Full Press Release Details
Aprea Therapeutics Reports Second
Quarter 2020 Financial Results and Provides Update on Business Operations
BOSTON, MA, August 11, 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
and six months ended June 30, 2020 and provided a business update.
"The full enrollment in June of
our Phase 3 clinical trial evaluating eprenetapopt (APR-246) with azacitidine for the treatment of front-line TP53 mutant
myelodysplastic syndromes (MDS) was a major milestone for Aprea and we look forward to top-line data by year-end 2020," said
Christian S. Schade, President and Chief Executive Officer of Aprea. "In addition, we continue to advance the clinical development
of eprenetapopt in different clinical settings and have recently enrolled the first patient in our solid tumor clinical trial program."
Business Operations Update:
The Company is conducting, supporting and planning multiple
clinical trials of eprenetapopt (APR-246):
Second Quarter Financial Results
About Aprea Therapeutics, Inc.
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.
Eprenetapopt (APR-246)
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 eprenetapopt 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 eprenetapopt 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.
A pivotal Phase 3 clinical trial of
eprenetapopt and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. Eprenetapopt has received Breakthrough
Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the EMA for MDS, AML and
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, Inc.
Sr. Vice President and Chief Financial Officer
Vice President of Business Development
Aprea Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| June 30, 2020 | December 31,2019 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 112,861,504 | $ | 130,088,869 | ||||
| Prepaid expenses and other current assets | 1,475,223 | 2,955,878 | ||||||
| Total current assets | 114,336,727 | 133,044,747 | ||||||
| Property and equipment, net | 43,906 | 41,639 | ||||||
| Right of use lease and other noncurrent assets | 438,162 | 521,499 | ||||||
| Total assets | $ | 114,818,795 | $ | 133,607,885 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,443,126 | $ | 2,176,852 | ||||
| Accrued expenses | 8,827,860 | 6,642,553 | ||||||
| Lease liability-current | 241,527 | 242,329 | ||||||
| Total current liabilities | 11,512,513 | 9,061,734 | ||||||
| Lease liability-noncurrent | 185,926 | 302,621 | ||||||
| Total liabilities | 14,698,439 | 9,364,355 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, par value $0.001; 21,186,827 and 21,022,752, shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively. | 21,187 | 21,023 | ||||||
| Additional paid-in capital | 228,597,264 | 226,284,548 | ||||||
| Accumulated other comprehensive loss | (12,201,648 | ) | (11,533,778 | ) | ||||
| Accumulated deficit | (116,296,447 | ) | (90,528,263 | ) | ||||
| Total stockholders' equity | 100,120,356 | 124,243,530 | ||||||
| Total liabilities and stockholders' equity | $ | 114,818,795 | $ | 133,607,885 |
Aprea Therapeutics, Inc.
Condensed Consolidated Statements of
Operations and Comprehensive Loss
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 10,694,029 | $ | 4,319,826 | $ | 19,790,151 | $ | 7,998,270 | ||||||||
| General and administrative | 3,786,886 | 1,618,589 | 6,563,354 | 2,347,915 | ||||||||||||
| Total operating expenses | 14,480,915 | 5,938,415 | 26,353,505 | 10,346,185 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense) | 2,678 | (4,091 | ) | 227,120 | (7,439 | ) | ||||||||||
| Foreign currency (loss) gain | (1,889,690 | ) | 680,058 | 358,201 | 1,615,974 | |||||||||||
| Total other income (expense) | (1,887,012 | ) | 675,967 | 585,321 | 1,608,535 | |||||||||||
| Net loss | $ | (16,367,927 | ) | $ | (5,262,448 | ) | $ | (25,768,184 | ) | $ | (8,737,650 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Foreign currency translation | 1,756,783 | 44,508 | (667,870 | ) | (1,986,667 | ) | ||||||||||
| Total comprehensive loss | (14,611,144 | ) | (5,217,940 | ) | (26,436,054 | ) | (10,724,317 | ) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.78 | ) | $ | (4.45 | ) | $ | (1.22 | ) | $ | (7.43 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 21,107,056 | 1,181,583 | 21,079,891 | 1,176,417 |