Revenue and Financial Performance - Revenue for the three months ended March 31, 2020, was $7,264,000, compared to $0 for the same period in 2019[19]. - The total comprehensive loss for Q1 2020 was $4,982,000, compared to $5,756,000 in Q1 2019, showing a 13% improvement[22]. - The company reported a net loss of $4.913 million for the three months ended March 31, 2020, compared to a net loss of $5.826 million for the same period in 2019, representing a decrease of approximately 15.7%[91]. - Basic and diluted net loss per share was $(0.16) for the three months ended March 31, 2020, compared to $(3.24) for the same period in 2019, indicating a significant improvement in loss per share[91]. - The net loss for the three months ended March 31, 2020, was $4.9 million, an improvement of $0.9 million compared to a net loss of $5.8 million in 2019[209]. - Interest income increased to $0.7 million for the three months ended March 31, 2020, compared to $0.1 million in 2019, reflecting an increase of $0.6 million[209]. Operating Expenses - Total operating expenses for Q1 2020 were $12,919,000, a 118% increase from $5,916,000 in Q1 2019[19]. - Research and development expenses for the three months ended March 31, 2020 totaled $6.67 million, a significant increase from $3.45 million in the same period in 2019[197]. - General and administrative expenses were $6.2 million for the three months ended March 31, 2020, compared to $2.5 million in 2019, an increase of $3.7 million[214]. - The company reported a stock-based compensation expense of $2,164,000 for Q1 2020, significantly higher than $49,000 in Q1 2019[27]. - FX-322 external development costs were $1.0 million for the three months ended March 31, 2020, compared to $0.8 million in 2019, an increase of $0.2 million[212]. - Platform development, early-stage research, and unallocated expenses rose to $5.6 million in Q1 2020, up from $2.6 million in Q1 2019, marking a $3.0 million increase[213]. Cash and Liquidity - Cash and cash equivalents increased to $203,090,000 as of March 31, 2020, from $200,158,000 at the end of 2019[16]. - Cash used in operating activities for Q1 2020 was $9,363,000, compared to $6,150,000 in Q1 2019, indicating a 52% increase in cash outflow[27]. - Total current liabilities decreased to $43,728,000 as of March 31, 2020, down from $52,780,000 at the end of 2019, a reduction of 17%[16]. - The company’s cash and cash equivalents at March 31, 2020, consist entirely of cash held in banks and money market funds[47]. Stock and Equity - Stockholders' equity as of March 31, 2020, was $164,849,000, compared to $167,358,000 at the end of 2019, reflecting a decrease of 1.5%[16]. - The weighted-average shares of common stock outstanding for Q1 2020 were 30,868,220, compared to 1,797,986 in Q1 2019, reflecting a significant increase in shares[19]. - As of March 31, 2020, the Company had 6,908,115 stock options outstanding, an increase from 5,968,672 as of December 31, 2019, indicating potential future dilution[110]. - The Company has authorized 200,000,000 shares of common stock, with 31,009,250 shares issued and outstanding as of March 31, 2020, reflecting ongoing equity management[107]. Research and Development - The company is focused on developing FX-322 for sensorineural hearing loss (SNHL), with a Phase 1/2 clinical trial showing statistically significant improvements in hearing measures among 23 patients[169]. - FX-322 demonstrated measurable concentrations in cochlear fluid in an exploratory study in Germany, with no serious treatment-related adverse events observed in seven patients[170]. - The company expects research and development expenses to continue to increase substantially as it completes the Phase 2a clinical trial for FX-322 and initiates additional clinical trials[197]. - The company has incurred recurring losses since its inception and has funded operations primarily through capital stock sales and collaboration agreements[36]. Collaboration and Agreements - The company completed its IPO on October 31, 2019, raising approximately $79.7 million in net proceeds from the sale of 6,325,000 shares at $14.00 per share[31]. - Astellas paid the Company an upfront payment of $80.0 million in July 2019, with potential development milestone payments up to $230.0 million and commercialization milestones of up to $315.0 million[141]. - The Company recognized revenue when customers obtain control of promised goods or services, following a five-step model under ASC Topic 606[73]. - The Astellas Agreement remains in effect until the expiration of all royalty obligations, which are paid on a licensed product-by-licensed product and country-by-country basis[142]. Risks and Uncertainties - The company expects to continue generating operating losses for the foreseeable future, with future viability dependent on raising additional capital[36]. - The company relies on a single manufacturer for its product candidates, which poses a risk of supply interruption[53]. - The COVID-19 pandemic has impacted clinical trial enrollment and operations, with some sites temporarily halting enrollment[169][174]. - The company has realized gains on investments and foreign exchange gains, but has not recorded any net tax benefit from cumulative net operating loss carryforwards due to uncertainty around utilizing these tax attributes[205][207].
Korro Bio(KRRO) - 2020 Q1 - Quarterly Report