Leap Therapeutics(LPTX) - 2019 Q1 - Quarterly Report

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].