Financial Performance - Total current assets increased to $58,401,000 as of September 30, 2020, compared to $4,241,000 as of December 31, 2019, representing a significant growth of 1,276%[17] - License revenue for the three months ended September 30, 2020, was $375,000, compared to $0 for the same period in 2019, indicating a new revenue stream[19] - Net loss for the three months ended September 30, 2020, was $7,057,000, a slight improvement from a net loss of $7,935,000 in the same period of 2019, reflecting a decrease of 11%[22] - The company reported a comprehensive loss of $7,265,000 for the three months ended September 30, 2020, compared to $7,930,000 in the same period of 2019, a decrease of 8.4%[22] - Net loss for the nine months ended September 30, 2020, was $20,804,000, compared to a net loss of $24,904,000 for the same period in 2019, representing a decrease of 12.5%[31] - The company reported a net loss from operations of $20.8 million for the nine months ended September 30, 2020, down from a net loss of $24.9 million in the same period of 2019, indicating an improvement of 16.7%[188] Cash and Liquidity - Cash and cash equivalents increased significantly to $57,975,000 as of September 30, 2020, compared to $3,891,000 as of December 31, 2019, marking an increase of 1,387%[17] - Cash and cash equivalents at the end of the period were $57,975,000, up from $10,058,000 at the end of the same period in 2019, indicating a significant increase of 475.5%[31] - The company experienced a net cash increase of $54,084,000 during the nine months ended September 30, 2020, compared to a decrease of $6,226,000 in the prior year[31] - As of September 30, 2020, the company had cash and cash equivalents of $58.0 million, expected to fund operating expenses for at least the next 12 months[186] Operating Expenses - Total operating expenses decreased to $7,883,000 for the three months ended September 30, 2020, from $7,923,000 in the same period of 2019, a reduction of 0.5%[19] - Research and development expenses for the three months ended September 30, 2020, were $5,369,000, slightly lower than $5,772,000 for the same period in 2019, a decrease of 7%[19] - Total operating expenses for the nine months ended September 30, 2020, were $22.5 million, down from $25.2 million in 2019, reflecting a decrease of $2.7 million[177] - Research and development expenses for the nine months ended September 30, 2020, were $15.3 million, a decrease of $3.4 million from $18.7 million in 2019, mainly due to reduced clinical trial costs[179] Revenue Streams - The company has not generated any product sales revenues and has not achieved profitable operations since inception[39] - The Company recognized $375 and $1,125 of license revenue related to the upfront fee received from BeiGene during the three and nine months ended September 30, 2020, respectively[85] - For the nine months ended September 30, 2020, license revenue was $1.1 million, an increase of $1.1 million compared to no license revenue in the same period in 2019[177] Financing Activities - Proceeds from the issuance of common stock during the June 2020 Public Offering amounted to $48,518,000[31] - The total cash provided by financing activities for the nine months ended September 30, 2020, was $73,997,000, compared to $14,836,000 in the same period of 2019, indicating a substantial increase of 396.5%[31] - The company raised $14,986,000 from the issuance of Series A convertible preferred stock and $12,000,000 from Series B convertible preferred stock during the reporting period[31] - The company raised $48.5 million from the issuance of common stock in connection with the 2020 Public Offering during the nine months ended September 30, 2020[190] Research and Development - Research and development expenses for the DKN-01 program were $5,275,000 for Q3 2020, compared to $3,806,000 for Q3 2019, reflecting a 39% increase[152] - The company plans to increase research and development expenses in the foreseeable future to support the development of DKN-01 and other product candidates[149] - The company has received Australian government R&D incentives, which amounted to $228,000 for Q3 2020, compared to a negative $7,000 in Q3 2019[152] Accumulated Deficit - The accumulated deficit as of September 30, 2020, was $216,275,000, compared to $195,168,000 as of December 31, 2019, indicating an increase in losses[17] - The company incurred a net loss of $20,804 during the nine months ended September 30, 2020, and has an accumulated deficit of $216,275 as of the same date[40] Clinical Trials and Product Development - DKN-01 is currently being studied in multiple clinical trials for esophagogastric cancer, hepatobiliary cancer, gynecologic cancers, and prostate cancer[142] - DKN-01 received Fast Track designation from the FDA for treating gastric and gastroesophageal junction adenocarcinoma, facilitating expedited development and review[142] - The ongoing COVID-19 pandemic may adversely affect the company's ability to conduct clinical trials for its lead product candidate, DKN-01, due to operational disruptions[201]

[PART I — FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=6&type=section&id=Item%201%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements and notes for the periods ended June 30, 2020 [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) The balance sheet reflects a significant increase in cash and total assets from financing activities, a decrease in liabilities, and a shift in stockholders' equity from a deficit to a positive balance Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2020 | December 31, 2019 | Change | % Change | | :-------------------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | $64,887 | $3,891 | $60,996 | 1567.6% | | Total current assets | $65,280 | $4,241 | $61,039 | 1439.3% | | Total assets | $67,673 | $7,448 | $60,225 | 808.6% | | Total current liabilities | $6,836 | $8,486 | $(1,650) | -19.4% | | Total liabilities | $7,940 | $9,197 | $(1,257) | -13.7% | | Total stockholders' equity (deficiency) | $59,733 | $(1,749) | $61,482 | N/A | [Condensed Consolidated Statements of Operations](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) The company reported its first license revenue and a decreased net loss for the period, driven by lower research and development expenses Condensed Consolidated Statements of Operations Highlights (in thousands, except per share) | Metric | 3 Months Ended June 30, 2020 | 3 Months Ended June 30, 2019 | Change | % Change | 6 Months Ended June 30, 2020 | 6 Months Ended June 30, 2019 | Change | % Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :----- | :------- | :--------------------------- | :--------------------------- | :----- | :------- | | License revenue | $375 | $- | $375 | N/A | $750 | $- | $750 | N/A | | Research and development | $5,350 | $6,136 | $(786) | -12.8% | $9,953 | $12,926 | $(2,973) | -23.0% | | General and administrative | $2,521 | $2,325 | $196 | 8.4% | $4,674 | $4,330 | $344 | 7.9% | | Total operating expenses | $7,871 | $8,461 | $(590) | -7.0% | $14,627 | $17,256 | $(2,629) | -15.2% | | Net loss | $(6,516) | $(8,366) | $1,850 | -22.1% | $(13,747) | $(16,969) | $3,222 | -19.0% | | Net loss per share (Basic & Diluted) | $(0.12) | $(0.37) | $0.25 | -67.6% | $(0.57) | $(0.82) | $0.25 | -30.5% | [Condensed Consolidated Statements of Comprehensive Loss](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20LOSS) Comprehensive loss was primarily driven by net loss, with additional impact from foreign currency translation adjustments Condensed Consolidated Statements of Comprehensive Loss Highlights (in thousands) | Metric | 3 Months Ended June 30, 2020 | 3 Months Ended June 30, 2019 | Change | 6 Months Ended June 30, 2020 | 6 Months Ended June 30, 2019 | Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :----- | :--------------------------- | :--------------------------- | :----- | | Net loss | $(6,516) | $(8,366) | $1,850 | $(13,747) | $(16,969) | $3,222 | | Foreign currency translation adjustments | $(867) | $44 | $(911) | $45 | $20 | $25 | | Comprehensive loss | $(7,383) | $(8,322) | $939 | $(13,702) | $(16,949) | $3,247 | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20STOCKHOLDERS'%20EQUITY) Stockholders' equity increased significantly due to substantial proceeds from public offerings and private placements of stock Condensed Consolidated Statements of Stockholders' Equity Highlights (in thousands, except shares) | Metric | June 30, 2020 | December 31, 2019 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Common Stock Shares Outstanding | 59,657,742 | 24,194,877 | 35,462,865 | | Common Stock Amount | $60 | $24 | $36 | | Additional Paid-in Capital | $268,770 | $193,319 | $75,451 | | Accumulated Deficit | $(209,218) | $(195,168) | $(14,050) | | Total Stockholders' Equity (Deficiency) | $59,733 | $(1,749) | $61,482 | - Major equity transactions during the six months ended June 30, 2020, include[29](index=29&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk)[116](index=116&type=chunk)[117](index=117&type=chunk): * Proceeds from June 2020 Public Offering: **$48,276 thousand** (net of issuance costs) * Issuance of Series A & B Convertible Preferred Stock: **$25,322 thousand** (net of underwriting discounts) * Conversion of Series B Preferred Stock to common stock: **11,531,133 shares** * Dividend attributable to down round feature of 2017 Warrants: **$303 thousand** * Beneficial conversion feature from Series A & B convertible preferred stock: **$9,399 thousand** recognized as a dividend [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) A significant net increase in cash was driven by substantial financing activities that offset cash used in operations Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | 6 Months Ended June 30, 2020 | 6 Months Ended June 30, 2019 | Change | | :-------------------------------- | :--------------------------- | :--------------------------- | :----- | | Net cash used in operating activities | $(13,377) | $(14,051) | $674 | | Net cash provided by (used) in investing activities | $25 | $(100) | $125 | | Net cash provided by financing activities | $74,382 | $13,582 | $60,800 | | Net increase (decrease) in cash and cash equivalents | $60,996 | $(537) | $61,533 | | Cash and cash equivalents at end of period | $64,887 | $15,747 | $49,140 | - Key financing activities for the six months ended June 30, 2020, included[189](index=189&type=chunk): * **$48.5 million** from the June 2020 Public Offering * **$27.0 million** from the issuance of Series A and B Preferred Stock in the January 2020 Private Placement * **$0.4 million** from the exercise of common stock warrants and stock options [Notes to Condensed Consolidated Financial Statements](index=13&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) These notes provide detailed explanations of the company's business, accounting policies, and specific financial transactions [1. Nature of Business, Basis of Presentation and Liquidity](index=13&type=section&id=1.%20Nature%20of%20Business%2C%20Basis%20of%20Presentation%20and%20Liquidity) Leap Therapeutics is a biopharmaceutical company developing novel cancer therapeutics and has sufficient cash to fund operations for at least the next 12 months - Leap Therapeutics is a biopharmaceutical company focused on acquiring and developing novel therapeutics at the leading edge of cancer biology, targeting tumor-promoting and immuno-oncology pathways[36](index=36&type=chunk) - As of June 30, 2020, the company had an **accumulated deficit of $209.2 million** and incurred a **net loss of $13.7 million** for the six months ended June 30, 2020[40](index=40&type=chunk) - The company believes its **cash and cash equivalents of $64.9 million** as of June 30, 2020, will be sufficient to fund operating expenses for at least the next 12 months from the issuance date of these financial statements[40](index=40&type=chunk) [2. Summary of Significant Accounting Policies](index=14&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines key accounting policies, including consolidation, use of estimates, R&D incentives, foreign currency, warrants, fair value, leases, and revenue recognition - The company recognizes other income from Australian research and development incentives when there is reasonable assurance of receipt, with a **refundable tax offset of 43.5%** for the periods presented[43](index=43&type=chunk)[45](index=45&type=chunk) - The company adopted ASU 2017-11 on January 1, 2019, reclassifying 2017 Warrants from liability to equity and prospectively recognizing the effect of **down round features as a dividend**[53](index=53&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) - The company adopted ASU 2016-02 on January 1, 2019, recognizing **right-of-use assets and lease liabilities** on the balance sheet for operating leases with terms greater than one year[60](index=60&type=chunk)[63](index=63&type=chunk) - Revenue is recognized under ASC Topic 606 when the customer obtains control of promised goods or services, with **upfront payments amortized over the performance period**[64](index=64&type=chunk)[66](index=66&type=chunk) [3. BeiGene Exclusive Option and License Agreement](index=21&type=section&id=3.%20BeiGene%20Exclusive%20Option%20and%20License%20Agreement) The company entered an exclusive option and license agreement with BeiGene, Ltd for DKN-01, recognizing initial license revenue in 2020 - Leap Therapeutics entered into an exclusive option and license agreement with BeiGene, Ltd on January 3, 2020, for DKN-01 development and commercialization in Asia (excluding Japan), Australia, and New Zealand[78](index=78&type=chunk) - The agreement included an **upfront cash payment of $3.0 million** and potential future option exercise and milestone payments of **up to $132.0 million**, plus tiered royalties on product sales[79](index=79&type=chunk) License Revenue and Contract Liabilities (in thousands) | Metric | 3 Months Ended June 30, 2020 | 6 Months Ended June 30, 2020 | Balance at June 30, 2020 | | :-------------------------------- | :--------------------------- | :--------------------------- | :----------------------- | | License Revenue | $375 | $750 | N/A | | Deferred revenue - current | N/A | N/A | $1,500 | | Deferred revenue - non current | N/A | N/A | $750 | | Total contract liabilities | N/A | N/A | $2,250 | [4. Accrued Expenses](index=22&type=section&id=4.%20Accrued%20Expenses) Accrued expenses decreased primarily due to reductions in clinical trial accruals, professional fees, and payroll-related expenses Accrued Expenses (in thousands) | Category | June 30, 2020 | December 31, 2019 | Change | | :-------------------- | :------------ | :---------------- | :----- | | Clinical trials | $1,539 | $1,828 | $(289) | | Professional fees | $110 | $609 | $(499) | | Payroll and related expenses | $583 | $1,004 | $(421) | | Total Accrued Expenses | $2,232 | $3,441 | $(1,209) | [5. Leases](index=23&type=section&id=5.%20Leases) The company recognized right-of-use assets and lease liabilities for its operating leases following the adoption of ASU 2016-02 - As of June 30, 2020, the company recorded a **right-of-use asset of $711 thousand** and a **lease liability of $742 thousand** on its consolidated balance sheets[91](index=91&type=chunk) Future Operating Lease Payments (in thousands) | Year | Amount | | :--- | :----- | | 2020 | $214 | | 2021 | $434 | | 2022 | $146 | | Total Lease Payments | $794 | | Less: imputed interest | $(52) | | Total operating lease liabilities | $742 | [6. Warrants](index=24&type=section&id=6.%20Warrants) The company has various outstanding warrants classified as equity, with a down round feature triggering a dividend in 2020 Outstanding Warrants as of June 30, 2020 | Date Exercisable | Number of Shares Issuable | Exercise Price | | :--------------- | :------------------------ | :------------- | | 1/23/2017 | 54,516 | $0.01 | | 11/14/2017 | 2,549,840 | $1.055 | | 2/5/2019 | 7,491,442 | $1.95 | | 3/5/2020 | 14,413,902 | $0.001 | | 3/5/2020 | 25,945,035 | $2.11 | | 6/22/2020 | 2,250,000 | $0.001 | | Total | 52,704,735 | | - In connection with the January 2020 Private Placement, the 2017 Warrants were repriced from $1.75 to $1.055, resulting in a **$303 thousand dividend** recorded during the six months ended June 30, 2020[98](index=98&type=chunk) - During the six months ended June 30, 2020, 208,254 of 2017 Warrants were exercised for **$220 thousand in gross proceeds**, and 65,700 of 2019 Warrants were exercised for **$128 thousand**[99](index=99&type=chunk)[100](index=100&type=chunk) [7. Common Stock](index=26&type=section&id=7.%20Common%20Stock) Common stock outstanding increased significantly due to public offerings and private placements that raised substantial net proceeds - In January 2020, the company completed a private placement of Series A and B Preferred Stock, generating approximately **$25.3 million in net proceeds**[111](index=111&type=chunk) - In March 2020, Series A Preferred Stock converted to pre-funded warrants (14,413,902 shares at $0.001 exercise price), and Series B Preferred Stock converted to **11,531,133 shares of common stock**[102](index=102&type=chunk)[103](index=103&type=chunk)[112](index=112&type=chunk) - In June 2020, the company completed a public offering, issuing 20,250,000 shares of common stock and 2,250,000 pre-funded warrants, generating approximately **$48.3 million in net proceeds**[116](index=116&type=chunk)[117](index=117&type=chunk) [8. Equity Incentive Plans](index=28&type=section&id=8.%20Equity%20Incentive%20Plans) The company operates under two equity incentive plans, with details on stock option activity and related compensation expenses provided Stock Option Activity (Six Months Ended June 30, 2020) | Metric | Options | Weighted Average Exercise Price Per Share | | :-------------------------------- | :------ | :-------------------------------------- | | Outstanding at December 31, 2019 | 4,024,566 | $7.48 | | Granted | 1,750,000 | $2.18 | | Exercised | (32,778) | $1.53 | | Forfeited | (260,157) | $6.96 | | Outstanding at June 30, 2020 | 5,481,631 | $5.85 | | Options exercisable at June 30, 2020 | 2,791,017 | $9.12 | Stock-Based Compensation Expense (in thousands) | Category | 3 Months Ended June 30, 2020 | 3 Months Ended June 30, 2019 | 6 Months Ended June 30, 2020 | 6 Months Ended June 30, 2019 | | :-------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $249 | $179 | $438 | $355 | | General and administrative | $290 | $720 | $658 | $1,491 | | Total | $539 | $899 | $1,096 | $1,846 | - During the six months ended June 30, 2020, the company granted **660,606 Restricted Stock Units (RSUs)** to an executive officer, which will cliff vest after three years or upon a change of control[126](index=126&type=chunk)[127](index=127&type=chunk) [9. Net Loss Per Share](index=29&type=section&id=9.%20Net%20Loss%20Per%20Share) Net loss per share improved year-over-year due to a lower net loss and a higher number of weighted average common shares outstanding Net Loss Per Share Attributable to Common Stockholders (in thousands, except per share) | Metric | 3 Months Ended June 30, 2020 | 3 Months Ended June 30, 2019 | 6 Months Ended June 30, 2020 | 6 Months Ended June 30, 2019 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss attributable to common stockholders | $(6,516) | $(8,366) | $(23,821) | $(17,328) | | Weighted average common shares outstanding | 52,442,597 | 22,906,025 | 42,037,405 | 21,081,869 | | Net loss per share (Basic & Diluted) | $(0.12) | $(0.37) | $(0.57) | $(0.82) | Anti-Dilutive Securities Excluded from EPS Calculation | Security Type | 3 Months Ended June 30, 2020 | 3 Months Ended June 30, 2019 | 6 Months Ended June 30, 2020 | 6 Months Ended June 30, 2019 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Restricted stock units | 660,606 | - | 660,606 | - | | Options to purchase common stock | 5,481,631 | 4,058,962 | 5,481,631 | 4,058,962 | | Warrants to purchase common stock | 36,040,833 | 10,369,752 | 36,040,833 | 10,369,752 | | Total | 42,183,070 | 14,428,714 | 42,183,070 | 14,428,714 | [10. Commitments and Contingencies](index=32&type=section&id=10.%20Commitments%20and%20Contingencies) The company has manufacturing commitments for DKN-01, potential future royalty payments, and is involved in ongoing patent opposition proceedings in Europe - As of June 30, 2020, the company had **$794 thousand in noncancelable commitments** under manufacturing agreements for DKN-01[135](index=135&type=chunk) - The company has license agreements with Eli Lilly and Company and Lonza Sales AG, which stipulate **low single-digit royalty payments** on net sales of developed products, if and when achieved[136](index=136&type=chunk)[137](index=137&type=chunk) - The company is appealing decisions from the European Patent Office (EPO) regarding patent oppositions for its TRX518 antibody, with hearings scheduled for September 2020 for one appeal and another pending scheduling[139](index=139&type=chunk)[140](index=140&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition, results of operations, liquidity, and critical accounting policies [Company Overview](index=33&type=section&id=Company%20Overview) Leap Therapeutics is a biopharmaceutical company developing novel cancer therapies with two clinical-stage programs, DKN-01 and TRX518 - Leap Therapeutics is a biopharmaceutical company developing novel therapies to treat cancer by inhibiting tumor-promoting pathways and harnessing the immune system[143](index=143&type=chunk) - The company's two clinical-stage programs are **DKN-01**, a monoclonal antibody inhibiting DKK1 for various cancers, and **TRX518**, a monoclonal antibody targeting GITR to enhance anti-tumor immune response[144](index=144&type=chunk) [Recent Developments](index=33&type=section&id=Recent%20Developments) The company advanced DKN-01 development, completed a public offering, and deprioritized the development of TRX518 - DKN-01 development progress includes ongoing clinical trials in esophagogastric, hepatobiliary, gynecologic, and prostate cancers, and an exclusive option and license agreement with BeiGene, Ltd[144](index=144&type=chunk) - Updated clinical data for DKN-01 in gynecologic cancers showed an **overall response rate (ORR) of 10%** and **disease control rate (DCR) of 50%** in endometrial cancer patients with Wnt signaling alteration[144](index=144&type=chunk) - The U.S. FDA granted **Orphan Drug Designation** for DKN-01 for the treatment of gastric and gastroesophageal junction cancer, providing benefits like market exclusivity and tax credits[145](index=145&type=chunk) - The company completed a **$51.75 million public offering** of common stock and pre-funded warrants in June 2020[144](index=144&type=chunk) - TRX518 development has been **deprioritized** as of November 2019[144](index=144&type=chunk) [Financial Overview](index=35&type=section&id=Financial%20Overview) Revenues are primarily from the BeiGene Agreement, while research and development expenses are expected to increase as DKN-01 development continues - Revenues are derived from performance obligations under the BeiGene Agreement, recognized using a proportional performance model over the service period[146](index=146&type=chunk) - Research and development expenses include costs for nonclinical studies, clinical trials, manufacturing, regulatory filings, and personnel, and are **expected to increase** with DKN-01 development[148](index=148&type=chunk) Research and Development Expenses by Program (in thousands) | Program | 3 Months Ended June 30, 2020 | 3 Months Ended June 30, 2019 | Change | 6 Months Ended June 30, 2020 | 6 Months Ended June 30, 2019 | Change | | :-------------------- | :--------------------------- | :--------------------------- | :----- | :--------------------------- | :--------------------------- | :----- | | DKN-01 program | $4,555 | $3,247 | $1,308 | $7,998 | $8,622 | $(624) | | TRX518 program | $795 | $2,889 | $(2,094) | $1,955 | $4,304 | $(2,349) | | Total R&D expenses | $5,350 | $6,136 | $(786) | $9,953 | $12,926 | $(2,973) | | Australian R&D incentives | $30 | $61 | $(31) | $115 | $136 | $(21) | [General and Administrative Expenses](index=38&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses consist of salaries, stock-based compensation, and professional fees, and are expected to increase - General and administrative expenses primarily include salaries, stock-based compensation for executive, finance, and administrative functions, as well as legal, patent, consulting, accounting, and audit services[155](index=155&type=chunk) - The company anticipates **increased general and administrative expenses** due to higher headcount for research activities and increased costs associated with being a public company[156](index=156&type=chunk) [Interest income](index=38&type=section&id=Interest%20income) Interest income is generated from the company's cash and cash equivalents - Interest income consists primarily of interest earned on cash and cash equivalents[157](index=157&type=chunk) [Research and development incentive income](index=38&type=section&id=Research%20and%20development%20incentive%20income) The company receives incentive income from the Australian government's R&D Incentive program for eligible research activities - Research and development incentive income is derived from the Australian government's R&D Incentive program, which offers a tax offset for eligible R&D activities[158](index=158&type=chunk) - Eligible companies with an aggregated turnover of less than A$20 million per annum can receive a **43.5% refundable tax offset**[164](index=164&type=chunk) [Foreign currency translation adjustment](index=38&type=section&id=Foreign%20currency%20translation%20adjustment) Foreign currency translation adjustments reflect gains or losses from revaluing foreign currency transactions of the Australian subsidiary - Foreign currency translation adjustments consist of gains (losses) due to the revaluation of foreign currency transactions associated with the Australian subsidiary, attributable to changes in foreign currency exchange rates[160](index=160&type=chunk) [Critical Accounting Policies and Estimates](index=38&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) The company's critical accounting policies involve significant judgment, particularly in revenue recognition, accrued R&D expenses, and stock-based compensation - Critical accounting policies requiring significant judgment and complexity include **revenue recognition, accrued research and development expenses, research and development incentive receivable, and stock-based compensation**[166](index=166&type=chunk) - The company adopted ASU 2017-11 (Earnings Per Share, Distinguishing Liabilities from Equity, and Derivatives and Hedging) and ASU 2016-02 (Leases) on January 1, 2019[162](index=162&type=chunk) - Revenue recognition under ASC Topic 606 involves a five-step model, requiring key assumptions to determine stand-alone selling prices for performance obligations[163](index=163&type=chunk)[165](index=165&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) The company recognized its first license revenue and saw decreased net losses, driven by reduced R&D expenses for the TRX518 program [Comparison of the Three Months Ended June 30, 2020 and 2019](index=40&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202020%20and%202019) Net loss decreased by $1.9 million due to new license revenue and a $0.6 million reduction in operating expenses Results of Operations (Three Months Ended June 30, in thousands) | Metric | 2020 | 2019 | Change | | :-------------------------------- | :--- | :--- | :----- | | License revenue | $375 | $- | $375 | | Research and development | $5,350 | $6,136 | $(786) | | General and administrative | $2,521 | $2,325 | $196 | | Total operating expenses | $7,871 | $8,461 | $(590) | | Net loss | $(6,516) | $(8,366) | $1,850 | - The decrease in R&D expenses by **$0.7 million** was primarily due to a **$0.9 million decrease** in clinical trial costs, partially offset by a $0.2 million increase in consulting fees[170](index=170&type=chunk) - General and administrative expenses increased by **$0.2 million**, driven by higher legal, audit, and consulting fees ($0.3 million) and payroll ($0.2 million), partially offset by a $0.3 million decrease in stock-based compensation[171](index=171&type=chunk) [Comparison of the Six Months Ended June 30, 2020 and 2019](index=41&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202020%20and%202019) Net loss decreased by $3.2 million, driven by new license revenue and a $2.6 million reduction in operating expenses Results of Operations (Six Months Ended June 30, in thousands) | Metric | 2020 | 2019 | Change | | :-------------------------------- | :--- | :--- | :----- | | License revenue | $750 | $- | $750 | | Research and development | $9,953 | $12,926 | $(2,973) | | General and administrative | $4,674 | $4,330 | $344 | | Total operating expenses | $14,627 | $17,256 | $(2,629) | | Net loss | $(13,747) | $(16,969) | $3,222 | - The **$2.9 million decrease** in R&D expenses was primarily due to a **$2.7 million decrease** in clinical trial costs and a $0.4 million decrease in consulting fees[178](index=178&type=chunk) - General and administrative expenses increased by **$0.4 million**, mainly due to a **$0.6 million increase** in payroll and related expenses and a $0.5 million increase in legal, audit, and consulting fees[179](index=179&type=chunk) [Financial Position, Liquidity and Capital Resources](index=43&type=section&id=Financial%20Position%2C%20Liquidity%20and%20Capital%20Resources) The company's cash position significantly increased from financing activities, providing sufficient capital to fund operations for at least the next 12 months - As of June 30, 2020, the company had an **accumulated deficit of $209.2 million** and incurred a **net loss of $13.7 million** for the six months ended June 30, 2020[184](index=184&type=chunk) - Cash and cash equivalents totaled **$64.9 million** as of June 30, 2020, an increase of **$61.0 million** from December 31, 2019[17](index=17&type=chunk)[184](index=184&type=chunk) - Net cash provided by financing activities for the six months ended June 30, 2020, was **$74.4 million**, primarily from public offerings and private placements of stock[189](index=189&type=chunk) [Off-Balance Sheet Arrangements](index=45&type=section&id=Off-Balance%20Sheet%20Arrangements) The company did not have any off-balance sheet arrangements - The company did not have any off-balance sheet arrangements during the periods presented and does not currently have any[191](index=191&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not applicable to the company [Item 4. Controls and Procedures](index=45&type=section&id=Item%204%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=45&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) The company's management concluded that its disclosure controls and procedures were effective as of June 30, 2020 - As of June 30, 2020, management, with the participation of the Chief Executive Officer and Chief Financial Officer, concluded that the company's **disclosure controls and procedures were effective**[194](index=194&type=chunk) [Changes in Internal Control over Financial Reporting](index=46&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in internal control over financial reporting occurred during the six months ended June 30, 2020 - During the six months ended June 30, 2020, there were **no changes in internal control over financial reporting** that materially affected, or are reasonably likely to affect, internal control over financial reporting[195](index=195&type=chunk) [PART II — OTHER INFORMATION](index=47&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=47&type=section&id=Item%201%20Legal%20Proceedings) The company is involved in ongoing patent opposition proceedings before the European Patent Office concerning its TRX518 antibody - The company has filed an appeal of the EPO Opposition Division's decision regarding a TRX518 patent, seeking broader claims, with a hearing scheduled for September 2020[139](index=139&type=chunk) - Another patent covering TRX518 in combination with chemotherapy was revoked by the EPO Opposition Division, and the company has filed an appeal seeking a reversal of this decision[140](index=140&type=chunk) [Item 1A. Risk Factors](index=47&type=section&id=Item%201A%20Risk%20Factors) The company highlights the material adverse impact of the COVID-19 pandemic on its business and clinical development of DKN-01 - The ongoing **COVID-19 outbreak could materially adversely impact** the company's business and operations, including the development of its lead product candidate, DKN-01[201](index=201&type=chunk) - Potential disruptions include **delays in initiating, conducting, and completing clinical trials** and laboratory operations due to remote work, facility closures, travel restrictions, and reduced capacity of third-party collaborators[201](index=201&type=chunk) - The ultimate extent of COVID-19's impact remains **highly uncertain** and depends on future developments such as the virus's spread, severity, duration, and effectiveness of containment measures[202](index=202&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report [Item 3. Defaults Upon Senior Securities](index=47&type=section&id=Item%203%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report [Item 4. Mine Safety Disclosures](index=47&type=section&id=Item%204%20Mine%20Safety%20Disclosures) There were no mine safety disclosures to report [Item 5. Other Information](index=47&type=section&id=Item%205%20Other%20Information) The company received and subsequently canceled and repaid a promissory note under the Paycheck Protection Program - On April 23, 2020, the company received a **$662,420 unsecured promissory note** under the Paycheck Protection Program (PPP)[206](index=206&type=chunk) - The company decided to cancel the PPP Note and **fully repaid the entire principal amount** to Silicon Valley Bank on April 28, 2020[206](index=206&type=chunk)[207](index=207&type=chunk) [Item 6. Exhibits](index=48&type=section&id=Item%206%20Exhibits) This section lists the exhibits filed with the Quarterly Report, including warrants, agreements, certifications, and XBRL formatted financials - Exhibits include Form of Pre-Funded Warrant to Purchase Common Stock, Employment Agreement, Certifications of CEO and CFO, and XBRL formatted financial statements[210](index=210&type=chunk)[212](index=212&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37990 LEAP THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) State or other jurisdiction of (I.R.S. Empl ...

Use these links to rapidly review the document TABLE OF CONTENTS PART IV INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ý ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37990 LEAP THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 27-4412575 S ...

PART I — FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Unaudited financial statements as of June 30, 2019, report a $17.0 million net loss for H1 2019, $15.7 million cash, and substantial doubt about going concern [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2019, total assets were $20.1 million, with $15.7 million in cash, and total stockholders' equity at $10.9 million Condensed Consolidated Balance Sheet Data (in thousands) | Account | June 30, 2019 (Unaudited) | December 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $15,747 | $16,284 | | Total current assets | $16,794 | $17,322 | | Total assets | $20,137 | $19,074 | | Total current liabilities | $8,456 | $6,451 | | Total liabilities | $9,198 | $9,899 | | Total stockholders' equity | $10,939 | $9,175 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss for Q2 2019 increased to $8.4 million, while H1 2019 net loss decreased to $17.0 million due to non-recurring warrant liability loss in prior year Operating Results (in thousands, except per share data) | Metric | Q2 2019 | Q2 2018 | H1 2019 | H1 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $6,136 | $4,234 | $12,926 | $8,465 | | General and administrative | $2,325 | $2,603 | $4,330 | $4,716 | | Loss from operations | $(8,461) | $(6,837) | $(17,256) | $(13,181) | | Net loss | $(8,366) | $(7,364) | $(16,969) | $(17,986) | | Net loss per share | $(0.37) | $(0.50) | $(0.82) | $(1.32) | [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $14.1 million in H1 2019, with financing activities providing $13.6 million Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,051) | $(11,531) | | Net cash used in investing activities | $(100) | $0 | | Net cash provided by financing activities | $13,582 | $16,013 | | Net (decrease) increase in cash | $(537) | $4,744 | [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's pre-revenue status, going concern doubt, adoption of new lease and financial instrument accounting standards, and recent financing activities - The company is a biopharmaceutical firm focused on developing cancer therapeutics and has not yet generated any revenue or achieved profitable operations[39](index=39&type=chunk)[42](index=42&type=chunk) - Management has concluded that **substantial doubt exists** about the company's ability to continue as a going concern for one year, given its need for additional capital to fund operations[44](index=44&type=chunk) - On January 1, 2019, the company adopted ASU 2017-11, reclassifying its **$3.448 million** 2017 Warrant liability to additional paid-in capital[58](index=58&type=chunk)[87](index=87&type=chunk) - The company adopted new lease accounting standard ASU 2016-02 on January 1, 2019, recording a right-of-use asset of **$1.755 million** and a lease liability of **$1.720 million**[83](index=83&type=chunk) - In February 2019, the company completed a public offering, raising net proceeds of approximately **$12.1 million**[93](index=93&type=chunk) - Subsequent to the quarter end, in July 2019, the company entered into an agreement with Lincoln Park Capital for the right to sell up to **$20.0 million** in common stock and completed an initial sale of **$1.0 million**[117](index=117&type=chunk)[118](index=118&type=chunk) - The company is involved in patent opposition proceedings at the European Patent Office (EPO) regarding its TRX518 antibody patents[110](index=110&type=chunk)[112](index=112&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased R&D expenses, critical liquidity with $15.7 million cash, and substantial doubt about going concern, mitigated by a $20 million equity commitment [Company Overview and Recent Developments](index=29&type=section&id=Company%20Overview%20and%20Recent%20Developments) The company focuses on developing DKN-01 and TRX518, with recent positive clinical data for DKN-01 and a new $21 million equity commitment facility - Presented positive data for DKN-01 in combination with KEYTRUDA for esophagogastric cancer, showing a **50% overall response rate** and **31.6 weeks median overall survival** in DKK1-high patients[124](index=124&type=chunk) - Initiated a clinical trial evaluating TRX518 in a triple combination with cyclophosphamide chemotherapy and BAVENCIO (avelumab)[125](index=125&type=chunk) - Entered into a purchase agreement with Lincoln Park Capital for an initial **$1 million** stock purchase and the option to sell up to an additional **$20 million** in common stock[127](index=127&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) R&D expenses increased to $6.1 million in Q2 2019 and $12.9 million in H1 2019, while H1 net loss decreased to $17.0 million due to non-recurring items R&D Expenses by Program (in thousands) | Program | Q2 2019 | Q2 2018 | H1 2019 | H1 2018 | | :--- | :--- | :--- | :--- | :--- | | DKN-01 program | $3,247 | $3,652 | $8,622 | $6,845 | | TRX518 program | $2,889 | $582 | $4,304 | $1,620 | | **Total R&D Expenses** | **$6,136** | **$4,234** | **$12,926** | **$8,465** | - The increase in R&D expenses for H1 2019 was primarily due to a **$4.7 million** increase in clinical trial costs from higher patient enrollment, partially offset by a **$1.2 million** decrease in manufacturing costs[156](index=156&type=chunk) - General and administrative expenses for H1 2019 decreased by **$0.4 million** compared to H1 2018, mainly due to lower bonus expense and reduced legal and consulting fees[158](index=158&type=chunk) [Financial Position, Liquidity and Capital Resources](index=38&type=section&id=Financial%20Position%2C%20Liquidity%20and%20Capital%20Resources) The company ended Q2 2019 with $15.7 million cash, faces substantial doubt about going concern, and relies on a July 2019 Lincoln Park agreement for future capital - As of June 30, 2019, the company had cash and cash equivalents of **$15.7 million**[166](index=166&type=chunk) - Due to the need for additional capital and uncertainties in raising it, management determined there is **substantial doubt** about the company's ability to continue as a going concern[166](index=166&type=chunk)[188](index=188&type=chunk) - In July 2019, the company secured access to up to **$20.0 million** in capital through a purchase agreement with Lincoln Park[167](index=167&type=chunk) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Cash used in operating activities | $(14,051) | $(11,531) | | Cash provided by financing activities | $13,582 | $16,013 | [Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable for the reporting period - Not Applicable[177](index=177&type=chunk) [Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2019, with no material changes in internal control - The Principal Executive Officer and Principal Financial Officer concluded that as of June 30, 2019, the company's disclosure controls and procedures were effective[179](index=179&type=chunk) - There were no changes in internal control over financial reporting during the quarter that materially affected, or are reasonably likely to affect, internal control[180](index=180&type=chunk) PART II — OTHER INFORMATION [Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings for the period - None[182](index=182&type=chunk) [Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including substantial financial losses, a $17.0 million net loss for H1 2019, and substantial doubt about its ability to continue as a going concern - The company has a history of significant losses, reporting a net loss of **$17.0 million** for the six months ended June 30, 2019, and an accumulated deficit of **$179.2 million**[186](index=186&type=chunk) - Management has concluded that **substantial doubt exists** as to the company's ability to continue as a going concern due to its need for additional capital[188](index=188&type=chunk) - The company will require substantial additional capital to fund operations and advance its clinical programs; failure to obtain this financing could force delays or elimination of R&D programs[191](index=191&type=chunk) - Raising additional capital may cause significant dilution to existing stockholders or require the company to relinquish valuable rights to its product candidates[193](index=193&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=43&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities for the period - None[194](index=194&type=chunk) [Other Information](index=45&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - None[197](index=197&type=chunk) [Exhibits](index=45&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including officer certifications and XBRL data files - The Exhibit Index lists certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1) and the company's financial statements formatted in XBRL (Exhibit 101)[198](index=198&type=chunk)[201](index=201&type=chunk)

Financial Performance - Net loss for Q1 2019 was $8,603,000, an improvement of 18.9% compared to a net loss of $10,622,000 in Q1 2018[25]. - For the three months ended March 31, 2019, the company reported a net loss of $8.6 million, increasing the accumulated deficit to $170.9 million[166]. - The basic and diluted net loss per share for the three months ended March 31, 2019, was $(0.47), compared to $(0.85) for the same period in 2018, indicating a 44.7% reduction in loss per share[99]. - The company incurred a net loss of $23.1 million for the year ended December 31, 2018, reflecting ongoing financial challenges[166]. - The company expects significant increases in expenses as it advances clinical trials and preclinical activities for its product candidates[147]. - The company anticipates continued significant operating losses as it advances the clinical development of its product candidates DKN-01 and TRX518[167]. - Management has expressed substantial doubt regarding the company's ability to continue as a going concern due to the need for additional capital[168]. Assets and Equity - Total current assets increased to $22,712,000 as of March 31, 2019, up from $17,322,000 as of December 31, 2018, representing a growth of 31.8%[19]. - Total stockholders' equity increased to $17,064,000 as of March 31, 2019, compared to $9,175,000 as of December 31, 2018, reflecting an increase of 85.8%[19]. - Cash and cash equivalents at the end of Q1 2019 were $21,709,000, a decrease of 38.5% from $35,376,000 at the end of Q1 2018[31]. - The company had cash and cash equivalents of $21.7 million as of March 31, 2019, indicating a need for additional capital to fund operations[170]. - The accumulated deficit as of March 31, 2019, was $(170,871,000), compared to $(153,535,000) as of December 31, 2018, reflecting an increase in the deficit of 11.3%[19]. Research and Development - Research and development expenses for Q1 2019 were $6,790,000, a 60.3% increase compared to $4,231,000 in Q1 2018[21]. - The DKN-01 program accounted for $5.375 million in research and development expenses, up from $3.193 million in 2018, a 68% increase[135]. - The company plans to increase research and development expenses to support the ongoing development of DKN-01 and TRX518, subject to funding availability[118]. - Research and development expenses increased to $6.79 million for the three months ended March 31, 2019, compared to $4.23 million in the same period of 2018, representing a 61% increase[135]. - The company recorded Australian research and development incentive income of $75,000 in Q1 2019, down from $646,000 in Q1 2018, a decrease of 88%[139]. - The percentage of eligible research and development expenses reimbursed under the Australian incentive program was 43.5% for both the year ended December 31, 2018, and the three months ended March 31, 2019[46]. Capital Raising and Financing - The company raised $12,331,000 from the issuance of common stock in Q1 2019, compared to $15,033,000 in Q1 2018, showing a decrease of 17.9%[31]. - The Company completed a public offering on February 5, 2019, issuing 7,557,142 shares at $1.75 per share, resulting in net proceeds of approximately $12,122,000[111]. - The company expects to seek additional capital through a combination of private and public equity offerings, debt financings, and strategic collaborations[172]. - The company plans to seek additional funding through public or private equity financings or government programs to support its operations and development programs[41]. Operational Activities - The company reported a net cash used in operating activities of $6,868,000 for Q1 2019, compared to $5,478,000 for Q1 2018, indicating a 25.3% increase in cash outflow[31]. - There were no investing activities reported during the three months ended March 31, 2019 and 2018[154]. - The company has not yet generated any revenues and continues to rely on raising capital for its operations[40]. - The company has incurred significant losses since its inception in 2011, with losses reported in every reporting period[166]. Clinical Trials and Product Development - DKN-01 is currently being studied in multiple ongoing clinical trials for various cancers, with significant clinical benefits reported in several patient populations[115]. - TRX518 is undergoing clinical trials in combination with gemcitabine chemotherapy and PD-1 antagonists, with positive responses observed in patients with advanced solid tumors[115]. - The company plans to pursue the clinical development of its advanced product candidates, DKN-01 and TRX518, and expand its intellectual property portfolio[151]. Expenses - General and administrative expenses for the three months ended March 31, 2019, were $771,000, compared to $611,000 in the same period of 2018, marking a 26.2% increase[98]. - General and administrative expenses decreased slightly to $2.005 million in Q1 2019 from $2.113 million in Q1 2018, a reduction of 5%[137]. - As of March 31, 2019, accrued expenses totaled $4,150,000, an increase from $2,872,000 as of December 31, 2018, with clinical trials accounting for $3,597,000[75].

.. . leaptherapeutics LEAP THERAPEUT Patient Number / Patienten Sponsor Trial Code / Drug name: DKN-01 for inte DKN-01 zur intravenösen Potency / Dosisstärke: 200 Sponsor/CRO: Universität Langenbeckstr. 1 5E4 . Company Overview| April 2019 Leap Therapeutics | | Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regardi ...

Use these links to rapidly review the document TABLE OF CONTENTS PART IV INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ý ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 Or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to (Exact name of registrant ...