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Apogee Therapeutics (Nasdaq: APGE) Q1 loss widens, cash runway to 2029

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Apogee Therapeutics reported a larger net loss but strong cash position for the first quarter of 2026 while highlighting significant pipeline progress. Net loss was $74.1 million for the quarter ended March 31, 2026, compared with $55.3 million a year earlier, driven by higher R&D and G&A spending.

R&D expenses rose to $60.8 million from $46.4 million, and G&A expenses increased to $22.0 million from $16.7 million, reflecting expansion of zumilokibart and combination programs and higher personnel costs. Cash, cash equivalents, marketable securities and long‑term marketable securities totaled $1.3 billion as of March 31, 2026, up from $902.9 million on December 31, 2025, supported by an upsized public equity offering with approximately $403 million in gross proceeds.

The company reported strong 52‑week Phase 2 APEX Part A data for zumilokibart in atopic dermatitis, with high maintenance of EASI‑75 and IGA 0/1 responses on 3‑ and 6‑month dosing, and plans to start Phase 3 trials in the second half of 2026. Interim positive Phase 1b asthma results, advancing combination assets APG279 and APG273, and a stated cash runway into 2029 underpin plans to pursue a future BLA filing for zumilokibart in atopic dermatitis.

Positive

  • Strengthened balance sheet and runway: Cash, cash equivalents, marketable securities and long-term marketable securities reached approximately $1.3 billion as of March 31, 2026, boosted by an upsized public equity offering with about $403 million in gross proceeds, which the company expects will fund operations into 2029.
  • Compelling zumilokibart data and clear path to Phase 3: APEX Phase 2 Part A 52-week results in atopic dermatitis showed durable, improving EASI and IGA responses on 3- and 6-month dosing, supporting Phase 3 trials planned to start in the second half of 2026 and a future BLA filing.

Negative

  • None.

Insights

Strong clinical data and a $403M raise extend Apogee's cash runway into 2029.

Apogee Therapeutics combines robust clinical momentum with fortified finances. APEX Phase 2 Part A 52‑week data for zumilokibart in atopic dermatitis show durable EASI‑75 and IGA 0/1 responses on infrequent dosing, supporting a potential best‑in‑class positioning and Phase 3 initiation in 2H 2026.

The company closed an upsized public equity offering with approximately $403 million in gross proceeds, lifting total cash, cash equivalents and securities to about $1.3 billion as of March 31, 2026. Management believes this funds operations into 2029, through a planned BLA filing for atopic dermatitis.

Quarterly R&D of $60.8 million and G&A of $22.0 million increased versus the prior year as Apogee scales multiple programs, leading to a net loss of $74.1 million. For investors, the key near‑term catalysts disclosed are APEX Part B 16‑week data in Q2 2026 and Phase 3 trial initiation in atopic dermatitis later in 2026.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Cash and securities $1.3 billion Cash, cash equivalents, marketable and long-term marketable securities as of March 31, 2026
Equity offering gross proceeds $403 million Upsized public equity offering completed after APEX Part A readout
R&D expenses $60.8 million Quarter ended March 31, 2026 vs $46.4 million in Q1 2025
G&A expenses $22.0 million Quarter ended March 31, 2026 vs $16.7 million in Q1 2025
Net loss $74.1 million Quarter ended March 31, 2026 vs $55.3 million in Q1 2025
Total assets $1,293.7 million Total assets as of March 31, 2026
Total stockholders’ equity $1,255.8 million Stockholders’ equity as of March 31, 2026
Shares outstanding 74,882,396 shares Common stock outstanding as of March 31, 2026
APEX Phase 2 medical
"APEX Phase 2 Part A 52-week data demonstrated durable maintenance and improved efficacy"
EASI-75 medical
"Of patients that achieved EASI-75 at Week 16, 75% and 85% maintained response at Week 52"
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.
IGA 0/1 medical
"Of patients that achieved IGA 0/1 at Week 16, 86% and 78% maintained response at Week 52"
BLA filing regulatory
"supporting advancement towards a BLA filing for AD and continued execution across our development programs"
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.
pipeline-in-a-product financial
"we remain confident in the pipeline-in-a-product potential for zumilokibart"
marketable securities financial
"Cash, cash equivalents, marketable securities and long-term marketable securities were $1.3 billion"
Marketable securities are financial assets — such as publicly traded stocks, bonds, and short-term government bills — that a company can quickly sell for cash at a known price. Investors watch them because they show how much ready cash a company can access without selling core operations, like keeping money in a highly liquid savings account versus being tied up in a house, and they affect short-term risk, financial flexibility, and balance-sheet strength.
R&D expenses $60.8 million
G&A expenses $22.0 million
Net loss $74.1 million
Cash and securities $1.3 billion
Understanding 8-K Material Events →
false000197464000019746402026-05-112026-05-11

 

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 11, 2026

 

 

Apogee Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-41740

93-4958665

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

221 Crescent St., Bldg 17, Suite 102b

 

Waltham, Massachusetts

 

02453

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (650) 394-5230

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

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 2.02 Results of Operations and Financial Condition.

On May 11, 2026, Apogee Therapeutics, Inc. (the “Company”) issued a press release providing a business update and announcing its financial results for the quarter ended March 31, 2026 (the “Earnings Press Release”).

A copy of the Earnings Press Release is furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Form 8-K”) and is incorporated by reference herein. The exhibit furnished under Item 2.02 of this Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), regardless of any general incorporation language in such filing.

 

 

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits. The following exhibits are being furnished herewith:

EXHIBIT INDEX

Exhibit
No.

 

Description

 

 

99.1

 

Earnings Press Release, dated May 11, 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 11, 2026

By:

/s/ Michael Henderson, M.D.

 

 

 

Michael Henderson, M.D.
Chief Executive Officer

 

img126220792_0.jpg

 

 

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

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 – 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.

 

img126220792_0.jpg

 

 

•
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.
o
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:
o
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:
o
The company plans to provide further details on asthma and EoE trials for zumilokibart later this year.
o
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:
o
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.
o
Plans to advance APG273 (zumilokibart + APG333) in respiratory indications expected to be disclosed later this year.

 

img126220792_0.jpg

 

 

•
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.

 

 

img126220792_0.jpg

 

 

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.

 

img126220792_0.jpg

 

 

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

 

 

 

img126220792_0.jpg

 

 

 

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

 

 

Source: View Original Filing on SEC EDGAR

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