On November 9, 2022 Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways reported financial results for the three and nine months ended September 30, 2022 and provided a business update (Press release, Aprea, NOV 9, 2022, View Source [SID1234623562]).

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"We are excited about the advancement of ATRN-119, the first macrocyclic ATR inhibitor, into clinical development," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We look forward to collecting clinical data from our Phase 1 trial."

Third Quarter Financial Results

Cash and cash equivalents: As of September 30, 2022, the Company had $33.1 million of cash and cash equivalents compared to $53.1 million of cash and cash equivalents as of December 31, 2021. The Company believes its cash and cash equivalents as of September 30, 2022 will be sufficient to meet its current projected operating requirements through the end of 2023.
Research and Development (R&D) expenses: R&D expenses were $1.1 million for the quarter ended September 30, 2022, compared to $6.0 million for the comparable period in 2021. R&D expenses for the quarter ended September 30, 2022 primarily represented close out costs for (i) the Company’s pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for the frontline treatment of TP53 mutant MDS, (ii) the Company’s Phase 2 post-transplant MDS/AML clinical trial, (iii) the Company’s Phase 1 AML trial, and (iv) the Company’s Phase 1/2 solid tumor trial and the Company’s Phase 1 dose-escalation trial of APR-548 as well as decreased non-cash stock-based compensation expense resulting from the acceleration of vesting of all outstanding stock options and restricted stock units in connection with the acquisition of Atrin in May 2022.
General and Administrative (G&A) expenses: G&A expenses were $3.1 million for the quarter ended September 30, 2022, compared to $3.4 million for the comparable period in 2021. The decrease in G&A expenses was primarily due to decreased non-cash stock-based compensation expense resulting from the acceleration of vesting of all outstanding stock options and restricted stock units in connection with the acquisition of Atrin in May 2022, offset in part by increased professional fees.
Net loss: Net loss was $4.0 million, or $0.12 per share for the quarter ended September 30, 2022, compared to a net loss of $9.5 million, or $0.45 per share for the quarter ended September 30, 2021. The Company had 52,237,885 shares of common stock outstanding as of September 30, 2022. The increased common stock outstanding resulted primarily from the conversion of 2,821,033 shares of Series A preferred stock into 28,210,330 shares of common stock during the third quarter of 2022.
Business Operations Update:

DDR Programs

ATRN-119 – ATRN-119 is an orally-bioavailable, highly potent and selective macrocyclic small molecule inhibitor of ATR, a protein with key roles in response to DNA damage. The Company is conducting a Phase 1 clinical trial to evaluate ATRN-119 monotherapy in cancer patients with defined genetic mutations. This trial was activated and opened for enrollment in the third quarter of 2022 and the Company expects to open 1-2 additional sites in the fourth quarter of 2022.

ATRN-W1051 – ATRN-W1051 is an orally-bioavailable, highly potent and selective small molecule inhibitor of WEE1, a key regulator of multiple phases of the cell cycle. ATRN-W1051 is currently in preclinical development and the Company anticipates commencing IND-enabling studies in the fourth quarter of 2022.

p53 Reactivator Programs

Eprenetapopt – APR-246, or eprenetapopt, is a small molecule p53 reactivator that has been tested in clinical trials for solid tumors and for hematologic malignancies. We currently have no ongoing clinical trials of eprenetapopt.

APR-548 – APR-548 is a second generation p53 reactivator that is being developed in an oral dosage form. We initiated a Phase 1 clinical trial testing APR-548 in relapsed/refractory MDS and AML and enrollment in the first dosing cohort was completed. There are currently no patients receiving APR-548 in this trial and enrollment into the trial has been closed.