Aprea Therapeutics Reports Second Quarter 2020 Financial Results and Provides Update on Business Operations
12 August 2020 - 6:15AM
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 six months
ended June 30, 2020 and provided a business update.
“The full enrollment in June of our Phase 3 clinical trial
evaluating eprenetapopt (APR-246) with azacitidine for the
treatment of front-line TP53 mutant myelodysplastic syndromes
(MDS) was a major milestone for Aprea and we look forward to
top-line data by year-end 2020,” said Christian S. Schade,
President and Chief Executive Officer of Aprea. “In addition,
we continue to advance the clinical development of eprenetapopt in
different clinical settings and have recently enrolled the first
patient in our solid tumor clinical trial program.”
Business Operations Update:
The Company is conducting, supporting and planning multiple
clinical trials of eprenetapopt (APR-246):
- Pivotal Phase 3 MDS Trial—During the second
quarter of 2020, the Company completed the full enrollment of 154
patients in its pivotal Phase 3 randomized, controlled trial
evaluating eprenetapopt with azacitidine as frontline therapy in
HMA-naïve TP53 mutant myelodysplastic syndromes (MDS) patients with
a primary endpoint of complete remission (CR) rate. The Company
remains confident it will have top-line data available by year-end
2020.
- Phase 2 MDS/AML Post-Transplant Trial—The
Company is currently enrolling its single-arm, open-label Phase 2
trial evaluating eprenetapopt 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. Though the Company had initially observed a decrease in
both patient screening and patient enrollment as a result of the
COVID-19 pandemic, patient screening activity has returned to
expected levels and the trial has currently enrolled 24 out of 31
patients with a number of additional patients in screening. The
Company anticipates completing enrollment of this trial in the
third quarter of 2020.
- Phase 1 AML Trial—The Company is currently
enrolling its Phase 1 trial evaluating the safety, tolerability,
and preliminary efficacy of eprenetapopt therapy in TP53 mutant AML
patients. The lead-in portion of the trial evaluated the
tolerability of eprenetapopt with venetoclax, with or without
azacitidine, and no dose-limiting toxicities were observed in
patients receiving either regimen. Based on these results, the
Company has expanded the trial to treat approximately 30 additional
frontline TP53 mutant AML patients with the combination of
eprenetapopt, venetoclax and azacitidine. The Company also plans to
activate a separate cohort in the trial to evaluate the combination
of eprenetapopt with azacitidine in approximately 30 frontline TP53
mutant AML patients.
- Phase 1 NHL Trial—To further assess
eprenetapopt 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 eprenetapopt with venetoclax
and rituximab, and eprenetapopt 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 vivo
data suggesting synergistic activity between eprenetapopt 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 eprenetapopt with anti-PD-1 therapy. The Company
enrolled its first patient in August 2020.
- APR-548 -- The Company’s second product
candidate, APR-548, is a pre-clinical, next-generation p53
reactivator with the potential for oral administration. APR-548
exhibits high oral bioavailability in preclinical testing and is
being developed in an oral dosage form. The Company completed
Investigational New Drug, or IND, enabling preclinical studies of
APR-548 and filed an IND with the FDA. However, based on feedback
from the FDA, the Company will not be able to initiate human
clinical trials of APR-548 until it is able to provide additional
information necessary to address questions raised by the FDA.
Second Quarter Financial Results
- Cash and cash equivalents: As of
June 30, 2020, the Company had $112.9 million of cash and
cash equivalents compared to $130.1 million of cash and
cash equivalents as of December 31, 2019. The Company
expects cash burn for the full year 2020 to be between $35.0
million $40.0 million. The Company believes its cash and cash
equivalents as of June 30, 2020 will be sufficient to
meet its current projected operating requirements into 2023.
- Research and Development (R&D)
expenses: R&D expenses were $10.7
million for the quarter ended June 30, 2020, compared
to $4.3 million for the comparable period in 2019. The
increase in R&D expenses was primarily related to the
advancement of the Company’s lead product candidate, eprenetapopt.
In Q1 2019 the Company commenced a pivotal Phase 3 clinical trial
of eprenetapopt with azacitidine for frontline treatment of TP53
mutant MDS which completed enrollment in Q2 2020 and is supported
by two ongoing Phase 1b/2 investigator initiated trials, one in the
U.S. and one in France, testing eprenetapopt with azacitidine as
frontline treatment in TP53 mutant MDS and AML patients. In
addition, in Q1 2020, the Company continued enrolling patients in a
Phase 2 post-transplant MDS/AML clinical trial began enrolling
patients in a Phase 1 clinical trial in frontline and
relapsed/refractory TP53 mutant AML assessing eprenetapopt with
venetoclax with or without azacitidine.
- General and Administrative (G&A)
expenses: G&A expenses were $3.8
million for the quarter ended June 30, 2020, compared
to $1.7 million for the comparable period in 2019.
The increase in G&A expenses was primarily due to increased
insurance expense, non-cash stock-based compensation, personnel
related costs and commercial development expense.
- Net loss: Net loss was $16.4
million, or $0.78 per share for the quarter ended June 30,
2020, compared to a net loss of $5.3 million, or $4.45 per
share for the quarter ended June 30, 2019. The Company
had 21,186,827 shares of common stock outstanding as of June 30,
2020.
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.
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.
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.
Eprenetapopt (APR-246) is a small molecule that has demonstrated
reactivation of mutant and inactivated p53 protein – by restoring
wild-type p53 conformation and function – thereby inducing
programmed cell death in human cancer cells. Pre-clinical
anti-tumor activity has been observed with eprenetapopt 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
eprenetapopt 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.
A pivotal Phase 3 clinical trial of eprenetapopt and azacitidine
for frontline treatment of TP53 mutant MDS is ongoing. Eprenetapopt
has received Breakthrough Therapy, Orphan Drug and Fast Track
designations from the FDA for MDS, and Orphan Drug designation from
the EMA for MDS, AML and ovarian cancer.
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,”
“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. KorbelVice President of Business
Development617-463-9385
Aprea Therapeutics,
Inc.Condensed Consolidated Balance
Sheets(Unaudited)
|
June 30, 2020 |
December 31, 2019 |
Assets |
|
|
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ |
112,861,504 |
|
$ |
130,088,869 |
|
Prepaid expenses and other current assets |
|
1,475,223 |
|
|
2,955,878 |
|
Total current assets . |
|
114,336,727 |
|
|
133,044,747 |
|
Property and equipment, net |
|
43,906 |
|
|
41,639 |
|
Right of use lease and other
noncurrent assets |
|
438,162 |
|
|
521,499 |
|
Total assets . |
$ |
114,818,795 |
|
$ |
133,607,885 |
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ |
5,443,126 |
|
$ |
2,176,852 |
|
Accrued expenses . |
|
8,827,860 |
|
|
6,642,553 |
|
Lease liability—current . |
|
241,527 |
|
|
242,329 |
|
Total current liabilities |
|
11,512,513 |
|
|
9,061,734 |
|
Lease liability—noncurrent . |
|
185,926 |
|
|
302,621 |
|
Total liabilities |
|
14,698,439 |
|
|
9,364,355 |
|
Commitments and
contingencies |
|
|
Stockholders’ equity: |
|
|
Common stock, par value $0.001; 21,186,827 and 21,022,752, shares
issued and outstanding at June 30, 2020 and December 31, 2019,
respectively |
|
21,187 |
|
|
21,023 |
|
Additional paid‑in capital |
|
228,597,264 |
|
|
226,284,548 |
|
Accumulated other comprehensive loss |
|
(12,201,648 |
) |
|
(11,533,778 |
) |
Accumulated deficit |
|
(116,296,447 |
) |
|
(90,528,263 |
) |
Total stockholders’ equity |
|
100,120,356 |
|
|
124,243,530 |
|
Total liabilities and stockholders’ equity . |
$ |
114,818,795 |
|
$ |
133,607,885 |
|
Aprea Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
10,694,029 |
|
|
$ |
4,319,826 |
|
|
$ |
19,790,151 |
|
|
$ |
7,998,270 |
|
|
General and administrative |
|
|
3,786,886 |
|
|
|
1,618,589 |
|
|
|
6,563,354 |
|
|
|
2,347,915 |
|
|
Total operating expenses |
|
|
14,480,915 |
|
|
|
5,938,415 |
|
|
|
26,353,505 |
|
|
|
10,346,185 |
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense) |
|
|
2,678 |
|
|
|
(4,091 |
) |
|
|
227,120 |
|
|
|
(7,439 |
) |
|
Foreign currency (loss) gain |
|
|
(1,889,690 |
) |
|
|
680,058 |
|
|
|
358,201 |
|
|
|
1,615,974 |
|
|
Total other income (expense) |
|
|
(1,887,012 |
) |
|
|
675,967 |
|
|
|
585,321 |
|
|
|
1,608,535 |
|
|
Net loss |
|
$ |
(16,367,927 |
) |
|
$ |
(5,262,448 |
) |
|
$ |
(25,768,184 |
) |
|
$ |
(8,737,650 |
) |
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
1,756,783 |
|
|
|
44,508 |
|
|
|
(667,870 |
) |
|
|
(1,986,667 |
) |
|
Total comprehensive loss |
|
|
(14,611,144 |
) |
|
|
(5,217,940 |
) |
|
|
(26,436,054 |
) |
|
|
(10,724,317 |
) |
|
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.78 |
) |
|
$ |
(4.45 |
) |
|
$ |
(1.22 |
) |
|
$ |
(7.43 |
) |
|
Weighted-average common shares
outstanding, basic and diluted |
|
|
21,107,056 |
|
|
|
1,181,583 |
|
|
|
21,079,891 |
|
|
|
1,176,417 |
|
|
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