Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical
company focused on developing and commercializing novel cancer
therapeutics targeting DNA damage response pathways today announced
that it has acquired Atrin Pharmaceuticals Inc. (“Atrin”) and
reported financial results for the three months ended March
31, 2022.
Business Operations Update:
On May 16, 2022 Aprea completed the acquisition of Atrin, a
privately held biotechnology company focused on the discovery and
development of novel therapeutics targeting proteins in the DNA
damage response, or DDR, pathway in oncology through synthetic
lethality. The Company believes its cash and cash equivalents as of
March 31, 2022 will be sufficient to meet its current
projected operating requirements through the second half of
2023.
With the acquisition of the Atrin programs, Aprea intends to
shift its primary focus to the ATR inhibitor ATRN-119, which will
be studied as both a monotherapy and in combination with standard
of care in Phase 1/2a clinical trials in solid tumor malignancies.
In parallel with ATRN-119 development, Atrin initiated separate
programs for a second-generation ATR inhibitor, ATRN-354, with
potentially improved potency and pharmacokinetics, as well as for a
potentially highly potent and selective WEE1 inhibitor –
ATRN-W1051. These programs are expected to enter IND-enabling
studies in 2022 and Aprea anticipates filing Investigational New
Drug applications for these programs in 2023. Furthermore, with the
acquisition of Atrin, Aprea obtained an active proprietary
development platform to drive the identification of new oncology
drug targets and biomarkers.
“Aprea has explored a range of strategic alternatives to
maximize shareholder value and we believe the acquisition of Atrin
represents an opportunity to create substantial value for Aprea
shareholders,” said Christian Schade, Chairman and Chief Executive
Officer of Aprea. “The founders of Atrin are pioneers in the
development of novel oncology compounds in the DNA damage pathway.
We are excited to work with the Atrin team to begin clinical
development of Atrin’s lead ATR program over the coming months,
hasten the development of its differentiated WEE1 program, and
support a robust platform to build a pipeline of novel inhibitors
of the DDR pathway.”
“We are excited to join forces with Aprea and expedite the
clinical development of our lead programs and drug development
platform,” said Oren Gilad, Ph.D., the former Chief Executive
Officer of Atrin. "Aprea’s knowledge of the p53 pathway in oncology
is complimentary to Atrin’s in-house expertise in developing novel
targets in the DNA damage response pathway. With supportive
resources we look forward to moving our programs into clinical
development to better understand the importance of our robust
synthetic lethality platform.”
Management and Organization
Christian Schade, our current Chairman and Chief Executive
Officer will remain with Aprea along with Scott Coiante, our
current Senior Vice President and Chief Financial Officer, and Greg
Korbel will remain with Aprea, but will transition from his current
role as Senior Vice President and Chief Business Officer to Senior
Vice President and Chief Operating Officer. Our management team
will be expanded with the appointment of Dr. Gilad, the former
Chief Executive Officer of Atrin, who will be President of Aprea
and Ze’ev Weiss, the former Chief Business Officer of Atrin, who
will be the Chief Business Officer of Aprea. After the 2022 annual
stockholder meeting of Aprea, Dr. Gilad will assume the role of
Chief Executive Officer from Mr. Schade and Mr. Schade will
continue as Executive Chairman of the Board of Directors.
In conjunction with the transaction, the Aprea board was
expanded to eight members. Immediately following the consummation
of the transaction, the Aprea board will consist of, Dr. Gilad,
Mike Grissinger, Rif Pamukcu, and Marc Duey, each of whom were
members of the Atrin board who will join the Aprea board, and
current Aprea Board members Christian Schade, Jack Henneman,
Richard Peters and Bernd Seizinger. Christian Schade
will remain the Executive Chairman of the Aprea Board for up to six
months, and he would remain as Non-Executive Chairman thereafter.
Aprea and Atrin have agreed to expand the Aprea board to nine
members following Aprea’s 2022 annual stockholder meeting. The
Aprea Board plans to fill the remaining vacancy after such
meeting.
About the Transactions
The acquisition of Atrin was structured as a stock-for-stock
transaction whereby all of Atrin’s outstanding equity interests
were exchanged for a combination of shares of Aprea common stock
and shares of Series A non-voting convertible preferred stock (the
“Series A preferred stock”). Subject to Aprea stockholder approval,
each share of Series A preferred stock will, at the option of the
holder, convert into 10 shares of common stock, subject to certain
beneficial ownership limitations set by each holder. On a pro forma
basis and based upon the number of shares of Aprea common stock and
preferred stock issued in the acquisition, holders of Aprea equity
holders immediately prior to the acquisition will own approximately
41.2% of Aprea on an as-converted basis and former Atrin equity
holders will own approximately 58.8% of Aprea on an as-converted
basis immediately after these transactions. The acquisition was
approved by the Board of Directors of Aprea and the Board of
Directors and the requisite equity holders of Atrin. The closing of
the transactions was not subject to the approval of Aprea
stockholders.
In connection with acquisition of Atrin, each holder of Aprea
common stock as of immediately before the closing of the
transaction will be entitled to a non-transferrable contingent
value right (“CVR”). Holders of the CVR will be entitled to receive
certain payments from proceeds received by Aprea, if any, related
to the disposition, if any, of its legacy p53 reactivator assets
during the 2-year period following the closing of the
transaction.
Wedbush PacGrow is serving as exclusive strategic advisor to
Aprea, H.C. Wainwright & Co. is serving as exclusive strategic
advisor to Atrin, Sidley Austin LLP is serving as legal counsel to
Aprea, and DLA Piper LLP (US) is serving as legal counsel to
Atrin.
Immediately after the completion of the acquisition, Aprea is
expected to have pro forma cash on hand, before transaction-related
expenses, of approximately $48 million (unaudited) and cash runway
through the second half of 2023.
Additional details will be available in an updated corporate
presentation that can be found in the investor section of the Aprea
website at Link.
First Quarter Financial Results
- Cash and
cash equivalents: As of March 31, 2022, the
Company had $47.6 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 March 31, 2022 will be sufficient to
meet its current projected operating requirements through the
second half of 2023.
- Research and
Development (R&D) expenses: R&D
expenses were $4.1 million for the quarter
ended March 31, 2022, compared to $6.8 million for
the comparable period in 2021. The decrease in R&D expenses was
primarily due to decreases in clinical trial activity and related
costs for (i) our pivotal Phase 3 clinical trial of eprenetapopt
with azacitidine for the frontline treatment of TP53 mutant MDS,
(ii) our Phase 2 post-transplant MDS/AML clinical trial, (iii) our
Phase 1 AML trial, (iv) our Phase 1/2 solid tumor trial and our
Phase 1 dose-escalation trial of APR-548.
- General and
Administrative (G&A) expenses: G&A
expenses were $4.0 million for the quarter
ended March 31, 2022, compared to $3.4 million for
the comparable period in 2021. The increase in G&A
expenses was primarily due to increases in legal expense and
non-cash stock-based compensation expense.
- Net
loss: Net loss was $7.9 million, or $0.36
per share for the quarter ended March 31, 2022, compared to a
net loss of $9.7 million, or $0.46 per share for the quarter
ended March 31, 2021. The Company had 21,974,302
shares of common stock outstanding as of March 31, 2022.
Conference Call and Webcast Details
Aprea will host a webcast on May 16, 2022 at 4:30pm EDT to
discuss the acquisition. The webcast can be accessed under the
"Events Calendar" in the Investors section of the Aprea website at
Link
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) |
|
March 31, 2022 |
|
December 31, 2021 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
47,651,774 |
|
|
$ |
53,076,052 |
|
Prepaid expenses and other current assets |
|
2,393,096 |
|
|
|
3,508,358 |
|
Total current assets |
|
50,044,870 |
|
|
|
56,584,410 |
|
Property and equipment, net |
|
20,587 |
|
|
|
23,870 |
|
Right of use lease and other
noncurrent assets |
|
271,552 |
|
|
|
215,183 |
|
Total assets |
$ |
50,337,009 |
|
|
$ |
56,823,463 |
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
1,988,007 |
|
|
$ |
1,773,032 |
|
Accrued expenses |
|
4,512,616 |
|
|
|
5,352,996 |
|
Lease liability—current |
|
219,499 |
|
|
|
190,471 |
|
Total current liabilities |
|
6,720,122 |
|
|
|
7,316,499 |
|
Lease liability—noncurrent |
|
28,061 |
|
|
|
-- |
|
Total liabilities |
|
6,748,183 |
|
|
|
7,316,499 |
|
Commitments and
contingencies |
|
|
Stockholders’ equity: |
|
|
Common stock, par value $0.001; 21,974,302 and 21,859,413 shares
issued and outstanding at March 31, 2022 and December 31, 2021,
respectively. |
|
21,974 |
|
|
|
21,859 |
|
Additional paid-in capital |
|
243,062,384 |
|
|
|
240,978,439 |
|
Accumulated other comprehensive loss |
|
(10,424,461 |
) |
|
|
(10,358,956 |
) |
Accumulated deficit |
|
(189,071,071 |
) |
|
|
(181,134,378 |
) |
Total stockholders’ equity |
|
43,588,826 |
|
|
|
49,506,964 |
|
Total liabilities and stockholders’ equity |
$ |
50,337,009 |
|
|
$ |
56,823,463 |
|
|
|
|
|
|
|
|
|
Aprea Therapeutics, Inc.Condensed
Consolidated Statements of Operations and Comprehensive
Loss(Unaudited) |
|
|
Three Months Ended March 31, |
|
2022 |
|
2021 |
Operating expenses: |
|
|
|
|
|
Research and development |
$ |
4,089,577 |
|
|
$ |
6,763,848 |
|
General and administrative |
|
3,985,298 |
|
|
|
3,425,833 |
|
Total operating expenses |
|
8,074,875 |
|
|
|
10,189,681 |
|
Other income (expense): |
|
|
|
|
|
Interest (expense) income |
|
1,971 |
|
|
|
(1,057 |
) |
Foreign currency (loss) gain |
|
136,211 |
|
|
|
521,983 |
|
Total other income (expense) |
|
138,182 |
|
|
|
520,926 |
|
Net loss |
$ |
(7,936,693 |
) |
|
$ |
(9,668,755 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
Foreign currency translation |
|
(65,505 |
) |
|
|
(402,850 |
) |
Total comprehensive loss |
|
(8,002,198 |
) |
|
|
(10,071,605 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(0.36 |
) |
|
$ |
(0.46 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
21,901,531 |
|
|
|
21,186,827 |
|
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