On March 15, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, reported financial results for the three months and year ended December 31, 2021 and provided a business update (Press release, Aprea, MAR 15, 2022, View Source [SID1234610096]).

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Fourth Quarter Financial Results

Cash and cash equivalents: As of December 31, 2021, the Company had $53.1 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 2022 to be between $25.0 million and $30.0 million. The Company believes its cash and cash equivalents as of December 31, 2021 will be sufficient to meet its current projected operating requirements into 2023.

Research and Development (R&D) expenses: R&D expenses were $4.5 million for the quarter ended December 31, 2021, compared to $9.3 million for the comparable period in 2020. The decrease in R&D expenses was primarily due to decreases in clinical trial costs for the Company’s pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS and the Company’s Phase 2 post-transplant MDS/AML clinical trial. These decreases were partially offset by increases in clinical trial costs for other ongoing clinical trials.

General and Administrative (G&A) expenses: G&A expenses were $3.4 million for the quarter ended December 31, 2021, compared to $4.9 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 $7.8 million, or $0.36 per share for the quarter ended December 31, 2021, compared to a net loss of $13.1 million, or $0.73 per share for the quarter ended December 31, 2020. The Company had 21,859,413 shares of common stock outstanding as of December 31, 2021.
Business Operations Update:

Myeloid Malignancy Program

The Company’s myeloid malignancy program includes fully enrolled and completed clinical trials in MDS, AML and post-transplant maintenance therapy in MDS/AML. In August 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 the Company’s Phase 3 frontline MDS clinical trial, the Company’s Phase 2 MDS/AML Post-Transplant clinical trial and the Company’s Phase 1/2 AML clinical trial. In December 2021 the Company discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and reached agreement on the Company’s proposals for new clinical trials in myeloid malignancies. In the first quarter of 2022 the Company received clearance from FDA to proceed under its existing myeloid malignancy IND with a new clinical trial in relapsed/refractory MDS and AML.

Lymphoid Malignancy Program

The Company’s lymphoid malignancy program includes a clinical trial evaluating eprenetapopt in patients with non-Hodgkin lymphomas (NHL). In August 2021, FDA placed a clinical hold on this trial. In October 2021, the Company discussed with FDA the requested data and analyses from the Phase 3 frontline MDS clinical trial and proposed amendments for clinical trials to proceed in its lymphoid malignancy program. Following interaction with the FDA, the clinical hold was lifted in December 2021.

The Company is in the planning phase for new clinical trials in both myeloid and lymphoid malignancies and is continuing to evaluate other development opportunities. The Company plans to provide updates on progress on all programs throughout 2022.

APR-548 Phase I 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 initiated a Phase 1 clinical trial testing APR-548 in relapsed/refractory MDS and AML. Enrollment in the first dosing cohort was completed and pharmacokinetic and adverse event data will be collected and analyzed. The Company does not plan to enroll additional patients into the trial.

Solid Tumor Program

The Company’s solid tumor program includes its clinical trial evaluating eprenetapopt with anti-PD-1 therapy in advanced solid tumors. The Company completed enrollment in its Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy. The Company is in the planning phase for a future clinical trial to further evaluate orally-administered eprenetapopt with immunotherapy checkpoint inhibitors.