Full Press Release Details
Aprea Therapeutics Reports Third Quarter 2023 Financial Results and Provides a Business Update
DOYLESTOWN, PA, Nov. 9, 2023 (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 three and nine months ended September 30, 2023, and provided a business update.
"We are very pleased by the progress of our diversified programs this past quarter. Importantly, we presented initial clinical data from our Phase 1/2a study of our ATR inhibitor, ATRN-119, in solid tumors in a poster at the recent AACR-NCI-EORTC International Conference. To date, ATRN-119 has demonstrated an ability to be a very compelling molecule, appearing to be well tolerated with no reports of dose-limiting toxicities and ongoing daily dosing may result in persistent tumor-reducing effect," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "We are continuing with patients in the dose escalation portion of the study, and the dose expansion cohort is on track to be initiated in 2Q 2024. In our WEE1 inhibitor, ATRN-1051, program we are on track to file an IND with the FDA by the end of 2023, and plan to begin clinical testing in the first half of 2024. Our strong balance sheet continues to support our strategy and plans through our near-term milestones in both our ATR and WEE1 programs, with a cash runway through the end of the fourth quarter of 2024. We look forward to providing more updates as we make progress and reach important milestones in the coming weeks and months."
Key Business and Financial Updates
Potential Upcoming Key Milestones
ATR Inhibitor Clinical Program (ATRN-119)
WEE1 Inhibitor Program (ATRN-1051)
Select Financial Results for the Third Quarter ended September 30, 2023
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. Its oral, small molecule WEE1 inhibitor, ATRN-1051, is being advanced to IND submission. 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, 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 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.
Aprea Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| September 30, | December 31, | |||||
| 2023 | 2022 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 25,353,513 | $ | 28,786,647 | ||
| Prepaid expenses and other current assets | 286,263 | 1,366,859 | ||||
| Total current assets | 25,639,776 | 30,153,506 | ||||
| Property and equipment, net | 86,198 | 2,321 | ||||
| Restricted cash | 40,449 | - | ||||
| Total assets | $ | 25,766,423 | $ | 30,155,827 | ||
| Liabilities and Stockholders' Equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 862,552 | $ | 842,754 | ||
| Accrued expenses | 3,303,510 | 2,358,332 | ||||
| Total current liabilities | 4,166,062 | 3,201,086 | ||||
| Total liabilities | 4,166,062 | 3,201,086 | ||||
| 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, 2023 and December 31, 2022, respectively. | 1,311,063 | 1,311,063 | ||||
| Stockholders' equity: | ||||||
| Common stock, $0.001 par value, 400,000,000 shares authorized, 3,736,673 and 2,655,269 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively. | 3,736 | 2,655 | ||||
| Additional paid-in capital | 335,561,343 | 330,060,836 | ||||
| Accumulated other comprehensive loss | (10,635,874) | (10,623,408) | ||||
| Accumulated deficit | (304,639,907) | (293,796,405) | ||||
| Total stockholders' equity | 20,289,298 | 25,643,678 | ||||
| Total liabilities and stockholders' equity | $ | 25,766,423 | $ | 30,155,827 |
Aprea Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||
| Grant revenue | $ | 319,468 | $ | - | $ | 569,156 | $ | - | ||||
| Operating expenses: | ||||||||||||
| Research and development | 2,122,603 | 1,117,576 | 5,581,802 | 15,870,867 | ||||||||
| General and administrative | 1,719,715 | 3,082,618 | 6,784,388 | 18,849,549 | ||||||||
| Acquired in-process research and development | - | - | - | 76,020,184 | ||||||||
| Total operating expenses | 3,842,318 | 4,200,194 | 12,366,190 | 110,740,600 | ||||||||
| Loss from operations | (3,522,850) | (4,200,194) | (11,797,034) | (110,740,600) | ||||||||
| Other income: | ||||||||||||
| Interest income, net | 321,215 | 151,123 | 913,846 | 205,585 | ||||||||
| Foreign currency gain (loss) | (2,880) | 24,353 | 39,686 | 315,130 | ||||||||
| Total other income | 318,335 | 175,476 | 953,532 | 520,715 | ||||||||
| Net loss | $ | (3,204,515) | $ | (4,024,718) | $ | (10,843,502) | $ | (110,219,885) | ||||
| Other comprehensive loss: | ||||||||||||
| Foreign currency translation | (1,002) | 26,161 | (12,466) | 118,311 | ||||||||
| Total comprehensive loss | (3,205,517) | (3,998,557) | (10,855,968) | (110,101,574) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.86) | $ | (2.32) | $ | (3.03) | $ | (83.33) | ||||
| Weighted-average common shares outstanding, basic and diluted | 3,735,176 | 1,732,783 | 3,577,482 | 1,322,652 |