Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical
company focused on developing and commercializing novel synthetic
lethality-based cancer therapeutics targeting DNA damage response
(DDR) pathways today reported financial results for the three and
six months ended June 30, 2022 and provided a business update.
“This is an exciting time for Aprea as we advance our ATR
program into clinical development this year, continue to progress
our WEE1 program toward IND submission and leverage our unique
discovery platform capabilities to build for future success,” said
Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea.
“We believe our current cash resources will last through the end of
2023 and enable us to execute on our development plan to reach near
term clinical milestones.”
Second Quarter Financial Results
- Cash and
cash equivalents: As of June 30, 2022, the Company
had $39.1 million of cash and cash equivalents compared
to $53.1 million of cash and cash equivalents as
of December 31, 2021. The Company believes its cash and
cash equivalents as of June 30, 2022 will be sufficient to
meet its current projected operating requirements through the end
of 2023.
- Research and
Development (R&D) expenses: R&D expenses
were $6.8 million for the quarter ended June 30,
2022, compared to $6.7 million for the comparable period
in 2021. R&D expenses for the quarter ended June 30, 2022
primarily represented close out costs for (i) the Company’s pivotal
Phase 3 clinical trial of eprenetapopt with azacitidine for the
frontline treatment of TP53 mutant MDS, (ii) the Company’s Phase 2
post-transplant MDS/AML clinical trial, (iii) the Company’s Phase 1
AML trial, and (iv) the Company’s Phase 1/2 solid tumor trial and
the Company’s Phase 1 dose-escalation trial of APR-548.
- General and
Administrative (G&A) expenses: G&A expenses
were $15.6 million for the quarter ended June 30,
2022, compared to $3.3 million for the comparable period
in 2021. The increase in G&A expenses was primarily due
to an increase in non-cash stock-based compensation expense
resulting from the acceleration of vesting of all outstanding stock
options and restricted stock units in connection with the
acquisition of Atrin in May 2022.
- Acquired
In-Process Research and Development (IPR&D) expenses:
Acquired IPR&D expense was $76.0 million for the quarter ended
June 30, 2022. Acquired IPR&D resulted from the Atrin
Acquisition in May 2022 which was accounted for as an asset
acquisition. The acquisition cost allocated to acquired IPR&D
with no alternative future use was recorded as an expense as of the
closing date.
- Net
loss: Net loss was $98.3 million, or $4.34 per
share for the quarter ended June 30, 2022, compared to a net
loss of $10.3 million, or $0.48 per share for the quarter
ended June 30, 2021. The increase in net loss was primarily
attributable to the acquired in process research and development of
$76.0 million associated with the Atrin acquisition. The Company
had 23,401,846 shares of common stock outstanding as of June 30,
2022.
Business Operations Update:
On May 16, 2022 the Company completed the acquisition of Atrin
Pharmaceuticals, Inc. (“Atrin”), a privately held biotechnology
company focused on the discovery and development of novel
therapeutics targeting proteins in the DDR, pathway in oncology
through synthetic lethality. Following the Company’s Annual Meeting
of Stockholders on July 28, 2022, Christian S. Schade transitioned
to the role of Executive Chairman of the Board of Directors and
Oren Gilad, Ph.D., assumed the role of Chief Executive Officer.
DDR Programs
ATRN-119 – ATRN-119 is an orally-bioavailable, highly potent and
selective macrocyclic small molecule inhibitor of ATR, a protein
with key roles in response to DNA damage. ATRN-119 has received FDA
IND approval for a first-in-human clinical trial for cancer
patients and this trial is expected to begin in the third quarter
of 2022.
ATRN-W1051 – ATRN-W1051 is an orally-bioavailable, highly potent
and selective small molecule inhibitor of WEE1, a key regulator of
multiple phases of the cell cycle. ATRN-W1051 is currently in
preclinical development and we anticipate commencing IND-enabling
studies in the second half of 2022.
p53 Reactivator Programs
Eprenetapopt - APR-246, or eprenetapopt, is a small molecule p53
reactivator that has been tested in clinical trials for solid
tumors and for hematologic malignancies. A manuscript describing
the results of a Phase 2 clinical trial of eprenetapopt with
azacitidine after allogeneic stem-cell transplantation in TP53
mutant acute myeloid leukemia and myelodyspastic syndromes has
recently been published online in the Journal of Clinical Oncology
and a manuscript describing results of a Phase 1b clinical trial of
eprenetapopt with pembrolizumab in advanced solid tumors has been
accepted for publication in ESMO Open. We currently have no ongoing
clinical trials of eprenetapopt.
APR-548 - APR-548 is a second generation p53 reactivator that is
a unique analog of eprenetapopt. APR-548 exhibits high oral
bioavailability in preclinical testing and is being developed in an
oral dosage form. We initiated a Phase 1 clinical trial testing
APR-548 in relapsed/refractory MDS and AML. Enrollment in the first
dosing cohort was completed. There are currently no patients
receiving APR-548 in this trial and enrollment into the trial has
been closed.
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is a biopharmaceutical company
headquartered in Boston, Massachusetts with research facilities in
Doylestown, Pennsylvania, focused on developing and commercializing
novel cancer therapeutics that target DNA damage response pathways.
The Company’s lead program is ATRN-119, a Phase 1-ready small
molecule ATR inhibitor being developed for solid tumor indications.
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.
Corporate Contacts:
Scott M. CoianteSr. Vice President and Chief Financial
Officer617-463-9385
Gregory A. KorbelSr. Vice President and Chief Operating
Officer617-463-9385
Aprea Therapeutics,
Inc.Condensed Consolidated Balance
Sheets(Unaudited)
|
|
June 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$39,062,415 |
|
$53,076,052 |
|
Prepaid expenses and other current assets |
|
1,400,837 |
|
|
3,508,358 |
|
Total current assets |
|
40,463,252 |
|
|
56,584,410 |
|
Property and equipment, net |
|
20,258 |
|
|
23,870 |
|
Right of use lease and other
noncurrent assets |
|
200,326 |
|
|
215,183 |
|
Total assets |
$40,683,836 |
|
$56,823,463 |
|
Liabilities and Stockholders’ Equity
(Deficit) |
|
|
Current liabilities: |
|
|
Accounts payable |
$3,989,794 |
|
$1,773,032 |
|
Accrued expenses |
|
3,505,287 |
|
|
5,352,996 |
|
Lease liability—current |
|
189,116 |
|
|
190,471 |
|
Total current liabilities |
|
7,684,197 |
|
|
7,316,499 |
|
Lease liability—noncurrent |
|
-- |
|
|
-- |
|
Total liabilities |
|
7,684,197 |
|
|
7,316,499 |
|
Commitments and contingencies |
|
|
Preferred stock, par value $0.001; 2,949,630 and 0 shares issued
and outstanding at June 30, 2022 and December 31, 2021,
respectively |
|
68,777,468 |
|
|
-- |
|
Stockholders’ equity (deficit): |
|
|
Common stock, par value $0.001; 23,401,846 and 21,859,413 shares
issued and outstanding at June 30, 2022 and December 31, 2021,
respectively. |
|
23,401 |
|
|
21,859 |
|
Additional paid-in capital |
|
261,795,121 |
|
|
240,978,439 |
|
Accumulated other comprehensive loss |
|
(10,266,806) |
|
|
(10,358,956) |
|
Accumulated deficit |
|
(287,329,545) |
|
|
(181,134,378) |
|
Total stockholders’ equity |
|
(35,777,829) |
|
|
49,506,964 |
|
Total liabilities and stockholders’ equity (deficit) |
$40,683,836 |
|
$56,823,463 |
|
Aprea Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,811,609 |
|
|
$ |
6,654,257 |
|
|
$ |
10,901,186 |
|
|
$ |
13,418,105 |
|
|
General and administrative |
|
|
15,633,738 |
|
|
|
3,343,325 |
|
|
|
19,619,036 |
|
|
|
6,769,158 |
|
|
Acquired in-process research and development |
|
|
76,020,184 |
|
|
|
-- |
|
|
|
76,020,184 |
|
|
|
-- |
|
|
Total operating expenses |
|
|
98,465,531 |
|
|
|
9,997,582 |
|
|
|
106,540,406 |
|
|
|
20,187,263 |
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense) |
|
|
52,491 |
|
|
|
(588) |
|
|
|
54,462 |
|
|
|
(1,645) |
|
|
Foreign currency (loss) gain |
|
|
154,566 |
|
|
|
(252,843) |
|
|
|
290,777 |
|
|
|
269,140 |
|
|
Total other income (expense) |
|
|
207,057 |
|
|
|
(253,431) |
|
|
|
345,239 |
|
|
|
267,495 |
|
|
Net loss |
|
$ |
(98,258,474) |
|
|
$ |
(10,251,013) |
|
|
$ |
(106,195,167) |
|
|
$ |
(19,919,768) |
|
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
157,655 |
|
|
|
193,020 |
|
|
|
92,150 |
|
|
|
(209,830) |
|
|
Total comprehensive loss |
|
|
(98,100,819) |
|
|
|
(10,057,993) |
|
|
|
(106,103,017) |
|
|
|
(20,129,598) |
|
|
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(4.34) |
|
|
$ |
(0.48) |
|
|
$ |
(4.77) |
|
|
$ |
(0.94) |
|
|
Weighted-average common shares
outstanding, basic and diluted |
|
|
22,661,835 |
|
|
|
21,186,827 |
|
|
|
22,283,783 |
|
|
|
21,186,827 |
|
|
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