On May 15, 2023 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical stage biopharmaceutical company focused on developing novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways, reported financial results for the three months ended March 31, 2023 and provided a business update (Press release, Aprea, MAY 15, 2023, View Source [SID1234631700]).

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"We are excited about the strong start for 2023 as we focus on the execution of the pipeline development plan and continue enrollment in our Phase 1/2a dose escalation study of our ATR inhibitor, ATRN-119, in patients with biomarkers related to DDR mutations," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "Our cash position remains strong with a runway to carry us into the third quarter of 2024 and cross meaningful clinical milestones in our two lead inhibitor programs, ATR and WEE1. In February, we closed an underwritten public offering pursuant to which the Company received approximately $4.9 million in net proceeds. In April, we participated in the American Association of Cancer Research Conference where we had the opportunity to share preclinical results pointing to the potential, groundbreaking benefits of combination therapy with ATRN-119 and ATRN-1051. Our IND-enabling studies continue to progress for our ATRN-1051 inhibitor program and anticipate filing an IND by the end of 2023."

Key Business and Financial Updates

ATR inhibitor program: ATRN-119 – Enrollment continues in the Phase 1/2a trial of Aprea’s lead clinical candidate, ATRN-119, a potential best-in-class ATR inhibitor for treatment of advanced solid tumors harboring defined mutations in DDR pathways. ATRN-119 is an orally bioavailable, potent and selective macrocyclic small molecule inhibitor of ATR. ATR is one of several key regulators impacting response to defective DNA replication and DNA damage, which occurs more commonly in cancer cells than in normal cells. Primary endpoints of the Phase 1 dose escalation part of the study include safety, tolerability, pharmacokinetics and a recommended Phase 2 dose. The Company expects to report initial safety, tolerability, and pharmacokinetic data from the ongoing Phase 1 trial of ATRN-119 in the first quarter of 2024.

WEE1 inhibitor program: ATRN-1051 – ATRN-1051 is an orally-bioavailable, highly potent and selective small molecule inhibitor of WEE1, a key regulator of multiple phases of the cell cycle. The Company believes preclinical findings support potentially favorable drug selectivity and exposure. Investigational New Drug (IND) enabling studies with ATRN-1051 are under way, and the Company anticipates filing an IND by the end of 2023.

Presented Preclinical data on pipeline programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Annual Meeting, held April 14-19, 2023, in Orlando, Florida. In April 2023, the Company presented a poster, titled "ATRN-119 and ATRN-W1051: Novel and potentially well tolerated ATR and WEE1 inhibitors for targeted cancer treatment," highlighting its lead program, ATRN-119, and preclinical WEE1 inhibitor, ATRN-1051. In in vivo models, ATRN-119 demonstrated anti-tumor efficacy, both as a monotherapy and in combination with PARP inhibitors. In xenograft models, ATRN-1051 demonstrated high potency, potentially favorable pharmacokinetic properties, and anti-tumor efficacy.

Secured non-dilutive funding via a research grant from the National Cancer Institute (NCI) supporting development of DDR inhibitors. In February 2023, the Company announced that it received an award notification from the NCI for the development of a first-in-class combination of DNA damage response inhibitors for the treatment of high-grade serous ovarian cancer (HGSOC). HGSOC is a devastating disease responsible for the deaths of about 125,000 women worldwide each year and has low survival rates.

Closed an underwritten public offering in February 2023 pursuant to which the Company received approximately $4.9 million in net proceeds, after deducting underwriting discounts and offering expenses. Net proceeds from the public offering support the continuing development of ATRN-119 and ATRN-1051 as well as general corporate overhead.
Appointed Gabriela Gruia, M.D., to the Board of Directors, strengthening the Company’s leadership. Dr. Gruia brings over 25 years of clinical, regulatory and life science leadership experience to Aprea, having worked for Novartis, Pfizer, Pharmacia, Aventis and Rhone Poulenc. Dr. Gruia received her M.D. from Bucharest Medical School in Romania and a Masters in Breast Pathology and Mammography from Rene Huguenin/Curie Institute Cancer Center in Paris, France.
Select Financial Results for the First Quarter ended March 31, 2023

As of March 31, 2023, the Company reported cash and cash equivalents of $31.0 million.
For the quarter ended March 31, 2023, the Company reported an operating loss of $4.6 million, compared to an operating loss of $8.1 million for the same period in 2022.
Research and Development (R&D) expenses were $1.3 million for the quarter ended March 31, 2023, compared to $4.1 million for the same period in 2022. The decrease in R&D expense was related to lower clinical trial expense primarily due to the close out of legacy Aprea clinical trials, lower personnel costs for the former facility in Sweden, and lower non-cash stock-based compensation expense.
General and Administrative (G&A) expenses were $3.4 million for the quarter ended March 31, 2023, compared to $4.0 million for the same period in 2022. The decrease in G&A expenses was due to a lower non-cash stock-based compensation and insurance premium expenses, partially offset by higher personnel costs in the quarter ended March 31, 2023 related to severance expenses for former executives.
The Company reported a net loss of $4.4 million ($1.34 per basic share) on approximately 3.3 million weighted-average common shares outstanding for the quarter ended March 31, 2023, compared to a net loss of $7.9 million ($7.25 per basic share) on approximately 1.1 million weighted average common shares outstanding for the same period in 2022.