Financial Performance - Total revenue for Q2 2020 was $746,000, a decrease of 34.6% compared to $1,142,000 in Q2 2019[5]. - Gross profit for Q2 2020 was $153,000, down 34.6% from $234,000 in Q2 2019[5]. - Net loss for Q2 2020 was $3,831,000, compared to a net loss of $4,314,000 in Q2 2019, reflecting an 11.2% improvement[5]. - Total revenue for the three months ended June 30, 2020, was $746,000, a decrease of 35% compared to $1,142,000 for the same period in 2019[47]. - Gross profit for the three months ended June 30, 2020, was $153,000, a decrease of 35% from $234,000 in the same period in 2019[47]. - Net loss for the three months ended June 30, 2020, was $3,831,000, a decrease of 11% from $4,314,000 in the same period in 2019[47]. - The net loss for the six months ended June 30, 2020, was $7,537,000, compared to a net loss of $8,030,000 for the same period in 2019, indicating a slight improvement[8]. Revenue Breakdown - Product revenue for the first half of 2020 was $1,953,000, up from $1,879,000 in the same period of 2019, representing a 3.9% increase[5]. - Product revenue decreased by 32% to $743,000 for the three months ended June 30, 2020, primarily due to a decrease in the number of tests performed[47]. - The number of OVA1plus tests performed decreased by 21% to approximately 2,458 tests during the three months ended June 30, 2020, compared to approximately 3,129 tests for the same period in 2019[47]. Expenses - Operating expenses for Q2 2020 totaled $3,979,000, a decrease of 12.3% compared to $4,539,000 in Q2 2019[5]. - Total operating expenses for the three months ended June 30, 2020, were $3,979,000, a decrease of 12% from $4,539,000 in the same period in 2019[48]. - Sales and marketing expenses decreased by 38% to $1,733,000 for the three months ended June 30, 2020, compared to $2,780,000 for the same period in 2019[48]. - General and administrative expenses increased by 28% to $787,000 for the six months ended June 30, 2020, primarily due to increased headcount and legal expenses[52]. Cash and Liquidity - Cash and cash equivalents at the end of Q2 2020 were $10,935,000, down from $16,179,000 at the end of Q2 2019[8]. - Cash used in operating activities for the first half of 2020 was $6,910,000, compared to $6,652,000 in the same period of 2019[8]. - The accumulated deficit as of June 30, 2020, was approximately $429,698,000, highlighting ongoing financial challenges[9]. - The company reported a cash and cash equivalents balance of $10,935,000 at the end of the period, down from $16,179,000 at the end of the previous period[8]. COVID-19 Impact - The company experienced a significant decrease in test volume and revenue due to the COVID-19 pandemic, with a notable decline in late March and the second quarter of 2020[9]. - The company implemented virtual sales meetings and increased digital marketing efforts to adapt to the challenges posed by the pandemic[9]. - The company began running COVID-19 antibody tests in Q2 2020, utilizing Roche Elecsys Anti-SARS-CoV-2 Emergency Use Assay kits with 99.81% sensitivity and 100% specificity[38]. - The COVID-19 pandemic has impacted patient enrollment and commercial efforts, but the company has implemented virtual sales strategies to adapt[36]. Financing Activities - The company received approximately $89,000 from the U.S. Department of Health and Human Services under the CARES Act on April 10, 2020[10]. - The company obtained a Paycheck Protection Program loan of $1,005,767 from BBVA USA on May 1, 2020[10]. - The company completed a private placement of common stock on July 20, 2020, for gross proceeds of approximately $11 million before transaction costs[10]. - The company expects to raise additional capital through various sources, including equity offerings and strategic alliances[54]. Research and Development - Research and development expenses increased to $380,000 in Q2 2020, up from $225,000 in Q2 2019, marking a 68.9% increase[5]. - The company plans to broaden its commercial focus from ovarian cancer to a range of gynecological disorders, including the development of new algorithms and molecular diagnostic tests[28]. - The company is developing three additional diagnostic products: OVANex™, EndoCheck™, and OVAInherit™, targeting pelvic masses and endometriosis detection[33]. Product Development and Market Strategy - OVA1 and Overa products have received FDA clearance, with OVA1 launched in September 2009 and Overa in March 2016[33]. - The company aims to transform women's health globally, focusing on ovarian cancer and providing personalized risk assessment solutions[32]. - The company is leveraging its existing database to build the largest specimen and data repository of gynecologic pelvic mass patients worldwide, enhancing research and development efforts[40]. - ASPiRA LABS launched OVA1plus in October 2018, combining OVA1 and Overa to drive earlier detection of ovarian cancer, which can lower overall healthcare costs[41].
Aspira Women’s Health (AWH) - 2020 Q2 - Quarterly Report