ACESOT-1051 trial evaluating WEE1 kinase inhibitor APR-1051 now enrolling patients in Cohort 5; open label safety and efficacy data expected H2 2025
Twice daily (BID) dosing regimen in ongoing ABOYA-119 trial expected to maximize clinical benefit of ATR inhibitor ATRN-119; plan to complete dose escalation H2 2025
$22.8 million in cash and cash equivalents as of December 31, 2024
DOYLESTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.
“We made excellent progress across our pipeline in 2024, laying a strong foundation for the year ahead,” said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. “We continue to enroll patients in the ACESOT-1051 trial evaluating our WEE1 kinase inhibitor, APR-1051, which we believe has best in class potential. The compound appears safe and well tolerated to date with no hematologic toxicity. We look forward to reporting open label data from ACESOT-1051 in the second half of the year. We are also advancing ATRN-119, our highly selective first-in-class macrocyclic ATR inhibitor. The ongoing ABOYA-119 trial is now evaluating ATRN-119 as continuous once daily and twice daily monotherapy in order to maximize therapeutic benefit. Our ultimate goal is to transform the treatment paradigm for difficult to treat cancers by unlocking the full potential of DDR-based therapies.”
Key Business Updates and Potential Upcoming Key Milestones
ACESOT-1051: A Biomarkers Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051
ABOYA-119: Ongoing Clinical Trial Evaluating ATR inhibitor, ATRN-119
Corporate
Select Financial Results for the Fourth Quarter ended December 31, 2024
Select Financial Results for the Year ended December 31, 2024
About Aprea
Aprea is pioneering a new approach to treat cancer by exploiting vulnerabilities associated with cancer cell mutations. This approach was developed to kill tumors but to minimize the effect on normal, healthy cells, decreasing the risk of toxicity that is frequently associated with chemotherapy and other treatments. Aprea’s technology has potential applications across multiple cancer types, enabling it to target a range of tumors, including ovarian, colorectal, prostate, and breast cancers. The company’s lead programs are APR-1051, an oral, small-molecule inhibitor of WEE1 kinase, and ATRN-119, a small molecule ATR inhibitor, both in clinical development for solid tumor indications. For more information, please visit the company website at www.aprea.com.
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.
Forward-Looking Statement
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 (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), 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, our understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs, our ability to continue as a going concern, 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 U.S. Securities and Exchange Commission. For all these reasons, actual results and developments could be materially different from those expressed in or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which are made only as of the date of this press release. We undertake no obligation to update such forward-looking statements for any reason, except as required by law.
Investor Contact:
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
| Aprea Therapeutics, Inc. | ||||||||
| Consolidated Balance Sheets | ||||||||
| December 31, | December 31, | |||||||
|
2024 |
2023 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,849,885 | $ | 21,606,820 | ||||
| Prepaid expenses and other current assets | 726,254 | 914,275 | ||||||
| Total current assets | 23,576,139 | 22,521,095 | ||||||
| Property and equipment, net | 81,522 | 88,362 | ||||||
| Restricted cash | 40,170 | 40,717 | ||||||
| Other noncurrent assets | 281,662 | — | ||||||
| Total assets | $ | 23,979,493 | $ | 22,650,174 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,352,240 | $ | 1,670,369 | ||||
| Accrued expenses | 2,008,735 | 2,186,262 | ||||||
| Deferred revenue | — | 528,974 | ||||||
| Total current liabilities | 3,360,975 | 4,385,605 | ||||||
| Commitments and contingencies | ||||||||
| Series A convertible preferred stock, $0.001 par value, 40,000,000 shares authorized; 56,227 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively. | 1,311,063 | 1,311,063 | ||||||
| Stockholders’ equity: | ||||||||
| Common stock, $0.001 par value, 400,000,000 shares authorized, 5,481,055 and 3,736,673 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively. | 5,481 | 3,736 | ||||||
| Additional paid-in capital | 350,971,225 | 335,644,204 | ||||||
| Accumulated other comprehensive loss | (10,627,379 | ) | (10,611,273 | ) | ||||
| Accumulated deficit | (321,041,872 | ) | (308,083,161 | ) | ||||
| Total stockholders’ equity | 19,307,455 | 16,953,506 | ||||||
| Total liabilities and stockholders' equity | $ | 23,979,493 | $ | 22,650,174 | ||||
| Aprea Therapeutics, Inc. | ||||||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
|
2024 |
2023 |
2024 |
2023 |
|||||||||||||
| (Unaudited) | ||||||||||||||||
| Grant revenue | $ | 205,817 | $ | 14,075 | 1,502,581 | $ | 583,231 | |||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 2,359,086 | 2,045,689 | $ | 9,363,537 | $ | 7,627,491 | ||||||||||
| General and administrative | 1,072,776 | 1,643,315 | 6,458,699 | $ | 8,427,703 | |||||||||||
| Total operating expenses | 3,431,862 | 3,689,004 | 15,822,236 | 16,055,194 | ||||||||||||
| Loss from operations | (3,226,045 | ) | (3,674,929 | ) | (14,319,655 | ) | (15,471,963 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income, net | 274,626 | 310,287 | 1,289,144 | $ | 1,224,133 | |||||||||||
| Foreign currency gain (loss) | 56,620 | (78,612 | ) | 71,800 | $ | (38,926 | ) | |||||||||
| Total other income | 331,246 | 231,675 | 1,360,944 | 1,185,207 | ||||||||||||
| Net loss | $ | (2,894,799 | ) | $ | (3,443,254 | ) | $ | (12,958,711 | ) | $ | (14,286,756 | ) | ||||
| Other comprehensive (loss) income : | ||||||||||||||||
| Foreign currency translation | (22,632 | ) | 24,601 | (16,106 | ) | $ | 12,135 | |||||||||
| Total comprehensive loss | (2,917,431 | ) | (3,418,653 | ) | $ | (12,974,817 | ) | $ | (14,274,621 | ) | ||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.49 | ) | $ | (0.92 | ) | $ | (2.35 | ) | $ | (3.95 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 5,954,700 | 3,736,673 | 5,509,921 | $ | 3,617,607 |