Full Press Release Details
Aprea Therapeutics Reports Second Quarter
2022 Financial Results and Provides Update on Business Operations
BOSTON, MA, August 11, 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 six months ended June 30, 2022 and provided a business update.
"This is an exciting time for Aprea
as we advance our ATR program into clinical development this year, continue to progress our WEE1 program toward IND submission and leverage
our unique discovery platform capabilities to build for future success," said Oren Gilad, Ph.D., President and Chief Executive Officer
of Aprea. "We believe our current cash resources will last through the end of 2023 and enable us to execute on our development plan
to reach near term clinical milestones."
Second Quarter Financial Results
Business Operations Update:
On May 16, 2022 the Company completed
the acquisition of Atrin Pharmaceuticals, Inc. ("Atrin"), a privately held biotechnology company focused on the discovery
and development of novel therapeutics targeting proteins in the DDR, pathway in oncology through synthetic lethality. Following the Company's
Annual Meeting of Stockholders on July 28, 2022, Christian S. Schade transitioned to the role of Executive Chairman of the Board
of Directors and Oren Gilad, Ph.D., assumed the role of Chief Executive Officer.
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. ATRN-119
has received FDA IND approval for a first-in-human clinical trial for cancer patients and this trial is expected to begin in the third
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 we anticipate commencing IND-enabling studies in the second half of 2022.
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. A manuscript
describing the results of a Phase 2 clinical trial of eprenetapopt with azacitidine after allogeneic stem-cell transplantation in TP53
mutant acute myeloid leukemia and myelodyspastic syndromes has recently been published online in the Journal of Clinical Oncology
and a manuscript describing results of a Phase 1b clinical trial of eprenetapopt with pembrolizumab in advanced solid tumors has been
accepted for publication in ESMO Open. We currently have no ongoing clinical trials of eprenetapopt.
APR-548 - APR-548 is a second generation
p53 reactivator that is a unique analog of eprenetapopt. APR-548 exhibits high oral bioavailability in preclinical testing and is being
developed in an oral dosage form. We initiated a Phase 1 clinical trial testing APR-548 in relapsed/refractory MDS and AML. Enrollment
in the first dosing cohort was completed. There are currently no patients receiving APR-548 in this trial and enrollment into the trial
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, a Phase 1-ready small molecule ATR
inhibitor being developed 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 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
| June 30, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 39,062,415 | $ | 53,076,052 | ||||
| Prepaid expenses and other current assets | 1,400,837 | 3,508,358 | ||||||
| Total current assets | 40,463,252 | 56,584,410 | ||||||
| Property and equipment, net | 20,258 | 23,870 | ||||||
| Right of use lease and other noncurrent assets | 200,326 | 215,183 | ||||||
| Total assets | $ | 40,683,836 | $ | 56,823,463 | ||||
| Liabilities and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,989,794 | $ | 1,773,032 | ||||
| Accrued expenses | 3,505,287 | 5,352,996 | ||||||
| Lease liability-current | 189,116 | 190,471 | ||||||
| Total current liabilities | 7,684,197 | 7,316,499 | ||||||
| Lease liability-noncurrent | -- | -- | ||||||
| Total liabilities | 7,684,197 | 7,316,499 | ||||||
| Commitments and contingencies | ||||||||
| Preferred stock, par value $0.001; 2,949,630 and 0 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 68,777,468 | -- | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock, par value $0.001; 23,401,846 and 21,859,413 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively. | 23,401 | 21,859 | ||||||
| Additional paid-in capital | 261,795,121 | 240,978,439 | ||||||
| Accumulated other comprehensive loss | (10,266,806 | ) | (10,358,956 | ) | ||||
| Accumulated deficit | (287,329,545 | ) | (181,134,378 | ) | ||||
| Total stockholders' equity | (35,777,829 | ) | 49,506,964 | |||||
| Total liabilities and stockholders' equity (deficit) | $ | 40,683,836 | $ | 56,823,463 |
Aprea Therapeutics, Inc.
Condensed Consolidated Statements of Operations
and Comprehensive Loss
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,811,609 | $ | 6,654,257 | $ | 10,901,186 | $ | 13,418,105 | ||||||||
| General and administrative | 15,633,738 | 3,343,325 | 19,619,036 | 6,769,158 | ||||||||||||
| Acquired in-process research and development | 76,020,184 | -- | 76,020,184 | -- | ||||||||||||
| Total operating expenses | 98,465,531 | 9,997,582 | 106,540,406 | 20,187,263 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense) | 52,491 | (588 | ) | 54,462 | (1,645 | ) | ||||||||||
| Foreign currency (loss) gain | 154,566 | (252,843 | ) | 290,777 | 269,140 | |||||||||||
| Total other income (expense) | 207,057 | (253,431 | ) | 345,239 | 267,495 | |||||||||||
| Net loss | $ | (98,258,474 | ) | $ | (10,251,013 | ) | $ | (106,195,167 | ) | $ | (19,919,768 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Foreign currency translation | 157,655 | 193,020 | 92,150 | (209,830 | ) | |||||||||||
| Total comprehensive loss | (98,100,819 | ) | (10,057,993 | ) | (106,103,017 | ) | (20,129,598 | ) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (4.34 | ) | $ | (0.48 | ) | $ | (4.77 | ) | $ | (0.94 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 22,661,835 | 21,186,827 | 22,283,783 | 21,186,827 |