Aprea Therapeutics Reports Third Quarter 2022 Financial Results and Provides Update on Business Operations
November 09 2022 - 3:15PM
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
nine months ended September 30, 2022 and provided a business
update.
“We are excited about the advancement of ATRN-119, the first
macrocyclic ATR inhibitor, into clinical development,” said Oren
Gilad, Ph.D., President and Chief Executive Officer of Aprea. “We
look forward to collecting clinical data from our Phase 1
trial.”
Third Quarter Financial Results
- Cash and
cash equivalents: As of September 30, 2022, the
Company had $33.1 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 September 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 $1.1 million for the quarter
ended September 30, 2022, compared to $6.0
million for the comparable period in 2021. R&D expenses
for the quarter ended September 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 as well as decreased
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.
- General and
Administrative (G&A) expenses: G&A
expenses were $3.1 million for the quarter
ended September 30, 2022, compared to $3.4
million for the comparable period in 2021. The decrease
in G&A expenses was primarily due to decreased 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, offset in
part by increased professional fees.
- Net
loss: Net loss was $4.0 million, or $0.12
per share for the quarter ended September 30, 2022, compared
to a net loss of $9.5 million, or $0.45 per share for the
quarter ended September 30, 2021. The Company had 52,237,885
shares of common stock outstanding as of September 30, 2022. The
increased common stock outstanding resulted primarily from the
conversion of 2,821,033 shares of Series A preferred stock into
28,210,330 shares of common stock during the third quarter of
2022.
Business Operations Update:
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. The Company is conducting
a Phase 1 clinical trial to evaluate ATRN-119 monotherapy in cancer
patients with defined genetic mutations. This trial was activated
and opened for enrollment in the third quarter of 2022 and the
Company expects to open 1-2 additional sites in the fourth 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 the Company anticipates commencing
IND-enabling studies in the fourth quarter 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. We currently have no
ongoing clinical trials of eprenetapopt.
APR-548 - APR-548 is a second generation p53 reactivator that is
being developed in an oral dosage form. We initiated a Phase 1
clinical trial testing APR-548 in relapsed/refractory MDS and AML
and 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, an orally-bioavailable,
highly potent and selective macrocyclic small molecule inhibitor of
ATR, that is being tested in a Phase 1 clinical trial in solid
tumor indications. ATRN-W1051, the Company’s novel WEE1 inhibitor,
is in preclinical development. 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)
|
September 30, 2022 |
|
December 31, 2021 |
Assets |
|
|
Current assets: |
|
|
Cash and cash
equivalents |
$ |
33,112,601 |
|
|
$ |
53,076,052 |
|
Prepaid expenses and other current
assets |
|
361,178 |
|
|
|
3,508,358 |
|
Total current
assets |
|
33,473,779 |
|
|
|
56,584,410 |
|
Property and equipment,
net |
|
12,237 |
|
|
|
23,870 |
|
Right of use lease and other noncurrent
assets |
|
135,888 |
|
|
|
215,183 |
|
Total
assets |
$ |
33,621,904 |
|
|
$ |
56,823,463 |
|
Liabilities and Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts
payable |
$ |
1,136,064 |
|
|
$ |
1,773,032 |
|
Accrued
expenses |
|
2,751,524 |
|
|
|
5,352,996 |
|
Lease
liability—current |
|
110,551 |
|
|
|
190,471 |
|
Total current
liabilities |
|
3,998,139 |
|
|
|
7,316,499 |
|
Lease
liability—noncurrent |
|
-- |
|
|
|
-- |
|
Total
liabilities |
|
3,998,139 |
|
|
|
7,316,499 |
|
Commitments and contingencies |
|
|
Preferred stock, par value $0.001; 128,597 and 0 shares issued and
outstanding at September 30, 2022 and December 31, 2021,
respectively |
|
2,998,537 |
|
|
|
-- |
|
Stockholders’ equity: |
|
|
Common stock, par value $0.001; 52,237,885 and 21,859,413 shares
issued and outstanding at September 30, 2022 and December 31, 2021,
respectively. |
|
52,237 |
|
|
|
21,859 |
|
Additional paid-in
capital |
|
328,167,899 |
|
|
|
240,978,439 |
|
Accumulated other comprehensive
loss |
|
(10,240,645 |
) |
|
|
(10,358,956 |
) |
Accumulated
deficit |
|
(291,354,263 |
) |
|
|
(181,134,378 |
) |
Total stockholders’
equity |
|
26,625,228 |
|
|
|
49,506,964 |
|
Total liabilities and stockholders’
equity |
$ |
33,621,904 |
|
|
$ |
56,823,463 |
|
|
|
|
|
|
|
|
|
Aprea Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,117,576 |
|
|
$ |
6,015,616 |
|
|
$ |
15,870,867 |
|
|
$ |
19,433,721 |
|
General and administrative |
|
|
3,082,618 |
|
|
|
3,414,795 |
|
|
|
18,849,549 |
|
|
|
10,183,953 |
|
Acquired in-process research and development |
|
|
-- |
|
|
|
-- |
|
|
|
76,020,184 |
|
|
|
-- |
|
Total operating expenses |
|
|
4,200,194 |
|
|
|
9,430,411 |
|
|
|
110,740,600 |
|
|
|
29,617,674 |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense) |
|
|
151,123 |
|
|
|
(33 |
) |
|
|
205,585 |
|
|
|
(1,678 |
) |
Foreign currency (loss) gain |
|
|
24,353 |
|
|
|
(21,907 |
) |
|
|
315,130 |
|
|
|
247,233 |
|
Total other income (expense) |
|
|
175,476 |
|
|
|
(21,940 |
) |
|
|
520,715 |
|
|
|
245,555 |
|
Net loss |
|
$ |
(4,024,718 |
) |
|
$ |
(9,452,351 |
) |
|
$ |
(110,219,885 |
) |
|
$ |
(29,372,119 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
26,161 |
|
|
|
(207,608 |
) |
|
|
118,311 |
|
|
|
(417,438 |
) |
Total comprehensive loss |
|
|
(3,998,557 |
) |
|
|
(9,659,959 |
) |
|
|
(110,101,574 |
) |
|
|
(29,789,557 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.45 |
) |
|
$ |
(4.17 |
) |
|
$ |
(1.39 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
34,655,750 |
|
|
|
21,231,584 |
|
|
|
26,453,091 |
|
|
|
21,201,910 |
|
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