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Nature of Business, Basis of Presentation and Liquidity | 6 Months Ended
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Jun. 30, 2025
Nature of Business, Basis of Presentation and Liquidity |
Nature of Business, Basis of Presentation and Liquidity | 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 of the Company 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 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 also has a preclinical antibody program FL-501. Basis of Presentation The December 31, 2024 year-end condensed consolidated balance sheet data in the accompanying interim condensed consolidated financial statements was derived from audited consolidated financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2024, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2025. The accompanying interim condensed consolidated financial statements are unaudited and have been prepared on the same basis as the audited consolidated financial statements as of and for the year ended December 31, 2024. In the opinion of management, the accompanying condensed consolidated financial statements contain all adjustments which are necessary for the fair presentation of the Company’s financial position as of June 30, 2025, statements of operations and statements of comprehensive loss for the three and six months ended June 30, 2025 and 2024 and statements of cash flows for the six months ended June 30, 2025 and 2024. Such adjustments are of a normal and recurring nature. The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2025. Liquidity and Going Concern 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 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 condensed consolidated financial statements are issued. As of June 30, 2025, the Company had cash and cash equivalents of $18,130. Additionally, the Company had an accumulated deficit of $499,449 as of June 30, 2025, and during the six months ended June 30, 2025, the Company incurred a net loss attributable to common stockholders of $32,078. The Company expects to continue to generate operating losses for the foreseeable future. The foregoing matters give rise to a substantial doubt about the Company’s ability to continue as a going concern for at least the next 12 months from the issuance of this report on Form 10-Q. The Company has engaged a leading financial advisor to explore strategic alternatives to preserve and maximize shareholder value, including any or all of the following: entering into a merger, asset sale, or license agreement with another company; selling or partnering sirexatamab or FL-501 in a transaction with a pharmaceutical company, biotechnology company, or investment fund; or seeking additional funding through public or private equity financings. There can be no assurance that the Company will successfully complete a transaction as part of the strategic alternative process, and any such transaction, if available, may not be on terms favorable to the Company. If the Company is not able to successfully complete any transaction, the Company’s business, operations and financial condition will be materially adversely affected, and the Company would be forced to discontinue its business and operations entirely, wind-up and liquidate.

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