Full Press Release Details
Reports Third Quarter 2022 Financial Results and Provides Update on Business Operations
BOSTON, MA, November 9, 2022 (GLOBE
NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing
novel synthetic lethality-based cancer therapeutics targeting DNA damage response (DDR) pathways today reported financial results for
the three and nine months ended September 30, 2022 and provided a business update.
"We are excited about the advancement
of ATRN-119, the first macrocyclic ATR inhibitor, into clinical development," said Oren Gilad, Ph.D., President and Chief Executive
Officer of Aprea. "We look forward to collecting clinical data from our Phase 1 trial."
Third Quarter Financial Results
Business Operations Update:
ATRN-119 - ATRN-119 is an orally-bioavailable,
highly potent and selective macrocyclic small molecule inhibitor of ATR, a protein with key roles in response to DNA damage. The Company
is conducting a Phase 1 clinical trial to evaluate ATRN-119 monotherapy in cancer patients with defined genetic mutations. This trial
was activated and opened for enrollment in the third quarter of 2022 and the Company expects to open 1-2 additional sites in the fourth
ATRN-W1051 - ATRN-W1051 is an
orally-bioavailable, highly potent and selective small molecule inhibitor of WEE1, a key regulator of multiple phases of the cell cycle.
ATRN-W1051 is currently in preclinical development and the Company anticipates commencing IND-enabling studies in the fourth quarter of
p53 Reactivator Programs
Eprenetapopt - APR-246, or eprenetapopt,
is a small molecule p53 reactivator that has been tested in clinical trials for solid tumors and for hematologic malignancies. We currently
have no ongoing clinical trials of eprenetapopt.
APR-548 - APR-548 is a second generation
p53 reactivator that is being developed in an oral dosage form. We initiated a Phase 1 clinical trial testing APR-548 in relapsed/refractory
MDS and AML and enrollment in the first dosing cohort was completed. There are currently no patients receiving APR-548 in this trial and
enrollment into the trial has been closed.
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered
in Boston, Massachusetts with research facilities in Doylestown, Pennsylvania, focused on developing and commercializing novel cancer
therapeutics that target DNA damage response pathways. The Company's lead program is ATRN-119, an orally-bioavailable, highly potent
and selective macrocyclic small molecule inhibitor of ATR, that is being tested in a Phase 1 clinical trial in solid tumor indications.
ATRN-W1051, the Company's novel WEE1 inhibitor, is in preclinical development. For more information, please visit the company website
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 that involve risks, potential changes in circumstances,
assumptions, and uncertainties. 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 risks related to the success and timing of our clinical trials or other studies, risks associated with the coronavirus pandemic
and the other risks set forth in our filings 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 publicly update such forward-looking statements to reflect subsequent events or circumstances.
Source: Aprea Therapeutics, Inc.
Sr. Vice President and Chief Financial Officer
Sr. Vice President and Chief Operating Officer
Aprea Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| September 30, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 33,112,601 | $ | 53,076,052 | ||||
| Prepaid expenses and other current assets | 361,178 | 3,508,358 | ||||||
| Total current assets | 33,473,779 | 56,584,410 | ||||||
| Property and equipment, net | 12,237 | 23,870 | ||||||
| Right of use lease and other noncurrent assets | 135,888 | 215,183 | ||||||
| Total assets | $ | 33,621,904 | $ | 56,823,463 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,136,064 | $ | 1,773,032 | ||||
| Accrued expenses | 2,751,524 | 5,352,996 | ||||||
| Lease liability-current | 110,551 | 190,471 | ||||||
| Total current liabilities | 3,998,139 | 7,316,499 | ||||||
| Lease liability-noncurrent | -- | -- | ||||||
| Total liabilities | 3,998,139 | 7,316,499 | ||||||
| Commitments and contingencies | ||||||||
| Preferred stock, par value $0.001; 128,597 and 0 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 2,998,537 | -- | ||||||
| Stockholders' equity: | ||||||||
| Common stock, par value $0.001; 52,237,885 and 21,859,413 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively. | 52,237 | 21,859 | ||||||
| Additional paid-in capital | 328,167,899 | 240,978,439 | ||||||
| Accumulated other comprehensive loss | (10,240,645 | ) | (10,358,956 | ) | ||||
| Accumulated deficit | (291,354,263 | ) | (181,134,378 | ) | ||||
| Total stockholders' equity | 26,625,228 | 49,506,964 | ||||||
| Total liabilities and stockholders' equity | $ | 33,621,904 | $ | 56,823,463 |
Aprea Therapeutics, Inc.
Condensed Consolidated Statements of Operations
and Comprehensive Loss
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 1,117,576 | $ | 6,015,616 | $ | 15,870,867 | $ | 19,433,721 | ||||||||
| General and administrative | 3,082,618 | 3,414,795 | 18,849,549 | 10,183,953 | ||||||||||||
| Acquired in-process research and development | -- | -- | 76,020,184 | -- | ||||||||||||
| Total operating expenses | 4,200,194 | 9,430,411 | 110,740,600 | 29,617,674 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense) | 151,123 | (33 | ) | 205,585 | (1,678 | ) | ||||||||||
| Foreign currency (loss) gain | 24,353 | (21,907 | ) | 315,130 | 247,233 | |||||||||||
| Total other income (expense) | 175,476 | (21,940 | ) | 520,715 | 245,555 | |||||||||||
| Net loss | $ | (4,024,718 | ) | $ | (9,452,351 | ) | $ | (110,219,885 | ) | $ | (29,372,119 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Foreign currency translation | 26,161 | (207,608 | ) | 118,311 | (417,438 | ) | ||||||||||
| Total comprehensive loss | (3,998,557 | ) | (9,659,959 | ) | (110,101,574 | ) | (29,789,557 | ) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.12 | ) | $ | (0.45 | ) | $ | (4.17 | ) | $ | (1.39 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 34,655,750 | 21,231,584 | 26,453,091 | 21,201,910 |