Full Press Release Details
Aprea Therapeutics Reports First Quarter
2021 Financial Results and Provides Update on Business Operations
BOSTON, MA, May 6, 2021 (GLOBE
NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical company focused on developing and commercializing
novel cancer therapeutics that reactivate the mutant tumor suppressor protein, p53, today reported financial results for the three months
ended March 31, 2021 and provided a business update.
"During our recent R&D Day presentation,
we reported an analysis of available data from its Phase 3 MDS trial. We identified an imbalance in dose modifications in the experimental
arm which we believe negatively impacted efficacy, particularly the primary CR endpoint," said Christian S. Schade, Chairman and
Chief Executive Officer of Aprea. "We remain confident that eprenetapopt and our next-generation oral agent, APR-548, represent
important potential therapeutic options for cancer patients and are encouraged by emerging data from our ongoing clinical trials. We look
forward to sharing data updates from these clinical trials as well as our continued progress in expanding the opportunity for our therapies
in new indications."
Business Operations Update:
The Company is conducting, supporting, and planning multiple clinical
trials of eprenetapopt (APR-246) and APR-548:
First 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 eprenetapopt (APR-246), a small molecule in clinical development for hematologic malignancies
and solid tumors. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for myelodysplastic
syndromes (MDS), Orphan Drug and Fast Track designations from the FDA for acute myeloid leukemia (AML), and Orphan Drug designation from
the European Commission for MDS, AML and ovarian cancer. APR-548, a next generation small molecule reactivator of mutant p53, is being
developed for oral administration. For more information, please visit the company website at www.aprea.com.
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, eprenetapopt and APR-548
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
A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine for
frontline treatment of TP53 mutant MDS has been completed and failed to meet the primary endpoint of complete remission. Additional
clinical trials in hematologic malignancies and solid tumors are ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug
and Fast Track designations from the FDA for MDS, Orphan Drug and Fast Track designations from the FDA for AML, and Orphan Drug designation
from the European Medicines Agency for MDS, AML and ovarian cancer.
APR-548 is a next-generation small molecule p53 reactivator. APR-548
has demonstrated high oral bioavailability, enhanced potency relative to eprenetapopt in TP53 mutant cancer cell lines and has
demonstrated in vivo tumor growth inhibition following oral dosing of tumor-bearing mice. Enrollment in a Phase 1 clinical trial of APR-548
is anticipated to begin early in the second quarter of 2021.
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 Business Officer
Aprea Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| March 31, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 77,616,074 | $ | 89,017,686 | ||||
| Prepaid expenses and other current assets | 2,467,443 | 3,399,019 | ||||||
| Total current assets | 80,083,517 | 92,416,705 | ||||||
| Property and equipment, net | 33,572 | 38,515 | ||||||
| Right of use lease and other noncurrent assets | 277,576 | 349,999 | ||||||
| Total assets | $ | 80,394,665 | $ | 92,805,219 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,456,728 | $ | 4,503,619 | ||||
| Accrued expenses | 7,532,473 | 10,571,237 | ||||||
| Lease liability-current | 225,537 | 256,309 | ||||||
| Total current liabilities | 11,214,738 | 15,331,165 | ||||||
| Lease liability-noncurrent | 33,763 | 78,847 | ||||||
| Total liabilities | 11,248,501 | 15,410,012 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, par value $0.001; 21,186,827 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively. | 21,187 | 21,187 | ||||||
| Additional paid-in capital | 233,240,918 | 231,418,356 | ||||||
| Accumulated other comprehensive loss | (10,440,111 | ) | (10,037,261 | ) | ||||
| Accumulated deficit | (153,675,830 | ) | (144,007,075 | ) | ||||
| Total stockholders' equity | 69,146,164 | 77,395,207 | ||||||
| Total liabilities and stockholders' equity | $ | 80,394,665 | $ | 92,805,219 |
Aprea Therapeutics, Inc.
Condensed Consolidated Statements of Operations
and Comprehensive Loss
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 6,763,848 | $ | 9,096,122 | ||||
| General and administrative | 3,425,833 | 2,776,468 | ||||||
| Total operating expenses | 10,189,681 | 11,872,590 | ||||||
| Other income (expense): | ||||||||
| Interest (expense) income | (1,057 | ) | 224,442 | |||||
| Foreign currency (loss) gain | 521,983 | 2,247,891 | ||||||
| Total other income (expense) | 520,926 | 2,472,333 | ||||||
| Net loss | $ | (9,668,755 | ) | $ | (9,400,257 | ) | ||
| Other comprehensive income (loss): | ||||||||
| Foreign currency translation | (402,850 | ) | (2,424,653 | ) | ||||
| Total comprehensive loss | (10,071,605 | ) | (11,824,910 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.46 | ) | $ | (0.45 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 21,186,827 | 21,052,726 |