Aprea Therapeutics(APRE) - 2020 Q2 - Quarterly Report

Financial Performance - As of June 30, 2020, the company reported net losses of $16.4 million and $25.8 million for the three and six months ended June 30, 2020, respectively, with an accumulated deficit of $116.3 million [73][75]. - The net loss for Q2 2020 was $16.4 million, compared to a net loss of $5.3 million in Q2 2019, representing an increase in loss of $11.1 million [117]. - The net loss for the six months ended June 30, 2020, was $25.8 million, compared to a net loss of $8.7 million for the same period in 2019, reflecting an increase of $17.0 million [122]. - Cash used in operating activities for the six months ended June 30, 2020, was $17.2 million, an increase of $8.0 million from $9.2 million in the same period of 2019 [127]. - The total operating expenses for the six months ended June 30, 2020, were $26.4 million, compared to $10.3 million for the same period in 2019, reflecting an increase of $16.0 million [122]. Cash and Funding - The company had cash and cash equivalents of $112.9 million as of June 30, 2020, which is expected to fund operations into 2023 [79]. - Net cash provided by financing activities for the six months ended June 30, 2020, was $150,949, compared to $5.6 million for the same period in 2019 [129]. Research and Development - Research and development expenses for Q2 2020 were $10.7 million, up from $4.3 million in Q2 2019, an increase of $6.4 million [117]. - The increase in R&D expenses was primarily due to the advancement of the clinical product candidate APR-246, which is involved in pivotal Phase 3 clinical trials [117]. - Research and development expenses for the six months ended June 30, 2020, were $19.8 million, up $11.8 million from $8.0 million in the prior year, primarily due to advancements in the clinical product candidate APR-246 [123]. - The company expects substantial increases in expenses related to ongoing development activities and operating as a public company [131]. Clinical Trials and Product Development - The company has completed enrollment of 154 patients in its pivotal Phase 3 trial of eprenetapopt with azacitidine for frontline treatment of TP53 mutant MDS, expecting top-line data by year-end 2020 [68]. - The second product candidate, APR-548, is in preclinical development and has filed an IND with the FDA, but human clinical trials cannot commence until additional information is provided [70]. - The company has received orphan drug, fast track, and breakthrough therapy designations from the FDA for eprenetapopt in MDS [68]. - The company anticipates significant commercialization expenses if marketing approval is obtained for any product candidates [76]. General and Administrative Expenses - General and administrative expenses for the six months ended June 30, 2020, were $6.5 million, an increase of $4.2 million compared to $2.3 million for the same period in 2019 [124]. - The company expects to incur increased general and administrative expenses as it expands its headcount and operations related to research and development [95]. Foreign Exchange and Taxation - The company did not record any U.S. federal, state, or foreign income tax expense due to uncertainty in realizing benefits from net losses [100]. - A valuation allowance was provided for the full amount of net deferred tax assets, indicating that it is more likely than not that these assets will not be realized in the future [100]. - The company considers investments in foreign subsidiaries with a functional currency other than the U.S. dollar as long-term [144]. - The company does not believe it currently has any significant direct foreign exchange risk [144]. - The company has not used any derivative financial instruments to hedge exposure to foreign exchange risk [144]. COVID-19 Impact - The COVID-19 pandemic initially decreased patient screening and enrollment in clinical trials, but recent activity has returned to expected levels [81].