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aprea therapeutics Aprea Therapeutics Reports Third Quarter 2021 Financial Results and Provides Update on Business Operations November 8 , 2021 BOSTON , Nov. 08 , 2021 ( GLOBE NEWSWIRE ) -- Aprea Therapeutics , Inc. ( Nasdaq : APRE ) , a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein , p53 , today reported financial results for the three and nine months ended September 30 , 2021 and provided a business update . Third Quarter Financial Results • Cash and cash equivalents : As of September 30 , 2021 , the Company had $ 61.4 million of cash and cash equivalents compared to $ 89.0 million of cash and cash equivalents as of December 31 , 2020. The Company expects cash burn for the full year 2021 to be between $ 30.0 million and $ 35.0 million . The Company believes its cash and cash equivalents as of September 30 , 2021 , will be sufficient to meet its current projected operating requirements into 2023 . • Research and Development ( R & D ) expenses : R & D expenses were $ 6.0 million for the quarter ended September 30 , 2021 , compared to $ 8.8 million for the comparable period in 2020. The decrease in R & D expenses was primarily due to decreases in clinical trial costs for our pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS which completed enrollment in Q2 2020 and our Phase 2 post - transplant MDS / AML clinical trial . These decreases were partially offset by increases in clinical trial costs for our other ongoing clinical trials . • General and Administrative ( G & A ) expenses : G & A expenses were $ 3.4 million for the quarter ended September 30 , 2021 , compared to $ 3.5 million for the comparable period in 2020. The decrease in G & A expenses was primarily due to a decrease in pre - commercialization development activities which was partially offset by increased non - cash stock - based compensation . • Net loss : Net loss was $ 9.5 million , or $ 0.45 per share for the quarter ended September 30 , 2021 , compared to a net loss of $ 12.3 million , or $ 0.58 per share for the quarter ended September 30 , 2020. The Company had 21,360,140 shares of common stock outstanding as of September 30 , 2021 . Business Operations Update : Myeloid Malignancy Program On August 4 , 2021 , the U.S. Food and Drug Administration ( FDA ) placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine in our Phase 3 frontline MDS clinical trial , our Phase 2 MDS / AML Post - Transplant clinical trial and our Phase 1/2 AML clinical trial . The FDA's concerns referred to the safety and efficacy data from the Phase 3 frontline MDS clinical trial . In particular , the FDA requested more information related to a potential risk - reward imbalance between the combination of eprenetapopt and azacitidine versus azacitidine alone as it relates to increased serious adverse events in the Company's Phase 3 frontline clinical trial in MDS . There are approximately 9 patients currently receiving eprenetapopt in combination with azacitidine in our myeloid malignancy programs , which includes the MDS , AML and post - transplant maintenance trials , all of which have completed enrollment . Patients who are benefiting from treatment can continue to receive study treatment . As part of the partial clinical hold , no additional patients should be enrolled to these clinical trials until the partial clinical hold is resolved , The Company intends to work with the FDA to analyze the data , address the specific questions raised , and seek to resolve the partial clinical hold as soon as possible . APR - 548 Phase 1 Trial -- The Company's second product candidate , APR - 548 , is a next - generation p53 reactivator that is being developed in an oral dosage form . The Company is currently enrolling a Phase 1 dose - escalation clinical trial evaluating the safety , tolerability , and preliminary efficacy of APR - 548 with azacitidine in frontline and relapsed / refractory MDS patients . The trial is open and patients are enrolled in the first dosing cohort . Lymphoid Malignancy Program On August 11 , 2021 , the FDA placed a clinical on the Company's clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies . The FDA's concerns referred to the safety and efficacy data from the Company's Phase 3 frontline clinical trial in MDS . There are no patients currently receiving study treatment in this trial and no additional patients can be enrolled until the clinical hold is resolved .