Aprea Therapeutics Inc logo

APRE - Aprea Therapeutics Inc News Story

$4.44 -0.0  -0.2%

Last Trade - 14/04/21

Sector
Healthcare
Size
Small Cap
Market Cap £68.6m
Enterprise Value £3.83m
Revenue £n/a
Position in Universe 5213th / 6848

Aprea Therapeutics Reports Third Quarter 2020 Financial Results and Provides Update on Business Operations

Thu 5th November, 2020 9:15pm
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20201105:nGNX9Q3pZF


BOSTON, Nov. 05, 2020 (GLOBE NEWSWIRE) -- 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, 2020 and provided a business update.

“We made solid progress during the third quarter across our development
pipeline as we approach top-line data from the Phase 3 clinical trial
evaluating eprenetapopt with azacitidine for the treatment of front-line TP53
mutant myelodysplastic syndromes (MDS) patients by year-end 2020” said
Christian S. Schade, Chairman and Chief Executive Officer of Aprea.  “We
continue to execute on our goal of expanding the clinical opportunities for
our p53 reactivator programs, including expansion of our front-line AML
clinical trials, enrollment of the first patients in our solid tumor trial,
initiation of our lymphoma trial and clearance from FDA to proceed with the
Phase 1 trial of our next-generation p53 reactivator, APR-548.”

Business Operations Update: 

The Company is conducting, supporting, and planning multiple clinical trials
of eprenetapopt (APR-246):
* Pivotal Phase 3 MDS Trial—The Company has 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 has completed the target
enrollment of 31 patients in 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.


* Phase 1/2 AML Trial—The Company is currently enrolling its Phase 1/2 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 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—The Company has designed and plans to conduct a Phase 1
clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia
(CLL) assessing eprenetapopt with venetoclax and rituximab, and eprenetapopt
with ibrutinib in order to further assess eprenetapopt in hematological
malignancies. A poster describing the clinical trial has been accepted for
presentation at the 62(nd) American Society of Hematology (ASH) Annual Meeting
(abstract # 1311) on December 5, 2020 from 10:00 am to 6:30 pm eastern time.
The Company is targeting the first patient to be enrolled in the fourth
quarter 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 is conducting Phase 1/2 clinical trials
in relapsed/refractory gastric, bladder and non-small cell lung cancers
assessing eprenetapopt with anti-PD-1 therapy. Five patients have been
enrolled in the safety review cohort of this trial.


* 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. The Company received clearance from the FDA in
October 2020 to initiate Phase 1 clinical trials for APR-548. The Company
anticipates enrollment in the Phase 1 clinical trial to begin in the first
quarter of 2021.
Third Quarter Financial Results
* Cash and cash equivalents:  As of September 30, 2020, the Company
had $101.1 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 September
30, 2020 will be sufficient to meet its current projected operating
requirements into 2023.  
 

* Research and Development (R&D) expenses:  R&D expenses were $8.8
million for the quarter ended September 30, 2020, compared to $4.9
million for the comparable period in 2019. The increase in R&D expenses was
primarily related to the continued development of the Company’s lead product
candidate, eprenetapopt in the following ongoing clinical trials; our pivotal
Phase 3 clinical trial of eprenetapopt with azacitidine for frontline
treatment of TP53 mutant MDS, our Phase 1/2 clinical trials in
relapsed/refractory gastric, bladder and non-small cell lung cancers assessing
eprenetapopt with anti-PD-1 therapy, our Phase 1 clinical trial in
relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) assessing
eprenetapopt with venetoclax and rituximab, and eprenetapopt with ibrutinib
and our Phase 2 post-transplant MDS/AML clinical trial.
  
* General and Administrative (G&A) expenses:  G&A expenses were $3.5
million for the quarter ended September 30, 2020, compared to $2.3
million for the comparable period in 2019.  The increase in G&A expenses was
primarily due to increased non-cash stock-based compensation, increased
insurance expense and increased commercial development expense.
  
* Net loss:  Net loss was $12.3 million, or $0.58 per share for the quarter
ended September 30, 2020, compared to a net loss of $6.2 million, or $5.29
per share for the quarter ended September 30, 2019. The Company had
21,186,827 shares of common stock outstanding as of September 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 eprenetapopt (APR-246), a small molecule in clinical development
for hematologic malignancies, including myelodysplastic syndromes (MDS) and
acute myeloid leukemia (AML).  Eprenetapopt 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. 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. 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 European Medicines Agency for MDS,
AML and ovarian cancer.

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. A Phase 1
clinical trial of APR-548 in TP53 MDS is planned.

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. Coiante
Sr. Vice President and Chief Financial Officer
617-463-9385

Gregory A. Korbel
Vice President of Business Development
617-463-9385

Aprea Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)

                                                                                                                                                                                                                     
                                                                                                                                                     September 30, 2020                 December 31, 2019            
 Assets                                                                                                                                                                                                              
 Current assets:                                                                                                                                                                                                     
 Cash and cash equivalents                                                                                                                           $        101,146,633               $       130,088,869          
 Prepaid expenses and other current assets                                                                                                                    1,257,077                         2,955,878            
 Total current assets                                                                                                                                         102,403,710                       133,044,747          
 Property and equipment, net                                                                                                                                  0,696                             41,639               
 Right of use lease and other noncurrent assets                                                                                                               389,982                           521,499              
 Total assets                                                                                                                                        $        102,834,388               $       133,607,885          
 Liabilities and Stockholders’ Equity                                                                                                                                                                                
 Current liabilities:                                                                                                                                                                                                
 Accounts payable                                                                                                                                    $        4,349,977                 $       2,176,852            
 Accrued expenses                                                                                                                                             9,084,389                         6,642,553            
 Lease liability—current                                                                                                                                      244,310                           242,329              
 Total current liabilities                                                                                                                                    13,678,676                        9,061,734            
 Lease liability—noncurrent                                                                                                                                   132,773                           302,621              
 Total liabilities                                                                                                                                            13,811,449                        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 September 30, 2020 and December 31, 2019, respectively           21,187                            21,023               
 Additional paid‑in capital                                                                                                                                   229,986,911                       226,284,548          
 Accumulated other comprehensive loss                                                                                                                         (12,370,630   )                   (11,533,778  )       
 Accumulated deficit                                                                                                                                          (128,614,529  )                   (90,528,263  )       
 Total stockholders’ equity.                                                                                                                                  89,022,939                        124,243,530          
 Total liabilities and stockholders’ equity                                                                                                          $        102,834,388               $       133,607,885          
                                                                                                                                                                                                                     

Aprea Therapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)

                                                                                                                                                                                                       
                                                                            Three Months Ended September 30,                              Nine Months Ended September 30,                              
                                                                            2020                              2019                        2020                              2019                       
 Operating expenses:                                                                                                                                                                                   
 Research and development                                                   $      8,761,095                  $      4,910,409            $      28,551,246                 $      12,908,679          
 General and administrative                                                        3,473,210                         2,307,946                   10,036,564                        4,655,861           
 Total operating expenses                                                          12,234,305                        7,218,355                   38,587,810                        17,564,540          
 Other income (expense):                                                                                                                                                                               
 Interest income (expense)                                                         (9,212       )                    (6,098      )               217,908                           (13,537      )      
 Foreign currency (loss) gain                                                      (74,565      )                    975,034                     283,636                           2,591,008           
 Total other income (expense)                                                      (83,777      )                    968,936                     501,544                           2,577,471           
 Net loss                                                                   $      (12,318,082  )             $      (6,249,419  )        $      (38,086,266  )             $      (14,987,069  )      
 Other comprehensive income (loss):                                                                                                                                                                    
 Foreign currency translation                                                      (168,982     )                    (2,940,174  )               (836,852     )                    (4,926,841   )      
 Total comprehensive loss                                                          (12,487,064  )                    (9,189,593  )               (38,923,118  )                    (19,913,910  )      
 Net loss per share attributable to common stockholders, basic and diluted  $      (0.58        )             $      (5.29       )        $      (1.80        )             $      (12.72       )      
 Weighted-average common shares outstanding, basic and diluted                     21,186,827                        1,181,726                   21,115,797                        1,178,206           



(https://www.globenewswire.com/NewsRoom/AttachmentNg/4b5be207-2832-49b4-9e6a-15869e433e16)



GlobeNewswire, Inc. 2020
© Stockopedia 2021, Refinitiv, Share Data Services.
This site cannot substitute for professional investment advice or independent factual verification. To use it, you must accept our Terms of Use, Privacy and Disclaimer policies.