Aprea Therapeutics(US:APRE)2021-05-05 16:00Revenue Generation - The company has not generated any revenue from product sales and does not expect to do so in the near future[87]. - The company does not expect to generate revenue from product sales for several years, if at all[120]. Clinical Trials and Product Development - The lead product candidate, eprenetapopt, is in clinical development for hematologic malignancies, with a pivotal Phase 3 trial involving 154 patients[67]. - In the Phase 3 trial, eprenetapopt with azacitidine showed a 53% higher complete remission (CR) rate compared to the control arm, although it did not reach statistical significance[67]. - The Phase 2 trial for post-transplant maintenance therapy showed a 62% rate of relapse-free survival (RFS) at 12 months, exceeding the benchmark of ~30%[68]. - The Phase 1/2 AML trial reported a 63% composite response rate and a 31% complete response rate among evaluable patients[72]. - The company is conducting multiple clinical trials for eprenetapopt, including a Phase 3 trial in the U.S. for TP53 mutant MDS[93]. - Eprenetapopt has received multiple designations from the FDA, including orphan drug and breakthrough therapy designations for MDS and AML[67]. - Future research and development expenses are expected to increase as the company initiates additional clinical trials and develops new product candidates[91]. Financial Performance - The company incurred net losses of $9.7 million for the three months ended March 31, 2021, and an accumulated deficit of $153.7 million[77]. - The net loss for Q1 2021 was $(9,668,755), compared to a net loss of $(9,400,257) in Q1 2020, an increase in loss of $268,498[114]. - Net cash used in operating activities was $11.5 million for Q1 2021, compared to $7.5 million in Q1 2020, an increase of $4.0 million[122]. Expenses - The company anticipates significant increases in expenses related to ongoing and future clinical trials, research, and commercialization efforts[79]. - Research and development expenses for Q1 2021 were $6,763,848, a decrease of $2,332,274 from $9,096,122 in Q1 2020[114]. - General and administrative expenses increased to $3,425,833 in Q1 2021 from $2,776,468 in Q1 2020, reflecting an increase of $649,365[114]. - Total operating expenses decreased to $10,189,681 in Q1 2021 from $11,872,590 in Q1 2020, a reduction of $1,682,909[114]. - The decrease in R&D expenses was primarily due to a $3.1 million reduction related to the Phase 3 clinical trial of eprenetapopt, which completed enrollment in Q2 2020[115]. - General and administrative expenses are anticipated to rise as the company increases headcount to support research and development activities[97]. Cash Position - As of March 31, 2021, the company had cash and cash equivalents of $77.6 million, expected to fund operations into 2023[81]. - As of March 31, 2021, the company's cash equivalents consisted of bank deposits and money market accounts, indicating a focus on liquidity management[135]. - The company has received net proceeds of $223.9 million from sales of preferred and common stock since inception[120]. Foreign Currency and Interest Rate Risks - The company is exposed to interest rate risk, with interest income sensitivity affected by changes in the general level of U.S. interest rates, although historical fluctuations have not been significant[135]. - The company faces foreign currency exchange rate risk related to its non-U.S. dollar functional currency foreign subsidiaries, impacting revenues, expenses, assets, and liabilities[136]. - The financial position of subsidiaries Aprea AB and Aprea Personal AB is measured using their local currency as the functional currency, with cash accounts holding U.S. dollars remeasured based on the exchange rate at the date of remeasurement[136]. - The company does not currently have any significant direct foreign exchange risk and has not used derivative financial instruments to hedge against such risk[136]. COVID-19 Impact - The company plans to continue monitoring the impact of the COVID-19 pandemic on its clinical trials and operations[86].