LEAP THERAPEUTICS INC
For the period ended Mar 31, 2025. Filed May 13, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 13, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
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Item 1. Financial Statements
CONDENSED CONSOLIDATED BALANCE SHEETS
| | | | | | | |
|---|---|---|---|---|---|---|
| · · March 31, · · December 31, | ||||||
| · 2025 · 2024 | ||||||
| Assets · · | ||||||
| Current assets: · · | ||||||
| Cash and cash equivalents | | $32,713 | | $47,249 | ||
| Research and development incentive receivable | | 711 | | 704 | ||
| Prepaid expenses and other current assets | | 446 | | 86 | ||
| Total current assets | | 33,870 | | 48,039 | ||
| | | | | | | |
| Right of use assets, net | | | 152 | | | 262 |
| Research and development incentive receivable, net of current portion | | | 55 | | | — |
| Deposits | | 802 | | 823 | ||
| Total assets | | $34,879 | | $49,124 | ||
| | | | | | | |
| Liabilities and Stockholders’ Equity | | | | |||
| Current liabilities: | | | | |||
| Accounts payable | | $6,357 | | $4,743 | ||
| Accrued expenses | | 6,992 | | 8,536 | ||
| Income tax payable | | | 536 | | | 531 |
| Lease liability - current portion | | | 154 | | | 266 |
| Total current liabilities | | | 14,039 | | | 14,076 |
| | | | | | | |
| | | | | | | |
| Stockholders’ equity: | | | | | | |
| Preferred stock, $0.001 par value; 10,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively | | | — | | | — |
| Common stock, $0.001 par value; 240,000,000 shares authorized; 41,439,529 and 38,329,894 shares issued and outstanding as of March 31, 2025 and December 31, 2024, respectively | | | 41 | | | 38 |
| Additional paid-in capital | | 503,718 | | 502,501 | ||
| Accumulated other comprehensive loss | | (113) | | (120) | ||
| Accumulated deficit | | (482,806) | | (467,371) | ||
| Total stockholders’ equity | | 20,840 | | 35,048 | ||
| Total liabilities and stockholders’ equity | | $34,879 | | $49,124 | ||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| | 2025 | 2024 | ||||
| Operating expenses: | | | | | | |
| Research and development | | $12,911 | | $11,299 | ||
| General and administrative | | 3,006 | | 3,526 | ||
| Total operating expenses | | 15,917 | | 14,825 | ||
| Loss from operations | | (15,917) | | (14,825) | ||
| Interest income | | 437 | | 775 | ||
| Interest expense | | | (6) | | | — |
| Australian research and development incentives | | 55 | | 246 | ||
| Foreign currency loss | | | (4) | | | (16) |
| Net loss | | $(15,435) | | $(13,820) | ||
| | | | | | | |
| Net loss per share | | | | | | |
| Basic and diluted | | $(0.37) | | $(0.51) | ||
| | | | | | | |
| Weighted average common shares outstanding | | | | | | |
| Basic and diluted | | | 41,268,894 | | | 27,014,100 |
LEAP THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(In thousands)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| · 2025 · 2024 | ||||||
| Net loss | | $(15,435) | | $(13,820) | ||
| Other comprehensive income (loss): | | | | | | |
| Foreign currency translation adjustments | | | 7 | | (226) | |
| Comprehensive loss | | $(15,428) | | $(14,046) | ||
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For the Three Months Ended March 31, 2024
(In thousands, except share amounts)
| | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · · · · · · 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 | | 10,557 | | — | | 29 | | — | | — | | 29 | |||||
| Foreign currency translation adjustment | | — | | | — | | | — | | | (226) | | | — | | | (226) |
| Stock-based compensation | | — | | | — | | | 1,248 | | | — | | | — | | | 1,248 |
| Net loss | | — | | | — | | | — | | | — | | | (13,820) | | | (13,820) |
| Balances at March 31, 2024 | | 25,603,471 | | $26 | | $460,868 | | $(120) | | $(413,402) | | $47,372 | |||||
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For the Three Months Ended March 31, 2025
(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, 2024 | 38,329,894 | | $38 | | $502,501 | | $(120) | | $(467,371) | | $35,048 | ||||||
| | | | | | | | | | | | | | | | | | |
| Issuance of common stock upon exercise of stock options | | 6,667 | | | — | | | 16 | | | — | | | — | | | 16 |
| Issuance of common stock upon exercise of prefunded warrants | | 2,921,041 | | | 3 | | | (3) | | | — | | | — | | | — |
| Issuance of common stock upon vest of restricted stock units | | 181,927 | | | — | | | — | | | — | | | — | | | — |
| Foreign currency translation adjustment | | — | | | — | | | — | | | 7 | | | — | | | 7 |
| Stock-based compensation | — | | — | | 1,204 | | — | | — | | 1,204 | ||||||
| Net loss | — | | — | | — | | — | | (15,435) | | (15,435) | ||||||
| Balances at March 31, 2025 | 41,439,529 | | $41 | | $503,718 | | $(113) | | $(482,806) | | $20,840 | ||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| · 2025 · 2024 | ||||||
| Cash flows from operating activities: · · | ||||||
| Net loss | | $(15,435) | | $(13,820) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | | | | | ||
| Depreciation expense | | — | | 5 | ||
| Non-cash operating lease expense | | | 110 | | | 100 |
| Stock-based compensation expense | | 1,204 | | 1,248 | ||
| Foreign currency loss | | | 4 | | | 16 |
| Changes in operating assets and liabilities: | | | | | ||
| Prepaid expenses and other assets | | 155 | | (343) | ||
| Research and development incentive receivable | | (55) | | (247) | ||
| Accounts payable and accrued expenses | | (373) | | (2,386) | ||
| Lease liability | | | (112) | | | (98) |
| Other assets | | | 22 | | | 9 |
| Net cash used in operating activities | | (14,480) | | (15,516) | ||
| | | | | | | |
| Cash flows from financing activities: | | | | | ||
| Proceeds from the exercise of stock options | | | 16 | | | 29 |
| Principal payments of insurance financing | | | (77) | | | — |
| Net cash provided by financing activities | | (61) | | 29 | ||
| | | | | | | |
| Effect of exchange rate changes on cash and cash equivalents | | 5 | | (235) | ||
| Net decrease in cash and cash equivalents | | (14,536) | | (15,722) | ||
| Cash and cash equivalents at beginning of period | | 47,249 | | 70,643 | ||
| Cash and cash equivalents at end of period | | $32,713 | | $54,921 | ||
| | | | | | | |
| Supplemental disclosure of non-cash financing activities: | | | | | | |
| Remeasurement of right-of-use asset and lease liability | | $— | | $420 | ||
| Prepayment of insurance through third-party financing | | $440 | | $— | ||
Leap Therapeutics, Inc.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
- 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 is currently studying sirexatamab in a clinical trial in patients with colorectal cancer. 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 March 31, 2025, statements of operations and statements of comprehensive loss for the three months ended March 31, 2025 and 2024 and statements of cash flows for the three months ended March 31, 2025 and 2024. Such adjustments are of a normal and recurring nature. The results of operations for the three months ended March 31, 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 March 31, 2025, the Company had cash and cash equivalents of $32,713. Additionally, the Company had an accumulated deficit of $482,806 as of March 31, 2025, and during the three months ended March 31, 2025, the Company incurred a net loss attributable to common stockholders of $15,435. 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.
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.
- Summary of Significant Accounting Policies
Principles of Consolidation
The accompanying condensed 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 condensed 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 condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
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.
Under the program, a percentage of eligible research and development expenses incurred by the Company through its subsidiary in Australia are reimbursed. The percentage was 43.5% for the year ended December 31, 2024 and for the three months ended March 31, 2025.
The research and development incentive receivable represents an amount due in connection with the above program. The Company recorded a research and development incentive receivable of $766 and $704 as of March 31, 2025 and December 31, 2024, respectively, in the condensed consolidated balance sheets and other income from Australian research and development incentives of $55 and $246, respectively, for the three months ended March 31, 2025 and 2024 in the condensed consolidated statements of operations related to refundable research and development incentive program payments in Australia.
The following table shows the change in the research and development incentive receivable from January 1, 2024 to March 31, 2025 (in thousands):
| | | | |
|---|---|---|---|
| Balance at January 1, 2024 | $771 | ||
| Foreign currency translation | | (67) | |
| Balance at December 31, 2024 | | $704 | |
| Australian research and development incentive income | | | 55 |
| Foreign currency translation | | | 7 |
| Balance at March 31, 2025 | | $766 | |
Foreign Currency Translation
The financial statements of the Company’s Australian subsidiary are measured using the local currency as the functional currency. The assets and liabilities of this subsidiary are translated into U.S. dollars at an exchange rate 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 period. The resulting cumulative translation adjustments have been recorded as a separate component of stockholders’ equity. Realized and unrealized foreign currency transaction gains and losses are included in the results of operations.
Concentration of Credit Risk
Financial instruments that 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 year ended December 31, 2024 or for the three months ended March 31,2025.
Deposits
As of March 31, 2025 and December 31, 2024, there were $802 and $823, 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, which were recorded in the condensed consolidated balance sheets.
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”) and in the warrants that were issued in a private placement in March 2020 (the “March 2020 Coverage 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 earnings per share (“EPS”) calculation. In connection with the private placement of common stock and prefunded warrants completed in April 2024 (the “April 2024 Private Placement”), when the 2017 Warrants were repriced from $10.55 to $2.82 as a result of a down round, the Company recorded a dividend of $234 during the three months ended June 30, 2024. The 2017 Warrants expired in November 2024.
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. |
A summary of the assets carried at fair value in accordance with the hierarchy defined above is as follows (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| | Total | Level 1 | Level 2 | Level 3 | ||||||||
| March 31, 2025 | | | | | | | | | | | | |
| Assets: | | | | | | | | | | | | |
| Cash equivalents | | $13,015 | | $13,015 | | $— | | $— | ||||
| Total assets | | $13,015 | | $13,015 | | $— | | $— | ||||
| | | | | | | | | | | | | |
| December 31, 2024 | | | | | | | | | | | | |
| Assets: | | | | | | | | | | | | |
| Cash equivalents | | $23,299 | | $23,299 | | $— | | $— | ||||
| Total assets | | $23,299 | | $23,299 | | $— | | $— | ||||
Cash equivalents of $13,015 and $23,299 as of March 31, 2025 and December 31, 2024, respectively, consisted of overnight investments and money market funds which are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets.
The carrying values of the research and development incentive receivable, accounts payable and accrued liabilities approximate their fair value due to the short-term nature of these assets and liabilities.
Leases
The Company accounts for leases in accordance with Accounting Standards Codification, or ASC, Topic 842,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. Most 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 Topic 842, 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.
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 effective date.
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 adopted ASU 2023-09 effective January 1, 2025 and it did not have a material impact on the Company’s consolidated financial statements at adoption date.
- Accrued Expenses
Accrued expenses consist of the following:
| · · · · · · | ||||
|---|---|---|---|---|
| · · March 31, · December 31, | ||||
| · 2025 · 2024 | ||||
| Clinical trials | | $4,694 | | $4,798 |
| Professional fees | | 600 | | 274 |
| Payroll and related expenses | | 1,698 | | 3,464 |
| Accrued expenses | | $6,992 | | $8,536 |
- 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.
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 three months ended March 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 March 31, 2025, a right-of-use asset of $152 and lease liability of$154 are reflected on the condensed consolidated balance sheet. The Company recorded rent expense of$118 and$110, respectively, during the three months ended March 31, 2025 and 2024. Cash paid for amounts included in the measurement of lease liabilities was$117 and$114, respectively, during the three months ended March 31, 2025 and 2024.
Future lease payments under non-cancelable operating leases as of March 31, 2025 are detailed as follows:
| | | | |
|---|---|---|---|
| Future Operating Lease Payments | |||
| 2025 | | | 156 |
| Total Lease Payments | | 156 | |
| Less: imputed interest | | (2) | |
| Total operating lease liabilities | | $154 | |
5. Warrants
As of March 31, 2025, the number of shares of common stock issuable upon the exercise of outstanding warrants, consisted of the following:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| March 31, 2025 · · | |||||||
| | | 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 Coverage Warrants | | 2,594,503 | | $21.10 | | Jan - March 2027 | |
| | | 3,290,766 | | | | | |
2017 Warrants
The 2017 Warrants contained full ratchet anti-dilution protection provisions. The Company recognized on a prospective basis the value of the effect of the down round feature in the warrant when it was triggered (i.e., when the exercise price was adjusted downward). This value was 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 was 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 three months ended June 30, 2024. The 2017 Warrants expired in November 2024.
March 2020 Pre-funded Warrants
During the three months ended March 31, 2025,824,718 March 2020 Pre-funded Warrants were cashless exercised, resulting in the issuance of 809,558 common shares of the Company’s common stock.
September 2021 Pre-funded Warrants
During the three months ended March 31, 2025,591,603 September 2021 Pre-funded warrants were cashless exercised, resulting in the issuance of 590,424 common shares of the Company’s common stock.
April 2024 Pre-funded Warrants
During the three months ended March 31, 2025,1,523,404 April 2024 Pre-funded Warrants were cashless exercised, resulting in the issuance of 1,521,059 common shares of the Company’s common stock.
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 had an exercise price of $6.78 per share and expired in February 2025.
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 three months ended June 30, 2023. The January 2023 Series X Preferred Stock Warrants had an exercise price of $6.78 per share and expired in February 2025.
6. Common Stock
Each share of common stock entitles the holder toone 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 March 31, 2025, no dividends have been declared for shares of common stock.
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.
- Equity Incentive Plans
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 4% of the Company’s outstanding common stock as of the end of the immediately preceding calendar year or such lesser 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 provides 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.
As of March 31, 2025, there were 2,688,242 shares available for grant under the Company’s equity incentive plans.
A summary of stock option activity under the Equity Plans is as follows:
| · · · · · · · · · · | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| · · · Weighted · · · | |||||||||
| · · · · Average · Weighted · · Aggregate | |||||||||
| · · · · Exercise Price · Average Remaining · · Intrinsic | |||||||||
| · Options · · Per Share · Life in Years · · Value | |||||||||
| Outstanding at December 31, 2024 | 6,416,744 | | $8.43 | 8.43 | | $1,937 | |||
| Exercised | | (6,667) | | $2.40 | | | | | |
| Forfeited | (130,411) | | $53.90 | | | | | ||
| Outstanding at March 31, 2025 | 6,279,666 | | $7.49 | 8.19 | | $— | |||
| Options exercisable at March 31, 2025 | 3,289,351 | | $11.83 | 7.45 | | | | ||
| Options vested and expected to vest at March 31, 2025 | 6,279,666 | | $7.49 | 8.19 | | $— | |||
The grant date fair value of the options granted during the three months ended March 31, 2024 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 three months ended March 31, 2024 was $2.12 per share. During the three months ended March 31, 2025, there wereno stock options granted.
The assumptions that the Company used to determine the grant-date fair value of stock options granted to employees and directors during the three months ended March 31, 2025 and 2024 were as follows, presented on a weighted average basis:
| | | | |
|---|---|---|---|
| | | Three Months Ended March 31, | |
| · 2024 · | |||
| | | | |
| Expected volatility | | 92.84% | |
| Weighted average risk-free interest rate | | 4.00% | |
| Expected dividend yield | | 0.00% | |
| Expected term (in years) | | 6.44 | |
Stock options generally vest over athree orfour year period, as determined by the compensation committee of the Board of Directors at the time of grant. The options expire 10 years from the grant date. As of March 31, 2025, there was approximately $6,224 of unrecognized compensation cost related to non-vested stock options, which is expected to be recognized over a remaining weighted-average period of approximately 1.92 years.
Restricted Stock Units (“RSUs”)
The Company did not grant any RSUs during the three months ended March 31, 2025 and 2024.
The following table presents RSU activity under the 2016 Plan during the three months ended March 31, 2025:
| · · · · · | ||||
|---|---|---|---|---|
| | | | | Weighted |
| | | | | Average Grant |
| · Number of Shares · Date Fair Value | ||||
| Outstanding at December 31, 2024 | 220,000 | | $19.40 | |
| Vested | | (220,000) | | $19.40 |
| Outstanding at March 31, 2025 | — | | $— | |
During the three months ended March 31, 2025,220,000 RSUs vested. As of March 31, 2025, there wereno shares outstanding covered by RSUs.
The Company recognized stock-based compensation expense related to the issuance of stock option awards and RSUs to employees and non-employees in the condensed consolidated statements of operations during the three months ended March 31, 2025 and 2024 as follows:
Stock Based Compensation Expense
| · · · · · · | |||||
|---|---|---|---|---|---|
| · · Three Months Ended March 31, | |||||
| · 2025 · 2024 | |||||
| · · · · · · | |||||
| Research and development | $634 | | $627 | ||
| General and administrative | | 570 | | 621 | |
| Total | | $1,204 | | $1,248 | |
- Net Loss Per Share
Basic and diluted net loss per share for the three months ended March 31, 2025 and 2024 was calculated as follows (in thousands except share and per share amounts).
| | | | | | | |
|---|---|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||||
| · 2025 · 2024 | ||||||
| Numerator: · · · | ||||||
| Net loss | | $(15,435) | | $(13,820) | ||
| Net loss attributable to common stockholders for basic and diluted loss per share | | $(15,435) | | $(13,820) | ||
| | | | | | | |
| Denominator: | | | | | ||
| Weighted average number of common shares outstanding – basic and diluted | | 41,268,894 | | 27,014,100 | ||
| Net loss per share attributable to common stockholders – basic and diluted | | $(0.37) | | $(0.51) | ||
Included within weighted average common shares outstanding for the three months ended March 31, 2025 and 2024 are 5,450, and 1,421,771, respectively, common shares issuable upon the exercise of certain warrants, which 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.
All warrants exercisable for common stock participate on a one-for-one basis and shares and warrants exercisable for Series X Preferred Stock issued participate on an as converted basis with common stock in the distribution of dividends, if and when declared by the board of directors, on the Company’s common stock. For purposes of computing EPS, these securities are considered to participate with common stock in earnings of the Company. Therefore, the Company calculates basic and diluted EPS using the two-class method. Under the two-class method, net income for the period is allocated between common stockholders and participating securities according to dividends declared and participation rights in undistributed earnings. No income was allocated to the warrants and Series X Preferred Stock for the three months ended March 31, 2025 and 2024, as results of operations were a loss for the period.
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 three months ended March 31, 2025 and 2024, as the effect would be to reduce the net loss per share. The following table includes the potential 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:
| | | | | |
|---|---|---|---|---|
| · · Three Months Ended March 31, | ||||
| · 2025 · 2024 | ||||
| Restricted stock units to purchase common stock | | — | | 227,500 |
| Options to purchase common stock | 6,279,666 | | 4,867,984 | |
| Warrants to purchase common stock | | 3,285,316 | | 3,586,373 |
| | 9,564,982 | | 8,681,857 | |
- 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 March 31, 2025, there were $98 noncancelable commitments under these agreements.
Insurance Financing Agreement—In March 2025, the Company entered into an insurance premium financing and security agreement with Aon Premium Finance, LLC. Under the agreement, the Company financed $440 of insurance premiums at a 8.74% fixed annual interest rate. Payments of approximately $42 are due monthly through February 2026. As of March 31, 2025, the outstanding principal of the loan was $363 and is included within accrued expenses in the condensed consolidated balance sheets.
License and Service Agreement—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, andno royalties have been paid or accrued through March 31, 2025.
**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, andno royalties have been paid or accrued through March 31, 2025.
**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 condensed consolidated financial statements as of March 31, 2025 or December 31, 2024.
- Subsequent Events
On May 6, 2025, the Company’s board of directors approved a restructuring to reduce cash burn and to prioritize clinical development of sirexatamab in CRC and advancing FL-501 in preclinical development. In connection with this restructuring, the Company reduced its workforce by 13 full-time employees and converted 3 full-time employees to part-time status, in addition to the 11 full-time employees who have departed since the end of the first quarter, resulting in approximately 50% reduction in headcount. The Company expects to incur one-time costs of approximately $350 to $450 in connection with the overall workforce reduction. The majority of these costs will be recognized in the second quarter of 2025. These costs consist primarily of cash expenditures related to one-time termination benefits (some of which are paid over a number of months), including severance. The estimate of costs that the Company expects to incur and the timing thereof are subject to a number of assumptions, and actual results may differ materially. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, the actions described above.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.