Can Eprenetapopt Data Help Reverse Course Of Aprea Therapeutics' Stock?

(RTTNews) - Shares of Aprea Therapeutics Inc. (APRE) have halved in value from their 52-week high of $53.11, recorded on Dec.30, 2019, and currently trade around $25.

The company is focused on developing and commercializing novel cancer therapeutics to reactivate the mutant tumor suppressor protein p53, the most commonly mutated gene in cancer. The lead product candidate is Eprenetapopt, also known as APR-246, which works by reactivating mutant p53 protein, inducing programmed cell death in human cancer cells.

The potential of Eprenetapopt is being explored in the treatment of myelodysplastic syndromes, acute myeloid leukemia, ovarian cancer, as well as additional hematologic and solid tumor malignancies.

A pivotal phase III trial evaluating Eprenetapopt with azacitidine as frontline therapy in HMA (hypomethylating agents)-naïve TP53 mutant myelodysplastic syndromes (MDS) patients is underway, with top-line data expected to be available the end of this month. The study's primary endpoint is complete remission (CR) rate.

The other ongoing and proposed trials with Eprenetapopt are:

-- A phase II trial of Eprenetapopt with chemotherapy drug Azacitidine as post-transplant maintenance therapy in TP53 mutant MDS and acute myeloid leukemia (AML) patients who have received an allogeneic stem cell transplant is ongoing.

-- A phase I/II trial of Eprenetapopt therapy in TP53 mutant acute myeloid leukemia patients is underway.

-- A phase I/II clinical trial of Eprenetapopt with anti-PD-1 therapy in cohorts of patients with relapsed/refractory gastric, bladder and non-small cell lung cancers is ongoing.

-- A phase I clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) assessing Eprenetapopt with cancer medicines Venetoclax and Rituximab, against Eprenetapopt with Ibrutinib is due to be initiated this quarter (Q4, 2020).

The company's second product candidate is APR-548, a next-generation p53 reactivator that is being developed for treating hematologic malignancies. The FDA clearance to initiate phase I trials for APR-548 was received in October and patient enrollment in the phase I trial is anticipated to begin in the first quarter of 2021.

Cash position:

As of September 30, 2020, Aprea had $101.1 million of cash and cash equivalents, expected to be sufficient to meet its current projected operating requirements into 2023.

APRE, which made its debut on the Nasdaq Global Select Market on October 3, 2019, has traded in a range of $19.67 to $53.11 in the last 1 year. The stock closed Friday's trading at $25.93, down 6.15%.