PART I: FINANCIAL INFORMATION Financial Statements 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 concern33 Management's Discussion and Analysis of Financial Condition and Results of Operations Analysis of financial condition and operations, noting a $16.5 million cash position insufficient for twelve months and raising going concern issues 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)838586 - 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 trial8586 - 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 20268586 Results of Operations 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 expenses121 Liquidity and Capital Resources 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 months124136 - In March 2024, the company raised approximately $16.0 million in gross proceeds through a securities purchase agreement involving common stock and warrants126 - 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 million129134 - 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 liabilities131132 Quantitative and Qualitative Disclosures About Market Risk 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 changes151 - The company faces foreign currency exchange rate risk from its Swedish subsidiary, Aprea AB, whose functional currency is the Swedish Krona152 - The company does not believe that inflation has had a material effect on its business during the six months ended June 30, 2025154 Controls and Procedures 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 effective156 - 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 controls157 PART II: OTHER INFORMATION Legal Proceedings 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 proceedings159 Risk Factors 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 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 million172 - 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 year176178 - 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 programs185187 Risks Related to Discovery, Development, and Commercialization 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-1051212 - There is a high risk of failure, as results from early-stage clinical trials may not be predictive of future results in later, larger studies216232 - The company faces substantial competition from major pharmaceutical and biotechnology companies with greater financial resources and expertise in developing and marketing cancer treatments260261 Risks Related to Dependence on Third Parties 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 responsibilities289290 - 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 place298299 Risks Related to Intellectual Property 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 uses310321322 - 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 products319324 Risks Related to Regulatory and Marketing Approval 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 approvals362365 - The marketing approval process is expensive, time-consuming, and uncertain, and regulatory authorities have substantial discretion to delay, limit, or deny approval364366 - 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 market276380 Risks Related to Common Stock 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 matters459 - 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 conditions463 - 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 liquidity477 Unregistered Sales of Equity Securities and Use of Proceeds 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-K478 Defaults Upon Senior Securities This item is not applicable to the company - Not applicable480 Mine Safety Disclosures This item is not applicable to the company - Not applicable481 Other Information This item is not applicable to the company - Not applicable482 Exhibits 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 files485
Aprea Therapeutics(APRE) - 2025 Q2 - Quarterly Report