Aprea Therapeutics(US:APRE)2021-08-11 16:00Financial Performance - As of June 30, 2021, the company reported net losses of $10.3 million and $19.9 million for the three and six months ended June 30, 2021, respectively, with an accumulated deficit of $163.9 million[79]. - The net loss for Q2 2021 was $10.3 million, compared to a net loss of $16.4 million in Q2 2020, representing an improvement of 37.3%[116]. - Total operating expenses for the six months ended June 30, 2021 were $20.2 million, down from $26.4 million in the same period of 2020, a decrease of 23.4%[121]. - Research and development expenses for Q2 2021 were $6.7 million, down from $10.7 million in Q2 2020, a decrease of 37.8%[117]. - Research and development expenses for the six months ended June 30, 2021 totaled $13.4 million, down 32.2% from $19.8 million in the same period of 2020[122]. - General and administrative expenses for Q2 2021 were $3.4 million, a decrease of 10.8% from $3.8 million in Q2 2020[119]. - The company experienced a net cash used in operating activities of $19.3 million for the six months ended June 30, 2021, compared to $17.2 million in the same period of 2020, an increase of 12.3%[129]. - The company has not generated any revenue from product sales and does not expect to do so in the near future[87]. - Interest income has decreased as cash balances decline and interest rates fall[100]. - The company reported a foreign currency loss of $0.3 million in Q2 2021, significantly improved from a loss of $1.9 million in Q2 2020, a decrease of 84.2%[120]. Clinical Trials and Research - The company is focused on developing eprenetapopt, a small molecule p53 reactivator, for hematologic malignancies, with FDA designations including orphan drug and breakthrough therapy for MDS and AML[65]. - The pivotal Phase 3 trial of eprenetapopt with azacitidine for frontline treatment of TP53 mutant MDS completed enrollment of 154 patients but failed to meet its primary endpoint of complete remission rate[67][70]. - In a Phase 2 trial for post-transplant maintenance therapy, the 1-year relapse-free survival rate was 58% and overall survival rate was 79% in 33 patients[71]. - The Phase 1/2 AML trial showed a complete remission rate of 37% and a composite response rate of 53% in 30 evaluable patients[72]. - The company is currently conducting multiple clinical trials for eprenetapopt, including a Phase 3 trial in the U.S. for TP53 mutant MDS[95]. - A partial clinical hold has been placed by the FDA on the company's clinical trials of eprenetapopt in combination with azacitidine, which the company intends to resolve[95]. - The company plans to expand its clinical trials and continue research on additional product candidates, which will increase expenses significantly[80]. - Research and development expenses are expected to continue increasing as the company initiates additional clinical trials and develops new product candidates[90]. Financial Position and Funding - The company had cash and cash equivalents of $69.8 million as of June 30, 2021, expected to fund operations into 2023[83]. - Cash and cash equivalents as of June 30, 2021 were $69.8 million, following net proceeds of $223.9 million from stock sales since inception[127]. - The company has received approximately $223.9 million in net proceeds from sales of preferred and common stock through June 30, 2021[78]. - The company anticipates substantial increases in expenses related to ongoing development activities for eprenetapopt and other product candidates[136]. - Future capital requirements will depend on the scope and costs of clinical trials, drug discovery, and regulatory reviews[138]. - The company has filed a universal shelf registration statement for the issuance of securities up to an aggregate of $350.0 million, including an at-the-market offering program for $50.0 million of common stock[143]. - The company does not currently have any committed external sources of funds and may face dilution if additional capital is raised through equity sales[140]. - The company may need to relinquish valuable rights or grant licenses on unfavorable terms if additional funds are raised through collaborations or licensing arrangements[141]. Operational Risks and Challenges - The company is currently facing partial clinical holds on multiple trials and is working with the FDA to resolve these issues[66][67]. - The COVID-19 pandemic has not materially affected the company's financial results for the three and six months ended June 30, 2021, but uncertainties remain regarding its future impact[86]. - The company is classified as an emerging growth company and a smaller reporting company, allowing it to delay adopting certain accounting standards[112][114]. - The company tracks outsourced development costs by product candidate but does not allocate internal personnel costs to specific programs[89]. - The company recognizes research and development costs as incurred, with expenses related to clinical trials based on evaluations of progress[89]. - The company has incurred additional costs associated with operating as a public company, which are expected to increase as development activities expand[136]. - The company is exposed to interest rate risk, with cash equivalents primarily in bank deposits and money market accounts[146]. - The company faces foreign currency exchange rate risk related to its non-U.S. dollar functional currency foreign subsidiaries[147]. - The company has no off-balance sheet arrangements during the periods presented[145].