BioXcel Therapeutics(US:BTAI)2020-08-14 13:44Financial Performance - The company reported a net loss of $36,330,000 for the six months ended June 30, 2020, compared to a net loss of $15,675,000 for the same period in 2019, indicating a 131% increase in losses [25]. - Net loss for the three months ended June 30, 2020 was $(21,419), an increase of $(12,948) or 153% compared to $(8,471) for the same period in 2019 [179]. - The company has not recognized any revenues since inception, indicating a need for significant product revenues to achieve profitability [188]. - The company expects to incur significant operating losses for the next several years as it expands clinical trials and seeks marketing approval for product candidates [214]. Assets and Liabilities - Total current assets increased to $68,313,000 as of June 30, 2020, compared to $34,107,000 as of December 31, 2019, representing a 100% increase [21]. - Total liabilities increased to $17,068,000 as of June 30, 2020, from $9,497,000 as of December 31, 2019, representing an 80% increase [21]. - The company’s total stockholders' equity rose to $53,394,000 as of June 30, 2020, compared to $26,895,000 at the end of 2019, a 98% increase [21]. - Cash and cash equivalents rose to $65,495,000 as of June 30, 2020, up from $32,426,000 at the end of 2019, reflecting a 102% increase [21]. Cash Flow and Financing - Net cash used in operating activities for the six months ended June 30, 2020, was $26,977,000, compared to $11,697,000 for the same period in 2019, indicating a 130% increase in cash outflow [36]. - Net cash provided by financing activities was $60,097,000 for the six months ended June 30, 2020, primarily from a February 2020 offering [212]. - The company raised $68,811,000 from the issuance of common stock during the six months ended June 30, 2020, compared to $230,000 in the same period of 2019 [36]. - The company received $537,000 under the Paycheck Protection Program but later decided to withdraw and repay the loan in full [205]. Research and Development - Research and development expenses for the six months ended June 30, 2020, were $30,277,000, compared to $12,180,000 for the same period in 2019, marking a 148% increase [25]. - The total research and development expenses for the year 2020 amounted to $30.3 million, a significant increase from $12.2 million in 2019 [172]. - Research and development expenses for the three months ended June 30, 2020 were $17,906, an increase of $11,400 or 175% compared to $6,506 for the same period in 2019 [179]. - The Company expenses research and development costs as incurred, with estimates subject to change as additional information becomes available [66]. Clinical Development - The company is focused on advancing its clinical development programs for BXCL501 and BXCL701, targeting neuropsychiatric disorders and certain cancers, respectively [38]. - BXCL501 demonstrated statistically significant reductions in the Positive and Negative Syndrome Scale (PEC) score at 120 minutes, with reductions of -10.3 for the 180 mcg dose in schizophrenia patients compared to -4.8 for placebo (p<0.0001) [143]. - The TRANQUILITY study for BXCL501 in geriatric dementia patients is expected to report topline results in mid-2020, with dose cohorts of 30 mcg, 60 mcg, and 90 mcg [148]. - BXCL701 is currently involved in three ongoing combination therapy clinical trials, including a Phase 2 trial with pembrolizumab for treatment emergent Neuroendocrine Prostate Cancer [160]. Stock and Equity - The weighted average shares outstanding increased to 20,293,216 for the six months ended June 30, 2020, from 15,668,588 for the same period in 2019 [24]. - The Company has authorized up to 50,000,000 shares of common stock, with 20,352,913 shares outstanding as of June 30, 2020, up from 18,087,382 shares at the end of 2019 [96]. - The fair value of options granted during the six months ended June 30, 2020 was estimated at $30,336, with an unrecognized compensation expense of $30,350 related to unvested awards [112]. - The company recognized stock-based compensation expense of $2,717 for the six months ended June 30, 2020, compared to $1,669 for the same period in 2019, reflecting a year-over-year increase of approximately 62.5% [111]. General and Administrative Expenses - General and administrative expenses are expected to increase as the company expands its clinical programs and prepares for potential product commercialization [174]. - General and administrative expenses for the three months ended June 30, 2020 were $3,529, an increase of $1,400 or 66% compared to $2,129 for the same period in 2019 [182]. - General and administrative expenses for the six months ended June 30, 2020 were $6,154, an increase of $2,280 or 59% compared to $3,874 for the same period in 2019 [193]. Impact of COVID-19 - The COVID-19 pandemic may significantly impact the Company's operations and financial condition, with potential delays in clinical studies and access to capital [92]. - The financial statements do not reflect any adjustments as a result of the COVID-19 pandemic, but there may be changes to current estimates in future periods [48]. - The company has not experienced significant delays in ongoing or planned clinical trials due to the COVID-19 pandemic, except for challenges in accessing elderly care facilities [136].