Aprea Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Corporate Update
March 26 2020 - 8:00AM
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 months and year
ended December 31, 2019 and provided a corporate update.
Corporate Update:
The Company is conducting, supporting and planning multiple
clinical trials of APR-246:
- Pivotal Phase 3 MDS Trial—The Company is
currently enrolling a pivotal Phase 3 randomized, controlled trial
evaluating APR-246 with azacitidine as frontline therapy in
HMA-naïve TP53 mutant myelodysplastic syndromes (MDS) patients. The
trial has a target enrollment of 154 patients randomized in a 1:1
ratio to either the azacitidine control arm or to the APR-246 +
azacitidine experimental arm, with a primary endpoint of CR rate.
The Company had anticipated full enrollment in its Phase 3 trial in
the first quarter of 2020 and as of March 25, 2020, the Company had
enrolled 133 patients. The Company has observed a recent decrease
in both patient screening and patient enrollment as a result of the
recent coronavirus (COVID 19) pandemic. Together with its
investigators and clinical sites, the Company is assessing the
potential impact of the coronavirus pandemic on enrollment and the
ability to maintain patients enrolled in the trial and the
corresponding impact on the timing of the completion of the trial
and subsequent availability of top-line data. The Company remains
confident that it can complete the trial and have top-line data
available before year end 2020.
- Phase 2 MDS/AML Post-Transplant Trial—The
Company is currently enrolling its single-arm, open-label Phase 2
trial evaluating APR-246 with azacitidine as post-transplant
maintenance therapy in TP53 mutant MDS and acute myeloid leukemia
(AML) patients who have received an allogeneic stem cell
transplant. The primary endpoint is relapse-free survival at 12
months. As of March 25, 2020, the Company had enrolled 11 patients
in this trial. Target enrollment is 31 patients and the Company had
anticipated full enrollment in the first half of 2020. Together
with its investigators and clinical sites, the Company is assessing
the potential impact of the coronavirus pandemic on the enrollment
and the ability to maintain patients enrolled in this trial.
- Phase 1 AML Trial—Based on in vitro data
evidencing synergistic activity between APR-246 and a Bcl-2
inhibitor, the Company is conducting a Phase 1 clinical trial in
frontline and relapsed/refractory TP53 mutant AML assessing APR-246
with venetoclax with or without azacitidine. The primary endpoint
is the composite rate of CR and CR with incomplete hematologic
recovery, or CRi. The first patient was enrolled in 1Q 2020 and the
Company completed enrollment of the first two safety cohorts of
three patients each. Together with its investigators and clinical
sites, the Company is assessing the potential impact of the
coronavirus pandemic on the enrollment and the ability to maintain
patients enrolled in this trial.
- Phase 1 NHL Trial—As further assessment of
APR-246 in hematological malignancies, the Company has designed and
plans to conduct a Phase 1 clinical trial in relapsed/refractory
TP53 mutant chronic lymphoid leukemia (CLL) and mantle cell
lymphoma (MCL) assessing APR-246 with venetoclax and rituximab, and
APR-246 with ibrutinib. The Company is targeting the first patient
to be enrolled in the second half of 2020.
- Phase 1/2 Solid Tumor Trial—Based on in vitro
data evidencing synergistic activity between APR-246 and
immuno-therapy agents including anti-PD-1 antibody, the Company has
designed and plans to conduct Phase 1/2 clinical trials in
relapsed/refractory gastric, bladder and non-small cell lung
cancers assessing APR-246 with anti-PD-1 therapy. The Company is
targeting the first patient to be enrolled in the second half of
2020.
- APR-548 -- The Company’s second product
candidate, APR-548, is a next-generation p53 reactivator with the
potential for oral administration. APR-548 is a unique analog of
APR-246 and therefore a pro-drug of MQ. APR-548 exhibits high oral
bioavailability in preclinical testing and is being developed in an
oral dosage form. The Company has completed Investigational New
Drug, or IND, enabling preclinical studies of APR-548. Final
reports from these studies are pending and the Company is targeting
the submission of an IND in the first half of 2020.
- APR-246 INN — The Company has secured
eprenetapopt as the international nonproprietary name (INN) for
APR-246.
Fourth Quarter Financial Results
- Cash and cash equivalents: As
of December 31, 2019, Aprea had $130.1 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 net
proceeds of approximately $86.9 million. The Company expects cash
burn for 2020 to be between $35.0 million $40.0 million. The
Company believes its cash and cash equivalents as of December
31, 2019 will be sufficient to meet its current projected
operating requirements into 2023.
- Research and Development (R&D)
expenses: R&D expenses were $8.0
million for the quarter ended December 31, 2019, compared
to $4.4 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 azacytidine 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 $3.9
million for the quarter ended December 31, 2019, compared
to $0.5 million for the comparable period in 2018.
The increase in G&A expenses was primarily due to increased
professional fees associated with operating as a public company, as
well as increased personnel costs.
- Net loss: Net loss was $13.1
million, or $0.64 per share for the quarter ended December 31,
2019, compared to a net loss of $4.7 million, or $4.05 per
share for the quarter ended December 31, 2018. Net loss
for the year ended December 31, 2019 was $28.1 million, or $4.67
per share, compared to a net loss of $15.5 million, or $13.45 per
share for the year ended December 31, 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 (eprenetapopt), a small molecule
in clinical development for hematologic malignancies, including
myelodysplastic syndromes (MDS) and acute myeloid leukemia
(AML). APR-246 has received Breakthrough Therapy, Orphan Drug
and Fast Track designations from the FDA for MDS, and Orphan Drug
designation from the European Commission for MDS, AML and ovarian
cancer. For more information, please visit the company website
at www.aprea.com.
About p53 and APR-246 (eprenetapopt)
The p53 tumor suppressor gene is the most frequently mutated
gene in human cancer, occurring in approximately 50% of all human
tumors. These mutations are often associated with resistance
to anti-cancer drugs and poor overall survival, representing a
major unmet medical need in the treatment of cancer.
APR-246 (eprenetapopt) is a small molecule that has demonstrated
reactivation of mutant and inactivated p53 protein – by restoring
wild-type p53 conformation and function – and thereby induce
programmed cell death in human cancer cells. Pre-clinical
anti-tumor activity has been observed with APR-246 in a wide
variety of solid and hematological cancers, including MDS, AML, and
ovarian cancer, among others. Additionally, strong synergy
has been seen with both traditional anti-cancer agents, such as
chemotherapy, as well as newer mechanism-based anti-cancer drugs
and immuno-oncology checkpoint inhibitors. In addition to
pre-clinical testing, a Phase 1/2 clinical program with APR-246 has
been completed, demonstrating a favorable safety profile and both
biological and confirmed clinical responses in hematological
malignancies and solid tumors with mutations in the TP53 gene. 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 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,”
“targets,” “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, including our Annual Report on
Form 10-K. 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. KorbelVice President of Business
Development617-463-9385
Aprea Therapeutics, Inc. |
Condensed Consolidated Balance Sheets |
|
|
|
|
December 31, 2019 |
|
December 31, 2018 |
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$130,088,869 |
|
$65,675,931 |
|
Prepaid expenses and other current assets |
|
2,955,878 |
|
|
322,146 |
|
Total current assets |
|
133,044,747 |
|
|
65,998,077 |
|
Property and equipment, net |
|
41,639 |
|
|
24,450 |
|
Right of use lease and other
noncurrent assets |
|
521,499 |
|
|
111 |
|
Total assets |
$133,607,885 |
|
$66,022,638 |
|
Liabilities, Convertible
Preferred Stock and Stockholders’ Equity (Deficit) |
|
|
|
|
|
|
Current liabilities: |
|
|
Accounts payable |
$2,176,852 |
|
$1,739,337 |
|
Accrued expenses |
|
6,642,553 |
|
|
3,128,772 |
|
Lease liability—current |
|
242,329 |
|
|
— |
|
Total current liabilities |
|
9,061,734 |
|
|
4,868,109 |
|
Lease liability—noncurrent |
|
302,621 |
|
|
— |
|
Total liabilities |
|
9,364,355 |
|
|
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 December 31, 2018 |
|
— |
|
|
6,483,044 |
|
Series B convertible preferred stock, $0.001 par value;
7,235,969 shares issued and outstanding at December 31,
2018 |
|
— |
|
|
49,742,942 |
|
Series C convertible preferred stock, $0.001 par value;
4,712,698 shares issued and outstanding at December 31,
2018 |
|
— |
|
|
56,364,645 |
|
Total convertible preferred stock |
|
— |
|
|
112,590,631 |
|
Stockholders’ equity
(deficit): |
|
|
Common stock, par value $0.001 at December 31, 2019 and $0.11 at
December 31, 2018; 21,022,752 and 1,155,366, shares issued and
outstanding at December 31, 2019 and December 31, 2018,
respectively |
|
21,023 |
|
|
127,091 |
|
Additional paid‑in capital |
|
226,284,548 |
|
|
19,666,588 |
|
Accumulated other comprehensive loss |
|
(11,533,778 |
) |
|
(8,761,325 |
) |
Accumulated deficit |
|
(90,528,263 |
) |
|
(62,468,456 |
) |
Total stockholders’ equity (deficit) |
|
124,243,530 |
|
|
(51,436,102 |
) |
Total liabilities, convertible preferred stock and stockholders’
equity (deficit) |
$133,607,885 |
|
$66,022,638 |
|
Aprea Therapeutics, Inc. |
Condensed Consolidated Statements of Operations and
Comprehensive Loss |
|
|
|
|
|
Three Months Ended December
31,
|
|
Year Ended December 31, |
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
2018 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$8,041,993 |
|
$4,394,921 |
|
$20,950,672 |
|
$14,194,732 |
|
General and administrative |
|
3,937,765 |
|
|
504,449 |
|
|
8,593,626 |
|
|
2,294,671 |
|
Total operating expenses |
|
11,979,758 |
|
|
4,899,370 |
|
|
29,544,298 |
|
|
16,489,403 |
|
Other income (expense): |
|
|
|
|
Interest income (expense) |
|
169,888 |
|
|
2 |
|
|
156,351 |
|
|
(182 |
) |
Foreign currency gain (loss) |
|
(1,262,868 |
) |
|
219,700 |
|
|
1,328,140 |
|
|
961,316 |
|
Total other income (expense) |
|
(1,092,980 |
) |
|
219,702 |
|
|
1,484,491 |
|
|
961,134 |
|
Net loss |
$(13,072,738 |
) |
$(4,679,668 |
) |
$(28,059,807 |
) |
$(15,528,269 |
) |
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
2,154,388 |
|
|
636,489 |
|
|
(2,772,453 |
) |
|
(473,919 |
) |
Total comprehensive loss |
|
(10,918,350 |
) |
|
(4,043,179 |
) |
|
(30,832,260 |
) |
|
(16,002,188 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
$(0.64 |
) |
$(4.05 |
) |
$(4.67 |
) |
$(13.45 |
) |
Weighted average basic and
diluted shares of common stock outstanding |
|
20,318,040 |
|
|
1,154,677 |
|
|
6,002,486 |
|
|
1,154,368 |
|
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