Aprea Therapeutics Reports Third Quarter 2021 Financial Results and Provides Update on Business Operations BOSTON, MA

Aprea Therapeutics Reports Third Quarter

2021 Financial Results and Provides Update on Business Operations

BOSTON, MA, November 8, 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

nine months ended September 30, 2021 and provided a business update.

Third Quarter Financial Results

Business Operations Update:

Myeloid Malignancy Program

On August 4, 2021, the U.S. Food and Drug Administration (FDA)

placed a partial clinical hold on the clinical trials of eprenetapopt in combination with azacitidine in our Phase 3 frontline MDS clinical

trial, our Phase 2 MDS/AML Post-Transplant clinical trial and our Phase 1/2 AML clinical trial. The FDA's concerns referred to the

safety and efficacy data from the Phase 3 frontline MDS clinical trial. In particular, the FDA requested more information related to a

potential risk-reward imbalance between the combination of eprenetapopt and azacitidine versus azacitidine alone as it relates to increased

serious adverse events in the Company's Phase 3 frontline clinical trial in MDS. There are approximately 9 patients currently receiving

eprenetapopt in combination with azacitidine in our myeloid malignancy programs, which includes the MDS, AML and post-transplant maintenance

trials, all of which have completed enrollment. Patients who are benefiting from treatment can continue to receive study treatment. As

part of the partial clinical hold, no additional patients should be enrolled to these clinical trials until the partial clinical hold

is resolved, The Company intends to work with the FDA to analyze the data, address the specific questions raised, and seek to

resolve the partial clinical hold as soon as possible.

APR-548 Phase 1 Trial -- The Company's second product

candidate, APR-548, is a next-generation p53 reactivator that is being developed in an oral dosage form. The Company is currently enrolling

a Phase 1 dose-escalation clinical trial evaluating the safety, tolerability, and preliminary efficacy of APR-548 with azacitidine in

frontline and relapsed/refractory MDS patients. The trial is open and patients are enrolled in the first dosing cohort.

Lymphoid Malignancy Program

On August 11, 2021, the FDA placed a clinical on the Company's

clinical trial evaluating eprenetapopt with acalabrutinib or with venetoclax and rituximab in lymphoid malignancies. The FDA's concerns

referred to the safety and efficacy data from the Company's Phase 3 frontline clinical trial in MDS. There are no patients currently

receiving study treatment in this trial and no additional patients can be enrolled until the clinical hold is resolved. The Company intends

to work with the FDA to address the specific questions raised and seek to resolve the clinical hold as soon as possible.

Solid Tumor Disease Program

Data from the Company's Phase 1/2 clinical trial in relapsed/refractory

gastric, bladder and non-small cell lung cancers assessing eprenetapopt with anti-PD-1 therapy was presented at the European Society of

Medical Oncology (ESMO) Congress 2021. Results were presented from 31 patients who had initiated treatment, including three gastric/GEJ,

three bladder/urothelial cancer and 19 non-small cell lung cancer (NSCLC) patients. In the bladder/urothelial cohort, one patient with

localized TP53 mutant high-grade transitional cell bladder cancer had achieved complete remission (CR) by RECIST criteria at the

first response assessment at 9 weeks. In the NSCLC cohort, two patients with TP53 mutant squamous NSCLC had reductions in target

lesions of 26.7% and 8.2%, respectively, from baseline by RECIST criteria at the first response assessment at 9 weeks.

Upcoming Presentations

Investigators will present data from Aprea Therapeutics' clinical

trials evaluating eprenetapopt at the upcoming 63rd American Society of Hematology Annual Meeting (ASH).

Title: Long-Term Follow-up and Combined Phase 2 Results of Eprenetapopt

(APR-246) and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia

Title: Phase II Trial of Eprenetapopt (APR-246) in Combination

with Azacitidine (AZA) As Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplantation (SCT)

Title: Phase I and Expansion Study of Eprenetapopt (APR-246)

in Combination with Venetoclax (VEN) and Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia (AML)

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.

Sr. Vice President and Chief Financial Officer

Sr. Vice President and Chief Business Officer

Aprea Therapeutics, Inc.

Condensed Consolidated Balance Sheets

Aprea Therapeutics, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss