Full Press Release Details
Aprea Therapeutics Reports Third Quarter 2024 Financial Results and Provides Business Update
Preliminary results from Phase 1 ACESOT-1051 trial of WEE1 inhibitor, APR-1051, demonstrate the product to be well-tolerated with no unexpected toxicities
Philippe Pultar, MD engaged as senior medical advisor to support the development and advancement of APR-1051
$26.2 million in cash and cash equivalents as of September 30, 2024 with cash runway for at least twelve months
DOYLESTOWN, PA, November 7, 2024 (GLOBE NEWSWIRE) - Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.
"We continue to make meaningful progress advancing our pipeline of two clinical stage therapeutic candidates as well as strengthening our clinical team," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We are ahead of schedule with the enrollment of the Phase 1 ACESOT-1051 trial evaluating our next generation WEE1 inhibitor, APR-1051. Preliminary results at subtherapeutic doses demonstrate the product to be well-tolerated with no unexpected toxicities. APR-1051 has been designed to limit off target toxicity and, based on its unique characteristics, we believe it will be best-in-class. Active enrollment is also ongoing in the Phase 1/2a ABOYA-119 study evaluating ATRN-119, our first-in-class macrocyclic ATR inhibitor. To optimize dosing and scheduling we added a twice-daily dosing regimen."
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
Select Financial Results for the third quarter ended September 30, 2024
Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company headquartered in Doylestown, Pennsylvania, focused on precision oncology through synthetic lethality. The Company's lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor in development for solid tumor indications. APR-1051, an oral, small-molecule WEE1 inhibitor, is our second clinical program. 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, 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.
Ignacio Guerrero-Ros, Ph.D., or David Schull
| Aprea Therapeutics, Inc. | ||||||
| Consolidated Balance Sheets | ||||||
| September 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 26,249,625 | $ | 21,606,820 | ||
| Prepaid expenses and other current assets | 234,195 | 914,275 | ||||
| Total current assets | 26,483,820 | 22,521,095 | ||||
| Property and equipment, net | 86,950 | 88,362 | ||||
| Restricted cash | 41,537 | 40,717 | ||||
| Other noncurrent assets | 281,662 | - | ||||
| Total assets | $ | 26,893,969 | $ | 22,650,174 | ||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,153,880 | $ | 1,670,369 | ||
| Accrued expenses | 2,482,008 | 2,186,262 | ||||
| Deferred revenue | - | 528,974 | ||||
| Total current liabilities | 3,635,888 | 4,385,605 | ||||
| Total liabilities | 3,635,888 | 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 September 30, 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, 5,434,903 and 3,736,673 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively. | 5,435 | 3,736 | ||||
| Additional paid-in capital | 350,693,403 | 335,644,204 | ||||
| Accumulated other comprehensive loss | (10,604,747) | (10,611,273) | ||||
| Accumulated deficit | (318,147,073) | (308,083,161) | ||||
| Total stockholders' equity | 21,947,018 | 16,953,506 | ||||
| Total liabilities and stockholders' equity | $ | 26,893,969 | $ | 22,650,174 |
| Aprea Therapeutics, Inc. | ||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||
| (Unaudited) | ||||||||||||
| Grant revenue | $ | 354,621 | $ | 319,468 | $ | 1,296,764 | $ | 569,156 | ||||
| Operating expenses: | ||||||||||||
| Research and development | 2,846,399 | 2,122,603 | 7,004,451 | 5,581,802 | ||||||||
| General and administrative | 1,605,238 | 1,719,715 | 5,385,923 | 6,784,388 | ||||||||
| Total operating expenses | 4,451,637 | 3,842,318 | 12,390,374 | 12,366,190 | ||||||||
| Loss from operations | (4,097,016) | (3,522,850) | (11,093,610) | (11,797,034) | ||||||||
| Other income (expense): | ||||||||||||
| Interest income, net | 348,741 | 321,215 | 1,014,518 | 913,846 | ||||||||
| Foreign currency (loss) gain | (35,494) | (2,880) | 15,180 | 39,686 | ||||||||
| Total other income | 313,247 | 318,335 | 1,029,698 | 953,532 | ||||||||
| Net loss | $ | (3,783,769) | $ | (3,204,515) | $ | (10,063,912) | $ | (10,843,502) | ||||
| Other comprehensive loss: | ||||||||||||
| Foreign currency translation | 23,557 | (1,002) | 6,526 | (12,466) | ||||||||
| Total comprehensive loss | (3,760,212) | (3,205,517) | (10,057,386) | (10,855,968) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.64) | $ | (0.86) | $ | (1.88) | $ | (3.03) | ||||
| Weighted-average common shares outstanding, basic and diluted | 5,939,755 | 3,735,176 | 5,360,579 | 3,577,482 |