Core Insights - Aprea Therapeutics is focused on developing innovative cancer treatments that target specific vulnerabilities in cancer cells while minimizing harm to healthy cells [1][4] - The company emphasizes the importance of its strong patent portfolio in advancing its oncology treatments and protecting its intellectual property [2] Patent Portfolio - Aprea's ATR inhibitor program includes four granted U.S. patents, one pending U.S. application, and one pending provisional application, with 19 granted non-U.S. patents and 16 pending non-U.S. applications [2] - The granted patents for the ATR inhibitor program will expire between 2035 and 2037, with potential extensions of exclusivity into 2044 if pending applications are granted [2] - The WEE1 kinase inhibitor program has one pending U.S. patent application and 12 pending non-U.S. patent applications, with potential expiration in 2043 [3] Clinical Development - The lead ATR inhibitor, ATRN-119, is currently in the ABOYA-119 clinical trial for patients with advanced solid tumors having specific mutations in DNA damage response-related genes [2] - The lead WEE1 inhibitor, APR-1051, is being evaluated in the ACESOT-1051 Phase 1 clinical trial for advanced/metastatic solid tumors with certain gene alterations [3] Company Overview - Aprea is pioneering a treatment approach that targets cancer cell mutations while reducing toxicity to normal cells, applicable across various cancer types including ovarian, colorectal, prostate, and breast cancers [4]

Core Insights - Aprea Therapeutics has initiated a Phase 1/2a clinical trial for its experimental drug ATRN-119, with the first patient dosed at a new twice-daily regimen of 550 mg [1][2] - The trial aims to evaluate ATRN-119 as a monotherapy for patients with advanced solid tumors that have mutations in DNA damage response-related genes [2][5] - The twice-daily dosing is expected to enhance the drug's efficacy and optimize therapeutic levels, potentially leading to better clinical outcomes and a faster path to regulatory approval [3][4] Company Overview - Aprea Therapeutics is focused on developing innovative therapies for cancers with specific genetic alterations, aiming to minimize damage to healthy cells [1][5] - ATRN-119 is a first-in-class macrocyclic ATR inhibitor designed for patients with mutations in DNA damage response-related genes, addressing a significant unmet medical need [5][7] - The company is committed to refining its clinical approach based on scientific evidence, which may enhance shareholder value and create partnership opportunities for commercialization [4][6] Clinical Trial Details - The ABOYA-119 trial has been amended to allow for twice-daily dosing, which is expected to improve the drug's pharmacokinetics and pharmacodynamics [2][3] - The primary endpoint of the trial is to assess the tolerability and pharmacokinetics of ATRN-119, with results anticipated in the second half of 2025 [4][3] - The trial will continue to explore both once-daily and twice-daily dosing schedules independently [4]

Core Viewpoint - Aprea Therapeutics, Inc. (APRE) has experienced a decline of 11.1% in its stock price over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal due to increased buying interest and analyst support for earnings estimates [1][3] Group 1: Technical Analysis - The hammer chart pattern indicates that the stock may have found support, suggesting a possible end to the selling pressure and a trend reversal [1] - A hammer pattern forms when there is a small candle body with a long lower wick, signaling that bears may be losing control during a downtrend [2] - This pattern can occur across various timeframes and is used by both short-term and long-term investors, although it should be combined with other bullish indicators for confirmation [2] Group 2: Fundamental Analysis - Recent upward revisions in earnings estimates for APRE are viewed as a bullish indicator, with a 6.6% increase in the consensus EPS estimate over the last 30 days [3] - APRE holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [3] - The Zacks Rank serves as a timing indicator, suggesting that the company's prospects are improving, further supporting the case for a potential turnaround [3]

Financial Position - As of September 30, 2024, the company expects cash and cash equivalents to be approximately $26.2 million, down from approximately $28.7 million as of June 30, 2024, representing a decrease of about 8.7%[4] - The preliminary cash and cash equivalents figure is subject to completion and may vary from the actual financial position as of September 30, 2024[5] Management Changes - The company announced the engagement of Dr. Phillipe Pultar as Senior Medical Advisor, while Dr. Nadeem Mirza will step down as Chief Medical Officer effective October 9, 2024[6]

Clinical Programs - Aprea Therapeutics has two clinical programs: ATRN-119, an oral macrocyclic ATR inhibitor, and APR-1051, a next-generation oral WEE1 kinase inhibitor[72][73]. - ATRN-119 is currently in a Phase 1/2a clinical trial, with preliminary data indicating it is safe and well-tolerated, and potential efficacy data expected in the second half of 2025[72]. - APR-1051 has received FDA clearance for its IND application, with the first patient enrolled in the ACESOT-1051 trial, and preliminary results show it is safe with no hematologic toxicity[73]. - Aprea Therapeutics is focusing on synthetic lethality as a treatment strategy for various cancer types, aiming to establish a leadership position in this emerging field[71]. - The company is exploring combination therapy opportunities for its product candidates, supported by a Phase II SBIR grant from the National Cancer Institute[75]. Financial Performance - The company has not generated any revenue from product sales and does not expect to do so in the near future, relying primarily on grant revenue[78][79]. - Grant revenue for the three months ended September 30, 2024, was approximately $354,621, an increase of $35,153 compared to $319,468 for the same period in 2023[105]. - For the nine months ended September 30, 2024, grant revenue was approximately $1.3 million, an increase of $727,608 from $569,156 in the same period in 2023[110]. - Net loss for the three months ended September 30, 2024, was $3,783,769, compared to a net loss of $3,204,515 for the same period in 2023, reflecting an increase of $579,254[105]. - The accumulated deficit as of September 30, 2024, was $318.1 million, with net losses of $10.1 million for the nine months ended September 30, 2024[115]. Expenses - 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[84]. - Research and development expenses for the three months ended September 30, 2024, were approximately $2.8 million, up $723,796 from $2.1 million in the same period in 2023[106]. - Total research and development expenses for the nine months ended September 30, 2024, were approximately $7.0 million, an increase of $1,422,649 from $5.6 million in the same period in 2023[111]. - General and administrative expenses are anticipated to rise due to increased headcount and activities related to potential commercialization of product candidates[89]. - General and administrative expenses for the three months ended September 30, 2024, were approximately $1.6 million, a decrease of $114,477 from $1.7 million in the same period in 2023[108]. - General and administrative expenses for the nine months ended September 30, 2024, were approximately $5.4 million, a decrease of $1,398,465 from $6.8 million in the same period in 2023[112]. Cash Flow and Financing - As of September 30, 2024, the company had cash and cash equivalents of $26.2 million, expected to fund operating expenses for at least the next twelve months[114]. - Net cash used in operating activities was $10.0 million for the nine months ended September 30, 2024, compared to $8.4 million for the same period in 2023, reflecting an increase of $1.6 million primarily due to changes in operating assets and liabilities[116]. - Cash used in investing activities was $15,478 for the nine months ended September 30, 2024, primarily for the purchase of property and equipment, with no cash used in investing activities for the same period in 2023[117]. - Net cash provided by financing activities was $14.7 million for the nine months ended September 30, 2024, from the sale of 1,687,712 shares of common stock and various warrants, after deducting approximately $1.3 million in expenses[118]. - The company raised approximately $4.9 million from the sale of 1,050,000 shares of common stock in February 2023, after deducting underwriting discounts and offering expenses[130]. - The company entered into a securities purchase agreement in March 2024, resulting in gross proceeds of approximately $16.0 million from the issuance of common stock and warrants[134]. Future Outlook - The company expects to continue incurring significant expenses and increasing operating losses for at least the next several years[115]. - The company anticipates increased expenses related to clinical trials, product development, and operating as a public company, necessitating additional financing[120]. - Future capital requirements will depend on various factors, including the scope and progress of clinical trials and potential commercialization activities[122]. - The company has no committed external sources of funds and may face challenges in raising additional capital on favorable terms[126]. Market and Economic Risks - The company does not currently have any significant direct foreign exchange risk and has not used derivative financial instruments to hedge such exposure[139]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the nine months ended September 30, 2024[140]. - The primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates[136]. - Historical fluctuations in interest income have not been significant for the company[137]. - The company faces market risk from changes in foreign currency exchange rates affecting its non-U.S. dollar functional currency foreign subsidiaries[138]. - The financial position of subsidiary Aprea AB is measured using the local currency as the functional currency[138]. - Cash accounts holding U.S. dollars at Aprea AB are remeasured based on the exchange rate at the date of remeasurement[138].

Core Viewpoint - Aprea Therapeutics, Inc. is actively participating in the Maxim Healthcare Virtual Summit, showcasing its focus on precision oncology through synthetic lethality [1][4]. Group 1: Company Overview - Aprea Therapeutics is a clinical-stage biopharmaceutical company based in Doylestown, Pennsylvania, specializing in precision oncology [4]. - The company's lead program is ATRN-119, a small molecule ATR inhibitor aimed at treating solid tumors [4]. - Aprea has recently initiated clinical development for APR1051, an oral small-molecule WEE1 inhibitor [4]. Group 2: Event Participation - Dr. Oren Gilad, President and CEO of Aprea, will present at two sessions during the Maxim Healthcare Virtual Summit [1]. - The first session is a Precision and Immune Oncology Panel scheduled for October 16, 2024, from 2:00 to 3:00 PM ET [2]. - The second session is a Fireside Chat on October 17, 2024, from 3:30 to 4:00 PM ET [2].

Company Update - Aprea Therapeutics has engaged Dr Philippe Pultar as its senior medical advisor to support the development and advancement of APR-1051, a potential best-in-class WEE1 inhibitor [1] - Dr Pultar brings extensive experience in oncology, including the development of a WEE1 inhibitor (azenosertib) from early to late-stage clinical development [2] - Dr Pultar's prior role at Zentalis Pharmaceuticals involved strategy and execution of the global clinical development of azenosertib, a WEE1 inhibitor [2] Clinical Development - Patient enrollment is ongoing in the Phase 1 ACESOT-1051 study, which assesses the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of APR-1051 in advanced solid tumors with certain cancer-associated gene alterations [3] - Aprea plans to provide an update on the progress of the ACESOT-1051 clinical study by the end of 2024 [3] - The WEE1 program is part of Aprea's portfolio of DDR-targeted therapeutics aimed at delivering precision medicine solutions [3] Leadership and Expertise - Dr Pultar has over 17 years of experience in early and late-stage clinical development, including roles at Zentalis Pharmaceuticals, Novartis Oncology, Agennix AG, and ImClone Systems [5] - Dr Pultar initiated seven Phase 1 and Phase 2 trials with azenosertib as a single agent and in combination with chemotherapy and targeted agents across multiple indications [5] - Dr Pultar's foundational education includes Medical Studies and Residency at Université de Médecine de Poitiers, France [6] Strategic Vision - Dr Pultar believes WEE1 inhibition is a promising therapeutic approach in oncology and is impressed by the progress of APR-1051, which has a differentiated profile and compelling pre-clinical data [4] - Aprea's President and CEO, Dr Oren Gilad, highlights Dr Pultar's track record of successfully leading programs through late-stage development and regulatory approval [4] - Dr Pultar's addition aligns with Aprea's strategy to bring in exceptional talent to advance its programs and maximize the therapeutic potential of APR-1051 [4] Leadership Transition - Dr Nadeem Mirza will step down as Chief Medical Officer effective October 9, 2024, but will remain with the company until no later than December 13, 2024, to ensure a smooth transition [4]

Company Performance - Aprea Therapeutics reported a quarterly loss of $0.58 per share, better than the Zacks Consensus Estimate of a loss of $0.64, and an improvement from a loss of $0.87 per share a year ago, indicating a 33.33% year-over-year improvement [1] - The company achieved a revenue of $0.56 million for the quarter, surpassing the Zacks Consensus Estimate by 462%, compared to $0.25 million in the same quarter last year [1] - Over the last four quarters, Aprea Therapeutics has exceeded consensus EPS estimates three times and topped consensus revenue estimates two times [1] Market Outlook - Aprea Therapeutics shares have declined approximately 28.5% since the beginning of the year, contrasting with the S&P 500's gain of 12% [2] - The current consensus EPS estimate for the upcoming quarter is -$0.65 on revenues of $0.15 million, and for the current fiscal year, it is -$2.57 on revenues of $0.8 million [4] Industry Context - The Medical - Biomedical and Genetics industry, to which Aprea Therapeutics belongs, is currently ranked in the top 30% of over 250 Zacks industries, suggesting a favorable industry outlook [5] - Precigen, Inc., another company in the same industry, is expected to report a quarterly loss of $0.09 per share, reflecting a year-over-year change of -12.5%, with revenues anticipated to be $1.28 million, down 27.7% from the previous year [5][6]

[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)

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, 2024 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 ...