Full Press Release Details
Aprea Therapeutics Reports First
Quarter 2020 Financial Results and Provides Update on Business Operations
BOSTON, MA, May 15, 2020 (GLOBE
NEWSWIRE) - Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing
novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today reported financial results for the three
months ended March 31, 2020 and provided a business update.
"Despite the challenges caused
by the emerging COVID-19 pandemic, we continued to make significant progress to advance the development of our lead compound, eprenetapopt.
In January 2020 we were granted Breakthrough Therapy Designation by the FDA to support our Phase 3 development program of eprenetapopt
in combination with azacitidine," said Christian S. Schade, President and Chief Executive Officer of Aprea. "We are
proud of the Aprea team, for their efforts to navigate through these uncharted times to support and advance our aggressive development
of both eprenetapopt and our next generation p53 reactivator, APR-548, with minimal interruption."
Business Operations Update:
The Company is conducting, supporting and planning multiple
clinical trials of eprenetapopt or APR-246:
First Quarter Financial Results
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is
a biopharmaceutical company headquartered in Boston, Massachusetts with
research facilities in Stockholm, Sweden, focused on developing and commercializing
novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53. The Company's lead product candidate
is APR-246 (eprenetapopt), a small molecule in clinical development for hematologic
malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). APR-246 has received Breakthrough Therapy,
Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the European Commission for MDS,
AML and ovarian cancer. 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.
About p53 and APR-246 (eprenetapopt)
The p53 tumor suppressor gene is the most frequently mutated
gene in human cancer, occurring in approximately 50% of all human tumors. These mutations are often associated with resistance
to anti-cancer drugs and poor overall survival, representing a major unmet medical need in the treatment of cancer.
APR-246 (eprenetapopt) is a
small molecule that has demonstrated reactivation of mutant and inactivated p53 protein - by restoring wild-type p53 conformation
and function - thereby inducing programmed cell death in human cancer cells. Pre-clinical anti-tumor activity has been observed
with APR-246 in a wide variety of solid and hematological cancers, including MDS, AML, and ovarian cancer, among others. Additionally,
strong synergy has been seen with both traditional anti-cancer agents, such as chemotherapy, as well as newer mechanism-based anti-cancer
drugs and immuno-oncology checkpoint inhibitors. In addition to pre-clinical testing, a Phase 1/2 clinical program with APR-246
has been completed, demonstrating a favorable safety profile and both biological and confirmed clinical responses in hematological
malignancies and solid tumors with mutations in the TP53 gene.
Forward-Looking Statement
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
clinical trials, regulatory submissions and projected cash position. We may, in some cases use terms such as "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,
Sr. Vice President and Chief Financial Officer
Vice President of Business Development
Aprea Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| March 31, 2020 | December 31, 2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 122,513,357 | $ | 130,088,869 | ||||
| Prepaid expenses and other current assets | 2,090,941 | 2,955,878 | ||||||
| Total current assets | 124,604,298 | 133,044,747 | ||||||
| Property and equipment, net | 45,934 | 41,639 | ||||||
| Right of use lease and other noncurrent assets | 474,898 | 521,499 | ||||||
| Total assets | $ | 125,125,130 | $ | 133,607,885 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,006,688 | $ | 2,176,852 | ||||
| Accrued expenses | 8,298,769 | 6,642,553 | ||||||
| Lease liability-current | 238,771 | 242,329 | ||||||
| Total current liabilities | 11,544,228 | 9,061,734 | ||||||
| Lease liability-noncurrent | 227,288 | 302,621 | ||||||
| Total liabilities | 11,771,516 | 9,364,355 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, par value $0.001; 21,054,842 and 21,022,752, shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively. | 21,055 | 21,023 | ||||||
| Additional paid-in capital | 227,219,510 | 226,284,548 | ||||||
| Accumulated other comprehensive loss | (13,958,431 | ) | (11,533,778 | ) | ||||
| Accumulated deficit | (99,928,520 | ) | (90,528,263 | ) | ||||
| Total stockholders' equity | 113,353,614 | 124,243,530 | ||||||
| Total liabilities and stockholders' equity | $ | 125,125,130 | $ | 133,607,885 |
Aprea Therapeutics, Inc.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
| Three Months Ended March 31, | ||||||||
| 2020 | 2019 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 9,096,122 | $ | 3,678,444 | ||||
| General and administrative | 2,776,468 | 729,326 | ||||||
| Total operating expenses | 11,872,590 | 4,407,770 | ||||||
| Other income (expense): | ||||||||
| Interest income (expense) | 224,442 | (3,348 | ) | |||||
| Foreign currency gain | 2,247,891 | 935,916 | ||||||
| Total other income | 2,472,333 | 932,568 | ||||||
| Net loss | $ | (9,400,257 | ) | $ | (3,475,202 | ) | ||
| Other comprehensive loss: | ||||||||
| Foreign currency translation | (2,424,653 | ) | (2,031,175 | ) | ||||
| Total comprehensive loss | (11,824,910 | ) | (5,506,377 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.45 | ) | $ | (2.97 | ) | ||
| Weighted average basic and diluted shares of common stock outstanding | 21,052,726 | 1,171,193 |