Aprea Therapeutics Reports First Quarter 2023 Financial Results and Provides Update on Business Operations
15 Maio 2023 - 5:05PM
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 ended March 31, 2023 and
provided a business update.
“We are excited about the strong start for 2023 as we focus on
the execution of the pipeline development plan and continue
enrollment in our Phase 1/2a dose escalation study of our ATR
inhibitor, ATRN-119, in patients with biomarkers related to DDR
mutations,” said Oren Gilad, Ph.D., President and Chief Executive
Officer of Aprea. “Our cash position remains strong with a runway
to carry us into the third quarter of 2024 and cross meaningful
clinical milestones in our two lead inhibitor programs, ATR and
WEE1. In February, we closed an underwritten public offering
pursuant to which the Company received approximately $4.9 million
in net proceeds. In April, we participated in the American
Association of Cancer Research Conference where we had the
opportunity to share preclinical results pointing to the potential,
groundbreaking benefits of combination therapy with ATRN-119 and
ATRN-1051. Our IND-enabling studies continue to progress for our
ATRN-1051 inhibitor program and anticipate filing an IND by the end
of 2023.”
Key Business and Financial Updates
- ATR inhibitor
program: ATRN-119 – Enrollment continues in the Phase 1/2a
trial of Aprea’s lead clinical candidate, ATRN-119, a potential
best-in-class ATR inhibitor for treatment of advanced solid tumors
harboring defined mutations in DDR pathways. ATRN-119 is an orally
bioavailable, potent and selective macrocyclic small molecule
inhibitor of ATR. ATR is one of several key regulators impacting
response to defective DNA replication and DNA damage, which occurs
more commonly in cancer cells than in normal cells. Primary
endpoints of the Phase 1 dose escalation part of the study include
safety, tolerability, pharmacokinetics and a recommended Phase 2
dose. The Company expects to report initial safety, tolerability,
and pharmacokinetic data from the ongoing Phase 1 trial of ATRN-119
in the first quarter of 2024.
- 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 preclinical findings support potentially favorable drug
selectivity and exposure. Investigational New Drug (IND) enabling
studies with ATRN-1051 are under way, and the Company anticipates
filing an IND by the end of 2023.
- Presented
Preclinical data on pipeline programs at the American Association
for Cancer Research (AACR) 2023 Annual Meeting, held April 14-19,
2023, in Orlando, Florida. In April 2023, the Company presented a
poster, titled “ATRN-119 and ATRN-W1051: Novel and potentially well
tolerated ATR and WEE1 inhibitors for targeted cancer treatment,”
highlighting its lead program, ATRN-119, and preclinical WEE1
inhibitor, ATRN-1051. In in vivo models, ATRN-119 demonstrated
anti-tumor efficacy, both as a monotherapy and in combination with
PARP inhibitors. In xenograft models, ATRN-1051 demonstrated high
potency, potentially favorable pharmacokinetic properties, and
anti-tumor efficacy.
- Secured
non-dilutive funding via a research grant from
the National Cancer Institute (NCI) supporting development of
DDR inhibitors. In February 2023, 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.
- Closed an
underwritten public offering in February 2023 pursuant to which the
Company received approximately $4.9 million in net proceeds, after
deducting underwriting discounts and offering expenses. Net
proceeds from the public offering support the continuing
development of ATRN-119 and ATRN-1051 as well as general corporate
overhead.
- Appointed Gabriela
Gruia, M.D., to the Board of Directors, strengthening the Company’s
leadership. Dr. Gruia brings over 25 years of clinical, regulatory
and life science leadership experience to Aprea, having worked for
Novartis, Pfizer, Pharmacia, Aventis and Rhone Poulenc. Dr. Gruia
received her M.D. from Bucharest Medical School in Romania and a
Masters in Breast Pathology and Mammography from Rene
Huguenin/Curie Institute Cancer Center in Paris, France.
Select Financial Results for the First Quarter ended
March 31, 2023
- As of March 31,
2023, the Company reported cash and cash equivalents of $31.0
million.
- For the quarter
ended March 31, 2023, the Company reported an operating loss of
$4.6 million, compared to an operating loss of $8.1 million for the
same period in 2022.
- Research and
Development (R&D) expenses were $1.3 million for the quarter
ended March 31, 2023, compared to $4.1 million for the same period
in 2022. The decrease in R&D expense was related to lower
clinical trial expense primarily due to the close out of legacy
Aprea clinical trials, lower personnel costs for the former
facility in Sweden, and lower non-cash stock-based compensation
expense.
- General and
Administrative (G&A) expenses were $3.4 million for the
quarter ended March 31, 2023, compared to $4.0
million for the same period in 2022. The decrease in G&A
expenses was due to a lower non-cash stock-based compensation and
insurance premium expenses, partially offset by higher personnel
costs in the quarter ended March 31, 2023 related to severance
expenses for former executives.
- The Company
reported a net loss of $4.4 million ($1.34 per basic
share) on approximately 3.3 million weighted-average common shares
outstanding for the quarter ended March 31, 2023, compared to
a net loss of $7.9 million ($7.25 per basic share) on
approximately 1.1 million weighted average common shares
outstanding for the same period in 2022.
About Aprea Therapeutics, Inc.
Aprea Therapeutics, Inc. is a clinical stage biopharmaceutical
company headquartered in Doylestown, Pennsylvania, focused on
developing novel synthetic lethality-based cancer therapeutics that
target DNA damage response pathways. 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, without
limitation, risks related to the success, timing and cost of our
ongoing clinical trials and anticipated clinical trials for our
current product candidates, including statements regarding the
timing of initiation, pace of enrollment and completion of the
trials, futility analyses, presentations at conferences and data
reported in an abstract, and receipt of interim or preliminary
results (including, without limitation, any preclinical results or
data), which are not necessarily indicative of the final results of
our ongoing clinical trials, and the other risks, uncertainties,
and other factors described under “Risk Factors,” “Management's
Discussion and Analysis of Financial Condition and Results of
Operations” and elsewhere in the documents we file 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 |
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
30,995,714 |
|
|
$ |
28,786,647 |
|
Prepaid expenses and other current assets |
|
|
1,022,803 |
|
|
|
1,366,859 |
|
Total current assets |
|
|
32,018,517 |
|
|
|
30,153,506 |
|
Property and
equipment, net |
|
|
1,912 |
|
|
|
2,321 |
|
Total assets |
|
$ |
32,020,429 |
|
|
$ |
30,155,827 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
826,027 |
|
|
$ |
842,754 |
|
Accrued expenses |
|
|
3,401,361 |
|
|
|
2,358,332 |
|
Total current liabilities |
|
|
4,227,388 |
|
|
|
3,201,086 |
|
Total liabilities |
|
|
4,227,388 |
|
|
|
3,201,086 |
|
Commitments
and contingencies (Note 8) |
|
|
|
|
|
|
Series A convertible preferred stock, $0.001 par value, 40,000,000
shares authorized; 56,227 shares issued and outstanding at
March 31, 2023 and December 31, 2022,
respectively. |
|
|
1,311,063 |
|
|
|
1,311,063 |
|
Stockholders’ equity: |
|
|
|
|
|
|
Common stock, $0.001 par value, 400,000,000 shares authorized,
3,731,562 and 2,655,269 shares issued and outstanding at
March 31, 2023 and December 31, 2022,
respectively. |
|
|
3,731 |
|
|
|
2,655 |
|
Additional paid-in capital |
|
|
335,215,994 |
|
|
|
330,060,836 |
|
Accumulated other comprehensive loss |
|
|
(10,561,452 |
) |
|
|
(10,623,408 |
) |
Accumulated deficit |
|
|
(298,176,295 |
) |
|
|
(293,796,405 |
) |
Total stockholders’ equity |
|
|
26,481,978 |
|
|
|
25,643,678 |
|
Total liabilities and stockholders' equity |
|
$ |
32,020,429 |
|
|
$ |
30,155,827 |
|
|
|
|
|
|
|
|
|
Aprea
Therapeutics, Inc.Condensed Consolidated
Statements of Operations and Comprehensive Loss |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2023 |
|
2022 |
Operating
expenses: |
|
|
|
|
|
|
Research and development |
|
$ |
1,256,542 |
|
|
$ |
4,089,577 |
|
General and administrative |
|
|
3,365,961 |
|
|
|
3,985,298 |
|
Acquired in-process research and development |
|
|
— |
|
|
|
— |
|
Total
operating expenses |
|
|
4,622,503 |
|
|
|
8,074,875 |
|
Other income
(expense): |
|
|
|
|
|
|
Interest income, net |
|
|
256,410 |
|
|
|
1,971 |
|
Foreign currency (loss) gain |
|
|
(13,797 |
) |
|
|
136,211 |
|
Total other
income |
|
|
242,613 |
|
|
|
138,182 |
|
Net
loss |
|
$ |
(4,379,890 |
) |
|
$ |
(7,936,693 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
Foreign currency translation |
|
|
61,956 |
|
|
|
(65,505 |
) |
Total
comprehensive loss |
|
|
(4,317,934 |
) |
|
|
(8,002,198 |
) |
Net loss per
share attributable to common stockholders, basic and diluted |
|
$ |
(1.34 |
) |
|
$ |
(7.25 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
3,260,484 |
|
|
|
1,095,076 |
|
|
|
|
|
|
|
|
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