Aprea Therapeutics, Inc. (Nasdaq: APRE), a biopharmaceutical
company focused on developing and commercializing novel cancer
therapeutics that reactivate the mutant tumor suppressor protein,
p53, today reported financial results for the three and nine months
ended September 30, 2021 and provided a business update.
Third Quarter Financial Results
- Cash and
cash equivalents: As of September 30, 2021, the
Company had $61.4 million of cash and cash equivalents
compared to $89.0 million of cash and cash equivalents as
of December 31, 2020. The Company expects cash burn for
the full year 2021 to be between $30.0 million and $35.0 million.
The Company believes its cash and cash equivalents as
of September 30, 2021, will be sufficient to meet its
current projected operating requirements into 2023.
- Research and
Development (R&D) expenses: R&D
expenses were $6.0 million for the quarter
ended September 30, 2021, compared to $8.8
million for the comparable period in 2020. The decrease in
R&D expenses was primarily due to decreases in clinical trial
costs for our pivotal Phase 3 clinical trial of eprenetapopt with
azacitidine for the frontline treatment of TP53 mutant MDS which
completed enrollment in Q2 2020 and our Phase 2 post-transplant
MDS/AML clinical trial. These decreases were partially offset by
increases in clinical trial costs for our other ongoing clinical
trials.
- General and
Administrative (G&A) expenses: G&A
expenses were $3.4 million for the quarter
ended September 30, 2021, compared to $3.5
million for the comparable period in 2020. The decrease in
G&A expenses was primarily due to a decrease in
pre-commercialization development activities which was partially
offset by increased non-cash stock-based compensation.
- Net
loss: Net loss was $9.5 million, or $0.45
per share for the quarter ended September 30, 2021, compared
to a net loss of $12.3 million, or $0.58 per share for the
quarter ended September 30, 2020. The Company had 21,360,140
shares of common stock outstanding as of September 30, 2021.
Business Operations Update:
Myeloid Malignancy Program
On August 4, 2021, the U.S. Food and Drug Administration (FDA)
placed a partial clinical hold on the clinical trials of
eprenetapopt in combination with azacitidine in our Phase 3
frontline MDS clinical trial, our Phase 2 MDS/AML Post-Transplant
clinical trial and our Phase 1/2 AML clinical trial. The FDA’s
concerns referred to the safety and efficacy data from the Phase 3
frontline MDS clinical trial. In particular, the FDA requested more
information related to a potential risk-reward imbalance between
the combination of eprenetapopt and azacitidine versus azacitidine
alone as it relates to increased serious adverse events in the
Company’s Phase 3 frontline clinical trial in MDS. There are
approximately 9 patients currently receiving eprenetapopt in
combination with azacitidine in our myeloid malignancy programs,
which includes the MDS, AML and post-transplant maintenance trials,
all of which have completed enrollment. Patients who are benefiting
from treatment can continue to receive study treatment. As part of
the partial clinical hold, no additional patients should be
enrolled to these clinical trials until the partial clinical hold
is resolved, The Company intends to work with the FDA to analyze
the data, address the specific questions raised, and seek to
resolve the partial clinical hold as soon as possible.
APR-548 Phase 1 Trial -- The Company’s second
product candidate, APR-548, is a next-generation p53 reactivator
that is being developed in an oral dosage form. The Company is
currently enrolling a Phase 1 dose-escalation clinical trial
evaluating the safety, tolerability, and preliminary efficacy of
APR-548 with azacitidine in frontline and relapsed/refractory MDS
patients. The trial is open and patients are enrolled in the first
dosing cohort.
Lymphoid Malignancy Program
On August 11, 2021, the FDA placed a clinical on the Company’s
clinical trial evaluating eprenetapopt with acalabrutinib or with
venetoclax and rituximab in lymphoid malignancies. The FDA’s
concerns referred to the safety and efficacy data from the
Company’s Phase 3 frontline clinical trial in MDS. There are no
patients currently receiving study treatment in this trial and no
additional patients can be enrolled until the clinical hold is
resolved. The Company intends to work with the FDA to address the
specific questions raised and seek to resolve the clinical hold as
soon as possible.
Solid Tumor Disease Program
Data from the Company’s Phase 1/2 clinical trial in
relapsed/refractory gastric, bladder and non-small cell lung
cancers assessing eprenetapopt with anti-PD-1 therapy was presented
at the European Society of Medical Oncology (ESMO) Congress 2021.
Results were presented from 31 patients who had initiated
treatment, including three gastric/GEJ, three bladder/urothelial
cancer and 19 non-small cell lung cancer (NSCLC) patients. In the
bladder/urothelial cohort, one patient with localized TP53 mutant
high-grade transitional cell bladder cancer had achieved complete
remission (CR) by RECIST criteria at the first response assessment
at 9 weeks. In the NSCLC cohort, two patients with TP53 mutant
squamous NSCLC had reductions in target lesions of 26.7% and 8.2%,
respectively, from baseline by RECIST criteria at the first
response assessment at 9 weeks.
Upcoming Presentations
Investigators will present data from Aprea Therapeutics’
clinical trials evaluating eprenetapopt at the upcoming 63rd
American Society of Hematology Annual Meeting (ASH).
Title: Long-Term Follow-up and Combined Phase 2
Results of Eprenetapopt (APR-246) and Azacitidine (AZA) in Patients
with TP53 Mutant Myelodysplastic Syndromes (MDS) and Oligoblastic
Acute Myeloid Leukemia (AML)
- Date & Time: Saturday, December 11, 2021
at 3:15 pm ET
- Oral Abstract Session: 637. Myelodysplastic
Syndromes—Clinical and Epidemiological: Treatment of High Risk
Myelodysplastic Syndrome
Title: Phase II Trial of Eprenetapopt (APR-246)
in Combination with Azacitidine (AZA) As Maintenance Therapy for
TP53 Mutated AML or MDS Following Allogeneic Stem Cell
Transplantation (SCT)
- Date & Time: Sunday, December 12, 2021 at
9:30 am ET
- Oral Abstract Session: 723. Allogeneic
Transplantation: Long-term Follow-up and Disease Recurrence
Title: Phase I and Expansion Study of
Eprenetapopt (APR-246) in Combination with Venetoclax (VEN) and
Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia (AML)
- Date & Time: Monday, December 13, 2021,
6:00 – 8:00 pm ET
- Poster Abstract Session: 616. Acute Myeloid
Leukemias: Investigational Therapies, Excluding Transplantation and
Cellular Immunotherapies: Poster III
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 eprenetapopt
(APR-246), a small molecule in clinical development for hematologic
malignancies and solid tumors. A pivotal Phase 3 clinical trial of
eprenetapopt and azacitidine for frontline treatment of TP53 mutant
MDS has been completed and failed to meet the primary statistical
endpoint of complete remission. Eprenetapopt is currently on
clinical hold in myeloid and lymphoid malignancies. Eprenetapopt
has received Orphan Drug and Fast Track designations from the FDA
for myelodysplastic syndromes (MDS), Orphan Drug and Fast Track
designations from the FDA for acute myeloid leukemia (AML), and
Orphan Drug designation from the European Commission for MDS and
AML. APR-548, a next generation small molecule reactivator of
mutant p53, is being developed for oral administration. 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 Business
Officer617-463-9385
Aprea Therapeutics,
Inc.Condensed Consolidated Balance
Sheets(Unaudited)
|
September 30, 2021 |
|
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
61,428,404 |
|
|
$ |
89,017,686 |
|
Prepaid expenses and other current assets |
|
750,929 |
|
|
|
3,399,019 |
|
Total current assets |
|
62,179,333 |
|
|
|
92,416,705 |
|
Property and equipment, net |
|
27,318 |
|
|
|
38,515 |
|
Right of use lease and other noncurrent assets |
|
278,209 |
|
|
|
349,999 |
|
Total assets |
$ |
62,484,860 |
|
|
$ |
92,805,219 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
2,548,388 |
|
|
$ |
4,503,619 |
|
Accrued expenses |
|
6,267,429 |
|
|
|
10,571,237 |
|
Lease liability—current |
|
223,999 |
|
|
|
256,309 |
|
Total current liabilities |
|
9,039,816 |
|
|
|
15,331,165 |
|
Lease liability—noncurrent |
|
29,773 |
|
|
|
78,847 |
|
Total liabilities |
|
9,069,589 |
|
|
|
15,410,012 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Common stock, par value $0.001; 21,360,140 and 21,186,827 shares
issued and outstanding at September 30, 2021 and December 31, 2020,
respectively. |
|
21,360 |
|
|
|
21,187 |
|
Additional paid-in capital |
|
237,227,804 |
|
|
|
231,418,356 |
|
Accumulated other comprehensive loss |
|
(10,454,699 |
) |
|
|
(10,037,261 |
) |
Accumulated deficit |
|
(173,379,194 |
) |
|
|
(144,007,075 |
) |
Total stockholders’ equity |
|
53,415,271 |
|
|
|
77,395,207 |
|
Total liabilities and stockholders’ equity |
$ |
62,484,860 |
|
|
$ |
92,805,219 |
|
Aprea Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,015,616 |
|
|
$ |
8,761,095 |
|
|
$ |
19,433,721 |
|
|
$ |
28,551,246 |
|
General and administrative |
|
|
3,414,795 |
|
|
|
3,473,210 |
|
|
|
10,183,953 |
|
|
|
10,036,564 |
|
Total operating expenses |
|
|
9,430,411 |
|
|
|
12,234,305 |
|
|
|
29,617,674 |
|
|
|
38,587,810 |
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest (expense) income |
|
|
(33 |
) |
|
|
(9,212 |
) |
|
|
(1,678 |
) |
|
|
217,908 |
|
Foreign currency (loss) gain |
|
|
(21,907 |
) |
|
|
(74,565 |
) |
|
|
247,233 |
|
|
|
283,636 |
|
Total other (expense) income |
|
|
(21,940 |
) |
|
|
(83,777 |
) |
|
|
245,555 |
|
|
|
501,544 |
|
Net loss |
|
$ |
(9,452,351 |
) |
|
$ |
(12,318,082 |
) |
|
$ |
(29,372,119 |
) |
|
$ |
(38,086,266 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
(207,608 |
) |
|
|
(168,982 |
) |
|
|
(417,438 |
) |
|
|
(836,852 |
) |
Total comprehensive loss |
|
|
(9,659,959 |
) |
|
|
(12,487,064 |
) |
|
|
(29,789,557 |
) |
|
|
(38,923,118 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.45 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.39 |
) |
|
$ |
(1.80 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
21,231,584 |
|
|
|
21,186,827 |
|
|
|
21,201,910 |
|
|
|
21,115,797 |
|
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