Aprea Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Update on Business Operations
March 30 2023 - 3:05PM
Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the
“Company”), a clinical stage biopharmaceutical company focused on
developing novel synthetic lethality-based cancer therapeutics
targeting DNA damage response (DDR) pathways, today reported
financial results for the three months and year ended December 31,
2022 and provided a business update.
“2022 has been another transformational year for Aprea with
progress on multiple fronts,” said Oren Gilad, Ph.D., President and
Chief Executive Officer of Aprea. “With the initiation of the Phase
1/2a clinical trial of our ATR inhibitor, ATRN-119, we remain on
track to provide an update on clinical data later this year.
Following this important achievement, we further strengthened our
cash position with the closing of a public offering pursuant to
which we received approximately $5.5 million in gross proceeds,
allowing us to extend our cash runway into the third quarter of
2024. We believe our current cash runway will allow us to cross
meaningful clinical milestones for our two lead programs.
Additionally, we announced a non-dilutive SBIR award from the
National Cancer Institute and welcomed John Hamill to the Aprea
team. We look forward to his contribution as Chief Financial
Officer as we advance our clinical pipeline of synthetic
lethality-based cancer therapeutics targeting DDR pathways.”
Key Business and Financial Updates
- ATR inhibitor program:
ATRN-119 – Significant progress made on the development of our
lead ATR inhibitor program. Our lead clinical candidate, ATRN-119,
is a potential best-in-class oral ATR inhibitor for treatment of
advanced solid tumors harboring defined mutations in DDR pathways.
The Phase 1/2a trial continues to enroll patients with biomarkers
related to DDR mutations. ATRN-119 is an orally bioavailable,
potent and selective macrocyclic small molecule inhibitor of ATR, a
protein with key roles in response to DNA damage. The primary
endpoint of the Phase 1 dose escalation part of the study is to
assess safety/tolerability, pharmacokinetics and recommended Phase
2 dose. The Phase 2a expansion part of the study is designed to
further evaluate tolerability and preliminary efficacy of ATRN-119
monotherapy in advanced solid tumors.
- WEE1 inhibitor
program: ATRN-1051 – ATRN-1051 is an orally-bioavailable,
highly potent and selective small molecule inhibitor of WEE1, a key
regulator of multiple phases of the cell cycle. The Company
believes that preclinical findings show potentially favorable drug
selectivity and exposure. IND-enabling studies with ATRN-1051 are
under way and the Company anticipates filing of an IND with the FDA
by the end of 2023.
- An abstract on
combination of ATRN-119 and ATRN-1051 was selected for presentation
as a poster at the American Association for Cancer Research (AACR)
2023 Annual Meeting, being held April 14-19, 2023, in Orlando,
Florida.
- Obtained
non-dilutive funding via a research grant from
the National Cancer Institute (NCI) supporting development of
DDR inhibitors. The Company announced that it received an award
notification from the NCI for the development of a
first-in-class combination of DNA damage response inhibitors for
the treatment of high-grade serous ovarian cancer (HGSOC). HGSOC is
a devastating disease responsible for the deaths of about 125,000
women worldwide each year and has low survival rates.
- Announced the
Company had regained compliance with Nasdaq’s minimum bid price
requirement for continued listing on the Nasdaq Global Select
Market.
- Closed an
underwritten public offering in Q1 of 2023 pursuant to which we
received approximately $5.5 million in gross proceeds. The net
proceeds received from the public offering will enable the Company
to continue developing its clinical asset, ATRN-119, its
pre-clinical asset ATRN-1051 and for general corporate
purposes.
Select Financial Results for the Fourth Quarter ended
December 31, 2022
- As of December 31,
2022, the Company reported cash and cash equivalents of $28.8
million.
- For the fourth
quarter ended December 31, 2022, the Company reported an operating
loss of $2.7 million, compared to an operating loss of $7.8 million
in the fourth quarter of 2021.
- Research and
Development (R&D) expenses were $0.5 million for the quarter
ended December 31, 2022, compared to $4.5 million for the fourth
quarter of 2021. The decrease in R&D expense was primarily
related to the wrap up and close out of legacy Aprea clinical
trials which were largely completed by the fourth quarter 2022.
Aprea only had one active clinical trial in the 4th quarter of 2022
compared to six active clinical trials in the 4th quarter of
2021.
- General and
Administrative (G&A) expenses were $2.1 million for the
quarter ended December 31, 2022, compared to $3.4
million for the comparable period in 2021. The decrease
in G&A expenses was primarily due to a decrease in non-cash
stock-based compensation.
- The Company
reported a net loss of $2.4 million ($0.92 per basic
share) on approximately 2.6 million weighted-average common shares
outstanding for the quarter ended December 31, 2022, compared
to a net loss of $7.8 million ($7.20 per basic share) on
approximately 1.1 million weighted average common shares
outstanding for the comparable period in 2021.
Select Financial Results for the Year ended December 31,
2022
- As of December 31,
2022, the Company reported cash and cash equivalents of $28.8
million compared to $53.1 million as of December 31, 2021. The
Company believes its cash and cash equivalents as of December 31,
2022, combined with the gross proceeds received from the Company’s
$5.5 million public offering of common stock in February 2023 will
be sufficient to meet its current projected operating requirements
into the third quarter of 2024.
- For the year ended
December 31, 2022, the Company reported an operating loss of $113.4
million, which include $76.0 million for acquired in-process
research and development, compared to an operating loss of $37.4
million for the year ended December 31, 2021.
- Research and
Development (R&D) expenses were $16.4 million for the year
ended December 31, 2022, compared to $23.9 million for the year
ended December 31, 2021. The decrease in R&D expense was
primarily related to the wrap up and close out of legacy Aprea
clinical trials which were largely completed by the fourth quarter
of 2022.
- General and
Administrative (G&A) expenses were $21.0 million for the
year ended December 31, 2022, compared to $13.6
million for the year ended December 31, 2021. The increase in
G&A expenses was primarily due to an increase in non-cash
stock-based compensation from the acceleration of vesting of all
outstanding stock options and restricted stock units in connection
with the acquisition of Atrin Pharmaceuticals Inc. in May
2022.
- The Company
reported a net loss was of $112.7 million ($67.99 per
basic share) on approximately 1.7 million weighted-average common
shares outstanding for the year ended December 31, 2022,
compared to a net loss of $37.1 million ($34.88 per basic
share) on approximately 1.1 million weighted average common shares
outstanding for the same period in 2021.
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is a clinical stage biopharmaceutical
company headquartered in Doylestown, Pennsylvania, focused on
developing and commercializing novel synthetic lethality-based
cancer therapeutics targeting a critical pathway and some of the
most central targets in DDR and cancer progression. The Company’s
lead program is ATRN-119, a clinical-stage small molecule ATR
inhibitor being developed for solid tumor indications. Our WEE1
inhibitor is being advanced to IND submission. 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 and on information currently
available to management that involve risks, potential changes in
circumstances, assumptions, and uncertainties. All statements
contained in this press release other than statements of historical
fact are forward-looking statements, including statements regarding
our ability to develop, commercialize and achieve market acceptance
of our current and planned products and services, our research and
development efforts, and other matters regarding our business
strategies, use of capital, results of operations and financial
position, and plans and objectives for future operations. 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 update such forward-looking statements for any
reason, except as required by law.
Source: Aprea Therapeutics, Inc.
Investors and Media:
aprea@argotpartners.com212-600-1902
Aprea Therapeutics,
Inc.Condensed Consolidated Balance
Sheets
|
December 31, 2022 |
|
|
December 31, 2021 |
|
Assets |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$28,786,647 |
|
|
$53,076,052 |
|
Prepaid expenses and other current assets |
|
1,366,859 |
|
|
|
3,508,358 |
|
Total current assets |
|
30,153,506 |
|
|
|
56,584,410 |
|
Property
and equipment, net |
|
2,321 |
|
|
|
23,870 |
|
Right of
use lease and other noncurrent assets |
|
-- |
|
|
|
215,183 |
|
Total assets |
$30,155,827 |
|
|
$56,823,463 |
|
Liabilities and Stockholders’ Equity |
|
|
Current
liabilities: |
|
|
Accounts payable |
$842,754 |
|
|
$1,773,032 |
|
Accrued expenses |
|
2,358,332 |
|
|
|
5,352,996 |
|
Lease liability—current |
|
-- |
|
|
|
190,471 |
|
Total current liabilities |
|
3,201,086 |
|
|
|
7,316,499 |
|
Lease liability—noncurrent |
|
-- |
|
|
|
-- |
|
Total liabilities |
|
3,201,086 |
|
|
|
7,316,499 |
|
Commitments and contingencies |
|
|
Preferred stock, par value $0.001; 56,227 and 0 shares issued and
outstanding at December 31, 2022 and 2021, respectively |
|
1,311,063 |
|
|
|
-- |
|
Stockholders’ equity: |
|
|
Common stock, par value $0.001; 2,655,269 and 1,092,967 shares
issued and outstanding at December 31, 2022 and 2021,
respectively. |
|
2,655 |
|
|
|
1,092 |
|
Additional paid-in capital |
|
330,060,836 |
|
|
|
240,999,206 |
|
Accumulated other comprehensive loss |
|
(10,623,408 |
) |
|
|
(10,358,956 |
) |
Accumulated deficit |
|
(293,796,405 |
) |
|
|
(181,134,378 |
) |
Total stockholders’ equity |
|
25,643,678 |
|
|
|
49,506,964 |
|
Total liabilities and stockholders’ equity |
|
$30,155,827 |
|
|
$56,823,463 |
|
Aprea Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive Loss
|
|
Three Months Ended
December 31,(Unaudited) |
|
Year Ended December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
531,406 |
|
|
$ |
4,462,154 |
|
|
$ |
16,402,273 |
|
|
$ |
23,895,875 |
|
|
General and administrative |
|
|
2,120,222 |
|
|
|
3,366,525 |
|
|
|
20,969,771 |
|
|
|
13,550,478 |
|
|
Acquired in-process research and development |
|
|
-- |
|
|
|
-- |
|
|
|
76,020,184 |
|
|
|
-- |
|
|
Total
operating expenses |
|
|
2,651,628 |
|
|
|
7,828,679 |
|
|
|
113,392,228 |
|
|
|
37,446,353 |
|
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
243,082 |
|
|
|
3,326 |
|
|
|
448,667 |
|
|
|
1,648 |
|
|
Foreign currency gain (loss) |
|
|
(33,596 |
) |
|
|
70,169 |
|
|
|
281,534 |
|
|
|
317,402 |
|
|
Total
other income |
|
|
209,486 |
|
|
|
73,495 |
|
|
|
730,201 |
|
|
|
319,050 |
|
|
Net
loss |
|
$ |
(2,442,142 |
) |
|
$ |
(7,755,184 |
) |
|
$ |
(112,662,027 |
) |
|
$ |
(37,127,303 |
) |
|
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
(382,763 |
) |
|
|
95,743 |
|
|
|
(264,452 |
) |
|
|
(321,695 |
) |
|
Total
comprehensive loss |
|
|
(2,824,905 |
) |
|
|
(7,659,441 |
) |
|
|
(112,926,479 |
) |
|
|
(37,448,998 |
) |
|
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.92 |
) |
|
$ |
(7.20 |
) |
|
$ |
(67.99 |
) |
|
$ |
(34.88 |
) |
|
Weighted-average common shares outstanding, basic and diluted |
|
|
2,649,349 |
|
|
|
1,076,940 |
|
|
|
1,657,055 |
|
|
|
1,064,325 |
|
|
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