Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Securities and Exchange Act of 1934 is (1) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (2) accumulated and communicated to our management, including our President and Chief Executive Officer, who is also serving as our Chief Financial Officer and therefore currently serves as both our principal executive officer and principal financial officer, as appropriate, to allow timely decisions regarding required disclosure.
As of December 31, 2024, our management, with the participation of our Chief Executive Officer, who is also serving as our Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as amended). Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our principal executive officer and principal financial and accounting officer has concluded based upon the evaluation described above that, as of December 31, 2024, our disclosure controls and procedures were effective at the reasonable assurance level.
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Management’s Report on Internal Control Over Financial Reporting
This Company’s management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act). Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including the individuals serving as our principal executive officer and principal financial officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America. Management conducted an assessment of the effectiveness of the Company’s internal control over financial reporting based on the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013 Framework). Based on this assessment, our management concluded that, as of December 31, 2024, our internal control over financial reporting was effective based on those criteria.
Attestation Report on Internal Control Over Financial Reporting
This Annual Report does not include an attestation report of our independent registered public accounting firm due to our status as a smaller reporting company and non-accelerated filer.
Changes in Internal Control Over Financial Reporting
There were no changes to our internal control over financial reporting that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information .
N o n e .
Item 9C. Disclosures Regarding Foreign Jurisdictions that Prevent Inspections
Not applicable
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PART III
Item 10. Directors, Executive Officers and Corporate Governance.
The Company has adopted an insider trading policy that governs the purchase, sale, and/or other transactions of our securities by our directors, officers and employees. A copy of our insider trading policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K for the fiscal year ended December 31, 2024. In addition, with regard to the Company’s trading in its own securities, it is the Company’s policy to comply with the federal securities laws and the applicable exchange listing requirements.
The remaining information required by this Item is set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2024, and is incorporated into this Annual Report on Form 10-K by reference.
Item 11. Executive Compensation.
The information required by this Item is set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2024, and is incorporated into this Annual Report on Form 10-K by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The information required by this Item is set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2024, and is incorporated into this Annual Report on Form 10-K by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this Item is set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2024, and is incorporated into this Annual Report on Form 10-K by reference.
Item 14. Principal Accounting Fees and Services.
The information required by this Item is set forth in our Proxy Statement for the 2025 Annual Meeting of Stockholders to be filed with the SEC within 120 days of December 31, 2024, and is incorporated into this Annual Report on Form 10-K by reference.
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PART IV
Item 15. Exhibits, Financial Statement Schedules.
(a)(1) Financial Statements
The financial statements listed below are filed as part of this Annual Report on Form 10-K.
Report of Independent Registered Public Accounting Firm (PCAOB ID Number 274 )
F-1
Consolidated Balance Sheets as of December 31, 2024 and 2023
F-3
Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023
F-4
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2024 and 2023
F-5
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2024 and 2023
F-6
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
F-8
Notes to Consolidated Financial Statements
F-9
(a)(2) Financial Statement Schedules
All financial schedules have been omitted because the required information is either presented in the Consolidated Financial Statements or the Notes thereto or is not applicable or required.
(a)(3) Exhibits
The exhibits required by Item 601 of Regulation S-K and Item 15(b) of this Annual Report on Form 10-K are listed in the Exhibit Index immediately preceding the exhibits and are incorporated herein by reference.
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EXHIBIT INDEX
Exhibit
No.
Description
2.1
Merger Agreement, dated January 17, 2023, by and among Leap Therapeutics, Inc., Fire Merger Sub, Inc., Flame Biosciences LLC, Flame Biosciences, Inc., and the Stockholder Representative named therein (incorporated by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2023).
3.1
Fourth Amended and Restated Certificate of Incorporation of Leap Therapeutics, Inc. (incorporated by reference to Exhibit 3.3 to the Company’s Current Report on Form 8-K, as filed on September 10, 2020).
3.2
Amended and Restated By-laws of Leap Therapeutics, Inc. (incorporated by reference to Exhibit 3.4 to the Company’s registration statement on Form S-4, as filed on September 26, 2016 and attached as Annex D to the prospectus which forms part of such registration statement).
3.3
Certificate of Designation of Preferences, Rights and Limitations of Series X Non-Voting Convertible Preferred Stock filed with the Secretary of State of the State of Delaware on January 17, 2023 (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2023).
3.4
Certificate of Amendment to the Certificate of Designation of Special Voting Stock (incorporated by reference to Exhibit 3.1 to the Company’s Current Report on Form 8 - K, as filed on March 16, 2023).
3.5
Certificate of Elimination of the Series X Non - Voting Convertible Preferred Stock of the Company (incorporated by reference to Exhibit 3.2 to the Company Quarterly Report on Form 10 - Q for the quarter ended September 30, 2023).
4.1
Form of Common Stock Certificate of the Registrant (incorporated by reference to Exhibit 4.1 to Amendment No. 2 to the Company’s registration statement on Form S-4, as filed on November 16, 2016).
4.2
Registration Rights Agreement, by and among Leap and certain stockholders, dated as of January 23, 2017 (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, as filed on January 26, 2017).
4.3
Registration Rights Agreement dated as of July 10, 2019, by and between the Company and Lincoln Park Capital Fund, LLC (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, as filed on July 11, 2019).
4.4
Registration Rights Agreement dated as of January 3, 2020, by and between the Company and the persons listed on the attached Schedule A thereto (incorporated by reference to Exhibit 10.4 to the Company’s Current Report on Form 8-K, as filed on January 7, 2020).
4.5
Registration Rights Agreement dated as of January 3, 2020, by and between the Company and the persons listed on the attached Schedule A thereto (incorporated by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K, as filed on January 7, 2020).
4.6
Form of Warrant, dated as of November 14, 2017 by and among Leap Therapeutics, Inc. and the Holders identified on the schedule thereto (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, as filed on November 17, 2017).
4.7
Form of Warrant, dated as of February 5, 2019 by and between Leap Therapeutics, Inc. and each of the purchasers in the Registrant’s 2019 Public Offering (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, as filed on February 1, 2019).
4.8
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K, as filed on January 7, 2020).
4.9
Form of Series A Coverage Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K, as filed on January 7, 2020).
4.10
Form of Series B Coverage Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K, as filed on January 7, 2020).
4.11
Amendment No. 2 to Warrant, by and among Macrocure, the Registrant and certain warrant holders, dated as of January 23, 2017 (incorporated by reference to Exhibit 4.4 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as filed on March 31, 2017).
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4.12
Description of the Registrant’s Securities registered pursuant to Section 12 of the Securities Exchange Act of 1934 (incorporated by reference to Exhibit 4.6 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed on March 16, 2020).
4.13
Form of Warrant, dated May 6, 2020, by and among the Flame Biosciences, Inc. and the Warrantholders (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 10Q, as filed on May 15, 2023).
10.1#
Exclusive Option and License Agreement dated as of January 3, 2020, by and between the Company and BeiGene, Ltd. (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as filed on May 14, 2020).
10.2**
License Agreement, between Eli Lilly and Company and Dekkun Corporation, effective as of January 3, 2011 (incorporated by reference to Exhibit 10.4 to the Company’s registration statement on Form S-4, as filed on September 26, 2016).
10.4
Royalty Agreement, between Leap Therapeutics, Inc. and Leap Shareholder Royalty Vehicle, Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed on January 26, 2017).
10.5
Letter Agreement, between Leap Shareholder Royalty Vehicle, Inc. and certain Leap stockholders (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, as filed on January 26, 2017).
10.6
Form of Purchase Agreement, dated as of November 14, 2017, by and among Leap Therapeutics, Inc. and the purchasers identified on the schedule thereto (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed on November 17, 2017).
10.9
Securities Purchase Agreement, dated January 3, 2020, by and among the Company and the institutional investors named therein (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, as filed on January 7, 2020).
10.10
Form of Indemnification Agreement (filed as Exhibit 10.10 to Amendment No. 1 to the Registrant’s registration statement on Form S-4, as filed on November 2, 2016).
10.11 ˄
Macrocure 2013 Share Incentive Plan (filed as Exhibit 10.4 to the Company’s registration statement on Form S-8, as filed on January 27, 2017).
10.12 ˄
Amendment No. 1 to Macrocure 2013 Share Incentive Plan (filed as Exhibit 10.5 to the Company’s registration statement on Form S-8, as filed on January 27, 2017).
10.13 ˄
Summary Translation of Macrocure 2008 Stock Option Plan stockholders (filed as Exhibit 10.3 to the Registrant’s registration statement on Form S-8, as filed on January 27, 2017).
10.14 ˄
Employment Agreement, by and between the Company and Douglas E. Onsi, dated as of April 10, 2020 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K/A, as filed on April 15, 2020).
10.15 ˄
Executive Employment Agreement and accompanying Employee Proprietary Information, Inventions, Non-Competition and Non-Solicitation Agreement, by and between Leap and Christopher K. Mirabelli, dated as of August 29, 2016 (incorporated by reference to Exhibit 10.7 to the Company’s registration statement on Form S-4, as filed on September 26, 2016).
10.16 ˄
Executive Employment Agreement and accompanying Employee Proprietary Information, Inventions, Non-Competition and Non-Solicitation Agreement, by and between Leap and Augustine Lawlor, dated as of August 29, 2016 (incorporated by reference to Exhibit 10.9 to the Company’s registration statement on Form S-4, as filed on September 26, 2016).
10.17 ˄
Employment Agreement, by and between the Company and Christine Granfield, dated as of August 16, 2020 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as filed on November 12, 2020).
10.18 ˄
Employment Agreement, by and between the Company and Cynthia Sirard, dated as of April 10, 2020 (incorporated by reference to Exhibit 10.18 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed on March 12, 2021).
10.19 ˄
Employment Agreement, by and between the Company and John Mark O’ Mahony, dated as of April 10, 2020 (incorporated by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020, as filed on March 12, 2021).
10.20 ˄
Amended and Restated 2012 Equity Incentive Plan of the Registrant (incorporated by reference to Exhibit 10.1 to the Company’s registration statement on Form S-8, as filed on January 27, 2017).
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10.21 ˄
Form of Stock Option Grant Notice and Stock Option Agreement under the Registrant’s Amended and Restated 2012 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.2 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as filed on March 31, 2017).
10.22 ˄
2016 Equity Incentive Plan of Leap Therapeutics, Inc. (incorporated by reference to Exhibit 10.2 to the Company’s registration statement on Form S-8, as filed on January 27, 2017).
10.23 ˄
Form of Stock Option Grant Notice and Stock Option Agreement under Leap’s 2016 Equity Incentive Plan, as amended (incorporated by reference to Exhibit 10.3 to the Company’s registration statement on Form S-4, as filed on November 2, 2016).
10.24 ˄
First Amendment to the 2016 Equity Incentive Plan (incorporated by reference to Exhibit 10.1 to the Company’s registration statement on Form S-8, as filed on June 11, 2019).
10.25
Lease, dated November 13, 2018, by and between the Company and Bulfinch Square Limited Partnership (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K, as filed on November 19, 2018).
10.26
First Amendment to Lease by and between Bulfinch Square Limited Partnership and Leap Therapeutics, Inc., dated as of August 17, 2021 (incorporated by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, as filed on November 12, 2021).
10.27
Second Amendment to Lease by and between Bulfinch Square Limited Partnership and Leap Therapeutics, Inc. dated as of October 1, 2021 (incorporated by reference to Exhibit 10.27 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed on March 24, 2023).
10.28
Third Amendment to Lease by and between Bulfinch Square Limited Partnership and Leap Therapeutics, Inc. dated as of May 16, 2022 (incorporated by reference to Exhibit 10.1 to the Company Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as filed on August 12, 2022).
10.29
Support Agreement by and between Leap Therapeutics, Inc. and HealthCare Ventures IX L.P., dated January 17, 2023 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2023).
10.30
Support Agreement by and between Leap Therapeutics, Inc. and HealthCare Ventures VIII Liquidating Trust, dated January 17, 2023 (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2023).
10.31
Registration Rights Agreement, dated January 17, 2023, by and among the Company and the Holders (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K, filed with the SEC on January 23, 2023).
10.32 ˄
Leap Therapeutics, Inc. 2022 Equity Incentive Plan (incorporated by reference to Exhibit 99.1 to the Company’s registration statement on Form S-8, as filed on August 17, 2022).
10.33 ˄
Amendment No. 1 to Leap Therapeutics, Inc. 2022 Equity Incentive Plan (incorporated by reference to Exhibit 10.33 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed on March 18, 2024)
10.34
Continuing Clinical Collaboration Letter Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8 - K, filed with the SEC on March 16, 2023.
10.35 ˄
Second Amendment to Executive Employment Agreement, by and between the Company and Dr. Cynthia Sirard, dated April 3, 2023 (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8 - K, filed with the SEC on April 7, 2023).
10.37#
Collaboration Agreement, dated August 10, 2020, by and between Adimab, LLC and Flame Biosciences, Inc. (incorporated by reference to Exhibit 10.2 to the Company Quarterly Report on Form 10 - Q for the quarter ended March 31, 2023).
10.38 ˄
Second Amendment to Executive Employment Agreement, dated April 3, 2023, by and between the Company and John Mark O’Mahony (incorporated by reference to Exhibit 10.5 to the Company Quarterly Report on Form 10 - Q for the quarter ended March 31, 2023).
10.39 ˄
Executive Employment Agreement, by and between the Company and Jason S. Baum. (incorporated by reference to Exhibit 10.6 to the Company Quarterly Report on Form 10 - Q for the quarter ended March 31, 2023).
10.40 ˄
First Amendment to Executive Employment Agreement, dated April 3, 2023, by and between the Company and Jason S. Baum. (incorporated by reference to Exhibit 10.7 to the Company Quarterly Report on Form 10 - Q for the quarter ended March 31, 2023).
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19.1*
Insider Trading Policy
21.1*
Subsidiaries of Leap Therapeutics, Inc.
23.1*
Consent of EisnerAmper LLP related to Leap Therapeutics, Inc. financial statements.
31.1*
Certification of Principal Executive and Principal Financial Officer Required Under Rule 13a- 14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.
32.1* +
Principal Executive and Principal Financial Officer Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1
Leap Therapeutics, Inc. Compensation Clawback Policy (incorporated by reference to Exhibit 97.1 to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed on March 18, 2024)
101*
The following materials from Leap Therapeutics, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2024, formatted in XBRL (Extensible Business Reporting Language): (i) Consolidated Balance Sheets at December 31, 2024 and 2023, (ii) Consolidated Statements of Operations for the year ended December 31, 2024 and December 31, 2023, (iii) Consolidated Statements of Shareholders’ Equity (Deficit) at December 31, 2024 and December 31, 2023 (iv) Consolidated Statements of Cash Flows for the year ended December 31, 2024 and December 31, 2023, and (v) Notes to Consolidated Financial Statements, tagged as blocks of text.
104
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
*
Exhibits filed herewith
˄
Indicates management contract or compensation plan
#
Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10).
+
This exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of the Section, nor shall it be deemed incorporated by reference in any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof and irrespective of any general incorporation language in any filing.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
LEAP THERAPEUTICS, INC.
March 25, 2025
By:
/s/ DOUGLAS E. ONSI
Name: Douglas E. Onsi
Title: President, Chief Executive Officer and Chief Financial Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
NAME
TITLE
DATE
Chief Executive Officer, President, Chief
/s/ DOUGLAS E. ONSI
Financial Officer and Director (Principal
March 25, 2025
Douglas E. Onsi
Executive Officer and Principal Financial Officer)
/s/ CHRISTOPHER K. MIRABELLI
Chairman of the Board of Directors
March 25, 2025
Christopher K. Mirabelli
/s/ JAMES CAVANAUGH
Director
March 25, 2025
James Cavanaugh
/s/ THOMAS DIETZ
Director
March 25, 2025
Thomas Dietz
/s/ WILLIAM LI
Director
March 25, 2025
William Li
/s/ JOSEPH LOSCALZO
Director
March 25, 2025
Joseph Loscalzo
/s/ PATRICIA MARTIN
Director
March 25, 2025
Patricia Martin
/s/ NISSIM MASHIACH
Director
March 25, 2025
Nissim Mashiach
/s/ CHRISTIAN RICHARD
Director
March 25, 2025
Christian Richard
/s/ RICHARD L. SCHILSKY
Director
March 25, 2025
Richard L Schilsky
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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 274)
F-1
Consolidated Balance Sheets as of December 31, 2024 and 2023
F-3
Consolidated Statements of Operations for the Years Ended December 31, 2024 and 2023
F-4
Consolidated Statements of Comprehensive Loss for the Years Ended December 31, 2024 and 2023
F-5
Consolidated Statements of Stockholders’ Equity for the Years Ended December 31, 2024 and 2023
F-6
Consolidated Statements of Cash Flows for the Years Ended December 31, 2024 and 2023
F-8
Notes to Consolidated Financial Statements
F-9
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of
Leap Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Leap Therapeutics, Inc. and Subsidiaries (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations, comprehensive loss, stockholders’ equity, and cash flows for each of the years then ended, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of their operations and their cash flows for each of the years then ended, in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Accruals for Clinical Trial Expenses
As described in Note 2 to the consolidated financial statements, at each balance sheet date, the Company records its accrued clinical trial expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants in connection with performing research and development activities, and in making that accrual, may depend on factors such as successful enrollment of certain numbers of patients, site initiation, and the completion of contract milestones. The Company accounts for research and development expenses based on services that have been performed on the Company’s behalf and the level of service performed and the associated cost incurred for the service when an invoice has not been received. The Company’s accrual for clinical trial expenses of $4,798,000 is included in accrued expenses on the December 31, 2024 consolidated balance sheet. The amounts accrued for clinical trial expenses represent the unpaid clinical trial expenses based on the information available to the Company at that time.
F-1
Table of Contents
We identified the accrual for clinical trial expenses as a critical audit matter due to the materiality of the contract values between the Company and certain clinical research organizations and the need to determine progress or state of completion of trials or services completed. This in turn led to significant audit effort in performing our procedures and evaluating audit evidence relating to accruals made by management.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the financial statements. We obtained an understanding and evaluated the design of controls over the Company’s accrual process, including the process of accruing the expenses incurred to date based on the status of the clinical trials. Our procedures also included, among others, reading agreements and contract amendments entered into with vendors in connection with conducting clinical trials, evaluating the methods used in developing the accrual for clinical trial expenses and calculating the amounts that were unpaid at the balance sheet date. We confirmed selected amounts and attributes used in determining the accrued clinical trial expenses directly with the third parties involved in performing the research and development services on behalf of the Company. We also made direct inquiries of financial and clinical trial client personnel regarding status and progress towards completion of clinical trials and descriptions of future commitments. We also examined invoices issued and payments made to service providers after the consolidated balance sheet date.
/s/ EisnerAmper LLP
We have served as the Company’s auditor since 2014.
EISNERAMPER LLP
Philadelphia, Pennsylvania
March 25, 2025
F-2
Table of Contents
LEAP THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
December 31,
December 31,
2024
2023
Assets
Current assets:
Cash and cash equivalents
$
47,249
$
70,643
Research and development incentive receivable
704
771
Prepaid expenses and other current assets
86
183
Total current assets
48,039
71,597
Property and equipment, net
—
5
Right of use assets, net
262
257
Deposits
823
966
Total assets
$
49,124
$
72,825
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
4,743
$
6,465
Accrued expenses
8,536
5,957
Income tax payable
531
—
Lease liability - current portion
266
262
Total current liabilities
14,076
12,684
Stockholders’ equity:
Preferred stock, $ 0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2024 and 2023, respectively
—
—
Common stock, $ 0.001 par value; 240,000,000 shares authorized; 38,329,894 and 25,565,414 shares issued and outstanding as of December 31, 2024 and 2023, respectively
38
26
Additional paid-in capital
502,501
459,591
Accumulated other comprehensive (loss) income
( 120 )
106
Accumulated deficit
( 467,371 )
( 399,582 )
Total stockholders’ equity
35,048
60,141
Total liabilities and stockholders’ equity
$
49,124
$
72,825
See notes to consolidated financial statements
F-3
Table of Contents
LEAP THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
Year Ended December 31,
2024
2023
Operating expenses:
Research and development
$
57,211
$
73,234
General and administrative
12,846
13,807
Total operating expenses
70,057
87,041
Loss from operations
( 70,057 )
( 87,041 )
Interest income
3,129
4,027
Australian research and development incentives
—
1,101
Other income
—
500
Foreign currency loss
( 42 )
( 13 )
Change in fair value of Series X preferred stock warrant liability
—
12
Loss before income taxes
( 66,970 )
( 81,414 )
Provision for income taxes
( 585 )
—
Net loss
( 67,555 )
( 81,414 )
Dividend attributable to down round feature of warrants
( 234 )
—
Net loss attributable to common stockholders
$
( 67,789 )
$
( 81,414 )
Net loss per share
Basic and diluted
$
( 1.81 )
$
( 3.98 )
Weighted average common shares outstanding
Basic and diluted
37,550,677
20,445,109
See notes to consolidated financial statements
F-4
Table of Contents
LEAP THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands)
Year Ended December 31,
2024
2023
Net loss
$
( 67,555 )
$
( 81,414 )
Other comprehensive loss:
Foreign currency translation adjustments
( 226 )
( 22 )
Comprehensive loss
$
( 67,781 )
$
( 81,436 )
See notes to consolidated financial statements
F-5
Table of Contents
LEAP THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE YEAR ENDED DECEMBER 31, 2023
(In thousands, except share amounts)
Mezzanine Equity
Stockholders Equity
Accumulated
Series X Non Voting Convertible
Additional
Other
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Shares
Amount
Capital
Income
Deficit
Equity
Balances at December 31, 2022
—
$
—
9,902,137
$
10
$
376,896
$
128
$
( 318,168 )
$
58,866
Issuance of Series X Preferred Stock in connection with Flame merger
136,248
67,715
—
—
—
—
—
—
Issuance of common stock in connection with Flame merger
—
—
1,972,901
2
9,803
—
—
9,805
Issuance of common stock warrants in connection with Flame merger
—
—
—
—
13
—
—
13
Redemption of 2019 Warrants
—
—
—
—
( 29 )
—
—
( 29 )
Issuance of common stock upon vest of restricted stock units
—
—
66,061
—
—
—
—
—
Conversion of Series X preferred stock to common stock
( 136,248 )
( 67,715 )
13,624,800
14
67,701
—
—
67,715
Reclassification of Series X preferred stock warrants to equity
—
—
—
—
78
—
—
78
Fractional shares paid in cash
—
—
( 485 )
—
1
—
—
1
Foreign currency translation adjustment
—
—
—
—
—
( 22 )
—
( 22 )
Stock-based compensation
—
—
—
—
5,128
—
—
5,128
Net loss
—
—
—
—
—
—
( 81,414 )
( 81,414 )
Balances at December 31, 2023
—
$
—
25,565,414
$
26
$
459,591
$
106
$
( 399,582 )
$
60,141
See notes to consolidated financial statements
F-6
Table of Contents
LEAP THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY
FOR THE YEAR ENDED DECEMBER 31, 2024
(In thousands, except share amounts)
Stockholders Equity
Accumulated
Additional
Other
Total
Common Stock
Paid-in
Comprehensive
Accumulated
Stockholders’
Shares
Amount
Capital
Income (loss)
Deficit
Equity
Balances at December 31, 2023
25,565,414
$
26
$
459,591
$
106
$
( 399,582 )
$
60,141
Issuance of common stock upon vest of restricted stock units
27,500
—
—
—
—
—
Issuance of common stock upon exercise of stock options
34,698
—
92
—
—
92
Issuance of common stock upon exercise of warrants
41,289
—
41
—
—
41
April 2024 Private Placement (net of issuance costs of $ 2,948 )
12,660,993
12
37,039
—
—
37,051
Dividend attributable to the down round feature of 2017 Warrants
—
—
234
—
( 234 )
—
Foreign currency translation adjustment
—
—
—
( 226 )
—
( 226 )
Stock-based compensation
—
—
5,504
—
—
5,504
Net loss
—
—
—
—
( 67,555 )
( 67,555 )
Balances at December 31, 2024
38,329,894
$
38
$
502,501
$
( 120 )
$
( 467,371 )
$
35,048
See notes to consolidated financial statements
F-7
Table of Contents
LEAP THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Year Ended December 31,
2024
2023
Cash flows from operating activities:
Net loss
$
( 67,555 )
$
( 81,414 )
Adjustments to reconcile net loss to net cash used in operating activities:
In-process research and development costs acquired in connection with the acquisition of Flame
—
29,582
Depreciation expense
5
15
Change in right-of-use asset
415
412
Stock-based compensation expense
5,504
5,128
Foreign currency loss
42
13
Changes in operating assets and liabilities:
Prepaid expenses and other assets
100
164
Research and development incentive receivable
—
1,302
Accounts payable and accrued expenses
902
712
Income tax payable
562
—
Lease liability
( 417 )
( 415 )
Other assets
143
748
Net cash used in operating activities
( 60,299 )
( 43,753 )
Cash flows from investing activities:
Cash acquired in connection with the acquistion of Flame
—
50,362
Payment of direct and incremental costs of the asset acquisition
—
( 1,393 )
Net cash provided by investing activities
—
48,969
Cash flows from financing activities:
Proceeds from April 2024 Private Placement
39,999
—
Payment of deferred offering costs
( 2,948 )
—
Payment of redemption of 2019 warrants
—
( 29 )
Payment of fractional shares
—
( 1 )
Proceeds from the exercise of warrants
41
—
Proceeds from the exercise of stock options
92
—
Net cash provided by (used in) financing activities
37,184
( 30 )
Effect of exchange rate changes on cash and cash equivalents
( 279 )
( 43 )
Net increase (decrease) in cash and cash equivalents
( 23,394 )
5,143
Cash and cash equivalents at beginning of year
70,643
65,500
Cash and cash equivalents at end of year
$
47,249
$
70,643
Supplemental disclosure of non-cash financing activities:
Remeasurement of right-of-use asset and lease liability
$
420
$
—
Dividend attributable to the down round feature of 2017 Warrants
$
234
$
—
Issuance and conversion of Series X Preferred Stock issued in connection with the acquisition of Flame to common stock
$
—
$
67,715
Reclassification of Series X Preferred Stock Warrants from liability to equity
$
—
$
78
Issuance of common stock in connection with the acquisition of Flame
$
—
$
9,805
Issuance of warrants for the purchase of common stock in connection with the acquisition of Flame
$
—
$
13
Net liabilities assumed from acquistion of Flame
$
—
$
928
See notes to consolidated financial statements
F-8
Table of Contents
LEAP THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
1. Nature of Business, Basis of Presentation and Liquidity
Nature of Business
Leap Therapeutics, Inc. (“the Company”) was incorporated in the state of Delaware on January 3, 2011. During 2015, HealthCare Pharmaceuticals Pty Ltd. (“HCP Australia”) was formed and is a wholly owned subsidiary of the Company.
On December 10, 2015, the Company entered into a merger agreement with GITR Inc. (“GITR”), an entity under common control, whereby a wholly owned subsidiary was merged with GITR and the surviving name of the wholly owned subsidiary was GITR Inc.
On August 29, 2016, the Company entered into a merger agreement with Macrocure Ltd. (“Macrocure”), a publicly held, clinical-stage biotechnology company based in Petach Tikva, Israel. In connection with the merger, Macrocure became a wholly owned subsidiary of the Company and the Company applied to be listed on the Nasdaq Global Market. Nasdaq approved the listing, and trading in the Company’s common stock commenced on January 24, 2017, under the trading symbol “LPTX.” On February 1, 2017, Macrocure’s name was changed to Leap Therapeutics Ltd. In 2020, Leap Therapeutics Ltd. was dissolved.
On December 15, 2021, Leap Securities Corp. was formed and is a wholly owned subsidiary of the Company.
On January 17, 2023, the Company entered into a merger agreement with Flame Biosciences, Inc., a privately held, biotechnology corporation (“Flame”), whereby Flame became a wholly owned subsidiary of the Company under the name Flame Biosciences, LLC.
The mailing address of the Company’s principal executive office is 47 Thorndike Street, Suite B1-1, Cambridge, MA 02141. The Company’s telephone number is 617-714 -0360 and its website address is www.leaptx.com (the information contained therein or linked thereto shall not be considered incorporated by reference in this Form 10-K).
The Company is a biopharmaceutical company developing novel biomarker-targeted antibody therapies designed to treat patients with cancer by inhibiting fundamental tumor-promoting pathways, targeting cancer-specific cell surface molecules, and harnessing the immune system to attack cancer cells. The Company’s strategy is to identify, acquire, and develop molecules that translate into therapeutics that generate durable clinical benefit and enhanced patient outcomes. The Company’s lead clinical stage program is sirexatamab (DKN-01), a monoclonal antibody that inhibits Dickkopf-related protein 1, or DKK1. The Company is currently studying sirexatamab in a clinical trial in patients with colorectal cancer. The Company also has a preclinical antibody program FL-501.
In January 2020, the Company entered into an Option and License Agreement with BeiGene, Ltd., or BeiGene, which granted BeiGene an option to obtain an exclusive license from the Company that would grant to BeiGene the right to develop and commercialize DKN-01 in Asia (excluding Japan), Australia, and New Zealand. In March 2023, BeiGene notified the Company that it did not intend to exercise its option, and the agreement is continuing as a clinical collaboration.
The Company intends to apply its experience identifying and developing products to build a pipeline of programs relating to the practice of cancer medicine.
Basis of Presentation
The accompanying consolidated financial statements of the Company include the accounts of its wholly owned subsidiaries and have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
F-9
Table of Contents
Reverse Stock Split
On June 21, 2023, the Company effected a one -for-ten reverse stock split of its issued and outstanding shares of common stock, which also adjusted the conversion ratio of its Series X Preferred Stock such that each share of Series X Preferred Stock became convertible into 100 shares of common stock. Accordingly, all share and per share amounts for all periods presented in the accompanying consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this stock split. All fractional shares resulting from the reverse stock split were paid in cash.
Liquidity
Since inception, the Company has been engaged in organizational activities, including raising capital, and research and development activities. The Company does not yet have a product that has been approved by the Food and Drug Administration (the “FDA”), has not generated any product sales revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flows from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital, its research and commercialization efforts, regulatory approval, and, ultimately, the market acceptance of the Company’s products.
In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. As of December 31, 2024, the Company had cash and cash equivalents of $ 47,249 . Additionally, the Company had an accumulated deficit of $ 467,371 at December 31, 2024, and during the year ended December 31, 2024, the Company incurred a net loss of $ 67,555 . The Company expects to continue to generate operating losses for the foreseeable future.
The Company believes that its cash and cash equivalents of $ 47,249 as of December 31, 2024 will be sufficient to fund its operating expenses for at least 12 months from the issuance of these financial statements.
In addition, to support its future operations, the Company will likely seek additional funding through public or private equity financings or government programs and will seek funding or development program cost-sharing through collaboration agreements or licenses with larger pharmaceutical or biotechnology companies. If the Company does not obtain additional funding or development program cost-sharing, or exceeds its current spending forecasts or fails to receive the research and development tax incentive payment, the Company has the ability and would be forced to: delay, reduce or eliminate certain clinical trials or research and development programs, reduce or eliminate discretionary operating expenses, and delay company and pipeline expansion, any of which could adversely affect its business prospects. The inability to obtain funding, as and when needed, could have a negative impact on the Company’s financial condition and ability to pursue its business strategies.
2. Summary of Significant Accounting Policies
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions are eliminated upon consolidation.
Use of Estimates
The presentation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents
The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Cash equivalents consisted of overnight investments and money market funds.
F-10
Table of Contents
Research and Development Expense
Research and development costs are expensed as incurred. Research and development expenses include personnel costs associated with research and development activities, including noncash share-based compensation and costs for third-party contractors to perform research, conduct clinical trials and manufacture drug supplies and materials. The Company accrues for costs incurred by external service providers, including contract research organizations and clinical investigators, based on its estimates of service performed and costs incurred. These estimates include the level of services performed by the third parties, patient enrollment in clinical trials, administrative costs incurred by the third parties, and other indicators of the services completed. Based on the timing of amounts invoiced by service providers, the Company may also record payments made to those providers as prepaid expenses that will be recognized as expense in future periods as the related services are rendered.
Research and development incentive income and receivable
The Company recognizes other income from Australian research and development incentives when there is reasonable assurance that the income will be received, the relevant expenditure has been incurred, and the consideration can be reliably measured. The research and development incentive is one of the key elements of the Australian Government’s support for Australia’s innovation system and is supported by legislative law primarily in the form of the Australian Income Tax Assessment Act 1997 as long as eligibility criteria are met.
Management has assessed the Company’s research and development activities and expenditures to determine which activities and expenditures are likely to be eligible under the research and development incentive regime described above. At each period end management estimates the refundable tax offset available to the Company based on available information at the time. This estimate is also reviewed by external tax advisors on an annual basis.
Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia is reimbursed. This percentage was 43.5 % for the years ended December 31, 2024 and 2023.
The research and development incentive receivable represents an amount due in connection with the above program. The Company has recorded a research and development incentive receivable of $ 704 and $ 771 as of December 31, 2024 and 2023, respectively, in the consolidated balance sheets and other income from Australian research and development incentives of $ 1,101 , in the consolidated statements of operations for the year ended December 31, 2023, related to refundable research and development incentive program payments in Australia. The company did no t record any income from Australian research and development incentives during the year ended December 31, 2024.
The following table shows the change in the research and development incentive receivable from January 1, 2023 to December 31, 2024:
Balance at January 1, 2023
$
2,099
Cash received for 2022 eligible expenses
( 2,333 )
Australian research and development incentive income, net
1,101
Foreign currency translation
( 96 )
Balance at December 31, 2023
771
Foreign currency translation
( 67 )
Balance at December 31, 2024
$
704
Concentration of Credit Risk
Financial instruments which potentially subject the Company to credit risk consist principally of cash and cash equivalents. All cash and cash equivalents are held in United States or Australian financial institutions and money market funds. At times, the Company may maintain cash balances in excess of the federally insured amount of $250 per depositor, per insured bank, for each account ownership category. Although the Company currently believes that the financial institutions with whom it does business will be able to fulfill their commitments to the Company, there is no assurance that those institutions will be able to continue to do so. The Company has not experienced any credit losses associated with its balances in such accounts for the years ended December 31, 2024 and 2023.
F-11
Table of Contents
Income Taxes
The Company accounts for income taxes using the asset and liability method. Under the asset and liability method, deferred income taxes are recognized for differences between the financial reporting and tax bases of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.
The Company follows accounting guidance concerning provisions for uncertainty in income tax positions. This guidance clarifies the accounting for income taxes by prescribing a minimum probability threshold that an uncertain tax position must meet before a financial statement benefit is recognized. The minimum threshold is defined as a tax position that is more likely than not to be sustained upon examination by the applicable taxing authority, of any related appeals or litigation processes, based on the technical merits of the position. The tax benefit to be recognized is measured as the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement.
The Company recognizes accrued interest and penalties associated with uncertain tax position as part of the income tax provision. There were no uncertain tax positions or income tax related interest and penalties recorded for the years ended December 31, 2024 and 2023. The income tax returns of the Company for the year ended December 31, 2021 and subsequent years are subject to examination by the Internal Revenue Service and other taxing authorities, generally for three years after the return is filed.
Foreign Currency Translation
The financial statements of the Company’s foreign subsidiary are measured using the local currency as the functional currency. Assets and liabilities of this subsidiary are translated into U.S. dollars at exchange rates as of the consolidated balance sheet date. Equity is translated at historical exchange rates. Revenues and expenses are translated into U.S. dollars at average rates of exchange in effect during the year. The resulting cumulative translation adjustments have been recorded as a separate component of stockholders’ equity. Foreign currency transaction gains and losses are included in the results of operations.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over the estimated useful life of each asset. Computer equipment is depreciated over three years . Laboratory equipment , office equipment and furniture and fixtures are depreciated over five years . Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. Upon 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 loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred.
Impairment of Long-Lived Assets
Long-lived assets consist of property and equipment. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset group to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset group over its fair value. The Company did not record any impairment losses on long-lived assets during 2024 and 2023.
Deferred Costs
The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering.
As of December 31, 2024 and 2023, the Company did no t have any deferred costs.
F-12
Table of Contents
Deposits
Deposits as of December 31, 2024 and 2023 included $ 823 and $ 966 , respectively, of deposits made by the Company with certain service providers that are to be applied to future payments due under the service agreements or returned to the Company if not utilized.
Warrants
The Company will recognize on a prospective basis the value of the effect of the down round feature in the warrants to purchase shares of common stock that were issued in a private placement in November 2017 (the “2017 Warrants”) when it is triggered (i.e., when the exercise price is adjusted downward). This value is measured as the difference between (1) the financial instrument’s fair value (without the down round feature) using the pre-trigger exercise price and (2) the financial instrument’s fair value (with the down round feature) using the reduced exercise price. The value of the effect of the down round feature will be treated as a dividend and a reduction to income available to common stockholders in the basic EPS calculation.
Fair Value of Financial Instruments
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
● Level 1—Quoted prices in active markets for identical assets or liabilities.
● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
● Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
During the years presented, the Company has not changed the manner in which it values assets and liabilities that are measured at fair value using Level 3 inputs. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers within the hierarchy during the years ended December 31, 2024 and 2023.
A summary of the assets and liabilities carried at fair value in accordance with the hierarchy defined above is as follows (in thousands):
Total
Level 1
Level 2
Level 3
December 31, 2024
Assets:
Cash equivalents
$
23,299
$
23,299
$
—
$
—
Total assets
$
23,299
$
23,299
$
—
$
—
December 31, 2023
Assets:
Cash equivalents
$
39,065
$
39,065
$
—
$
—
Total assets
$
39,065
$
39,065
$
—
$
—
Cash equivalents of $ 23,299 and $ 39,065 as of December 31, 2024 and 2023, respectively, consisted of overnight investments and money market funds and are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets.
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Table of Contents
The carrying value of the research and development incentive receivable, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these assets and liabilities.
Leases
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. All leases with a term greater than one year are recognized on the balance sheet as right-of-use assets, lease liabilities and, if applicable, long-term lease liabilities. The Company has elected not to recognize on the balance sheet leases with terms of one year or less. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. The Company has determined that the rate implicit in the lease is not determinable and the Company does not have borrowings with similar terms and collateral. Therefore, the Company considered a variety of factors, including observable debt yields from comparable companies and the volatility in the debt market for securities with similar terms, in determining that 8 % was reasonable to use as the incremental borrowing rate for purposes of the calculation of lease liabilities.
In accordance with the guidance in ASC 842 “Leases”, components of a lease should be split into three categories: lease components (e.g. land, building, etc.), non-lease components (e.g. common area maintenance, maintenance, consumables, etc.), and non-components (e.g. property taxes, insurance, etc.). Then the fixed and in-substance fixed contract consideration (including any related to non-components) must be allocated based on fair values to the lease components and non-lease components.
Although separation of lease and non-lease components is required, certain practical expedients are available. Entities may elect the practical expedient to not separate lease and non-lease components. Rather, they would account for each lease component and the related non-lease component together as a single component. The Company has elected to account for the lease and non-lease components of each of its operating leases as a single lease component and allocate all of the contract consideration to the lease component only. The lease component results in an operating right-of-use asset being recorded on the consolidated balance sheets and amortized such that lease expense is recorded on a straight line basis over the term of the lease.
Segment Information
The Company’s chief operating decision maker (“CODM”), the Chief Executive Officer, manages the Company’s business activities as a single operating and reportable segment at the consolidated level. Accordingly, the Company’s CODM uses consolidated net loss to measure segment loss, allocate resources and assess performance. Further, the CODM reviews and utilizes functional expenses (research and development and general and administrative) at the consolidated level to manage the Company’s operations. Other segment items included in consolidated net loss are interest income and foreign currency gain (loss), which are reflected in the consolidated statements of operations and comprehensive loss.
Patent Costs
All patent related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses.
Stock-Based Compensation
The Company measures all stock options and other stock-based awards granted to employees, consultants and nonemployees based on the fair value on the date of the grant and recognizes compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award. Generally, the Company issues stock options with only service-based vesting conditions and records the expense for these awards using the straight-line method.
Stock-based compensation is classified in the accompanying consolidated statements of operations based on the function to which the related services are provided.
F-14
Table of Contents
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The expected volatility is based on the historical volatility of the Company. The expected term of the Company’s stock options granted to employees has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to nonemployees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield of zero is based on the fact that the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future.
Net Loss per Share
Basic net loss per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options and warrants.
Subsequent Events
The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the financial statements to provide additional evidence for certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated as required.
Recently Issued Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified date.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 will improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses on an interim and annual basis. The adoption of this standard did not have a material impact on the Company’s financial statements at adoption date.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, requiring additional disclosure of the nature of expenses included in the income statement. The standard is effective for public companies for annual reporting periods beginning after December 15, 2026. The Company is currently evaluating the impact that the adoption of ASU 2024-03 may have on its consolidated financial statements.
3. Acquisition of Flame Biosciences
Merger
On January 17, 2023 (the “Effective Date”), Leap acquired 100 % of the outstanding equity of Flame, in accordance with the terms of the Agreement and Plan of Merger, dated as of the Effective Date (the “Merger Agreement”), by and among Leap, Fire Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Leap (“First Merger Sub”), Flame Biosciences LLC, a Delaware limited liability company and wholly owned subsidiary of Leap (“Second Merger Sub”), Flame, and the Stockholder Representative named therein. Pursuant to the Merger Agreement, First Merger Sub merged with and into Flame, and Flame was the surviving corporation of such merger and became a wholly owned subsidiary of Leap (the “First Merger”). Immediately following the First Merger, Flame merged with and into Second Merger Sub, and Second Merger Sub was the surviving entity of such merger (together with the First Merger, the “Merger”).
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Pursuant to the Merger, Leap agreed to issue to the stockholders of Flame (the “Flame Stockholders”) 1,972,901 shares of common stock, and 136,248 shares of Series X Preferred Stock, which was a newly designated series of preferred stock that was intended to have economic rights equivalent to the common stock, but with limited voting rights, and issued to the warrant holders of Flame (the “Flame Warrant Holders”) the right to acquire 6,530 shares of common stock (the “January 2023 Common Stock Warrants”) and 443 shares of Series X Preferred Stock (the “January 2023 Series X Preferred Stock Warrants”). Each share of Series X Preferred Stock converted into 100 shares of common stock during the year ended December 31, 2023, as a result of the one -for-ten reverse stock split approved by the stockholders and effected by the Board of Directors. Under the terms of the Merger Agreement, Leap held back approximately 15,604 Series X Preferred shares (the “Holdback Shares”), which converted into 1,560,400 shares of common stock out of the aggregate number of shares that the Flame Stockholders otherwise would be entitled to receive pursuant to the Merger so that Leap can have recourse to the Holdback Shares for purposes of satisfying certain claims for indemnification that Leap may have against the Flame Stockholders in connection with the Merger. In January 2024, Leap released the Holdback Shares to the Flame Shareholders.
On June 16, 2023, the Company obtained Stockholder Approval to convert the Series X Preferred Stock into shares of its common stock, which occurred on June 21, 2023.
The Company accounted for the acquisition of Flame as an asset acquisition allocating the purchase price under GAAP of $ 79,016 to net assets acquired. Although there is a presumption under SEC Rule 11-01(d) (“11-01(d)”) that when a legal entity is acquired, it represents a business acquisition, the Company concluded that, in this case, the transaction did not represent the acquisition of a business. After considering the criteria set forth in 11-01(d), the Company concluded that the acquisition of Flame by the Company was an acquisition of assets and not an acquisition of a business in accordance with 11-01(d). Specifically, the Company concluded that 1) the entity did not generate revenue and 2) there was not sufficient continuity of Flame’s operations prior to and following the transaction, in that no facilities, employees, sales force, distribution system, customer base, trade names or production techniques remained with the entity after the acquisition.
Leap primarily acquired cash of $ 50,362 , certain working capital items ($ 928 ) and a portfolio of clinical- and pre-clinical-stage intellectual property, in connection with the acquisition of Flame. The Company accounted for the acquisition of Flame by recording the cash and any other assets and liabilities of Flame on its consolidated balance sheet at their historical carrying values, which approximated fair values. The remaining fair value of the consideration transferred was allocated to the in-process research and development (“IPR&D”) assets acquired. Certain transaction costs that were not deemed to meet the criteria of costs directly attributable to the issuance of securities were capitalized in accordance with ASC 805-50-30-1 and recognized as part of fair value of assets acquired. As the Company concluded that such IPR&D did not have an alternative future use, the relative fair value allocated to acquired IPR&D of $ 29,582 was expensed in research and development expenses within the Company’s consolidated statement of operations during the year ended December 31, 2023.
In addition, subject to and upon the terms and conditions set forth in the Merger Agreement, the Company may also (i) pay Contingent Merger Consideration (as defined in the Merger Agreement) that may become payable if, and only if, certain assets of Flame related to Flame’s FL-101 program and/or FL-103 program are sold after the consummation of the Merger pursuant to the FL-101/103 Disposition Agreement (as defined in the Merger Agreement), which Contingent Merger Consideration shall be 80 % of the after-tax net proceeds of such sale, if any, and the payment thereof is subject to the terms and conditions set forth in the Merger Agreement and (ii) issue pursuant to the Merger additional shares of Series X Preferred Stock or common stock as a result of any applicable post-closing purchase price adjustment in the event that Flame’s actual Company Net Cash (as defined in the Merger Agreement) as of the Effective Date is determined to be greater than Flame’s estimated Company Net Cash as of the closing.
Sale of FL-101/FL-103 to AlmataBio, Inc.
On December 6, 2023 the Company sold certain IPR&D assets previously acquired from Flame related to Flame’s FL-101/FL-103 program which included permits, clinical trial material, clinical data, and related identified contracts, such as licensing, research, clinical trials, and various other agreements. The Company received total consideration in the form of a non-refundable closing date cash payment of $ 500 .
Pursuant to the terms of the asset purchase agreement, the Company is entitled to receive milestone payments of up to $ 70,000 upon achievement of certain regulatory approval and sales milestones specified in the asset purchase agreement.
The IPR&D assets sold related to Flame’s FL-101/FL-103 program did not meet the definition of a business and had a carrying value of $ 0 at the time of the sale. In addition, the Company estimated the likelihood of receiving any milestone payments to be
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remote. As such, management elected the most likely amount method to determine the transaction price of the sale, which included the non-refundable closing date cash payment of $ 500 and future milestone payments of $ 0 . Therefore, the Company recognized a non-operating gain in other income for the difference between the amount of non-refundable consideration received of $ 500 and the carrying value of $ 0 during the year ended December 31, 2023. In the event of a change in circumstances, such that it becomes likely that the Company will receive milestone payments, the Company will recognize income for the change in transaction price in the period in which the transaction price changes.
In addition, during the year ended December 31, 2023, the Company incurred various qualified expenses, such as legal fees, consulting and general and administrative expenses in connection with the sale of Flame’s FL-101 program. Such expenses exceeded the non-refundable consideration received of $ 500 , and therefore, the Company was not obligated to pay Contingent Merger Consideration to the Flame Stockholders.
Series X Preferred Stock
Pursuant to the Merger, the Company agreed to issue 136,248 shares of Series X Preferred Stock to Flame Stockholders and January 2023 Series X Preferred Stock Warrants for 443 shares of Series X Preferred Stock to Flame Warrant Holders. The Company obtained Stockholder Approval during the year ended December 31, 2023 to convert each issued share of Series X Preferred Stock and each share of Series X Preferred Stock issuable pursuant to the January 2023 Series X Preferred Stock Warrants into 100 shares of its common stock. The Series X Preferred Stock was converted to common stock on June 21, 2023, and the carrying value of the Series X Preferred Stock was reclassified from mezzanine equity to permanent equity.
January 2023 Common Stock Warrants and January 2023 Series X Preferred Stock Warrants
In January 2023, pursuant to the Merger, the warrants held by the Flame Warrant Holders became exercisable for 6,530 shares of Leap’s common stock (the “January 2023 Common Stock Warrants”). The January 2023 Common Stock Warrants have an exercise price of $ 6.78 per share and expire in February 2025. The January 2023 Common Stock Warrants qualify for equity classification.
Also in January 2023, pursuant to the Merger, the warrants held by the Flame Warrant Holders became exercisable for 443 shares of Series X Preferred Stock (the “January 2023 Series X Preferred Stock Warrants”). Upon obtaining Stockholder Approval for the conversion of the Series X Preferred Stock and the one -for-ten reverse stock split, each share of Series X Preferred Stock converted into 100 shares of Common Stock. The January 2023 Series X Preferred Stock Warrants have an exercise price of $ 6.78 per share and expire in February 2025.
The Company initially recorded the January 2023 Series X Preferred Stock Warrants as a liability on the Effective Date and the warrant liability was subsequently remeasured to fair value at each reporting date and on the date on which Stockholder Approval to convert shares of Series X Preferred Stock into shares of common stock was obtained. On June 21, 2023, after obtaining stockholder approval for the conversion of the Series X Preferred Stock into common stock, the January 2023 Series X Preferred Stock Warrants were reclassified from liability to equity.
Changes in the fair value of the warrant liability are recognized as gains (losses) in the Company’s consolidated statement of operations. During the year ended December 31, 2023, the Company recorded a gain of $ 12 in its consolidated statement of operations.
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4. Property and equipment, net
Property and equipment, net consisted of the following:
December 31,
2024
2023
Computer office equipment
$
51
$
51
Leasehold improvements
69
69
Lab equipment
76
76
Furniture and fixtures
30
30
226
226
Less: accumulated depreciation
( 226 )
( 221 )
Property and equipment, net
$
—
$
5
Depreciation expense was $ 5 and $ 15 for the years ended December 31, 2024 and 2023, respectively.
5. Accrued Expenses
Accrued expenses consist of the following:
December 31,
2024
2023
Clinical trials
$
4,798
$
2,522
Professional fees
274
254
Payroll and related expenses
3,464
3,181
Accrued expenses
$
8,536
$
5,957
6. Leases
The Company has an operating lease for real estate in the United States and does not have any finance leases. The Company’s leases may contain options to renew and extend lease terms and options to terminate leases early. Reflected in the right-of-use asset and lease liability on the Company’s consolidated balance sheets are the periods provided by renewal and extension options that the Company is reasonably certain to exercise, as well as the periods provided by termination options that the Company is reasonably certain to not exercise.
The Company’s existing lease expires in July 2025 and includes variable lease and non-lease components that are not included in the right-of-use asset and lease liability and are reflected as an expense in the period incurred. Such payments primarily include common area maintenance charges.
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In calculating the present value of future lease payments, the Company utilized its incremental borrowing rate based on the lease term. The Company has an existing net lease in which the non-lease components (e.g. common area maintenance, maintenance, consumables, etc.) are paid separately from rent based on actual costs incurred and therefore are not included in the right-of-use asset and lease liability and are reflected as an expense in the period incurred. During the year ended December 31, 2024, the Company extended the term of its operating lease to July 31,2025 and recorded an additional right-of-use asset and lease liability of $ 420 . As of December 31, 2024, a right-of-use asset of $ 262 and lease liability of $ 266 are reflected on the consolidated balance sheet. The Company recorded rent expense of $ 461 and $ 449 , respectively, during the years ended December 31, 2024 and 2023. Cash paid for amounts included in the measurement of lease liabilities was $ 463 and $ 452 , respectively, during the years ended December 31, 2024 and 2023.
Future lease payments under non-cancelable operating leases as of December 31, 2024 are detailed as follows:
Future Operating Lease Payments
2025
273
Total Lease Payments
273
Less: imputed interest
( 7 )
Total operating lease liabilities
$
266
7. Warrants
As of December 31, 2024, outstanding warrants to purchase common stock, all of which are classified as equity warrants, consisted of the following:
December 31, 2024
Number of Common Shares
Description
Issuable
Exercise Price
Expiration Date
January 23, 2017 Warrants
5,450
$
0.10
Upon M&A Event
2019 Warrants
690,813
$
19.50
February 2026
March 2020 Pre-funded Warrants
824,718
$
0.01
No Expiry
March 2020 Coverage Warrants
2,594,503
$
21.10
Jan - March 2027
September 2021 Pre-funded Warrants
591,603
$
0.01
No Expiry
January 2023 Common Stock Warrants
50,830
$
6.78
February 2025
April 2024 Pre-funded Warrants
1,523,404
$
0.001
No Expiry
6,281,321
2017 Warrants
The 2017 Warrants contain full ratchet anti-dilution protection provisions. The Company will recognize on a prospective basis the value of the effect of the down round feature in the warrant when it is triggered (i.e., when the exercise price is adjusted downward). This value is measured as the difference between (1) the financial instrument’s fair value (without the down round feature) using the pre-trigger exercise price and (2) the financial instrument’s fair value (with the down round feature) using the reduced exercise price. The value of the effect of the down round feature will be treated as a dividend and a reduction to income available to common stockholders in the basic EPS calculation. In connection with the April 2024 Private Placement, when the 2017 Warrants were repriced from $ 10.55 to $ 2.82 , the Company recorded a dividend of $ 234 during the year ended December 31, 2024. The 2017 Warrants expired in November 2024.
2019 Warrants
During the year ended December 31, 2023, the Company redeemed 10,000 of the 2019 Warrants at a purchase price of $ 2.90 per share.
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January 2023 Common Stock Warrants
In January 2023, pursuant to the Merger, the warrants held by the Flame Warrant Holders became exercisable for 6,530 shares of Leap’s common stock (the “January 2023 Common Stock Warrants”). The January 2023 Common Stock Warrants have an exercise price of $ 6.78 per share and expire in February 2025. The January 2023 Common Stock Warrants qualify for equity classification.
January 2023 Series X Preferred Stock Warrants
In January 2023, pursuant to the Merger, the warrants held by the Flame Warrant Holders also became exercisable for 443 shares of Series X Preferred Stock (the “January 2023 Series X Preferred Stock Warrants”). Following Stockholder Approval, each share of Series X Preferred Stock converted into 100 shares of common stock, during the year ended December 31, 2023. The January 2023 Series X Preferred Stock Warrants have an exercise price of $ 6.78 per share and expire in February 2025.
The Company initially recorded the January 2023 Series X Preferred Stock Warrants as a liability on its consolidated balance sheet as of the Effective Date and subsequently remeasured the warrant liability to fair value at each reporting date and on the date Stockholder Approval was obtained to convert shares of Series X Preferred Stock into shares of common stock. Changes in the fair value of the warrant liability were recognized as gains (losses) in the Company’s consolidated statement of operations. During the year ended December 31, 2023, the Company recorded a gain of $ 12 in its consolidated statement of operations.
During the year ended December 31, 2023, upon obtaining Stockholder Approval, the January 2023 Series X Preferred Stock Warrants were converted into common stock warrants and reclassified from liability to equity.
8. Common Stock
Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the board of directors, if any, subject to the preferential dividend rights of the preferred stockholders. Through December 31, 2024, no dividends have been declared for shares of common stock.
Acquisition of Flame – January 2023
On January 17, Leap acquired 100 % of the outstanding equity of Flame. Pursuant to the Merger, Leap issued to Flame Stockholders 1,972,901 shares of common stock. The Company also issued Series X Preferred Stock to Flame Stockholders pursuant to the Merger (see Note 3).
Private Placement - April 2024
On April 15, 2024, the Company completed a private placement whereby the Company issued 12,660,993 shares of its common stock at a purchase price of $ 2.82 per share, and 1,523,404 prefunded warrants at a purchase price of $ 2.819 per share (which is equal to the price per share less the $ 0.001 exercise price per warrant share). The aggregate net proceeds received by the Company from the offering was $ 37,051 , net of $ 2,948 of underwriting discounts and commissions and offering expenses payable by the Company.
9. Stock-Based Compensation
Equity Incentive Plans
On January 20, 2017, the Company’s stockholders approved the 2016 Equity Incentive Plan (the “2016 Plan”). Beginning on January 1, 2018, the number of shares of common stock authorized for issuance pursuant to the 2016 Plan was increased each January 1 by an amount equal to four percent ( 4 %) of the Company’s outstanding common stock as of the end of the immediately preceding calendar year or such other amount as determined by the compensation committee of the Company’s board of directors.
On June 16, 2022, the Company’s stockholders approved the 2022 Equity Incentive Plan (the “2022 Plan”), which provided for a total of 750,000 new shares of the Company’s common stock to be granted. In addition, on June 16, 2023, and July 2, 2024, stockholders approved new shares of the Company’s common stock to be added to the 2022 Plan for future issuance of 2,250,000 and 2,000,000 , respectively.
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As of December 31, 2024, there were 986,563 shares available for grant under the Company’s Equity Incentive Plans.
A summary of stock option activity under the Company’s Equity Incentive Plans is as follows:
Weighted
Average
Weighted
Aggregate
Exercise Price
Average Remaining
Intrinsic
Options
Per Share
Life in Years
Value
Outstanding at December 31, 2022
1,191,715
$
35.94
7.47
$
7,673
Granted
2,393,500
$
2.67
Forfeited
( 200,849 )
$
9.73
Outstanding at December 31, 2023
3,384,366
$
13.97
8.40
$
3,431
Granted
3,460,000
$
2.57
Exercised
( 34,698 )
$
2.68
Forfeited
( 392,924 )
$
4.98
Outstanding at December 31, 2024
6,416,744
$
8.43
8.43
$
1,937
Options exercisable at December 31, 2024
2,844,056
$
15.53
7.43
Options vested and expected to vest at December 31, 2024
6,416,744
$
8.43
8.43
$
1,937
The grant date fair value of the options granted during the years ended December 31, 2024 and 2023 was estimated at the date of grant using the Black-Scholes option valuation model. The expected life was estimated using the “simplified” method as defined by the SEC’s Staff Accounting Bulletin 107, Share-Based Payment. The expected volatility was based on the historical volatility of the Company. The risk-free interest rate was based on the continuous rates provided by the U.S. Treasury with a term approximating the expected life of the option. The expected dividend yield was 0 % because the Company does not expect to pay any dividends for the foreseeable future. The Company elected the straight-line attribution method in recognizing the grant date fair value of options issued over the requisite service periods of the awards, which are generally the vesting periods.
The weighted average grant date fair value for the stock options granted during the years ended December 31, 2024 and 2023 was $ 2.04 and $ 2.07 per share, respectively.
The assumptions that the Company used to determine the grant-date fair value of stock options granted to employees and directors during the years ended December 31, 2024 and 2023 were as follows, presented on a weighted average basis:
Year Ended December 31,
2024
2023
Expected volatility
93.92
%
90.44
%
Weighted average risk-free interest rate
3.82
%
4.05
%
Expected dividend yield
0.00
%
0.00
%
Expected term (in years)
6.46
6.49
Stock options generally vest over a three or four year period, as determined by the compensation committee of the board of directors at the time of grant. The options expire ten years from the grant date. As of December 31, 2024, there was approximately $ 7,527 of unrecognized compensation cost related to non-vested stock options, which is expected to be recognized over a remaining weighted-average period of approximately 2.07 years.
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Restricted Stock Units
The Company did not grant any RSUs during the year ended December 31, 2024 and 2023.
The following table presents RSU activity under the 2016 Plan as of December 31, 2024:
Weighted
Number of
Average Grant
Shares
Date Fair Value
Outstanding at December 31, 2022
358,560
$
18.90
Vested
( 66,060 )
$
14.20
Forfeited
( 30,000 )
$
19.40
Outstanding at December 31, 2023
262,500
$
19.97
Vested
( 27,500 )
$
25.70
Forfeited
( 15,000 )
$
17.80
Outstanding at December 31, 2024
220,000
$
19.40
As of December 31, 2024, there were 220,000 shares outstanding covered by RSUs that were vested and expected to vest with a weighted average grant date fair value of $ 19.40 per share and an aggregate grant date fair value of $ 4,268 . As of December 31, 2024, there was approximately $ 121 of unrecognized compensation costs related to RSUs granted to employees, which are expected to be recognized as expense over a remaining weighted average period of 0.1 years.
The Company recognized stock-based compensation expense related to the issuance of stock option awards and RSUs to employees and non-employees in the consolidated statements of operations during the years ended December 31, 2024 and 2023 as follows:
Stock Based Compensation Expense
Year Ended
December 31,
2024
2023
Research and development
$
2,855
$
2,647
General and administrative
2,649
2,481
Total
$
5,504
$
5,128
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10. Income Taxes
There is no provision for income taxes in the United States because the Company has historically incurred operating losses and maintains a full valuation allowance against its deferred tax assets in these jurisdictions. A provision for income taxes was recorded in Australia based on the results of the Company’s foreign subsidiary.
Loss before income taxes consisted of the following:
Year Ended
December 31,
2024
2023
U.S.
$
( 69,475 )
$
( 80,895 )
Foreign
2,505
( 519 )
Loss before income taxes
$
( 66,970 )
$
( 81,414 )
A summary of the Company’s current and deferred expense for income tax is as follows:
Year Ended
December 31,
2024
2023
Current expense:
Federal
$
—
$
—
State
—
—
Foreign
585
—
Total current expense:
$
585
$
—
Deferred expense:
Federal
$
—
$
—
State
—
—
Foreign
—
—
Total deferred expense
$
—
$
—
Total income tax expense
$
585
$
—
A reconciliation of the Company’s statutory income tax rate to the Company’s effective income tax rate is as follows:
Year Ended
December 31,
2024
2023
Income at US Statutory Rate
21.0
%
21.0
%
State taxes, net of federal benefit
5.6
%
4.1
%
Permanent differences
( 0.1 )
%
0.3
%
Research and development credits
2.7
%
1.6
%
Foreign rate differential
( 0.2 )
%
0.0
%
Change in valuation allowance
( 28.9 )
%
63.5
%
Section 382 limitations
0.0
%
( 90.1 )
%
Other
( 1.0 )
%
( 0.4 )
%
( 0.9 )
%
0.0
%
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The significant components of the Company’s deferred tax assets as of December 31, 2024 and 2023 were as follows:
Year Ended
December 31,
2024
2023
Federal net operating loss carryforwards
$
8,865
$
3,672
State net operating loss carryforwards
2,741
967
Research and development (R&D) tax credits
3,488
1,649
Capitalized R&D expenses
23,554
12,915
Start-up costs
10,386
11,355
Stock based compensation
6,696
5,812
Accrued expenses
911
831
License fees
505
676
Other
403
365
Total deferred tax assets
57,549
38,242
Valuation allowance
( 57,549 )
( 38,242 )
Net deferred tax assets
$
—
$
—
As of December 31, 2024, the Company had federal and state net operating loss (“NOL”) carryforwards of approximately $ 42,216 , and $ 47,178 , respectively. The Company’s federal NOL’s can be carried forward indefinitely and the state NOL’s begin to expire in 2032.
Under Internal Revenue Code Section 382, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change NOL carryforwards and other pre-change tax attributes to offset its post-change income may be limited. The Company has completed a study to assess whether an ownership change occurred or whether there had been multiple ownership changes since the Company became a “loss corporation” as defined in Section 382. The Company experienced multiple ownership changes occurring in 2019, 2020, and 2023. The ownership changes have and will continue to subject the Company’s pre-ownership change NOL carryforwards to an annual limitation, which will significantly restrict its ability to use them to offset taxable income in periods following the ownership changes. In general, the annual use limitation equals the aggregate value of the Company’s stock at the time of the ownership change multiplied by a specified tax-exempt interest rate. As a result of the ownership changes, the Company is limited to a $ 0 annual limitation on its ability to utilize its NOL’s and research and development (“R&D”) credits recognized prior to the Flame merger. Due to this limitation, approximately $ 210,732 of the federal NOL’s and $ 7,818 of federal R&D credits that had been available to offset future taxable income prior to the date of the ownership change, will expire unutilized. Additionally, approximately $ 192,224 and $ 1,757 of state NOL’s and R&D tax credits that had been available to offset future taxable income prior to the date of the ownership change, will expire unutilized. As a result, during the year ended December 31, 2023, the Company has reduced its deferred tax assets related to the federal and state NOL and R&D credits which is offset by the corresponding decrease in a valuation allowance.
In addition, As of December 31, 2024, the Company has federal and state R&D tax credits of approximately $ 3,024 and $ 588 , respectively, that begin to expire in 2043 and 2038, respectively, for federal and state tax purposes.
As of December 31, 2024 and 2023, the Company has provided a full valuation allowance against its net deferred tax assets, as realization of any associated tax benefit in the future is not more likely than not. The valuation allowance increased by $ 19,307 and decreased by $ 47,726 during the years ended December 31, 2024 and 2023, respectively.
The Tax Cuts and Jobs Act (“TCJA”) resulted in significant changes to the treatment of R&D expenditures under Section 174. For tax years beginning after December 31, 2021, taxpayers are required to capitalize and amortize all R&D expenditures that are paid or incurred in connection with their trade or business. Specifically, costs for U.S.-based R&D activities must be amortized over five years and costs for foreign R&D activities must be amortized over 15 years, both using a midyear convention. During the year ended December 31, 2024, the Company capitalized $ 53,662 of R&D expenses.
The Company follows the authoritative guidance on accounting for and disclosure of uncertainty in tax positions, which requires the Company to determine whether a tax position of the Company is more likely than not to be sustained upon examination, including resolution of any related appeals of litigation processes, based on the technical merits of the position. For tax positions meeting the more likely than not threshold, the tax amount recognized in the financial statements is reduced by the largest benefit that has a greater
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than 50% likelihood of being realized upon the ultimate settlement with the relevant taxing authority. As of December 31, 2024, the Company has not recorded any uncertain tax positions.
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending tax examinations. The earliest tax years that may be subject to examination by jurisdiction are 2020 for both federal and state purposes. The Company’s policy is to record interest and penalties related to income taxes as part of the tax provision. There were no interest and penalties pertaining to uncertain tax positions for the years ended December 31, 2024 or 2023.
11. Net Loss Per Share
Basic and diluted net loss per share for the years ended December 31, 2024 and 2023 was calculated as follows:
Year Ended December 31,
2024
2023
Numerator:
Net loss
$
( 67,555 )
$
( 81,414 )
Dividend attributable to down round feature of warrants
( 234 )
—
Net loss attributable to common stockholders for basic and diluted loss per share
$
( 67,789 )
$
( 81,414 )
Denominator:
Weighted average number of common shares outstanding - basic and diluted
37,550,677
20,445,109
Net loss per share attributable to common stockholders - basic and diluted
$
( 1.81 )
$
( 3.98 )
Included within weighted average common shares outstanding for the years ended December 31, 2024 and 2023, are 2,945,175 , and 1,421,768 common shares issuable upon the exercise of the pre-funded warrants and penny warrants, as the warrants are exercisable at any time for nominal consideration, and as such, the shares are considered outstanding for the purpose of calculating basic and diluted net loss per share attributable to common stockholders.
The Company’s potentially dilutive securities include RSUs, stock options and warrants. These securities were excluded from the computations of diluted net loss per share for the years ended December 31, 2024 and 2023, as the effect would be to reduce the net loss per share. The following table includes the potential common shares of common stock, presented based on amounts outstanding at each period end, that were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
Year Ended December 31,
2024
2023
Restricted stock units to purchase common stock
220,000
262,500
Options to purchase common stock
6,416,744
3,384,366
Warrants to purchase common stock
3,336,146
3,586,371
9,972,890
7,233,237
12. Commitments and Contingencies
Manufacturing Agreements— The Company is party to manufacturing agreements with vendors to manufacture DKN-01, its lead product candidate, for use in clinical trials. As of December 31, 2024, noncancelable commitments under these agreements totaled $ 81 .
License and Service Agreements— On January 3, 2011, the Company entered into a license agreement with Eli Lilly and Company (“Lilly”), a shareholder, to grant a license to the Company for certain intellectual property rights relating to pharmaceutically active compounds that may be useful in the treatment of bone healing, cancer and, potentially, other medical conditions. As defined in the license agreement, the Company would be required to pay royalties to Lilly based upon a percentage in the low single digits of net sales of developed products, if and when achieved. However, there can be no assurance that clinical or commercialization success of developed products will occur, and no royalties have been paid or accrued through December 31, 2024.
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Collaboration Agreement --On August 10, 2020, the Company entered into a collaboration agreement with Adimab, LLC (the “Adimab Agreement”), pursuant to which Adimab will conduct research programs to develop monoclonal antibodies to certain targets identified by the Company and provide it with an option to acquire exclusive rights to such antibodies. Upon payment of an option fee, on a product-by-product basis, Adimab will grant the Company a world-wide, exclusive license for, or assign ownership to the Company of, certain intellectual property rights and grant the Company a non-exclusive license with respect to the Adimab platform technology. As defined in the Adimab Agreement, after exercising an option and making the option payment, the Company would be required to pay Adimab milestones upon the completion of clinical development and regulatory milestones, along with a royalty in the low-single digits of net sales of each product, if and when achieved. However, there can be no assurance that clinical, or commercialization success will occur, and no royalties have been paid or accrued through December 31, 2024.
Legal Proceedings— At each reporting date, the Company evaluates whether a potential loss amount or a potential range of loss is probable and reasonably estimable under the provisions of the authoritative guidance that addresses accounting for contingencies. The Company expenses as incurred the costs related to its legal proceedings. As of the date of this report, the Company is not currently a party to any material legal proceedings.
Indemnification Agreements— In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2024 and 2023.
13. Defined Contribution Plan
The Company has a 401(k) defined contribution plan (the “401(k) Plan”) for substantially all of its employees. Eligible employees may make pretax contributions to the 401(k) Plan up to statutory limits.
The Company makes matching employee contributions in cash to the 401(k) Plan at a rate of 100 % of the first 3 % of earnings contributed and 50 % of the next 2 % of earnings contributed.
Employees participating in the 401(k) Plan are fully vested in the Company matching contributions, and investments are directed by participants. The Company made matching contributions of $ 471 and $ 443 for the years ended December 31, 2024 and 2023, respectively.
14. Related Party Transactions
The Company has a license agreement with a stockholder (See Note 12).
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15. Subsequent Events
Prefunded Warrant Exercises
During the first quarter of 2025, there were 824,718 March 2020 Pre-funded Warrants that were cashless exercised, resulting in the issuance of 809,558 common shares of the Company’s common stock and 591,603 September 2021 Pre-funded warrants that were cashless exercised, resulting in the issuance of 590,424 common shares of the Company’s common stock. Also during the first quarter of 2025, there were 1,523,404 April 2024 Pre-funded Warrants that were cashless exercised, resulting in the issuance of 1,521,059 common shares of the Company’s common stock.
January 2023 Common Stock Warrants
The January 2023 Common Stock Warrants expired in February 2025.
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