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 months and year
ended December 31, 2021 and provided a business update.
Fourth Quarter Financial Results
- Cash and cash equivalents: As of
December 31, 2021, the Company had $53.1 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 2022 to be between $25.0
million and $30.0 million. The Company believes its cash and cash
equivalents as of December 31, 2021 will be sufficient to
meet its current projected operating requirements into 2023.
- Research and Development (R&D)
expenses: R&D expenses were $4.5
million for the quarter ended December 31, 2021, compared
to $9.3 million for the comparable period in 2020. The
decrease in R&D expenses was primarily due to decreases in
clinical trial costs for the Company’s pivotal Phase 3 clinical
trial of eprenetapopt with azacitidine for the frontline treatment
of TP53 mutant MDS and the Company’s Phase 2 post-transplant
MDS/AML clinical trial. These decreases were partially offset by
increases in clinical trial costs for other ongoing clinical
trials.
- General and Administrative (G&A)
expenses: G&A expenses were $3.4
million for the quarter ended December 31, 2021, compared
to $4.9 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 $7.8
million, or $0.36 per share for the quarter ended December 31,
2021, compared to a net loss of $13.1 million, or $0.73 per
share for the quarter ended December 31, 2020. The Company had
21,859,413 shares of common stock outstanding as of December 31,
2021.
Business Operations Update:
Myeloid Malignancy Program
The Company’s myeloid malignancy program includes fully enrolled
and completed clinical trials in MDS, AML and post-transplant
maintenance therapy in MDS/AML. In August 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
the Company’s Phase 3 frontline MDS clinical trial, the Company’s
Phase 2 MDS/AML Post-Transplant clinical trial and the Company’s
Phase 1/2 AML clinical trial. In December 2021 the Company
discussed with FDA the requested data and analyses from the Phase 3
frontline MDS clinical trial and reached agreement on the Company’s
proposals for new clinical trials in myeloid malignancies. In the
first quarter of 2022 the Company received clearance from FDA to
proceed under its existing myeloid malignancy IND with a new
clinical trial in relapsed/refractory MDS and AML.
Lymphoid Malignancy Program
The Company’s lymphoid malignancy program includes a clinical
trial evaluating eprenetapopt in patients with non-Hodgkin
lymphomas (NHL). In August 2021, FDA placed a clinical hold on this
trial. In October 2021, the Company discussed with FDA the
requested data and analyses from the Phase 3 frontline MDS clinical
trial and proposed amendments for clinical trials to proceed in its
lymphoid malignancy program. Following interaction with the FDA,
the clinical hold was lifted in December 2021.
The Company is in the planning phase for new clinical trials in
both myeloid and lymphoid malignancies and is continuing to
evaluate other development opportunities. The Company plans to
provide updates on progress on all programs throughout 2022.
APR-548 Phase I 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 initiated a Phase 1 clinical trial testing
APR-548 in relapsed/refractory MDS and AML. Enrollment in the first
dosing cohort was completed and pharmacokinetic and adverse event
data will be collected and analyzed. The Company does not plan to
enroll additional patients into the trial.
Solid Tumor Program
The Company’s solid tumor program includes its clinical trial
evaluating eprenetapopt with anti-PD-1 therapy in advanced solid
tumors. The Company completed enrollment in its Phase 1/2 clinical
trial in relapsed/refractory gastric, bladder and non-small cell
lung cancers assessing eprenetapopt with anti-PD-1 therapy. The
Company is in the planning phase for a future clinical trial to
further evaluate orally-administered eprenetapopt with
immunotherapy checkpoint inhibitors.
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 endpoint of complete
remission. Eprenetapopt has received Orphan Drug and Fast Track
designations from the FDA for myelodysplastic syndromes (MDS),
Orphan Drug and Fast Track designation 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.
About p53, eprenetapopt and APR-548
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.
APR-548 is a next-generation small molecule p53 reactivator.
APR-548 has demonstrated high oral bioavailability, enhanced
potency relative to eprenetapopt in TP53 mutant cancer cell lines
and has demonstrated in vivo tumor growth inhibition following oral
dosing of tumor-bearing mice.
Forward-Looking StatementCertain 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 |
|
December 31, 2021 |
|
December 31, 2020 |
Assets |
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
53,076,052 |
|
|
$ |
89,017,686 |
|
Prepaid expenses and other current assets |
|
3,508,358 |
|
|
|
3,399,019 |
|
Total current assets |
|
56,584,410 |
|
|
|
92,416,705 |
|
Property
and equipment, net |
|
23,870 |
|
|
|
38,515 |
|
Right of
use lease and other noncurrent assets |
|
215,183 |
|
|
|
349,999 |
|
Total assets |
$ |
56,823,463 |
|
|
$ |
92,805,219 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
1,773,032 |
|
|
$ |
4,503,619 |
|
Accrued expenses |
|
5,352,996 |
|
|
|
10,571,237 |
|
Lease liability—current |
|
190,471 |
|
|
|
256,309 |
|
Total current liabilities |
|
7,316,499 |
|
|
|
15,331,165 |
|
Lease liability—noncurrent |
|
-- |
|
|
|
78,847 |
|
Total liabilities |
|
7,316,499 |
|
|
|
15,410,012 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
Common stock, par value $0.001; 21,859,413 and
21,186,827, |
|
|
|
|
|
|
|
shares issued and outstanding at December 31, 2021 and 2020,
respectively. |
|
21,859 |
|
|
|
21,187 |
|
Additional paid-in capital |
|
240,978,439 |
|
|
|
231,418,356 |
|
Accumulated other comprehensive loss |
|
(10,358,956 |
) |
|
|
(10,037,261 |
) |
Accumulated deficit |
|
(181,134,378 |
) |
|
|
(144,007,075 |
) |
Total stockholders’ equity |
|
49,506,964 |
|
|
|
77,395,207 |
|
Total liabilities and stockholders’ equity |
$ |
56,823,463 |
|
|
$ |
92,805,219 |
|
|
|
|
|
|
|
|
|
Aprea Therapeutics, Inc.Condensed Consolidated
Statements of Operations and Comprehensive
Loss(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,462,154 |
|
|
$ |
9,328,079 |
|
|
$ |
23,895,875 |
|
|
$ |
37,879,325 |
|
General and administrative |
|
|
3,366,525 |
|
|
|
4,895,323 |
|
|
|
13,550,478 |
|
|
|
14,931,887 |
|
Total
operating expenses |
|
|
7,828,679 |
|
|
|
14,223,402 |
|
|
|
37,446,353 |
|
|
|
52,811,212 |
|
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,326 |
|
|
|
4,744 |
|
|
|
1,648 |
|
|
|
222,652 |
|
Foreign currency gain (loss) |
|
|
70,169 |
|
|
|
(1,173,888 |
) |
|
|
317,402 |
|
|
|
(890,252 |
) |
Total
other income (expense) |
|
|
73,495 |
|
|
|
(1,169,144 |
) |
|
|
319,050 |
|
|
|
(667,600 |
) |
Net
loss |
|
$ |
(7,755,184 |
) |
|
$ |
(15,392,546 |
) |
|
$ |
(37,127,303 |
) |
|
$ |
(53,478,812 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
95,743 |
|
|
|
2,333,369 |
|
|
|
(321,695 |
) |
|
|
1,496,517 |
|
Total
comprehensive loss |
|
|
(7,659,441 |
) |
|
|
(13,059,177 |
) |
|
|
(37,448,998 |
) |
|
|
(51,982,295 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.36 |
) |
|
$ |
(0.73 |
) |
|
$ |
(1.74 |
) |
|
$ |
(2.53 |
) |
Weighted-average common shares outstanding, basic and diluted |
|
|
21,538,800 |
|
|
|
21,186,827 |
|
|
|
21,286,547 |
|
|
|
21,133,651 |
|
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