[Executive Summary](index=1&type=section&id=Executive%20Summary) Aprea Therapeutics presents its Q2 2024 performance, emphasizing clinical trial advancements and a strong cash position [Second Quarter 2024 Highlights](index=1&type=section&id=Second%20Quarter%202024%20Highlights) Aprea Therapeutics reported Q2 2024 results, initiating ACESOT-1051 Phase 1 trial with no myelosuppression and extending cash runway into Q4 2025 - Enrollment commenced in the ACESOT-1051 Phase 1 trial evaluating APR-1051, with **no myelosuppression observed** in the first of eight planned cohorts at a sub-therapeutic dose[1](index=1&type=chunk) - The Company reported **$28.7 million in cash and cash equivalents** as of June 30, 2024[1](index=1&type=chunk) - Cash runway is extended into **Q4 2025**[1](index=1&type=chunk) [Business Update](index=1&type=section&id=Business%20Update) Aprea provides updates on its clinical pipeline progress and key corporate developments, including leadership changes [Clinical Pipeline Progress](index=1&type=section&id=Clinical%20Pipeline%20Progress) Aprea advances its clinical pipeline with APR-1051 and ATRN-119, targeting oncology with promising early clinical development [ACESOT-1051 (APR-1051, WEE1 Inhibitor)](index=1&type=section&id=ACESOT-1051%20(APR-1051,%20WEE1%20Inhibitor)) Details on the ACESOT-1051 Phase 1 trial for APR-1051, a WEE1 inhibitor, covering enrollment and anticipated readouts - APR-1051 is a potent and selective small molecule WEE1 inhibitor designed for greater clinical activity, especially in cancers with Cyclin E overexpression[2](index=2&type=chunk) - Enrollment commenced in June 2024 for the ACESOT-1051 Phase 1 clinical trial, with the first patient dosed without **dose-limiting toxicities or myelosuppression**[2](index=2&type=chunk) - Primary objectives of the Phase 1 study include measuring safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD/MAD), and recommended Phase 2 dose (RP2D)[2](index=2&type=chunk) - An update on clinical study progress is expected by **year-end 2024**, with open-label safety/efficacy data anticipated in **H1 2025**[3](index=3&type=chunk) - APR-1051 was featured in a virtual KOL event in **June 2024** and two posters at the **AACR annual meeting in April 2024**[3](index=3&type=chunk) [ABOYA-119 (ATRN-119, ATR Inhibitor)](index=2&type=section&id=ABOYA-119%20(ATRN-119,%20ATR%20Inhibitor)) Outlines the ABOYA-119 Phase 1/2a clinical trial for ATRN-119, an ATR inhibitor, detailing dose cohorts and protocol amendments - ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed for patients with **DDR-related gene mutations**[4](index=4&type=chunk) - The ABOYA-119 Phase 1/2a clinical trial is ongoing as monotherapy in advanced solid tumors with DDR-related gene mutations, with **five dose cohorts completed**[4](index=4&type=chunk) - Aprea plans to amend the study protocol to add a group for **twice-daily ATRN-119 administration** and investigate food effect on drug absorption[4](index=4&type=chunk) - The ABOYA-119 Phase 1 readout is anticipated in **H1 2025**[4](index=4&type=chunk) - An update on the ongoing trial was featured in a poster at the **AACR Annual Meeting in April**[4](index=4&type=chunk) [Corporate Developments](index=2&type=section&id=Corporate%20Developments) Aprea strengthened its leadership with the appointment of Nadeem Q. Mirza as Chief Medical Officer, effective May 1, 2024 - **Nadeem Q. Mirza, M.D., M.P.H.** was appointed as Chief Medical Officer (CMO), effective **May 1, 2024**, to lead the Company's clinical pipeline development[5](index=5&type=chunk) [Financial Results](index=2&type=section&id=Financial%20Results) Aprea presents its financial performance, including balance sheet and statements of operations, detailing key changes [Balance Sheet Overview](index=2&type=section&id=Balance%20Sheet%20Overview) Aprea's cash and cash equivalents increased to $28.7 million by June 30, 2024, extending cash runway into Q4 2025, with decreased liabilities Consolidated Balance Sheet Highlights | Metric | June 30, 2024 ($) | December 31, 2023 ($) | Change ($) | Change (%) | | :-------------------------- | :------------ | :---------------- | :--------- | :--------- | | Cash and cash equivalents | $28,694,694 | $21,606,820 | $7,087,874 | 32.8% | | Total current assets | $29,559,786 | $22,521,095 | $7,038,691 | 31.3% | | Total assets | $29,964,587 | $22,650,174 | $7,314,413 | 32.3% | | Total current liabilities | $3,094,229 | $4,385,605 | $(1,291,376) | -29.4% | | Total liabilities | $3,094,229 | $4,385,605 | $(1,291,376) | -29.4% | | Total stockholders' equity | $25,559,295 | $16,953,506 | $8,605,789 | 50.7% | - The Company believes its cash and cash equivalents as of **June 30, 2024**, will be sufficient to meet operating expenses and capital expenditure requirements into **Q4 2025**[5](index=5&type=chunk) [Statements of Operations Overview](index=3&type=section&id=Statements%20of%20Operations%20Overview) Aprea reported a Q2 2024 operating loss of $3.8 million, driven by increased R&D and G&A expenses, with decreased net loss per share Consolidated Statements of Operations Highlights (Three Months Ended June 30) | Metric | Q2 2024 ($) | Q2 2023 ($) | Change ($) | Change (%) | | :-------------------------- | :------------ | :------------ | :--------- | :--------- | | Grant revenue | $561,574 | $249,688 | $311,886 | 124.9% | | Research and development | $2,557,679 | $2,202,657 | $355,022 | 16.1% | | General and administrative | $1,850,819 | $1,698,712 | $152,107 | 9.0% | | Total operating expenses | $4,408,498 | $3,901,369 | $507,129 | 13.0% | | Loss from operations | $(3,846,924) | $(3,651,681) | $(195,243) | 5.3% | | Net loss | $(3,470,052) | $(3,259,097) | $(210,955) | 6.5% | | Net loss per share (basic) | $(0.58) | $(0.87) | $0.29 | -33.3% | | Weighted-average common shares outstanding | 5,937,291 | 3,731,571 | 2,205,720 | 59.1% | - Research and development expenses increased by approximately **$0.35 million**, primarily due to the initiation of the ACESOT-1051 Phase 1 dose-escalation study in **Q2 2024**[6](index=6&type=chunk) - General and administrative expenses increased by approximately **$0.15 million**, primarily due to increased personnel costs, including severance expense[7](index=7&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) Overview of Aprea Therapeutics, its forward-looking statements, and contact information for investors and media [About Aprea Therapeutics](index=3&type=section&id=About%20Aprea%20Therapeutics) Aprea Therapeutics is a clinical-stage biopharmaceutical company focused on precision oncology, with lead programs ATRN-119 and APR-1051 - Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on **precision oncology through synthetic lethality**[8](index=8&type=chunk) - The Company's lead programs are **ATRN-119**, a clinical-stage small molecule ATR inhibitor, and **APR-1051**, an oral, small-molecule WEE1 inhibitor that recently entered the clinic[8](index=8&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) Standard disclaimer on forward-looking statements, cautioning about inherent risks and uncertainties, with no obligation to update unless legally required - The press release contains "forward-looking statements" regarding study analyses, clinical trials, regulatory submissions, and projected cash position, based on current beliefs and expectations but involving risks and uncertainties[9](index=9&type=chunk) - These statements are subject to risks including the success, timing, and cost of ongoing and anticipated clinical trials, and readers are cautioned not to place undue reliance on them[10](index=10&type=chunk) - The Company undertakes no obligation to update such forward-looking statements for any reason, except as required by law[10](index=10&type=chunk) [Investor and Media Contacts](index=4&type=section&id=Investor%20and%20Media%20Contacts) Contact information for investor relations and media inquiries is provided for external communication - Investor contact: **Mike Moyer at LifeSci Advisors** (mmoyer@lifesciadvisors.com)[11](index=11&type=chunk) - Media contact: **Ignacio Guerrero-Ros, Ph.D., or David Schull at Russo Partners, LLC** (Ignacio.guerrero-ros@russopartnersllc.com, David.schull@russopartnersllc.com)[11](index=11&type=chunk)

Clinical Programs - Aprea Therapeutics has two clinical programs: ATRN-119, an oral macrocyclic ATR inhibitor, and APR-1051, a next-generation oral WEE1 inhibitor, both targeting synthetic lethality in cancer treatment[70][73] - The Phase 1/2a clinical trial for ATRN-119 (ABOYA-119) has completed the first five dose cohorts, with readout expected in the first half of 2025[70] - The FDA cleared the IND application for APR-1051 in March 2024, with the first patient enrolled in the ACESOT-1051 study in Q2 2024, and updates anticipated by year-end 2024[73] - The initiation of the second clinical trial study for APR-1051 contributed to an increase of $0.5 million in research and development expenses[101] - The company is exploring combination therapy opportunities for its product candidates, including a preclinical research program on the combination of ATRN-119 and APR-1051[74] Financial Performance - Aprea Therapeutics has not generated any revenue from product sales and relies primarily on grant revenue, which is recognized as research and development services are performed[76][77] - Grant revenue for Q2 2024 was approximately $0.6 million, up from $0.2 million in Q2 2023, representing a 180% increase[98] - Total operating expenses for Q2 2024 were approximately $4.4 million, compared to $3.9 million in Q2 2023, reflecting a 13% increase[99] - Research and development expenses for Q2 2024 were approximately $2.6 million, an increase of $0.4 million or 18% compared to $2.2 million in Q2 2023[101] - General and administrative expenses for Q2 2024 were approximately $1.9 million, up from $1.7 million in Q2 2023, indicating a 12% increase[102] - Net loss for Q2 2024 was approximately $3.5 million, compared to a net loss of $3.3 million in Q2 2023, representing a 6% increase in loss[99] - Grant revenue for the six months ended June 30, 2024, was approximately $0.9 million, up from $0.2 million in the same period of 2023, representing a 350% increase[105] - Total operating expenses decreased to $7.9 million for the six months ended June 30, 2024, from $8.5 million in 2023, a reduction of $0.6 million or 6.9%[104] - Research and development expenses increased to approximately $4.2 million for the six months ended June 30, 2024, compared to $3.5 million in 2023, an increase of $0.7 million or 20.2%[107] - General and administrative expenses decreased to approximately $3.8 million for the six months ended June 30, 2024, down from $5.1 million in 2023, a decrease of $1.3 million or 25.5%[108] - Net loss for the six months ended June 30, 2024, was $6.3 million, compared to a net loss of $7.6 million in 2023, reflecting an improvement of $1.4 million or 18.4%[111] Cash and Financing - Cash and cash equivalents as of June 30, 2024, were $28.7 million, expected to fund operations into the fourth quarter of 2025[110] - Net cash used in operating activities was $7.6 million for the six months ended June 30, 2024, compared to $6.2 million in 2023, an increase of $1.4 million or 22.6%[113] - Net cash provided by financing activities was $14.7 million for the six months ended June 30, 2024, compared to $5.1 million in 2023, an increase of $9.6 million or 188.2%[114] - The company filed a universal shelf registration statement for the issuance of securities up to an aggregate of $350 million, which expired on November 30, 2023[127] - In February 2023, the company issued 1,050,000 shares at a public offering price of $5.25 per share, resulting in net proceeds of approximately $4.9 million after expenses[128] - A new shelf registration statement was filed on January 26, 2024, for the issuance of securities up to $150 million, including a prospectus for the sale of $1 million of common stock[128] - The company entered into an ATM Agreement allowing the issuance of up to $2 million of common stock, but no sales were made under this agreement before its termination in March 2024[129] - On March 11, 2024, the company agreed to issue 1,687,712 shares at a purchase price of $7.29 per share, with gross proceeds expected to total approximately $16 million before fees[130] - The potential future warrant cash exercises from the recent securities purchase agreement are expected to yield up to approximately $18 million[130] Expenses and Liabilities - Research and development expenses are expected to increase as clinical trials for ATRN-119 and APR-1051 are initiated, reflecting the higher costs associated with later-stage clinical development[81] - General and administrative expenses are projected to rise due to increased headcount and activities related to potential commercialization of product candidates[86] - The company has provided a valuation allowance for deferred tax assets, indicating uncertainty in realizing tax benefits from net losses incurred[88] - The accumulated deficit as of June 30, 2024, was $314.4 million, indicating the ongoing financial challenges faced by the company[111] - The company does not currently have any off-balance sheet arrangements[132] Company Classification - The company remains classified as an emerging growth company until December 31, 2024, unless certain financial thresholds are met[95] - The company is also classified as a smaller reporting company, with market value held by non-affiliates below $700 million and annual revenue below $100 million[96] Market and Economic Conditions - The company does not believe that inflation has materially affected its business during the six months ended June 30, 2024[135] - The company has not used any derivative financial instruments to hedge foreign exchange risk, as it does not currently have significant direct foreign exchange exposure[134] - As of June 30, 2024, the company’s cash equivalents consisted of bank deposits and money market accounts, with no significant historical fluctuations in interest income[133]

Enrollment commenced in the ACESOT-1051 Phase 1 trial evaluating APR-1051 – no myelosuppression observed in the first of eight planned cohorts at sub-therapeutic dose $28.7 million in cash and cash equivalents as of June 30, 2024 with cash runway extended into Q4 2025 DOYLESTOWN, Pa., Aug. 12, 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 reported financ ...

Core Insights - Aprea Therapeutics is hosting a virtual KOL event on June 24, 2024, to discuss APR-1051, a selective oral WEE1 inhibitor [1][2] - The event will feature presentations from experts in medicinal chemistry and cancer biology, focusing on the drug's design and preclinical findings [1][4] - APR-1051 is currently in a Phase 1 trial as a monotherapy for patients with significant unmet medical needs, particularly those with Cyclin E overexpression [2] Company Overview - Aprea Therapeutics, Inc. is a clinical-stage biopharmaceutical company based in Doylestown, Pennsylvania, specializing in precision oncology through synthetic lethality [5] - The company's lead program is ATRN-119, an ATR inhibitor in development for solid tumor indications, alongside APR-1051, which has recently entered clinical trials [5] Expert Contributions - Joseph Vacca, PhD, a medicinal chemistry expert with a significant background in drug development, will discuss the medicinal chemistry history and preclinical findings of APR-1051 [1][3] - Eric J. Brown, PhD, an Associate Professor at the University of Pennsylvania, will present on preclinical findings related to the WEE1 inhibitor class and its implications for cancer therapy [1][4]

APR-1051 is a highly selective and potentially best-in-class oral WEE1 inhibitor Phase 1 ACESOT-1051 clinical trial is evaluating APR-1051 as monotherapy treatment in patients with significant unmet medical need Dosing of the first patient in the ACESOT-1051 study represents a key advancement in Aprea's clinical pipeline DOYLESTOWN, Pa., June 17, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (NASDAQ:APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncolo ...

Core Insights - ATRN-119 is the first and only macrocyclic ATR inhibitor in clinical trials, showing best-in-class potential [1] - The ongoing ABOYA-119 clinical trial is on track to complete dose escalation and potentially generate initial human efficacy data in the second half of 2024 [1][4] - Safety Review Committee has approved the commencement of dosing at 800 mg once daily for Cohort 6, following positive safety and pharmacokinetic data from Cohort 5 [2][3] Clinical Trial Progress - A total of 17 patients have been enrolled across the first five cohorts with doses ranging from 50 mg to 550 mg once daily [3] - Preliminary signs of clinical benefit have been observed, with two patients achieving stable disease at different dose levels [3] - The Phase 1 dose escalation is expected to be completed by the fourth quarter of 2024, with the recommended Phase 2 dose anticipated in the first quarter of 2025 [4] Drug Characteristics - ATRN-119 is designed for patients with mutations in DNA damage response (DDR) pathways, addressing a high unmet medical need in oncology [4] - The drug has demonstrated a differentiated selectivity and toxicity profile compared to other ATR inhibitors [2][4] - Pharmacokinetic data indicate that systemic exposure increases with each dose level, with therapeutic plasma concentrations observed at doses of 550 mg and above [2][5]

Financial Performance - Aprea Therapeutics reported cash and cash equivalents of $32.4 million as of March 31, 2024, up from $21.6 million at December 31, 2023[6]. - The company experienced an operating loss of $3.1 million for Q1 2024, an improvement from an operating loss of $4.6 million in the same period in 2023[6]. - Grant revenue for the three months ended March 31, 2024, was $380,569, compared to $0 in the same period last year[13]. - Total operating expenses decreased to $3.53 million in Q1 2024 from $4.62 million in Q1 2023, a reduction of about 23.5%[13]. - Net loss narrowed to $2.81 million for the three months ended March 31, 2024, compared to a net loss of $4.38 million in the same period last year, reflecting an improvement of approximately 35.9%[13]. - Net loss per share attributable to common stockholders improved to $(0.67) in Q1 2024 from $(1.34) in Q1 2023[13]. Research and Development - Research and Development (R&D) expenses increased to $1.6 million in Q1 2024, compared to $1.3 million in Q1 2023, primarily due to IND enabling studies for APR-1051[6]. - Aprea plans to initiate the Phase 1 ACESOT-1051 clinical trial for APR-1051 in June 2024, following FDA clearance of the IND[2][3]. - The ATRN-119 clinical trial (ABOYA-119) is on track to complete dose escalation by the end of 2024, with initial efficacy data expected in 2H 2024[2][4]. - As of March 12, 2024, 16 patients were enrolled in the dose escalation stage of the ABOYA-119 trial, with preliminary signs of clinical benefit observed in two patients[2]. - A lead candidate for a third synthetic lethality program is expected to be selected in Q3 2024, potentially providing new treatment options for cancer patients[4]. Administrative Expenses - General and Administrative (G&A) expenses decreased to $1.9 million in Q1 2024, down from $3.4 million in Q1 2023, mainly due to reduced personnel costs[6]. - General and administrative expenses decreased significantly to $1.93 million in Q1 2024 from $3.37 million in Q1 2023, a decline of approximately 42.5%[13]. Assets and Liabilities - Total assets increased to $33.20 million as of March 31, 2024, up from $22.65 million at December 31, 2023, representing a growth of approximately 46.5%[11]. - Total current liabilities decreased to $2.97 million as of March 31, 2024, down from $4.39 million at December 31, 2023, a reduction of about 32.2%[11]. - Cash and cash equivalents increased to $32.37 million as of March 31, 2024, compared to $21.61 million at December 31, 2023, representing a growth of approximately 49.9%[11]. Leadership Changes - Nadeem Q. Mirza, M.D., M.P.H. was appointed as Chief Medical Officer effective May 1, 2024, to lead the company's expanding clinical pipeline[5]. Shareholder Information - Weighted-average common shares outstanding increased to 4,198,326 in Q1 2024 from 3,260,484 in Q1 2023, reflecting an increase of approximately 28.7%[13].

Oncology Focus - Aprea Therapeutics is focused on precision oncology through synthetic lethality, with a pipeline enriched by novel targets in cancer treatment[65] - The company is exploring combination therapies with other agents, such as PARP inhibitors, to enhance synthetic lethality[71] - Aprea Therapeutics has no ongoing preclinical studies or clinical trials involving reactivators of mutant p53, focusing instead on DDR pathways[66] Clinical Trials - The lead product candidate, ATRN-119, is currently in a Phase 1/2a clinical trial, with readout expected in Q1 2025[68] - The first four dose cohorts of the ATRN-119 trial have been completed, with ongoing enrollment for additional cohorts[68] - The FDA cleared the IND application for APR-1051, with patient enrollment anticipated in Q2 2024 and safety/efficacy data expected in Q2 2025[69] Financial Performance - Grant revenue for Q1 2024 was approximately $0.4 million, a significant increase of $380,569 compared to no grant revenue in Q1 2023[95] - Total operating expenses decreased to $3.5 million in Q1 2024 from $4.6 million in Q1 2023, a reduction of $1.1 million[96] - Research and development expenses increased to approximately $1.6 million in Q1 2024 from $1.3 million in Q1 2023, an increase of $0.3 million[97] - General and administrative expenses decreased to approximately $1.9 million in Q1 2024 from $3.4 million in Q1 2023, a decrease of $1.4 million[98] - Net loss for Q1 2024 was $2.8 million, compared to a net loss of $4.4 million in Q1 2023, reflecting an improvement of $1.6 million[101] - Cash and cash equivalents as of March 31, 2024, were $32.4 million, expected to fund operations into Q3 2025[100] Funding and Capital - Net cash provided by financing activities was $14.7 million in Q1 2024, significantly higher than $5.1 million in Q1 2023[105][106] - A total of $350 million was registered for issuance under the 2020 Shelf Registration Statement, which expired on November 30, 2023[117] - In February 2023, the company raised approximately $4.9 million by issuing 1,050,000 shares at a public offering price of $5.25 per share[118] - A new shelf registration statement for $150 million was filed on January 26, 2024, including a prospectus for the sale of $1 million of common stock[119] - The company entered into an At the Market Offering Agreement allowing for the sale of up to $2 million of common stock, but no sales have been made under this agreement to date[120] - A private placement offering on March 11, 2024, resulted in gross proceeds of approximately $16 million from the sale of 1,687,712 shares at $7.29 per share[121] - The company has no committed external source of funds and may face dilution of ownership interests if additional capital is raised through equity or convertible debt securities[114] Expenses and Deficits - Research and development expenses are expected to increase as clinical trials for ATRN-119 and APR-1051 are initiated[77] - General and administrative expenses are projected to rise due to increased headcount and activities related to potential commercialization[81] - The company anticipates increased expenses related to ongoing and planned development activities, including clinical trials and product commercialization[107][109] - The accumulated deficit as of March 31, 2024, was $310.9 million, primarily due to research and development costs and general administrative expenses[101] Market Risks - Interest income sensitivity is the primary exposure to market risk, with no significant historical fluctuations noted[124] - Inflation has not materially affected the company's business or financial condition during the three months ended March 31, 2024[126] - Developing drug products is a lengthy and costly process, with no guarantee of obtaining marketing approval or generating revenue[113] Team and Expertise - Aprea Therapeutics has assembled a team with extensive experience in oncology drug development to support its mission[71]

DOYLESTOWN, Pa., May 02, 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 the appointment of Nadeem Q. Mirza, M.D., M.P.H. as Chief Medical Officer (CMO) of the Company, effective May 1, 2024. Dr. Mirza has been an integral part of the Company's senior team as a consultant since February, 2023 and will now assume a more central role in leading the ...

Pre-clinical findings underscore the potential of APR-1051, a next-generation WEE1 kinase inhibitor, to be a well-tolerated and effective treatment for Cyclin E-overexpressing cancers IND for APR-1051 has been cleared; details on planned Phase 1 first in human trial (ACESOT-1051) presented ATRN-119, a novel macrocyclic ATR inhibitor, continues to appear safe and well tolerated with no Dose Limiting Toxicities observed in ongoing Phase 1/2a study; preliminary signs of clinical benefit reported; enrollment in ...