Aprea Therapeutics Reports Second Quarter 2023 Financial Results and Provides Update on Business Operations
“We continue to execute across all our programs, with notable progress in enrollment in our lead Phase 1/2a dose escalation study with ATRN-119, our ATR inhibitor for the treatment of advanced solid tumors and anticipate initial preliminary data in the fourth quarter 2023,” said
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 the 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 interim safety, tolerability, and pharmacokinetic data from the ongoing Phase 1 trial of ATRN-119 in the fourth quarter of 2023.
- 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.
Gabriela Gruia, M.D., to the Board of Directors, strengthening the Company’s leadership. Dr. Gruiabrings over 25 years of clinical, regulatory and life science leadership experience to Aprea, having worked for Novartis, Pfizer, Pharmacia, Aventis, and Rhone Poulenc. Dr. Gruiareceived her M.D. from Bucharest Medical Schoolin Romaniaand a Masters in Breast Pathology and Mammography from René Huguenin/Curie Institute Cancer Centerin Paris, France.
Select Financial Results for the Second Quarter ended
- As of
June 30, 2023, the Company reported cash and cash equivalents of $27.7 million.
- For the quarter ended
June 30, 2023, the Company reported an operating loss of $3.7 million, compared to an operating loss of $98.5 millionfor the same period in 2022.
- Research and Development (R&D) expenses were
$2.2 millionfor the quarter ended June 30, 2023, compared to $6.8 millionfor 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
$1.7million for the quarter ended June 30, 2023, compared to $15.6million for the same period in 2022. The decrease in G&A expenses was due to lower non-cash stock-based compensation expense, lower insurance premium expenses and lower personnel costs for the former facility in Sweden.
- Acquired in-process research and development (IPR&D) expenses were
$0for the quarter ended June 30, 2023, compared to $76.0 millionfor the same period in 2022. The decrease in IPR&D was related to the 2022 acquisition of Atrin, which was accounted for as an asset acquisition. The acquisition cost allocated to acquired IPR&D with no alternative future use was recorded as an expense as of the closing date in May 2022.
- The Company reported a net loss of $3.3 million (
$0.87 per basic share) on approximately 3.7 million weighted-average common shares outstanding for the quarter ended June 30, 2023, compared to a net loss of $98.3 million ( $86.72 per basic share) on approximately 1.1 million weighted average common shares outstanding for the same period in 2022. The decrease in net loss was primarily attributable to the acquired IPR&D associated with the Atrin acquisition in May 2022, as well as lower R&D and G&A expenses as described above.
The Company may use, and intends to use, its investor relations website at https://ir.aprea.com/ as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.
Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, related to our study analyses, clinical trials, regulatory submissions, and projected cash position. We may, in some cases use terms such as “future,” “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “targeting,” “confidence,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team and on information currently available to management that involve risks, potential changes in circumstances, assumptions, and uncertainties. All statements contained in this press release other than statements of historical fact are forward-looking statements, including statements regarding our ability to develop, commercialize and achieve market acceptance of our current and planned products and services, our research and development efforts, including timing considerations and other matters regarding our business strategies, use of capital, results of operations and financial position, and plans and objectives for future operations. Any or all of the forward-looking statements may turn out to be wrong or be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties including, without limitation, risks related to the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials, futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of our ongoing clinical trials, and the other risks, uncertainties, and other factors described under “Risk Factors,” “Management's Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the
|Cash and cash equivalents||$||27,685,131||$||28,786,647|
|Prepaid expenses and other current assets||953,670||1,366,859|
|Total current assets||28,638,801||30,153,506|
|Property and equipment, net||1,687||2,321|
|Liabilities and Stockholders’ Equity|
|Total current liabilities||3,950,821||3,201,086|
|Commitments and contingencies|
|Series A convertible preferred stock,
|Additional paid-in capital||335,485,317||330,060,836|
|Accumulated other comprehensive loss||(10,634,872||)||(10,623,408||)|
|Total stockholders’ equity||23,418,784||25,643,678|
|Total liabilities and stockholders' equity||$||28,680,668||$||30,155,827|
|Three Months Ended
||Six Months Ended
|Research and development||2,202,657||6,811,609||3,459,199||10,901,186|
|General and administrative||1,698,712||15,633,738||5,064,673||19,619,036|
|Acquired in-process research and development||—||76,020,184||—||76,020,184|
|Total operating expenses||3,901,369||98,465,531||8,523,872||106,540,406|
|Loss from operations||(3,651,681||)||(98,465,531||)||(8,274,184||)||(106,540,406||)|
|Interest income, net||336,221||52,491||592,631||54,462|
|Foreign currency gain||56,363||154,566||42,566||290,777|
|Total other income||392,584||207,057||635,197||345,239|
|Other comprehensive loss:|
|Foreign currency translation||(73,420||)||157,655||(11,464||)||92,150|
|Total comprehensive loss||(3,332,517||)||(98,100,819||)||(7,650,451||)||(106,103,017||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.87||)||$||(86.72||)||$||(2.18||)||$||(95.31||)|
|Weighted-average common shares outstanding, basic and diluted||3,731,571||1,133,092||3,497,329||1,114,189|
Source: Aprea Therapeutics