Full Press Release Details
Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update
MA, March 26, 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 and year ended December 31, 2019 and provided a corporate update.
Company is conducting, supporting and planning multiple clinical trials of APR-246:
Quarter Financial Results
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.
p53 and APR-246 (eprenetapopt)
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) is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein - by
restoring wild-type p53 conformation and function - and thereby induce 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. 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.
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," "targets,"
"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
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, including our Annual Report on Form 10-K. 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.
Vice President and Chief Financial Officer
President of Business Development
Consolidated Balance Sheets
| December 31, 2019 | December 31, 2018 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 130,088,869 | $ | 65,675,931 | ||||
| Prepaid expenses and other current assets | 2,955,878 | 322,146 | ||||||
| Total current assets | 133,044,747 | 65,998,077 | ||||||
| Property and equipment, net | 41,639 | 24,450 | ||||||
| Right of use lease and other noncurrent assets | 521,499 | 111 | ||||||
| Total assets | $ | 133,607,885 | $ | 66,022,638 | ||||
| Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,176,852 | $ | 1,739,337 | ||||
| Accrued expenses | 6,642,553 | 3,128,772 | ||||||
| Lease liability-current | 242,329 | - | ||||||
| Total current liabilities | 9,061,734 | 4,868,109 | ||||||
| Lease liability-noncurrent | 302,621 | - | ||||||
| Total liabilities | 9,364,355 | 4,868,109 | ||||||
| Commitments and contingencies | ||||||||
| Convertible preferred stock: | ||||||||
| Series A convertible preferred stock, $0.001 par value; 612,446 shares issued and outstanding at December 31, 2018 | - | 6,483,044 | ||||||
| Series B convertible preferred stock, $0.001 par value; 7,235,969 shares issued and outstanding at December 31, 2018 | - | 49,742,942 | ||||||
| Series C convertible preferred stock, $0.001 par value; 4,712,698 shares issued and outstanding at December 31, 2018 | - | 56,364,645 | ||||||
| Total convertible preferred stock | - | 112,590,631 | ||||||
| Stockholders' equity (deficit): | ||||||||
| Common stock, par value $0.001 at December 31, 2019 and $0.11 at December 31, 2018; 21,022,752 and 1,155,366, shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively. | 21,023 | 127,091 | ||||||
| Additional paid-in capital | 226,284,548 | 19,666,588 | ||||||
| Accumulated other comprehensive loss | (11,533,778 | ) | (8,761,325 | ) | ||||
| Accumulated deficit | (90,528,263 | ) | (62,468,456 | ) | ||||
| Total stockholders' equity (deficit) | 124,243,530 | (51,436,102 | ) | |||||
| Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ | 133,607,885 | $ | 66,022,638 |
Consolidated Statements of Operations and Comprehensive Loss
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 8,041,993 | $ | 4,394,921 | $ | 20,950,672 | $ | 14,194,732 | ||||||||
| General and administrative | 3,937,765 | 504,449 | 8,593,626 | 2,294,671 | ||||||||||||
| Total operating expenses | 11,979,758 | 4,899,370 | 29,544,298 | 16,489,403 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense) | 169,888 | 2 | 156,351 | (182 | ) | |||||||||||
| Foreign currency gain (loss) | (1,262,868 | ) | 219,700 | 1,328,140 | 961,316 | |||||||||||
| Total other income (expense) | (1,092,980 | ) | 219,702 | 1,484,491 | 961,134 | |||||||||||
| Net loss | $ | (13,072,738 | ) | $ | (4,679,668 | ) | $ | (28,059,807 | ) | $ | (15,528,269 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Foreign currency translation | 2,154,388 | 636,489 | (2,772,453 | ) | (473,919 | ) | ||||||||||
| Total comprehensive loss | (10,918,350 | ) | (4,043,179 | ) | (30,832,260 | ) | (16,002,188 | ) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.64 | ) | $ | (4.05 | ) | $ | (4.67 | ) | $ | (13.45 | ) | ||||
| Weighted average basic and diluted shares of common stock outstanding | 20,318,040 | 1,154,677 | 6,002,486 | 1,154,368 |