Aprea Therapeutics Reports First Quarter 2020 Financial Results and Provides Update on Business Operations
May 15 2020 - 6:30AM
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
ended March 31, 2020 and provided a business update.
“Despite the challenges caused by the emerging COVID-19
pandemic, we continued to make significant progress to advance the
development of our lead compound, eprenetapopt. In January
2020 we were granted Breakthrough Therapy Designation by the FDA to
support our Phase 3 development program of eprenetapopt in
combination with azacitidine,” said Christian S. Schade, President
and Chief Executive Officer of Aprea. “We are proud of the
Aprea team, for their efforts to navigate through these uncharted
times to support and advance our aggressive development of both
eprenetapopt and our next generation p53 reactivator, APR-548, with
minimal interruption.”
Business Operations Update:
The Company is conducting, supporting and planning multiple
clinical trials of eprenetapopt or 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 with
a primary endpoint of CR rate. Though the Company had initially
observed a decrease in both patient screening and patient
enrollment as a result of the coronavirus (COVID-19) pandemic, the
Company has recently observed increased patient screening activity
and has currently enrolled 140 patients in the trial with a number
of additional patients now scheduled for screening. The Company
currently plans to close enrollment of this trial in the second
quarter of 2020 and 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 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. Though the Company had initially observed a decrease in
both patient screening and patient enrollment as a result of the
COVID-19 pandemic, the Company has recently observed increased
patient screening activity and has currently enrolled 16 out of 31
patients in this trial with a number of additional patients
scheduled for screening. The Company believes that it will complete
enrollment in this trial in the third quarter of 2020.
- Phase 1 AML Trial—Based on in vitro data
evidencing synergistic activity between APR-246 and venetoclax, 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 goals of the study
include determining the safety, tolerability and preliminary
efficacy of the combinations. 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 continues to assess the impact of the
COVID-19 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 vivo
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 and is
targeting the submission of an IND in the first half of 2020.
First Quarter Financial Results
- Cash and cash equivalents: As
of March 31, 2020, the Company had $122.5 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 2020 to be between $35.0 million
$40.0 million. The Company believes its cash and cash
equivalents as of March 31, 2020 will be sufficient to
meet its current projected operating requirements into 2023.
- Research and Development (R&D)
expenses: R&D expenses were $9.1
million for the quarter ended March 31, 2020, compared
to $3.7 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, 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. In addition, in Q1 2020, the Company began enrolling
patients in a Phase 1 clinical trial in frontline and
relapsed/refractory TP53 mutant AML assessing APR-246 with
venetoclax with or without azacitidine.
- General and Administrative (G&A)
expenses: G&A expenses were $2.8
million for the quarter ended March 31, 2020, compared
to $0.7 million for the comparable period in 2019.
The increase in G&A expenses was primarily due to increased
insurance and professional fees associated with operating as a
public company, as well as increased personnel costs.
- Net loss: Net loss was $9.4
million, or $0.45 per share for the quarter ended March 31,
2020, compared to a net loss of $3.5 million, or $2.97 per
share for the quarter ended March 31, 2019. The Company
had 21,054,842 shares of common stock outstanding as of March 31,
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.
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 – thereby inducing
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.
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)
|
March 31, 2020 |
|
|
December 31, 2019 |
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$122,513,357 |
|
|
$130,088,869 |
|
Prepaid expenses and other current assets |
|
2,090,941 |
|
|
|
2,955,878 |
|
Total current assets |
|
124,604,298 |
|
|
|
133,044,747 |
|
Property and equipment,
net |
|
45,934 |
|
|
|
41,639 |
|
Right of use lease and other
noncurrent assets |
|
474,898 |
|
|
|
521,499 |
|
Total assets |
$125,125,130 |
|
|
$133,607,885 |
|
Liabilities and
Stockholders’ Equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$3,006,688 |
|
|
$2,176,852 |
|
Accrued expenses |
|
8,298,769 |
|
|
|
6,642,553 |
|
Lease liability—current |
|
238,771 |
|
|
|
242,329 |
|
Total current liabilities |
|
11,544,228 |
|
|
|
9,061,734 |
|
Lease liability—noncurrent |
|
227,288 |
|
|
|
302,621 |
|
Total liabilities |
|
11,771,516 |
|
|
|
9,364,355 |
|
Commitments and
contingencies |
|
|
Stockholders’ equity: |
|
|
Common stock, par value $0.001; 21,054,842 and 21,022,752, shares
issued and outstanding at March 31, 2020 and December 31,
2019, respectively. |
|
21,055 |
|
|
|
21,023 |
|
Additional paid‑in capital |
|
227,219,510 |
|
|
|
226,284,548 |
|
Accumulated other comprehensive loss |
|
(13,958,431 |
) |
|
|
(11,533,778 |
) |
Accumulated deficit |
|
(99,928,520 |
) |
|
|
(90,528,263 |
) |
Total stockholders’ equity |
|
113,353,614 |
|
|
|
124,243,530 |
|
Total liabilities and stockholders’ equity |
$125,125,130 |
|
|
$133,607,885 |
|
Aprea Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
|
Three Months Ended March
31, |
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
Research and development |
$9,096,122 |
|
$3,678,444 |
|
General and administrative |
|
2,776,468 |
|
|
|
729,326 |
|
Total operating
expenses |
|
11,872,590 |
|
|
|
4,407,770 |
|
Other income (expense): |
|
|
Interest income (expense) |
|
224,442 |
|
|
|
(3,348 |
) |
Foreign currency gain |
|
2,247,891 |
|
|
|
935,916 |
|
Total other income |
|
2,472,333 |
|
|
|
932,568 |
|
Net loss |
$(9,400,257 |
) |
|
|
|
$(3,475,202 |
) |
Other comprehensive loss: |
|
|
Foreign currency translation |
|
(2,424,653 |
) |
|
|
(2,031,175 |
) |
Total comprehensive
loss |
|
(11,824,910 |
) |
|
|
(5,506,377 |
) |
|
|
|
|
|
|
|
|
Net loss per share attributable
to common stockholders, basic and diluted |
$(0.45 |
) |
|
|
|
$(2.97 |
) |
|
|
|
|
|
|
|
|
Weighted average basic and
diluted shares of common stock outstanding |
|
21,052,726 |
|
|
|
1,171,193 |
|
Aprea Therapeutics (NASDAQ:APRE)
Historical Stock Chart
From Jun 2024 to Jul 2024
Aprea Therapeutics (NASDAQ:APRE)
Historical Stock Chart
From Jul 2023 to Jul 2024