Aprea Therapeutics Reports Third Quarter 2019 Financial Results
November 14 2019 - 4:15PM
Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical
company focused on developing and commercializing novel cancer
therapeutics that reactivate mutant tumor suppressor protein, p53,
today reported financial results for the three and nine months
ended September 30, 2019 and provided a corporate update.
Third quarter 2019 Corporate
Update:
APR-246 Update
Earlier this month, the Company announced that
it will present updated data from two Phase 1b/2 clinical studies
at the 61st American Society of Hematology Annual Meeting (ASH) on
December 9, 2019. Data from the U.S. Phase 1b/2 trial and interim
results from the French Phase 1b/2 trial of the Company’s lead
product candidate APR-246 in combination with Azacitidine (AZA) in
patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Acute
Myeloid Leukemia (AML) were both chosen for oral presentations at
ASH. The titles of the oral presentations are:
- “Phase 2 Results of APR-246 and Azacitidine (AZA) in
Patients with TP53 mutant Myelodysplastic Syndromes (MDS) and
Oligoblastic Acute Myeloid Leukemia (AML)”; and
- “APR-246 combined with Azacitidine (AZA) in TP53 mutated
myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). A
phase 2 study by Groupe Francophone des Myélodysplasies (GFM)”
The Company will host a Clinical Update Meeting
and Webcast on December 9, 2019 at 12:00 PM ET. This Clinical
Update meeting will be webcast live and can be accessed from
“Events Calendar” in the News and Events section of the Company’s
website at https://ir.aprea.com/
Initial Public Offering
On October 7, 2019, Aprea completed its initial
public offering (IPO) of 6,516,667 shares of its common stock at a
price to the public of $15.00 per share, which included the
exercise in full by the underwriters of their option to purchase an
additional 850,000 shares of common stock. The Company received
gross proceeds, before deducting underwriting discounts and
commissions and other offering expenses, of approximately $97.75
million.
Third Quarter Financial
Results
- Cash and cash
equivalents: As of September 30, 2019, prior to
completing its IPO on October 7, 2019, Aprea had $52.3
million of cash and cash equivalents compared to $65.7
million of cash and cash equivalents as of December 31,
2018. In October 2019, the Company completed the sale of 6,516,667
shares of common stock in an initial public offering resulting in
gross proceeds of approximately $97.75 million. The Company
believes its cash and cash equivalents as of September 30,
2019 along with the proceeds received from its initial public
offering will be sufficient to meet its current projected
operating requirements into 2023.
- Research and Development
(R&D) expenses: R&D expenses were $4.9
million for the quarter ended September 30, 2019,
compared to $2.3 million for the comparable period in
2018. The increase in R&D expenses was primarily related to the
advancement of the Company’s lead product candidate, APR-246. In Q1
2019 the Company commenced a pivotal Phase 3 clinical trial of
APR-246 with azacitidine for frontline treatment of TP53 mutant MDS
which is supported by two ongoing Phase 1b/2 investigator initiated
trials, one in the U.S. and one in France, testing APR-246 with
azacitidine as frontline treatment in TP53 mutant MDS and AML
patients.
- General and Administrative
(G&A) expenses: G&A expenses were $2.3
million for the quarter ended September 30, 2019,
compared to $0.6 million for the comparable period in
2018. The increase in G&A expenses was primarily due to
increased professional fees of approximately $1.3 million
associated with preparation for the Company’s IPO, which was
completed in October 2019, as well as increased personnel costs of
$0.3 million.
- Net loss: Net
loss was $6.2 million for the quarter ended September 30,
2019, compared to a net loss of $3.1 million for the quarter
ended September 30, 2018.
About Aprea Therapeutics,
Inc.
Aprea Therapeutics, Inc. is a
biopharmaceutical company headquartered in Boston,
Massachusetts with research facilities in Stockholm,
Sweden, focused on developing and commercializing novel cancer
therapeutics that reactivate mutant tumor suppressor protein,
p53. The Company’s lead product candidate is APR-246, a small
molecule in clinical development for hematologic malignancies,
including myelodysplastic syndromes (MDS) and acute myeloid
leukemia (AML). 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 www.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
clinical trials, regulatory submissions and projected cash
position. We may, in some cases use terms such as “predicts,”
“believes,” “potential,” “continue,” “anticipates,” “estimates,”
“expects,” “plans,” “intends,” “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 and the other risks set forth in our
filings with the U.S. Securities and Exchange Commission,
including our Registration Statement on Form S-1 (File No.
333-233662) and our Quarterly Report on Form 10-Q. 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
Corporate Contacts:
Scott M. CoianteSr. Vice President and Chief
Financial Officer617-463-9385
Gregory A. KorbelVice President of Business
Development617-463-9385
Aprea Therapeutics,
Inc.Condensed Consolidated Balance
Sheets(Unaudited)
|
|
|
|
September 30,2019 |
|
December 31,2018 |
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
52,334,102 |
|
|
$ |
65,675,931 |
|
Deferred offering cost |
|
4,070,690 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
339,814 |
|
|
|
322,146 |
|
Total current assets |
|
56,744,606 |
|
|
|
65,998,077 |
|
Property and equipment, net |
|
31,032 |
|
|
|
24,450 |
|
Right of use lease asset |
|
560,318 |
|
|
|
— |
|
Other noncurrent assets |
|
102 |
|
|
|
111 |
|
Total assets |
$ |
57,336,058 |
|
|
$ |
66,022,638 |
|
Liabilities, Convertible
Preferred Stock and Stockholders’ Deficit |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
3,510,105 |
|
|
$ |
1,739,337 |
|
Accrued expenses |
|
5,847,364 |
|
|
|
3,128,772 |
|
Lease liability—current |
|
226,852 |
|
|
|
— |
|
Total current liabilities |
|
9,584,321 |
|
|
|
4,868,109 |
|
Lease liability—noncurrent |
|
358,404 |
|
|
|
— |
|
Total liabilities |
|
9,942,725 |
|
|
|
4,868,109 |
|
Commitments and
contingencies |
|
|
Convertible preferred stock: |
|
|
Series A convertible preferred stock, $0.001 par value;
612,446 shares issued and outstanding at September 30, 2019 and
December 31, 2018 (liquidation preference of $6,483,044 at
September 30, 2019) |
|
6,483,044 |
|
|
|
6,483,044 |
|
Series B convertible preferred stock, $0.001 par value;
7,235,969 shares issued and outstanding at September 30, 2019 and
December 31, 2018 (liquidation preference of $62,288,856 at
September 30, 2019) |
|
49,742,942 |
|
|
|
49,742,942 |
|
Series C convertible preferred stock, $0.001 par value;
5,179,877 and 4,712,698 shares issued and outstanding at September
30, 2019 and December 31, 2018, respectively (liquidation
preference of $66,451,815 at September 30, 2019) |
|
61,963,007 |
|
|
|
56,364,645 |
|
Total convertible preferred stock |
|
118,188,993 |
|
|
|
112,590,631 |
|
Stockholders’ equity
(deficit): |
|
|
Common stock, par value $0.001 at September 30, 2019 and $0.11 at
December 31, 2018; 1,181,733 and 1,155,366, shares issued and
outstanding at September 30, 2019 and December 31, 2018,
respectively |
|
1,182 |
|
|
|
127,091 |
|
Additional paid‑in capital |
|
20,346,849 |
|
|
|
19,666,588 |
|
Accumulated other comprehensive loss |
|
(13,688,166 |
) |
|
|
(8,761,325 |
) |
Accumulated deficit |
|
(77,455,525 |
) |
|
|
(62,468,456 |
) |
Total stockholders’ deficit |
|
(70,795,660 |
) |
|
|
(51,436,102 |
) |
Total liabilities, convertible preferred stock and stockholders’
deficit |
$ |
57,336,058 |
|
|
$ |
66,022,638 |
|
|
|
|
|
|
|
|
|
Aprea Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
|
|
|
|
Three Months Ended September 30, |
Nine Months Ended September
30, |
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
Operating expenses: |
|
|
|
|
Research and development |
$ |
4,910,409 |
|
|
$ |
2,307,022 |
|
|
$ |
12,908,679 |
|
|
$ |
9,799,811 |
|
General and administrative |
|
2,307,946 |
|
|
|
623,702 |
|
|
|
4,655,861 |
|
|
|
1,790,222 |
|
Total operating expenses |
|
7,218,355 |
|
|
|
2,930,724 |
|
|
|
17,564,540 |
|
|
|
11,590,033 |
|
Other income (expense): |
|
|
|
|
Interest expense |
|
(6,098 |
) |
|
|
4 |
|
|
|
(13,537 |
) |
|
|
(184 |
) |
Foreign currency gain (loss) |
|
975,034 |
|
|
|
(207,542 |
) |
|
|
2,591,008 |
|
|
|
741,616 |
|
Total other income (expense) |
|
968,936 |
|
|
|
(207,538 |
) |
|
|
2,577,471 |
|
|
|
741,432 |
|
Net loss |
$ |
(6,249,419 |
) |
|
$ |
(3,138,262 |
) |
|
$ |
(14,987,069 |
) |
|
$ |
(10,848,601 |
) |
Other comprehensive loss: |
|
|
|
|
Foreign currency translation |
|
(2,940,174 |
) |
|
|
65,800 |
|
|
|
(4,926,841 |
) |
|
|
(1,110,408 |
) |
Total comprehensive loss |
|
(9,189,593 |
) |
|
|
(3,072,462 |
) |
|
|
(19,913,910 |
) |
|
|
(11,959,009 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$ |
(5.29 |
) |
|
$ |
(2.72 |
) |
|
$ |
(12.72 |
) |
|
$ |
(9.40 |
) |
Weighted average basic and
diluted shares of common stock outstanding |
|
1,181,726 |
|
|
|
1,154,573 |
|
|
|
1,178,206 |
|
|
|
1,154,264 |
|
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