Financial Performance - Aprea Therapeutics reported cash and cash equivalents of $21.6 million as of December 31, 2023[8]. - The company experienced an operating loss of $3.7 million for Q4 2023, compared to an operating loss of $2.7 million in Q4 2022, reflecting a 37% increase in losses[8]. - For the full year 2023, Aprea reported an operating loss of $15.5 million, a substantial decrease from $113.4 million in 2022, primarily due to reduced R&D expenses[9]. - Net loss for the three months ended December 31, 2023, was $(3,443,254), compared to $(2,442,142) for the same period in 2022[14]. - Total operating expenses for the year ended December 31, 2023, were $113,392,228, an increase from $16,055,194 in 2022[14]. - Cash and cash equivalents decreased to $21,606,820 as of December 31, 2023, from $28,786,647 in 2022[15]. - Total current liabilities increased to $4,385,605 as of December 31, 2023, from $3,201,086 in 2022[15]. - Accumulated deficit rose to $(308,083,161) as of December 31, 2023, compared to $(293,796,405) in 2022[15]. - Total assets decreased to $22,650,174 as of December 31, 2023, from $30,155,827 in 2022[15]. Research and Development - Research and Development (R&D) expenses for Q4 2023 were $2.0 million, up from $0.5 million in Q4 2022, indicating a significant increase in clinical trial activities[8]. - The company’s R&D expenses for the year ended December 31, 2023, were $7.6 million, down from $16.4 million in 2022, reflecting the completion of previous clinical trials[9]. - Research and development expenses for the year ended December 31, 2023, totaled $16,402,273, up from $531,406 in 2022[14]. - Aprea plans to initiate the Phase 1 ACESOT-1051 clinical trial for APR-1051 in H1 2024 following FDA clearance of its IND[5]. - The ATRN-119 trial is on track to complete dose escalation by the end of 2024, with initial efficacy data expected in H2 2024[3]. Administrative Expenses - General and Administrative (G&A) expenses for Q4 2023 were $1.6 million, a decrease from $2.1 million in Q4 2022, due to lower personnel costs[8]. - General and administrative expenses for the year ended December 31, 2023, were $20,969,771, compared to $2,120,222 in 2022[14]. Financing and Cash Position - Aprea raised approximately $16 million in a private placement financing in March 2024 to support its clinical programs[1]. - The company anticipates that its current cash position, combined with the recent financing, will be sufficient to meet operating expenses into Q3 2025[9]. Revenue - Grant revenue for the three months ended December 31, 2023, was $14,075, compared to $0 for the same period in 2022[14]. - Interest income for the three months ended December 31, 2023, was $310,287, an increase from $243,082 in the same period of 2022[14].

Financial Performance - The company incurred significant net losses of $14.3 million, $112.7 million, and $37.1 million for the years ended December 31, 2023, 2022, and 2021, respectively, with an accumulated deficit of $308.1 million as of December 31, 2023[214]. - The company has not generated any commercial revenue to date and expects to continue incurring significant expenses and increasing operating losses for the foreseeable future[214]. - The company received approximately $16.0 million in gross proceeds from a private placement of common stock and warrants in March 2024, which is expected to fund operations into the third quarter of 2025[221]. Product Development and Clinical Trials - The lead product candidate, ATRN-119, is currently in clinical development, and it may take several years before any product candidates are ready for commercialization[214]. - The company is in the early stages of clinical trials for ATRN-119, and initial success may not predict future results in later studies[242][243]. - The company has not tested APR-1051 in clinical trials, and the results of preclinical studies may not be indicative of future clinical trial outcomes[242][243]. - The company may not be able to file INDs or commence additional clinical trials on expected timelines, and the FDA may not permit proceeding with trials[244]. - The company has filed INDs for ATRN-119 and APR-1051, but may face delays in filing INDs for other product candidates due to manufacturing or study delays[245]. - Delays in patient enrollment for clinical trials could significantly impact the timeline for obtaining necessary marketing approvals[248]. - The company may struggle to enroll a sufficient number of eligible patients, which is critical for timely clinical trial completion[250]. - Adverse events in clinical trials could lead to increased regulatory scrutiny and impact the perception of the company's product candidates[251]. - The outcome of preclinical studies and early clinical trials may not predict success in later trials, leading to potential setbacks[267]. - The company may need to conduct additional clinical trials if initial results are inconclusive, requiring substantial additional funds[265]. - Clinical drug development is lengthy and expensive, with uncertain outcomes that could lead to additional costs and delays[266]. - Clinical trials may face delays due to various factors, including regulatory authorization and patient recruitment challenges[268]. Regulatory and Compliance Risks - The company has never obtained marketing approval for any product candidate, and the approval process is expensive, time-consuming, and uncertain[211]. - Regulatory authorities retain broad discretion in evaluating clinical trial results, which may affect the approval process for product candidates[264]. - The FDA and comparable foreign regulatory authorities may refuse to accept or approve new drug applications (NDAs) or marketing authorization applications (MAAs), potentially delaying the approval process by several years[376]. - Any delay in obtaining marketing approvals could prevent the company from commercializing product candidates, generating revenues, and achieving profitability[377]. - The research, testing, and approval processes for drugs are subject to extensive regulation, and the company has limited experience in managing clinical trials necessary for obtaining marketing approvals[379]. - The FDA and EMA require compliance with Good Clinical Practice (GCP) standards, and failure to comply could result in unreliable clinical data and delays in marketing approvals[317]. - The company may encounter unfavorable pricing regulations and reimbursement policies that could harm its business[300]. - Delays in obtaining reimbursement for newly approved drugs could adversely affect the company's financial condition and operating results[303]. Funding and Financial Needs - Future capital requirements will depend on various factors, including the costs of clinical trials, regulatory reviews, and commercialization activities for ATRN-119 and other product candidates[222]. - The company may need substantial additional funding, which may not be available on acceptable terms, potentially delaying or reducing research and drug development programs[219]. - The company has incurred and expects to incur additional costs associated with operating as a public company, which may impact future funding needs[220]. - The company expects expenses to increase due to planned operations and will finance cash needs through equity offerings, debt financings, collaborations, and licensing arrangements[224]. Intellectual Property Risks - The company faces risks related to intellectual property protection, which could impact its ability to commercialize product candidates successfully[211]. - The patent portfolio for eprenetapopt consists of method-of-use and formulation claims, but lacks composition-of-matter patents, limiting protection against competitors[330]. - The company faces challenges in maintaining patent protection, as existing patents may be narrowed or invalidated through litigation or administrative proceedings[338]. - The company may need to obtain licenses from third parties if it loses patent rights, which could limit its ability to develop and commercialize product candidates[342]. - The company may become involved in expensive and time-consuming lawsuits to protect its patents, which could distract management and impact financial resources[355]. - The company faces risks of infringement claims from third parties, which could result in substantial damages and impact its ability to market its product candidates[360]. Market and Competitive Landscape - The pharmaceutical industry is highly competitive, with many companies having greater financial resources and expertise[283]. - The market acceptance of approved product candidates will depend on efficacy, safety, and competitive pricing[280]. - Existing cancer treatments may hinder the market penetration of new product candidates, even if approved[284]. - The company is developing ATRN-119 and APR-1051, both of which will face competition from other candidates in clinical development[285][287]. Operational Risks - The company lacks a sales and marketing infrastructure and has no experience in selling or marketing pharmaceutical drugs, which may hinder the commercialization of product candidates[291]. - Establishing a sales and marketing organization or outsourcing these functions could incur significant costs and delays in product launches[292]. - The company faces risks in recruiting and retaining effective sales and marketing personnel, which could impact commercialization efforts[292]. - IT system failures or cybersecurity issues could adversely affect the company's operations and business[288]. External Factors - The ongoing military conflict between Russia and Ukraine, along with geopolitical tensions, has created economic uncertainty that could adversely affect the company's business and financial condition[226][227]. - The company is monitoring inflation and global capital markets, assessing potential impacts on its operations due to geopolitical tensions and market disruptions[227]. - The company may face challenges in obtaining additional funding due to adverse developments in the financial services industry, which could impair its business operations[232][235]. - Ongoing clinical trials may face delays or disruptions due to epidemic or pandemic disease outbreaks, affecting the company's operations and financial condition[309].

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 ...

Core Insights - Aprea Therapeutics has submitted an Investigational New Drug (IND) application to the FDA for APR-1051, an oral WEE1 kinase inhibitor aimed at precision oncology [1][2] - The company believes APR-1051 has unique characteristics that may differentiate it from other WEE1 inhibitors, including its molecular structure and selectivity [2] - If the IND is cleared, Aprea plans to initiate a Phase 1/2a clinical trial in the first half of 2024 to evaluate APR-1051's safety and efficacy [2] Company Overview - Aprea Therapeutics is a clinical-stage biopharmaceutical company based in Doylestown, Pennsylvania, focusing on precision oncology through synthetic lethality [3] - The company's lead program is ATRN-119, an ATR inhibitor for solid tumor indications, and it has completed all IND enabling studies for APR-1051 [3]

Core Insights - Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, with a significant emphasis on developing new therapeutics targeting the DDR pathway for cancer treatment [1][3] Company Overview - Aprea's lead program is ATRN-119, a clinical-stage small molecule ATR inhibitor aimed at solid tumor indications [3] - The company has completed all IND enabling studies for its oral, small molecule WEE1 inhibitor, APR-1051, and is targeting FDA clearance of its IND during Q1 2024 [3] Event Participation - Dr. Oren Gilad, President and CEO of Aprea, will present at the 7th DDR Inhibitors Summit from January 30 to February 1, 2024, in Boston, MA [1] - The presentation titled "Prioritizing Patient Selection for Combination Studies to Optimize Treatments" is scheduled for February 1, 2024, at 9 am ET [2] - Following the presentation, there will be a roundtable panel discussion on defining clinical success for current and next-generation DDR inhibitors [2]

Company Overview - Aprea Therapeutics is focused on precision oncology through synthetic lethality, with a pipeline enriched by integrated discovery technologies[73]. - The acquisition of Atrin Pharmaceuticals was completed on May 16, 2022, and is now fully integrated into Aprea's operations[74]. - Aprea has shifted focus from reactivating mutant p53 tumor suppressor proteins to developing molecules targeting DDR pathways through synthetic lethality[79]. Product Development - The company’s lead product candidate, ATRN-119, is currently in a Phase 1/2a clinical trial, with tolerability and pharmacokinetic data expected in Q1 2024[76]. - Aprea anticipates filing an IND for its WEE1 inhibitor, ATRN-1051, by the end of 2023[77]. - The company has no ongoing preclinical studies or clinical trials involving reactivators of mutant p53, focusing instead on synthetic lethality[79]. Financial Performance - The company has not generated any revenue from product sales and relies primarily on grant revenue from government organizations[86][87]. - Grant revenue for the three months ended September 30, 2023 was approximately $0.3 million, compared to $0 for the same period in 2022, representing a change of $319,468[113]. - Grant revenue for the nine months ended September 30, 2023 was approximately $0.6 million, compared to no grant revenue for the same period in 2022[122]. - Total operating expenses for the three months ended September 30, 2023 were approximately $3.8 million, compared to $4.2 million for the same period in 2022, a decrease of $357,876[113]. - Total operating expenses decreased to $12.4 million for the nine months ended September 30, 2023, down from $110.7 million in 2022, a reduction of $98.4 million[121]. - The net loss for the three months ended September 30, 2023 was $3.2 million, compared to a net loss of $4.0 million for the same period in 2022, an improvement of $820,203[113]. - Net loss for the nine months ended September 30, 2023 was $10.8 million, significantly improved from a net loss of $110.2 million in 2022, an improvement of $99.4 million[129]. Expenses - Research and development expenses are expected to increase as clinical trials for ATRN-119 and other candidates are initiated[91]. - Research and development expenses increased to approximately $2.1 million for the three months ended September 30, 2023, up from approximately $1.1 million in the same period of 2022, an increase of $1.0 million[115]. - The increase in research and development expenses was primarily due to a $1.2 million increase related to IND enabling studies for ATRN-1051, a small molecule WEE1 inhibitor[117]. - General and administrative expenses decreased to approximately $1.7 million for the three months ended September 30, 2023, down from approximately $3.1 million in the same period of 2022, a decrease of $1.4 million[116]. - General and administrative expenses decreased to approximately $6.8 million for the nine months ended September 30, 2023, down from $18.8 million in 2022, a reduction of $12.1 million[126]. - The company expects general and administrative expenses to increase in the future due to headcount growth and commercialization activities[95]. Cash Flow and Financing - Cash and cash equivalents as of September 30, 2023 were $25.4 million, expected to fund operations through the end of Q4 2024[135]. - Net cash used in operating activities was $8.4 million for the nine months ended September 30, 2023, compared to $21.0 million in 2022, a decrease of $12.6 million[130]. - Net cash provided by financing activities was $5.1 million for the nine months ended September 30, 2023, attributed to the sale of common stock[131]. - The company raised approximately $4.9 million from the sale of 1,050,000 shares of common stock at a public offering price of $5.25 per share in February 2023[146]. - During the nine months ended September 30, 2023, the company issued 26,302 shares under the ATM offering program, resulting in net proceeds of approximately $0.3 million[145]. - The company is subject to a limitation on raising funds through primary public offerings, restricted to one-third of the aggregate market value of common equity held by non-affiliates until the public float exceeds $75 million[145]. - The company expects to incur significant expenses related to ongoing development activities and may require additional financing to support operations[138]. Other Financial Information - The company has provided a valuation allowance for the full amount of net deferred tax assets, indicating uncertainty in realizing benefits from these items[99]. - The company does not currently have any off-balance sheet arrangements[148]. - The company does not believe that inflation has had a material effect on its business during the three months ended September 30, 2023[151]. - The company has not used derivative financial instruments to hedge foreign exchange risk, as it does not currently have significant direct foreign exchange exposure[150]. - The company does not believe that any recently issued accounting pronouncements will have a material impact on its financial statements[147]. - A reverse stock split at a ratio of one-for-20 was approved and became effective on February 10, 2023[85]. - As of September 30, 2023, the company’s cash equivalents consisted of bank deposits and money market accounts, with no significant historical fluctuations in interest income[149]. - Foreign currency loss for the three months ended September 30, 2023 was $2,880, compared to a foreign currency gain of $24,353 for the same period in 2022, a change of $27,233[120].

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 ...

Financial Performance - Aprea Therapeutics has not generated any revenue from product sales and does not expect to do so in the near future[84]. - The net loss for Q1 2023 was $4.4 million, an improvement from a net loss of $7.9 million in Q1 2022, representing a reduction of $3.6 million[115]. - General and administrative expenses for Q1 2023 were approximately $3.4 million, a decrease of $0.6 million compared to $4.0 million in Q1 2022[113]. - Research and development expenses for Q1 2023 were approximately $1.3 million, down from approximately $4.1 million in Q1 2022, reflecting a decrease of $2.8 million[109]. - The total operating expenses for Q1 2023 were $4.6 million, down from $8.1 million in Q1 2022, a decrease of $3.5 million[108]. - Net cash used in operating activities was $3.0 million for the three months ended March 31, 2023, a decrease of $2.5 million compared to $5.5 million for the same period in 2022[118]. - Net cash provided by financing activities was $5.1 million for the three months ended March 31, 2023, primarily from the sale of 1,050,000 shares of common stock[119]. - The accumulated deficit as of March 31, 2023, was $298.2 million, primarily due to research and development costs and general administrative expenses[115]. - As of March 31, 2023, the company had cash and cash equivalents of $31.0 million, expected to fund operations into Q3 2024[114]. - The company expects to require additional financing to support ongoing operations and product development[123]. - The company has no committed external source of funds and may face dilution if additional capital is raised through equity sales[126]. Clinical Development - The company is currently enrolling patients in a Phase 1/2a clinical trial for ATRN-119, with tolerability and pharmacokinetic data expected in Q1 2024[73]. - Aprea anticipates filing an IND for its lead WEE1 inhibitor product candidate, ATRN-1051, by the end of 2023[74]. - The company has shifted its focus to developing synthetic lethality-based cancer therapeutics following the acquisition of Atrin[77]. - Aprea's most advanced product candidate, ATRN-119, targets the ATR kinase involved in DNA damage response pathways[73]. - The company is exploring combination therapies with poly (ADP-ribose) polymerase inhibitors to enhance synthetic lethality[76]. - Aprea has no ongoing preclinical studies or clinical trials involving reactivators of mutant p53, focusing instead on DDR pathways[77]. - Research and development expenses are expected to increase as Aprea initiates clinical trials for ATRN-119 and other candidates[89]. - The company anticipates increased expenses related to clinical trials, product development, and commercialization efforts[120]. Acquisition and Stock Information - The acquisition of Atrin Pharmaceuticals was completed on May 16, 2022, with Aprea issuing 55,869 shares of common stock and 2,949,630 shares of Series A Non-Voting Convertible Preferred Stock[80]. - As of March 31, 2023, a total of 2,893,403 shares of Series A Non-Voting Convertible Preferred Stock were converted into 1,446,701 shares of common stock[81]. - Acquired in-process research and development expense from the Atrin Acquisition in May 2022 was recorded as an expense at the acquisition date, with no additional IPR&D expense expected in future periods[94]. - The company issued 26,302 shares under the ATM offering program, resulting in net proceeds of approximately $0.3 million during the three months ended March 31, 2023[130]. Other Financial Information - Interest income for Q1 2023 was $256,410, a significant increase from $1,971 in Q1 2022, reflecting a change of $254,439[108]. - The company incurred a foreign currency loss of $13,797 in Q1 2023, compared to a gain of $136,211 in Q1 2022, indicating a change of $150,008[113]. - The company expects to continue incurring increased expenses associated with being a public company, including compliance and regulatory costs[94]. - The company is exposed to interest rate risk, but historical fluctuations in interest income have not been significant[133]. - The company does not currently have any off-balance sheet arrangements[132]. - The company is not currently subject to any material legal proceedings[139].

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,” ...