Aprea Therapeutics Reports Second Quarter 2021 Financial Results and Provides Update on Business Operations
13 August 2021 - 6:15AM
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 six months
ended June 30, 2021 and provided a business update.
Business Operations Update:
The Company is conducting, supporting, and planning multiple
clinical trials of eprenetapopt (APR-246) and APR-548. 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 myeloid malignancy programs.
There are approximately 20 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 closely with the FDA to analyze the data, address the specific
questions raised, and seek to resolve the partial clinical hold as
soon as possible.
On August 11, 2021, the FDA placed a clinical hold on the
Company’s clinical trial evaluating eprenetapopt with acalabrutinib
or with venetoclax and rituximab in lymphoid malignancies. There is
one CLL patient currently on study treatment receiving eprenetapopt
in combination with venetoclax and rituximab. This patient may
continue to receive study treatment as long as the patient is
deriving clinical benefit. No additional patients can be enrolled
until the clinical hold is resolved. The Company intends to work
closely with the FDA to address the specific questions raised, and
seek to resolve the clinical hold as soon as possible.
The Company’s current clinical trials are as follows:
- Phase 3 Frontline MDS Trial
-- In June 2020, the Company completed full enrollment of
154 patients in a pivotal Phase 3 trial of eprenetapopt with
azacitidine for frontline treatment of patients with TP53 mutant
MDS. The pivotal Phase 3 trial is supported by data from two
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. The data from the
U.S. and French Phase 1b/2 trials were published in The Journal of
Clinical Oncology in January 2021 and February 2021, respectively.
In December 2020, the Company announced that its pivotal Phase 3
trial failed to meet its predefined primary endpoint of complete
remission (CR) rate. Analysis of the primary endpoint at this data
cut demonstrated a higher CR rate (53% more patients achieving a
CR) in the experimental arm receiving eprenetapopt with azacitidine
versus the control arm receiving azacitidine alone but did not
reach statistical significance. Based on a thorough analysis of the
current Phase 3 trial data and comparisons to the U.S. and French
Phase 1b/2 trials the Company believes that despite similar types
and frequency of adverse events observed in the Phase 3
experimental arm and the Phase 1b/2 trials, patients in the Phase 3
experimental arm experienced substantially more study treatment
dose modifications compared to the experience in the U.S. and
French Phase 1b/2 trials. The Company believes that dose
modifications of eprenetapopt and azacitidine led to undertreatment
in the Phase 3 experimental arm that negatively impacted efficacy,
particularly the primary endpoint of CR rate. The Company continues
to follow patients who remain on-study. Based on initial feedback
from the FDA and the partial clinical hold on its myeloid
malignancy programs, the Company believes that there is no
registrational pathway for this Phase 3 trial.
- Phase 2 MDS/AML
Post-Transplant Trial – In July 2021, the Company
announced positive results from a single-arm, open-label Phase 2
clinical trial evaluating eprenetapopt with azacitidine as
post-transplant maintenance therapy in TP53 mutant MDS and AML
patients who have received an allogeneic stem cell transplant. The
primary endpoint of the trial is the rate of relapse-free survival
(RFS) at 12 months. In 33 patients enrolled in the trial, the RFS
at one-year post-transplant was 58% and the median RFS was 12.1
months. The overall survival (OS) at 1-year post-transplant was 79%
with a median OS at 19.3 months. Prior clinical trials evaluating
post-transplant outcomes in TP53 mutant MDS and AML patients have a
reported 1-year post-transplant RFS of ~30% and a median OS of ~5-8
months. As part of the Company’s plan to seek to resolve the
partial clinical hold, the Company plans to share data with the
FDA. The Company also expects to present data from the clinical
trial at a future scientific or medical conference.
- Phase 1/2 AML
Trial – The Company is currently enrolling a Phase 1/2
clinical 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 12 patients receiving
either regimen. Based on these results, the Company has expanded
the trial to treat 33 additional frontline TP53 mutant AML patients
with the combination of eprenetapopt, venetoclax and azacitidine.
In June 2021, the Company announced that the regimen of
eprenetapopt with venetoclax and azacitidine met the CR primary
efficacy endpoint. In 30 patients who were evaluable for efficacy
at the time of the analysis, the CR rate was 37% and the complete
response rate was CR plus CR with incomplete hematologic recovery
(CRi), CR/CRi, was 53%. The trial met the primary efficacy endpoint
of CR, which is based on a Simon 2-stage design. As of that data
cut, 11 patients remain on study treatment and continue to be
followed for safety and efficacy. The Company plans to continue
collecting data from this Phase 2 clinical trial and share data
with the FDA as part of the Company’s effort to resolve the partial
clinical hold. The Company also expects to present data from this
clinical trial at a future scientific or medical conference.
- Phase 1 NHL Trial
– The Company is currently enrolling a Phase 1 clinical trial in
relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL)
assessing eprenetapopt with venetoclax and rituximab and
eprenetapopt with acalabrutinib in order to further assess
eprenetapopt in hematological malignancies. The first patient was
enrolled in the first quarter of 2021. 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.
- Phase 1/2 Solid Tumor
Trial – The Company is currently enrolling a Phase 1/2
clinical trial in relapsed/refractory gastric, bladder and
non-small cell lung cancers assessing eprenetapopt with anti-PD-1
therapy. The dose-escalation phase of the trial enrolled 6 patients
with advanced solid tumors and no dose-limiting toxicities were
observed. Based on these results, the Company is enrolling
expansion cohorts for patients with advanced gastric, bladder and
non-small cell lung cancers and has currently enrolled 26 patients
across these expansion arms. A poster presentation for this trial
was presented at the 2021 ASCO Annual Meeting (abstract
TPS3161).
- 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 has planned 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 Company anticipates the first
patient to be enrolled in the second half of 2021.
Second Quarter Financial Results
- Cash and
cash equivalents: As of June 30, 2021, the
Company had $69.8 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 $35.0 million. The
Company believes its cash and cash equivalents as of June 30,
2021, will be sufficient to meet its current projected
operating requirements into 2023.
- Research and
Development (R&D) expenses: R&D
expenses were $6.7 million for the quarter
ended June 30, 2021, compared to $10.7 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 June 30, 2021, compared to $3.8 million for
the comparable period in 2020. The decrease in G&A
expenses was primarily due to a decrease in pre-commercialization
development activities.
- Net
loss: Net loss was $10.3 million, or $0.48
per share for the quarter ended June 30, 2021, compared to a
net loss of $16.4 million, or $0.78 per share for the quarter
ended June 30, 2020. The Company had 21,186,827
shares of common stock outstanding as of June 30, 2021.
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 Breakthrough Therapy, 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)
|
June 30, 2021 |
|
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash
equivalents |
$69,803,845 |
|
|
$89,017,686 |
|
Prepaid expenses and other current
assets |
|
1,494,453 |
|
|
|
3,399,019 |
|
Total current
assets |
|
71,298,298 |
|
|
|
92,416,705 |
|
Property and equipment,
net |
|
30,955 |
|
|
|
38,515 |
|
Right of use lease and other noncurrent
assets |
|
220,477 |
|
|
|
349,999 |
|
Total assets |
$71,549,730 |
|
|
$92,805,219 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts
payable |
$2,361,318 |
|
|
$4,503,619 |
|
Accrued
expenses |
|
8,037,524 |
|
|
|
10,571,237 |
|
Lease
liability—current |
|
199,219 |
|
|
|
256,309 |
|
Total current
liabilities |
|
10,598,061 |
|
|
|
15,331,165 |
|
Lease
liability—noncurrent |
|
-- |
|
|
|
78,847 |
|
Total
liabilities |
|
10,598,061 |
|
|
|
15,410,012 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Common stock, par value $0.001; 21,186,827 shares issued and
outstanding at June 30, 2021 and December 31, 2020,
respectively. |
|
21,187 |
|
|
|
21,187 |
|
Additional paid-in
capital |
|
235,104,416 |
|
|
|
231,418,356 |
|
Accumulated other comprehensive
loss |
|
(10,247,091 |
) |
|
|
(10,037,261 |
) |
Accumulated
deficit |
|
(163,926,843 |
) |
|
|
(144,007,075 |
) |
Total stockholders’
equity |
|
60,951,669 |
|
|
|
77,395,207 |
|
Total liabilities and stockholders’
equity |
$71,549,730 |
|
|
$92,805,219 |
|
Aprea Therapeutics,
Inc.Condensed Consolidated Statements of
Operations and Comprehensive
Loss(Unaudited)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
6,654,257 |
|
|
$ |
10,694,029 |
|
|
$ |
13,418,105 |
|
|
$ |
19,790,151 |
|
|
General and administrative |
|
3,343,325 |
|
|
|
3,786,886 |
|
|
|
6,769,158 |
|
|
|
6,563,354 |
|
|
Total operating expenses |
|
9,997,582 |
|
|
|
14,480,915 |
|
|
|
20,187,263 |
|
|
|
26,353,505 |
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense) |
|
(588 |
) |
|
|
2,678 |
|
|
|
(1,645 |
) |
|
|
227,120 |
|
|
Foreign currency (loss) gain |
|
(252,843 |
) |
|
|
(1,889,690 |
) |
|
|
269,140 |
|
|
|
358,201 |
|
|
Total other income
(expense) |
|
(253,431 |
) |
|
|
(1,887,012 |
) |
|
|
267,495 |
|
|
|
585,321 |
|
|
Net loss |
$ |
(10,251,013 |
) |
|
$ |
(16,367,927 |
) |
|
$ |
(19,919,768 |
) |
|
$ |
(25,768,184 |
) |
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
193,020 |
|
|
|
1,756,783 |
|
|
|
(209,830 |
) |
|
|
(667,870 |
) |
|
Total comprehensive loss |
|
(10,057,993 |
) |
|
|
(14,611,144 |
) |
|
|
(20,129,598 |
) |
|
|
(26,436,054 |
) |
|
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.48 |
) |
|
$ |
(0.78 |
) |
|
$ |
(0.94 |
) |
|
$ |
(1.22 |
) |
|
Weighted-average common shares
outstanding, basic and diluted |
|
21,186,827 |
|
|
|
21,107,056 |
|
|
|
21,186,827 |
|
|
|
21,079,891 |
|
|
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