Full Press Release Details
Aprea Therapeutics Reports Second Quarter
2021 Financial Results and Provides Update on Business Operations
BOSTON, MA, August 12, 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 and
six months ended June 30, 2021 and provided a business update.
Business Operations Update:
The Company is conducting, supporting, and planning multiple clinical
trials of eprenetapopt (APR-246) and APR-548. On August 4, 2021, the U.S. Food and Drug Administration (FDA) placed a partial clinical
hold on the clinical trials of eprenetapopt in combination with azacitidine in our myeloid malignancy programs.
There are approximately 20 patients currently receiving eprenetapopt
in combination with azacitidine in our myeloid malignancy programs, which includes the MDS, AML and post-transplant maintenance trials,
all of which have completed enrollment. Patients who are benefiting from treatment can continue to receive study treatment. As part of
the partial clinical hold, no additional patients should be enrolled to these clinical trials until the partial clinical hold is resolved,
The Company intends to work closely with the FDA to analyze the data, address the specific questions raised, and seek to resolve the partial
clinical hold as soon as possible.
On August 11, 2021, the FDA placed a clinical hold on the
Company's clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies.
There is one CLL patient currently on study treatment receiving eprenetapopt in combination with venetoclax and rituximab. This
patient may continue to receive study treatment as long as the patient is deriving clinical benefit. No additional patients can be
enrolled until the clinical hold is resolved. The Company intends to work closely with the FDA to address the specific questions
raised, and seek to resolve the clinical hold as soon as possible.
The Company's current clinical trials are as follows:
Second 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 eprenetapopt (APR-246), a small molecule
in clinical development for hematologic malignancies and solid tumors. 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 statistical endpoint of complete
remission. Eprenetapopt is currently on clinical hold in myeloid and lymphoid malignancies. 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 and AML. 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.
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 Business Officer
Aprea Therapeutics, Inc.
Condensed Consolidated Balance Sheets
| June 30, 2021 | December 31, 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 69,803,845 | $ | 89,017,686 | ||||
| Prepaid expenses and other current assets | 1,494,453 | 3,399,019 | ||||||
| Total current assets | 71,298,298 | 92,416,705 | ||||||
| Property and equipment, net | 30,955 | 38,515 | ||||||
| Right of use lease and other noncurrent assets | 220,477 | 349,999 | ||||||
| Total assets | $ | 71,549,730 | $ | 92,805,219 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,361,318 | $ | 4,503,619 | ||||
| Accrued expenses | 8,037,524 | 10,571,237 | ||||||
| Lease liability-current | 199,219 | 256,309 | ||||||
| Total current liabilities | 10,598,061 | 15,331,165 | ||||||
| Lease liability-noncurrent | -- | 78,847 | ||||||
| Total liabilities | 10,598,061 | 15,410,012 | ||||||
| Commitments and contingencies Stockholders' equity: | ||||||||
| Common stock, par value $0.001; 21,186,827 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively. | 21,187 | 21,187 | ||||||
| Additional paid-in capital | 235,104,416 | 231,418,356 | ||||||
| Accumulated other comprehensive loss | (10,247,091 | ) | (10,037,261 | ) | ||||
| Accumulated deficit | (163,926,843 | ) | (144,007,075 | ) | ||||
| Total stockholders' equity | 60,951,669 | 77,395,207 | ||||||
| Total liabilities and stockholders' equity | $ | 71,549,730 | $ | 92,805,219 |
Aprea Therapeutics, Inc.
Condensed Consolidated Statements of Operations
and Comprehensive Loss
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,654,257 | $ | 10,694,029 | $ | 13,418,105 | $ | 19,790,151 | ||||||||
| General and administrative | 3,343,325 | 3,786,886 | 6,769,158 | 6,563,354 | ||||||||||||
| Total operating expenses | 9,997,582 | 14,480,915 | 20,187,263 | 26,353,505 | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income (expense) | (588 | ) | 2,678 | (1,645 | ) | 227,120 | ||||||||||
| Foreign currency (loss) gain | (252,843 | ) | (1,889,690 | ) | 269,140 | 358,201 | ||||||||||
| Total other income (expense) | (253,431 | ) | (1,887,012 | ) | 267,495 | 585,321 | ||||||||||
| Net loss | $ | (10,251,013 | ) | $ | (16,367,927 | ) | $ | (19,919,768 | ) | $ | (25,768,184 | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Foreign currency translation | 193,020 | 1,756,783 | (209,830 | ) | (667,870 | ) | ||||||||||
| Total comprehensive loss | (10,057,993 | ) | (14,611,144 | ) | (20,129,598 | ) | (26,436,054 | ) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.48 | ) | $ | (0.78 | ) | $ | (0.94 | ) | $ | (1.22 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 21,186,827 | 21,107,056 | 21,186,827 | 21,079,891 |