq: APGE) reported Q1 2026 results and major pipeline progress. Cash, cash equivalents and securities rose to $1.3 billion, aided by a $403 million upsized equity offering, extending runway into 2029.

Phase 2 APEX 52-week data for zumilokibart in atopic dermatitis showed durable maintenance and improved efficacy with every 3- and 6-month dosing, supporting planned Phase 3 initiation in 2H 2026 and a future BLA filing in AD.

Loading...
Loading translation...

AI-generated analysis. Not financial advice.

Positive

  • Cash, cash equivalents and securities increased to $1.3 billion at March 31, 2026
  • Upsized equity offering raised approximately $403 million in gross proceeds
  • Cash runway expected to fund operations into 2029
  • APEX Phase 2 Part A 52-week data showed durable AD responses at 3- and 6-month dosing
  • Planned Phase 3 zumilokibart trials in atopic dermatitis expected to start in 2H 2026
  • Phase 1b asthma trial showed positive interim results, with more data expected in 2026

Negative

  • Quarterly net loss widened to $74.1 million from $55.3 million year over year
  • R&D expenses rose to $60.8 million from $46.4 million
  • G&A expenses increased to $22.0 million from $16.7 million

Key Figures

Cash & securities: $1.3B Cash & securities: $902.9M R&D expenses: $60.8M +5 more
8 metrics
Cash & securities $1.3B As of March 31, 2026; runway into 2029
Cash & securities $902.9M As of December 31, 2025
R&D expenses $60.8M Quarter ended March 31, 2026
R&D expenses $46.4M Quarter ended March 31, 2025
G&A expenses $22.0M Quarter ended March 31, 2026
Net loss $74.1M Quarter ended March 31, 2026
Net loss $55.3M Quarter ended March 31, 2025
Equity offering $403M Upsized public equity offering in March 2026

Market Reality Check

Price: $83.03 Vol: Volume 689,424 is 1.14x t...
normal vol
$83.03 Last Close
Volume Volume 689,424 is 1.14x the 20-day average of 603,733, indicating modestly elevated trading activity into this earnings update. normal
Technical Shares at $83.03 are trading above the 200-day MA of $62.93 and sit 12.89% below the $95.32 52-week high while up strongly from the $34.34 52-week low.

Peers on Argus

APGE is up 1.49% while momentum peers TARS and DNLI are down 3.14% and 4.04%, re...
2 Down

APGE is up 1.49% while momentum peers TARS and DNLI are down 3.14% and 4.04%, respectively, pointing to a stock-specific reaction rather than a broad biotech move.

Previous Earnings Reports

5 past events · Latest: Mar 02 (Positive)
Same Type Pattern 5 events
Date Event Sentiment Move Catalyst
Mar 02 Full-year 2025 results Positive +1.3% Full-year 2025 earnings with strong cash and upcoming trial milestones.
Nov 10 Q3 2025 earnings Positive +3.8% Q3 2025 results plus multiple 2026 readouts and large cash balance.
Aug 11 Q2 2025 earnings Positive -2.1% Q2 2025 financials and positive APEX Part A 16-week data.
May 12 Q1 2025 earnings Positive +6.1% Q1 2025 results with strong cash runway and APG777 progress.
Mar 03 Full-year 2024 results Positive -0.2% 2024 financials, higher R&D and G&A, and advancing APEX trial.
Pattern Detected

Earnings and pipeline updates have usually seen modest positive reactions, though there are occasional negative responses despite constructive news.

Recent Company History

Over the past year, Apogee’s earnings and pipeline updates have consistently highlighted advancing APG777/Zumilokibart and a strengthening balance sheet. Prior earnings releases in 2024–2025 emphasized growing cash balances (up to $731.1M) and multiple upcoming readouts, with share reactions mostly positive but mixed. Today’s Q1 2026 update, combining strong $1.3B cash, extended runway into 2029, and detailed efficacy data, fits this pattern of using earnings as a platform for pipeline milestones and funding visibility.

Historical Comparison

+1.8% avg move · In the past five earnings-style updates, APGE moved an average of 1.79%. Today’s 1.49% gain sits wit...
earnings
+1.8%
Average Historical Move earnings

In the past five earnings-style updates, APGE moved an average of 1.79%. Today’s 1.49% gain sits within that typical range, suggesting a historically consistent response.

Earnings releases have tracked APGE’s evolution from early APEX enrollment to multiple readouts, growing cash from $621.2M$902.9M to $1.3B, and a clearer path toward Phase 3 and BLA plans.

Market Pulse Summary

This announcement combines detailed long-term Zumilokibart data with Q1 2026 financials, highlightin...
Analysis

This announcement combines detailed long-term Zumilokibart data with Q1 2026 financials, highlighting a strengthened cash balance of $1.3B and projected runway into 2029. Historically, Apogee has used earnings events to flag key milestones, and today’s update reinforces the path to Phase 3 trials and a potential BLA filing in atopic dermatitis. Investors may focus on execution against upcoming APEX Part B readout, expansion into asthma and EoE, and trends in rising R&D and G&A expenses.

Key Terms

eosinophilic esophagitis, EASI-75, EASI-90, BLA filing, +2 more
6 terms
eosinophilic esophagitis medical
"expansion plans are underway with additional trial details for asthma and eosinophilic esophagitis (EoE) expected later this year"
A chronic allergic condition in which a type of white blood cell builds up in the tube that carries food from the mouth to the stomach, causing inflammation, difficulty swallowing and chest or throat pain; think of it as sticky residue narrowing a pipe. It matters to investors because prevalence, diagnostic rates and treatment options drive demand for drugs, tests and procedures, and clinical or regulatory news can quickly change revenue and valuation for healthcare companies working on therapies or diagnostics.
EASI-75 medical
"Of patients that achieved EASI-75 at Week 16, 75% of patients with every 3-month dosing"
EASI-75 is a clinical result meaning a patient has achieved at least a 75% improvement on the Eczema Area and Severity Index, a standardized score that combines how much skin is affected and how severe the symptoms are. Investors watch EASI-75 because it serves as a clear, widely accepted benchmark of a drug’s effectiveness in eczema trials—like a pass/fail meter—so higher EASI-75 rates improve a therapy’s approval odds and commercial prospects.
EASI-90 medical
"EASI-90 of 75% and 48% at Week 52 improving up to 36% from Week 16"
A clinical-trial endpoint that measures a 90% improvement in a patient’s eczema signs and affected skin area compared with their baseline score. It’s a high bar for treatment effectiveness—like cutting nine out of ten problem spots—and matters to investors because achieving EASI-90 can signal a therapy is substantially better than existing options, boosting chances of regulatory approval, market adoption, and commercial value.
BLA filing regulatory
"runway into 2029, through planned BLA filing for AD, subject to regulatory alignment"
A BLA filing is a formal application to the U.S. Food and Drug Administration requesting permission to market a biological product, such as a vaccine or therapeutic made from living cells. It contains the company’s complete data on safety, effectiveness and manufacturing quality. For investors, a BLA filing is a major regulatory milestone: approval clears the way to sell the product and generate revenue, while delays or rejection can sharply affect a company’s prospects — think of it like applying for a commercial license to operate a new, tightly regulated business.
Phase 3 medical
"Phase 3 initiation in atopic dermatitis (AD) expected later this year"
Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
rule 10b5-1 trading plan regulatory
"sales totaling 5,500 shares of common stock ... under a pre-arranged Rule 10b5-1 trading plan"
A Rule 10b5-1 trading plan is a pre-arranged schedule that allows company insiders to buy or sell stock at specific times, even if they have inside information. It helps prevent accusations of unfair trading by making these transactions look planned and transparent, rather than sneaky or illegal.

AI-generated analysis. Not financial advice.

Zumilokibart advancing across multiple indications, with Phase 3 initiation in atopic dermatitis (AD) expected later this year:
- APEX Phase 2 Part A 52-week data demonstrated durable maintenance and improved efficacy over time with every 3- and 6-month dosing in moderate-to-severe AD
- APEX Phase 2 Part B 16-week data in AD expected in Q2 2026
- Following positive Phase 1b asthma results earlier this year, expansion plans are underway with additional trial details for asthma and eosinophilic esophagitis (EoE) expected later this year

Strong cash position of $1.3B following successful public equity offering extending runway into 2029, through planned BLA filing for AD, subject to regulatory alignment

SAN FRANCISCO and BOSTON, May 11, 2026 (GLOBE NEWSWIRE) -- Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing optimized, novel biologics with the potential for best-in-class profiles in the largest inflammatory and immunology (I&I) markets, today provided pipeline progress and reported first quarter 2026 financial results.

“We are off to a rapid start in 2026, reflecting the team’s relentless focus on execution. Most notably, the APEX Phase 2 Part A 52-week results exceeded our expectations and reinforced the potentially best-in-class profile of zumilokibart as well as the central role of IL-13 as the master cytokine in AD. Zumilokibart demonstrated durable maintenance of response with 3- and 6-month dosing and improved efficacy of responses across all lesional and itch endpoints with meaningfully fewer doses than current therapies, representing a potentially transformational opportunity as a first-line product for AD patients,” said Michael Henderson, M.D., Chief Executive Officer of Apogee Therapeutics. “Based on these results, together with the positive Phase 1b asthma data shared in January 2026, we remain confident in the pipeline-in-a-product potential for zumilokibart and plan to outline broader expansion into asthma and EoE trials later this year. Following our recent successful financing, Apogee is well capitalized with cash runway into 2029, supporting advancement towards a BLA filing for AD and continued execution across our development programs, including the APEX Phase 2 Part B readout expected this quarter and initiation of our Phase 3 trials in AD expected later this year.”

Pipeline Progress, Corporate Highlights and Upcoming Milestones

  • APEX Phase 2 Part A 52-week data for zumilokibart demonstrated durable maintenance and improved efficacy with every 3- and 6-month dosing in moderate-to-severe AD; APEX Phase 2 Part B 16-week data expected in Q2 2026:
    • In March 2026, the company reported 52-week maintenance data evaluating 360mg of zumilokibart at 3- and 6-month intervals. At Week 52, durable maintenance of response was observed among Week 16 responders, as well as improved efficacy across the full treated population for all lesion and itch endpoints. Zumilokibart was well-tolerated with a safety profile consistent with other agents in the class.
      • Of patients that achieved EASI-75 at Week 16, 75% of patients with every 3-month dosing and 85% of patients with every 6-month dosing maintained response at Week 52.
      • Of patients that achieved IGA 0/1 at Week 16, 86% of patients with every 3-month dosing and 78% of patients with every 6-month dosing maintained response at Week 52.
      • Across the entire population treated with zumilokibart, responses improved through Week 52 for both every 3- and 6-month regimens, with IGA 0/1 of 72% and 52% at Week 52 improving up to 35% from Week 16, EASI-90 of 75% and 48% at Week 52 improving up to 36% from Week 16, and EASI-100 of 41% and 19% at Week 52 improving by up to 33% from Week 16, for every 3- and 6-month dosing, respectively.
    • At this year’s American Academy of Dermatology (AAD) Annual Meeting, the company presented additional data including a late-breaking oral session, highlighting:
      • Of patients who achieved EASI-90 at Week 16, 88% of patients with every 3-month dosing and 72% of patients with every 6-month dosing maintained such response at Week 52.
      • Zumilokibart demonstrated improvements in lesional skin transcriptome across Type 1, 2, and 3 inflammatory pathways.
    • Part B of the APEX trial is designed to determine the optimized induction dose of zumilokibart, looking at low, medium (Part A dose), and high dose regimens vs. placebo. Results will determine the induction dosing regimen for the planned Phase 3 trials of zumilokibart, expected to initiate in the second half of 2026.
  • Completed $403 million upsized public equity offering:
    • Following the Phase 2 APEX Part A readout in March 2026, Apogee closed on an upsized public equity offering, including the full exercise of the underwriters’ option to purchase additional shares, with aggregate gross proceeds of approximately $403 million (before deducting underwriting discounts, commissions, and other offering expenses), which supports cash runway into 2029 through a planned BLA filing for zumilokibart in AD.
  • Zumilokibart demonstrated positive interim results from the Phase 1b trial in mild-to-moderate asthma in January 2026, reinforcing pipeline-in-a-product potential across I&I indications:
    • The company plans to provide further details on asthma and EoE trials for zumilokibart later this year.
    • Additional data from the Phase 1b asthma trial is expected to be shared at an upcoming medical conference.
  • Combination pipeline continues to advance across AD and respiratory indications for APG279 and APG273 with potential for improved efficacy and dosing:
    • Phase 1b head-to-head study of APG279 (zumilokibart + APG990) versus DUPIXENT in AD is fully enrolled and expanded to 86 patients, with interim 24-week data expected in 2H 2026.
    • Plans to advance APG273 (zumilokibart + APG333) in respiratory indications expected to be disclosed later this year.
      • Positive read-through from competitor proof-of-concept data in respiratory indications supports continued development of APG273.

First Quarter 2026 Financial Results

  • Cash Position: Cash, cash equivalents, marketable securities and long-term marketable securities were $1.3 billion as of March 31, 2026, compared to $902.9 million as of December 31, 2025. Based on current operating plans, Apogee expects its existing cash, cash equivalents, marketable securities and long-term marketable securities will enable the company to fund its operating expenses into 2029.

  • R&D Expenses: Research and development (R&D) expenses were $60.8 million for the quarter ended March 31, 2026, compared to $46.4 million for the quarter ended March 31, 2025. R&D expenses increased primarily driven by the continued development of our zumilokibart (APG777) and APG990/APG279 programs, increased external-discovery related costs, and higher personnel and equity-based compensation expenses associated with the growth in our research and development team, partially offset by decreases in expenses related to the APG333/APG273 program.

  • G&A Expenses: General and administrative (G&A) expenses were $22.0 million for the quarter ended March 31, 2026, compared to $16.7 million for the quarter ended March 31, 2025. G&A expenses increased primarily due to increases in personnel-related expenses and equity-based compensation, primarily driven by increased headcount and an increase in the fair value of equity awards granted. These increases are the result of the company’s expansion of operations to support the growth of its business.

  • Net Loss: Net loss was $74.1 million for the quarter ended March 31, 2026, compared to a net loss of $55.3 million for the quarter ended March 31, 2025. Net loss increased primarily as a result of higher R&D and G&A expenses as described above.

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 and programs; the anticipated timing of its clinical trials and clinical trial results, including the APEX Phase 2 Part B 16-week data readout, Phase 3 trials for zumilokibart in AD, APG279 Phase 1b head-to-head interim 24-week data readout against DUPIXENT in AD, and additional Phase 1b asthma trial data; its planned clinical trial designs; its plans for current and future clinical trials, including planned asthma and EoE trials for zumilokibart and advancement of APG273 in respiratory indications; the potential clinical benefit, dosing regimen, safety, PK, PD and efficacy profiles and treatment outcomes of zumilokibart, APG279, APG273, APG990, and APG333, any other product candidates, including combination therapies, and any other potential programs; the pipeline-in-a-product potential and best-in-class profile for zumilokibart; its planned business strategies; its expected timing for future pipeline updates, regulatory decisions, BLA filing for zumilokibart in AD, and potential commercialization; 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 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.

 
APOGEE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share data)
 
 MARCH 31,
2026
  DECEMBER 31,
2025
 
Assets     
Current assets:     
Cash and cash equivalents$451,797  $131,549 
Marketable securities 608,088   598,643 
Prepaid expenses and other current assets 13,912   11,166 
Total current assets 1,073,797   741,358 
Long-term marketable securities 198,354   172,730 
Property and equipment, net 5,280   5,688 
Right-of-use asset, net 7,707   8,687 
Other non-current assets 8,516   8,671 
Total assets$1,293,654  $937,134 
Liabilities and stockholders' equity     
Current liabilities:     
Accounts payable$1,237  $1,221 
Lease liability 3,138   3,504 
Accrued expenses and other current liabilities 28,577   23,181 
Total current liabilities 32,952   27,906 
Long-term liabilities:     
Lease liability, net of current 4,909   5,345 
Total liabilities 37,861   33,251 
Stockholders' equity:     
Common Stock; $0.00001 par value, 400,000,000 authorized, 75,323,726 issued and 74,882,396 outstanding as of March 31, 2026; 400,000,000 authorized, 69,038,943 issued and 68,401,349 outstanding as of December 31, 2025 1   1 
Additional paid-in capital 1,892,411   1,464,561 
Accumulated other comprehensive income (loss) (749)  1,080 
Accumulated deficit (635,870)  (561,759)
Total stockholders’ equity 1,255,793   903,883 
Total liabilities and stockholders’ equity$1,293,654  $937,134 


 
APOGEE THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(In thousands)
 
 THREE MONTHS ENDED MARCH 31, 
 2026  2025 
Operating expenses:     
Research and development$60,819  $46,387 
General and administrative 21,953   16,709 
Total operating expenses 82,772   63,096 
Loss from operations (82,772)  (63,096)
Other income, net:     
Interest income, net 8,740   7,840 
Total other income, net 8,740   7,840 
Net loss before taxes (74,032)  (55,256)
Provision for income taxes (79)  (83)
Net loss after taxes$(74,111) $(55,339)


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 were Apogee Therapeutics (APGE) Q1 2026 financial results?

Apogee reported a Q1 2026 net loss of $74.1 million on rising R&D and G&A expenses. According to Apogee, cash, cash equivalents and marketable securities totaled $1.3 billion, providing funding runway into 2029 based on current operating plans.

How strong is Apogee Therapeutics (APGE) cash position after Q1 2026?

Apogee ended Q1 2026 with $1.3 billion in cash, cash equivalents and securities. According to Apogee, this reflects a $403 million upsized equity offering and is expected to fund operating expenses into 2029, including planned Phase 3 trials and a future BLA filing in atopic dermatitis.

What did the APEX Phase 2 52-week data show for zumilokibart in atopic dermatitis?

APEX Phase 2 Part A 52-week data showed durable maintenance and improved efficacy with 3- and 6-month zumilokibart dosing. According to Apogee, high proportions of Week 16 responders maintained EASI-75 and IGA 0/1 responses at Week 52, with responses improving across lesion and itch endpoints.

When will Apogee Therapeutics start Phase 3 trials of zumilokibart in atopic dermatitis?

Phase 3 trials of zumilokibart in atopic dermatitis are expected to begin in the second half of 2026. According to Apogee, APEX Phase 2 Part B will determine the optimized induction dose, guiding the Phase 3 design and supporting a planned BLA filing, subject to regulatory alignment.

What are the key upcoming clinical milestones for Apogee Therapeutics (APGE) in 2026?

Key 2026 milestones include APEX Phase 2 Part B 16-week data in Q2, Phase 3 AD trial initiation in 2H, and additional asthma data. According to Apogee, further details on asthma and eosinophilic esophagitis trials and APG273 respiratory plans are also expected later in 2026.

How did R&D and G&A expenses change for Apogee Therapeutics in Q1 2026?

R&D expenses rose to $60.8 million and G&A to $22.0 million in Q1 2026. According to Apogee, increases were driven by zumilokibart and combination program development, external discovery costs, higher headcount, and equity-based compensation as operations expanded.

What is the status of Apogee Therapeutics’ combination programs APG279 and APG273?

APG279’s Phase 1b head-to-head study versus DUPIXENT in atopic dermatitis is fully enrolled with 86 patients, with 24-week interim data expected in 2H 2026. According to Apogee, advancement plans for APG273 in respiratory indications are expected to be disclosed later this year.