Financing led by Sphera Healthcare with participation from new and existing healthcare-focused institutional investors $16.0 million in upfront gross proceeds with the potential to receive up to an additional $18.0 million in potential warrant exercise proceeds for an aggregate of up to $34.0 million in total gross proceeds DOYLESTOWN, Pa., March 11, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision on ...

DOYLESTOWN, Pa., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE) ("Aprea", or the "Company"), a clinical stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food & Drug Administration (FDA) to initiate clinical trials of APR-1051. APR-1051 is an oral inhibitor of WEE1 kinase, which plays important role in cell cycle regulation and DNA damage repair. ...

DOYLESTOWN, Pa., Jan. 30, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE) ("Aprea", or the "Company"), a clinical stage biopharmaceutical company focused on precision oncology through synthetic lethality, today announced that Dr. Oren Gilad, President and CEO, will deliver a presentation at the 7th DDR Inhibitors Summit, to take place January 30 to February 1, 2024 in Boston, MA. "We are excited to have the opportunity to present at the DDR Inhibitors Summit," said Dr. Oren Gilad. "DDR has b ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39069 Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-2246769 (State or o ...

Precision Oncology through Synthetic Lethality Forward-Looking Statements Certain information contained in this presentation 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 strategic plans. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39069 Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-2246769 (State or other ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39069 Aprea Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 84-2246769 (State or other ...

Precision Oncology through Synthetic Lethality Forward-Looking Statements Certain information contained in this presentation 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 strategic plans. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” ...

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Financial Performance and Losses - The company has incurred significant losses since inception and expects to continue incurring losses for the foreseeable future, with no revenues generated to date[175]. - The company incurred significant net losses of $53.5 million, $28.1 million, and $15.5 million for the years ended December 31, 2020, 2019, and 2018, respectively, with an accumulated deficit of $144.0 million as of December 31, 2020[185]. - The company has not generated any revenue from drug sales to date and has financed operations primarily through private placements and IPO proceeds[185]. - The company expects to incur significant expenses and increasing operating losses for the foreseeable future, with future capital requirements dependent on various factors including clinical trial costs and regulatory reviews[189]. - The company expects substantial increases in expenses related to ongoing development activities for eprenetapopt and other product candidates[362]. Clinical Trials and Product Development - The pivotal Phase 3 MDS trial for the lead product candidate, eprenetapopt, failed to meet its predefined primary endpoint, which may materially harm the business[175]. - The pivotal Phase 3 trial for eprenetapopt failed to meet its predefined primary endpoint of complete remission (CR) rate[195]. - Clinical trials for eprenetapopt include patients with deteriorating health, with common adverse events reported such as nausea, vomiting, and fatigue[197]. - Serious adverse events in trials included febrile neutropenia, pneumonia, and sepsis, with some patient deaths reported possibly related to eprenetapopt[197]. - The company is conducting multiple clinical trials for its product candidates, including eprenetapopt and APR-548, with various phases currently enrolling patients[322]. Regulatory and Approval Challenges - The company has never obtained marketing approval for any product candidate, and the approval process is expensive, time-consuming, and uncertain[181]. - Regulatory authorities may require additional clinical trials or impose restrictions on approved products, affecting commercialization[199]. - The company faces challenges in obtaining marketing approval for p53 reactivators, as this has never been done before[195]. - The company may face significant delays in obtaining reimbursement for newly approved drugs, which could adversely affect its operating results[216]. - The company must comply with extensive regulatory requirements, including safety reporting, quality control, and advertising restrictions for approved drugs[267]. Competition and Market Risks - The company faces substantial competition, which may result in others commercializing products before it does[179]. - The company is dependent on the success of eprenetapopt, and difficulties in patient enrollment for clinical trials could delay necessary marketing approvals[175]. - The company operates in a highly competitive environment with major pharmaceutical and biotechnology companies, which may have greater resources and expertise[208]. - The success of product candidates will depend on market acceptance, efficacy, safety, and competitive pricing compared to existing treatments[206]. Intellectual Property and Patent Risks - The company may not be able to protect its intellectual property rights effectively, which could allow competitors to develop similar products[179]. - The company does not own or license any composition of matter patents for eprenetapopt, which is in the public domain[230]. - The current patent portfolio for eprenetapopt consists of method-of-use and formulation patent claims, which may not prevent competitors from using the same product candidate for other uses[232]. - The company may face challenges in maintaining valid and enforceable patents, which could adversely affect its business and financial condition[234]. - The company’s ability to stop unauthorized third parties from using its product candidates depends on valid and enforceable patents or trade secrets[230]. Funding and Financial Resources - The company may need substantial additional funding, which may not be available on acceptable terms, potentially delaying or eliminating research and development programs[175]. - Existing cash and cash equivalents as of December 31, 2020, are expected to fund operations into 2023, but changing circumstances may require seeking additional funds sooner[187]. - The company may need to transition from a research-focused entity to one capable of supporting commercial activities, which poses additional risks[187]. - If the company fails to raise additional capital when needed, it may have to delay or eliminate research and development programs or commercialization efforts[189]. Compliance and Legal Risks - The company must comply with Good Clinical Practice (GCP) regulations, and failure to do so could result in unreliable clinical data and delays in marketing approvals[222]. - The company is subject to ongoing changes in healthcare regulations that could impact the profitability of its products[273]. - The company faces substantial costs to ensure compliance with healthcare laws and regulations, and violations could lead to significant penalties, damages, and operational restructuring[283]. - The company is exposed to significant risks related to employee misconduct, which could lead to substantial fines or sanctions impacting business operations[285]. Market and Economic Conditions - The company expects that healthcare reform measures may lead to more rigorous coverage criteria and downward pressure on drug prices[275]. - Legislative changes may result in aggregate reductions in Medicare payments to providers of up to 2% per fiscal year through 2030[274]. - The company anticipates that pricing negotiations with governmental authorities outside the United States may delay revenue generation after marketing approval[275]. - The company may face significant costs and management diversion due to potential securities class action litigation following stock price declines, which is common in the pharmaceutical sector[309]. Employee and Operational Growth - The company anticipates significant growth in employee numbers and operational scope, particularly in drug development and clinical operations[294]. - The company may face challenges in managing growth due to limited financial resources and management experience[294]. - The company does not maintain "key person" insurance for its executives, which could impede its objectives if key personnel leave[294]. - General and administrative expenses are anticipated to rise as the company increases its headcount to support research and development activities[333].