1. BOSTON, Sept. 14, 2021 (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 announced an upcoming presentation of data for eprenetapopt in combination with pembrolizumab for the treatment of advanced solid tumors at the European Society of Medical Oncology (ESMO) Congress 2021 from September 16 – 21, 2021.

    Details for the ESMO 2021 mini oral presentation are as follows: 

    Title: Phase I/II study of eprenetapopt (APR-246) in combination with pembrolizumab in patients with solid tumor malignancies
    Speaker: Haeseong Park, Washington University in St. Louis
    Presentation #: 516MO
    Session…

    BOSTON, Sept. 14, 2021 (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 announced an upcoming presentation of data for eprenetapopt in combination with pembrolizumab for the treatment of advanced solid tumors at the European Society of Medical Oncology (ESMO) Congress 2021 from September 16 – 21, 2021.

    Details for the ESMO 2021 mini oral presentation are as follows: 

    Title: Phase I/II study of eprenetapopt (APR-246) in combination with pembrolizumab in patients with solid tumor malignancies

    Speaker: Haeseong Park, Washington University in St. Louis

    Presentation #: 516MO

    Session: Mini oral session – Developmental therapeutics

    Date and Time: Monday, September 20, 2021; 17:35 – 17:40 CEST (11:35 – 11:40am EDT)

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Sr. Vice President and Chief Business Officer

    617-463-9385



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  2. BOSTON, Aug. 12, 2021 (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 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…

    BOSTON, Aug. 12, 2021 (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 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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Sr. Vice President and Chief Business Officer

    617-463-9385

    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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  3. BOSTON, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. No additional patients can be enrolled until the clinical hold is resolved, though patients on study deriving clinical benefit can continue to receive study treatment.

    Subsequent to receiving notification of a partial clinical hold on its myeloid malignancies program, Aprea was informed by FDA of a…

    BOSTON, Aug. 12, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. No additional patients can be enrolled until the clinical hold is resolved, though patients on study deriving clinical benefit can continue to receive study treatment.

    Subsequent to receiving notification of a partial clinical hold on its myeloid malignancies program, Aprea was informed by FDA of a clinical hold on its lymphoid malignancy study. The FDA's concerns referred to the safety and efficacy data from the Phase 3 MDS clinical trial. One CLL patient is currently on study treatment receiving eprenetapopt in combination with venetoclax and rituximab and has achieved complete remission (CR). Aprea intends to work closely with the FDA to address the specific questions raised, and seek to resolve the clinical hold as soon as possible.

    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," "seek" 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

    Sr. Vice President and Chief Business Officer

    617-463-9385



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  4. BOSTON, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its clinical trials of eprenetapopt in combination with azacitidine in its myeloid malignancy programs. The partial clinical hold does not apply to the Company's ongoing clinical trials in lymphoid malignancies and solid tumors, or the APR-548 clinical trial.

    There are approximately 20 patients currently receiving eprenetapopt in combination with azacitidine in the Company's myeloid malignancy programs, which…

    BOSTON, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its clinical trials of eprenetapopt in combination with azacitidine in its myeloid malignancy programs. The partial clinical hold does not apply to the Company's ongoing clinical trials in lymphoid malignancies and solid tumors, or the APR-548 clinical trial.

    There are approximately 20 patients currently receiving eprenetapopt in combination with azacitidine in the Company's 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 clinical hold, no additional patients can be enrolled to these trials until the partial clinical hold is resolved. Aprea 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.

    "Patient safety is our highest priority," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. "Based on the totality of the data we have for eprenetapopt, we believe that it continues to be a promising therapeutic option for cancer patients. We are working closely with the FDA to review the data specific to eprenetapopt with azacitidine in our myeloid malignancy trials and will provide an update when we have additional information."

    The Company will host a webcast conference call to discuss this announcement on August 6, 2021 at 8:30 AM (ET). Connection details are provided below and are also available on the Events page of Aprea's website.

    Webcast Link: https://edge.media-server.com/mmc/p/8kjgeas4

    Participant Dial in Number:

    US/CANADA Participant Toll-Free Dial-In Number: (855) 547-3866

    US/CANADA Participant International Dial-In Number: (409) 217-8798

    Conference ID: 3119839

    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. 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.

    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.

    Aprea's myeloid malignancy program consists of clinical trials in frontline MDS, AML and post-transplant maintenance therapy in MDS/AML. 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. Additional clinical trials, including lymphoid malignancies and solid tumors, are ongoing.

    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 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," "seek" 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

    Sr. Vice President and Chief Business Officer

    617-463-9385



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    • 58% relapse free survival at 1 year post-transplant
    • 79% overall survival at 1 year post-transplant

    BOSTON, July 21, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced positive results from its Phase 2 trial evaluating eprenetapopt with azacitidine for post-transplant maintenance therapy in patients with TP53 mutant MDS and AML.

    In 33 patients enrolled in the trial, the relapse free survival (RFS) at 1 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 of 19.3 months. Prior…

    • 58% relapse free survival at 1 year post-transplant
    • 79% overall survival at 1 year post-transplant

    BOSTON, July 21, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced positive results from its Phase 2 trial evaluating eprenetapopt with azacitidine for post-transplant maintenance therapy in patients with TP53 mutant MDS and AML.

    In 33 patients enrolled in the trial, the relapse free survival (RFS) at 1 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 of 19.3 months. Prior clinical trials evaluating post-transplant outcomes in TP53 mutant MDS and AML patients have reported a 1-year post-transplant RFS of ~30% and a median OS of ~5-8 months. In addition, the post- transplant regimen of eprenetapopt and azacitidine was well tolerated among patients in the clinical trial. The Company plans to discuss the data from this Phase 2 clinical trial with the U.S. Food and Drug Agency (FDA) in the second half of 2021 and expects to present data at a future scientific or medical conference.

    "The post-transplant RFS and OS data with eprenetapopt and azacitidine maintenance therapy in these very difficult-to-treat TP53 mutant MDS and AML patients are incredibly exciting," said trial principal investigator Asmita Mishra, M.D., of the H. Lee Moffitt Cancer Center and Research Institute. "Although transplant is currently the only potentially curative treatment for patients with TP53 mutant MDS and AML, the risk of relapse with current standard of care remains unacceptably high and the median OS post-transplant is very limited at 8 months or less. Post-transplant maintenance therapy with eprenetapopt and azacitidine could, if approved, represent a new treatment paradigm that meaningfully improves outcomes for these patients with limited treatment options."

    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. 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.

    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 has been completed and failed to meet the primary statistical endpoint of complete remission. A Phase 1/2 clinical trial of eprenetapopt with venetoclax and azacitidine for the frontline treatment of TP53 mutant AML met the primary efficacy endpoint of complete remission. Additional clinical trials in hematologic malignancies and solid tumors are ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Orphan Drug and Fast Track designations from the FDA for AML, and Orphan Drug designation from the European Medicines Agency for MDS and AML.

    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.

    About MDS

    Myelodysplastic syndromes (MDS) represent a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to contribute to disease progression. Mutations in p53 are found in up to 20% of MDS and AML patients and are associated with poor overall prognosis. There are no currently approved therapies specifically for TP53 mutant MDS or AML patients.

    About AML

    AML is the most common form of adult leukemia, with the highest incidence in patients aged 60 years and older. AML is characterized by proliferation of abnormal immature white blood cells that impairs production of normal blood cells. AML can develop de novo or may arise secondary to progression of other hematologic disorders or from chemotherapy or radiation treatment for a different, prior malignancy; secondary AML carries a worse prognosis than de novo AML. Mutations in TP53, which are associated with poor overall prognosis, occur in approximately 20% of patients with newly diagnosed AML, more than 30% of patients with therapy-related AML and approximately 70-80% of patients with complex karyotype.

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Sr. Vice President and Chief Business Officer

    617-463-9385



    Primary Logo

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    • 37% CR rate in 30 efficacy-evaluable patients

    BOSTON, June 16, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the Phase 1/2 trial evaluating the frontline treatment of eprenetapopt with venetoclax and azacitidine in patients with TP53 mutant AML has met the pre-specified primary efficacy endpoint of complete remission (CR) rate.

    In 30 patients who were evaluable for efficacy at the time of the analysis, the CR rate was 37% and the composite response rate of CR plus CR with incomplete hematologic recovery (CRi), CR/CRi, was 53%. The trial met the primary…

    • 37% CR rate in 30 efficacy-evaluable patients

    BOSTON, June 16, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that the Phase 1/2 trial evaluating the frontline treatment of eprenetapopt with venetoclax and azacitidine in patients with TP53 mutant AML has met the pre-specified primary efficacy endpoint of complete remission (CR) rate.

    In 30 patients who were evaluable for efficacy at the time of the analysis, the CR rate was 37% and the composite response rate of 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 the data cut, 11 patients remain on study treatment and continue to be followed for safety and efficacy. The Company plans to discuss the dataset with the U.S. Food and Drug Agency (FDA) in the second half of 2021 and expects to present data from the trial at a future scientific or medical conference.

    "We are pleased with these results from the combination of eprenetapopt with venetoclax and azacitidine in this very difficult-to-treat TP53 mutant AML population, a patient group with significant unmet medical need," said Eyal Attar, M.D., Chief Medical Officer of Aprea Therapeutics. "These data, which follow the recent granting of Fast Track and Orphan Drug designations by FDA, provide further demonstration of the potential for eprenetapopt in the treatment of myeloid malignancies. We continue to make excellent progress across our myeloid malignancies program and look forward to providing an update in July 2021 on our Phase 2 trial evaluating eprenetapopt with azacitidine as maintenance therapy in TP53 mutant MDS and AML patients who have received allogeneic stem cell transplant."

    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. 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.

    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 has been completed and failed to meet the primary statistical endpoint of complete remission. Additional clinical trials in hematologic malignancies and solid tumors are ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Orphan Drug and Fast Track designations from the FDA for AML, and Orphan Drug designation from the European Medicines Agency for MDS and AML.

    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.

    About AML

    AML is the most common form of adult leukemia, with the highest incidence in patients aged 60 years and older. AML is characterized by proliferation of abnormal immature white blood cells that impairs production of normal blood cells. AML can develop de novo or may arise secondary to progression of other hematologic disorders or from chemotherapy or radiation treatment for a different, prior malignancy; secondary AML carries a worse prognosis than de novo AML. Mutations in TP53, which are associated with poor overall prognosis, occur in approximately 20% of patients with newly diagnosed AML, more than 30% of patients with therapy-related AML and approximately 70-80% of patients with complex karyotype.

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Sr. Vice President and Chief Business Officer

    617-463-9385 



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  5. BOSTON, May 21, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that Greg Korbel, Senior Vice President and Chief Business Officer, will present a corporate update at the 2021 Oppenheimer Rare & Orphan Disease Summit on Friday, May 21, 2021 at 3:45 p.m. ET.

    A webcast of the presentation can be accessed from the "Events Calendar" in the News and Events section of the Aprea website at Link.

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden…

    BOSTON, May 21, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that Greg Korbel, Senior Vice President and Chief Business Officer, will present a corporate update at the 2021 Oppenheimer Rare & Orphan Disease Summit on Friday, May 21, 2021 at 3:45 p.m. ET.

    A webcast of the presentation can be accessed from the "Events Calendar" in the News and Events section of the Aprea website at Link.

    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. 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, 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 has been completed and failed to meet the primary endpoint of complete remission. Additional clinical trials in hematologic malignancies and solid tumors are ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Orphan Drug and Fast Track designations from the FDA for AML, 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. Enrollment in a Phase 1 clinical trial of APR-548 is anticipated to begin early in the second quarter of 2021.

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Sr. Vice President and Chief Business Officer

    617-463-9385



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  6. BOSTON, May 18, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that Christian S. Schade, Chairman and Chief Executive Officer, and Eyal C. Attar, Senior Vice President and Chief Medical Officer, will participate in a fireside discussion at the 2021 RBC Capital Markets Global Healthcare Conference on Tuesday, May 18, 2021 at 2:30 p.m. ET.

    A webcast of the presentation can be accessed from the "Events Calendar" in the News and Events section of the Aprea website at Link.

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered…

    BOSTON, May 18, 2021 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that Christian S. Schade, Chairman and Chief Executive Officer, and Eyal C. Attar, Senior Vice President and Chief Medical Officer, will participate in a fireside discussion at the 2021 RBC Capital Markets Global Healthcare Conference on Tuesday, May 18, 2021 at 2:30 p.m. ET.

    A webcast of the presentation can be accessed from the "Events Calendar" in the News and Events section of the Aprea website at Link.

    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. 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, 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 has been completed and failed to meet the primary endpoint of complete remission. Additional clinical trials in hematologic malignancies and solid tumors are ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Orphan Drug and Fast Track designations from the FDA for AML, 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. Enrollment in a Phase 1 clinical trial of APR-548 is anticipated to begin early in the second quarter of 2021.

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Sr. Vice President and Chief Business Officer

    617-463-9385



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  7. BOSTON, May 06, 2021 (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 months ended March 31, 2021 and provided a business update.

    "During our recent R&D Day presentation, we reported an analysis of available data from its Phase 3 MDS trial. We identified an imbalance in dose modifications in the experimental arm which we believe negatively impacted efficacy, particularly the primary CR endpoint," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. "We remain confident that eprenetapopt and our next-generation…

    BOSTON, May 06, 2021 (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 months ended March 31, 2021 and provided a business update.

    "During our recent R&D Day presentation, we reported an analysis of available data from its Phase 3 MDS trial. We identified an imbalance in dose modifications in the experimental arm which we believe negatively impacted efficacy, particularly the primary CR endpoint," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. "We remain confident that eprenetapopt and our next-generation oral agent, APR-548, represent important potential therapeutic options for cancer patients and are encouraged by emerging data from our ongoing clinical trials. We look forward to sharing data updates from these clinical trials as well as our continued progress in expanding the opportunity for our therapies in new indications."

    Business Operations Update: 

    The Company is conducting, supporting, and planning multiple clinical trials of eprenetapopt (APR-246) and APR-548:

    • 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 and anticipates discussing with FDA the Phase 3 data and future possible regulatory pathways in the second half of 2021.
    • Phase 2 MDS/AML Post-Transplant Trial – The Company has completed enrollment of 33 patients in 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, with a published benchmark of ~30%. An interim analysis in April 2021 showed a 62% rate of RFS at 12 months, with a median RFS of 462 days. An interim analysis of overall survival (OS) showed a 77% OS at 1 year, with a median number of events not yet reached. The Company anticipates initial results from the primary endpoint of RFS at 12 months in the second quarter of 2021.
    • 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 the 19 frontline AML patients who are evaluable for efficacy with the triplet regimen, the Company has observed a 63% CR + CRi composite response rate and a 31% CR rate. The Company anticipates completion of enrollment in the triplet regimen expansion cohort during the second quarter of 2021 and availability of preliminary response rate data from the cohort also in the second quarter of 2021.
    • 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 ibrutinib in order to further assess eprenetapopt in hematological malignancies. The first patient was enrolled in the first quarter of 2021. The Company is also planning to evaluate the combination of eprenetapopt with venetoclax in relapsed/refractory mantle cell lymphoma.
    • 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 15 patients across these expansion arms. A poster presentation for this trial has been accepted for presentation 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 quarter of 2021.

    First Quarter Financial Results

    • Cash and cash equivalents:  As of March 31, 2021, the Company had $77.6 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 March 31, 2021 will be sufficient to meet its current projected operating requirements into 2023.
    • Research and Development (R&D) expenses:  R&D expenses were $6.8 million for the quarter ended March 31, 2021, compared to $9.1 million for the comparable period in 2020. The decrease in R&D expenses was primarily due to decreases in clinical trial costs for (i) 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 (ii) our Phase 2 post-transplant MDS/AML clinical trial. These decreases were partially offset by increases in clinical trial costs for our Phase 1/2 clinical trial for the treatment of TP53 mutant AML with venetoclax and azacitidine, our Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy, and our Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) assessing eprenetapopt with venetoclax and rituximab, and eprenetapopt with ibrutinib. 
    • General and Administrative (G&A) expenses:  G&A expenses were $3.4 million for the quarter ended March 31, 2021, compared to $2.8 million for the comparable period in 2020.  The increase in G&A expenses was primarily due to increases in non-cash stock-based compensation and insurance expense.

    • Net loss:  Net loss was $9.7 million, or $0.46 per share for the quarter ended March 31, 2021, compared to a net loss of $9.4 million, or $0.45 per share for the quarter ended March 31, 2020.   The Company had 21,186,827 shares of common stock outstanding as of March 31, 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. 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, 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 has been completed and failed to meet the primary endpoint of complete remission. Additional clinical trials in hematologic malignancies and solid tumors are ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Orphan Drug and Fast Track designations from the FDA for AML, 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. Enrollment in a Phase 1 clinical trial of APR-548 is anticipated to begin early in the second quarter of 2021.

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Sr. Vice President and Chief Business Officer

    617-463-9385

     
    Aprea Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)
            
     March 31, 2021

     December 31, 2020
    Assets       
    Current assets:       
    Cash and cash equivalents$77,616,074  $89,017,686 
    Prepaid expenses and other current assets 2,467,443   3,399,019 
    Total current assets 80,083,517   92,416,705 
    Property and equipment, net 33,572   38,515 
    Right of use lease and other noncurrent assets 277,576   349,999 
    Total assets$80,394,665  $92,805,219 
    Liabilities and Stockholders' Equity        
    Current liabilities:       
    Accounts payable$3,456,728  $4,503,619 
    Accrued expenses 7,532,473   10,571,237 
    Lease liability—current 225,537   256,309 
    Total current liabilities 11,214,738   15,331,165 
    Lease liability—noncurrent 33,763   78,847 
    Total liabilities 11,248,501   15,410,012 
    Commitments and contingencies       
    Stockholders' equity:       
    Common stock, par value $0.001; 21,186,827 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively. 21,187   21,187 
    Additional paid-in capital 233,240,918   231,418,356 
    Accumulated other comprehensive loss (10,440,111)  (10,037,261)
    Accumulated deficit (153,675,830)  (144,007,075)
    Total stockholders' equity 69,146,164   77,395,207 
    Total liabilities and stockholders' equity$80,394,665  $92,805,219 
            



     
    Aprea Therapeutics, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)
       
      Three Months Ended March 31,
      2021

     2020

    Operating expenses:      
    Research and development $6,763,848  $9,096,122 
    General and administrative  3,425,833   2,776,468 
    Total operating expenses  10,189,681   11,872,590 
    Other income (expense):      
    Interest (expense) income  (1,057)  224,442 
    Foreign currency (loss) gain  521,983   2,247,891 
    Total other income (expense)  520,926   2,472,333 
    Net loss $(9,668,755) $(9,400,257)
    Other comprehensive income (loss):      
    Foreign currency translation  (402,850)  (2,424,653)
    Total comprehensive loss  (10,071,605)  (11,824,910)
    Net loss per share attributable to common stockholders, basic and diluted $(0.46) $(0.45)
    Weighted-average common shares outstanding, basic and diluted  21,186,827   21,052,726 
             



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  8. BOSTON, April 16, 2021 (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 announced that it will host a virtual R&D Day at 1:00 p.m. ET on Thursday, April 22, 2021.

    Aprea's R&D Day will be presented by Christian S. Schade, Chairman and Chief Executive Officer, and Eyal C. Attar, Chief Medical Officer, with a focus on the Company's analysis of its recently completed Phase 3 MDS trial and the continued progress across its ongoing research and clinical development pipeline.

    The live webinar will begin at 1:00 pm Eastern Time and last approximately one hour. Registration…

    BOSTON, April 16, 2021 (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 announced that it will host a virtual R&D Day at 1:00 p.m. ET on Thursday, April 22, 2021.

    Aprea's R&D Day will be presented by Christian S. Schade, Chairman and Chief Executive Officer, and Eyal C. Attar, Chief Medical Officer, with a focus on the Company's analysis of its recently completed Phase 3 MDS trial and the continued progress across its ongoing research and clinical development pipeline.

    The live webinar will begin at 1:00 pm Eastern Time and last approximately one hour. Registration is accessible on the Events page of Aprea's website. Following the webinar, a replay will be available for a limited time on Aprea's website.

    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. 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, 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 has been completed and failed to meet the primary endpoint of complete remission. Additional clinical trials in hematologic malignancies and solid tumors are ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Orphan Drug and Fast Track designations from the FDA for AML, 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. Enrollment in a Phase 1 clinical trial of APR-548 is anticipated to begin early in the second quarter of 2021.

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Chief Business Officer

    617-463-9385



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  9. BOSTON, April 08, 2021 (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 announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to eprenetapopt for treatment of AML.

    "We are pleased to have been granted Orphan Drug designation by FDA for eprenetapopt in AML, building on the Fast Track designation in AML that was granted in November 2020," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. "We look forward to continued productive dialogue with FDA and bringing eprenetapopt to patients as soon as possible."

    Orphan…

    BOSTON, April 08, 2021 (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 announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to eprenetapopt for treatment of AML.

    "We are pleased to have been granted Orphan Drug designation by FDA for eprenetapopt in AML, building on the Fast Track designation in AML that was granted in November 2020," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. "We look forward to continued productive dialogue with FDA and bringing eprenetapopt to patients as soon as possible."

    Orphan Drug designation is granted by the FDA Office of Orphan Products Development to advance the evaluation and development of safe and effective therapies for the treatment of rare diseases or conditions affecting fewer than 200,000 people in the U.S. The designation can provide development and commercial incentives for designated compounds and medicines, including eligibility for a seven-year period of market exclusivity in the U.S. after product approval, FDA assistance in clinical trial design, tax credits related to clinical trial expenses, and an exemption from FDA user fees.

    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. 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, 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 has been completed and failed to meet the primary endpoint of complete remission. Additional clinical trials in hematologic malignancies and solid tumors are ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Orphan Drug and Fast Track designations from the FDA for AML, 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. Enrollment in a Phase 1 clinical trial of APR-548 is anticipated to begin early in the second quarter of 2021.

    About AML

    AML is the most common form of adult leukemia, with the highest incidence in patients aged 60 years and older. AML is characterized by proliferation of abnormal immature white blood cells that impairs production of normal blood cells. AML can develop de novo or may arise secondary to progression of other hematologic disorders or from chemotherapy or radiation treatment for a different, prior malignancy; secondary AML carries a worse prognosis than de novo AML. Mutations in TP53, which are associated with poor overall prognosis, occur in approximately 20% of patients with newly diagnosed AML, more than 30% of patients with therapy-related AML and approximately 70-80% of patients with complex karyotype.

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385



    Gregory A. Korbel

    Chief Business Officer

    617-463-9385



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  10. BOSTON, March 16, 2021 (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 months and year ended December 31, 2020 and provided a business update.

    "Though disappointed the topline complete remission rate from the Phase 3 clinical trial narrowly missed its primary endpoint, we continue to analyze the totality of the data from the study to understand those differences from our prior Phase 2 experience in frontline MDS patients and expect to present these findings in the second quarter of 2021," said Christian S. Schade, Chairman…

    BOSTON, March 16, 2021 (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 months and year ended December 31, 2020 and provided a business update.

    "Though disappointed the topline complete remission rate from the Phase 3 clinical trial narrowly missed its primary endpoint, we continue to analyze the totality of the data from the study to understand those differences from our prior Phase 2 experience in frontline MDS patients and expect to present these findings in the second quarter of 2021," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea. "Our dedicated team remains committed to the clinical development of eprenetapopt and our next generation, oral p53 reactivator, APR-548, in hematological and solid tumor malignancies. In 2021, we look forward to sharing data from our current clinical studies as well as our plans to expand the clinical pipeline to include new indications."

    Business Operations Update: 

    The Company is conducting, supporting, and planning multiple clinical trials of eprenetapopt (APR-246) and APR-548:

    • Pivotal Phase 3 MDS Trial—In December 2020, the Company announced its pivotal Phase 3 randomized, controlled trial evaluating eprenetapopt with azacitidine as frontline therapy in HMA-naïve TP53 mutant myelodysplastic syndromes (MDS) patients failed to meet its predefined primary endpoint of complete remission (CR) rate. Analysis of the primary endpoint at this data cut demonstrated a 53% higher number of 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. The Company is completing analysis from this Phase 3 clinical trial and expects to present additional information in the second quarter of 2021.
    • Phase 2 MDS/AML Post-Transplant Trial – The Company has completed enrollment of 33 patients in 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 Company anticipates initial results from the primary endpoint of relapse-free survival at 12 months in the second quarter of 2021.
    • 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 the 19 frontline AML patients who are evaluable for efficacy with the triplet regimen, the Company has observed a 63% CR + CRi composite response rate and a 31% CR rate. The Company anticipates completion of enrollment in the triplet regimen expansion cohort during the second quarter of 2021 with availability of preliminary response rate data from the cohort also in the second quarter of 2021.
    • 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 ibrutinib in order to further assess eprenetapopt in hematological malignancies. The first patient was enrolled in the first quarter of 2021. The Company is also planning to evaluate the combination of eprenetapopt with venetoclax in relapsed/refractory mantle cell lymphoma.
    • 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 8 patients across these expansion arms.
    • APR-548 -- 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 early in the second quarter of 2021.

    Fourth Quarter Financial Results

    • Cash and cash equivalents:  As of December 31, 2020, the Company had $89.0 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 2021 to be between $30.0 million $35.0 million. The Company believes its cash and cash equivalents as of December 31, 2020 will be sufficient to meet its current projected operating requirements into 2023.  

    • Research and Development (R&D) expenses:  R&D expenses were $9.3 million for the quarter ended December 31, 2020, compared to $8.0 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; its pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for frontline treatment of TP53 mutant MDS, its Phase 1/2 clinical trial for the treatment of TP53 mutant AML with venetoclax and azacitidine, its Phase 1/2 clinical trial in relapsed/refractory gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy, its Phase 1 clinical trial in relapsed/refractory TP53 mutant chronic lymphoid leukemia (CLL) assessing eprenetapopt with venetoclax and rituximab, and eprenetapopt with ibrutinib and its Phase 2 post-transplant MDS/AML clinical trial.

    • General and Administrative (G&A) expenses:  G&A expenses were $4.9 million for the quarter ended December 31, 2020, compared to $3.9 million for the comparable period in 2019. The increase in G&A expenses was primarily due to increases in non-cash stock-based compensation, insurance expense and commercial development expense.

    • Net loss:  Net loss was $15.4 million, or $0.73 per share for the quarter ended December 31, 2020, compared to a net loss of $13.1 million, or $0.64 per share for the quarter ended December 31, 2019.   The Company had 21,186,827 shares of common stock outstanding as of December 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 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, Fast Track designation from the FDA for AML, 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 but at the primary data cut, it failed to meet its predefined primary endpoint of complete remission rate. 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

    Chief Business Officer

    617-463-9385

    Aprea Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

     December 31, 2020

     December 31, 2019
    Assets     
    Current assets:     
    Cash and cash equivalents$89,017,686  $130,088,869 
    Prepaid expenses and other current assets 3,399,019   2,955,878 
    Total current assets 92,416,705   133,044,747 
    Property and equipment, net 38,515   41,639 
    Right of use lease and other noncurrent assets 349,999   521,499 
    Total assets$92,805,219  $133,607,885 
          
    Liabilities and Stockholders' Equity   
    Current liabilities:  
    Accounts payable$4,503,619  $2,176,852 
    Accrued expenses 10,571,237   6,642,553 
    Lease liability—current 256,309   242,329 
    Total current liabilities 15,331,165   9,061,734 
    Lease liability—noncurrent 78,847   302,621 
    Total liabilities 15,410,012   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 December 31, 2020 and 2019, respectively. 21,187   21,023 
    Additional paid-in capital 231,418,356   226,284,548 
    Accumulated other comprehensive loss (10,037,261)  (11,533,778)
    Accumulated deficit (144,007,075)  (90,528,263)
    Total stockholders' equity 77,395,207   124,243,530 
    Total liabilities and stockholders' equity$92,805,219  $133,607,885 

    Aprea Therapeutics, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

      Three Months Ended December 31,  Year Ended December 31,  
         2020     2019     2020     2019  
    Operating expenses:                 
    Research and development $9,328,079  $8,041,993  $37,879,325  $20,950,672  
    General and administrative  4,895,323   3,937,765   14,931,887   8,593,626  
    Total operating expenses  14,223,402   11,979,758   52,811,212   29,544,298  
    Other income (expense):             
    Interest income  4,744        169,888          222,652         156,351  
    Foreign currency (loss) gain  (1,173,888)  (1,262,868)  (890,252)  1,328,140  
    Total other income (expense)  (1,169,144)  (1,092,980)  (667,600)  1,484,491  
    Net loss $(15,392,546) $(13,072,738) $(53,478,812) $(28,059,807) 
    Other comprehensive income (loss):             
    Foreign currency translation  2,333,369   2,154,388   1,496,517   (2,772,453) 
    Total comprehensive loss  (13,059,177)  (10,918,350)  (51,982,295)  (30,832,260) 
    Net loss per share attributable to common stockholders, basic and diluted $(0.73) $(0.64) $(2.53) $(4.67) 
    Weighted-average common shares outstanding, basic and diluted  21,186,827   20,318,040   21,133,651   6,002,486  



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  11. BOSTON, Jan. 08, 2021 (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 announced that Christian S. Schade, Chairman and Chief Executive Officer, will present a corporate update at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 2:50 p.m. ET.

    A live webcast of the presentation can be accessed under the "Events Calendar" in the Investors section of the Aprea website at Link.

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm…

    BOSTON, Jan. 08, 2021 (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 announced that Christian S. Schade, Chairman and Chief Executive Officer, will present a corporate update at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021 at 2:50 p.m. ET.

    A live webcast of the presentation can be accessed under the "Events Calendar" in the Investors section of the Aprea website at Link.

    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. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for myelodysplastic syndromes (MDS), 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.

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Vice President of Business Development

    617-463-9385



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    • The trial failed to meet its primary endpoint of complete remission (CR) rate
    • CR rate was 53% higher in eprenetapopt with AZA arm compared to AZA alone, but did not reach statistical significance

    BOSTON, Dec. 28, 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 announced results of the primary data cut from its Phase 3 clinical trial evaluating the safety and efficacy of eprenetapopt with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS). The trial did not meet the predefined primary endpoint of complete remission (CR) rate.   Analysis of…

    • The trial failed to meet its primary endpoint of complete remission (CR) rate

    • CR rate was 53% higher in eprenetapopt with AZA arm compared to AZA alone, but did not reach statistical significance

    BOSTON, Dec. 28, 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 announced results of the primary data cut from its Phase 3 clinical trial evaluating the safety and efficacy of eprenetapopt with azacitidine (AZA) versus AZA alone in TP53 mutant myelodysplastic syndromes (MDS). The trial did not meet the predefined primary endpoint of complete remission (CR) rate.   Analysis of the primary endpoint at this data cut demonstrated a higher CR rate in the experimental arm receiving eprenetapopt with AZA versus the control arm receiving AZA alone, but did not reach statistical significance. In the intention-to-treat population of 154 patients, the CR rate in the eprenetapopt with AZA arm was 33.3% (95% CI: 23.1% - 44.9%) compared to 22.4% (95% CI: 13.6% - 33.4%) in the AZA alone arm (P = 0.13).

    While analysis of certain secondary endpoints (ORR and duration of responses) appears to favor the experimental arm at this data cut, they are not significantly different. The median duration of overall survival at the primary data cut was similar between the arms. Additional patients in the study who have not achieved a CR remain on study treatment and the data will be analyzed at future pre-specified timepoints as set forth in the statistical analysis plan. The combination of eprenetapopt with AZA appeared well-tolerated, with an adverse event profile that was similar to the Company's prior Phase 2 clinical trials. Subsequent analyses of the trial data, including secondary endpoints, will be conducted as the duration of patient follow-up increases. The Company expects to present the data at a future scientific conference.

    "Though we are disappointed the topline results did not reach statistical significance, we continue to believe that eprenetapopt can offer clinical benefit to patients with TP53 mutant malignancies," said Dr. Eyal Attar, Chief Medical Officer of Aprea. "We will continue to analyze data as it matures and follow patients who are still receiving study treatment. Our other clinical trials continue to progress and we remain committed to pursuing our clinical development programs."

    About the Phase 3 Trial in TP53 Mutant MDS

    The Phase 3 trial enrolled 154 TP53 mutant MDS patients, randomized 1:1 to either the eprenetapopt with AZA arm or the AZA alone arm. Response criteria are those defined by International Working Group 2006 (IWG 2006) and include measures of peripheral blood counts and bone marrow blasts.

    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. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for myelodysplastic syndromes (MDS), Fast Track designation from the FDA for acute myeloid leukemia (AML), 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 has been completed and additional clinical trials in hematologic malignancies and solid tumors are ongoing. Eprenetapopt has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, Fast Track designation from the FDA for AML, 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. Enrollment in a Phase 1 clinical trial of APR-548 is anticipated to begin in the first quarter of 2021.

    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. Coiante

    Sr. Vice President and Chief Financial Officer

    617-463-9385

    Gregory A. Korbel

    Vice President of Business Development

    617-463-9385



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  12. BOSTON, Nov. 30, 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 announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eprenetapopt in the treatment of patients with TP53 mutant acute myeloid leukemia (AML). The Company previously received Breakthrough Therapy, Orphan Drug and Fast Track designations for eprenetapopt in the treatment of patients with TP53 mutant myelodysplastic syndromes (MDS).

    The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions…

    BOSTON, Nov. 30, 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 announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for eprenetapopt in the treatment of patients with TP53 mutant acute myeloid leukemia (AML). The Company previously received Breakthrough Therapy, Orphan Drug and Fast Track designations for eprenetapopt in the treatment of patients with TP53 mutant myelodysplastic syndromes (MDS).

    The FDA's Fast Track designation is intended to facilitate the development and review of drug candidates that treat serious conditions and address an unmet medical need. A drug candidate that receives Fast Track designation may be eligible for more frequent interaction with the FDA to discuss the drug candidate's development plan as well as eligibility for accelerated approval and priority review.

    "We are pleased to have received Fast Track designation for eprenetapopt in the treatment of TP53 mutant AML, a cancer for which outcomes are poor and there are no current therapeutic options specifically for these patients," said Eyal C. Attar, M.D., Chief Medical Officer of Aprea. "Emerging data from our AML trials evaluating eprenetapopt with azacitidine, and with eprenetapopt, azacitidine and venetoclax, are promising and we continue to enroll patients to identify the best treatment regimen. As these data mature in 2021, we look forward to continued interaction with FDA as we map out opportunities for an accelerated pathway to potential approval."

    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, Fast Track designation from the FDA for AML,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, Fast Track designation from the FDA for AML, 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. Enrollment in a Phase 1 clinical trial of APR-548 is anticipated to begin in the first quarter of 2021

    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



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  13. BOSTON, Nov. 19, 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 announced that Christian S. Schade, Chairman and Chief Executive Officer, and Eyal Attar, M.D., Chief Medical Officer, will participate in a fireside chat at the virtual Piper Sandler Healthcare Conference being held December 1-3, 2020.

    The pre-recorded fireside chat will be accessible for a limited time beginning November 23, 2020 in the Investors section of Aprea Therapeutics' website at www.aprea.com.

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered…

    BOSTON, Nov. 19, 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 announced that Christian S. Schade, Chairman and Chief Executive Officer, and Eyal Attar, M.D., Chief Medical Officer, will participate in a fireside chat at the virtual Piper Sandler Healthcare Conference being held December 1-3, 2020.

    The pre-recorded fireside chat will be accessible for a limited time beginning November 23, 2020 in the Investors section of Aprea Therapeutics' website at www.aprea.com.

    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.

    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



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  14. 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…

    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 62nd 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 



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  15. BOSTON, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics to reactivate mutant tumor suppressor protein, p53, will host a live virtual R&D Day Webinar, with presentations by key opinion leaders in hematology, today from 1:00 – 3:00 pm Eastern Time.

    R&D Day Webinar Agenda:

    1:00 pm – 2:00 pm:
    Introduction and discussion with Drs. David Sallman (Moffitt Cancer Center), Guillermo Garcia-Manero (MD Anderson Cancer Center), and Eyal Attar (Aprea's Chief Medical Officer) to review current clinical therapy options for TP53 mutant MDS/AML patients and the potential role of eprenetapopt. Discussion with review of Aprea's Phase 3 Clinical…

    BOSTON, Oct. 30, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics to reactivate mutant tumor suppressor protein, p53, will host a live virtual R&D Day Webinar, with presentations by key opinion leaders in hematology, today from 1:00 – 3:00 pm Eastern Time.

    R&D Day Webinar Agenda:

    1:00 pm – 2:00 pm:

    Introduction and discussion with Drs. David Sallman (Moffitt Cancer Center), Guillermo Garcia-Manero (MD Anderson Cancer Center), and Eyal Attar (Aprea's Chief Medical Officer) to review current clinical therapy options for TP53 mutant MDS/AML patients and the potential role of eprenetapopt. Discussion with review of Aprea's Phase 3 Clinical program in MDS to be followed by Q&A.

    2:00 pm – 2:15 pm:

    Overview of Aprea's ongoing commercial preparations in front-line MDS by Greg Wessels, Aprea's Chief Commercial Officer

    2:15 pm – 3:00 pm:

    Review of Aprea's hematology and solid tumor clinical pipeline, by Dr. Eyal Attar followed by Q&A and Wrap-up.

    Virtual R&D Day Webinar Information

    The live webinar will begin at 1:00 pm Eastern Time and conclude at approximately 3:00 pm. Registration is accessible on the Events page of Aprea's website. Following the webinar, a replay will be available for a limited time on Aprea's website.

    About Aprea Therapeutics

    Aprea Therapeutics, Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the 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 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce 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 U.S. Food and Drug Administration 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 mutant MDS is planned.

    Forward-Looking Statements

    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 and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. 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.



    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



    Source: Aprea Therapeutics, Inc.

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  16. BOSTON, Oct. 14, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics to reactivate mutant tumor suppressor protein, p53, today announced the launch of p53reactivation.com. The new website contributes to Aprea's disease awareness initiative to educate healthcare professionals on the importance of p53 mutations in cancer and reactivation of mutant p53 as a potential therapeutic option for the treatment of cancer.

    "Mutations in p53 are present in approximately half of all cancers and are often associated with poor treatment outcomes and resistance to traditional anti-cancer therapies," said Eyal Attar, M.D., Senior Vice President and…

    BOSTON, Oct. 14, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics to reactivate mutant tumor suppressor protein, p53, today announced the launch of p53reactivation.com. The new website contributes to Aprea's disease awareness initiative to educate healthcare professionals on the importance of p53 mutations in cancer and reactivation of mutant p53 as a potential therapeutic option for the treatment of cancer.

    "Mutations in p53 are present in approximately half of all cancers and are often associated with poor treatment outcomes and resistance to traditional anti-cancer therapies," said Eyal Attar, M.D., Senior Vice President and Chief Medical Officer of Aprea Therapeutics. "Knowledge of the poor prognoses that accompany p53 mutations, the availability of diagnostic tests for their identification, and awareness of mutant p53 reactivation as a potential targeted therapeutic option, may collectively advance detection and treatment for cancer patients with this important and significant unmet medical need."

    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

    Source: Aprea Therapeutics, Inc.

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  17. BOSTON, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for APR-548 to treat TP53 mutant myelodysplastic syndromes (MDS). APR-548 is a next-generation small molecule reactivator of mutant p53 that is being developed for oral administration.

    "The IND acceptance by FDA is an important milestone for APR-548 and Aprea's development of next-generation reactivators of mutant p53," said Christian S. Schade, Chairman and Chief Executive…

    BOSTON, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application for APR-548 to treat TP53 mutant myelodysplastic syndromes (MDS). APR-548 is a next-generation small molecule reactivator of mutant p53 that is being developed for oral administration.

    "The IND acceptance by FDA is an important milestone for APR-548 and Aprea's development of next-generation reactivators of mutant p53," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea Therapeutics. "We look forward to initiating the Phase 1 clinical trial of APR-548 in MDS and to expanding our leadership in the development of needed therapeutic options for patients with p53 mutated cancers."

    About Aprea Therapeutics

    Aprea Therapeutics, Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the 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 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce 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 U.S. Food and Drug Administration 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 mutant MDS is planned.

    Forward-Looking Statements

    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 and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. 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.

    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

    Source: Aprea Therapeutics, Inc.

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  18. BOSTON, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the appointment of Michael A. Kelly to its Board of Directors. Mr. Kelly will serve as a member of the audit committee and nominating and corporate governance committee.

    Mr. Kelly brings more than 20 years of executive leadership in the life sciences industry, including 14 years in senior leadership roles with Amgen Inc., and is the Founder and President of Sentry Hill Partners, LLC, a global life sciences management consulting business. Prior to founding Sentry Hill Partners, Mr. Kelly…

    BOSTON, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the appointment of Michael A. Kelly to its Board of Directors. Mr. Kelly will serve as a member of the audit committee and nominating and corporate governance committee.

    Mr. Kelly brings more than 20 years of executive leadership in the life sciences industry, including 14 years in senior leadership roles with Amgen Inc., and is the Founder and President of Sentry Hill Partners, LLC, a global life sciences management consulting business. Prior to founding Sentry Hill Partners, Mr. Kelly held multiple finance and operations positions at Amgen, most recently serving as Senior Vice President of Global Business Services and, in 2010 and 2014, was acting CFO. Prior to Amgen, he held senior and executive leadership positions at Tanox, Inc. Biogen, Inc., and Monsanto Life Sciences. Mr. Kelly holds a Bachelor of Science degree in business administration from Florida A&M University.

    "Michael Kelly is a distinguished industry executive with considerable experience in the management and growth of innovative life sciences companies," said Christian S. Schade, Chairman and Chief Executive Officer of Aprea Therapeutics. "His deep operational and financial expertise will be invaluable as Aprea continues with its progress to advance our mutant p53 reactivator oncology programs toward commercialization. It is a great pleasure to welcome Michael to the Aprea team and our Board of Directors."

    About Aprea Therapeutics

    Aprea Therapeutics, Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the 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

    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 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce 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.

    A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for MDS, and Orphan Drug designation from the European Medicines Agency for MDS, AML and ovarian cancer.

    Forward-Looking Statements

    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 and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020. 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.

    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

    Source: Aprea Therapeutics, Inc.

    Primary Logo

    View Full Article Hide Full Article
  19. BOSTON, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the promotion of Gregory S. Wessels to the newly created position of Chief Commercial Officer.

    "We are excited to have Greg assume the role of Chief Commercial Officer as we approach key milestones in our frontline MDS program and continue to execute on our plans for the future development of eprenetapopt," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "Greg's leadership and oncology market experience will be essential as we build out our commercial…

    BOSTON, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the promotion of Gregory S. Wessels to the newly created position of Chief Commercial Officer.

    "We are excited to have Greg assume the role of Chief Commercial Officer as we approach key milestones in our frontline MDS program and continue to execute on our plans for the future development of eprenetapopt," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "Greg's leadership and oncology market experience will be essential as we build out our commercial capabilities."

    Mr. Wessels joined Aprea in February 2020 from Bristol-Myers Squibb where he most recently served as Executive Director – US Marketing for Lymphoma and Acute Myeloid Leukemia.  Prior to joining Aprea from BMS, Mr. Wessels held global and regional oncology marketing positions of increasing responsibility over more than 11 years at Celgene Corporation.

    The Company also announced today that two of its independent directors, Scott Rocklage, Ph.D. and Jonathan Hepple, Ph.D. have decided to step down after nearly a decade of collective service on the Board. In connection with the departure from the Board of Drs. Rocklage and Hepple, Christian S. Schade was appointed Chairman of the Board of Directors, John B. Henneman was named Lead Independent Director, Richard Peters, M.D., Ph.D, became Chairman of the Company's Compensation Committee and Fouad Namouni, M.D. became a member of the Company's Nominating and Corporate Governance Committee.

    "On behalf of the Board of Directors and all Aprea employees, we are grateful to both Scott Rocklage and Jonathan Hepple for their contributions and years of invaluable service to the Company," added Christian S. Schade.

    "Aprea has made tremendous progress in advancing therapeutics to target TP53 mutations in oncology," said Scott Rocklage. "With the addition to the Board of Drs. Namouni and Peters in June, I believe that the Company has the right team in place to transition to the next phase of its development leading with its Phase 3 program in frontline MDS. It has been a pleasure to be a part of the Aprea team."

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics, Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the 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.

    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 – and 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 U.S. Food and Drug Administration for MDS, and Orphan Drug designation from the European Medicines Agency for MDS, AML and ovarian cancer.

    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 and regulatory submissions. 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

    Primary Logo

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  20. BOSTON, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that  the Company is scheduled to present at two upcoming healthcare investor conferences:

    • Baird 2020 Global Healthcare Conference
      Date: Thursday, September 10, 2020
      Presentation Time: 11:25 a.m. ET

    • Morgan Stanley 18th Annual Global Healthcare Conference
      Date: Monday, September 14, 2020
      Presentation Time: 2:15 p.m. ET

    Webcasts of the presentations can be accessed from the "Events Calendar" in the News and Events section of the Aprea website at Link.

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics…

    BOSTON, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that  the Company is scheduled to present at two upcoming healthcare investor conferences:

    • Baird 2020 Global Healthcare Conference

      Date: Thursday, September 10, 2020

      Presentation Time: 11:25 a.m. ET



    • Morgan Stanley 18th Annual Global Healthcare Conference

      Date: Monday, September 14, 2020

      Presentation Time: 2:15 p.m. ET

    Webcasts of the presentations can be accessed from the "Events Calendar" in the News and Events section of the Aprea website at Link.

    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.

    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

    Primary Logo

    View Full Article Hide Full Article
  21. BOSTON, Aug. 11, 2020 (GLOBE NEWSWIRE) -- 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 and six months ended June 30, 2020 and provided a business update.

    "The full enrollment in June of our Phase 3 clinical trial evaluating eprenetapopt (APR-246) with azacitidine for the treatment of  front-line TP53 mutant myelodysplastic syndromes (MDS) was a major milestone for Aprea and we look forward to top-line data by year-end 2020," said Christian S. Schade, President and Chief Executive Officer of Aprea.  "In addition, we continue to advance the clinical development…

    BOSTON, Aug. 11, 2020 (GLOBE NEWSWIRE) -- 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 and six months ended June 30, 2020 and provided a business update.

    "The full enrollment in June of our Phase 3 clinical trial evaluating eprenetapopt (APR-246) with azacitidine for the treatment of  front-line TP53 mutant myelodysplastic syndromes (MDS) was a major milestone for Aprea and we look forward to top-line data by year-end 2020," said Christian S. Schade, President and Chief Executive Officer of Aprea.  "In addition, we continue to advance the clinical development of eprenetapopt in different clinical settings and have recently enrolled the first patient in our solid tumor clinical trial program."

    Business Operations Update: 

    The Company is conducting, supporting and planning multiple clinical trials of eprenetapopt (APR-246):

    • Pivotal Phase 3 MDS Trial—During the second quarter of 2020, the Company 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 is currently enrolling 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. Though the Company had initially observed a decrease in both patient screening and patient enrollment as a result of the COVID-19 pandemic, patient screening activity has returned to expected levels and the trial has currently enrolled 24 out of 31 patients with a number of additional patients in screening. The Company anticipates completing enrollment of this trial in the third quarter of 2020.



    • Phase 1 AML Trial—The Company is currently enrolling its Phase 1 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 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—To further assess eprenetapopt 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 eprenetapopt with venetoclax and rituximab, and eprenetapopt 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 suggesting synergistic activity between eprenetapopt 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 eprenetapopt with anti-PD-1 therapy. The Company enrolled its first patient in August 2020.



    • 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. However, based on feedback from the FDA, the Company will not be able to initiate human clinical trials of APR-548 until it is able to provide additional information necessary to address questions raised by the FDA.

    Second Quarter Financial Results

    • Cash and cash equivalents:  As of June 30, 2020, the Company had $112.9 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 June 30, 2020 will be sufficient to meet its current projected operating requirements into 2023.  



    • Research and Development (R&D) expenses:  R&D expenses were $10.7 million for the quarter ended June 30, 2020, compared to $4.3 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, eprenetapopt. In Q1 2019 the Company commenced a pivotal Phase 3 clinical trial of eprenetapopt with azacitidine for frontline treatment of TP53 mutant MDS which completed enrollment in Q2 2020 and is supported by two ongoing 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. In addition, in Q1 2020, the Company continued enrolling patients in a Phase 2 post-transplant MDS/AML clinical trial began enrolling patients in a Phase 1 clinical trial in frontline and relapsed/refractory TP53 mutant AML assessing eprenetapopt with venetoclax with or without azacitidine.

       
    • General and Administrative (G&A) expenses:  G&A expenses were $3.8 million for the quarter ended June 30, 2020, compared to $1.7 million for the comparable period in 2019.  The increase in G&A expenses was primarily due to increased insurance expense, non-cash stock-based compensation, personnel related costs and commercial development expense.

       
    • Net loss:  Net loss was $16.4 million, or $0.78 per share for the quarter ended June 30, 2020, compared to a net loss of $5.3 million, or $4.45 per share for the quarter ended June 30, 2019.  The Company had 21,186,827 shares of common stock outstanding as of June 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 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.

    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 EMA for MDS, AML and ovarian cancer.

    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)

       June 30, 2020  December 31, 2019
    Assets    
    Current assets:  
    Cash and cash equivalents$112,861,504 $130,088,869 
    Prepaid expenses and other current assets 1,475,223  2,955,878 
    Total current assets . 114,336,727  133,044,747 
    Property and equipment, net 43,906  41,639 
    Right of use lease and other noncurrent assets 438,162  521,499 
    Total assets .$114,818,795 $133,607,885 
    Liabilities and Stockholders' Equity   
    Current liabilities:  
    Accounts payable$5,443,126 $2,176,852 
    Accrued expenses . 8,827,860  6,642,553 
    Lease liability—current . 241,527  242,329 
    Total current liabilities 11,512,513  9,061,734 
    Lease liability—noncurrent . 185,926  302,621 
    Total liabilities 14,698,439  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 June 30, 2020 and December 31,

    2019, respectively
     21,187  21,023 
    Additional paid‑in capital 228,597,264  226,284,548 
    Accumulated other comprehensive loss (12,201,648) (11,533,778)
    Accumulated deficit (116,296,447) (90,528,263)
    Total stockholders' equity 100,120,356  124,243,530 
    Total liabilities and stockholders' equity .$114,818,795 $133,607,885 

    Aprea Therapeutics, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

      Three Months Ended June 30,  Six Months Ended June 30,  
      2020  2019  2020  2019  
    Operating expenses:             
    Research and development $ 10,694,029  $ 4,319,826  $ 19,790,151  $ 7,998,270  
    General and administrative   3,786,886    1,618,589    6,563,354    2,347,915  
    Total operating expenses   14,480,915    5,938,415    26,353,505    10,346,185  
    Other income (expense):             
    Interest income (expense)   2,678    (4,091)   227,120    (7,439) 
    Foreign currency (loss) gain   (1,889,690)   680,058    358,201    1,615,974  
    Total other income (expense)   (1,887,012)   675,967    585,321    1,608,535  
    Net loss $ (16,367,927) $ (5,262,448) $ (25,768,184) $ (8,737,650) 
    Other comprehensive income (loss):             
    Foreign currency translation   1,756,783    44,508    (667,870)   (1,986,667) 
    Total comprehensive loss   (14,611,144)   (5,217,940)   (26,436,054)   (10,724,317) 
    Net loss per share attributable to common stockholders, basic and diluted $ (0.78) $ (4.45) $ (1.22) $ (7.43) 
    Weighted-average common shares outstanding, basic and diluted   21,107,056    1,181,583    21,079,891    1,176,417  

     

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    • Commenced expansion cohort in combination with venetoclax and azacitidine
    • Added cohort to be activated in combination with azacitidine

    BOSTON, July 16, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced the expansion of patient enrollment in its Phase 1 clinical trial evaluating eprenetapopt in TP53 mutant AML. Following the completion of the safety lead-in portion of the clinical trial, the first expansion cohort will evaluate the combination of eprenetapopt with venetoclax and azacitidine in frontline TP53 mutant AML. The Company also plans to activate a cohort in…

    • Commenced expansion cohort in combination with venetoclax and azacitidine
    • Added cohort to be activated in combination with azacitidine

    BOSTON, July 16, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced the expansion of patient enrollment in its Phase 1 clinical trial evaluating eprenetapopt in TP53 mutant AML. Following the completion of the safety lead-in portion of the clinical trial, the first expansion cohort will evaluate the combination of eprenetapopt with venetoclax and azacitidine in frontline TP53 mutant AML. The Company also plans to activate a cohort in the trial that will evaluate eprenetapopt with azacitidine in frontline TP53 mutant AML, expanding upon results for TP53 mutant AML patients recently presented from two independent Phase 1b/2 clinical trials.

    The lead-in portion of the Phase 1 AML Trial evaluated the tolerability of eprenetapopt with venetoclax, with or without azacitidine, and no dose-limiting toxicities were observed in patients receiving either regimen.  The expansion part of the clinical trial will treat approximately 30 front-line TP53 mutant AML patients with the triplet therapy of eprenetapopt with venetoclax and azacitidine.  The Company will also evaluate front-line treatment with the doublet therapy of eprenetapopt and azacitidine in approximately 30 additional TP53 mutant AML patients. Safety and efficacy will be evaluated in both patient cohorts.

    "We are encouraged by the tolerability of the eprenetapopt regimens observed to-date in the trial and look forward to continued evaluation of the potential efficacy of eprenetapopt with venetoclax and azacitidine for the frontline treatment of TP53 mutant AML," said Dr. Eyal Attar, Senior Vice President and Chief Medical Officer of Aprea. "In addition, we plan to also enroll a cohort of patients with TP53 mutant AML that will receive eprenetapopt with azacitidine to expand on the promising data generated in the two Phase 1b/2 MDS/AML trials, where the results in AML patients compare favorably to recently presented data for the venetoclax and azacitidine doublet regimen in TP53 mutant AML."

    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 – and thereby induce 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.

    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 EMA for MDS, AML and ovarian cancer.

    About AML

    AML is the most common form of adult leukemia, with the highest incidence in patients aged 60 years and older. AML is characterized by proliferation of abnormal immature white blood cells which impairs production of normal blood cells. AML can develop de novo or may arise secondary to progression of other hematologic disorders or from chemotherapy or radiation treatment for a different, prior malignancy. Mutations in p53 are found in up to 20% of AML patients and are associated with poor overall prognosis. There are no currently approved therapies specifically for TP53 mutant AML patients.

    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

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  22. BOSTON, June 29, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the appointments of Fouad Namouni, M.D. and Richard Peters, M.D., Ph.D. to its Board of Directors. In addition, Guido Magni, M.D., Ph.D. will step down from the Company's Board of Directors, effective June 30, 2020.

    Fouad Namouni, M.D., brings more than 20 years of oncology and immuno-oncology drug development expertise, most recently serving as Senior Vice President & Head of Oncology Development at Bristol-Myers Squibb (BMS), with responsibility for driving product development plans…

    BOSTON, June 29, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the appointments of Fouad Namouni, M.D. and Richard Peters, M.D., Ph.D. to its Board of Directors. In addition, Guido Magni, M.D., Ph.D. will step down from the Company's Board of Directors, effective June 30, 2020.

    Fouad Namouni, M.D., brings more than 20 years of oncology and immuno-oncology drug development expertise, most recently serving as Senior Vice President & Head of Oncology Development at Bristol-Myers Squibb (BMS), with responsibility for driving product development plans from early-stage clinical development through commercialization. Prior to serving as Head of Oncology Development, Dr. Namouni was Head of Medical Affairs at BMS and prior to that position, he was Head of Development for Opdivo® and Yervoy®, immunotherapy medications used in the treatment of cancer. Dr. Namouni holds an M.D. degree from the University of Annaba Medical School in Algeria, and a Pediatrics degree from Université Rene Descartes in Paris, France. In addition, he received a Pediatric Oncology and Hematology degree and M.S. in clinical and experimental pharmacology from Université Paris-Sud in France.

    Richard Peters, M.D., Ph.D, brings more than 25 years of experience developing new therapies for difficult-to-treat diseases. He currently serves as President, Chief Executive Officer and Director at Yumanity Therapeutics Inc. Dr. Peters joined Yumanity from Merrimack Pharmaceuticals, Inc. where he was President & Chief Executive Officer. Prior to Merrimack, he served as Senior Vice President and Head, Global Rare Diseases at Genzyme (Sanofi). Dr. Peters is a Harvard-trained physician and scientist, has served on the faculty at the Massachusetts General Hospital, and completed a Howard Hughes Medical Institute Fellowship in biophysics at Harvard Medical School. Dr. Peters holds M.D. and Ph.D. degrees from the Medical University of South Carolina.

    "Both Drs. Namouni and Peters are distinguished industry leaders with years of experience in advancing important new therapeutics to patients in need," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "Their advice and counsel will be invaluable as Aprea continues with its progress to advance our mutant p53 reactivator oncology programs. We are thrilled to welcome Fouad and Richard to the Aprea team and our Board of Directors. Finally, on behalf of the Board of Directors and all Aprea employees, we are grateful to Guido Magni for his years of strategic insight and guidance throughout his tenure on Aprea's Board."

    About Aprea Therapeutics

    Aprea Therapeutics Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein p53. The Company's lead product candidate is APR-246, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). 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

    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 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce 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.

    A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration for MDS, and Orphan Drug designation from the European Medicines Agency for MDS, AML and ovarian cancer.

    Forward-Looking Statements

    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 and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020.  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.

    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
    
    Source:  Aprea Therapeutics, Inc.

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    • 57% CR and 75% ORR rate by IWG criteria in all evaluable MDS patients
    • 12.1 months median OS in intention-to-treat MDS patients with 9.7 months median duration of follow-up
    • 13.7 months median OS in patients receiving 3 or more cycles of therapy with 9.7 months duration of follow-up

    BOSTON, June 12, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced the oral presentation of updated data from its French Phase 1b/2 clinical trial at the 25th European Hematology Association Annual Meeting (EHA). The trial is evaluating the safety and efficacy of APR-246 (eprenetapopt) in…

    • 57% CR and 75% ORR rate by IWG criteria in all evaluable MDS patients
    • 12.1 months median OS in intention-to-treat MDS patients with 9.7 months median duration of follow-up
    • 13.7 months median OS in patients receiving 3 or more cycles of therapy with 9.7 months duration of follow-up

    BOSTON, June 12, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced the oral presentation of updated data from its French Phase 1b/2 clinical trial at the 25th European Hematology Association Annual Meeting (EHA). The trial is evaluating the safety and efficacy of APR-246 (eprenetapopt) in combination with azacitidine (AZA) for the treatment of TP53 mutant myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The clinical trial is sponsored by the Groupe Francophone des Myélodysplasies (GFM).

    As of the April 1, 2020 data cutoff, the overall response rate (ORR) in 28 evaluable MDS patients was 75%, with a 57% complete remission (CR) rate, by International Working Group (IWG) criteria. With a median duration of follow-up of 9.7 months, the median overall survival (OS) for all enrolled patients (n=52) was 12.1 months and in MDS patients (n=34) was 12.1 months. For patients who remained on treatment for 3 or more cycles of treatment the median OS was higher at 13.7 months versus 2.8 months for patients who were on treatment for fewer than 3 cycles. Relative to baseline, mutant TP53 variant allele frequency (VAF) was decreased in responding patients by 3 cycles of treatment, including 20 (51%) patients who achieved mutant TP53 negativity by next-generation sequencing (NGS).

    "The data from this ongoing trial of eprenetapopt with azacitidine continue to be very encouraging in these most difficult-to-treat TP53 mutant MDS and AML patients, who not only have at least one TP53 mutation but the majority of whom also have high risk cytogenetic abnormalities," said Thomas Cluzeau, M.D., co-lead investigator for the GFM trial. "We continue to observe ORR and CR rates in these patients that are substantially higher than the GFM's experience with azacitidine monotherapy. Furthermore, with increased duration of follow-up, we now also see the emergence of highly encouraging overall survival that appears to be better than azacitidine alone or in combination with others agents in this very high-risk molecular group of patients with a TP53 mutation."

    Details of the on-demand oral presentation are as follows:

    Title: APR-246 Combined with Azacitidine in TP53 Mutated Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia. A Phase 2 Study by the Groupe Francophone des Myélodysplasies (GFM)

    Oral Abstract Session: Novel treatments for MDS I

    Abstract: S181

    About the Clinical Trial

    Eligible patients in the Phase Ib/II clinical trial include hypomethylating agent (HMA) naïve, TP53 mutated MDS and AML. All enrolled patients were to receive APR-246 as a 4,500 mg fixed dose IV daily for 4 days and AZA over 7 days in 28-day cycles. The primary endpoint of the trial is CR rate.

    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 Myelodysplastic Syndromes

    Myelodysplastic syndromes (MDS) represents a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to contribute to disease progression. Mutations in p53 are found in up to 20% of MDS and AML patients and are associated with poor overall prognosis.

    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 – and thereby induce 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. Coiante
    Sr. Vice President and Chief Financial Officer
    617-463-9385
    
    Gregory A. Korbel
    Vice President of Business Development
    617-463-9385

    Primary Logo

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    • Topline data expected by year-end 2020
    • Applications for US and EU regulatory approval planned for 2021

    BOSTON, June 03, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that patient enrollment in its Phase 3 clinical trial evaluating eprenetapopt with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes (MDS) has been completed. Topline results are expected by year-end 2020. Aprea plans to include the results of the trial in a New Drug Application (NDA) to the U.S. FDA and a Marketing Authorization Application (MAA) to the EMA in 2021…

    • Topline data expected by year-end 2020
    • Applications for US and EU regulatory approval planned for 2021

    BOSTON, June 03, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that patient enrollment in its Phase 3 clinical trial evaluating eprenetapopt with azacitidine for the treatment of front-line TP53 mutant myelodysplastic syndromes (MDS) has been completed. Topline results are expected by year-end 2020. Aprea plans to include the results of the trial in a New Drug Application (NDA) to the U.S. FDA and a Marketing Authorization Application (MAA) to the EMA in 2021.

    "Completion of enrollment in this Phase 3 trial is an important milestone for Aprea and our first-in-class p53 reactivator, eprenetapopt," said Christian S. Schade, President and Chief Executive Officer of Aprea. "We continue to advance the development of eprenetapopt with the goal of providing an urgently needed therapeutic option to patients with p53 mutated MDS."

    The randomized, controlled pivotal Phase 3 trial is designed to evaluate eprenetapopt with azacitidine compared with azacitidine alone as front-line therapy in intermediate, high, and very high risk TP53 mutant MDS patients. The multi-center trial enrolled 154 patients, randomized 1:1 to the two arms with a primary endpoint of CR rate. The trial has 90% power with P-value < 0.05 to detect a difference in CR rates of 50% in the eprenetapopt-containing arm versus 25% in the azacitidine-only control arm.

    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 – and thereby induce 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.

    About MDS

    Myelodysplastic syndromes (MDS) represent a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to contribute to disease progression. Mutations in p53 are found in up to 20% of MDS and AML patients and are associated with poor overall prognosis. There are no currently approved therapies specifically for TP53 mutant MDS or AML patients.

    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

    Primary Logo

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  23. BOSTON, May 18, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that Christian S. Schade, President and Chief Executive Officer, and Eyal C. Attar, Senior Vice President and Chief Medical Officer, will participate in a fireside discussion at the 2020 RBC Capital Markets Global Healthcare Conference on Wednesday, May 20, 2020 at 11:30 a.m. ET.

    A webcast of the presentation can be accessed from the "Events Calendar" in the News and Events section of the Aprea website at Link.

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics, Inc. is a biopharmaceutical company…

    BOSTON, May 18, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced that Christian S. Schade, President and Chief Executive Officer, and Eyal C. Attar, Senior Vice President and Chief Medical Officer, will participate in a fireside discussion at the 2020 RBC Capital Markets Global Healthcare Conference on Wednesday, May 20, 2020 at 11:30 a.m. ET.

    A webcast of the presentation can be accessed from the "Events Calendar" in the News and Events section of the Aprea website at Link.

    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.

    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 

    Primary Logo

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  24. BOSTON, May 15, 2020 (GLOBE NEWSWIRE) -- 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…

    BOSTON, May 15, 2020 (GLOBE NEWSWIRE) -- 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. 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)

        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  

     

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  25. BOSTON, April 06, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics to reactivate mutant tumor suppressor protein, p53, today announced that it has launched a new, redesigned website, www.aprea.com. With an updated design, the new aprea.com web-site offers easy-to-navigate functionality and a content-rich site experience created to provide fulsome information on Aprea's scientific focus, strategy and progress as the leader in developing important anti-cancer therapies to reactivate the tumor suppressor protein, p53.

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics, Inc. is a biopharmaceutical company headquartered in Boston, Massachusetts with…

    BOSTON, April 06, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics to reactivate mutant tumor suppressor protein, p53, today announced that it has launched a new, redesigned website, www.aprea.com. With an updated design, the new aprea.com web-site offers easy-to-navigate functionality and a content-rich site experience created to provide fulsome information on Aprea's scientific focus, strategy and progress as the leader in developing important anti-cancer therapies to reactivate the tumor suppressor protein, p53.

    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 to 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.

    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 – and thereby induce 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 and AML.  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.

    A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the EMA for MDS, AML and ovarian cancer.

    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 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," "targets," "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, including our Annual Report on Form 10-K.  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

    Primary Logo

    View Full Article Hide Full Article
  26. BOSTON, March 26, 2020 (GLOBE NEWSWIRE) -- 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 and year ended December 31, 2019 and provided a corporate update.

    Corporate Update: 

    The Company is conducting, supporting and planning multiple clinical trials of 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. The trial has a target enrollment of 154 patients randomized…

    BOSTON, March 26, 2020 (GLOBE NEWSWIRE) -- 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 and year ended December 31, 2019 and provided a corporate update.

    Corporate Update: 

    The Company is conducting, supporting and planning multiple clinical trials of 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. The trial has a target enrollment of 154 patients randomized in a 1:1 ratio to either the azacitidine control arm or to the APR-246 + azacitidine experimental arm, with a primary endpoint of CR rate. The Company had anticipated full enrollment in its Phase 3 trial in the first quarter of 2020 and as of March 25, 2020, the Company had enrolled 133 patients. The Company has observed a recent decrease in both patient screening and patient enrollment as a result of the recent coronavirus (COVID 19) pandemic. Together with its investigators and clinical sites, the Company is assessing the potential impact of the coronavirus pandemic on enrollment and the ability to maintain patients enrolled in the trial and the corresponding impact on the timing of the completion of the trial and subsequent availability of top-line data. The Company remains confident that it can complete the trial and have top-line data available before 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. The primary endpoint is relapse-free survival at 12 months. As of March 25, 2020, the Company had enrolled 11 patients in this trial. Target enrollment is 31 patients and the Company had anticipated full enrollment in the first half of 2020. Together with its investigators and clinical sites, the Company is assessing the potential impact of the coronavirus pandemic on the enrollment and the ability to maintain patients enrolled in this trial.

    • Phase 1 AML Trial—Based on in vitro data evidencing synergistic activity between APR-246 and a Bcl-2 inhibitor, 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 primary endpoint is the composite rate of CR and CR with incomplete hematologic recovery, or CRi. 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 is assessing the potential impact of the coronavirus 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 vitro 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. Final reports from these studies are pending and the Company is targeting the submission of an IND in the first half of 2020.

    • APR-246 INN — The Company has secured eprenetapopt as the international nonproprietary name (INN) for APR-246.

    Fourth Quarter Financial Results

    • Cash and cash equivalents:  As of December 31, 2019, Aprea had $130.1 million of cash and cash equivalents compared to $65.7 million of cash and cash equivalents as of December 31, 2018.  In October 2019, the Company completed the sale of 6,516,667 shares of common stock in an initial public offering resulting in net proceeds of approximately $86.9 million. 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 December 31, 2019 will be sufficient to meet its current projected operating requirements into 2023.  

    • Research and Development (R&D) expenses:  R&D expenses were $8.0 million for the quarter ended December 31, 2019, compared to $4.4 million for the comparable period in 2018. 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 azacytidine 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.
       
    • General and Administrative (G&A) expenses:  G&A expenses were $3.9 million for the quarter ended December 31, 2019, compared to $0.5 million for the comparable period in 2018.  The increase in G&A expenses was primarily due to increased professional fees associated with operating as a public company, as well as increased personnel costs.
       
    • Net loss:  Net loss was $13.1 million, or $0.64 per share for the quarter ended December 31, 2019, compared to a net loss of $4.7 million, or $4.05 per share for the quarter ended December 31, 2018.  Net loss for the year ended December 31, 2019 was $28.1 million, or $4.67 per share, compared to a net loss of $15.5 million, or $13.45 per share for the year ended December 31, 2018.

    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.

    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 – and thereby induce 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. 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 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," "targets," "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, including our Annual Report on Form 10-K.  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
         
      December 31,
    2019

      December 31,
    2018

     
    Assets    
    Current assets:    
    Cash and cash equivalents $130,088,869   $65,675,931  
    Prepaid expenses and other current assets   2,955,878     322,146  
    Total current assets   133,044,747     65,998,077  
    Property and equipment, net   41,639     24,450  
    Right of use lease and other noncurrent assets   521,499     111  
    Total assets $133,607,885   $66,022,638  
    Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)            
    Current liabilities:    
    Accounts payable $2,176,852   $1,739,337  
    Accrued expenses   6,642,553     3,128,772  
    Lease liability—current   242,329      
    Total current liabilities   9,061,734     4,868,109  
    Lease liability—noncurrent   302,621      
    Total liabilities   9,364,355     4,868,109  
    Commitments and contingencies    
    Convertible preferred stock:    
    Series A convertible preferred stock, $0.001 par value; 612,446 shares issued and outstanding at December 31, 2018       6,483,044  
    Series B convertible preferred stock, $0.001 par value; 7,235,969 shares issued and outstanding at December 31, 2018       49,742,942  
    Series C convertible preferred stock, $0.001 par value; 4,712,698 shares issued and outstanding at December 31, 2018       56,364,645  
    Total convertible preferred stock       112,590,631  
    Stockholders' equity (deficit):    
    Common stock, par value $0.001 at December 31, 2019 and $0.11 at December 31, 2018; 21,022,752 and 1,155,366, shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively   21,023     127,091  
    Additional paid‑in capital   226,284,548     19,666,588  
    Accumulated other comprehensive loss   (11,533,778 )   (8,761,325 )
    Accumulated deficit   (90,528,263 )   (62,468,456 )
    Total stockholders' equity (deficit)   124,243,530     (51,436,102 )
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $133,607,885   $66,022,638  


    Aprea Therapeutics, Inc.
    Condensed Consolidated Statements of Operations and Comprehensive Loss
           
      Three Months Ended December 31,            Year Ended December 31,
     
       2019     2018     2019    2018
     
    Operating expenses:                        
    Research and development $8,041,993   $4,394,921   $20,950,672   $14,194,732  
    General and administrative   3,937,765     504,449     8,593,626     2,294,671  
    Total operating expenses   11,979,758     4,899,370     29,544,298     16,489,403  
    Other income (expense):        
    Interest income (expense)   169,888     2     156,351     (182 )
    Foreign currency gain (loss)   (1,262,868 )   219,700     1,328,140     961,316  
    Total other income (expense)   (1,092,980 )   219,702     1,484,491     961,134  
    Net loss $(13,072,738 ) $(4,679,668 ) $(28,059,807 ) $(15,528,269 )
    Other comprehensive loss:                            
    Foreign currency translation   2,154,388     636,489     (2,772,453 )   (473,919 )
    Total comprehensive loss   (10,918,350 )   (4,043,179 )   (30,832,260 )   (16,002,188 )
    Net loss per share attributable to common stockholders, basic and diluted $(0.64 ) $(4.05 ) $(4.67 ) $(13.45 )
    Weighted average basic and diluted shares of common stock outstanding   20,318,040     1,154,677     6,002,486     1,154,368  

     

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  27. BOSTON, Feb. 13, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the appointment of Gregory S. Wessels to the newly created position of Vice President, Commercial. An experienced biotech executive, Mr. Wessels brings to Aprea nearly 23 years of experience in sales, marketing and commercialization strategy, most recently having served as Executive Director - US Marketing for Lymphoma and Acute Myeloid Leukemia at Bristol-Myers Squibb.

    "We are excited to welcome Greg to the Aprea team as we continue our progress towards key upcoming milestones," said Christian…

    BOSTON, Feb. 13, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics Inc., (NASDAQ:APRE), a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapeutics that reactivate mutant p53 tumor suppressor protein, today announced the appointment of Gregory S. Wessels to the newly created position of Vice President, Commercial. An experienced biotech executive, Mr. Wessels brings to Aprea nearly 23 years of experience in sales, marketing and commercialization strategy, most recently having served as Executive Director - US Marketing for Lymphoma and Acute Myeloid Leukemia at Bristol-Myers Squibb.

    "We are excited to welcome Greg to the Aprea team as we continue our progress towards key upcoming milestones," said Christian S. Schade, President and Chief Executive Officer of Aprea Therapeutics. "Greg's leadership and broad commercialization experiences in launching new therapies are essential to help drive Aprea's future plans to bring our novel, p53-targeted oncology therapies to patients in need."

    Mr. Wessels added, "Aprea has made significant progress in the development of a breakthrough therapy for patients with limited therapeutic options. I look forward to joining the team and building a commercial organization focused on bringing important new therapies to patients with cancer."

    Prior to joining Aprea from BMS, Mr. Wessels held global and regional oncology marketing positions of increasing responsibility over more than 11 years at Celgene Corporation. Prior to joining Celgene he spent 11 years with Sanofi US in sales, marketing and business planning roles. Mr. Wessels received a BS in Biochemistry from the University of Notre Dame and an MBA from the Kellogg School of Management at Northwestern University.

    About Aprea Therapeutics

    Aprea Therapeutics Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein p53. The Company's lead product candidate is APR-246, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). 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 http://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

    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 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce 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.

    A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has received Breakthrough Therapy, Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the EMA for MDS, AML and ovarian cancer.

    Forward-Looking Statements

    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 and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Quarterly Report on Form 10-Q. 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.

    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

    Source: Aprea Therapeutics, Inc.

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  28. BOSTON, Jan. 30, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for APR-246 in combination with azacitidine for the treatment of myelodysplastic syndromes (MDS) with a susceptible TP53 mutation.

    MDS represents a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is…

    BOSTON, Jan. 30, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for APR-246 in combination with azacitidine for the treatment of myelodysplastic syndromes (MDS) with a susceptible TP53 mutation.

    MDS represents a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to directly contribute to disease progression and a poor overall prognosis.

    "Breakthrough Therapy Designation further supports our development program for APR-246 in combination with azacitidine in MDS patients with a TP53 mutation," said Christian S. Schade, Chief Executive Officer of Aprea. "Outcomes for MDS patients with a TP53 mutation are poor and there are no current therapeutic options specifically for these patients. We look forward to continued interaction with FDA regarding our ongoing Phase 3 clinical study and our clinical development program to advance APR-246."

    The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.

    About p53 and APR-246

    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 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce 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.

    A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has received Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the EMA for MDS, AML and ovarian cancer.

    About Aprea Therapeutics

    Aprea Therapeutics Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein p53. The Company's lead product candidate is APR-246, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). 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 www.ir.aprea.com as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

    Forward-Looking Statements

    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 and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Quarterly Report on Form 10-Q.  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.

    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

    Source:  Aprea Therapeutics, Inc. 

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  29. BOSTON, Jan. 09, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, today announced that Christian S. Schade, President & Chief Executive Officer, will present a corporate update at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 3:30 p.m. PT (6:30 p.m. ET).

    A live webcast of the presentation can be accessed from "Events Calendar" in the News and Events section of the Aprea website at Link.

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities…

    BOSTON, Jan. 09, 2020 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, today announced that Christian S. Schade, President & Chief Executive Officer, will present a corporate update at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 3:30 p.m. PT (6:30 p.m. ET).

    A live webcast of the presentation can be accessed from "Events Calendar" in the News and Events section of the Aprea website at Link.

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics Inc., (NASDAQ:APRE) 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, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).For more information, please visit the company website at www.aprea.com

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the federal securities laws. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The forward-looking statements contained in this press release reflect Aprea's current views with respect to future events, and Aprea does not undertake and specifically disclaims any obligation to update any forward-looking statements.

    Source:  Aprea Therapeutics

    Corporate Contacts:

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

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

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    • 74% ORR, 66% CR rate in 24 evaluable MDS patients
    • Median duration of follow-up is 6.4 months

    BOSTON, Dec. 09, 2019 (GLOBE NEWSWIRE) --  Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, presented preliminary results at the 2019 ASH Annual Meeting from its French Phase Ib/II clinical trial in MDS and AML. The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of patients with TP53 mutated MDS and AML. The clinical trial is sponsored by the Groupe Francophone des Myélodysplasies.

    As of the data cutoff, the overall response rate (ORR) in 24 evaluable MDS…

    • 74% ORR, 66% CR rate in 24 evaluable MDS patients
    • Median duration of follow-up is 6.4 months

    BOSTON, Dec. 09, 2019 (GLOBE NEWSWIRE) --  Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, presented preliminary results at the 2019 ASH Annual Meeting from its French Phase Ib/II clinical trial in MDS and AML. The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of patients with TP53 mutated MDS and AML. The clinical trial is sponsored by the Groupe Francophone des Myélodysplasies.

    As of the data cutoff, the overall response rate (ORR) in 24 evaluable MDS patients was 74%, with a 66% complete remission (CR) rate, based on International Working Group criteria. With a median duration of follow-up of 6.4 months, the median overall survival (OS) for all enrolled patients (n=53) had not been reached.  In addition, all responding patients were alive at data cutoff.  Relative to baseline, mutant TP53 variant allele frequency (VAF) was significantly decreased in responding patients and undetectable in all patients who achieved a CR.

    About the Clinical Trial

    Eligible patients in the Phase Ib/II clinical trial include HMA naïve, TP53 mutated MDS and acute myeloid leukemia (AML). All enrolled patients were to receive APR-246 as a 4,500 mg fixed dose IV daily (days 1-4) and AZA over 7 days (days 4-10 or 4-5 and 8-12) in 28-day cycles. The primary endpoint of the trial is CR rate.

    About Myelodysplastic Syndrome

    Myelodysplastic syndromes (MDS) represents a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to contribute to disease progression. Mutations in p53 are found in up to 20% of MDS and AML patients and are associated with poor overall prognosis.

    About p53 and APR-246

    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 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce 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 I/II 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.

    A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has received Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the EMA for MDS, AML and ovarian cancer.

    About Aprea Therapeutics

    Aprea Therapeutics Inc., (NASDAQ:APRE) is a biopharmaceutical company headquartered in Boston, Massachusetts with research facilities in Stockholm, Sweden, focused on developing and commercializing novel cancer therapeutics that reactivate the mutant tumor suppressor protein p53. The Company's lead product candidate is APR-246, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). 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 www.ir.aprea.com as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

    The Company will host a 2019 ASH Clinical Update meeting and webcast as follows:

    Time and Date: Monday, December 9 at 12:00 pm ET
    Location: Hyatt Regency Orlando, Rainbow Spring 2 Room, 9801 International Drive, Orlando, Florida
    Webcast: The Clinical Update meeting will be webcast live and can be accessed from "Events Calendar" in the News and Events section of the company's website at Link
    Presentation: The presentation will be available as a PDF on the Company's website at Link

    Forward-Looking Statements

    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 and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Quarterly Report on Form 10-Q.  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.

    Corporate Contacts:

    Christian S. Schade
    President and Chief Executive Officer
    chris.schade@aprea.com

    Gregory A. Korbel
    Vice President of Business Development
    greg.korbel@aprea.com

    Source:  Aprea Therapeutics, Inc.

     

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    • 88% ORR, 61% CR rate by IWG criteria in 33 evaluable MDS patients
    • 8.4 months median duration of response, with 7.3 months median duration of CR in evaluable MDS patients
    • 52% of evaluable MDS patients discontinued treatment for stem cell transplant

    BOSTON, Dec. 09, 2019 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, presented results at the 2019 ASH Annual Meeting from its U.S. Phase Ib/II clinical trial in MDS and AML. The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of TP53 mutated MDS and AML. The clinical trial is sponsored…

    • 88% ORR, 61% CR rate by IWG criteria in 33 evaluable MDS patients
    • 8.4 months median duration of response, with 7.3 months median duration of CR in evaluable MDS patients
    • 52% of evaluable MDS patients discontinued treatment for stem cell transplant

    BOSTON, Dec. 09, 2019 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, presented results at the 2019 ASH Annual Meeting from its U.S. Phase Ib/II clinical trial in MDS and AML. The trial is evaluating the safety and efficacy of APR-246 in combination with azacitidine for the treatment of TP53 mutated MDS and AML. The clinical trial is sponsored by the Moffitt Cancer Center with financial support from the MDS Foundation and the Aplastic Anemia and MDS International Foundation as administrator for the Evans MDS Clinical Research Consortium.

    As of the data cutoff, the overall response rate (ORR) in 33 evaluable MDS patients was 88%, with a 61% complete remission (CR) rate, by International Working Group (IWG) criteria. With a median duration of follow-up of 10.8 months, the median duration of response was 8.4 months and the median duration of CR was 7.3 months. Seventeen (52%) evaluable MDS patients discontinued therapy to pursue stem cell transplant. Median overall survival (OS) for all enrolled patients (n=55) was 10.8 months. Median OS in responding patients versus non-responders was 13.7 vs. 3.9 months. Adverse events, regardless of causality, were mostly grade 1/2. Grade 3+ adverse events occurring in ≥20% of patients were limited to cytopenias and infection, consistent with underlying hematopoietic malignancies, and no exacerbation of the expected AZA-related safety profile has been observed.

    About the Clinical Trial

    Eligible patients in the Phase Ib/II clinical trial include HMA-naïve, TP53 mutated MDS, oligoblastic acute myeloid leukemia (AML, ≤ 30% blasts), MDS-myeloproliferative neoplasm (MDS-MPN) overlap and chronic myelomonocytic leukemia (CMML). In the Phase Ib part of the clinical trial, patients received APR-246 in a 3+3 dose escalation design (50, 75, 100 mg/kg lean body weight) IV daily over 4 days in a lead-in phase (days -14 to -10), followed by the same dose of APR-246 (days 1-4) and AZA 75 mg/m2 SC/IV daily for 7 days (days 4-10 or 4-5 and 8-12) in 28-day cycles. In the Phase II part of the clinical trial, patients receive APR-246 as a 4,500 mg fixed dose IV daily (days 1-4) and AZA daily for 7 days (days 4-10 or 4-5 and 8-12) in 28-day cycles. Primary objective in Phase Ib part of the clinical trial was safety, with AEs graded by CTCAE v4.03 and DLT assessment over 6 weeks. Secondary endpoints included response rate by IWG 2006 criteria, PFS, OS, as well as serial next generation sequencing and p53 immunohistochemistry for evaluation of clonal suppression and depth of remission. In the Phase II part of the clinical trial the primary endpoint is CR rate.

    About Myelodysplastic Syndrome

    Myelodysplastic syndromes (MDS) represents a spectrum of hematopoietic stem cell malignancies in which bone marrow fails to produce sufficient numbers of healthy blood cells. Approximately 30-40% of MDS patients progress to acute myeloid leukemia (AML) and mutation of the p53 tumor suppressor protein is thought to contribute to disease progression. Mutations in p53 are found in up to 20% of MDS and AML patients and are associated with poor overall prognosis.

    About p53 and APR-246

    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 is a small molecule that has demonstrated reactivation of mutant and inactivated p53 protein – by restoring wild-type p53 conformation and function – and thereby induce 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 I/II 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.

    A pivotal Phase 3 clinical trial of APR-246 and azacitidine for frontline treatment of TP53 mutant MDS is ongoing. APR-246 has received Orphan Drug and Fast Track designations from the FDA for MDS, and Orphan Drug designation from the EMA for MDS, AML and ovarian cancer.

    About Aprea Therapeutics

    Aprea Therapeutics Inc., (NASDAQ:APRE) 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, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). 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 www.ir.aprea.com as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD.

    The Company will host a 2019 ASH Clinical Update meeting and webcast as follows:

    Time and Date: Monday, December 9 at 12:00 pm ET
    Location: Hyatt Regency Orlando, Rainbow Spring 2 Room, 9801 International Drive, Orlando, Florida
    Webcast: The Clinical Update meeting will be webcast live and can be accessed from "Events Calendar" in the News and Events section of the company's website at Link
    Presentation: The presentation will be available as a PDF on the Company's website at Link

    Forward-Looking Statements

    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 and regulatory submissions. We may, in some cases use terms such as "predicts," "believes," "potential," "continue," "anticipates," "estimates," "expects," "plans," "intends," "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 and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Quarterly Report on Form 10-Q.  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.

    Corporate Contacts:

    Christian S. Schade

    President and Chief Executive Officer

    chris.schade@aprea.com


    Gregory A. Korbel

    Vice President of Business Development

    greg.korbel@aprea.com


    Source:  Aprea Therapeutics, Inc.

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  30. BOSTON, Nov. 14, 2019 (GLOBE NEWSWIRE) -- 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 and nine months ended September 30, 2019 and provided a corporate update.

    Third quarter 2019 Corporate Update: 

    APR-246 Update

    Earlier this month, the Company announced that it will present updated data from two Phase 1b/2 clinical studies at the 61st American Society of Hematology Annual Meeting (ASH) on December 9, 2019. Data from the U.S. Phase 1b/2 trial and interim results from the French Phase 1b/2 trial of the Company's lead product candidate APR-246 in combination…

    BOSTON, Nov. 14, 2019 (GLOBE NEWSWIRE) -- 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 and nine months ended September 30, 2019 and provided a corporate update.

    Third quarter 2019 Corporate Update: 

    APR-246 Update

    Earlier this month, the Company announced that it will present updated data from two Phase 1b/2 clinical studies at the 61st American Society of Hematology Annual Meeting (ASH) on December 9, 2019. Data from the U.S. Phase 1b/2 trial and interim results from the French Phase 1b/2 trial of the Company's lead product candidate APR-246 in combination with Azacitidine (AZA) in patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) were both chosen for oral presentations at ASH. The titles of the oral presentations are:

    •  "Phase 2 Results of APR-246 and Azacitidine (AZA) in Patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)"; and
    • "APR-246 combined with Azacitidine (AZA) in TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). A phase 2 study by Groupe Francophone des Myélodysplasies (GFM)"

    The Company will host a Clinical Update Meeting and Webcast on December 9, 2019 at 12:00 PM ET. This Clinical Update meeting will be webcast live and can be accessed from "Events Calendar" in the News and Events section of the Company's website at https://ir.aprea.com/

    Initial Public Offering

    On October 7, 2019, Aprea completed its initial public offering (IPO) of 6,516,667 shares of its common stock at a price to the public of $15.00 per share, which included the exercise in full by the underwriters of their option to purchase an additional 850,000 shares of common stock. The Company received gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of approximately $97.75 million.            

    Third Quarter Financial Results

    • Cash and cash equivalents: As of September 30, 2019, prior to completing its IPO on October 7, 2019, Aprea had $52.3 million of cash and cash equivalents compared to $65.7 million of cash and cash equivalents as of December 31, 2018. In October 2019, the Company completed the sale of 6,516,667 shares of common stock in an initial public offering resulting in gross proceeds of approximately $97.75 million. The Company believes its cash and cash equivalents as of September 30, 2019 along with the proceeds received from its initial public offering will be sufficient to meet its current projected operating requirements into 2023.  

    • Research and Development (R&D) expenses: R&D expenses were $4.9 million for the quarter ended September 30, 2019, compared to $2.3 million for the comparable period in 2018. 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.
       
    • General and Administrative (G&A) expenses: G&A expenses were $2.3 million for the quarter ended September 30, 2019, compared to $0.6 million for the comparable period in 2018. The increase in G&A expenses was primarily due to increased professional fees of approximately $1.3 million associated with preparation for the Company's IPO, which was completed in October 2019, as well as increased personnel costs of $0.3 million.
       
    • Net loss: Net loss was $6.2 million for the quarter ended September 30, 2019, compared to a net loss of $3.1 million for the quarter ended September 30, 2018.

    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, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). 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 www.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 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," "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  and the other risks set forth in our filings with the U.S. Securities and Exchange Commission, including our Registration Statement on Form S-1 (File No. 333-233662) and our Quarterly Report on Form 10-Q.  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

    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,
    2019
      December 31,
    2018

    Assets    
    Current assets:    
    Cash and cash equivalents $ 52,334,102     $ 65,675,931  
    Deferred offering cost   4,070,690        
    Prepaid expenses and other current assets   339,814       322,146  
    Total current assets   56,744,606       65,998,077  
    Property and equipment, net   31,032       24,450  
    Right of use lease asset   560,318        
    Other noncurrent assets   102       111  
    Total assets $ 57,336,058     $ 66,022,638  
    Liabilities, Convertible Preferred Stock and Stockholders' Deficit    
    Current liabilities:    
    Accounts payable $ 3,510,105     $ 1,739,337  
    Accrued expenses   5,847,364       3,128,772  
    Lease liability—current   226,852        
    Total current liabilities   9,584,321       4,868,109  
    Lease liability—noncurrent   358,404        
    Total liabilities   9,942,725       4,868,109  
    Commitments and contingencies    
    Convertible preferred stock:    
    Series A convertible preferred stock, $0.001 par value; 612,446 shares issued and outstanding at September 30, 2019 and December 31, 2018 (liquidation preference of $6,483,044 at September 30, 2019)   6,483,044       6,483,044  
    Series B convertible preferred stock, $0.001 par value; 7,235,969 shares issued and outstanding at September 30, 2019 and December 31, 2018 (liquidation preference of $62,288,856 at September 30, 2019)   49,742,942       49,742,942  
    Series C convertible preferred stock, $0.001 par value; 5,179,877 and 4,712,698 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively (liquidation preference of $66,451,815 at September 30, 2019)   61,963,007       56,364,645  
    Total convertible preferred stock   118,188,993       112,590,631  
    Stockholders' equity (deficit):    
    Common stock, par value $0.001 at September 30, 2019 and $0.11 at December 31, 2018; 1,181,733 and 1,155,366, shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively   1,182       127,091  
    Additional paid‑in capital   20,346,849       19,666,588  
    Accumulated other comprehensive loss   (13,688,166 )     (8,761,325 )
    Accumulated deficit   (77,455,525 )     (62,468,456 )
    Total stockholders' deficit   (70,795,660 )     (51,436,102 )
    Total liabilities, convertible preferred stock and stockholders' deficit $ 57,336,058     $ 66,022,638  
                   

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

         
      Three Months Ended September 30,
    Nine Months Ended September 30, 
        2019       2018       2019       2018  
    Operating expenses:        
    Research and development $ 4,910,409     $ 2,307,022     $ 12,908,679     $ 9,799,811  
    General and administrative   2,307,946       623,702       4,655,861       1,790,222  
    Total operating expenses   7,218,355       2,930,724       17,564,540       11,590,033  
    Other income (expense):        
    Interest expense   (6,098 )     4       (13,537 )     (184 )
    Foreign currency gain (loss)   975,034       (207,542 )     2,591,008       741,616  
    Total other income (expense)   968,936       (207,538 )     2,577,471       741,432  
    Net loss $ (6,249,419 )   $ (3,138,262 )   $ (14,987,069 )   $ (10,848,601 )
    Other comprehensive loss:        
    Foreign currency translation   (2,940,174 )     65,800       (4,926,841 )     (1,110,408 )
    Total comprehensive loss   (9,189,593 )     (3,072,462 )     (19,913,910 )     (11,959,009 )
    Net loss per share attributable to common stockholders, basic and diluted $ (5.29 )   $ (2.72 )   $ (12.72 )   $ (9.40 )
    Weighted average basic and diluted shares of common stock outstanding   1,181,726       1,154,573       1,178,206       1,154,264  

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  31. BOSTON, Nov. 06, 2019 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, today announced that it will present updated data from two Phase 1b/2 clinical studies at 61st American Society of Hematology Annual Meeting (ASH) on December 9, 2019. Data from the US Phase 1b/2 Trial and interim results from the French Phase 1b/2 Trial for its lead candidate APR-246 in combination with Azacitidine (AZA) in patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) were both chosen for oral presentations.

    Details of the oral presentations are as follows:

    Title: Phase…

    BOSTON, Nov. 06, 2019 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, today announced that it will present updated data from two Phase 1b/2 clinical studies at 61st American Society of Hematology Annual Meeting (ASH) on December 9, 2019. Data from the US Phase 1b/2 Trial and interim results from the French Phase 1b/2 Trial for its lead candidate APR-246 in combination with Azacitidine (AZA) in patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) were both chosen for oral presentations.

    Details of the oral presentations are as follows:

    Title: Phase 2 Results of APR-246 and Azacitidine (AZA) in Patients with TP53 mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)
    Date & Time: Monday, December 9, 2019 at 11:15 am ET
    Oral Abstract Session: 637. Myelodysplastic Syndromes—Clinical Studies: Targeting Gene Mutations in MDS
    Abstract: 676
    Location: Orange County Convention Center, W311ABCD
    Presenter: David A Sallman, M.D., Assistant Member, Malignant Hematology Department H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida

    Title: APR-246 combined with Azacitidine (AZA) in TP53 mutated myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). A phase 2 study by the Groupe Francophone des Myélodysplasies (GFM)
    Date & Time: Monday, December 9, 2019 at 11:30 am ET
    Oral Abstract Session: 637. Myelodysplastic Syndromes—Clinical Studies: Targeting Gene Mutations in MDS
    Abstract: 677
    Location: Orange County Convention Center, W311ABCD
    Presenter: Thomas Cluzeau, M.D., Ph.D., Professor, Department of Clinical Hematology, Cote d'Azur University, Nice, France

    Details of the Company's Clinical Update meeting and webcast are as follows:

    Time and Date: Monday, December 9 at 12:00 pm ET
    Location: Hyatt Regency Orlando, Rainbow Spring 2 Room, 9801 International Drive, Orlando, Florida
    Webcast: The Clinical Update meeting will be webcast live and can be accessed from "Events Calendar" in the News and Events section of the company's website at Link
    Presentation: The presentation will be available as a PDF on the Company's website at Link

    About Aprea Therapeutics, Inc.

    Aprea Therapeutics Inc., (NASDAQ:APRE) 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, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

    Forward Looking Statements

    This press release includes forward-looking statements within the meaning of the federal securities laws. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The forward-looking statements contained in this press release reflect Aprea's current views with respect to future events, and Aprea does not undertake and specifically disclaims any obligation to update any forward-looking statements.

    Corporate Contacts:
    
    Christian S. Schade
    President and Chief Executive Officer
    chris.schade@aprea.com
    
    Gregory A. Korbel, Ph.D.
    Vice President of Business Development
    greg.korbel@aprea.com

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  32. BOSTON, Oct. 07, 2019 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced the closing of its initial public offering of 6,516,667 shares of its common stock at a price to the public of $15.00 per share, which includes the exercise in full by the underwriters of their option to purchase an additional 850,000 shares of common stock. Aprea Therapeutics received gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of approximately $97.75 million.  The shares began trading on The Nasdaq Global Select Market on October 3, 2019…

    BOSTON, Oct. 07, 2019 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein, p53, today announced the closing of its initial public offering of 6,516,667 shares of its common stock at a price to the public of $15.00 per share, which includes the exercise in full by the underwriters of their option to purchase an additional 850,000 shares of common stock. Aprea Therapeutics received gross proceeds, before deducting underwriting discounts and commissions and other offering expenses, of approximately $97.75 million.  The shares began trading on The Nasdaq Global Select Market on October 3, 2019 under the symbol "APRE."

    J.P. Morgan, Morgan Stanley and RBC Capital Markets acted as joint book-running managers for the offering. The offering was made only by means of a prospectus. A copy of the final prospectus may be obtained from: J.P. Morgan Securities LLC, c/o J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone, at (866) 803-9204; Morgan Stanley, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department or via email: prospectus@morganstanley.com; or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone, at (877) 822-4089.

    Registration statements relating to these securities have been filed with the U.S. Securities and Exchange Commission and became effective under the Securities Act of 1933, as amended, on October 2, 2019.  This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described above, nor shall there be any sale of such securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

    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, a small molecule in clinical development for hematologic malignancies, including myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

    Corporate Contacts:
    
    Christian S. Schade
    President and Chief Executive Officer
    chris.schade@aprea.com
    
    Gregory A. Korbel
    Vice President of Business Development
    greg.korbel@aprea.com

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