APGE

EX-99.1

2 apge-ex99_1.htm

EX-99.1

EX-99.1

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.

• 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 approxima

8-K

0001974640false00019746402025-11-102025-11-10

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): November 10, 2025

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 November 10, 2025, Apogee Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2025 (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 7.01 Regulation FD Disclosure.

On November 10, 2025, the Company issued a press release announcing positive interim Phase 1 results from the healthy volunteer trial of APG333 (the “Data Press Release”).

A copy of the Data Press Release is furnished as Exhibit 99.2 to this Form 8-K and is incorporated by reference herein. The exhibit furnished under Item 7.01 of this Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of 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, 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 November 10, 2025

99.2

Data Press Release, dated November 10, 2025

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:

November 10, 2025

By:

/s/ Michael Henderson, M.D.

Michael Henderson, M.D. Chief Executive Officer

8-K

0001974640false00019746402025-08-112025-08-11

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): August 11, 2025

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 August 11, 2025, Apogee Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2025 (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 August 11, 2025

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:

August 11, 2025

By:

/s/ Michael Henderson, M.D.

Michael Henderson, M.D. Chief Executive Officer