Aprea Therapeutics, Inc. (APRE) is up 3.98% in the pre-market trading session at the price of $4.70 after the company announced the upcoming presentation of data for eprenetapopt at ESMO Congress 2021.
Data Presentation from Eprenetapopt at ESMO Conference
APRE is a biopharmaceutical company located in Boston. It develops and commercializes novel cancer therapeutics to reactivate mutant tumor suppressor protein named p53. The eprenetapopt (APR-246) is the lead product candidate of the company. On 14th September 2021, APRE published about upcoming data presentation for eprenetapopt combined with pembrolizumab to treat advanced solid tumors. The data will be presented at the European Society of Medical Oncology (ESMO) Congress 2021 from 16th to 21st September 2021. The title of the presentation is “Phase I/II study of eprenetapopt (APR-246) in combination with pembrolizumab in patients with solid tumor malignancies”.
APRE Reported Second Quarter 2021 Financial Results
On 12th August 2021, APRE published its financial results for the three and six months ended 30th June 2021 and provided a business update. The company had $69.8 million of cash and cash equivalents for the quarter that ended on 30th June 2021. For the six months ended 30th June 2021, cash and cash equivalents were $89.0 million. The cash and cash equivalents as of 30th June 2021 will be sufficient to meet the company’s current projected operating requirements into 2023. APRE expects a cash burn of approximately $30.0 to $35.0 million for full-year 2021. Net loss was $10.3 million or $0.48 per share for the quarter ended 30th June 2021. For the quarter ended 30th June 2020, net loss was $16.4 million or $0.78 per share. The company reported 21,186,827 shares of common stock outstanding as of 30th June 2021.
Clinical Hold on Lymphoid Malignancy Program by FDA
On 12th August 2021, APRE reported a clinical hold on trial evaluating eprenetapopt with acalabrutinib, venetoclax, and rituximab in lymphoid malignancies by the U.S. Food and Drug Administration. The FDA’s concerns are about safety and efficacy data from the Phase 3 MDS clinical trial. APRE was informed by FDA of the clinical hold on lymphoid malignancies study after it received notification about the partial clinical hold on the myeloid malignancies program. The company aims to work closely with the FDA to address the inquiries and issues related to clinical hold. Additional patients are not allowed to enroll before the resolution of clinical hold. However, the patients receiving study deriving clinical benefits can continue their study treatment.