10-Q – 2025-08-11 – apge-20250630.htm

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10-Q

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Table of Contents

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
 
FORM 10-Q
 
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2025
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 001-41740
 
 
Apogee Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
 
 
 

 

 

Delaware

93-4958665

(State or other jurisdiction of
incorporation or organization)

(I.R.S. Employer
Identification Number)

 
221 Crescent St ., Building 17 , Suite 102b
Waltham , MA 02453
( 650 ) 394‑5230
(Address including zip code, and telephone number including area code, of registrant’s principal executive offices)
Former name, former address and former fiscal year, if changed since last report: N/A
 
 
Securities registered pursuant to Section 12(b) of the Exchange 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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b‑2 of the Exchange Act.
 

Large accelerated filer

☒

Accelerated filer

☐

Non-accelerated filer

☐

Smaller reporting company

☐

 

 

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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b‑2 of the Exchange Act). Yes ☐ No ☒
As of August 4, 2025 , the registrant had 59,596,409 shares of common stock, $0.00001 par value per share, outstanding, comprising 46,109,767 shares of voting common stock, $0.00001 par value per share and 13,486,642 shares of non-voting common stock, $0.00001 par value per share.
 

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APOGEE THERAPEUTICS, INC.
TABLE O F CONTENTS

 

 

 

 

 

Page

PART I

FINANCIAL INFORMATION

1

Item 1.

Condensed Consolidated Financial Statements (Unaudited)

1

 

Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024

1

 

Condensed Consolidated Statement of Operations for the Three and Six Months Ended June 30, 2025 and 2024

2

 

Condensed Consolidated Statement of Comprehensive Loss for the Three and Six Months Ended June 30, 2025 and 2024

3

 

Condensed Consolidated Statement of Stockholders’ Equity for the Three and Six Months Ended June 30, 2025 and 2024

4

 

Condensed Consolidated Statement of Cash Flows for the Six Months Ended June 30, 2025 and 2024

6

 

Notes to the Unaudited Interim Condensed Consolidated Financial Statements

7

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

25

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

42

Item 4.

Controls and Procedures

42

PART II

OTHER INFORMATION

43

Item 1.

Legal Proceedings

43

Item 1A.

Risk Factors

43

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

75

Item 3.

Defaults Upon Senior Securities

75

Item 4.

Mine Safety Disclosures

75

Item 5.

Other Information

75

Item 6.

Exhibits

76

 

Signatures

77

 
 

 

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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (this “Quarterly Report”) contains “forward-looking statements” within the meaning of the federal securities laws, which statements are subject to substantial risks and uncertainties and are based on current expectations, estimates, forecasts and assumptions. All statements other than statements of historical fact included in this Quarterly Report, including statements concerning our plans, objectives, goals, strategies, future events, future revenues or performance, capital requirements or financing needs, capital expenditures, commitments, preclinical studies, clinical trials, plans or intentions relating to product candidates, expected markets, business trends and other statements, including without limitation, those discussed under the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “would,” “shall,” “intend,” “target,” “should,” “could,” “can,” “expect,” “anticipate,” “believe,” “design,” “estimate,” “forecast,” “predict,” “potential,” “plan,” “seek,” or “continue” or the negative of these terms and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events. Given the significant risks and uncertainties, you should not place undue reliance on these forward-looking statements.
There are a number of risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this Quarterly Report. Such risks, uncertainties and other factors include, among others, the following:
• our plans to develop and commercialize our programs for the treatment of atopic dermatitis, asthma, eosinophilic esophagitis, chronic obstructive pulmonary disease, and related inflammatory and immunology indications with high unmet need;

• our ability to obtain funding for our operations, including funding necessary to complete the development and commercialization of our programs;

• the timing and focus of our ongoing and future preclinical studies and clinical trials and the reporting of data from those studies and trials;

• the beneficial characteristics, safety, efficacy and therapeutic effects of our programs;

• our plans relating to the further development of our programs, including additional indications we may pursue;

• the size of the market opportunity for our programs, including our estimates of the number of patients who suffer from the diseases we are targeting;

• our continued reliance on third parties to conduct additional preclinical studies and clinical trials of our programs and for the manufacture of our product candidates for preclinical studies and clinical trials;

• the success, cost and timing of our preclinical and clinical development activities and planned clinical trials;

• our plans regarding, and our ability to obtain, and negotiate favorable terms of, any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our programs;

• the timing of and our ability to obtain and maintain regulatory approvals for our programs, as well as potential future programs;

• the rate and degree of market acceptance and clinical utility of our programs;

• the success of competing treatments that are or may become available;

• our ability to attract and retain key management and technical personnel;

• our expectations regarding our ability to obtain, maintain and enforce intellectual property protection for our programs;

• our financial performance;

• the period over which we estimate our existing cash and cash equivalents, marketable securities and long-term marketable securities will be sufficient to fund our future operating expenses and capital expenditure requirements;

• our anticipated use of our existing resources;

 

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• adverse macroeconomic conditions, including inflation, slower growth or recession, new or increased tariffs and other barriers to trade, changes to fiscal and monetary policy or government budget dynamics (particularly in the pharmaceutical and biotech areas), volatility in financial markets and other challenges in the global economy; and

• uncertainty around the funding, functioning and policy priorities of the U.S. federal regulatory agencies, including the U.S. Food and Drug Administration.

These and other risks and uncertainties and other factors, including those discussed under the section titled “Risk Factors” of this Quarterly Report, may cause our actual results and outcomes, or timing of our results or outcomes, to differ materially and adversely from the forward-looking statements expressed or implied in this Quarterly Report including factors disclosed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” You should evaluate all forward-looking statements made in this Quarterly Report in the context of these risks and uncertainties.
We caution you that the risks, uncertainties and other factors referred to above and elsewhere in this Quarterly Report may not contain all of the risks, uncertainties and other factors that may affect us, our future results or our operations. Moreover, new risks may emerge from time to time. It is not possible for us to predict all risks. In addition, we cannot assure you that we will realize the results, benefits or developments that we expect or anticipate or, even if substantially realized, that they will result in the consequences or affect us or our business in the way expected.
All forward-looking statements in this Quarterly Report apply only as of the date made and are expressly qualified in their entirety by this and other cautionary statements included in this Quarterly Report. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, subsequent events, changes in assumptions or circumstances or otherwise.
In addition, statements such as “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report, and while we believe we have a reasonable basis for such statements, our information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to unduly rely upon these statements.
The Apogee name and logo are our registered trademarks. This Quarterly Report contains references to our trademarks and to trademarks and service marks belonging to other entities. Solely for convenience, trademarks, service marks and trade names referred to in this Quarterly Report, including logos, artwork and other visual displays, may appear without the ®, SM , or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity.

 

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PART I – FINA NCIAL INFORMATION
APOGEE THERAPEUTICS, INC.
CONDENSED CON SOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share data)
 

 

JUNE 30,
2025

 

 

DECEMBER 31,
2024

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

124,192

 

 

$

141,789

 

Marketable securities

 

 

381,228

 

 

 

378,864

 

Prepaid expenses and other current assets

 

 

10,702

 

 

 

9,060

 

Total current assets

 

 

516,122

 

 

 

529,713

 

Long-term marketable securities

 

 

115,769

 

 

 

210,416

 

Property and equipment, net

 

 

6,438

 

 

 

1,959

 

Right-of-use asset, net

 

 

10,586

 

 

 

11,365

 

Other non-current assets

 

 

8,857

 

 

 

498

 

Total assets

 

$

657,772

 

 

$

753,951

 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,678

 

 

$

1,071

 

Lease liability

 

 

4,025

 

 

 

3,234

 

Accrued expenses and other current liabilities

 

 

21,848

 

 

 

24,255

 

Total current liabilities

 

 

31,551

 

 

 

28,560

 

Long-term liabilities:

 

 

 

 

 

 

Lease liability, net of current

 

 

6,820

 

 

 

8,597

 

Total liabilities

 

 

38,371

 

 

 

37,157

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Common Stock; $ 0.00001  par value, 400,000,000  authorized, 59,587,430  issued and 58,560,525  outstanding as of June 30, 2025; 400,000,000  authorized, 59,478,725  issued and 58,062,898  outstanding as of December 31, 2024

 

 

1

 

 

 

1

 

Additional paid-in capital

 

 

1,046,066

 

 

 

1,021,794

 

Accumulated other comprehensive income

 

 

685

 

 

 

915

 

Accumulated deficit

 

 

( 427,351

)

 

 

( 305,916

)

Total stockholders’ equity

 

 

619,401

 

 

 

716,794

 

Total liabilities and stockholders’ equity

 

$

657,772

 

 

$

753,951

 

 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 

1

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APOGEE THERAPEUTICS, INC.
CONDENSED CONSOLIDA TED STATEMENT OF OPERATIONS
(UNAUDITED)
(In thousands, except share and per share data)

 

THREE MONTHS ENDED
JUNE 30,

 

 

SIX MONTHS ENDED
JUNE 30,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development (1)

 

$

55,703

 

 

$

33,206

 

 

$

102,090

 

 

$

61,922

 

General and administrative

 

 

17,462

 

 

 

10,916

 

 

 

34,171

 

 

 

20,381

 

Total operating expenses

 

 

73,165

 

 

 

44,122

 

 

 

136,261

 

 

 

82,303

 

Loss from operations

 

 

( 73,165

)

 

 

( 44,122

)

 

 

( 136,261

)

 

 

( 82,303

)

Other income, net:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income, net

 

 

7,141

 

 

 

10,306

 

 

 

14,981

 

 

 

16,393

 

Total other income, net

 

 

7,141

 

 

 

10,306

 

 

 

14,981

 

 

 

16,393

 

Net loss before taxes

 

 

( 66,024

)

 

 

( 33,816

)

 

 

( 121,280

)

 

 

( 65,910

)

Provision for income taxes

 

 

( 72

)

 

 

—

 

 

 

( 155

)

 

 

—

 

Net loss after taxes

 

$

( 66,096

)

 

$

( 33,816

)

 

$

( 121,435

)

 

$

( 65,910

)

Net loss per share, basic and diluted

 

$

( 1.13

)

 

$

( 0.60

)

 

$

( 2.08

)

 

$

( 1.24

)

Weighted-average common shares outstanding, basic and diluted

 

 

58,428,344

 

 

 

56,515,003

 

 

 

58,312,452

 

 

 

53,352,406

 

 
(1) Includes related-party amounts of $ 98 and $ 130 for the three and six months ended June 30, 2025, respectively, and $ 2,221 and $ 8,678 for the three and six months ended June 30, 2024 , respectively.

The accompanying notes are an integral part of these condensed consolidated financial statements.

2

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APOGEE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STAT EMENT OF COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands)

 

THREE MONTHS ENDED
JUNE 30,

 

 

SIX MONTHS ENDED
JUNE 30,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Net loss

 

$

( 66,096

)

 

$

( 33,816

)

 

$

( 121,435

)

 

$

( 65,910

)

Unrealized losses on marketable securities, net of tax

 

 

( 389

)

 

 

( 112

)

 

 

( 230

)

 

 

( 618

)

Comprehensive loss

 

$

( 66,485

)

 

$

( 33,928

)

 

$

( 121,665

)

 

$

( 66,528

)

The accompanying notes are an integral part of these condensed consolidated financial statements.

3

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APOGEE THERAPEUTICS, INC.
CONDENSED CONSOLIDAT ED STATEMENT OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
(In thousands, except share data)

 

COMMON STOCK

 

 

ADDITIONAL
PAID-IN
CAPITAL

 

 

ACCUMULATED
DEFICIT

 

 

ACCUMULATED
OTHER
COMPREHENSIVE
INCOME (LOSS)

 

 

TOTAL
STOCKHOLDERS'
EQUITY

 

 

SHARES

 

 

AMOUNT

 

 

AMOUNT

 

 

AMOUNT

 

 

AMOUNT

 

 

AMOUNT

 

Balance at December 31, 2024

 

 

58,062,898

 

 

$

1

 

 

$

1,021,794

 

 

$

( 305,916

)

 

$

915

 

 

$

716,794

 

Vesting of restricted stock

 

 

213,104

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon exercise of stock options

 

 

28,799

 

 

 

—

 

 

 

622

 

 

 

—

 

 

 

—

 

 

 

622

 

Equity-based compensation expense

 

 

—

 

 

 

—

 

 

 

11,126

 

 

 

—

 

 

 

—

 

 

 

11,126

 

Unrealized gain on marketable securities, net of tax

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

159

 

 

 

159

 

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 55,339

)

 

 

—

 

 

 

( 55,339

)

Balance at March 31, 2025

 

 

58,304,801

 

 

$

1

 

 

$

1,033,542

 

 

$

( 361,255

)

 

$

1,074

 

 

$

673,362

 

Vesting of restricted stock

 

 

213,031

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon exercise of stock options

 

 

21,123

 

 

 

—

 

 

 

384

 

 

 

—

 

 

 

—

 

 

 

384

 

Issuance of common stock under employee stock purchase plan

 

 

21,570

 

 

 

—

 

 

 

796

 

 

 

—

 

 

 

—

 

 

 

796

 

Equity-based compensation expense

 

 

—

 

 

 

—

 

 

 

11,344

 

 

 

—

 

 

 

—

 

 

 

11,344

 

Unrealized loss on marketable securities, net of tax

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 389

)

 

 

( 389

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 66,096

)

 

 

—

 

 

 

( 66,096

)

Balance at June 30, 2025

 

 

58,560,525

 

 

$

1

 

 

$

1,046,066

 

 

$

( 427,351

)

 

$

685

 

 

$

619,401

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

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APOGEE THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
(In thousands, except share data)

 

COMMON STOCK

 

 

ADDITIONAL
PAID-IN
CAPITAL

 

 

ACCUMULATED
DEFICIT

 

 

ACCUMULATED
OTHER
COMPREHENSIVE
INCOME (LOSS)

 

 

TOTAL
STOCKHOLDERS'
EQUITY

 

 

SHARES

 

 

AMOUNT

 

 

AMOUNT

 

 

AMOUNT

 

 

AMOUNT

 

 

AMOUNT

 

Balance at December 31, 2023

 

 

48,338,769

 

 

$

—

 

 

$

503,354

 

 

$

( 123,770

)

 

$

329

 

 

$

379,913

 

Common stock issued, net of issuance costs of $ 33,045

 

 

7,790,321

 

 

 

1

 

 

 

449,954

 

 

 

—

 

 

 

—

 

 

 

449,955

 

Vesting of restricted stock

 

 

237,665

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon exercise of stock options

 

 

1,047

 

 

 

—

 

 

 

24

 

 

 

—

 

 

 

—

 

 

 

24

 

Equity-based compensation expense

 

 

—

 

 

 

—

 

 

 

4,186

 

 

 

—

 

 

 

—

 

 

 

4,186

 

Unrealized loss on marketable securities, net of tax

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 506

)

 

 

( 506

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 32,094

)

 

 

—

 

 

 

( 32,094

)

Balance at March 31, 2024

 

 

56,367,802

 

 

$

1

 

 

$

957,518

 

 

$

( 155,864

)

 

$

( 177

)

 

$

801,478

 

Vesting of restricted stock

 

 

292,477

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Issuance of common stock upon exercise of stock options

 

 

628

 

 

 

—

 

 

 

14

 

 

 

—

 

 

 

—

 

 

 

14

 

Issuance of common stock under employee stock purchase plan

 

 

15,558

 

 

 

—

 

 

 

377

 

 

 

—

 

 

 

—

 

 

 

377

 

Equity-based compensation expense

 

 

—

 

 

 

—

 

 

 

5,698

 

 

 

—

 

 

 

—

 

 

 

5,698

 

Unrealized loss on marketable securities, net of tax

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 112

)

 

 

( 112

)

Net loss

 

 

—

 

 

 

—

 

 

 

—

 

 

 

( 33,816

)

 

 

—

 

 

 

( 33,816

)

Balance at June 30, 2024

 

 

56,676,465

 

 

$

1

 

 

$

963,607

 

 

$

( 189,680

)

 

$

( 289

)

 

$

773,639

 

The accompanying notes are an integral part of these condensed consolidated financial statements.
 

5

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APOGEE THERAPEUTICS, INC.
CONDENSED CONSOLI DATED STATEMENT OF CASH FLOWS
(UNAUDITED)
(In thousands)

 

SIX MONTHS ENDED JUNE 30,

 

 

2025

 

 

2024

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

( 121,435

)

 

$

( 65,910

)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

 

 

 

 

 

 

Depreciation expense

 

 

606

 

 

 

65

 

Equity-based compensation expense

 

 

22,470

 

 

 

9,884

 

Amortization of discounts on marketable securities

 

 

( 4,139

)

 

 

( 5,750

)

Non-cash lease expense

 

 

1,778

 

 

 

546

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

( 1,642

)

 

 

( 2,675

)

Other non-current assets

 

 

( 8,359

)

 

 

( 67

)

Accounts payable

 

 

4,607

 

 

 

3,384

 

Operating lease liability

 

 

( 1,985

)

 

 

( 507

)

Accrued expenses

 

 

( 2,407

)

 

 

94

 

Net cash used in operating activities

 

 

( 110,506

)

 

 

( 60,936

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchases of marketable securities

 

 

( 145,580

)

 

 

( 352,859

)

Maturities of marketable securities

 

 

241,772

 

 

 

152,810

 

Purchases of property and equipment

 

 

( 5,085

)

 

 

( 402

)

Net cash provided by (used in) investing activities

 

 

91,107

 

 

 

( 200,451

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

—

 

 

 

449,955

 

Proceeds from exercise of options and employee stock purchase plan purchases

 

 

1,802

 

 

 

415

 

Net cash provided by financing activities

 

 

1,802

 

 

 

450,370

 

Increase (decrease) in cash, cash equivalents and restricted cash

 

 

( 17,597

)

 

 

188,983

 

Cash, cash equivalents and restricted cash, beginning of period

 

 

142,083

 

 

 

118,610

 

Cash, cash equivalents and restricted cash, end of period

 

$

124,486

 

 

$

307,593

 

Supplemental disclosures of non-cash activities:

 

 

 

 

 

 

Operating lease right-of-use asset obtained in exchange for operating lease liability

 

$

999

 

 

$

2,556

 

Reconciliation of cash, cash equivalents and restricted cash:

 

 

 

 

 

 

Cash and cash equivalents

 

$

124,192

 

 

$

307,299

 

Restricted cash

 

 

294

 

 

 

294

 

Total

 

$

124,486

 

 

$

307,593

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

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APOGEE THERAPEUTICS, INC.
NOTES TO CONDENSED CONSO LIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. Nature of the Business

Apogee Therapeutics, Inc., together with its consolidated subsidiary (collectively, “Apogee” or the “Company”), is a clinical-stage biotechnology company advancing optimized, novel biologics with potential for differentiated efficacy and dosing in the largest inflammatory and immunology (“I&I”) markets, including for the treatment of atopic dermatitis (“AD”), asthma, eosinophilic esophagitis (“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.
The Company commenced its operations in February 2022 as a Delaware limited liability company named Apogee Therapeutics, LLC. The Company was founded by leading healthcare investors, Fairmount Funds Management LLC and Venrock Healthcare Capital Partners and has since assembled a management team of drug developers and an executive team with significant experience in clinical development, manufacturing of biologics and leading public biopharmaceutical company operations, financings and transactions. As a result of the Company’s reorganization from a limited liability company to a corporation in July 2023 (the “Reorganization”) and in connection with the Company’s initial public offering (“IPO”) in July 2023, the Company directly wholly owns the assets of Apogee Therapeutics, LLC, including the stock of its subsidiary. In addition, the Company engages third parties, including Paragon Therapeutics, Inc. (“Paragon”), who is also a related party, to perform ongoing research and development and other services on its behalf.
In February 2022, the Company entered into an antibody discovery and option agreement with Paragon, which was subsequently amended in November 2022 (as amended, the “2022 Option Agreement”). Under the terms of the 2022 Option Agreement, Paragon identifies, evaluates and develops antibodies directed against certain mutually agreed therapeutic targets of interest to the Company. The 2022 Option Agreement initially included two selected targets, IL-13 and IL-4Rα, and was subsequently amended in November 2022 to include an additional selected target, OX40L. Under the 2022 Option Agreement, the Company has the exclusive option to, on a research program-by-research program basis, be granted an exclusive, worldwide license to all of Paragon’s right, title and interest in and to the intellectual property resulting from the applicable research program to develop, manufacture and commercialize the antibodies and products directed to the selected targets. In November 2023, the Company entered into an additional antibody discovery and option agreement for the thymic stromal lymphopoietin (“TSLP”) target with Paragon (the “2023 Option Agreement” and, together with the 2022 Option Agreement, collectively the “Option Agreements”). Under the terms of the 2023 Option Agreement, Paragon identifies, evaluates and develops antibodies directed against certain mutually agreed therapeutic targets of interest to the Company.
In November 2022, the Company exercised its option available under the 2022 Option Agreement with respect to the IL-13 Research Program (as defined below) and, in April 2023, the Company exercised its options available under the 2022 Option Agreement with respect to the IL-4Rα Research Program and the OX40L Research Program. Upon such exercises, the parties entered into associated license agreements for each target. Under the terms of each license agreement, Paragon granted to the Company an exclusive, worldwide, royalty-bearing, sublicensable right and license with respect to certain information, patent rights and sequence information related to antibodies directed at the respective target to use, make, sell, import, export and otherwise exploit the antibodies directed at the respective target. In August 2024, the Company exercised its option under the 2023 Option Agreement with the respect to the TSLP Research Program. The Company is solely responsible for the development, manufacture and commercialization of IL-13, IL-4Rα, OX40L and TSLP product candidates and products at its own cost and expense.
In July 2023, the Company completed its IPO, pursuant to which it issued and sold an aggregate of 20,297,500 shares of its common stock (inclusive of 2,647,500 shares pursuant to the exercise of the underwriters’ overallotment option in full) at the IPO price of $ 17.00 per share for net cash proceeds of $ 315.4 million, after deducting underwriting discounts and commissions and other offering expenses. The shares of Apogee Therapeutics, Inc. began trading on the Nasdaq Global Market on July 14, 2023 under the symbol APGE. On March 12, 2024, the Company issued and sold an aggregate of 7,790,321 shares of its common stock (inclusive of 1,016,128 shares pursuant to the exercise in full of the underwriters’ option to purchase additional shares) at a public offering price of $ 62.00 per share, for aggregate net proceeds of $ 450.0 million after deducting underwriting discounts and commissions and other offering expenses.
The Company is subject to risks and uncertainties common to early stage companies in the biotechnology industry, including, but not limited to, completing preclinical studies and clinical trials, obtaining regulatory approval for its programs, market acceptance of products, development by competitors of new technological innovations, dependence on key personnel, the ability to attract and retain qualified employees, reliance on third-party organizations, protection of proprietary technology, compliance with government

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regulations, and the ability to raise additional capital to fund operations. The Company’s programs currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure, and extensive compliance reporting capabilities. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales. The Company has primarily funded its operations with proceeds from the sales of preferred units and common stock and has not generated any revenue since inception.
As a result, the Company will need substantial additional funding to support its continued operations and growth strategy. Until such a time as the Company can generate significant revenue from product sales, if ever, the Company expects to finance its operations through the sale of equity, debt financings or other capital sources, including collaborations with other companies or other strategic transactions. The Company may be unable to raise additional funds or enter into such other agreements on favorable terms, or at all. If the Company fails to raise capital or enter into such agreements as, and when, needed, the Company may have to significantly delay, scale back or discontinue the development and commercialization of one or more of its programs.
Company Liquidity
The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year after the date that the accompanying consolidated financial statements are issued. The Company had an accumulated deficit of $ 427.4 million as of June 30, 2025. Further, the Company incurred a net loss of $ 121.4 million and experienced negative cash flows from operations of $ 110.5 million for the six months ended June 30, 2025. Based on the Company’s current operating plan, it estimates that its existing cash and cash equivalents of $ 124.2 million, marketable securities of $ 381.2 million and long-term marketable securities of $ 115.8 million as of June 30, 2025, will be sufficient to enable the Company to fund its operating expenses and capital requirements through at least the next 12 months from the issuance of these consolidated financial statements.
The Company is subject to those risks associated with any biotechnology company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants. If the Company fails to become profitable or is unable to sustain profitability on a continuing basis, then it may be unable to continue its operations at planned levels and be forced to reduce its operations.
This Quarterly Report contains references to the Company’s programs, which are used interchangeably to refer to the Company’s clinical programs within its pipeline and its products under development.

2. Summary of Significant Accounting Policies

There have been no material changes to the significant accounting policies as disclosed in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.
Basis of Presentation
The condensed consolidated financial statements include the accounts of Apogee Therapeutics, Inc. and its wholly-owned subsidiaries, Apogee Therapeutics Securities Corporation, formed as a Massachusetts security corporation in September 2024, and Apogee Biologics, Inc. until December 31, 2024, when Apogee Biologics, Inc. merged with and into Apogee Therapeutics, Inc. with Apogee Therapeutics, Inc. surviving the merger.
These condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Updates of the Financial Accounting Standards Board (“FASB”). In the Company’s management opinion, the information furnished in these unaudited condensed consolidated financial statements reflect all adjustments, all of which are of a normal and recurring nature, necessary for a fair presentation of the financial position and results of operations for the interim reported periods. The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. The results of operations for interim periods are not necessarily indicative of results to be expected for the full year or any other interim period.

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Principles of Consolidation
The accompanying consolidated financial statements include the accounts of Apogee Therapeutics, Inc. and its wholly-owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. Actual results could materially differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. Significant estimates relied upon in preparing the accompanying consolidated financial statements include, among others: research and development expenses and related prepaid or accrued costs, the valuation of equity-based compensation awards and related expense.

Segments
The Company has one operating segment and one reporting unit. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of assessing performance and allocating resources. All of the Company’s assets are located in the United States.

Fair Value of Financial Instruments
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC Topic 820, Fair Value Measurements and Disclosures (“ASC 820”), establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:
Level 1— Valuations based on quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2— Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
Level 3— Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Items measured at fair value on a recurring basis as of June 30, 2025 include cash equivalents and marketable securities (Notes 3 and 4). The carrying amounts reflected in the accompanying consolidated balance sheets for prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to their short-term nature.

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Property and Equipment, net
Property and equipment are recorded at cost. Depreciation is calculated using the straight-line method over the following estimated useful lives of the assets:

 

ESTIMATED
USEFUL LIFE

Furniture and fixtures

 

5  years

Lab equipment

 

5  years

IT equipment

 

3  years

Leasehold improvements

 

Shorter of the lease
term or useful life

Upon disposal, retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Expenditures for repairs and maintenance that do not improve or extend the lives of the respective assets are charged to expense as incurred.

Research and Development Expense
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries and bonuses, overhead costs, contract services and other related costs. The value of goods and services received from contract research organizations and contract manufacturing organizations in the reporting period are estimated based on the level of services performed, and progress in the period in cases when the Company has not received an invoice from the supplier. In circumstances where amounts have been paid in excess of costs incurred, the Company records a prepaid expense. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations to those third parties as of period end. Any accrual estimates are based on a number of factors, including the Company’s knowledge of the progress towards completion of the specific tasks to be performed, invoicing to date under the contracts, communication from the vendors of any actual costs incurred during the period that have not yet been invoiced and the costs included in the contracts. Significant judgments and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the estimates made by the Company.

Income Taxes
Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.
Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The Company makes estimates and judgments about future taxable income based on assumptions that are consistent with the Company’s plans and estimates. Should the actual amounts differ from these estimates, the amount of the Company’s valuation allowance could be materially impacted. Changes in these estimates may result in significant increases or decreases to the tax provision in a period in which such estimates are changed, which in turn would affect net income or loss.
The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit to the extent that the position is more likely than not to be sustained on examination by the taxing authorities based on the technical merits of the position as well as consideration of the available facts and circumstances. The Company records interest and penalties related to uncertain tax positions, if applicable, as a component of income tax expense.

Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with original final maturities of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held in interest-bearing money market funds, U.S. treasury securities, U.S. Government agency securities, and commercial paper.

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Marketable Securities
The Company’s investments are comprised of U.S. government agency securities, U.S. treasury securities, commercial paper and corporate debt securities. Investments are classified at the time of purchase, based on management’s intent, as held-to-maturity, available-for-sale, or trading. All of the Company’s marketable security investments are classified as available-for-sale securities and are reported at fair market value using quoted prices in active markets for similar securities. The cost of securities sold is determined on a specific identification basis, and realized gains and losses are included as a component of other income within the condensed consolidated statements of operations and comprehensive loss. Unrealized gains and losses are included within the condensed consolidated statements of comprehensive loss.
The Company assesses its available-for-sale securities under the available-for-sale security impairment model in ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Statements as of each reporting date in order to determine if a portion of any decline in fair value below carrying value is the result of a credit loss for its available-for-sale securities. The Company records credit losses for its available-for-sale securities in the condensed consolidated statements of operations and comprehensive loss as credit loss expense, which is limited to the difference between the fair value and the amortized cost of the security. To date, the Company has not recorded any credit losses on its available-for-sale securities. Declines in fair value below carrying value attributable to non-credit related factors are recorded as accumulated other comprehensive loss, which is a separate component of stockholders’ equity.
The Company classifies its available-for-sale securities that mature within one year from the balance sheet date as current assets on the condensed consolidated balance sheets. Available-for-sale securities that mature more than one year from the balance sheet date are classified as non-current assets on the condensed consolidated balance sheets.

Leases
The Company determines the initial classification and measurement of its right-of-use assets and lease liabilities at the lease commencement date and thereafter if modified. The lease term includes any renewal options and termination options that the Company is reasonably assured to exercise. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment.
Fixed lease expense for operating leases is recognized on a straight-line basis, unless the right-of-use assets have been impaired, over the reasonably assured lease term based on the total lease payments and is included in operating expenses in the statements of operations and comprehensive loss.

Equity-Based Compensation
The Company issues equity-based awards to employees, managers, executives, non-employees and service providers in the form of restricted common stock, restricted stock units, and stock options. The Company accounts for equity-based compensation awards in accordance with FASB ASC Topic 718, Compensation-Stock Compensation (“ASC 718”).
The fair value of the Company’s common stock underlying its equity awards is based on the quoted market price of the Company’s common stock on the grant date. The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which uses as inputs the fair value of the Company’s common stock, and certain management estimates, including the expected stock price volatility, the expected term of the award, the risk-free rate, and expected dividends. Expected volatility is calculated based on reported volatility data for a representative group of publicly traded companies for which historical information is available. The Company selects companies with comparable characteristics with historical share price information that approximates the expected term of the equity-based awards. The Company computes the historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period that approximates the calculated expected term of the stock options. The Company will continue to apply this method until a sufficient amount of historical information regarding the volatility of its stock price becomes available. The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant commensurate with the expected term assumption. The Company uses the simplified method, under which the expected term is presumed to be the midpoint between the vesting date and the end of the contractual term. The Company utilizes this method due to lack of historical exercise data. The expected dividend yield is assumed to be zero as the Company has no current plans to pay any dividends on common stock. The fair value of the restricted stock units are based on the Company’s stock price on the date of the grant.

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The Company generally issues equity awards that are subject to either service-based vesting conditions and in limited instances, service-based and performance-based vesting conditions. Compensation expense for awards issued to grantees with service-based vesting conditions are recognized on a straight-line basis based on the grant date fair value over the associated requisite service period of the award, which is generally the vesting term. Compensation expense for awards to grantees with service-based and performance-based vesting conditions are recognized based on the grant-date fair value over the requisite service period using the accelerated attribution method to the extent achievement of the performance condition is probable. As of each reporting date, the Company estimates the probability that specified performance criteria will be met and does not recognize compensation expense until it is probable that the performance-based vesting condition will be achieved.
The Company evaluates whether an equity award should be classified and accounted for as a liability award or equity award for all equity-based compensation awards granted. As of June 30, 2025 , all of the Company’s equity-based awards were equity classified. Forfeitures are recognized as they occur. The Company classifies equity-based compensation expense in the accompanying consolidated statements of operations and comprehensive loss in the same manner in which the award recipient’s salary and related costs are classified or in which the award recipient’s service payments are classified, as applicable.

Concentrations of Credit Risk and Significant Suppliers
Financial instruments that potentially expose the Company to credit risk primarily consist of cash, cash equivalents and marketable securities. The Company’s investment portfolio is comprised of money market funds, debt securities issued by U.S. government and corporate debt securities. The Company maintains its deposits with accredited financial institutions and, consequently, the Company does not believe it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Bank accounts in the United States are insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000. As of June 30, 2025 and December 31, 2024, predominantly all of the Company’s primary operating accounts significantly exceeded the FDIC limits.
The Company is dependent on third-party organizations to research, develop, manufacture and process its product candidates for its development programs. In particular, the Company currently relies on a limited number of third-party manufacturers for preclinical, clinical, and future commercial manufacturing activities. The Company expects to continue to be dependent on a small number of manufacturers to supply it with its requirements for all products. The Company’s research and development programs could be adversely affected by a significant interruption in the supply of the necessary materials.

Off-Balance Sheet Arrangements
As of June 30, 2025 and December 31, 2024 , the Company had no off-balance sheet risks such as foreign exchange contracts, option contracts or other foreign hedging arrangements.

Comprehensive Loss
Comprehensive loss includes net loss as well as other changes in stockholders' equity that result from transactions and events other than those with stockholders. The Company’s unrealized gains and losses on marketable securities represent the only component of other comprehensive loss that are excluded from the reported net loss and that are presented in the condensed consolidated statements of comprehensive loss.

Net Loss Per Share
The Company has two classes of common stock outstanding comprised of voting and non-voting shares. The rights of the holders of voting and non-voting shares are identical, except with respect to voting and conversion. Each share of non-voting stock may be converted into one share of voting stock at any time at the option of the stockholder, subject to certain beneficial ownership limitations. Net loss per share for each class of common stock issued is the same as they are entitled to the same liquidation and dividend rights.
The Company calculates basic net loss per common share by dividing net loss by the weighted-average number of common shares outstanding for the period. The Company has generated a net loss in the periods presented so the basic and diluted net loss per share are the same as the inclusion of the potentially dilutive securities would be anti-dilutive.

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3. Marketable Securities

The following is a summary of the Company’s investing portfolio (in thousands):

 

AS OF JUNE 30, 2025

 

 

 

 

 

UNREALIZED

 

 

 

 

 

COST

 

 

GAINS

 

 

LOSSES

 

 

FAIR VALUE

 

Marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

Maturities within one year:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

186,447

 

 

$

192

 

 

$

( 32

)

 

$

186,607

 

Debt securities issued by U.S. government agencies

 

 

90,048

 

 

 

316

 

 

 

( 11

)

 

 

90,353

 

Commercial paper

 

 

34,306

 

 

 

—

 

 

 

( 10

)

 

 

34,296

 

Corporate debt securities

 

 

69,981

 

 

 

16

 

 

 

( 25

)

 

 

69,972

 

Total maturities within one year

 

 

380,782

 

 

 

524

 

 

 

( 78

)

 

 

381,228

 

Maturities between one and two years:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

67,914

 

 

$

156

 

 

$

( 32

)

 

$

68,038

 

Debt securities issued by U.S. government agencies

 

 

26,409

 

 

 

92

 

 

 

—

 

 

 

26,501

 

Corporate debt securities

 

 

21,207

 

 

 

32

 

 

 

( 9

)

 

 

21,230

 

Total maturities between one and two years

 

 

115,530

 

 

 

280

 

 

 

( 41

)

 

 

115,769

 

Total marketable securities

 

$

496,312

 

 

$

804

 

 

$

( 119

)

 

$

496,997

 

 

 

AS OF DECEMBER 31, 2024

 

 

 

 

 

UNREALIZED

 

 

 

 

 

COST

 

 

GAINS

 

 

LOSSES

 

 

FAIR VALUE

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

Maturities within one year:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

158,332

 

 

$

469

 

 

$

( 34

)

 

$

158,767

 

Debt securities issued by U.S. government agencies

 

 

115,425

 

 

 

169

 

 

 

—

 

 

 

115,594

 

Commercial paper

 

 

35,508

 

 

 

49

 

 

 

—

 

 

 

35,557

 

Corporate debt securities

 

 

68,831

 

 

 

146

 

 

 

( 31

)

 

 

68,946

 

Total maturities within one year

 

 

378,096

 

 

 

833

 

 

 

( 65

)

 

 

378,864

 

Maturities between one and two years:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

90,330

 

 

$

109

 

 

$

( 271

)

 

$

90,168

 

Debt securities issued by U.S. government agencies

 

 

102,707

 

 

 

470

 

 

 

( 75

)

 

 

103,102

 

Corporate debt securities

 

 

17,232

 

 

 

—

 

 

 

( 86

)

 

 

17,146

 

Total maturities between one and two years

 

 

210,269

 

 

 

579

 

 

 

( 432

)

 

 

210,416

 

Total marketable securities

 

$

588,365

 

 

$

1,412

 

 

$

( 497

)

 

$

589,280

 

As of June 30, 2025, the Company had 57 securities with a total fair market value of $ 182.2 million in an unrealized loss position. The Company does not intend to sell its investments before recovery of the amortized cost basis of its debt securities at maturity and no allowance for credit losses was recorded as of June 30, 2025 and December 31, 2024. Securities are evaluated at the end of each reporting period. The Company did not record any impairment related to its marketable securities during the six months ended June 30, 2025 and 2024 .

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4. Fair Value Measurements

The following table presents information about the Company’s financial assets and liabilities measured at fair value on a reoccurring basis and indicates the level of fair value hierarchy utilized to determine such values (in thousands):

 

AS OF JUNE 30, 2025

 

 

LEVEL 1

 

 

LEVEL 2

 

 

LEVEL 3

 

 

TOTAL

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

77,800

 

 

$

—

 

 

$

—

 

 

$

77,800

 

Commercial paper

 

 

—

 

 

 

40,447

 

 

 

—

 

 

 

40,447

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

 

254,645

 

 

 

—

 

 

 

—

 

 

 

254,645

 

Debt securities issued by U.S. government agencies

 

 

—

 

 

 

116,854

 

 

 

—

 

 

 

116,854

 

Commercial paper

 

 

—

 

 

 

34,296

 

 

 

—

 

 

 

34,296

 

Corporate debt securities

 

 

—

 

 

 

91,202

 

 

 

—

 

 

 

91,202

 

Total

 

$

332,445

 

 

$

282,799

 

 

$

—

 

 

$

615,244

 

 

 

AS OF DECEMBER 31, 2024

 

 

LEVEL 1

 

 

LEVEL 2

 

 

LEVEL 3

 

 

TOTAL

 

Cash equivalents:

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

132,491

 

 

$

—

 

 

$

—

 

 

$

132,491

 

Marketable securities:

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

 

248,935

 

 

 

—

 

 

 

—

 

 

 

248,935

 

Debt securities issued by U.S. government agencies

 

 

—

 

 

 

218,696

 

 

 

—

 

 

 

218,696

 

Commercial paper

 

 

—

 

 

 

35,557

 

 

 

—

 

 

 

35,557

 

Corporate debt securities

 

 

—

 

 

 

86,092

 

 

 

—

 

 

 

86,092

 

Total

 

$

381,426

 

 

$

340,345

 

 

$

—

 

 

$

721,771

 

 
5. Prepaids and Other Assets

Prepaid expenses and other current assets consisted of the following (in thousands):

 

JUNE 30,
2025

 

 

DECEMBER 31,
2024

 

Prepaid expenses

 

$

5,603

 

 

$

2,621

 

Interest receivable

 

 

4,136

 

 

 

4,697

 

Other current assets

 

 

963

 

 

 

1,742

 

Total

 

$

10,702

 

 

$

9,060

 

As of June 30, 2025 and December 31, 2024, the Company had restricted cash of $ 0.3 million held as a letter of credit for the benefit of a clinical research organization. The related letter of credit was classified within other non-current assets on the condensed consolidated balance sheet as of June 30, 2025 and December 31, 2024.
As of June 30, 2025, the Company also had $ 8.3 million in long-term prepayments, made in conjunction with the Company's research and development activities, classified within other non-current assets.

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6. Property and Equipment, net

Property and Equipment, net consisted of the following (in thousands):

 

JUNE 30,
2025

 

 

DECEMBER 31,
2024

 

Lab equipment

 

$

1,407

 

 

$

1,285

 

Leasehold improvements

 

 

3,075

 

 

 

863

 

Furniture and fixtures

 

 

1,760

 

 

 

—

 

IT equipment

 

 

992

 

 

 

—

 

Less: Accumulated depreciation

 

 

( 796

)

 

 

( 189

)

Total

 

$

6,438

 

 

$

1,959

 

The Company recognized $ 0.4 million and $ 0.6 million of depreciation expense for the three and six months ended June 30, 2025, respectively. The Company recognized an immaterial amount of depreciation expense for the three and six months ended June 30, 2024 .

7. Accrued Expenses

Accrued expenses consisted of the following (in thousands):

 

JUNE 30,
2025

 

 

DECEMBER 31,
2024

 

Accrued external research and development expenses

 

$

6,217

 

 

$

4,957

 

Accrued manufacturing expenses

 

 

5,210

 

 

 

15,505

 

Accrued employee compensation

 

 

8,156

 

 

 

1,895

 

Accrued other

 

 

2,265

 

 

 

1,898

 

Total

 

$

21,848

 

 

$

24,255

 

 
8. Other Significant Agreements

Paragon Option and License Agreements
For the three and six months ended June 30, 2025, the Company recognized $ 0.1 million of research and development expense in connection with services provided by Paragon under the Option and License Agreements. For the three and six months ended June 30, 2024, the Company recognized $ 2.2 million and $ 8.7 million, respectively, of research and development expense in connection with services provided by Paragon under the Option and License Agreements.
Option Agreements
In February 2022, the Company entered into an antibody discovery and option agreement with Paragon, which was subsequently amended in November 2022 (as amended, the “2022 Option Agreement”). Under the terms of the 2022 Option Agreement, Paragon identifies, evaluates and develops antibodies directed against certain mutually agreed therapeutic targets of interest to the Company. The 2022 Option Agreement initially included two selected targets, IL-13 and IL-4Rα, and was subsequently amended in November 2022 to include an additional selected target, OX40L. Under the 2022 Option Agreement, the Company has the exclusive option to, on a research program-by-research program basis, be granted an exclusive, worldwide license to all of Paragon’s right, title and interest in and to the intellectual property resulting from the applicable research program to develop, manufacture and commercialize the antibodies and products directed to the selected targets (each, an “Option”). From time to time, the Company can choose to add additional targets to the collaboration by mutual agreement with Paragon.
Pursuant to the terms of the 2022 Option Agreement, the parties initiated certain research programs that generally focused on a particular target (each, a “Research Program”). Each Research Program is aimed at discovering, generating, identifying and/or characterizing antibodies directed to the respective target. For each Research Program, the parties established a research plan that sets forth the activities that will be conducted, and the associated research budget (each, a “Research Plan”). Upon execution of the 2022 Option Agreement, the Company agreed with Paragon on an initial Research Plan that outlined the services that will be performed commencing at inception of the arrangement related to IL-13 and IL-4Rα. The Research Plan for OX40L was agreed to prior to

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December 31, 2022. The Company's exclusive option with respect to any future Research Program is exercisable at the Company's sole discretion at any time during the period beginning on the initiation of activities under the associated Research Program and ending a specified number of days following the delivery of the data package from Paragon related to the results of the Research Plan activities (the “Option Period”). There is no payment due upon exercise of an Option pursuant to the 2022 Option Agreement.
Unless terminated earlier, the 2022 Option Agreement shall continue in force on a Research Program-by-Research Program basis until the earlier of: (i) the end of the Option Period for such Research Program, as applicable, if such Option is not exercised by the Company; and (ii) the effective date of the license agreement for such Research Program if the Company exercises its Option with respect to such Research Program (the “2022 Term”). Upon the expiration of the 2022 Term for all then-existing Research Programs, under the 2022 Option Agreement, the 2022 Option Agreement will automatically expire in its entirety. The Company may terminate the 2022 Option Agreement or any Research Program at any time for any or no reason upon 30 days ’ prior written notice to Paragon, provided that the Company must pay certain unpaid fees due to Paragon upon such termination, as well as any non-cancellable obligations reasonably incurred by Paragon in connection with its activities under any terminated Research Program. Each party has the right to terminate the 2022 Option Agreement or any Research Program upon (i) 30 days ’ prior written notice of the other party’s material breach that remains uncured for the 30-day period and (ii) the other party’s bankruptcy.
In consideration for the exclusive options granted under the 2022 Option Agreement, the Company paid an upfront cash amount of $ 1.3 million and issued 1,250,000 common units to Paragon. Paragon was also entitled to up to an additional 3,750,000 of common units in exchange for the rights granted under the 2022 Option Agreement, which were issued in connection with the closings of the additional tranches of the Series A Preferred Unit financing. Under the 2022 Option Agreement, on a Research Program-by-Research Program basis following the finalization of the Research Plan for each respective Research Program, the Company is required to pay Paragon a nonrefundable fee in cash of $ 0.5 million. The Company is also obligated to compensate Paragon on a quarterly basis for its services performed under each Research Program based on the actual costs incurred.
In November 2023, the Company entered into an additional antibody discovery and option agreement with Paragon (the “2023 Option Agreement” and together with the 2022 Option Agreement, collectively, the “Option Agreements”). Under the terms of the 2023 Option Agreement, Paragon identifies, evaluates and develops antibodies directed against certain mutually agreed therapeutic targets of interest to the Company. The 2023 Option Agreement initially includes one target, TSLP. Under the 2023 Option Agreement, the Company has the exclusive option to, on a research program-by-research program basis, be granted an exclusive, worldwide license to all of Paragon’s right, title and interest in and to the intellectual property resulting from the applicable research program to develop, manufacture and commercialize the antibodies and products directed to the selected targets. From time to time, the Company can choose to add additional targets to the collaboration by mutual agreement with Paragon.
Pursuant to the terms of the 2023 Option Agreement, the parties may initiate Research Programs. Each Research Program will be aimed at discovering, generating, identifying and/or characterizing antibodies directed to the respective target. For each Research Program, the parties must establish a Research Plan. In January 2024, the Company and Paragon agreed on an initial Research Plan that outlines the services that will be performed commencing at inception of the arrangement related to TSLP. The Company's exclusive option with respect to each Research Program is exercisable at the Company's sole discretion at any time during the period beginning on the initiation of activities under the associated Research Program and ending a specified number of days following the delivery of the data package from Paragon related to the results of the Research Plan activities. There is no payment due upon exercise of an Option pursuant to the 2023 Option Agreement.
Under the 2023 Option Agreement, on a Research Program-by-Research Program basis following the finalization of the Research Plan for each respective Research Program, the Company is required to pay Paragon a nonrefundable fee in cash of $ 2.0 million. The Company is also obligated to compensate Paragon on a quarterly basis for its services performed under each Research Program based on the actual costs incurred. The Company expenses the service fees as the associated costs are incurred when the underlying services are rendered. In January 2024, the Company finalized the Research Plan with Paragon related to the TSLP target. As such, the Company made a one-time non-refundable payment of $ 2.0 million to Paragon in the first quarter of 2024.

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Unless terminated earlier, the 2023 Option Agreement shall continue in force on a Research Program-by-Research Program basis until the earlier of: (i) the end of the Option Period for such Research Program, as applicable, if such Option is not exercised by the Company; and (ii) the effective date of the license agreement for such Research Program if the Company exercises its Option with respect to such Research Program (the “2023 Term”). Upon the expiration of the 2023 Term for all then-existing Research Programs, under the 2023 Option Agreement, the 2023 Option Agreement will automatically expire in its entirety. The Company may terminate the 2023 Option Agreement or any Research Program at any time for any or no reason upon 30 days ’ prior written notice to Paragon, provided that the Company must pay certain unpaid fees due to Paragon upon such termination, as well as any non-cancellable obligations reasonably incurred by Paragon in connection with its activities under any terminated Research Program. Each party has the right to terminate the 2023 Option Agreement or any Research Program upon (i) 30 days ’ prior written notice of the other party’s material breach that remains uncured for the 30-day period and (ii) the other party’s bankruptcy.
License Agreements
In November 2022, the Company exercised its option available under the 2022 Option Agreement with respect to the IL-13 Research Program. Upon such exercise, the parties entered into an associated license agreement (the “IL-13 License Agreement”). In April 2023, the Company exercised its option available under the 2022 Option Agreement with respect to the IL- 4Rα Research Program and the OX40L Research Program. Upon such exercise, the parties entered into associated license agreements (the “IL-4Rα License Agreement” and the “OX40L License Agreement,” respectively). In August 2024, the Company exercised its option available under the 2023 Option Agreement with respect to the TSLP Research Program and entered into the associated license agreement (the “TSLP License Agreement” and collectively with the IL-13 License Agreement, the IL-4Rα License Agreement and the OX40L License Agreement, the “License Agreements”). Under the terms of the License Agreements, Paragon granted to the Company an exclusive, worldwide, royalty-bearing, sublicensable right and license with respect to certain information, patent rights and sequence information related to antibodies directed at the respective target to use, make, sell, import, export and otherwise exploit the antibodies directed at the respective target. Pursuant to the License Agreements, the Company granted to Paragon a similar license (except that such license the Company granted to Paragon is non-exclusive) to the respective licenses with respect to multispecific antibodies that are directed at the respective targets and one or more other antibodies. The Company was also granted a right of first negotiation with Paragon concerning the development, license and grant of rights to certain multispecific antibodies associated with each respective license. The Company is solely responsible for the continued development, manufacture and commercialization of products at its own cost and expense for each licensed target.
Under the IL-13 License Agreement, the IL-4Rα License Agreement and the OX40L License Agreement, the Company is obligated to pay Paragon up to $ 3.0 million upon the achievement of specific development and clinical milestones for the first product under each of the License Agreements that achieves such specified milestones, including a payment of $ 1.0 million upon the nomination of a development candidate and $ 2.0 million upon the first dosing of a human patient in a Phase 1 trial. Under the TSLP License Agreement, the Company is obligated to pay Paragon up to $ 28.0 million upon the achievement of specific development and clinical milestones for the first product, including a payment of $ 3.0 million upon the nomination of a development candidate and $ 5.0 million upon the first dosing of a human patient in a Phase 1 trial.
Upon execution of the IL‑13 License Agreement, the Company paid Paragon a $ 1.0 million fee for the nomination of a development candidate. In August 2023, the Company announced the dosing of its first participant in the Phase 1 trial of APG777 and made a milestone payment of $ 2.0 million in the fourth quarter of 2023. In November 2023, the Company finalized the nomination of a development candidate under the IL‑4Rα License Agreement and made a milestone payment of $ 1.0 million to Paragon in the fourth quarter of 2023. In March 2024, the Company announced the dosing of its first participant in a Phase 1 trial of APG808 and made a milestone payment of $ 2.0 million to Paragon in the first quarter of 2024. In May 2024, the Company finalized the nomination of a development candidate under the OX40L License Agreement and made a milestone payment of $ 1.0 million to Paragon in the second quarter of 2024. In August 2024, the Company announced the dosing of its first participant in the Phase 1 trial of APG990 and made a milestone payment of $ 2.0 million to Paragon in the third quarter of 2024. In October 2024, the Company finalized the nomination of a development candidate under the TSLP License Agreement and made a milestone payment of $ 3.0 million to Paragon in the fourth quarter of 2024. In December 2024, the Company announced the dosing of its first participant in the Phase 1 trial of APG333 and made a milestone payment of $ 5.0 million in the fourth quarter of 2024.
The Company is also obligated to pay royalties to Paragon equal to a low-single digit percentage of net sales of any products under each of the respective License Agreements, and Paragon has a similar obligation to pay royalties to the Company with respect to each of the multispecific licenses. Royalties are due on a product-by-product and country-by-country basis beginning upon the first commercial sale of each product and ending on the later of (i) 12 years after the first commercial sale of such product in such country and (ii) expiration of the last valid claim of a patent covering such product in such country (the “Royalty Term”).

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Unless earlier terminated, the License Agreements remain in effect until the expiration of the last-to-expire Royalty Term for any and all products associated with the respective license. The Company may terminate the agreement in its entirety or on a country-by-country or product-by-product at any time for any or no reason upon 60 days ’ advance written notice to Paragon, and either party may terminate for (i) the other party’s material breach that remains uncured for 90 days (or 30 days with respect to any failure to make payments) following notice of such breach and (ii) the other party’s bankruptcy. Upon any termination prior to the expiration of a License Agreement, all licenses and rights granted pursuant to such License Agreement will automatically terminate and revert to the granting party and all other rights and obligations of the parties will terminate.
The Company concluded that each of the License Agreements constitutes an asset acquisition of in-process research and development assets with no alternative future use. Each of the arrangements did not qualify as a business combination because substantially all of the fair value of the assets acquired was concentrated in the license which comprises a single identifiable asset. Therefore, the aggregate acquisition cost for each license was recognized as research and development expense.
Biologics Master Services Agreement — WuXi Biologics (Hong Kong) Limited
In June 2022, Paragon and WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”) entered into a biologics master services agreement (the “WuXi Biologics MSA”), which was subsequently novated to the Company by Paragon in the second quarter of 2023. The WuXi Biologics MSA governs all development activities and GMP manufacturing and testing for the Company’s APG777, APG990, APG333 and APG808 programs, as well as potential future programs, on a work order basis. Under the WuXi Biologics MSA, the Company is obligated to pay WuXi Biologics a service fee and all non-cancellable obligations in the amount specified in each work order associated with the agreement for the provision of services.
The WuXi Biologics MSA terminates on the later of (i) June 20, 2027 or (ii) the completion of services under all work orders executed by the parties prior to June 20, 2027, unless terminated earlier. The term of each work order terminates upon completion of the services under such work order, unless terminated earlier. The Company can terminate the WuXi Biologics MSA or any work order at any time upon 30 days’ prior written notice and immediately upon written notice if WuXi Biologics fails to obtain or maintain required material governmental licenses or approvals. Either party may terminate a work order (i) at any time upon six months ’ prior notice with reasonable cause, provided however that if WuXi Biologics terminates a work order in such manner, no termination or cancellation fees shall be paid by the Company and (ii) immediately for cause upon (a) the other party’s material breach that remains uncured for 30 days after notice of such breach, (b) the other party’s bankruptcy or (c) a force majeure event that prevents performance for a period of at least 90 days .
For the three and six months ended June 30, 2025, the Company recognized $ 3.3 million and $ 4.5 million, respectively, of research and development expense in connection with the WuXi Biologics MSA. For the three and six months ended June 30, 2024, the Company recognized $ 8.9 million and $ 13.2 million, respectively, of research and development expense in connection with the WuXi Biologics MSA.
Cell Line License Agreement — WuXi Biologics (Hong Kong) Limited
In June 2022, Paragon and WuXi Biologics entered into a cell line license agreement (the “Cell Line License Agreement”), which was subsequently novated to the Company by Paragon in the second quarter of 2023. Under the Cell Line License Agreement, the Company received a non-exclusive, worldwide, sublicensable license to certain of WuXi Biologics’ know-how, cell line, biological materials (the “WuXi Biologics Licensed Technology”) and media and feeds to make, have made, use, sell and import certain therapeutic products produced through the use of the cell line licensed by WuXi Biologics under the Cell Line License Agreement (the “WuXi Biologics Licensed Products”). Specifically, the WuXi Biologics Licensed Technology is used to manufacture a component of the Company’s APG777, APG990, APG279, APG333 and APG808 programs.
In consideration for the license, the Company paid WuXi Biologics a non-refundable license fee of $ 150,000 . Additionally, if the Company manufactures all of its commercial supplies of bulk drug product with a manufacturer other than WuXi Biologics or its affiliates, the Company is required to make royalty payments to WuXi Biologics in an amount equal to a fraction of a single digit percentage of global net sales of WuXi Biologics Licensed Products manufactured by a third-party manufacturer (the “Royalty”). If the Company manufactures part of its commercial supplies of the WuXi Biologics Licensed Products with WuXi Biologics or its affiliates, then the Royalty will be reduced accordingly on a pro rata basis.

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The Cell Line License Agreement will continue indefinitely unless terminated (i) by the Company upon six months ’ prior written notice and the Company's payment of all undisputed amounts due to WuXi Biologics through the effective date of termination, (ii) by WuXi Biologics for a material breach by the Company that remains uncured for 60 days after written notice, (iii) by WuXi Biologics if the Company fails to make a payment and such failure continues for 30 days after receiving notice of such failure, or (iv) by either party upon the other party’s bankruptcy.
Master Services Agreement and Project Specific Agreements — Samsung Biologics Limited
In March 2025, the Company entered into a Master Services Agreement (the “Samsung Biologics MSA”), made effective as of February 28, 2025, with Samsung Biologics Co., Ltd. (“Samsung Biologics”), pursuant to which Samsung Biologics will manufacture and supply the Company with APG777 drug substance (the “Samsung Biologics Product”) for clinical development and commercial sale, if approved. The Company is obligated to pay Samsung Biologics service fees for each manufactured batch, as well as the costs of materials purchased by Samsung Biologics and expenses including testing and storage, which such costs and fees will be specified in Project Specific Agreements (each a “PSA”).
Also in March 2025, the Company entered into a PSA (the “Initial PSA”) with Samsung Biologics, made effective as of February 28, 2025, pursuant to which Samsung Biologics will produce clinical batches of the Samsung Biologics Product at its facility in Incheon, South Korea, perform process characterization and validation, and manufacture process performance qualification lots of the Samsung Biologics Product. Under the Initial PSA, the Company must purchase certain minimum quantities of the Samsung Biologics Product and has agreed to pay Samsung Biologics as determined pursuant to the terms of the Initial PSA. The Company has also agreed to enter into a separate PSA with Samsung Biologics for the manufacture of commercial supply of APG777 drug substance, which will provide for certain minimum purchase commitments for each year from 2029 to 2034. If the Company elects not to enter into the PSA for commercial supply, it will incur an exit fee in the high single digit millions.
The Samsung Biologics MSA will terminate in February 2035, or, if a PSA is still in effect, when such PSA terminates, and may be extended upon mutual agreement of the parties. The Initial PSA will terminate in December 2034. Either the Company or Samsung Biologics may terminate the Samsung Biologics MSA or the Initial PSA in the event of an uncured material breach by, insolvency of or inability to perform due to a force majeure event by the other party. In the event all applicable PSAs have been terminated, Samsung Biologics has agreed to provide assistance with certain technology transfer matters, subject to exceptions. If the Company terminates the Samsung Biologics MSA or Initial PSA without cause, the Company will generally be responsible for paying the purchase price for the Company’s aggregate product commitment for the remainder of the term, less any amounts the Company has already paid.
For the three and six months ended June 30, 2025, the Company recognized $ 5.7 million and $ 7.4 million, respectively, of research and development expense in connection with the Samsung Biologics MSA.

9. Commitments and Contingencies

Other Contracts
Currently, all of the Company’s preclinical and clinical drug manufacturing, storage, distribution or quality testing are outsourced to third-party manufacturers. As development programs progress and new process efficiencies are built, the Company expects to continually evaluate this strategy with the objective of satisfying demand for registration trials and, if approved, the manufacture, sale and distribution of commercial products. Under such agreements, the Company is contractually obligated to make certain payments to vendors upon early termination, primarily to reimburse them for their unrecoverable outlays incurred prior to cancellation as well as any amounts owed by the Company prior to early termination. The actual amounts the Company could pay in the future to the vendors under such agreements may differ from the purchase order amounts due to cancellation provisions.
Indemnification Agreements
The Company enters into standard indemnification agreements and/or indemnification sections in other agreements in the ordinary course of business. Pursuant to the agreements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified party for losses suffered or incurred by the indemnified party, generally the Company’s business partners. The term of these indemnification agreements is generally perpetual any time after execution of the agreement. There is no limit to the maximum potential amount of future payments the Company could be required to make under these indemnification agreements. As of June 30, 2025, the Company has not incurred costs to defend lawsuits or settle claims related to these indemnification agreements. The Company was not aware of any claims under these indemnification arrangements as of June 30, 2025 and December 31, 2024.

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Legal Proceedings
The Company is not currently party to any material legal proceedings. At each reporting date, the Company evaluates whether or not a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of FASB ASC Topic 450, Contingencies (“ASC 450”). The Company expenses as incurred the costs related to its legal proceedings.

10. Common Stock

In July 2023, the Company completed its IPO, selling an aggregate 20,297,500 shares of common stock. All outstanding preferred units were exchanged into 24,987,750 shares of common stock in connection with the IPO. Following the IPO, the Company is authorized to issue up to 400,000,000 shares of common stock, par value $ 0.00001 .
In March 2024, the Company issued and sold an aggregate of 7,790,321 shares of its common stock in an underwritten public offering.
In August 2024, the Company entered into an Open Market Sale Agreement (the “Sale Agreement”) with Jefferies LLC (the “Sales Agent”), pursuant to which the Company may offer and sell shares of common stock up to a maximum aggregate offering price of $ 300.0 million through an at-the-market offering program. The Sales Agent will be entitled to compensation at a commission of up to 3.0 % of the aggregate gross sales price per share sold under the Sale Agreement, unless otherwise agreed to by the Sales Agent and the Company under the Sale Agreement. In December 2024, the Company sold 926,049 shares of common stock under the ATM at a price per share of $ 48.50 . For the six months ended June 30, 2025, the Company made no sales pursuant to the Sale Agreement. As of June 30, 2025 , $ 255.1 million remained available for sale under the Sale Agreement.
As of June 30, 2025, 59,587,430 and 58,560,525 shares of common stock were issued and outstanding, respectively. The 59,587,430 shares of common stock issued are comprised of 46,100,788 shares of voting common stock and 13,486,642 shares of non-voting common stock. As of June 30, 2025, there were 1,026,905 shares of unvested restricted common stock included within the shares of common stock issued.
As of December 31, 2024, 59,478,725 and 58,062,898 shares of common stock were issued and outstanding, respectively. The 59,478,725 shares of common stock issued are comprised of 45,992,083 shares of voting common stock and 13,486,642 shares of non-voting common stock. As of December 31, 2024, there were 1,415,827 shares of unvested restricted common stock included within the shares of common stock issued.

11. Equity-Based Compensation

Restricted Common Stock
Concurrent with the Reorganization, all outstanding incentive units were exchanged into 3,469,546 shares of common stock, of which 2,779,358 were unvested restricted common stock. The following table provides a summary of the unvested restricted common stock award activity during the six months ended June 30, 2025:

 

NUMBER OF SHARES

 

 

WEIGHTED-
AVERAGE
GRANT DATE FAIR
VALUE PER
SHARE

 

Unvested restricted common stock as of December 31, 2024

 

 

1,415,827

 

 

$

5.30

 

Vested

 

 

( 388,922

)

 

 

4.98

 

Unvested restricted common stock as of June 30, 2025

 

 

1,026,905

 

 

$

5.43

 

The fair value of restricted stock vested during the three and six months ended June 30, 2025 was $ 0.9 million and $ 1.9 million, respectively.

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Stock Options and Restricted Stock Units
In July 2023, in connection with the IPO, the Company’s Board of Directors (the “Board”) and stockholders approved the 2023 Equity Incentive Plan (the “2023 Plan”), which became effective on the date of the effectiveness of the registration statement for the IPO. The 2023 Plan provides for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, awards of restricted stock, restricted stock units and other stock-based awards. As of June 30, 2025, the number of shares of common stock available for future grants under the 2023 Plan is equal to 6,039,446 shares of common stock. The number of shares available for grant and issuance under the 2023 Plan will be automatically increased on January 1 of each year by a number of shares equal to up to 5 % of the outstanding shares of common stock on such date.
The Company uses the Black-Scholes option pricing model to estimate the fair value of stock options granted with the following assumptions:

 

THREE MONTHS ENDED JUNE 30,

 

SIX MONTHS ENDED JUNE 30,

 

2025

 

2025

Risk-free interest rate

 

3.9 % - 4.1 %

 

3.9 % - 4.4 %

Expected dividend yield

 

0.0 %

 

0.0 %

Expected term (in years)

 

5.5  - 6.25

 

5.5  - 6.25

Expected volatility

 

74.8 % - 75.5 %

 

74.8 % - 75.5 %

The following table provides a summary of stock option activity during the six months ended June 30, 2025:

 

OPTIONS

 

 

WEIGHTED-
AVERAGE
EXERCISE
PRICE

 

 

WEIGHTED-
AVERAGE
REMAINING
CONTRACTUAL TERM
(IN YEARS)

 

 

AGGREGATE
INTRINSIC
VALUE
(IN THOUSANDS)

 

Outstanding as of December 31, 2024

 

 

5,155,414

 

 

$

35.12

 

 

 

9.4

 

 

$

61,506

 

Granted

 

 

686,403

 

 

$

39.19

 

 

 

—

 

 

$

—

 

Exercised

 

 

( 49,922

)

 

$

20.16

 

 

 

—

 

 

$

—

 

Forfeited

 

 

( 77,208

)

 

$

34.87

 

 

 

—

 

 

$

—

 

Outstanding as of June 30, 2025

 

 

5,714,687

 

 

$

35.74

 

 

 

9.0

 

 

$

57,200

 

Exercisable as of June 30, 2025

 

 

1,323,751

 

 

$

28.93

 

 

 

8.6

 

 

$

20,760

 

The fair value of options vested during the three and six months ended June 30, 2025 was $ 10.9 million and $ 18.2 million, respectively.
The following table provides a summary of the unvested restricted stock unit activity under the 2023 Plan during the six months ended June 30, 2025:

 

NUMBER OF
SHARES

 

 

WEIGHTED-
AVERAGE
GRANT DATE FAIR
VALUE PER SHARE

 

Unvested restricted stock units as of December 31, 2024

 

 

267,564

 

 

$

38.48

 

Vested

 

 

( 37,213

)

 

 

36.54

 

Forfeited

 

 

( 5,908

)

 

 

43.61

 

Unvested restricted stock units as of June 30, 2025

 

 

224,443

 

 

$

38.67

 

The fair value of restricted stock units vested during the three and six months ended June 30, 2025 was $ 0.7 million and $ 1.4 million, respectively.

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2023 Employee Stock Purchase Plan
In July 2023, the Board adopted and the Company’s stockholders approved the 2023 Employee Stock Purchase Plan (the “ESPP”), which became effective on July 13, 2023. The ESPP provides that eligible employees may contribute up to 15 % of their eligible earnings toward the semi-annual purchase of the Company's common stock, subject to any plan limitations. The purchase period under the ESPP has a duration of six months , and the purchase price with respect to each purchase period is equal to 85 % of the lesser of (i) the fair market value of the Company's common stock at the commencement of the applicable six-month purchase period or (ii) the fair market value of the Company's common stock on the exercise date. As of June 30, 2025 , 49,221 shares have been issued under the ESPP and 1,493,797 shares remain available for issuance.
The following table presents the classification of equity-based compensation expense related to equity awards granted to employees, managers, executives, and service providers (in thousands):

 

THREE MONTHS ENDED
JUNE 30,

 

 

SIX MONTHS ENDED
JUNE 30,

 

 

2025

 

 

2024

 

 

2025

 

2024

 

Research and development expense

 

$

5,538

 

 

$

2,154

 

 

$

10,910

 

$

4,084

 

General and administrative expense

 

 

5,806

 

 

 

3,544

 

 

 

11,560

 

 

5,800

 

Total

 

$

11,344

 

 

$

5,698

 

 

$

22,470

 

$

9,884

 

As of June 30, 2025, the total unrecognized compensation expense related to the Company’s stock options, unvested restricted stock and ESPP was $ 128.5 million, which the Company expects to recognize over a weighted-average period of approximately 2.7 years.
In August 2023, the Board approved two option grants to the new Chairman of the Board, (1) to purchase 50,000 shares of the Company’s common stock under the 2023 Plan (“first option”), and (2) to purchase 100,000 shares of the Company’s common stock outside of the 2023 Plan (“second option”), in which the shares underlying both options will vest and become exercisable in equal monthly installments over a three-year period from August 2023. The second option was contingent upon approval of the shares underlying the award by the Company’s stockholders at the 2024 Annual Meeting of Stockholders and failure to obtain stockholder approval would have resulted in the forfeiture of the award. Prior to receiving stockholder approval for the second option, neither a grant date nor a service inception date occurred, and no compensation cost was recognized for the award. In June 2024, the Company's stockholders approved the shares underlying the second option at the 2024 Annual Meeting of Stockholders. Therefore, a cumulative catch-up in equity-based compensation was recognized during the second quarter of 2024.

12. Related Parties

Under the Option Agreements and the License Agreements, Paragon, a stockholder of the Company that was founded by a Series A Preferred Unit investor, received upfront consideration in the form of common units, is entitled to receive milestone and royalty payments upon specific conditions and receives payments from the Company for providing ongoing services under the agreements (see Note 8). As of June 30, 2025 and December 31, 2024, $ 0.1 million was due to Paragon. For the three and six months ended June 30, 2025, the Company incurred research and development expenses of $ 0.1 million with Paragon. For the three and six months ended June 30, 2024, the Company incurred research and development expenses of $ 2.2 million and $ 8.7 million, respectively, with Paragon.

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13. Net Loss Per Share

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share data):

 

THREE MONTHS ENDED JUNE 30,

 

 

SIX MONTHS ENDED JUNE 30,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

( 66,096

)

 

$

( 33,816

)

 

$

( 121,435

)

 

$

( 65,910

)

Net loss attributable to common stockholders, basic and diluted

 

$

( 66,096

)

 

$

( 33,816

)

 

$

( 121,435

)

 

$

( 65,910

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares of common stock outstanding, basic and diluted

 

 

58,428,344

 

 

 

56,515,003

 

 

 

58,312,452

 

 

 

53,352,406

 

Net loss per share attributable to common stockholders, basic and diluted

 

$

( 1.13

)

 

$

( 0.60

)

 

$

( 2.08

)

 

$

( 1.24

)

The following potential common shares, presented based on amounts outstanding at period end, were excluded from the calculation of diluted net loss per share attributable to common stockholders for the period indicated because including them would have been anti-dilutive:

 

THREE MONTHS ENDED JUNE 30,

 

 

SIX MONTHS ENDED JUNE 30,

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Stock options

 

 

5,714,687

 

 

 

2,973,471

 

 

 

5,714,687

 

 

 

2,973,471

 

Unvested restricted common stock

 

 

1,026,905

 

 

 

1,804,749

 

 

 

1,026,905

 

 

 

1,804,749

 

Unvested restricted stock units

 

 

224,443

 

 

 

126,101

 

 

 

224,443

 

 

 

126,101

 

Total

 

 

6,966,035

 

 

 

4,904,321

 

 

 

6,966,035

 

 

 

4,904,321

 

 
14. Operating Leases

In November 2023, the Company entered into a lease agreement for lab space. In June 2024, the agreement was amended to expand the space and extend the lease term through November 2026, with the option to extend for one year. In January 2025, the agreement was amended to further expand the space. As of June 30, 2025, the remaining lease term was 1.4 years and the weighted average incremental borrowing rate used to determine the operating lease liability was 9.1 % .
In September 2024, the Company entered into a lease agreement for office space. The lease term is five years with two one-year options to extend . As of June 30, 2025, the remaining lease term was 4.3 years and the incremental borrowing rate used to determine the operating lease liability was 6.0 % .
As of June 30, 2025, total current and non-current operating lease liabilities were $ 4.0 million and $ 6.8 million, respectively. The Company incurred lease expense of $ 1.1 million and $ 2.2 million for the three and six months ended June 30, 2025 , respectively. The Company incurred lease expense of $ 0.4 million and $ 0.7 million for the three and six months ended June 30, 2024 , respectively.

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15. Segment Information

The Company has one operating segment and one reporting unit. The Company’s chief operating decision maker (“CODM”), its Chief Executive Officer , manages the Company’s operations on a consolidated basis for the purposes of assessing performance and allocating resources. All of the Company’s assets are located in the United States.
The following table summarizes the Company’s segment information for the periods presented (in thousands):

 

 

THREE MONTHS ENDED
JUNE 30,

 

 

SIX MONTHS ENDED
JUNE 30,

 

 

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Operating expenses (1) :

 

 

 

 

 

 

 

 

 

 

 

 

Research and development personnel-related (excluding equity-based compensation)

 

$

16,105

 

 

$

7,782

 

 

$

31,401

 

 

$

13,685

 

External research and development costs - APG777

 

 

22,052

 

 

 

8,103

 

 

 

36,623

 

 

 

14,058

 

External research and development costs - APG990 / APG279

 

 

3,975

 

 

 

6,905

 

 

 

7,188

 

 

 

12,115

 

External research and development costs - APG333 / APG777 + APG333

 

 

1,185

 

 

 

3,796

 

 

 

3,619

 

 

 

7,455

 

External research and development costs - APG808

 

 

1,467

 

 

 

2,213

 

 

 

2,777

 

 

 

6,172

 

External-discovery related costs and other

 

 

5,307

 

 

 

2,217

 

 

 

9,434

 

 

 

4,288

 

General and administrative personnel-related (excluding equity-based compensation)

 

 

6,395

 

 

 

3,099

 

 

 

12,102

 

 

 

6,632

 

General and administrative operations (2)

 

 

4,936

 

 

 

4,273

 

 

 

10,041

 

 

 

7,949

 

Equity-based compensation

 

 

11,344

 

 

 

5,698

 

 

 

22,470

 

 

 

9,884

 

Depreciation expense

 

 

399

 

 

 

36

 

 

 

606

 

 

 

65

 

Interest income

 

 

( 7,141

)

 

 

( 10,306

)

 

 

( 14,981

)

 

 

( 16,393

)

Provision for income taxes

 

 

72

 

 

 

—

 

 

 

155

 

 

 

—

 

Consolidated net loss

 

$

66,096

 

 

$

33,816

 

 

$

121,435

 

 

$

65,910

 

(1) The significant expense categories and amounts align with the segment-level information that is regularly provided to the CODM

(2) General and administrative operations are comprised of finance, investor relations, business development, human resources, legal, facilities & IT, and certain overhead expenses

 
16. Subsequent Events

The Company evaluated subsequent events through the date on which these financial statements were issued to ensure that these condensed consolidated financial statements include appropriate disclosure of events both recognized in the financial statements as of June 30, 2025 and events which occurred subsequently but not recognized in the financial statements. No subsequent events have occurred that require disclosure.

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Item 2. Manag ement’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report, as well as our audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”). The following discussion contains forward-looking statements that reflect our current plans, forecasts, estimates and beliefs and involve risks and uncertainties. Our historical results are not necessarily indicative of the results that may be expected for any period in the future. Our actual results, outcomes and the timing of events could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, particularly in the section titled “Special Note Regarding Forward Looking Statements” and “Risk Factors.” We urge you to consider these factors carefully in evaluating the forward-looking statements contained in this Quarterly Report. Forward-looking statements are not historical facts, reflect our current views with respect to future events, and apply only as of the date made. We do not intend, and undertake no obligation, to update these forward-looking statements, except as required by law. Unless the context requires otherwise, references to “we,” “us,” “our,” “Apogee” or “the Company” refer to Apogee Therapeutics, Inc. and its subsidiaries.
This Quarterly Report contains references to our programs, which are used interchangeably to refer to our clinical programs within our pipeline and our products under development.
Overview
We are a clinical stage biotechnology company advancing optimized, novel biologics with the potential for differentiated efficacy and dosing in the largest inflammatory and immunology (“I&I”) markets, including for the treatment of atopic dermatitis (“AD”), asthma, eosinophilic esophagitis (“EoE”), chronic obstructive pulmonary disease (“COPD”), and other I&I indications. Our 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.
Our pipeline comprises multiple antibody programs being developed initially for the treatment of I&I indications as monotherapies and combinations, including APG777, APG279, APG777 + APG333, APG990, APG333 and APG808. With four validated targets in our portfolio, we are seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of our novel antibodies. Based on a broad pipeline and depth of expertise, we believe we can deliver value and meaningful benefit to patients underserved by today’s standard of care. We believe each of our programs has potential for broad application across multiple I&I indications.
APG777 – anti-IL13 antibody, same mechanism of action as EBGLYSS (lebrikizumab)
APG777 is a subcutaneous (“SQ”) extended half-life monoclonal antibody (“mAb”) targeting IL-13. In August 2023, we announced the dosing of our first participant in our first clinical trial for APG777. In 2024, we announced positive interim safety and pharmacokinetic (“PK”) data from this trial with APG777 demonstrating a potential best-in-class PK profile, including a half-life of 77 days, supporting the potential for every three- to six- month maintenance dosing in AD. Single doses of APG777 demonstrated a deep and sustained effect on pharmacodynamic (“PD”) markers out to approximately 12 months. APG777 was well-tolerated across all dose groups. In May 2024, we announced the dosing of our first participant in the Phase 2 APEX trial. In July 2025, we announced positive 16-week data from the Part A portion of the APEX Phase 2 clinical trial of APG777.
The APEX trial is a randomized, placebo-controlled study evaluating APG777 in patients with moderate-to-severe AD. Part A of the trial enrolled 123 adult patients who were randomized 2:1 to APG777 versus placebo and received an induction regimen dosing of 720mg at Weeks 0 and 2, followed by 360mg at Weeks 4 and 12. The primary endpoint for the induction arm of Part A was percentage change in Eczema Area Severity Index (“EASI”) score from baseline at Week 16. Secondary endpoints included EASI-75, EASI-90, Validated Investigator Global Assessment (“vIGA”) 0/1 and Itch Numeric Rating Scale (“NRS”) at Week 16. In non-head-to-head trial comparisons, the initial 16-week findings from Part A include efficacy results, which compare favorably versus standard of care across endpoints as well as rapid onset of itch relief and lesion reduction, and a favorable safety profile consistent with its class.
The trial met its primary endpoint, with APG777 showing significantly greater least squares mean percent change from baseline at Week 16 with an EASI reduction of 71.0% compared to placebo of 33.8% (p < 0.001). APG777 showed the highest absolute and placebo-adjusted EASI-75 of any biologic in a 16-week global study with 66.9% of participants treated with APG777 achieving EASI-75 compared to 24.6% on placebo (p < 0.001). Pre-specified sensitivity analysis showed consistent results in both moderate and severe

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patients based on baseline EASI score. The results demonstrated a vIGA 0/1 of 34.9% compared to placebo of 17.3% (p < 0.05) and an EASI-90 of 33.9% compared to placebo of 14.7% (p < 0.05). Treatment of patients with APG777 led to rapid onset of itch relief and achieved a statistically significant reduction by Week 1, with a 50.7% reduction of Itch NRS from baseline compared to placebo of 23.2% (p < 0.01) at Week 16. APG777 was well tolerated, with 56.1% of APG777-exposed patients experiencing treatment-emergent adverse events (“TEAEs”) (vs. 63.4% in placebo). The most common TEAEs, occurring in more than 5% of patients, were non-infective conjunctivitis (14.6% vs. 2.4% in placebo), upper respiratory tract infection (8.5% vs 12.2% in placebo), nasopharyngitis (4.9% vs. 12.2% in placebo), and pain in extremity (0.0% vs. 7.3% in placebo) with the latter three being numerically lower in APG777 treated patients compared to placebo. Serious TEAEs were rare for APG777-exposed patients (1.2% vs. 2.4% in placebo). The discontinuation rate due to adverse events was low for APG777-exposed patients (2.4%). There were no injection site reactions in the APG777 treated group.
All Part A patients that benefited from treatment in the induction arm will have the opportunity to continue to APG777 maintenance treatment, which will evaluate three and six-month dosing intervals. In February 2025, we also announced that we had commenced dosing of the Part B portion of the APEX Phase 2 trial. Part B is testing a higher dose of APG777. We anticipate topline maintenance data from Part A in the first half of 2026, 16-week topline induction data from Part B in the middle of 2026 and initiation of a Phase 3 trial in 2026.
In April 2025, we initiated a Phase 1b trial in asthma with topline results expected in the first half of 2026. Results from this trial, in addition to topline data from the Part B portion of the APEX Phase 2 trial in AD expected in mid-2026, will allow us to determine dose selections for further expansion indications in 2027 and beyond, including but not limited to asthma and EoE. We expect to announce plans for Phase 2b trials in asthma and EoE in 2026. Based on our clinical data, we expect to further evaluate additional opportunities to develop APG777 for other I&I indications, including alopecia areata (“AA”), chronic rhinosinusitis with nasal polyps (“CRSwNP”), chronic spontaneous urticaria (“CSU”), and prurigo nodularis (“PN”).
In addition, we plan to evaluate APG777 in combination with other investigational therapies within our pipeline to potentially enable greater efficacy for I&I conditions. The first of these combinations is APG279, which combines APG777 with APG990, our novel, SQ, half-life extended mAb targeting OX40L.
APG990 – anti-OX40L antibody, same mechanism of action as amlitelimab and APG279, a potential combination therapy of APG777 + APG990
APG990 is an SQ extended half-life mAb that utilizes advanced antibody engineering to target OX40L. In August 2024, we initiated a Phase 1 clinical trial of APG990 in healthy volunteers and in March 2025, we announced positive interim safety and PK data from the APG990 Phase 1 clinical trial. PK data showed a half-life of approximately 60 days across doses tested. APG990, in single doses up to 1,200mg, was well tolerated and showed a favorable safety profile, consistent with other assets targeting OX40L.
We plan to develop APG777 and APG990 (“APG279”) together as a potential first-in-class coformulation for the treatment of AD by combining deep and sustained inhibition of Type 2 inflammation via APG777’s inhibition of IL-13 with broader inhibition of Type 1-3 inflammation through APG990’s inhibition of OX40L. APG279 has been shown to retain stability, injectability, and convenience of individual components in preclinical studies. In preclinical studies, APG279 has also demonstrated broad inhibition of Type 1, Type 2 and Type 3 inflammation, similar to what was seen with Janus kinase (“JAK”) inhibition, but with potential for better tolerability than JAK inhibitors. In preclinical toxicology studies, the combination of APG777 and APG990 showed no findings at any dose level, including the highest dose tested of 150-mg/kg per agent per week. We believe these combined mechanisms offer the potential for improved clinical responses over monotherapy while our planned approach of coformulating two extended half-life mAbs holds the potential for best-in-class dosing.
In July 2025, we announced that we commenced dosing in the Phase 1b trial of APG279 against DUPIXENT in approximately 50 patients with moderate-to-severe AD with a data readout expected in the second half of 2026. The initial clinical trial of APG279 is being conducted as a coadministration of APG777 and APG990. We plan to advance the development of APG279 in future studies as a coformulation. The PK data for APG990, when considered together with APG279 coformulation data, provides the potential for dosing the combination two to four times per year with a single 2 mL coformulated injection.

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APG333 – anti-TSLP antibody, same mechanism of action as TEZPIRE (tezepelumab); potential combination therapy with APG777
APG333 is a fully-human mAb against thymic stromal lymphopoietin (“TSLP”), an epithelial cell-derived cytokine that has emerged as an attractive validated target for the treatment of people living with asthma and COPD. In preclinical studies, the combination of APG777 and APG333 has been shown to impact both central inflammation and local airway responses. This has the potential to improve clinical outcomes compared to approved or in-development biologics which only target peripheral or central inflammation, not both, and retains the potential for a significantly less frequent dosing schedule. In December 2024, we initiated a Phase 1 trial of APG333 in healthy volunteers and we expect interim data from the trial in the fourth quarter of 2025.
Subject to positive data for APG777 as a monotherapy in asthma, we plan to study APG777 in combination with APG333 to drive potential best-in-class efficacy in respiratory conditions.
APG808 – anti-IL4Rα antibody, same mechanism of action as DUPIXENT
APG808 is an SQ extended half-life mAb targeting IL-4Rα, a target with clinical validation across eight different Type 2 allergic diseases. In March 2024, we commenced dosing of the first healthy volunteers in the APG808 Phase 1 trial and in September 2024, we commenced dosing of the first asthma patients as a cohort in that Phase 1 trial. In December 2024, we announced positive interim safety, PK and PD data from the Phase 1 trial. APG808 demonstrated a potential best-in-class PK profile, including a half-life of approximately 55 days at projected, clinically relevant steady state exposures, supporting the potential for every two- to three-month maintenance dosing. Single doses of APG808 demonstrated a deep and sustained effect on PD markers out to approximately three months (longest follow-up available at time of data cut). APG808 was well-tolerated across all dose groups.
In May 2025, we announced positive interim results from the Phase 1b trial of APG808 in patients with mild-to-moderate asthma. The trial was a double-blind, placebo-controlled, multiple-dose trial, which evaluated the safety and tolerability of APG808 in 22 adult patients with mild-to-moderate asthma. The trial also evaluated fractional exhaled nitric oxide concentration (“FeNO”), thymus and activation-regulated chemokine (“TARC”), and pSTAT6. Participants were randomized 3:1, receiving 600mg of APG808 or placebo on day 1 and day 29.
The results demonstrated that APG808 was well-tolerated, with multiple doses of APG808 resulting in rapid suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma, with a maximal robust FeNO decrease from baseline of 53% and sustained FeNO decrease from baseline of 50% at 12 weeks. APG808 also demonstrated sustained and near-complete reduction in pSTAT6 as well as deep reduction of TARC maintained through 12 weeks. The most common TEAEs observed were headache, injection site erythema, and upper respiratory tract infections. There were no Grade 3 TEAEs or severe adverse events, and no adverse events led to study discontinuation.
APG808’s optimized PK profile coupled with FeNO suppression out to 12-weeks reinforces the potential for 2-months or longer maintenance dosing, offering a significant advantage compared to the current bi-weekly standard of care.
Funding and Capital Resources
Since our inception in February 2022, we have devoted substantially all of our resources to raising capital, organizing and staffing our company, business and scientific planning, conducting discovery and research activities, acquiring product programs, establishing and protecting our intellectual property portfolio, developing and progressing our pipeline, establishing arrangements with third parties for the manufacture of our programs and component materials, and providing general and administrative support for these operations. We do not have any programs approved for sale and have not generated any revenue from product sales. To date, we have funded our operations primarily with proceeds from the issuance of preferred units and sale of common stock. Prior to our IPO, we received gross proceeds of $169.0 million from sales of our preferred units. On July 13, 2023, our Registration Statement on Form S-1, as amended (File Nos. 333-272831 and 333-273236) (the “IPO Registration Statement”), relating to our IPO was declared effective by the SEC. Pursuant to the IPO Registration Statement, we issued and sold an aggregate of 20,297,500 shares of common stock (inclusive of 2,647,500 shares pursuant to the exercise in full of the underwriters’ option to purchase additional shares) at a public offering price of $17.00 per share, for aggregate net proceeds of $315.4 million after deducting underwriting discounts and commissions and other offering expenses.
On March 7, 2024, our Registration Statement on Form S-1, as amended (File Nos. 333-277664 and 333-277763) (the “2024 Registration Statement”), relating to our public offering (the “March 2024 Offering”) was declared effective by the SEC. Pursuant to the 2024 Registration Statement we issued and sold an aggregate of 7,790,321 shares of common stock (inclusive of 1,016,128 shares

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pursuant to the exercise in full of the underwriters’ option to purchase additional shares) at a public offering price of $62.00 per share, for aggregate net proceeds of $450.0 million after deducting underwriting discounts and commissions and other offering expenses.
We have incurred significant operating losses since inception. Our ability to generate sufficient product revenue to achieve profitability will depend heavily on the successful development and eventual commercialization of any programs we may develop. We generated a net loss of $121.4 million for the six months ended June 30, 2025. As of June 30, 2025, we had an accumulated deficit of $427.4 million. We expect to continue to incur significantly increased expenses for the foreseeable future if and as we:
• advance our programs, APG777, APG279, APG777 + APG333, APG990, APG333 and APG808, into and through clinical trials and regulatory approval prior to commercialization;

• continue our research and development and preclinical development of our other programs;

• seek and identify additional research programs and product candidates and initiate preclinical studies for those programs;

• maintain, expand, enforce, defend and protect our intellectual property portfolio and provide reimbursement of third-party expenses related to our patent portfolio;

• hire additional research and development and clinical personnel;

• experience any delays, challenges, or other issues associated with the clinical development of our programs, including with respect to our regulatory strategies;

• seek marketing approvals for any programs for which we successfully complete clinical trials;

• develop, maintain and enhance a sustainable, scalable, reproducible and transferable manufacturing process for our programs;

• ultimately establish a sales, marketing and distribution infrastructure to commercialize any programs for which we may obtain marketing approval;

• add operational, financial and management information systems and personnel, including personnel to support our product development;

• acquire or in-license product candidates or programs, intellectual property and technologies;

• establish and maintain our current and any future collaborations, including making royalty, milestone or other payments thereunder; and

• operate as a public company.

We will not generate revenue from product sales unless and until we successfully initiate and complete clinical development and obtain regulatory approval for any product candidates. If we obtain regulatory approval for any of our programs and do not enter into a commercialization partnership, we expect to incur significant expenses related to developing our commercialization capability to support product sales, manufacturing, marketing, and distribution. Further, we expect to incur additional costs associated with operating as a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services associated with compliance with exchange listing and SEC requirements, director and officer insurance costs and investor and public relations costs.
As a result, we will need substantial additional funding to support our continued operations and growth strategy. Until such a time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through the sale of equity, debt financings or other capital sources, including licensing arrangements, royalty financings, collaborations with other companies or other strategic transactions. We may be unable to raise additional funds or enter into such other agreements on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our programs.
Because of the numerous risks associated with product development, we are unable to accurately predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
We expect that our existing cash and cash equivalents of $124.2 million, marketable securities of $381.2 million and long-term marketable securities of $115.8 million as of June 30, 2025, will be sufficient to enable us to fund our operating expenses and capital

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expenditure requirements into the first quarter of 2028. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. See “Liquidity and Capital Resources” for further information.
Reorganization
Apogee Therapeutics, LLC was formed as a limited liability company under the laws of the State of Delaware in February 2022. Apogee Therapeutics, Inc. was incorporated in June 2023 in connection with our IPO to serve as a holding company that would wholly own the assets of Apogee Therapeutics, LLC. Prior to July 13, 2023, our business was conducted by Apogee Therapeutics, LLC and its subsidiary at the time, Apogee Biologics, Inc. In July 2023, in connection with our IPO, we completed a series of transactions which are referred to, collectively, as the “Reorganization,” and pursuant to which Apogee Therapeutics, Inc., became the parent and holding company that wholly owns the assets of Apogee Therapeutics, LLC, including stock of its subsidiary at the time, Apogee Biologics, Inc. In connection with our Reorganization:
• holders of Series A preferred units of Apogee Therapeutics, LLC received 7,678,000 shares of non-voting common stock of Apogee Therapeutics, Inc.;

• holders of Series B preferred units of Apogee Therapeutics, LLC received 11,501,108 shares of common stock and 5,808,642 shares of non-voting common stock of Apogee Therapeutics, Inc.;

• holders of common units of Apogee Therapeutics, LLC received 1,919,500 shares of common stock of Apogee Therapeutics, Inc.;

• holders of vested incentive units of Apogee Therapeutics, LLC received 690,188 shares of common stock of Apogee Therapeutics, Inc.; and

• holders of unvested incentive units of Apogee Therapeutics, LLC received 2,779,358 shares of restricted common stock of Apogee Therapeutics, Inc.

Effective December 31, 2024, Apogee Biologics, Inc. merged with and into Apogee Therapeutics, Inc. with Apogee Therapeutics, Inc. surviving the merger.
Collaboration, License and Services Agreements
Paragon Option Agreements
In February 2022, we entered into an antibody discovery and option agreement with Paragon Therapeutics, Inc. (“Paragon”), which was subsequently amended in November 2022 (as amended, the “2022 Option Agreement”). Under the terms of the 2022 Option Agreement, Paragon identifies, evaluates and develops antibodies directed against certain mutually agreed therapeutic targets of interest to us. The 2022 Option Agreement initially included two selected targets, IL-13 and IL-4Rα, and was subsequently amended in November 2022 to include an additional selected target, OX40L. Under the 2022 Option Agreement, we have the exclusive option to, on a research program-by-research program basis, be granted an exclusive, worldwide license to all of Paragon’s right, title and interest in and to the intellectual property resulting from the applicable research program to develop, manufacture and commercialize the antibodies and products directed to the selected targets (each, an “Option”). From time to time, we can choose to add additional targets to the collaboration by mutual agreement with Paragon.
Pursuant to the terms of the 2022 Option Agreement, the parties initiated certain research programs that generally focused on a particular target (each, a “Research Program”). Each Research Program is aimed at discovering, generating, identifying and/or characterizing antibodies directed to the respective target. For each Research Program, the parties established a research plan that sets forth the activities that will be conducted, and the associated research budget (each, a “Research Plan”). Upon execution of the 2022 Option Agreement, we agreed with Paragon on an initial Research Plan that outlined the services that will be performed commencing at inception of the arrangement related to IL-13 and IL-4Rα. The Research Plan for OX40L was agreed to prior to December 31, 2022. Our exclusive option with respect to any future Research Program is exercisable at our sole discretion at any time during the period beginning on the initiation of activities under the associated Research Program and ending a specified number of days following the delivery of the data package from Paragon related to the results of the Research Plan activities (the “Option Period”). There is no payment due upon exercise of an Option pursuant to the 2022 Option Agreement.

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In consideration for the exclusive options granted under the 2022 Option Agreement, we paid an upfront cash amount of $1.3 million and issued 1,250,000 common units to Paragon. Paragon was also entitled to up to an additional 3,750,000 of common units in exchange for the rights granted under the 2022 Option Agreement, which were issued in connection with the closings of the additional tranches of the Series A Preferred Unit financing. Under the 2022 Option Agreement, on a Research Program-by-Research Program basis following the finalization of the Research Plan for each respective Research Program, we are required to pay Paragon a nonrefundable fee in cash of $0.5 million. We are also obligated to compensate Paragon on a quarterly basis for its services performed under each Research Program based on the actual costs incurred.
In November 2023, we entered into an additional antibody discovery and option agreement with Paragon (the “2023 Option Agreement” and together with the 2022 Option Agreement, collectively, the “Option Agreements”). Under the terms of the 2023 Option Agreement, Paragon identifies, evaluates and develops antibodies directed against certain mutually agreed therapeutic targets of interest to us. The 2023 Option Agreement initially includes one target, TSLP. Under the 2023 Option Agreement, we have the exclusive option to, on a research program-by-research program basis, be granted an exclusive, worldwide license to all of Paragon’s right, title and interest in and to the intellectual property resulting from the applicable research program to develop, manufacture and commercialize the antibodies and products directed to the selected targets. From time to time, we can choose to add additional targets to the collaboration by mutual agreement with Paragon.
Pursuant to the terms of the 2023 Option Agreement, the parties may initiate Research Programs. Each Research Program will be aimed at discovering, generating, identifying and/or characterizing antibodies directed to the respective target. For each Research Program, the parties must establish a Research Plan. In January 2024, we agreed on an initial Research Plan with Paragon that outlines the services that will be performed commencing at inception of the arrangement related to TSLP. Our exclusive option with respect to each Research Program is exercisable at our sole discretion at any time during the period beginning on the initiation of activities under the associated Research Program and ending a specified number of days following the delivery of the data package from Paragon related to the results of the Research Plan activities. There is no payment due upon exercise of an Option pursuant to the 2023 Option Agreement.
Under the 2023 Option Agreement, on a Research Program-by-Research Program basis following the finalization of the Research Plan for each respective Research Program, we are required to pay Paragon a nonrefundable fee in cash of $2.0 million. We are also obligated to compensate Paragon on a quarterly basis for its services performed under each Research Program based on the actual costs incurred. We expense the service fees as the associated costs are incurred when the underlying services are rendered. In January 2024, we finalized the Research Plan with Paragon related to the TSLP target. As such, we made a one-time non-refundable payment of $2.0 million to Paragon in the first quarter of 2024.
Unless terminated earlier, the Option Agreements shall continue in force on a Research Program-by-Research Program basis until the earlier of: (i) the end of the Option Period for such Research Program, as applicable, if such Option is not exercised by us; and (ii) the effective date of the license agreement for such Research Program if we exercise our Option with respect to such Research Program (the “Term”). Upon the expiration of the Term for all then-existing Research Programs, the applicable Option Agreement will automatically expire in its entirety. We may terminate either Option Agreement or any Research Program at any time for any or no reason upon 30 days’ prior written notice to Paragon, provided that we must pay certain unpaid fees due to Paragon upon such termination, as well as any non-cancellable obligations reasonably incurred by Paragon in connection with its activities under any terminated Research Program. Each party has the right to terminate either Option Agreement or any Research Program upon (i) 30 days’ prior written notice of the other party’s material breach that remains uncured for the 30-day period and (ii) the other party’s bankruptcy.
Paragon License Agreements
In November 2022, we exercised our option available under the 2022 Option Agreement with respect to the IL-13 Research Program. Upon such exercise, the parties entered into an associated license agreement (the “IL-13 License Agreement”). In April 2023, we exercised our option available under the 2022 Option Agreement with respect to the IL-4Rα Research Program and the OX40L Research Program. Upon such exercise, the parties entered into associated license agreements (the “IL-4Rα License Agreement” and the “OX40L License Agreement,” respectively). In August 2024, we exercised our option available under the 2023 Option Agreement with respect to the TSLP Research Program and entered into the associated license agreement (the “TSLP License Agreement,” and collectively with the IL-13 License Agreement, the IL-4Rα License Agreement and the OX40L License Agreement, the “License Agreements”). Under the terms of the License Agreements, Paragon granted to us an exclusive, worldwide, royalty-bearing, sublicensable right and license with respect to certain information, patent rights and sequence information related to antibodies directed at the respective target to use, make, sell, import, export and otherwise exploit the antibodies directed at the respective target. Pursuant to the License Agreements, we granted to Paragon a similar license (except that such license we granted to Paragon is non-exclusive) to the respective licenses with respect to multispecific antibodies that are directed at the respective targets and one or more other antibodies. We were also granted a right of first negotiation with Paragon concerning the development, license and grant of rights to certain

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multispecific antibodies associated with each respective license. We are solely responsible for the continued development, manufacture and commercialization of products at our own cost and expense for each licensed target.
Under the IL-13 License Agreement, the IL-4Rα License Agreement and the OX40L License Agreement, we are obligated to pay Paragon up to $3.0 million upon the achievement of specific development and clinical milestones for the first product under each of the License Agreements that achieves such specified milestones, including a payment of $1.0 million upon the nomination of a development candidate and $2.0 million upon the first dosing of a human patient in a Phase 1 trial. Under the TSLP License Agreement, we are obligated to pay Paragon up to $28.0 million upon the achievement of specific development and clinical milestones for the first product, including a payment of $3.0 million upon the nomination of a development candidate and $5.0 million upon the first dosing of a human patient in a Phase 1 trial.
Upon execution of the IL-13 License Agreement, we paid Paragon a $1.0 million fee for the nomination of a development candidate. In August 2023, we announced the dosing of our first participants in the Phase 1 trial of APG777 and made a milestone payment of $2.0 million in the fourth quarter of 2023. In November 2023, we finalized the nomination of a development candidate under the IL-4Rα License Agreement and made a milestone payment of $1.0 million to Paragon in the fourth quarter of 2023. In March 2024, we announced the dosing of our first participants in a Phase 1 trial of APG808 and made a milestone payment of $2.0 million to Paragon in the first quarter of 2024. In May 2024, we finalized the nomination of a development candidate under the OX40L License Agreement and made a milestone payment of $1.0 million to Paragon in the second quarter of 2024. In August 2024, we announced the dosing of our first participants in the Phase 1 trial of APG990 and made a milestone payment of $2.0 million in the third quarter of 2024. In October 2024, we finalized the nomination of a development candidate under the TSLP License Agreement and made a milestone payment of $3.0 million to Paragon in the fourth quarter of 2024. In December 2024, we announced the dosing of our first participant in the Phase 1 trial of APG333 and made a milestone payment of $5.0 million in the fourth quarter of 2024.
We are also obligated to pay royalties to Paragon equal to a low-single digit percentage of net sales of any products under each of the respective License Agreements, and Paragon has a similar obligation to pay royalties to us with respect to each of the multispecific licenses. Royalties are due on a product-by-product and country-by-country basis beginning upon the first commercial sale of each product and ending on the later of (i) 12 years after the first commercial sale of such product in such country and (ii) expiration of the last valid claim of a patent covering such product in such country (the “Royalty Term”).
Unless earlier terminated, the License Agreements remain in effect until the expiration of the last-to-expire Royalty Term for any and all products associated with the respective license. We may terminate the agreement in its entirety or on a country-by-country or product-by-product at any time for any or no reason upon 60 days’ advance written notice to Paragon, and either party may terminate for (i) the other party’s material breach that remains uncured for 90 days (or 30 days with respect to any failure to make payments) following notice of such breach and (ii) the other party’s bankruptcy. Upon any termination prior to the expiration of a License Agreement, all licenses and rights granted pursuant to such License Agreement will automatically terminate and revert to the granting party and all other rights and obligations of the parties will terminate.
We concluded that each of the License Agreements constitutes an asset acquisition of in-process research and development assets with no alternative future use. Each of the arrangements did not qualify as a business combination because substantially all of the fair value of the assets acquired was concentrated in the license which comprises a single identifiable asset. Therefore, the aggregate acquisition cost for each license was recognized as research and development expense.
Biologics Master Services Agreement - WuXi Biologics (Hong Kong) Limited
In June 2022, Paragon and WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”) entered into a biologics master services agreement (the “WuXi Biologics MSA”), which was subsequently novated to us by Paragon in the second quarter of 2023. The WuXi Biologics MSA governs all development activities and GMP manufacturing and testing for our APG777, APG990, APG333 and APG808 programs, as well as potential future programs, on a work order basis. Under the WuXi Biologics MSA, we are obligated to pay WuXi Biologics a service fee and all non-cancellable obligations in the amount specified in each work order associated with the agreement for the provision of services.
The WuXi Biologics MSA terminates on the later of (i) June 20, 2027 or (ii) the completion of services under all work orders executed by the parties prior to June 20, 2027, unless terminated earlier. The term of each work order terminates upon completion of the services under such work order, unless terminated earlier. We can terminate the WuXi Biologics MSA or any work order at any time upon 30 days’ prior written notice and immediately upon written notice if WuXi Biologics fails to obtain or maintain required material governmental licenses or approvals. Either party may terminate a work order (i) at any time upon six months’ prior notice with reasonable cause, provided however that if WuXi Biologics terminates a work order in such manner, no termination or cancellation fees shall be

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paid by us and (ii) immediately for cause upon (a) the other party’s material breach that remains uncured for 30 days after notice of such breach, (b) the other party’s bankruptcy or (c) a force majeure event that prevents performance for a period of at least 90 days.
Cell Line License Agreement — WuXi Biologics (Hong Kong) Limited
In June 2022, Paragon and WuXi Biologics entered into a cell line license agreement (the “Cell Line License Agreement”), which was subsequently novated to us by Paragon in the second quarter of 2023. Under the Cell Line License Agreement, we received a non-exclusive, worldwide, sublicensable license to certain of WuXi Biologics’ know-how, cell line, biological materials (the “WuXi Biologics Licensed Technology”) and media and feeds to make, have made, use, sell and import certain therapeutic products produced through the use of the cell line licensed by WuXi Biologics under the Cell Line License Agreement (the “WuXi Biologics Licensed Products”). Specifically, the WuXi Biologics Licensed Technology is used to manufacture a component of the APG777, APG990, APG279, APG333 and APG808 programs.
In consideration for the license, we have paid WuXi Biologics a non-refundable license fee of $150,000. Additionally, if we manufacture all of our commercial supplies of bulk drug product with a manufacturer other than WuXi Biologics or its affiliates, we are required to make royalty payments to WuXi Biologics in an amount equal to a fraction of a single digit percentage of global net sales of WuXi Biologics Licensed Products manufactured by a third-party manufacturer (the “Royalty”). If we manufacture part of our commercial supplies of the WuXi Biologics Licensed Products with WuXi Biologics or its affiliates, then the Royalty will be reduced accordingly on a pro rata basis.
The Cell Line License Agreement will continue indefinitely unless terminated (i) by us upon six months’ prior written notice and our payment of all undisputed amounts due to WuXi Biologics through the effective date of termination, (ii) by WuXi Biologics for a material breach by us that remains uncured for 60 days after written notice, (iii) by WuXi Biologics if we fail to make a payment and such failure continues for 30 days after receiving notice of such failure, or (iv) by either party upon the other party’s bankruptcy.
Master Services Agreement and Project Specific Agreements — Samsung Biologics Limited
In March 2025, we entered into a Master Services Agreement (the “Samsung Biologics MSA”), made effective as of February 28, 2025, with Samsung Biologics Co., Ltd. (“Samsung Biologics”), pursuant to which Samsung Biologics will manufacture and supply us with APG777 drug substance (the “Samsung Biologics Product”) for clinical development and commercial sale, if approved. We are obligated to pay Samsung Biologics service fees for each manufactured batch, as well as the costs of materials purchased by Samsung Biologics and expenses including testing and storage, which such costs and fees will be specified in Project Specific Agreements (each a “PSA”).
Also in March 2025, we entered into a PSA (the “Initial PSA”) with Samsung Biologics, made effective as of February 28, 2025, pursuant to which Samsung Biologics will produce clinical batches of the Samsung Biologics Product at its facility in Incheon, South Korea, perform process characterization and validation, and manufacture process performance qualification lots of the Samsung Biologics Product. Under the Initial PSA, we must purchase certain minimum quantities of the Samsung Biologics Product and have agreed to pay Samsung Biologics as determined pursuant to the terms of the Initial PSA. We have also agreed to enter into a separate PSA with Samsung Biologics for the manufacture of commercial supply of APG777 drug substance, which will provide for certain minimum purchase commitments for each year from 2029 to 2034. If we elect not to enter into the PSA for commercial supply, we will incur an exit fee in the high single digit millions. The Samsung Biologics MSA will terminate in February 2035, or, if a PSA is still in effect, when such PSA terminates, and may be extended upon mutual agreement of the parties. The Initial PSA will terminate in December 2034. We or Samsung Biologics may terminate the Samsung Biologics MSA or the Initial PSA in the event of an uncured material breach by, insolvency of or inability to perform due to a force majeure event by the other party. In the event all applicable PSAs have been terminated, Samsung Biologics has agreed to provide assistance with certain technology transfer matters, subject to exceptions. If we terminate the Samsung Biologics MSA or Initial PSA without cause, we will generally be responsible for paying the purchase price for our aggregate product commitment for the remainder of the term, less any amounts we have already paid.
For additional detail regarding the agreements described above, see the section titled “Notes to Condensed Consolidated Financial Statements—Other Significant Agreements” included elsewhere in this Quarterly Report.

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Overview of Financial Results
Revenue
We have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products for several years, if at all. If our development efforts for our programs are successful and result in regulatory approval or collaboration or license agreements with third parties, we may generate revenue in the future from product sales or payments from collaboration or license agreements that we may enter into with third parties, or any combination thereof.
Operating Expenses
Our operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
Research and Development
Research and development expenses consist primarily of costs incurred in connection with the development and research of our programs. These expenses include:
• the cost of developing and validating our manufacturing process for use in our preclinical studies and current and future clinical trials;

• expenses incurred in connection with continuing our current research programs and preclinical development of any programs we may identify, including under agreements with third parties, such as consultants and contractors;

• costs of funding research performed by third parties, including Paragon, that conduct research and development and preclinical or clinical activities on our behalf;

• the cost to acquire in-process research and development, with no alternative future use associated with asset acquisitions, such as the Option Agreements, and License Agreements;

• expenses incurred under agreements with clinical trial sites that conduct research and development activities on our behalf;

• costs related to production of clinical supplies and preclinical materials, including fees paid to contract manufacturers; and

• personnel-related expenses, including salaries, bonuses and equity-based compensation expense.

We measure and recognize asset acquisitions or licenses to intellectual property that are not deemed to be business combinations based on the cost to acquire or license the asset or group of assets, which includes transaction costs. In an asset acquisition or license to intellectual property, the cost allocated to acquired in-process research and development, with no alternative future use is recognized as research and development expense on the acquisition date.
We expense research and development costs as incurred. Non-refundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered.
Our primary focus since inception has been the identification and development of our pipeline programs. Our research and development costs primarily consist of external costs, such as fees paid to Paragon under the Option Agreements and the License Agreements. We do not separately track or segregate the amount of costs incurred under the Option Agreements due to the early-stage and discovery nature of the services. We do not allocate personnel-related costs by program because these resources are used and these costs are deployed across multiple programs under development, and, as such, are not separately classified.
We expect that our research and development expenses will increase substantially for the foreseeable future as we continue to invest in research and development activities for our programs, and any potential future programs, including investments in manufacturing. The success of programs we may identify and develop will depend on many factors, including the following:
• timely and successful completion of preclinical studies;

• effective Investigational New Drug applications (“INDs”) or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for any programs we may develop;

• successful enrollment and completion of clinical trials;

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• positive results from our future clinical trials that support a finding of safety and effectiveness, acceptable PK profile, and an acceptable risk-benefit profile in the intended populations;

• receipt of marketing approvals from applicable regulatory authorities;

• establishment of arrangements through our own facilities or with third-party manufacturers for clinical supply and, where applicable, commercial manufacturing capabilities;

• establishment, maintenance, defense and enforcement of patent, trademark, trade secret and other intellectual property protection or regulatory exclusivity for any products we may develop; and

• maintenance of a continued acceptable safety, tolerability and efficacy profile of any programs we may develop following approval.

Any changes in the outcome of any of these variables with respect to the development of programs that we may identify could mean a significant change in the costs and timing associated with the development of such programs. For example, if the U.S. Food and Drug Administration (“FDA”) or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development of a program, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development. We may never obtain regulatory approval for any of our programs.
General and Administrative
General and administrative expenses consist primarily of personnel-related expenses, including salaries, bonuses, and equity-based compensation, for individuals in our executive, finance, legal, operations, human resources, business development, commercial and other administrative functions. Other significant general and administrative expenses include legal fees relating to corporate matters, professional fees for accounting, auditing, tax and administrative consulting services, insurance costs and recruiting costs. These costs relate to the operation of the business, unrelated to the research and development function, or any individual program.
We expect that our general and administrative expenses will increase substantially for the foreseeable future as we increase our headcount to support the expected growth in our research and development activities and the potential commercialization of our programs, if approved. We also expect to continue incurring expenses associated with being a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance costs, and investor and public relations costs.
Other Income (Expense), Net
Interest Income
Interest income consists of interest income earned from our cash, cash equivalents, and marketable securities and amortization of investment discounts.
Income Taxes
Since our inception, we have not recorded any income tax benefits for the net losses we have incurred or for the research and development tax credits generated in each period as we believe, based upon the weight of available evidence, that it is more likely than not that all of our net operating loss (“NOL”) carryforwards and the vast majority of our tax credit carryforwards will not be realized.
As of December 31, 2024, we had U.S. federal NOL carryforwards of approximately $68.1 million, which may be available to reduce future taxable income and have an indefinite carryforward period but are limited in their usage to an annual deduction equal to 80% of annual taxable income. We also had state net operating loss carryforwards of approximately $28.5 million, which will begin to expire in 2043 for state tax purposes. As of December 31, 2024, we also had U.S. federal and research and development tax credit carryforwards of approximately $10.5 million, which may be available to reduce future tax liabilities. We also had California research and development credit carryforwards of approximately $1.5 million. Additionally, we had Massachusetts research and development credit carryforwards of approximately $2.1 million. The U.S. federal and Massachusetts research and development tax credit carryforwards expire at various dates beginning in 2042 and the California research and development tax credit carryforwards do not expire. We have recorded a full valuation allowance against our net deferred tax assets at the balance sheet date.
The Company’s provision for state income taxes was $0.1 million and $0.2 million for the three and six months ended June 30, 2025, respectively. There was no provision for state income taxes for the three and six months ended June 30, 2024.

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On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law. OBBBA introduces significant changes to U.S. income-tax legislation. Key provisions affecting the Company include (i) permanent immediate expensing of domestic research and experimental expenditures starting January 1, 2025, and (ii) 100 percent bonus depreciation for qualified property placed in service after January 19, 2025.
Because OBBBA was enacted after June 30, 2025, its provisions have not been reflected in these financial statements. Management is evaluating the effect of OBBBA on the Company’s financial condition and results of operations.
Results of Operations
A discussion regarding our financial condition and results of operations for the three and six months ended June 30, 2025 compared to the three and six months ended June 30, 2024 is presented below.
Comparison of the Three Months Ended June 30, 2025 and 2024
Results of Operations
The following table summarizes our consolidated statements of operations for the periods presented (in thousands):

 

THREE MONTHS ENDED JUNE 30,

 

 

 

 

 

2025

 

 

2024

 

 

$ CHANGE

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

55,703

 

 

$

33,206

 

 

$

22,497

 

General and administrative

 

 

17,462

 

 

 

10,916

 

 

 

6,546

 

Total operating expenses

 

 

73,165

 

 

 

44,122

 

 

 

29,043

 

Loss from operations

 

 

(73,165

)

 

 

(44,122

)

 

 

(29,043

)

Other income, net:

 

 

 

 

 

 

 

 

 

Interest income

 

 

7,141

 

 

 

10,306

 

 

 

(3,165

)

Total other income, net

 

 

7,141

 

 

 

10,306

 

 

 

(3,165

)

Net loss before taxes

 

$

(66,024

)

 

$

(33,816

)

 

$

(32,208

)

Provision for income taxes

 

 

(72

)

 

 

—

 

 

 

(72

)

Net loss after taxes

 

$

(66,096

)

 

$

(33,816

)

 

$

(32,280

)

Research and Development Expense
The following table summarizes our research and development expenses incurred for the periods presented (in thousands):

 

THREE MONTHS ENDED JUNE 30,

 

 

2025

 

 

2024

 

External research and development costs by program:

 

 

 

 

 

 

APG777

 

$

22,052

 

 

$

8,103

 

APG990/APG279

 

 

3,975

 

 

 

6,905

 

APG333/APG777 + APG333

 

 

1,185

 

 

 

3,796

 

APG808

 

 

1,467

 

 

 

2,213

 

Unallocated research and development costs:

 

 

 

 

 

 

External-discovery related costs and other

 

 

5,307

 

 

 

2,217

 

Personnel-related (excluding equity-based compensation)

 

 

16,105

 

 

 

7,782

 

Equity-based compensation

 

 

5,538

 

 

 

2,154

 

Depreciation expense

 

 

74

 

 

 

36

 

Total research and development expenses

 

$

55,703

 

 

$

33,206

 

 

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Research and development expenses for the three months ended June 30, 2025 and 2024 were $55.7 million and $33.2 million, respectively. The increase of $22.5 million was primarily driven by further development of our APG777 program and increases in personnel costs and equity-based compensation, associated with the growth in our research and development team, partially offset by decreases in expenses related to the APG990/APG279, APG333/APG777 + APG333 and APG808 programs.
Research and development expense related to the APG777 program increased by $13.9 million in the three months ended June 30, 2025, compared to the three months ended June 30, 2024, primarily driven by an increase in clinical trial-related expenses and clinical manufacturing activities to support our Phase 1 and Phase 2 clinical trials. Research and development expense related to the APG990/APG279 program decreased by $2.9 million in the three months ended June 30, 2025, compared to the three months ended June 30, 2024, primarily due to a reduction in clinical manufacturing activities and a decrease in expenses incurred under the Option Agreements and License Agreements, including a milestone payment of $1.0 million to Paragon in May 2024 for the nomination of a development candidate, partially offset by an increase in clinical trial expenses. Research and development expense related to the APG333/APG777 + APG333 program decreased by $2.6 million in the three months ended June 30, 2025, compared to the three months ended June 30, 2024, primarily due to a reduction in clinical manufacturing activities and a decrease in expenses incurred under the Option Agreements and License Agreements.
External-discovery related costs and other expenses increased by $3.1 million in the three months ended June 30, 2025, compared to the three months ended June 30, 2024, primarily driven by increases in travel and other employee related expenses, professional service fees and non-program specific research and development expenses. Personnel-related expenses and equity-based compensation increased by $8.3 million and $3.4 million in the three months ended June 30, 2025, respectively, compared to the three months ended June 30, 2024, primarily due to increased headcount and an increase in the fair value of equity awards granted.
General and Administrative Expense
The following table summarizes our general and administrative expenses for the periods presented (in thousands):
 

 

THREE MONTHS ENDED JUNE 30,

 

 

2025

 

 

2024

 

Personnel-related (excluding equity-based compensation)

 

$

6,395

 

 

$

3,099

 

Equity-based compensation

 

 

5,806

 

 

 

3,544

 

Legal and professional fees

 

 

1,211

 

 

 

1,850

 

Depreciation expense

 

 

325

 

 

 

—

 

Other

 

 

3,725

 

 

 

2,423

 

Total general and administrative expenses

 

$

17,462

 

 

$

10,916