Protara Therapeutics(TARA) - 2021 Q2 - Quarterly Report

Financial Performance - The total operating expenses for Q2 2021 were $12.8 million, up from $7.3 million in Q2 2020, resulting in an operating loss of $12.8 million compared to a loss of $7.3 million in the prior year [126]. - The net loss for Q2 2021 was approximately $12.8 million, an increase of $5.6 million compared to a net loss of $7.1 million in Q2 2020 [126]. - Net loss for the six months ended June 30, 2021, was approximately $26.2 million, compared to a net loss of $17.2 million for the same period in 2020, representing an increase of $9.0 million [134]. - The company incurred net losses of approximately $12.8 million and $7.1 million for the three months ended June 30, 2021, and 2020, respectively [134]. Expenses - Research and development expenses for Q2 2021 were approximately $5.9 million, an increase of $3.4 million compared to Q2 2020, primarily due to manufacturing activities for TARA-002 [126]. - General and administrative expenses for Q2 2021 were approximately $6.9 million, reflecting an increase of $2.1 million compared to Q2 2020, driven by higher stock-based compensation and new corporate headquarters expenses [127]. - Research and development expenses for the six months ended June 30, 2021, were approximately $12.9 million, an increase of $7.4 million compared to the same period in 2020 [130]. - General and administrative expenses for the six months ended June 30, 2021, were approximately $13.4 million, reflecting an increase of $1.6 million from the prior year [131]. Cash Position - The company had approximately $145.0 million in cash, cash equivalents, and marketable debt securities as of June 30, 2021 [116]. - The company's cash, cash equivalents, and marketable debt securities as of June 30, 2021, were $145.0 million, down from $168.6 million as of December 31, 2020 [134]. - Cash flows used in operating activities for the six months ended June 30, 2021, were approximately $21.4 million, an increase of $8.5 million compared to $12.9 million in 2020 [139]. - Net cash used in investing activities was $100.2 million for the six months ended June 30, 2021, compared to net cash provided of $3.5 million in 2020, a change of $103.7 million [140]. Future Outlook - The company does not expect to generate revenues prior to 2022, if ever, and will need to raise additional capital to finance ongoing and future clinical trials [113]. - As of June 30, 2021, the company had an accumulated deficit of approximately $73.0 million and expected to continue incurring significant operating losses for the next few years [114]. - The company believes its current financial resources are sufficient to meet liquidity needs for at least twelve months from the issuance of the financial statements [136]. - The company faces uncertainty in raising additional capital due to global economic conditions and the impact of the COVID-19 pandemic [137]. Clinical Development - TARA-002 is in later stage development for lymphatic malformations (LMs) and non-muscle invasive bladder cancer (NMIBC), with approximately 65,000 NMIBC diagnoses annually in the U.S. [107][113]. - The FDA granted Rare Pediatric Disease designation for TARA-002 for the treatment of LMs, with a significant dataset from a Phase 2 study involving over 500 patients secured [109]. - The company anticipates that the COVID-19 pandemic may negatively impact clinical trials and overall business operations due to resource limitations at trial sites [119].