Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 05, 2024 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2024 | |
Document Transition Report | false | |
Entity File Number | 001-41740 | |
Entity Registrant Name | Apogee Therapeutics, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 93-4958665 | |
Entity Address, Address Line One | 221 Crescent St | |
Entity Address, Address Line Two | Building 17 | |
Entity Address, Address Line Three | Suite 102b | |
Entity Address, City or Town | Waltham | |
Entity Address State Or Province | MA | |
Entity Address, Postal Zip Code | 02453 | |
City Area Code | 650 | |
Local Phone Number | 394‑5230 | |
Title of 12(b) Security | Common Stock, par value $0.00001 per share | |
Trading Symbol | APGE | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001974640 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Voting Common Stock | ||
Entity Common Stock, Shares Outstanding | 44,999,063 | |
Nonvoting Common Stock | ||
Entity Common Stock, Shares Outstanding | 13,486,642 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 307,299 | $ 118,316 |
Marketable securities | 368,929 | 277,143 |
Prepaid expenses and other current assets | 5,625 | 2,950 |
Total current assets | 681,853 | 398,409 |
Long-term marketable securities | 113,395 | |
Property and equipment, net | 714 | 377 |
Right-of-use asset, net | 4,227 | 2,217 |
Other non-current assets | 468 | 401 |
Total assets | 800,657 | 401,404 |
Current liabilities: | ||
Accounts payable | 5,527 | 2,143 |
Lease liability | 1,682 | 1,101 |
Accrued expenses | 17,408 | 17,314 |
Total current liabilities | 24,617 | 20,558 |
Long-term liabilities: | ||
Lease liability, net of current | 2,401 | 933 |
Total liabilities | 27,018 | 21,491 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity/members' deficit: | ||
Common Stock; $0.00001 par value, 400,000,000 authorized, 58,481,214 issued and 56,676,465 outstanding as of June 30, 2024; 400,000,000 authorized, 50,655,671 issued and 48,338,769 outstanding as of December 31, 2023 | 1 | |
Additional paid-in capital | 963,607 | 503,354 |
Accumulated other comprehensive (loss) income | (289) | 329 |
Accumulated deficit | (189,680) | (123,770) |
Total stockholders' equity | 773,639 | 379,913 |
Total liabilities and stockholders' equity | $ 800,657 | $ 401,404 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 | Jul. 18, 2023 |
CONDENSED CONSOLIDATED BALANCE SHEETS | |||
Common stock, par value | $ 0.00001 | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 400,000,000 | 400,000,000 | 400,000,000 |
Common stock, shares, issued | 58,481,214 | 50,655,671 | |
Common stock, shares outstanding | 56,676,465 | 48,338,769 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | ||
Operating expenses: | |||||
Research and development | [1] | $ 33,206 | $ 13,946 | $ 61,922 | $ 22,401 |
General and administrative | [2] | 10,916 | 4,939 | 20,381 | 9,142 |
Total operating expenses | 44,122 | 18,885 | 82,303 | 31,543 | |
Loss from operations | (44,122) | (18,885) | (82,303) | (31,543) | |
Other income, net: | |||||
Interest income, net | 10,306 | 16,393 | 133 | ||
Total other income, net | 10,306 | 16,393 | 133 | ||
Net loss | $ (33,816) | $ (18,885) | $ (65,910) | $ (31,410) | |
Net loss per share, basic | $ (0.6) | $ (3.78) | $ (1.24) | $ (6.28) | |
Net loss per share, diluted | $ (0.6) | $ (3.78) | $ (1.24) | $ (6.28) | |
Weighted-average common shares outstanding, basic | 56,515,003 | 5,000,000 | 53,352,406 | 5,000,000 | |
Weighted-average common shares outstanding, diluted | 56,515,003 | 5,000,000 | 53,352,406 | 5,000,000 | |
[1] Includes related-party amounts of $ 2,221 and $ 8,678 for the three and six months ended June 30, 2024, respectively, and $ 5,884 and $ 13,411 for the three and six months ended June 30, 2023 , respectively. No related-party amounts for the three and six months ended June 30, 2024, and $ 14 and $ 33 for the three and six months ended June 30, 2023 , respectively. |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | ||
Research and development | [1] | $ 33,206 | $ 13,946 | $ 61,922 | $ 22,401 |
General and administrative | [2] | 10,916 | 4,939 | 20,381 | 9,142 |
Related Party | |||||
Research and development | 2,221 | 5,884 | 8,678 | 13,411 | |
General and administrative | $ 0 | $ 14 | $ 0 | $ 33 | |
[1] Includes related-party amounts of $ 2,221 and $ 8,678 for the three and six months ended June 30, 2024, respectively, and $ 5,884 and $ 13,411 for the three and six months ended June 30, 2023 , respectively. No related-party amounts for the three and six months ended June 30, 2024, and $ 14 and $ 33 for the three and six months ended June 30, 2023 , respectively. |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS | ||||
Net loss | $ (33,816) | $ (18,885) | $ (65,910) | $ (31,410) |
Change in unrealized losses on marketable securities, net of tax | (112) | (618) | ||
Comprehensive loss | $ (33,928) | $ (18,885) | $ (66,528) | $ (31,410) |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Units | Incentive Units | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Series A Preferred Units | Series B Preferred Units |
Beginning balance at Dec. 31, 2022 | $ 28,971 | $ 148,496 | |||||||
Beginning balance (in shares) at Dec. 31, 2022 | 20,000,000 | 45,089,212 | |||||||
Ending balance at Mar. 31, 2023 | $ 28,971 | $ 148,496 | |||||||
Ending balance (in shares) at Mar. 31, 2023 | 20,000,000 | 45,089,212 | |||||||
Beginning balance at Dec. 31, 2022 | $ (35,392) | $ 2,251 | $ 2,142 | $ (39,785) | |||||
Beginning balance (in shares) at Dec. 31, 2022 | 5,000,000 | 1,625,086 | |||||||
MEMBERS' DEFICIT | |||||||||
Equity Based Compensation Expense | 1,274 | $ 1,274 | |||||||
Net loss | (12,525) | (12,525) | |||||||
Ending balance at Mar. 31, 2023 | $ (46,643) | $ 2,251 | $ 3,416 | (52,310) | |||||
Ending balance (in shares) at Mar. 31, 2023 | 5,000,000 | 1,625,086 | |||||||
Beginning balance at Dec. 31, 2022 | $ 28,971 | $ 148,496 | |||||||
Beginning balance (in shares) at Dec. 31, 2022 | 20,000,000 | 45,089,212 | |||||||
Ending balance at Jun. 30, 2023 | $ 28,971 | $ 148,496 | |||||||
Ending balance (in shares) at Jun. 30, 2023 | 65,089,212 | 20,000,000 | 45,089,212 | ||||||
Beginning balance at Dec. 31, 2022 | $ (35,392) | $ 2,251 | $ 2,142 | (39,785) | |||||
Beginning balance (in shares) at Dec. 31, 2022 | 5,000,000 | 1,625,086 | |||||||
MEMBERS' DEFICIT | |||||||||
Net loss | (31,410) | ||||||||
Ending balance at Jun. 30, 2023 | $ (64,415) | $ 2,251 | $ 4,529 | (71,195) | |||||
Ending balance (in shares) at Jun. 30, 2023 | 5,000,000 | 2,481,543 | |||||||
Beginning balance at Mar. 31, 2023 | $ 28,971 | $ 148,496 | |||||||
Beginning balance (in shares) at Mar. 31, 2023 | 20,000,000 | 45,089,212 | |||||||
Ending balance at Jun. 30, 2023 | $ 28,971 | $ 148,496 | |||||||
Ending balance (in shares) at Jun. 30, 2023 | 65,089,212 | 20,000,000 | 45,089,212 | ||||||
Beginning balance at Mar. 31, 2023 | $ (46,643) | $ 2,251 | $ 3,416 | (52,310) | |||||
Beginning balance (in shares) at Mar. 31, 2023 | 5,000,000 | 1,625,086 | |||||||
MEMBERS' DEFICIT | |||||||||
Issuance of common stock upon exercise of stock options (in shares) | 856,457 | ||||||||
Equity Based Compensation Expense | 1,113 | $ 1,113 | |||||||
Net loss | (18,885) | (18,885) | |||||||
Ending balance at Jun. 30, 2023 | (64,415) | $ 2,251 | $ 4,529 | (71,195) | |||||
Ending balance (in shares) at Jun. 30, 2023 | 5,000,000 | 2,481,543 | |||||||
Beginning balance at Dec. 31, 2023 | 379,913 | $ 503,354 | (123,770) | $ 329 | |||||
Beginning balance (in shares) at Dec. 31, 2023 | 48,338,769 | ||||||||
MEMBERS' DEFICIT | |||||||||
Common stock issued, net of issuance costs of $33,045 | 449,955 | $ 1 | 449,954 | ||||||
Common stock issued, net of issuance costs of $33,045 (in shares) | 7,790,321 | ||||||||
Vesting of restricted stock (in shares) | 237,665 | ||||||||
Issuance of common stock upon exercise of stock options | 24 | 24 | |||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,047 | ||||||||
Equity Based Compensation Expense | 4,186 | 4,186 | |||||||
Change in unrealized loss on marketable securities, net of tax | (506) | (506) | |||||||
Net loss | (32,094) | (32,094) | |||||||
Ending balance at Mar. 31, 2024 | 801,478 | $ 1 | 957,518 | (155,864) | (177) | ||||
Ending balance (in shares) at Mar. 31, 2024 | 56,367,802 | ||||||||
Beginning balance at Dec. 31, 2023 | $ 379,913 | 503,354 | (123,770) | 329 | |||||
Beginning balance (in shares) at Dec. 31, 2023 | 48,338,769 | ||||||||
MEMBERS' DEFICIT | |||||||||
Issuance of common stock upon exercise of stock options (in shares) | 1,675 | ||||||||
Change in unrealized loss on marketable securities, net of tax | $ (618) | ||||||||
Net loss | (65,910) | ||||||||
Ending balance at Jun. 30, 2024 | 773,639 | $ 1 | 963,607 | (189,680) | (289) | ||||
Ending balance (in shares) at Jun. 30, 2024 | 56,676,465 | ||||||||
Beginning balance at Mar. 31, 2024 | 801,478 | $ 1 | 957,518 | (155,864) | (177) | ||||
Beginning balance (in shares) at Mar. 31, 2024 | 56,367,802 | ||||||||
MEMBERS' DEFICIT | |||||||||
Vesting of restricted stock (in shares) | 292,477 | ||||||||
Issuance of common stock upon exercise of stock options | 14 | 14 | |||||||
Issuance of common stock upon exercise of stock options (in shares) | 628 | ||||||||
Issuance of common stock under employee stock purchase plan | 377 | 377 | |||||||
Issuance of common stock under employee stock purchase plan (in shares) | 15,558 | ||||||||
Equity Based Compensation Expense | 5,698 | 5,698 | |||||||
Change in unrealized loss on marketable securities, net of tax | (112) | (112) | |||||||
Net loss | (33,816) | (33,816) | |||||||
Ending balance at Jun. 30, 2024 | $ 773,639 | $ 1 | $ 963,607 | $ (189,680) | $ (289) | ||||
Ending balance (in shares) at Jun. 30, 2024 | 56,676,465 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Mar. 31, 2024 | Jun. 30, 2023 | |
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY | ||
Stock issuance costs | $ 33,045 | $ 1,694 |
CONDENSED CONSOLIDATED STATEM_6
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Cash flows from operating activities: | ||
Net loss | $ (65,910) | $ (31,410) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation expense | 65 | |
Equity-based compensation expense | 9,884 | 2,387 |
Amortization of discounts on marketable securities | (5,750) | |
Non-cash lease expense | 546 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (2,675) | (1,964) |
Other non-current assets | (67) | |
Accounts payable | 3,384 | 10,339 |
Operating lease liability | (507) | |
Accrued expenses | 94 | (4,479) |
Net cash used in operating activities | (60,936) | (25,127) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (352,859) | |
Maturities of marketable securities | 152,810 | |
Purchases of property and equipment | (402) | |
Net cash used in investing activities | (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 | 415 | |
Payment of deferred offering costs | (1,694) | |
Net cash provided by (used in) financing activities | 450,370 | (1,694) |
Increase (decrease) in cash, cash equivalents and restricted cash | 188,983 | (26,821) |
Cash, cash equivalents and restricted cash, beginning of period | 118,610 | 15,189 |
Cash, cash equivalents and restricted cash, end of period | 307,593 | 125,069 |
Supplemental disclosures of non-cash activities: | ||
Operating lease right-of-use asset obtained in exchange for operating lease liability | 2,556 | |
Deferred financing issuance costs in accrued liability | 1,384 | |
Deferred financing issuance costs in accounts payable | 391 | |
Reconciliation of cash, cash equivalents and restricted cash: | ||
Cash and cash equivalents | 307,299 | 125,069 |
Restricted cash | 294 | |
Total | $ 307,593 | $ 125,069 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (33,816) | $ (32,094) | $ (18,885) | $ (12,525) | $ (65,910) | $ (31,410) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Rule 10b5-1 Arr Modified Flag | false |
Non Rule 10b5-1 Arr Modified Flag | false |
Nature of the Business
Nature of the Business | 6 Months Ended |
Jun. 30, 2024 | |
Nature of the Business | |
Nature of the Business | 1. Nature of the Business Apogee Therapeutics, Inc., together with its consolidated subsidiary (collectively, “Apogee” or the “Company”), a successor to Apogee Therapeutics, LLC, is a clinical-stage biotechnology company advancing 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, 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 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, financing and transactions. As a result of the Reorganization (as defined below) 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 rights, 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 newly disclosed 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 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. On July 13, 2023, the Company completed a reorganization, pursuant to which the members of Apogee Therapeutics, LLC contributed their units in Apogee Therapeutics, LLC to Apogee Therapeutics, Inc. in exchange for shares of common stock or non-voting common stock of Apogee Therapeutics, Inc. and Apogee Therapeutics, LLC became a wholly-owned subsidiary of Apogee Therapeutics, Inc. (the “Reorganization”), as follows: • 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. On July 18, 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 regulations, and the ability to raise additional capital to fund operations. The Company’s programs currently under development, APG777, APG808, APG990 and APG333, 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 $ 189.7 million as of June 30, 2024. Further, the Company incurred a net loss of $ 65.9 million and experienced negative cash flows from operations of $ 60.9 million for the six months ended June 30, 2024. Based on the Company’s current operating plan, it estimates that its existing cash and cash equivalents of $ 307.3 million, marketable securities of $ 368.9 million and long-term marketable securities of $ 113.4 million as of June 30, 2024, 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies There have been no material changes to the significant accounting policies as disclosed in Note 2 to the Company consolidated financial statements for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 5, 2024, except as noted below. Basis of Presentation The condensed consolidated financial statements prior to the Reorganization include the accounts of Apogee Therapeutics, LLC and its wholly-owned subsidiary. The condensed consolidated financial statements subsequent to the Reorganization include the accounts of Apogee Therapeutics, Inc. and its wholly-owned subsidiary. 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 reported interim 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. Principles of Consolidation The accompanying consolidated financial statements include the accounts of Apogee Therapeutics, Inc. and its wholly-owned subsidiary, Apogee Biologics, Inc. 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, 2024 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. 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 Laboratory equipment 5 years 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. Preferred Units The Company has classified the preferred units as temporary equity because the units could become effectively settled for cash or other assets due to certain contingent event clauses that are outside of the Company’s control. The preferred units are not currently settleable, but are entitled to a distribution of available proceeds upon a change of control or a sale event which is a bona fide, negotiated transaction in which the Company has determined to affect a change of control. Because the occurrence of a change of control and a sale event is not currently probable, the carrying values of the preferred units are not being accreted to their redemption values. Subsequent adjustments to the carrying values of the preferred units would be made only when the change of control or sale event becomes probable. 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. 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. 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 Prior to the Reorganization, the Company issued equity-based awards to employees, managers, executives, non-employees and service providers in the form of common units and incentive units. Subsequent to the Reorganization, the Company issued equity-based awards to employees, managers, executives, non-employees and service providers in the form of restricted common units and stock options. The Company accounts for equity-based compensation awards in accordance with FASB ASC Topic 718, Compensation-Stock Compensation (“ASC 718”). Due to the absence of an active market for the Company’s common units or incentive units prior to the completion of the IPO, the Company utilized methodologies in accordance with the framework of the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation of Privately-Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common units and incentive units. The estimated fair value of the common units and incentive units was determined at each grant date based upon a variety of factors, including the illiquid nature of the common units, arm’s-length sales of the Company’s equity units (including preferred units), the effect of the rights and preferences of the preferred unit unitholders, and the prospects of a liquidity event. Among other factors are the Company’s financial position and historical financial performance, the status of technological developments within the Company’s research, the composition and ability of the current research and management team, an evaluation or benchmark of the Company’s competition, and the current business climate in the marketplace. Significant changes to the key assumptions underlying the factors used could have resulted in different fair values of the common units and incentive units at each valuation date. Subsequent to the completion of the IPO, 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. 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, 2024 , 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, 2024 and December 31, 2023, 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 relies on one third-party contract manufacturer to produce and process its programs, APG777, APG808, APG990 and APG333 for preclinical and clinical 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 June 30, 2024 and December 31, 2023, 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 follows the two-class method when computing net loss per share. Prior to the Reorganization, the Company issued units that met the definition of participating securities, including the Company’s Series A Preferred Units, the Series B Preferred Units, and vested incentive units (each a participating security), and subsequent to the Reorganization, 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. The two-class method determines net loss per unit and net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income for the period to be allocated between common and participating securities based upon their respective rights to share in the income as if all income for the period had been distributed. Prior to the Reorganization, during periods of loss, there was no allocation required under the two-class method since the participating securities did not have a contractual obligation to fund the losses of the Company. Subsequent to the Reorganization, 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. Prior to the Reorganization, the Company calculated basic net loss per common share by dividing net loss by the weighted-average number of common units outstanding for the period. Subsequent to the Reorganization, 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 unit and net loss per share are the same as the inclusion of the potentially dilutive securities would be anti-dilutive. For periods presented that include the Reorganization, the weighted-average shares of common stock outstanding include the weighted average number of common units outstanding prior to the Reorganization. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2024 | |
Marketable Securities | |
Marketable Securities | 3. Marketable Securities The following is a summary of the Company’s investing portfolio (in thousands): AS OF JUNE 30, 2024 UNREALIZED COST GAINS LOSSES FAIR VALUE Marketable securities Maturities within one year: U.S. treasury securities $ 165,313 $ - $ ( 117 ) $ 165,196 Debt securities issued by U.S. government agencies 157,592 7 ( 182 ) 157,417 Commercial paper 15,591 — ( 24 ) 15,567 Corporate debt securities 30,765 — ( 16 ) 30,749 Total maturities within one year 369,261 7 ( 339 ) 368,929 Maturities between one and two years: U.S. treasury securities $ 66,968 $ 36 $ ( 8 ) $ 66,996 Debt securities issued by U.S. government agencies 46,378 26 ( 5 ) 46,399 Total maturities between one and two years 113,346 62 ( 13 ) 113,395 Total marketable securities $ 482,607 $ 69 $ ( 352 ) $ 482,324 AS OF DECEMBER 31, 2023 UNREALIZED COST GAINS LOSSES FAIR VALUE Marketable securities: Maturities within one year: U.S. treasury securities $ 123,836 $ 140 $ ( 2 ) $ 123,974 Debt securities issued by U.S. government agencies 152,978 199 ( 8 ) 153,169 Total marketable securities $ 276,814 $ 339 $ ( 10 ) $ 277,143 As of June 30, 2024, the Company had 47 securities with a total fair market value of $ 418.3 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, 2024 and December 31, 2023. 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, 2024 and 2023 . |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Measurements | |
Fair Value Measurements | 4. Fair Value Measurements The Company estimated the fair value of the Tranche Options, as defined below (see Note 10), at the time of issuance and subsequently remeasured them at each reporting period and prior to settlement, which occurred prior to December 31, 2022. The fair value of the Tranche Options was determined using a contingent forward model, which considered as inputs the estimated fair value of the preferred units as of each valuation date, the risk-free interest rate, probability of achievement, salvage value and estimated time to each tranche closing. The most significant assumptions in the contingent forward model impacting the fair value of the Tranche Options is the fair value of the Company’s Series A Preferred Unit, probability of achievement and time to the tranche closing as of each measurement date. The Company determined the fair value per share of the underlying preferred unit by taking into consideration the most recent sales of its preferred units, results obtained from third-party valuations and additional factors the Company deems relevant. 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, 2024 LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Cash equivalents: Money market funds $ 206,398 $ — $ — $ 206,398 U.S. treasury securities 24,938 — — 24,938 Commercial paper — 56,767 — 56,767 Debt securities issued by U.S. government agencies — 9,949 — 9,949 Marketable securities: U.S. treasury securities 232,191 — — 232,191 Debt securities issued by U.S. government agencies — 203,817 — 203,817 Commercial paper — 15,567 — 15,567 Corporate debt securities — 30,749 — 30,749 Total $ 463,527 $ 316,849 $ — $ 780,376 AS OF DECEMBER 31, 2023 LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Cash equivalents: Money market funds $ 110,655 $ — $ — $ 110,655 Marketable securities: U.S. treasury securities 123,974 — — 123,974 Debt securities issued by U.S. government agencies — 153,169 — 153,169 Total $ 234,629 $ 153,169 $ — $ 387,798 |
Prepaids and Other Assets
Prepaids and Other Assets | 6 Months Ended |
Jun. 30, 2024 | |
Prepaids and Other Assets | |
Prepaids and Other Assets | 5. Prepaids and Other Assets Prepaid expenses and other current assets consisted of the following (in thousands): JUNE 30, DECEMBER 31, Prepaid expenses $ 2,238 $ 1,736 Other current assets 3,387 1,214 Total $ 5,625 $ 2,950 As of June 30, 2024 and December 31, 2023, the Company had restricted cash of $ 0.3 million held as a letter of credit for the benefit of a contract research organization. The related letter of credit was classified within other non-current assets on the consolidated balance sheet as of June 30, 2024 and December 31, 2023. |
Property and Equipment, net
Property and Equipment, net | 6 Months Ended |
Jun. 30, 2024 | |
Property and Equipment, net | |
Property and Equipment, net | 6. Property and Equipment, net The Company had property and equipment, net of $ 0.7 million and $ 0.4 million, as of June 30, 2024 and December 31, 2023, respectively, which consisted entirely of lab equipment. The Company recognized an immaterial amount of depreciation expense for the three and six months ended June 30, 2024 . |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses | |
Accrued Expenses | 7. Accrued Expenses Accrued expenses consisted of the following (in thousands): JUNE 30, DECEMBER 31, Accrued external research and development expenses $ 2,810 $ 6,685 Accrued manufacturing expenses 9,536 9,219 Accrued other 1,007 1,243 Accrued employee compensation 4,055 167 Total $ 17,408 $ 17,314 |
Other Significant Agreements
Other Significant Agreements | 6 Months Ended |
Jun. 30, 2024 | |
Other Significant Agreements | |
Other Significant Agreements | 8. Other Significant Agreements Paragon 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. For the three and six months ended June 30, 2023, the Company recognized $ 5.9 million and $ 13.4 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 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 focus 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 and Paragon agreed 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. The Company’s exclusive option with respect to each Research Program is exercisable at its 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 Tranche Options of the Series A Preferred Unit financing (see Note 10). Through June 30, 2024, the Company had issued a total of 5,000,000 common units to Paragon with an aggregate fair value of $ 2.2 million on the grant date. 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. The Company expenses the service fees as the associated costs are incurred when the underlying services are rendered. Such amounts are classified within research and development expenses in the accompanying condensed consolidated statement of operations and comprehensive loss. The Company concluded that the rights obtained under the 2022 Option Agreement represent an asset acquisition whereby the underlying assets comprise in-process research and development assets with no alternative future use. The 2022 Option Agreement did not qualify as a business combination because substantially all of the fair value of the assets acquired was concentrated in the exclusive license options, which represent a group of similar identifiable assets. Therefore, the aggregate acquisition cost of $ 3.5 million, related to the upfront cash and equity payments, was recognized as acquired in-process research and development expense, which is reported as a component of research and development expense during the period from February 4, 2022 (inception) to December 31, 2022. Amounts paid as on-going development cost reimbursements associated with services being rendered under the related Research Programs is recognized as research and development expense when incurred. In November 2023, the Company entered the 2023 Option Agreement. 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 newly disclosed 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 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 2023 Option Agreement, the parties may initiate Research Programs. Each Research Program is 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 its 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. Following entry into the 2023 Option Agreement, the Company and Paragon will negotiate a form of License Agreement to be entered into in the event that the Company exercises its exclusive option with respect to each Research Program, which License Agreement will include certain pre-agreed economic and other business terms. 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. 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. 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 (the “TSLP License Agreement” and collectively with the IL-13 License Agreement, the IL-4Ra License Agreement and the OX40L License Agreement, the “License Agreements". Under the terms of each 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 target 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 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-4Ra 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 incurred a milestone payment of $ 2.0 million to Paragon in the third 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 first dosing of a human patient in a Phase 1 trial of APG808 in healthy volunteers 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. 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 License Agreements, and Paragon has a similar obligation to pay royalties to the Company with respect to the 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. 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 APG777, APG990, APG808 and APG333 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 busy 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, 2024, the Company recognized $ 8.9 million and $ 13.2 million, respectively, of research and development expense in connection with the WuXi Biologics MSA. For the three and six months ended June 30, 2023, the Company recognized $ 5.9 million of research and development expense in connection with the WuXi Biologics MSA subsequent to novation. 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’s 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, APG808, APG990 and APG333 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, it 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. The Cell Line License Agreement will continue indefinitely unless terminated (i) by the Company upon six months ’ prior written notice and its 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. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies | |
Commitments and Contingencies | 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, 2024, 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, 2024 and December 31, 2023. 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. |
Preferred Shares
Preferred Shares | 6 Months Ended |
Jun. 30, 2024 | |
Preferred Shares | |
Preferred Shares | 10. Preferred Shares As of June 30, 2023 , the Company had authorized, issued and outstanding an aggregate of 65,089,212 preferred units, of which 20,000,000 units had been designated as Series A Preferred Units and 45,089,212 units had been designated as Series B Preferred Units. All outstanding preferred units were exchanged for 24,987,750 shares of common stock (or non-voting common stock in lieu thereof) in connection with the IPO in July 2023. As of June 30, 2024, the Company did not have any outstanding preferred units. Series A Preferred Units On February 24, 2022, the Company executed the Series A Preferred Unit Purchase Agreement (the “Series A Agreement”) to issue and sell up to 20,000,000 Series A Preferred Units at a purchase price of $ 1.00 per unit. In the initial closing on February 24, 2022, the Company issued 5,000,000 Series A Preferred Units at a purchase price of $ 1.00 , resulting in gross cash proceeds to the Company of $ 5.0 million, and incurred $ 0.2 million of issuance costs. The Series A Agreement provided for three tranche option closings following the initial closing (the “Tranche Options”), which Tranche Option closings were subject to approval of the Board of Managers of Apogee Therapeutics, LLC (the “Board of Managers”), which was controlled by the holders of the Series A Preferred Units. The Board of Managers approved all such subsequent closings resulting in investors purchasing 5,000,000 Series A Preferred Units in each of the three subsequent Tranche Option closings throughout 2022. As a result, the Company received an aggregate of $ 20.0 million in gross proceeds associated with the Series A Agreement. The Company assessed the Tranche Options and concluded that they met the definition of a freestanding financial instrument, as the Tranche Options were legally detachable and separately exercisable from the Series A Preferred Units. Therefore, the Company allocated the proceeds between the Tranche Options and the Series A Preferred Units sold at the initial closing. As the Series A Preferred Units are contingently redeemable upon an event that is not completely within the control of the Company, the Tranche Options are classified as an asset or liability and are initially recorded at fair value. The Tranche Options are measured at fair value at each reporting period, through the settlement of the instrument. Since the Tranche Options are subject to fair value accounting, the Company allocated $ 1.1 million of the initial proceeds to the Tranche Options based on the fair value at the date of issuance with the remaining proceeds beings allocated to the Series A Preferred Units. Upon the Tranche Option closings in August and October 2022, the respective Tranche Option value was remeasured at fair value and then reclassified to Series A Preferred Units upon settlement. Series B Preferred Units On November 15, 2022, the Company executed the Series B Preferred Unit Purchase Agreement (the “Series B Agreement”) to issue and sell 45,089,212 Series B Preferred Units in a single closing at a purchase price of $ 3.30456 per unit, resulting in gross cash proceeds to the Company of $ 149.0 million. The Company incurred $ 0.5 million of issuance costs in connection with the issuance of the Series B Preferred Units. Embedded Securities Evaluation The Company assessed the Series A Preferred Units and the Series B Preferred Units for any features that may require separate accounting under FASB ASC Topic 815‑ Derivatives and Hedging (“ASC 815”). The Company concluded that none of the features required separate accounting as a derivative. |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2024 | |
Common Stock | |
Common Stock | 11. 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 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. As of June 30, 2024, 58,481,214 and 56,676,465 shares of common stock were issued and outstanding, respectively. The 58,481,214 shares of common stock issued is comprised of 44,994,572 shares of voting common stock and 13,486,642 shares of non-voting common stock. As of June 30, 2024, there were 1,804,749 shares of unvested restricted common stock included within the shares of common stock issued. As of December 31, 2023, 50,655,671 and 48,338,769 shares of common stock were issued and outstanding, respectively. The 50,655,671 shares of common stock issued is comprised of 37,169,029 shares of voting common stock and 13,486,642 shares of non-voting common stock. As of December 31, 2023, there were 2,316,902 shares of unvested restricted common stock included within the shares of common stock issued. |
Equity-Based Compensation
Equity-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Equity-Based Compensation | |
Equity-Based Compensation | 12. Equity-Based Compensation Incentive Units Prior to the Reorganization, the Company periodically granted incentive units to employees, managers and executives, as well as to consultants and service providers of the Company. The incentive units represent a separate substantive class of members’ equity with defined rights. The incentive units represent profits interest in the increase in the value of the entity over a threshold value, or strike price, as determined at the time of grant. The strike price is established for tax compliance purposes related to Internal Revenue Service Revenue Procedure 93-27 and 2001-43 where the Company allocates equity value to separate classes of equity in a hypothetical liquidation transaction as of the date of grant. Each incentive unit issued includes a strike price determined by the Board of Managers. The strike price is based on an estimate of the amount a common unit would receive on the date of issuance of such incentive units in a hypothetical liquidation of the Company in which the Company sold its assets for their fair market value, satisfied its liabilities, and distributed the net proceeds to the holders of units in liquidation of the Company. The Company accounts for equity-based compensation in accordance with ASC 718. In accordance with ASC 718, compensation cost is measured at estimated fair value and is included as compensation expense over the vesting period during which service is provided in exchange for the award. The service-based incentive unit grants generally vest over a four-year service period, with the first 25 % vesting on the 12-month anniversary of the vesting start date and the remaining vesting in equal monthly installments over the following 36 months . The service-based and performance-based incentive unit grant, which the Company has one such award, vests in the same manner as the service-based award upon the achievement of the performance condition. The Company had one incentive unit grant which vested immediately upon issuance. The holders of vested incentive units are entitled to distributions and are not required to purchase or “exercise” their incentive units in order to receive such distributions. However, distributions to incentive unit holders began only after the cumulative amount distributed to common unit holders exceeds the strike price with respect to such incentive unit. The Company determined that incentive units issued to employees, managers, executives, non-employees and service providers are equity-based service payments and, as such, the Company measures and recognizes the related compensation expense in a manner consistent with its accounting policy for equity-based awards. The fair value of each incentive unit grant was estimated on the grant date using either an option pricing method (“OPM”), or a hybrid method, both of which used market approaches to estimate the Company’s enterprise value. The OPM treats common units, incentive units and preferred units as call options on the total equity value of a company, with exercise prices based on the value thresholds at which the allocation among the various holders of a company’s securities changes. Under this method, the incentive units have value only if the funds available for distribution to unitholders exceed the value of the preferred and common unit distribution preferences and the strike price with respect to such incentive unit at the time of the liquidity event. The hybrid method is a probability-weighted expected return method (“PWERM”), where the equity value is allocated in one or more of the scenarios using an OPM. The PWERM is a scenario-based methodology that estimates the fair value of each unit based upon an analysis of future values, assuming various outcomes. The incentive unit value is based on the probability-weighted value across the scenarios, considering the OPM to estimate the value within each scenario given the rights of each class of unit. A discount for lack of marketability of the incentive unit is then applied to arrive at an indication of fair value for the incentive unit. The following assumptions were used in determining the fair value of incentive units granted during the period: THREE MONTHS ENDED JUNE 30, SIX MONTHS ENDED JUNE 30, 2023 2023 Risk-free interest rate 4.1 % - 4.9 % 4.1 % - 4.9 % Expected dividend yield 0.0 % 0.0 % Expected term (in years) 0.17 - 2.00 0.17 - 2.00 Expected volatility 84 % - 90 % 84 % - 90 % Restricted Common Stock Concurrent with the Reorganization, all of the 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, 2024: NUMBER OF SHARES WEIGHTED- Unvested restricted common stock as of December 31, 2023 2,316,902 $ 5.31 Vested ( 512,153 ) $ 5.58 Unvested restricted common stock as of June 30, 2024 1,804,749 $ 5.23 The fair value of restricted stock vested during the three and six months ended June 30, 2024 was $ 1.9 million and $ 2.9 million, respectively. 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, 2024 , the number of shares of common stock reserved for issuance under the 2023 Plan is equal to 9,122,975 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, 2024 2024 Common stock fair value $ 39.35 - $ 50.30 $ 33.50 - $ 66.45 Risk-free interest rate 4.3 % - 4.7 % 3.9 % - 4.7 % Expected dividend yield 0.00 % 0.00 % Expected term (in years) 5.5 - 6.25 5.5 - 6.25 Expected volatility 95.1 % - 96.1 % 95.0 % - 96.4 % The following table provides a summary of stock option activity during the six months ended June 30, 2024: OPTIONS 'WEIGHTED- WEIGHTED- AGGREGATE Outstanding as of December 31, 2023 2,506,017 $ 21.49 9.80 16,154 Granted 487,590 $ 38.86 — — Exercised ( 1,675 ) $ 22.86 — — Forfeited ( 18,461 ) $ 19.51 — — Outstanding as of June 30, 2024 2,973,471 $ 24.35 9.43 46,412 Vested and expected to vest as of June 30, 2024 2,973,471 $ 24.35 9.43 46,412 Exercisable as of June 30, 2024 226,208 $ 22.98 9.40 3,706 The fair value of options vested during the three and six months ended June 30, 2024 was $ 2.9 million and $ 4.7 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, 2024: NUMBER OF WEIGHTED- Unvested restricted stock units as of December 31, 2023 144,090 $ 22.86 Vested ( 17,989 ) 22.86 Unvested restricted stock units as of June 30, 2024 126,101 $ 22.86 The fair value of restricted stock units vested during the three and six months ended June 30, 2024 was $ 0.2 million and $ 0.4 million, respectively. 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. The first purchase period ended in January 2024. As of June 30, 2024 , 15,558 shares have been issued under the ESPP and 946,832 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 SIX MONTHS ENDED 2024 2023 2024 2023 Research and development expense $ 2,154 $ 205 $ 4,084 $ 338 General and administrative expense 3,544 908 5,800 2,049 Total $ 5,698 $ 1,113 $ 9,884 $ 2,387 As of June 30, 2024, the total unrecognized compensation expense related to the Company’s stock options, unvested restricted stock and ESPP was $ 62.9 million, which the Company expects to recognize over a weighted-average period of approximately 3.1 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 . |
Related Parties
Related Parties | 6 Months Ended |
Jun. 30, 2024 | |
Related Parties | |
Related Parties | 13. 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, 2024 and December 31, 2023, $ 1.2 million and $ 5.2 million were due to Paragon, respectively. 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. For the three and six months ended June 30, 2023, the Company incurred research and development expenses of $ 5.9 million and $ 13.4 million, respectively, and immaterial general and administrative expenses with Paragon. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2024 | |
Net Loss Per Share | |
Net Loss Per Share | 14. 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, 2024 2023 2024 2023 Numerator: Net loss $ ( 33,816 ) $ ( 18,885 ) $ ( 65,910 ) $ ( 31,410 ) Net loss attributable to common stockholders, basic and diluted $ ( 33,816 ) $ ( 18,885 ) $ ( 65,910 ) $ ( 31,410 ) Denominator: Weighted average shares of common stock outstanding, basic and diluted 56,515,003 5,000,000 53,352,406 5,000,000 Net loss per share attributable to common stockholders, basic and diluted $ ( 0.60 ) $ ( 3.78 ) $ ( 1.24 ) $ ( 6.28 ) 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, 2024 2023 2024 2023 Series A Preferred Units — 20,000,000 — 20,000,000 Series B Preferred Units — 45,089,212 — 45,089,212 Vested Incentive Units — 2,481,543 — 2,481,543 Unvested Incentive Units — 11,788,732 — 11,788,732 Stock options 2,973,471 — 2,973,471 — Unvested restricted common stock 1,804,749 — 1,804,749 — Unvested restricted stock units 126,101 — 126,101 — Total 4,904,321 79,359,487 4,904,321 79,359,487 |
Operating Leases
Operating Leases | 6 Months Ended |
Jun. 30, 2024 | |
Operating Leases | |
Operating Leases | 15. 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 lab space and extend the lease term. As a result, the total operating lease liability increased from $ 2.0 million as of December 31, 2023 to $ 4.1 million as of June 30, 2024. As of June 30, 2024, the current and non-current portions of the total liability for the operating lease were $ 1.7 million and $ 2.4 million, respectively. As of June 30, 2024, the remaining lease term on the Company’s operating lease was 2.4 years and the incremental borrowing rate used to determine the operating lease liabilities included on the balance sheet was 10 %. The Company incurred lease expense of $ 0.4 million and $ 0.7 million for the three and six months ended June 30, 2024 , respectively. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events | |
Subsequent Events | 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, 2024 and events which occurred subsequently but not recognized in the financial statements. No subsequent events have occurred that require disclosure, except as disclosed below. On August 9, 2024, the Company exercised its option available under the 2023 Option Agreement with respect to the TSLP Research Program. Upon such exercise, the Company entered into the TSLP License Agreement. Under the terms of the TSLP 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 TSLP target to use, make, sell, import, export and otherwise exploit the antibodies directed at the TSLP target. Pursuant to the TSLP License Agreement, the Company granted to Paragon a similar license (except that such license the Company granted to Paragon is non-exclusive) to the TSLP license with respect to multispecific antibodies that are directed at the TSLP target 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. The Company is solely responsible for the continued development, manufacture and commercialization of products at its own cost and expense. 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. The Company is also obligated to pay royalties to Paragon equal to a low-single digit percentage of net sales of any products under the TSLP License Agreement, including for TSLP products in combination with other products licensed from Paragon, and Paragon has a similar obligation to pay royalties to the Company with respect to the TSLP multispecific license. 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. Unless earlier terminated, the TSLP License Agreement remains in effect until the expiration of the last-to-expire Royalty Term for any and all products. 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 an agreement, all licenses and rights granted pursuant to the agreement will automatically terminate and revert to the granting party and all other rights and obligations of the parties will terminate. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The condensed consolidated financial statements prior to the Reorganization include the accounts of Apogee Therapeutics, LLC and its wholly-owned subsidiary. The condensed consolidated financial statements subsequent to the Reorganization include the accounts of Apogee Therapeutics, Inc. and its wholly-owned subsidiary. 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 reported interim 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. |
Principles of Consolidation | Principles of Consolidation The accompanying consolidated financial statements include the accounts of Apogee Therapeutics, Inc. and its wholly-owned subsidiary, Apogee Biologics, Inc. All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | 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 | 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 | 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, 2024 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. |
Property and Equipment, net | 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 Laboratory equipment 5 years 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. |
Preferred Units | Preferred Units The Company has classified the preferred units as temporary equity because the units could become effectively settled for cash or other assets due to certain contingent event clauses that are outside of the Company’s control. The preferred units are not currently settleable, but are entitled to a distribution of available proceeds upon a change of control or a sale event which is a bona fide, negotiated transaction in which the Company has determined to affect a change of control. Because the occurrence of a change of control and a sale event is not currently probable, the carrying values of the preferred units are not being accreted to their redemption values. Subsequent adjustments to the carrying values of the preferred units would be made only when the change of control or sale event becomes probable. |
Research and Development Expense | 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 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 | 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. |
Marketable Securities | 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. 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 | 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 | Equity-Based Compensation Prior to the Reorganization, the Company issued equity-based awards to employees, managers, executives, non-employees and service providers in the form of common units and incentive units. Subsequent to the Reorganization, the Company issued equity-based awards to employees, managers, executives, non-employees and service providers in the form of restricted common units and stock options. The Company accounts for equity-based compensation awards in accordance with FASB ASC Topic 718, Compensation-Stock Compensation (“ASC 718”). Due to the absence of an active market for the Company’s common units or incentive units prior to the completion of the IPO, the Company utilized methodologies in accordance with the framework of the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation of Privately-Held Company Equity Securities Issued as Compensation, to estimate the fair value of its common units and incentive units. The estimated fair value of the common units and incentive units was determined at each grant date based upon a variety of factors, including the illiquid nature of the common units, arm’s-length sales of the Company’s equity units (including preferred units), the effect of the rights and preferences of the preferred unit unitholders, and the prospects of a liquidity event. Among other factors are the Company’s financial position and historical financial performance, the status of technological developments within the Company’s research, the composition and ability of the current research and management team, an evaluation or benchmark of the Company’s competition, and the current business climate in the marketplace. Significant changes to the key assumptions underlying the factors used could have resulted in different fair values of the common units and incentive units at each valuation date. Subsequent to the completion of the IPO, 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. 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, 2024 , 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 | 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, 2024 and December 31, 2023, 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 relies on one third-party contract manufacturer to produce and process its programs, APG777, APG808, APG990 and APG333 for preclinical and clinical 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 | Off-Balance Sheet Arrangements As June 30, 2024 and December 31, 2023, the Company had no off-balance sheet risks such as foreign exchange contracts, option contracts or other foreign hedging arrangements. |
Comprehensive Loss | 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 | Net Loss Per Share The Company follows the two-class method when computing net loss per share. Prior to the Reorganization, the Company issued units that met the definition of participating securities, including the Company’s Series A Preferred Units, the Series B Preferred Units, and vested incentive units (each a participating security), and subsequent to the Reorganization, 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. The two-class method determines net loss per unit and net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income for the period to be allocated between common and participating securities based upon their respective rights to share in the income as if all income for the period had been distributed. Prior to the Reorganization, during periods of loss, there was no allocation required under the two-class method since the participating securities did not have a contractual obligation to fund the losses of the Company. Subsequent to the Reorganization, 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. Prior to the Reorganization, the Company calculated basic net loss per common share by dividing net loss by the weighted-average number of common units outstanding for the period. Subsequent to the Reorganization, 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 unit and net loss per share are the same as the inclusion of the potentially dilutive securities would be anti-dilutive. For periods presented that include the Reorganization, the weighted-average shares of common stock outstanding include the weighted average number of common units outstanding prior to the Reorganization. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Summary of Significant Accounting Policies | |
Schedule of estimated useful lives of the assets | ESTIMATED Laboratory equipment 5 years |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Marketable Securities | |
Schedule of Company's investing portfolio | The following is a summary of the Company’s investing portfolio (in thousands): AS OF JUNE 30, 2024 UNREALIZED COST GAINS LOSSES FAIR VALUE Marketable securities Maturities within one year: U.S. treasury securities $ 165,313 $ - $ ( 117 ) $ 165,196 Debt securities issued by U.S. government agencies 157,592 7 ( 182 ) 157,417 Commercial paper 15,591 — ( 24 ) 15,567 Corporate debt securities 30,765 — ( 16 ) 30,749 Total maturities within one year 369,261 7 ( 339 ) 368,929 Maturities between one and two years: U.S. treasury securities $ 66,968 $ 36 $ ( 8 ) $ 66,996 Debt securities issued by U.S. government agencies 46,378 26 ( 5 ) 46,399 Total maturities between one and two years 113,346 62 ( 13 ) 113,395 Total marketable securities $ 482,607 $ 69 $ ( 352 ) $ 482,324 AS OF DECEMBER 31, 2023 UNREALIZED COST GAINS LOSSES FAIR VALUE Marketable securities: Maturities within one year: U.S. treasury securities $ 123,836 $ 140 $ ( 2 ) $ 123,974 Debt securities issued by U.S. government agencies 152,978 199 ( 8 ) 153,169 Total marketable securities $ 276,814 $ 339 $ ( 10 ) $ 277,143 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Fair Value Measurements | |
Schedule of Financial Assets and Liabilities Measured at Fair Value on a Reoccurring Basis | 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, 2024 LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Cash equivalents: Money market funds $ 206,398 $ — $ — $ 206,398 U.S. treasury securities 24,938 — — 24,938 Commercial paper — 56,767 — 56,767 Debt securities issued by U.S. government agencies — 9,949 — 9,949 Marketable securities: U.S. treasury securities 232,191 — — 232,191 Debt securities issued by U.S. government agencies — 203,817 — 203,817 Commercial paper — 15,567 — 15,567 Corporate debt securities — 30,749 — 30,749 Total $ 463,527 $ 316,849 $ — $ 780,376 AS OF DECEMBER 31, 2023 LEVEL 1 LEVEL 2 LEVEL 3 TOTAL Cash equivalents: Money market funds $ 110,655 $ — $ — $ 110,655 Marketable securities: U.S. treasury securities 123,974 — — 123,974 Debt securities issued by U.S. government agencies — 153,169 — 153,169 Total $ 234,629 $ 153,169 $ — $ 387,798 |
Prepaids and Other Assets (Tabl
Prepaids and Other Assets (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Prepaids and Other Assets | |
Schedule of Prepaid Expenses and Other Assets | Prepaid expenses and other current assets consisted of the following (in thousands): JUNE 30, DECEMBER 31, Prepaid expenses $ 2,238 $ 1,736 Other current assets 3,387 1,214 Total $ 5,625 $ 2,950 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accrued Expenses | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following (in thousands): JUNE 30, DECEMBER 31, Accrued external research and development expenses $ 2,810 $ 6,685 Accrued manufacturing expenses 9,536 9,219 Accrued other 1,007 1,243 Accrued employee compensation 4,055 167 Total $ 17,408 $ 17,314 |
Equity-Based Compensation (Tabl
Equity-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of stock option activity | OPTIONS 'WEIGHTED- WEIGHTED- AGGREGATE Outstanding as of December 31, 2023 2,506,017 $ 21.49 9.80 16,154 Granted 487,590 $ 38.86 — — Exercised ( 1,675 ) $ 22.86 — — Forfeited ( 18,461 ) $ 19.51 — — Outstanding as of June 30, 2024 2,973,471 $ 24.35 9.43 46,412 Vested and expected to vest as of June 30, 2024 2,973,471 $ 24.35 9.43 46,412 Exercisable as of June 30, 2024 226,208 $ 22.98 9.40 3,706 |
Schedule of restricted stock unit activity | NUMBER OF WEIGHTED- Unvested restricted stock units as of December 31, 2023 144,090 $ 22.86 Vested ( 17,989 ) 22.86 Unvested restricted stock units as of June 30, 2024 126,101 $ 22.86 |
Schedule of equity-based compensation expense | THREE MONTHS ENDED SIX MONTHS ENDED 2024 2023 2024 2023 Research and development expense $ 2,154 $ 205 $ 4,084 $ 338 General and administrative expense 3,544 908 5,800 2,049 Total $ 5,698 $ 1,113 $ 9,884 $ 2,387 |
Incentive Units | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of fair value assumptions of share based payment | THREE MONTHS ENDED JUNE 30, SIX MONTHS ENDED JUNE 30, 2023 2023 Risk-free interest rate 4.1 % - 4.9 % 4.1 % - 4.9 % Expected dividend yield 0.0 % 0.0 % Expected term (in years) 0.17 - 2.00 0.17 - 2.00 Expected volatility 84 % - 90 % 84 % - 90 % |
Unvested restricted common stock | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of activity of equity instrument other than option | NUMBER OF SHARES WEIGHTED- Unvested restricted common stock as of December 31, 2023 2,316,902 $ 5.31 Vested ( 512,153 ) $ 5.58 Unvested restricted common stock as of June 30, 2024 1,804,749 $ 5.23 |
2023 Equity Incentive Plan | Employee Stock Option | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Schedule of fair value assumptions of share based payment | THREE MONTHS ENDED JUNE 30, SIX MONTHS ENDED JUNE 30, 2024 2024 Common stock fair value $ 39.35 - $ 50.30 $ 33.50 - $ 66.45 Risk-free interest rate 4.3 % - 4.7 % 3.9 % - 4.7 % Expected dividend yield 0.00 % 0.00 % Expected term (in years) 5.5 - 6.25 5.5 - 6.25 Expected volatility 95.1 % - 96.1 % 95.0 % - 96.4 % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Net Loss Per Share | |
Schedule of basic and diluted net loss per share attributable to common unitholders | 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, 2024 2023 2024 2023 Numerator: Net loss $ ( 33,816 ) $ ( 18,885 ) $ ( 65,910 ) $ ( 31,410 ) Net loss attributable to common stockholders, basic and diluted $ ( 33,816 ) $ ( 18,885 ) $ ( 65,910 ) $ ( 31,410 ) Denominator: Weighted average shares of common stock outstanding, basic and diluted 56,515,003 5,000,000 53,352,406 5,000,000 Net loss per share attributable to common stockholders, basic and diluted $ ( 0.60 ) $ ( 3.78 ) $ ( 1.24 ) $ ( 6.28 ) |
Schedule of potential common units excluded from calculation of diluted net loss per share attributable to common unitholders | 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, 2024 2023 2024 2023 Series A Preferred Units — 20,000,000 — 20,000,000 Series B Preferred Units — 45,089,212 — 45,089,212 Vested Incentive Units — 2,481,543 — 2,481,543 Unvested Incentive Units — 11,788,732 — 11,788,732 Stock options 2,973,471 — 2,973,471 — Unvested restricted common stock 1,804,749 — 1,804,749 — Unvested restricted stock units 126,101 — 126,101 — Total 4,904,321 79,359,487 4,904,321 79,359,487 |
Nature of the Business (Details
Nature of the Business (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||
Mar. 12, 2024 USD ($) $ / shares shares | Jul. 18, 2023 USD ($) $ / shares shares | Nov. 30, 2022 Item | Jun. 30, 2024 USD ($) | Mar. 31, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | Mar. 31, 2023 USD ($) | Jun. 30, 2024 USD ($) | Jun. 30, 2023 USD ($) | Dec. 31, 2023 USD ($) | Jul. 13, 2023 shares | |
Nature of the Business | |||||||||||
Net proceeds from IPO | $ | $ 450,000 | $ 315,400 | |||||||||
Accumulated deficit | $ | $ (189,680) | $ (189,680) | $ (123,770) | ||||||||
Net Income (Loss) | $ | (33,816) | $ (32,094) | $ (18,885) | $ (12,525) | (65,910) | $ (31,410) | |||||
Negative cash flows from operations | $ | 60,936 | 25,127 | |||||||||
Cash and cash equivalents | $ | 307,299 | $ 125,069 | 307,299 | $ 125,069 | |||||||
Marketable securities | $ | 368,929 | 368,929 | $ 277,143 | ||||||||
Long-term marketable securities | $ | $ 113,395 | $ 113,395 | |||||||||
IPO | |||||||||||
Nature of the Business | |||||||||||
Shares issued | 7,790,321 | 20,297,500 | |||||||||
Share price | $ / shares | $ 62 | $ 17 | |||||||||
Overallotment option | |||||||||||
Nature of the Business | |||||||||||
Shares issued | 1,016,128 | 2,647,500 | 7,790,321 | ||||||||
Apogee Therapeutics, LLC | Common Units | |||||||||||
Nature of the Business | |||||||||||
Common stock shares issued | 1,919,500 | ||||||||||
Apogee Therapeutics, LLC | Vested incentive units | |||||||||||
Nature of the Business | |||||||||||
Common stock shares issued | 690,188 | ||||||||||
Apogee Therapeutics, LLC | Unvested incentive units | |||||||||||
Nature of the Business | |||||||||||
Common stock shares issued | 2,779,358 | ||||||||||
Apogee Therapeutics, LLC | Series A Preferred Units | |||||||||||
Nature of the Business | |||||||||||
Nonvoting common stock shares issued | 7,678,000 | ||||||||||
Apogee Therapeutics, LLC | Series B Preferred Units | |||||||||||
Nature of the Business | |||||||||||
Nonvoting common stock shares issued | 5,808,642 | ||||||||||
Common stock shares issued | 11,501,108 | ||||||||||
Option Agreement | Related party | Paragon Therapeutics, Inc | |||||||||||
Nature of the Business | |||||||||||
Number of selected targets initially included under the agreement | Item | 2 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 USD ($) Segment | Dec. 31, 2023 USD ($) | |
Summary of Significant Accounting Policies | ||
Number of Operating Segments | 1 | |
Number of Reportable Segments | 1 | |
Concentration Risk, Credit Risk, Financial Instrument, Maximum Exposure | $ | $ 0 | $ 0 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment (Details) | Jun. 30, 2024 |
Laboratory equipment | |
Property and Equipment, net | |
Property and equipment useful Life | 5 years |
Marketable Securities - Schedul
Marketable Securities - Schedule of Company's investing portfolio (Details) - Marketable securities - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Marketable Securities | ||
COST | $ 482,607 | |
UNREALIZED GAINS | 69 | |
UNREALIZED LOSSES | (352) | |
FAIR VALUE | 482,324 | |
Maturities within one year | ||
Marketable Securities | ||
COST | 369,261 | $ 276,814 |
UNREALIZED GAINS | 7 | 339 |
UNREALIZED LOSSES | (339) | (10) |
FAIR VALUE | 368,929 | 277,143 |
Maturities between one and two years | ||
Marketable Securities | ||
COST | 113,346 | |
UNREALIZED GAINS | 62 | |
UNREALIZED LOSSES | (13) | |
FAIR VALUE | 113,395 | |
U.S. Treasury Securities | Maturities within one year | ||
Marketable Securities | ||
COST | 165,313 | 123,836 |
UNREALIZED GAINS | 140 | |
UNREALIZED LOSSES | (117) | (2) |
FAIR VALUE | 165,196 | 123,974 |
U.S. Treasury Securities | Maturities between one and two years | ||
Marketable Securities | ||
COST | 66,968 | |
UNREALIZED GAINS | 36 | |
UNREALIZED LOSSES | (8) | |
FAIR VALUE | 66,996 | |
Commercial paper | Maturities within one year | ||
Marketable Securities | ||
COST | 15,591 | |
UNREALIZED LOSSES | (24) | |
FAIR VALUE | 15,567 | |
Debt securities issued by U.S. government agencies | Maturities within one year | ||
Marketable Securities | ||
COST | 157,592 | 152,978 |
UNREALIZED GAINS | 7 | 199 |
UNREALIZED LOSSES | (182) | (8) |
FAIR VALUE | 157,417 | $ 153,169 |
Debt securities issued by U.S. government agencies | Maturities between one and two years | ||
Marketable Securities | ||
COST | 46,378 | |
UNREALIZED GAINS | 26 | |
UNREALIZED LOSSES | (5) | |
FAIR VALUE | 46,399 | |
Corporate Debt Securities | Maturities within one year | ||
Marketable Securities | ||
COST | 30,765 | |
UNREALIZED LOSSES | (16) | |
FAIR VALUE | $ 30,749 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Details) | Jun. 30, 2024 USD ($) Security | Dec. 31, 2023 USD ($) |
Marketable Securities | ||
Number of securities in unrealized loss position, less than 12 months | Security | 47 | |
Value of securities in unrealized loss position, less than 12 months | $ 418,300,000 | |
Allowance for credit loss | $ 0 | $ 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Financial Assets and Liabilities Measured at Fair Value on a Reoccurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 368,929 | $ 277,143 |
Fair Value, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 780,376 | 387,798 |
Fair Value, Recurring | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 463,527 | 234,629 |
Fair Value, Recurring | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total | 316,849 | 153,169 |
Fair Value, Recurring | Money Market Funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 206,398 | 110,655 |
Fair Value, Recurring | Money Market Funds | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 206,398 | 110,655 |
Fair Value, Recurring | U.S. Treasury Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 24,938 | |
Marketable securities | 232,191 | 123,974 |
Fair Value, Recurring | U.S. Treasury Securities | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 24,938 | |
Marketable securities | 232,191 | 123,974 |
Fair Value, Recurring | Debt Securities Issued by U.S. Government Agencies | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 9,949 | |
Marketable securities | 203,817 | 153,169 |
Fair Value, Recurring | Debt Securities Issued by U.S. Government Agencies | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 9,949 | |
Marketable securities | 203,817 | $ 153,169 |
Fair Value, Recurring | Commercial Paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 15,567 | |
Fair Value, Recurring | Commercial Paper | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 15,567 | |
Fair Value, Recurring | Corporate Debt Securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 30,749 | |
Fair Value, Recurring | Corporate Debt Securities | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 30,749 | |
Fair Value, Recurring | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 56,767 | |
Fair Value, Recurring | Commercial paper | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 56,767 |
Prepaids and Other Assets - Sch
Prepaids and Other Assets - Schedule of Prepaid Expenses and Other Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Prepaids and Other Assets | ||
Prepaid expenses | $ 2,238 | $ 1,736 |
Other current assets | 3,387 | 1,214 |
Total | $ 5,625 | $ 2,950 |
Prepaids and Other Assets - Add
Prepaids and Other Assets - Additional Information (Details) - USD ($) $ in Millions | Jun. 30, 2024 | Dec. 31, 2023 |
Prepaids and Other Assets | ||
Restricted cash | $ 0.3 | $ 0.3 |
Property and Equipment, net - A
Property and Equipment, net - Additional Information (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Property and Equipment, net | ||
Property and equipment, net | $ 714 | $ 377 |
Laboratory equipment | ||
Property and Equipment, net | ||
Property and equipment, net | $ 700 | $ 400 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued Expenses | ||
Accrued external research and development expenses | $ 2,810 | $ 6,685 |
Accrued manufacturing expenses | 9,536 | 9,219 |
Accrued other | 1,007 | 1,243 |
Accrued employee compensation | 4,055 | 167 |
Total | $ 17,408 | $ 17,314 |
Other Significant Agreements -
Other Significant Agreements - Paragon Agreement (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||||
Aug. 12, 2024 USD ($) | Nov. 30, 2023 USD ($) | Nov. 30, 2022 USD ($) Item shares | Jun. 30, 2024 USD ($) shares | Mar. 31, 2024 USD ($) | Dec. 31, 2023 USD ($) shares | Sep. 30, 2023 USD ($) | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | ||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Research and development | [1] | $ 33,206 | $ 13,946 | $ 61,922 | $ 22,401 | ||||||
Issued total common units (in shares) | shares | 58,481,214 | 50,655,671 | 58,481,214 | ||||||||
Option Agreement | |||||||||||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Aggregate acquisition cost | $ 3,500 | ||||||||||
Paragon Therapeutics, Inc | Related party | |||||||||||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Research and development | $ 2,200 | $ 5,900 | $ 8,700 | $ 13,400 | |||||||
Paragon Therapeutics, Inc | Option Agreement | |||||||||||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Payments due upon exercise of option | $ 0 | ||||||||||
Termination period of agreement | 30 days | 30 days | |||||||||
Period of material breach | 30 days | 30 days | |||||||||
Threshold number of days for termination upon failure to make payment and such failure persists even after the notice | 30 days | 30 days | |||||||||
Payment of non-refundable fees | $ 2,000 | ||||||||||
Paragon Therapeutics, Inc | Option Agreement | Related party | |||||||||||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Number of selected targets initially included under the agreement | Item | 2 | ||||||||||
Upfront cash amount paid | $ 1,300 | ||||||||||
Issued common units (in shares) | shares | 1,250,000 | ||||||||||
Issued total common units (in shares) | shares | 5,000,000 | ||||||||||
Aggregate fair value on grant date | $ 2,200 | ||||||||||
Non-refundable fee | $ 2,000 | $ 500 | |||||||||
Paragon Therapeutics, Inc | Option Agreement | Maximum | Related party | |||||||||||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Issued total common units (in shares) | shares | 3,750,000 | ||||||||||
Paragon Therapeutics, Inc | Paragon IL13 License Agreement | |||||||||||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Expiration period of commercial sale | 12 years | ||||||||||
Termination period of agreement | 60 days | ||||||||||
Period of material breach | 90 days | ||||||||||
Threshold number of days for termination upon failure to make payment and such failure persists even after the notice | 30 days | ||||||||||
Paragon Therapeutics, Inc | Paragon IL13 License Agreement | Related party | |||||||||||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Maximum amount of achievement of development and clinical mile stones | $ 3,000 | ||||||||||
Nomination fee paid | 1,000 | $ 1,000 | $ 2,000 | $ 1,000 | $ 2,000 | ||||||
Milestone payment of trial payable | $ 2,000 | ||||||||||
Paragon Therapeutics, Inc | TSLP License Agreement | Subsequent Event | |||||||||||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Expiration period of commercial sale | 12 years | ||||||||||
Termination period of agreement | 60 days | ||||||||||
Period of material breach | 90 days | ||||||||||
Threshold number of days for termination upon failure to make payment and such failure persists even after the notice | 30 days | ||||||||||
Paragon Therapeutics, Inc | TSLP License Agreement | Related party | Subsequent Event | |||||||||||
Other Significant Agreements Paragon Option Agreement | |||||||||||
Maximum amount of achievement of development and clinical mile stones | $ 28,000 | ||||||||||
Nomination fee paid | 3,000 | ||||||||||
Milestone payment of trial payable | $ 5,000 | ||||||||||
[1] Includes related-party amounts of $ 2,221 and $ 8,678 for the three and six months ended June 30, 2024, respectively, and $ 5,884 and $ 13,411 for the three and six months ended June 30, 2023 , respectively. |
Other Significant Agreements _2
Other Significant Agreements - WuXi Biologics (Hong Kong) limited agreements (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | ||
Other Significant Agreements Paragon Option Agreement | ||||||
Research and development | [1] | $ 33,206,000 | $ 13,946,000 | $ 61,922,000 | $ 22,401,000 | |
Biologics Master Services Agreement | WuXi Biologics | ||||||
Other Significant Agreements Paragon Option Agreement | ||||||
Prior notice period for termination of work order | 6 months | |||||
Threshold number of days for no termination or cancellation fee upon uncured breach after notice of such breach | 30 days | |||||
Threshold number of days for no termination or cancellation fee upon performance breach | 90 days | |||||
Research and development | $ 8,900,000 | $ 5,900,000 | $ 13,200,000 | $ 5,900,000 | ||
Cell Line License Agreement | WuXi Biologics | ||||||
Other Significant Agreements Paragon Option Agreement | ||||||
Prior notice period for termination of work order | 6 months | |||||
Non-refundable license fee | $ 150,000 | |||||
Threshold number of days for no termination or cancellation fee upon uncured breach after notice of such breach | 60 days | |||||
Threshold number of days for termination upon uncured material breach after notice of such breach | 30 days | |||||
[1] Includes related-party amounts of $ 2,221 and $ 8,678 for the three and six months ended June 30, 2024, respectively, and $ 5,884 and $ 13,411 for the three and six months ended June 30, 2023 , respectively. |
Preferred Shares - Additional I
Preferred Shares - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Jul. 18, 2023 | Nov. 15, 2022 | Feb. 24, 2022 | Jun. 30, 2023 |
Preferred Shares | ||||
Preferred Units, units issued | 65,089,212 | |||
Preferred Units, units outstanding | 65,089,212 | |||
Preferred Units, units authorized | 65,089,212 | |||
Preferred Units, units converted | 24,987,750 | |||
Series A Preferred Units | ||||
Preferred Shares | ||||
Preferred Units, units authorized | 20,000,000 | |||
Series A Preferred Units | Tranche Option | ||||
Preferred Shares | ||||
Initial proceeds of issuance of preferred units | $ 1.1 | |||
Series A Preferred Units | Series A Agreement | ||||
Preferred Shares | ||||
Preferred Units, units issued | 5,000,000 | |||
Maximum number of issue and sell of preferred shares | 20,000,000 | |||
Preferred units purchase price (in dollars per share) | $ 1 | |||
Gross cash proceeds | $ 5 | |||
Net issuance cost | $ 0.2 | |||
Series A Preferred Units | Series A Agreement | Tranche Option | ||||
Preferred Shares | ||||
Preferred Units, units issued | 5,000,000 | |||
Gross cash proceeds | $ 20 | |||
Series B Preferred Units | ||||
Preferred Shares | ||||
Preferred Units, units authorized | 45,089,212 | |||
Series B Preferred Units | Series B Agreement | ||||
Preferred Shares | ||||
Maximum number of issue and sell of preferred shares | 45,089,212 | |||
Gross cash proceeds | $ 149 | |||
Net issuance cost | $ 0.5 | |||
Temporary equity preferred shares purchase price (in dollars per share) | $ 3.30456 |
Common Stock - Additional Infor
Common Stock - Additional Information (Details) - $ / shares | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||
Mar. 12, 2024 | Jul. 18, 2023 | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Common Stock | ||||||||
Preferred Units, units converted | 24,987,750 | |||||||
Common stock, shares authorized | 400,000,000 | 400,000,000 | 400,000,000 | 400,000,000 | ||||
Common stock, par value | $ 0.00001 | $ 0.00001 | $ 0.00001 | $ 0.00001 | ||||
Common stock, shares, issued | 58,481,214 | 58,481,214 | 50,655,671 | |||||
Common stock, shares outstanding | 56,676,465 | 56,676,465 | 48,338,769 | |||||
Antidilutive units | 4,904,321 | 79,359,487 | 4,904,321 | 79,359,487 | ||||
Voting Common Stock | ||||||||
Common Stock | ||||||||
Common stock, shares, issued | 44,994,572 | 44,994,572 | 37,169,029 | |||||
Nonvoting Common Stock | ||||||||
Common Stock | ||||||||
Common stock, shares, issued | 13,486,642 | 13,486,642 | 13,486,642 | |||||
Unvested restricted common stock | ||||||||
Common Stock | ||||||||
Antidilutive units | 1,804,749 | 2,316,902 | ||||||
IPO | ||||||||
Common Stock | ||||||||
Shares issued | 7,790,321 | 20,297,500 | ||||||
Overallotment option | ||||||||
Common Stock | ||||||||
Shares issued | 1,016,128 | 2,647,500 | 7,790,321 |
Equity-Based Compensation - Det
Equity-Based Compensation - Determining fair value of incentive units (Details) - Incentive Units | 3 Months Ended | 6 Months Ended |
Jun. 30, 2023 | Jun. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk free interest rate, Minimum | 4.10% | 4.10% |
Risk free interest rate, Maximum | 4.90% | 4.90% |
Expected dividend yield | 0% | 0% |
Expected volatility, Minimum | 84% | 84% |
Expected volatility, Maximum | 90% | 90% |
Minimum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term | 2 months 1 day | 2 months 1 day |
Maximum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected term | 2 years | 2 years |
Equity-Based Compensation - Sum
Equity-Based Compensation - Summary of Company's Unvested Restricted Common Stock Award Activity (Details) - Unvested restricted common stock | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
NUMBER OF SHARES | |
Beginning balance | shares | 2,316,902 |
Vested | shares | (512,153) |
Ending balance | shares | 1,804,749 |
WEIGHTED-AVERAGE GRANT DATE FAIR VALUE PER SHARE | |
Beginning balance (in dollars per share) | $ / shares | $ 5.31 |
Vested (in dollars per share) | $ / shares | 5.58 |
Ending balance (in dollars per share) | $ / shares | $ 5.23 |
Equity-Based Compensation - D_2
Equity-Based Compensation - Determining fair value of stock options (Details) - 2023 Equity Incentive Plan - Employee Stock Option - $ / shares | 3 Months Ended | 6 Months Ended |
Jun. 30, 2024 | Jun. 30, 2024 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Risk free interest rate, Minimum | 4.30% | 3.90% |
Risk free interest rate, Maximum | 4.70% | 4.70% |
Expected dividend yield | 0% | 0% |
Expected volatility, Minimum | 95.10% | 95% |
Expected volatility, Maximum | 96.10% | 96.40% |
Minimum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Common stock fair value | $ 39.35 | $ 33.5 |
Expected term | 5 years 6 months | 5 years 6 months |
Maximum | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Common stock fair value | $ 50.3 | $ 66.45 |
Expected term | 6 years 3 months | 6 years 3 months |
Equity-Based Compensation - S_2
Equity-Based Compensation - Summary of stock option activity (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
OPTIONS | |||
Outstanding as of beginning | 2,506,017 | ||
Granted | 487,590 | ||
Exercised | (1,675) | ||
Forfeited | (18,461) | ||
Outstanding as of ending | 2,973,471 | 2,973,471 | 2,506,017 |
Vested and expected to vest | 2,973,471 | 2,973,471 | |
Exercisable | 226,208 | 226,208 | |
WEIGHTED-AVERAGE EXERCISE PRICE | |||
Outstanding as of beginning (in dollars per share) | $ 21.49 | ||
Granted (in dollars per share) | 38.86 | ||
Exercised (in dollars per share) | 22.86 | ||
Forfeited (in dollars per share) | 19.51 | ||
Outstanding as of ending (in dollars per share) | $ 24.35 | 24.35 | $ 21.49 |
Vested and expected to vest (in dollars per share) | 24.35 | 24.35 | |
Exercisable (in dollars per share) | $ 22.98 | $ 22.98 | |
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Additional Disclosures [Abstract] | |||
Outstanding weighted-average remaining contractual term (in years) | 9 years 5 months 4 days | 9 years 9 months 18 days | |
Vested and expected to vest weighted-average remaining contractual term (in years) | 9 years 5 months 4 days | ||
Exercisable weighted-average remaining contractual term | 9 years 4 months 24 days | ||
Outstanding aggregate intrinsic value | $ 46,412 | $ 46,412 | $ 16,154 |
Vested and expected to vest aggregate intrinsic value | 46,412 | 46,412 | |
Exercisable aggregate intrinsic value | 3,706 | 3,706 | |
Fair value units vested | $ 2,900,000 | $ 4,700,000 |
Equity-Based Compensation - S_3
Equity-Based Compensation - Summary of restricted stock unit activity (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended |
Aug. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2024 | |
NUMBER OF SHARES | |||
Granted | 100,000 | ||
WEIGHTED-AVERAGE GRANT DATE FAIR VALUE PER SHARE | |||
Fair value of vested units | $ 0.2 | $ 0.4 | |
Restricted stock unit | |||
NUMBER OF SHARES | |||
Beginning balance | 144,090 | ||
Vested | (17,989) | ||
Ending balance | 126,101 | 126,101 | |
WEIGHTED-AVERAGE GRANT DATE FAIR VALUE PER SHARE | |||
Beginning balance (in dollars per share) | $ 22.86 | ||
Vested (in dollars per share) | 22.86 | ||
Ending balance (in dollars per share) | $ 22.86 | $ 22.86 | |
Fair value of vested units | $ 1.9 | $ 2.9 |
Equity-Based Compensation - S_4
Equity-Based Compensation - Summary of classification of equity-based compensation expense related to incentive units (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||
Aug. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Equity-based compensation expense | $ 0 | $ 5,698 | $ 1,113 | $ 9,884 | $ 2,387 |
Research and development expense | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Equity-based compensation expense | 2,154 | 205 | 4,084 | 338 | |
General and administrative expense | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Equity-based compensation expense | $ 3,544 | $ 908 | $ 5,800 | $ 2,049 |
Equity-Based Compensation - Add
Equity-Based Compensation - Additional Information (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Feb. 04, 2022 shares | Aug. 31, 2023 USD ($) Option shares | Jul. 31, 2023 | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | Jun. 30, 2024 USD ($) shares | Jun. 30, 2023 USD ($) | |
Equity-Based Compensation | |||||||
Vesting period (in years) | 3 years | ||||||
Shares converted | 3,469,546 | ||||||
Granted | 487,590 | ||||||
Number of stock option grants | Option | 2 | ||||||
Equity-based compensation expense | $ | $ 0 | $ 5,698 | $ 1,113 | $ 9,884 | $ 2,387 | ||
Granted (in shares) | 100,000 | ||||||
Incentive Units | |||||||
Equity-Based Compensation | |||||||
Vesting period (in years) | 4 years | ||||||
Incentive Units | Tranche One [Member] | |||||||
Equity-Based Compensation | |||||||
Vesting period (in years) | 12 months | ||||||
Vesting (as percentage) | 25% | ||||||
Incentive Units | Tranche Two [Member] | |||||||
Equity-Based Compensation | |||||||
Vesting period (in years) | 36 months | ||||||
Vesting (as percentage) | 0.75% | ||||||
Unvested restricted common stock | |||||||
Equity-Based Compensation | |||||||
Exchange of incentive units | 2,779,358 | ||||||
2023 Equity Incentive Plan | |||||||
Equity-Based Compensation | |||||||
Common stock reserved for issuance | 9,122,975 | 9,122,975 | |||||
Increase in shares available for grand (as percentage) | 5% | ||||||
Granted | 50,000 | ||||||
2023 Employee Stock Purchase Plan | |||||||
Equity-Based Compensation | |||||||
Common stock reserved for issuance | 946,832 | 946,832 | |||||
Unrecognized compensation expense | $ | $ 62,900 | $ 62,900 | |||||
Share based compensation recognition period | 3 years 1 month 6 days | ||||||
Granted (in shares) | 15,558 | ||||||
Maximum percentage of eligible employees contribution | 15% | ||||||
Purchase Period | 6 months | ||||||
Purchase price percentage | 85% |
Related Parties - Additional In
Related Parties - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | ||
Related Parties | ||||||
Research and development | [1] | $ 33,206 | $ 13,946 | $ 61,922 | $ 22,401 | |
Related party | Paragon Therapeutics, Inc | ||||||
Related Parties | ||||||
Due to related party | 1,200 | 1,200 | $ 5,200 | |||
Research and development | $ 2,200 | $ 5,900 | $ 8,700 | $ 13,400 | ||
[1] Includes related-party amounts of $ 2,221 and $ 8,678 for the three and six months ended June 30, 2024, respectively, and $ 5,884 and $ 13,411 for the three and six months ended June 30, 2023 , respectively. |
Net Loss Per Share - Basic and
Net Loss Per Share - Basic and diluted net loss per unit attributable to common unitholders (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Numerator: | ||||||
Net loss | $ (33,816) | $ (32,094) | $ (18,885) | $ (12,525) | $ (65,910) | $ (31,410) |
Net loss attributable to common stockholders, basic | (33,816) | (18,885) | (65,910) | (31,410) | ||
Net loss attributable to common stockholders, diluted | $ (33,816) | $ (18,885) | $ (65,910) | $ (31,410) | ||
Denominator: | ||||||
Weighted average shares of common stock outstanding, basic | 56,515,003 | 5,000,000 | 53,352,406 | 5,000,000 | ||
Weighted average shares of common stock outstanding, diluted | 56,515,003 | 5,000,000 | 53,352,406 | 5,000,000 | ||
Net loss per share attributable to common stockholders, basic | $ (0.6) | $ (3.78) | $ (1.24) | $ (6.28) | ||
Net loss per share attributable to common stockholders, diluted | $ (0.6) | $ (3.78) | $ (1.24) | $ (6.28) |
Net Loss Per Share - Potential
Net Loss Per Share - Potential common units excluded from calculation of diluted net loss per unit attributable to common unitholders (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Net Loss Per Share | ||||
Antidilutive units | 4,904,321 | 79,359,487 | 4,904,321 | 79,359,487 |
Series A Preferred Units | ||||
Net Loss Per Share | ||||
Antidilutive units | 20,000,000 | 20,000,000 | ||
Series B Preferred Units | ||||
Net Loss Per Share | ||||
Antidilutive units | 45,089,212 | 45,089,212 | ||
Vested incentive units | ||||
Net Loss Per Share | ||||
Antidilutive units | 2,481,543 | 2,481,543 | ||
Unvested incentive units | ||||
Net Loss Per Share | ||||
Antidilutive units | 11,788,732 | 11,788,732 | ||
Stock options | ||||
Net Loss Per Share | ||||
Antidilutive units | 2,973,471 | 2,973,471 | ||
Unvested restricted common stock | ||||
Net Loss Per Share | ||||
Antidilutive units | 1,804,749 | 1,804,749 | ||
Unvested restricted stock units | ||||
Net Loss Per Share | ||||
Antidilutive units | 126,101 | 126,101 |
Operating Leases - Additional I
Operating Leases - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | |
Operating Leases | |||
Operating lease liability | $ 4,100 | $ 4,100 | $ 2,000 |
Lease liability, current | 1,682 | 1,682 | 1,101 |
Lease liability, Non-current | $ 2,401 | $ 2,401 | $ 933 |
Operating lease, remaining lease term | 2 years 4 months 24 days | 2 years 4 months 24 days | |
Incremental borrowing rate used to determine the operating lease liabilities | 10% | 10% | |
Lease expense | $ 400 | $ 700 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event - Paragon Therapeutics, Inc - TSLP License Agreement $ in Millions | Aug. 12, 2024 USD ($) |
Subsequent Event [Line Items] | |
Termination period of agreement | 60 days |
Period of material breach | 90 days |
Threshold number of days for termination upon failure to make payment and such failure persists even after the notice | 30 days |
Expiration period of commercial sale | 12 years |
Related party | |
Subsequent Event [Line Items] | |
Maximum amount of achievement of development and clinical mile stones | $ 28 |
Nomination fee paid | 3 |
Milestone payment of trial payable | $ 5 |