Aprea Therapeutics (NasdaqCM:APRE) FY Conference September 09, 2025 03:30 PM ET Speaker0On that note, good afternoon, everyone, and welcome to our next session. I'm your moderator, Sara Nick. I'm an equity research VP at HC Wainwright, and it's my pleasure to introduce our next presenter, Aurin Gilad, CEO at Apraya Therapeutics, a biopharmaceutical company developing small molecule inhibitors to exploit genetic mutations in cancer. With that, the floor is yours, Aurin.Speaker1Thank you. Thank you, Sarah, fo ...

DOYLESTOWN, Pa., Aug. 28, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabilities while minimizing damage to healthy cells, today announced that management will present at the H.C. Wainwright 27th Annual Global Investment Conference, to take place September 8-10, 2025, in New York. Presentation Details Date/ time: Tuesday, September 9 at 3:30 PM  ...

PART I: FINANCIAL INFORMATION [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Unaudited condensed consolidated financial statements are presented, highlighting a **$16.5 million** cash balance and going concern doubt Condensed Consolidated Balance Sheet Data (Unaudited) | Indicator | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $16,532,199 | $22,849,885 | | Total current assets | $16,927,210 | $23,576,139 | | Total assets | $17,309,710 | $23,979,493 | | Total current liabilities | $3,167,668 | $3,360,975 | | Total stockholders' equity | $13,414,681 | $19,307,455 | Condensed Consolidated Statements of Operations (Unaudited) | Indicator | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | Six Months Ended June 30, 2025 (USD) | Six Months Ended June 30, 2024 (USD) | | :--- | :--- | :--- | :--- | :--- | | Grant revenue | $118,111 | $561,574 | $280,574 | $942,143 | | Research and development | $1,912,213 | $2,557,679 | $4,395,279 | $4,158,052 | | General and administrative | $1,593,671 | $1,850,819 | $3,358,650 | $3,780,685 | | Net loss | $(3,238,870) | $(3,470,052) | $(7,171,529) | $(6,280,143) | | Net loss per share | $(0.53) | $(0.58) | $(1.19) | $(1.24) | Condensed Consolidated Statements of Cash Flows (Unaudited, Six Months Ended June 30) | Indicator | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,761,917) | $(7,577,512) | | Net cash provided by financing activities | $440,728 | $14,688,645 | - The company has concluded that its cash balance of approximately **$16.5 million** as of June 30, 2025, is not sufficient to fund operations for at least twelve months, raising substantial doubt about its ability to continue as a going concern[33](index=33&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Analysis of financial condition and operations, noting a **$16.5 million** cash position insufficient for twelve months and raising going concern issues [Overview](index=19&type=section&id=Overview) Aprea focuses on precision oncology with lead candidates APR-1051 and ATRN-119 in Phase 1 trials, anticipating initial data in H2 2025 - The company's primary focus is on its two clinical-stage synthetic lethality product candidates: **APR-1051** (WEE1 inhibitor) and **ATRN-119** (ATR inhibitor)[83](index=83&type=chunk)[85](index=85&type=chunk)[86](index=86&type=chunk) - Key clinical milestones include the enrollment of the first patient in the ACESOT-1051 (**APR-1051**) Phase 1 study in **Q2 2024** and ongoing enrollment in the ABOYA-119 (**ATRN-119**) Phase 1/2a trial[85](index=85&type=chunk)[86](index=86&type=chunk) - Aprea anticipates releasing open-label safety/efficacy data for both **APR-1051** and **ATRN-119** in the **second half of 2025** and determining the Recommended Phase 2 Dose (RP2D) for both in the **first half of 2026**[85](index=85&type=chunk)[86](index=86&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) Net loss decreased to **$3.2 million** for Q2 2025 but increased to **$7.2 million** for the six-month period, due to lower grant revenue and higher R&D Comparison of Operations (Three Months Ended June 30) | Indicator | 2025 (USD) | 2024 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | Grant revenue | $118,111 | $561,574 | $(443,463) | | Research and development | $1,912,213 | $2,557,679 | $(645,466) | | General and administrative | $1,593,671 | $1,850,819 | $(257,148) | | Net loss | $(3,238,870) | $(3,470,052) | $231,182 | Comparison of Operations (Six Months Ended June 30) | Indicator | 2025 (USD) | 2024 (USD) | Change (USD) | | :--- | :--- | :--- | :--- | | Grant revenue | $280,574 | $942,143 | $(661,569) | | Research and development | $4,395,279 | $4,158,052 | $237,227 | | General and administrative | $3,358,650 | $3,780,685 | $(422,035) | | Net loss | $(7,171,529) | $(6,280,143) | $(891,386) | - The **$0.2 million** increase in R&D expenses for the six months ended June 30, 2025, was primarily driven by a **$0.5 million** increase in costs for the ABOYA-119 clinical trial for **ATRN-119**, partially offset by a decrease in non-program consulting expenses[121](index=121&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds **$16.5 million** in cash, insufficient for twelve months, raising going concern doubts, despite recent capital raises - The company's cash and cash equivalents were **$16.5 million** as of June 30, 2025, which is not sufficient to fund operations for at least the next twelve months[124](index=124&type=chunk)[136](index=136&type=chunk) - In March 2024, the company raised approximately **$16.0 million** in gross proceeds through a securities purchase agreement involving common stock and warrants[126](index=126&type=chunk) - During the six months ended June 30, 2025, the company sold **243,139 shares** of common stock under its At the Market (ATM) agreement, resulting in net proceeds of approximately **$0.4 million**[129](index=129&type=chunk)[134](index=134&type=chunk) - Net cash used in operating activities decreased to **$6.8 million** for the first six months of 2025, compared to **$7.6 million** for the same period in 2024, primarily due to changes in operating assets and liabilities[131](index=131&type=chunk)[132](index=132&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Market risks include interest rate sensitivity on cash and foreign currency exposure from its Swedish subsidiary, with no derivative use or material inflation impact - The primary market risk is interest income sensitivity on cash and cash equivalents, affected by U.S. interest rate changes[151](index=151&type=chunk) - The company faces foreign currency exchange rate risk from its Swedish subsidiary, Aprea AB, whose functional currency is the Swedish Krona[152](index=152&type=chunk) - The company does not believe that inflation has had a material effect on its business during the six months ended June 30, 2025[154](index=154&type=chunk) [Controls and Procedures](index=40&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting - Based on an evaluation as of June 30, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were effective[156](index=156&type=chunk) - There were no changes in internal control over financial reporting during the most recent fiscal quarter that materially affected, or are reasonably likely to materially affect, internal controls[157](index=157&type=chunk) PART II: OTHER INFORMATION [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - As of the reporting date, Aprea Therapeutics is not a party to any material legal proceedings[159](index=159&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include financial instability, high development risks for lead candidates, reliance on third parties, IP challenges, regulatory uncertainty, and stock volatility [Risks Related to Financial Position and Need for Additional Capital](index=46&type=section&id=Risks%20related%20to%20our%20financial%20position%20and%20the%20need%20for%20additional%20capital) Ongoing significant net losses, no commercial revenue, and insufficient cash raise going concern doubts, necessitating substantial additional funding - The company has incurred significant losses since inception, with a net loss of **$7.2 million** for the six months ended June 30, 2025, and an accumulated deficit of **$328.2 million**[172](index=172&type=chunk) - Management has identified conditions that raise substantial doubt about the company's ability to continue as a going concern, as its cash of **$16.5 million** is insufficient to fund operations for the next year[176](index=176&type=chunk)[178](index=178&type=chunk) - The company will need substantial additional funding to continue operations, and if unable to raise capital, it may be forced to delay, reduce, or eliminate its drug development programs[185](index=185&type=chunk)[187](index=187&type=chunk) [Risks Related to Discovery, Development, and Commercialization](index=58&type=section&id=Risks%20related%20to%20the%20discovery%2C%20development%20and%20commercialization%20of%20our%20product%20candidates) Success depends on lead candidates ATRN-119 and APR-1051, facing high development risks, unpredictable trial outcomes, patient enrollment challenges, and intense competition - The company's future success is substantially dependent on its ability to obtain marketing approval for and commercialize its two lead product candidates, **ATRN-119** and **APR-1051**[212](index=212&type=chunk) - There is a high risk of failure, as results from early-stage clinical trials may not be predictive of future results in later, larger studies[216](index=216&type=chunk)[232](index=232&type=chunk) - The company faces substantial competition from major pharmaceutical and biotechnology companies with greater financial resources and expertise in developing and marketing cancer treatments[260](index=260&type=chunk)[261](index=261&type=chunk) [Risks Related to Dependence on Third Parties](index=85&type=section&id=Risks%20related%20to%20our%20dependence%20on%20third%20parties) Aprea relies on third-party CROs for clinical trials and a single manufacturer for API, increasing supply chain risk and reducing direct control - The company relies on third parties like CROs and medical institutions to conduct its clinical trials, which reduces its control over these activities but does not relieve it of its regulatory responsibilities[289](index=289&type=chunk)[290](index=290&type=chunk) - The company is dependent on a single contract manufacturer for the API and drug product for its product candidates and does not currently have redundant supply arrangements in place[298](index=298&type=chunk)[299](index=299&type=chunk) [Risks Related to Intellectual Property](index=90&type=section&id=Risks%20related%20to%20our%20intellectual%20property) IP risks include limited patent protection for eprenetapopt and the potential for current DDR inhibitor patents to be challenged or invalidated by competitors - The chemical structure of **eprenetapopt** is in the public domain, meaning the company does not have composition of matter patents and relies on method-of-use and formulation patents, which may not prevent competitors from using the same compound for other uses[310](index=310&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk) - The company's patents could be challenged in court or before administrative bodies and be found invalid or unenforceable, which would limit its ability to stop competitors from commercializing similar products[319](index=319&type=chunk)[324](index=324&type=chunk) [Risks Related to Regulatory and Marketing Approval](index=110&type=section&id=Risks%20related%20to%20regulatory%20and%20marketing%20approval%20and%20other%20legal%20compliance%20matters) Significant risks exist in the expensive, lengthy, and uncertain regulatory approval process, with no prior approvals and ongoing compliance challenges post-approval - The company has never obtained marketing approval for a product candidate and has limited experience in conducting the clinical trials necessary to obtain such approvals[362](index=362&type=chunk)[365](index=365&type=chunk) - The marketing approval process is expensive, time-consuming, and uncertain, and regulatory authorities have substantial discretion to delay, limit, or deny approval[364](index=364&type=chunk)[366](index=366&type=chunk) - Even if a product is approved, it will be subject to extensive ongoing regulation, and failure to comply could lead to significant penalties, including withdrawal of the product from the market[276](index=276&type=chunk)[380](index=380&type=chunk) [Risks Related to Common Stock](index=141&type=section&id=Risks%20related%20to%20our%20common%20stock) Stock price volatility is expected, with significant insider ownership influencing decisions, and a risk of Nasdaq delisting impacting liquidity and price - As of June 30, 2025, executive officers, directors, and principal stockholders beneficially owned approximately **50.9%** of the common stock, giving them substantial influence over corporate matters[459](index=459&type=chunk) - The company's stock price has been and is likely to continue to be volatile due to factors such as clinical trial results, regulatory actions, and market conditions[463](index=463&type=chunk) - The company is required to meet Nasdaq's continued listing requirements and may be subject to delisting if it fails to do so, which would negatively affect the stock's price and liquidity[477](index=477&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=149&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales or repurchases occurred during the quarter or six months ended June 30, 2025, beyond prior 8-K disclosures - There were no sales of unregistered equity securities during the quarter ended June 30, 2025, other than those previously disclosed on Form 8-K[478](index=478&type=chunk) [Defaults Upon Senior Securities](index=149&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[480](index=480&type=chunk) [Mine Safety Disclosures](index=149&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[481](index=481&type=chunk) [Other Information](index=149&type=section&id=Item%205.%20Other%20Information) This item is not applicable to the company - Not applicable[482](index=482&type=chunk) [Exhibits](index=150&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including CEO/CFO certifications and Inline XBRL data files - The exhibits filed with this report include certifications from the CEO and CFO under Sections 302 and 906 of the Sarbanes-Oxley Act, as well as XBRL data files[485](index=485&type=chunk)

[Business and Clinical Update](index=1&type=section&id=Business%20and%20Clinical%20Update) Aprea Therapeutics reported positive progress in its two lead clinical programs, APR-1051 and ATRN-119, showing early clinical activity and disease control in Phase 1 trials - CEO Oren Gilad highlighted emerging data from both lead programs (APR-1051 and ATRN-119) showing evidence of clinical activity, strengthening confidence in the company's DDR (DNA Damage Response) assets[2](index=2&type=chunk) [ACESOT-1051: WEE1 inhibitor, APR-1051](index=1&type=section&id=ACESOT-1051%3A%20WEE1%20inhibitor%2C%20APR-1051) The Phase 1 trial for oral WEE1 inhibitor APR-1051 shows early disease control, with three patients achieving stable disease, expanded enrollment for HPV+ tumors, and further data expected in H2 2025 - **Three patients** achieved stable disease: one in the 70mg cohort and two in the 100mg cohort, including patients with HPV+ head and neck, rectal, and uterine cancers[1](index=1&type=chunk)[2](index=2&type=chunk) - The trial is currently enrolling patients at a **100 mg once-daily dose**, with plans to escalate to 150 mg, following a 2025 revision to optimize the therapeutic window[4](index=4&type=chunk) - Enrollment criteria expanded to include HPV+ tumors after a patient with HPV+ HNSCC showed stable disease with a **5% tumor reduction** at a 70 mg dose[4](index=4&type=chunk) - A collaboration with MD Anderson Cancer Center demonstrated potent single-agent activity of APR-1051 in head and neck cancer cell lines and significant synergy with anti-PD-1 therapies in preclinical models[5](index=5&type=chunk) - Future plans include releasing additional data in **H2 2025**, completing dose-escalation in **H1 2026**, and potentially evaluating APR-1051 in combination with checkpoint inhibitors[8](index=8&type=chunk) [ABOYA-119: ATR inhibitor, ATRN-119](index=2&type=section&id=ABOYA-119%3A%20ATR%20inhibitor%2C%20ATRN-119) The Phase 1/2a trial for ATR inhibitor ATRN-119 shows early activity with seven patients achieving stable disease, and three patients at 550 mg showing tumor shrinkage, leading to a dose reduction to 400 mg due to toxicity - In the ongoing Phase 1/2a trial, **seven patients** with advanced solid tumors demonstrated stable disease[2](index=2&type=chunk)[9](index=9&type=chunk) - **Three patients** in the 550 mg twice-daily cohort showed meaningful tumor shrinkage of **7%, 14%, and 21%**[9](index=9&type=chunk) - Dose-limiting toxicity observed in two patients at the 550 mg level led to a dose reduction to **400 mg twice daily** to optimize the therapeutic profile[9](index=9&type=chunk) - Additional safety and efficacy data are expected in **H2 2025**, with the recommended Phase 2 dose anticipated in **H1 2026**[9](index=9&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) Aprea reported a net loss of **$3.2 million** for Q2 2025, an improvement from Q2 2024, driven by decreased operating expenses, with **$16.5 million** in cash expected to fund operations into Q2 2026 [Financial Performance](index=2&type=section&id=Financial%20Performance) The company's Q2 2025 operating loss narrowed to **$3.4 million** from **$3.8 million** year-over-year, driven by reduced R&D and G&A expenses, with net loss per share improving to **$0.53** Q2 2025 vs. Q2 2024 Statement of Operations | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Operating Loss | $3.4 million | $3.8 million | Decreased | | Net Loss | $3.2 million | $3.5 million | Decreased | | Net Loss Per Share | $0.53 | $0.58 | Improved | | R&D Expenses | $1.9 million | $2.6 million | Decreased | | G&A Expenses | $1.6 million | $1.9 million | Decreased | - The decrease in R&D expenses was mainly due to higher study start-up costs in 2024 for the ACESOT-1051 trial and lower personnel costs in 2025[9](index=9&type=chunk) - The decrease in G&A expenses was primarily driven by lower professional fees, particularly legal expenses, and a reduction in personnel costs[9](index=9&type=chunk)[10](index=10&type=chunk) [Financial Position and Cash Runway](index=2&type=section&id=Financial%20Position%20and%20Cash%20Runway) As of June 30, 2025, Aprea held **$16.5 million** in cash and cash equivalents, projected to fund operations into Q2 2026 Cash and Cash Equivalents | Date | Amount | | :--- | :--- | | June 30, 2025 | $16.5 million | | December 31, 2024 | $22.8 million | - The company believes its current cash and cash equivalents are sufficient to meet operating and capital expenditure requirements into **Q2 2026**[9](index=9&type=chunk) [Corporate Information and Forward-Looking Statements](index=4&type=section&id=Corporate%20Information%20and%20Forward-Looking%20Statements) Aprea is a clinical-stage biopharmaceutical company focused on cancer treatment through targeted therapies like APR-1051 and ATRN-119, with the report including standard forward-looking statement disclaimers - Aprea's strategy is to develop treatments that exploit vulnerabilities in cancer cell mutations to kill tumors while minimizing effects on healthy cells[11](index=11&type=chunk) - The company's lead programs, **APR-1051** (WEE1 inhibitor) and **ATRN-119** (ATR inhibitor), are in clinical development for solid tumor indications[11](index=11&type=chunk) - The press release contains forward-looking statements concerning clinical trials, regulatory submissions, and financial projections, which are subject to inherent risks and uncertainties, cautioning readers against undue reliance[13](index=13&type=chunk)[14](index=14&type=chunk)

Early evidence of disease control was observed in the ongoing Phase 1 ACESOT-1051 trial, with three patients achieving stable disease in the 70 mg and 100 mg cohorts treated with the WEE1 inhibitor, APR-1051 $16.5 million in cash and cash equivalents as of June 30, 2025 DOYLESTOWN, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company developing innovative treatments that exploit specific cancer cell vulnerabili ...

Pipeline and Milestones - Aprea Therapeutics' WEE1 inhibitor (APR-1051) ACESOT-1051 Phase 1 study expects safety/efficacy data in H2 2025 and complete dose escalation in H1 2026 [7, 43] - Aprea Therapeutics' ATR inhibitor (ATRN-119) ABOYA-119 Phase 1/2a study expects safety/efficacy data in H2 2025 and Recommended Phase 2 Dose (RP2D) in H1 2026 [8, 68] - Six patients in the ATRN-119 dose escalation cohorts achieved stable disease, with three patients (50%) in the 550mg BID cohort demonstrating measurable tumor shrinkage of 7%, 14%, and 21% [53] APR-1051 (WEE1 Inhibitor) - APR-1051 is a potent WEE1 inhibitor with high selectivity, showing >150-fold, >50-fold, and >600-fold difference in IC50 compared to PLK1, PLK2, and PLK3 inhibition, respectively [31] - Clinical data cutoff on March 4, 2025, for APR-1051 (N=9) showed treatment-related adverse events, including alanine aminotransferase increased (2 patients), aspartate aminotransferase increased (2 patients), and lymphocyte count decreased (1 patient) [26] ATRN-119 (ATR Inhibitor) - ATRN-119 exhibits near-dose proportional exposure following oral administration, with AUC 0-24hr ranging from 180 ng*h/mL at 50mg to 6899 ng*h/mL at 550mg [55] - Clinical data cutoff on May 1, 2025, for ATRN-119 (N=32) showed treatment-related adverse events, including nausea (13 patients), diarrhea (12 patients), and fatigue (10 patients) [57] - ATRN-119 is the first and only macrocyclic ATR inhibitor, potentially offering increased selectivity and improved tolerability compared to first-generation acyclic structures [59, 66] Financials and Capitalization - As of March 31, 2025, Aprea Therapeutics had approximately $19.3 million in cash and equivalents [73] - Aprea Therapeutics has 5,531,373 common stock, 2,701,864 warrants, 782,243 options, and 30,607 restricted stock units outstanding as of May 14, 2025, resulting in 9,061,683 fully diluted equivalents [73]

Core Insights - Aprea Therapeutics announced promising preclinical data and an initial clinical update for APR-1051, a next-generation oral WEE1 inhibitor targeting HPV+ head and neck squamous cell carcinoma (HNSCC) [1][2] - The findings suggest that APR-1051 may provide significant differentiation in oncology, both as a single agent and in combination with checkpoint inhibitors [2] Preclinical Data - Preclinical studies conducted in collaboration with MD Anderson Cancer Center demonstrated robust antiproliferative effects of APR-1051 across various human and murine head and neck cancer cell lines, with IC₅₀ values ranging from 8.9 to 230 nM [6] - Significant anti-tumor synergy was observed when combining APR-1051 with anti–PD-1 therapies in HPV+ HNSCC models, indicating its potential for combination-based clinical trials [6] - Mechanistically, APR-1051 activates cGAS/STING-mediated immunogenic cell death and exploits the HPV E6-driven G2 checkpoint dependency in HPV+ tumors, highlighting a biomarker-driven strategy for patient selection [6] Clinical Update - In the Phase 1 ACESOT-1051 trial, a 62-year-old male patient with advanced HPV-positive oropharyngeal squamous cell carcinoma showed stable disease and a 5% tumor reduction after treatment with a subtherapeutic 70 mg oral dose of APR-1051 [7] - The patient tolerated the therapy well, with no dose-limiting toxicities reported [7] Future Development - Experts from MD Anderson Cancer Center expressed optimism regarding APR-1051 as a promising addition to the treatment portfolio for HPV-associated head and neck cancers, supported by robust preclinical data [8] - Aprea is committed to advancing APR-1051 as a precision oncology agent, leveraging biomarker insights to optimize patient outcomes [8][9] - Enrollment in the ACESOT-1051 trial is ongoing, with plans to evaluate APR-1051 in combination with checkpoint inhibitors for distinct patient populations [12]

Oncology Development - The company is focused on precision oncology through synthetic lethality, aiming to establish a pipeline of clinical and preclinical programs for cancer treatment [88]. - The lead product candidate, APR-1051, received FDA clearance for its IND application in March 2024, with the first patient enrolled in a Phase 1 study in Q2 2024 [90]. - The second product candidate, ATRN-119, is an oral small molecule inhibitor currently in a Phase 1/2a clinical trial, with safety and efficacy data expected in the second half of 2025 [91]. - The company is exploring combination therapies with other agents, such as PARP inhibitors, to enhance the therapeutic impact of its product candidates [92]. - The company has a preclinical research program in lead optimization for an undisclosed DDR target, focusing on synthetic lethality in oncology [93]. Financial Performance - Grant revenue for the three months ended March 31, 2025 was approximately $0.2 million, a decrease of 47.4% compared to $0.4 million for the same period in 2024 [125]. - Total operating expenses increased to $4.25 million for the three months ended March 31, 2025, up 20.4% from $3.53 million in the same period in 2024 [124]. - Research and development expenses rose to approximately $2.48 million for the three months ended March 31, 2025, an increase of 55.1% from $1.6 million in 2024 [126]. - Net loss for the three months ended March 31, 2025 was $3.93 million, compared to a net loss of $2.81 million for the same period in 2024, reflecting an increase of 40% [130]. - Cash and cash equivalents as of March 31, 2025 were $19.3 million, with substantial doubt about the ability to fund operations for the next twelve months [143]. - Net cash used in operating activities was $3.63 million for the three months ended March 31, 2025, a decrease of 7.7% from $3.94 million in 2024 [137]. - Foreign currency loss for the three months ended March 31, 2025 was $51,803, compared to a gain of $56,176 in 2024, indicating a change of $107,979 [128]. Future Outlook - The company anticipates completing dose escalation for APR-1051 in the first half of 2026 and determining the Recommended Phase 2 Dose for ATRN-119 in the same timeframe [90][91]. - The company expects to incur significant expenses and increasing operating losses for at least the next several years due to ongoing development activities [130]. - The company plans to seek marketing approvals for product candidates that successfully complete clinical trials and establish a commercialization infrastructure [145]. - The company requires additional financing to support ongoing operations and may rely on public or private equity, debt financings, or collaborations [147]. - There is uncertainty regarding the timing and amount of increased expenses, and the company may not achieve or maintain profitability [148]. - Developing drug products is a lengthy and costly process, and the company may not generate necessary data for marketing approval [149]. - The company currently has no committed external source of funds and may face dilution of ownership interests if additional capital is raised through equity sales [150]. - Collaborations or licensing arrangements may require the company to relinquish valuable rights to technology or future revenue streams [151]. - The company anticipates costs related to patent applications, headcount growth, and operating as a public company [152]. Risk Factors - The company is exposed to interest rate risk, but historical fluctuations in interest income have not been significant [158]. - Foreign currency exchange rate changes may affect the revenues and expenses of the company's foreign subsidiaries [159]. - The company does not currently have significant direct foreign exchange risk and has not used derivative financial instruments for hedging [160]. - Inflation has not materially affected the company's business or financial condition in the recent quarter [161].

Financial Performance - Aprea reported cash and cash equivalents of $19.3 million, down from $22.8 million as of December 31, 2024, providing runway into early Q2 2026[15]. - The company incurred an operating loss of $4.1 million for Q1 2025, compared to an operating loss of $3.1 million in Q1 2024[15]. - Aprea reported a net loss of $3.9 million ($0.66 per basic share) for Q1 2025, compared to a net loss of $2.8 million ($0.67 per basic share) in Q1 2024[15]. - Total current assets decreased to $19.8 million as of March 31, 2025, from $23.6 million as of December 31, 2024[19]. - Total stockholders' equity decreased to $15.5 million as of March 31, 2025, from $19.3 million as of December 31, 2024[19]. - Grant revenue for Q1 2025 was $162,463, a decrease of 57.4% compared to $380,569 in Q1 2024[20]. - Total operating expenses increased to $4,248,045 in Q1 2025, up 20.3% from $3,530,239 in Q1 2024[20]. - Net loss for Q1 2025 was $3,932,659, representing an increase of 40% from a net loss of $2,810,091 in Q1 2024[20]. - Net loss per share attributable to common stockholders was $0.66 in Q1 2025, slightly improved from $0.67 in Q1 2024[20]. - Weighted-average common shares outstanding increased to 5,993,866 in Q1 2025, compared to 4,198,326 in Q1 2024[20]. - Total other income decreased to $152,923 in Q1 2025, down 55% from $339,579 in Q1 2024[20]. - Interest income, net, was $204,726 in Q1 2025, a decrease of 27.7% from $283,403 in Q1 2024[20]. - The comprehensive loss for Q1 2025 was $3,932,016, compared to a comprehensive loss of $2,825,174 in Q1 2024[20]. Research and Development - Research and Development (R&D) expenses increased to $2.5 million in Q1 2025 from $1.6 million in Q1 2024, primarily due to the initiation of clinical trials for APR-1051 and ATRN-119[15]. - Aprea's ATR inhibitor, ATRN-119, showed early evidence of anti-tumor activity with tumor shrinkage of 7%, 14%, and 21% in three patients at the 550 mg twice daily dose level[2]. - The ongoing ACESOT-1051 trial for the WEE1 inhibitor APR-1051 is advancing, with patients now being dosed at 100 mg once daily, and preliminary efficacy data is expected in the second half of 2025[3]. - The recommended Phase 2 dose (RP2D) for ATRN-119 is expected to be identified in the first half of 2026, with preliminary safety and efficacy data anticipated in the second half of 2025[6]. - Aprea entered into a Material Transfer Agreement with MD Anderson Cancer Center to support preclinical research on APR-1051 for treating head and neck squamous cell carcinoma[9].

ATRN-119, our ATR inhibitor, exhibits early evidence of single agent, anti-tumor activity and is progressing toward the recommended Phase 2 dose (RP2D) in the ongoing ABOYA-119 clinical trial Three patients in the 550 mg twice daily cohort in the ongoing ABOYA-119 clinical trial demonstrated tumor shrinkage of 7%, 14% and 21% ACESOT-1051, the Phase 1 trial of WEE1 inhibitor APR-1051, continues to advance, with patients now being dosed at 100 mg once daily $19.3 million in cash and cash equivalents as of Mar ...