Clinical Trials and Research - The company plans to initiate a 60-patient clinical trial in the second half of 2026 to validate its oral insulin formulation, aiming for a cost-effective approach to regulatory submissions[26] - The ORA-D-013-1 Phase 3 trial for the oral insulin capsule did not meet its primary or secondary endpoints, leading to a strategic review and a revised Phase 3 trial submission to the FDA[90][91] - The results of the ORA-D-013-1 Phase 3 trial did not meet primary or secondary endpoints, leading to a comprehensive analysis and submission of a new protocol for a Phase 3 clinical trial to the FDA[152] - The ORA-D-013-1 trial did not meet its primary or secondary endpoints, leading to the termination of the ORA-D-013-2 Phase 3 trial[160] - Alpha Tau is conducting five concurrent FDA-approved clinical trials in the U.S. and additional trials in France, Italy, Israel, and planned studies in the UK[52] - The company reported encouraging interim data from a clinical study in Israel combining Alpha DaRT with checkpoint inhibitors for head and neck cancer patients[53] - Alpha Tau anticipates a response from Japan's Ministry of Health regarding its application for Alpha DaRT in recurrent head and neck cancer, which would be its first commercial approval outside of Israel[54] - Alpha Tau is targeting completion of patient recruitment for the ReSTART pivotal trial by Q1 2026 and expects full PMA submission by year-end 2026[58] Financial Transactions and Investments - In the 2023 Scilex Transaction, the company received a senior secured promissory note with a principal amount of $101,875,000, maturing on March 31, 2026, with an interest rate of SOFR plus 8.5%[32] - The company acquired the right to receive 4% royalties on worldwide net sales of ZTLido and related products for 10 years, in exchange for a $2,500,000 reduction in the Tranche A Note[38] - The company participated in a registered direct offering by BioXcel, acquiring shares and warrants for a total consideration of $14,000,000[46] - The company purchased 14,110,121 shares of Alpha Tau Medical Ltd. at a price of $2.612 per share, for an aggregate purchase price of approximately $36,900,000[48] - The company has the right to nominate two directors to Alpha Tau's board and will receive a non-refundable fee of $3,000,000 over three years for providing investor relations services[49] - The company has approved investments of up to $10 million in real estate assets and an additional $20 million, with investments made in various projects including the Rabi Binyamin Project and land in Mevaseret Zion, Israel[180] - The company committed to invest NIS 7,000,000 (approximately $2,185,000) in the Ruby Sapphire II Investment Fund, with NIS 1,556,493 (approximately $499,000) funded as of March 26, 2026[87] - The company has purchased 150,000 shares of Pelthos Therapeutics Inc. for $1,500,000 and currently holds 143,423 shares after selling some[57] - The company has entered into a secured promissory note with Lifeward for $3,000,000 at 15% interest, maturing on May 14, 2026[61] - Lifeward issued shares and warrants to Alpha Tau in exchange for acquiring OraTech, with revenue-sharing payments of 4% from Lifeward's ReWalk products for up to 10 years[66] - The company invested approximately $36.9 million in Alpha Tau, a clinical-stage oncology therapeutics company, with the investment's value dependent on successful clinical results and regulatory approvals[182] Market and Competitive Landscape - The diabetes market is projected to grow from approximately 589 million adults with diabetes in 2024 to 853 million by 2050, highlighting significant market potential[93] - The company faces intense competition in the diabetes treatment sector from established therapeutic options, including GLP-1 receptor agonists[122] - The biotechnology and biopharmaceutical industries are characterized by rapid technological developments and high competition, which may hinder the company's ability to compete[130] - The biotechnology industry is characterized by rapid technological developments and high competition, which may affect the company's ability to recoup R&D expenses[168] Financial Condition and Risks - The company has incurred net losses since inception and currently has only licensing revenues with no product revenues, indicating a challenging path to profitability[146] - The company expects to incur substantial expenditures related to research and development programs, which will be conducted through its strategic evaluation process[142] - The company may require substantial additional financing to implement potential strategic alternatives and continue research and development programs[144] - The company has a history of losses and cannot assure future operating results, with no products expected to be on the market for several years[146] - The company may face significant operational and financial risks if a strategic transaction is pursued, including increased expenditures and potential litigation[138] - The company may need to delay or scale back its research and development programs if adequate financing is not secured[145] - The company is dependent on third-party suppliers for raw materials and services, which poses risks to its operations[130] - The company is dependent on third-party suppliers for oral insulin capsules and lacks long-term agreements for supply[161] - The approval process for new drugs can take several months to years, with an average review lasting 18 months[116] Corporate Governance and Compliance - The company has contracted with thirteen individuals for employment or consulting arrangements, with a focus on retaining top talent[125] - The company must maintain compliance with Nasdaq listing requirements, including a minimum bid price of $1.00 per share, to avoid delisting[191] - The company has implemented anti-takeover Rights that may discourage favorable acquisitions, potentially causing substantial dilution to unauthorized acquirers[215] - Delaware law may complicate or delay changes in control or acquisitions, even if they are in the best interests of stockholders[217] - The company prioritizes cybersecurity, with measures including firewalls, intrusion detection systems, and access controls to mitigate risks[220] - The Chief Operating and Business Officer is responsible for cybersecurity protection measures and incident response[221] - The company maintains compliance programs to address potential cyber-security breaches, which could materially affect its financial position if not managed effectively[210] External Factors and Economic Conditions - The company is subject to political, economic, and military risks due to its operations in Israel, which could negatively impact its business[199] - Recent political events have led to a downgrade of Israel's credit rating from A1 to A2 in October 2023, and further to Baa1 with a negative outlook in September 2024[204] - The company is exposed to currency exchange rate fluctuations, with significant expenses in non-dollar currencies affecting financial results, particularly with the dollar's depreciation against the NIS in 2025[178] Shareholder Considerations - Stockholders may experience significant dilution if the company raises additional funds by issuing equity securities[197] - The company anticipates needing to raise capital through equity offerings, which may adversely affect the trading price of its common stock[196] - The company has outstanding 40,446,179 shares of common stock as of March 26, 2026, which could be affected by future sales from existing stockholders[189] - The company experienced a significant decline in stock price following the announcement of the ORA-D-013-1 Phase 3 trial results in January 2023[195] - The management has significant flexibility in using the net proceeds from any securities offerings, which could impact the company's future financial health[211]

Financial Performance - Net sales increased by $1,335, or 11.8%, to $12,609 for the year ended December 31, 2025, compared to $11,274 for 2024, primarily driven by increased sales from the primary customer[206] - Gross profit margin decreased to 44.6% for the year ended December 31, 2025, down from 46.2% in 2024, mainly due to rising produce costs, particularly citrus[207] - Net income for the year ended December 31, 2025, was approximately $3.5 million, a decrease of $41 from $3.6 million in 2024[205] Operating Expenses - Total operating expenses rose by $382, or 21.3%, to $2,180 for the year ended December 31, 2025, compared to $1,798 for 2024[208] - Selling, general, and administrative expenses increased by $374, or 28.8%, to $1,671 for the year ended December 31, 2025, driven by increased administrative personnel expenses in preparation for the initial public offering[209] Cash Flow and Working Capital - Working capital increased by $512, reaching approximately $2.6 million as of December 31, 2025, compared to $2.1 million in 2024[213] - Cash flows from operating activities decreased by $824, or 20.7%, to $3,150 for the year ended December 31, 2025, compared to $3,974 for 2024[217] - Net cash used in investing activities was $246 for the year ended December 31, 2025, a decrease from $684 in 2024, reflecting reduced capital spending after a significant expansion in 2024[218] Other Income and Future Funding - Total other income decreased by $79, or 48.5%, to $84 for the year ended December 31, 2025, compared to $163 in 2024[210] - The company expects to fund long-term cash requirements, including approximately $0.7 million in lease obligations, through operating cash flows and proceeds from the initial public offering in January 2026[215] Revenue Recognition and Credit Management - The Company recognizes revenue based on ASC Topic 606, with revenue recognized at the point of product delivery and customer acceptance[224] - As of December 31, 2025 and 2024, all accounts receivable were deemed fully collectible, resulting in no allowance for doubtful accounts[226] - The Company evaluates credit losses using the CECL methodology, assessing expected credit losses over the life of financial assets[227] - Credit risk is managed through customer evaluations, with management believing that credit risk is minimal and collection of receivables is probable[228] - A significant portion of revenue is derived from a limited number of customers, with no collateral required and credit policies in place to mitigate risk[229]

Product Development and Innovation - The company launched the BolaWrap® 150 in Q1 2022, a next-generation device that is smaller, lighter, and simpler to deploy than its predecessor, the BolaWrap 100, which has been phased out [27]. - The company expanded its product portfolio with the launch of WrapTactics™, a digital training platform aimed at integrating human-factors awareness and tactical proficiency [29]. - The company is investing in the development of the next-generation BolaWrap, focusing on manufacturing process improvements and design changes to reduce production costs and enhance reliability [97]. - The company is actively pursuing strategic partnerships to enhance technology integration capabilities and extend market reach [58]. - The company has acquired rights to software assets and services to enhance its Wrap Reality Cloud platform and acquired Intrensic, which includes a Body-Worn Camera and Digital Evidence Management solution [160]. Market Trends and Projections - The global non-lethal weapons market was valued at approximately $9.9 billion in 2024 and is expected to grow to approximately $19.1 billion by 2033, representing a compound annual growth rate of 7.6% [40]. - The U.S. law enforcement training market was valued at approximately $4.0 billion in 2025 and is projected to reach approximately $5.4 billion by 2032, with a compound annual growth rate of 4.5% [42]. - The global body-worn camera market was valued at approximately $2.9 billion in 2025 and is expected to reach approximately $4.1 billion by 2030, while the digital evidence management market is estimated at approximately $9.7 billion in 2025, growing to approximately $16.1 billion by 2030, with a compound annual growth rate of 10.8% [43]. - The counter-unmanned aircraft system market is projected to grow from approximately $6.6 billion in 2025 to approximately $20.3 billion by 2030, representing a compound annual growth rate of 25.1% [44]. Financial Performance and Revenue Streams - The company generates revenue through two primary streams: product sales and technology-enabled services, with a focus on expanding technology-enabled services revenue [55]. - The company reported a net loss of approximately $10.3 million for the year ended December 31, 2025, compared to a net loss of $5.9 million for 2024, primarily due to lower non-cash income and continued operating losses [110]. - A significant portion of revenue, approximately 43%, is expected to be generated from international sales in the year ending December 31, 2026 [148]. - The company anticipates fluctuations in quarterly and annual results due to various factors, which may hinder the ability to predict future operating results [206]. Regulatory and Compliance Challenges - The company continues to work with regulatory bodies to pursue reclassification of its non-lethal products, aiming to ease transfer restrictions for private security firms [45]. - The company’s products are classified as "Any Other Weapon" by the ATF, requiring compliance with federal firearms regulations [77]. - The company must obtain export licenses for its products, and compliance with U.S. export regulations could significantly affect international sales [168]. - The regulatory framework for AI technologies is rapidly changing, which may impact the company's ability to develop and commercialize AI solutions [199]. - The EU AI Act, effective from August 2, 2024, may impose additional compliance costs and affect the company's operations and financial condition [203]. Operational and Supply Chain Considerations - The company faces potential revenue volatility due to its subscription-based revenue model, which may not align with sales efforts and customer deployments [128]. - The company relies on third-party suppliers for key components, with 71% of its supply chain sourced from domestic U.S. suppliers, making it vulnerable to price increases and supply shortages [156]. - The company does not have long-term supply agreements with suppliers, increasing the risk of supply chain disruptions [158]. - Manufacturing and supply-chain challenges may arise as the company increases production capacity for new technologies [138]. Intellectual Property and Competitive Landscape - The company holds 93 issued patents and 149 pending patent applications related to non-lethal systems and digital evidence management, with expiration dates ranging from 2032 to 2047 [95]. - The law enforcement market is highly competitive, with larger companies potentially developing superior technologies that could render the company's products obsolete [192]. - The company may face substantial costs and resource diversion from potential intellectual property litigation, which could harm its operating results [187]. - Patent rights are territorial, and the company may face challenges in protecting its intellectual property rights globally, particularly in jurisdictions with weaker enforcement laws [177]. Workforce and Organizational Growth - The company employed approximately 25 full-time employees as of December 31, 2025, reflecting a 32% increase in workforce compared to the previous year, with growth concentrated in R&D, sales, and marketing [104]. - The company is committed to strengthening its domestic manufacturing footprint, having relocated to a new facility in Norton, Virginia, in September 2025 to support future growth [68]. Risks and Uncertainties - Global economic uncertainty and geopolitical conflicts may adversely affect the company's revenues and growth rates [144]. - Negative perceptions regarding privacy rights related to the company's products could harm its reputation and financial results [131]. - The company may incur substantial warranty costs due to product defects, which could adversely affect its financial position [139]. - The company faces potential delays in sales due to budgetary and political constraints affecting government agencies, which are its primary customers [155].

Financial Condition and Performance - The company has incurred significant losses and negative cash flows from operations since inception, with expectations of continued losses for the foreseeable future[46]. - The independent registered public accounting firm's report contains an explanatory paragraph regarding substantial doubt about the company's ability to continue as a going concern[46]. - As of December 31, 2025, the company had total cash and cash equivalents of $4.1 million, raising substantial doubt about its ability to continue as a going concern[60]. - The company incurred operating losses of approximately $4.8 million, $14.6 million, and $9.3 million for the years ended December 31, 2025, 2024, and 2023, respectively, with an accumulated deficit of $61.3 million as of December 31, 2025[61]. - The company expects to continue incurring losses for the foreseeable future, particularly if OcuRing™-K and PRF-110 fail in clinical trials or do not gain regulatory approval[62]. - The company will require substantial additional funding to support ongoing operations and product development, with no committed external sources of funds currently available[64]. Product Development and Regulatory Challenges - The company has not yet commercialized any products or technologies and may never become profitable[50]. - The company has limited experience in conducting and managing clinical trials necessary for obtaining regulatory approvals[50]. - The company has not received regulatory approval for its products OcuRing-K or PRF-110, and currently has no drug candidates pending approval with the FDA or other regulatory authorities[82]. - Clinical trials are subject to rigorous regulatory requirements, and delays in these trials can significantly increase costs and slow down product development[83]. - The company faces risks related to the success of its product candidates, including the need for additional clinical development and compliance with regulatory requirements[73]. - The company has scaled back research and development activities on PRF-110 after the Phase 3 clinical trial did not meet its primary endpoint, focusing instead on OcuRing™-K[72]. Market and Competitive Landscape - The market for the DeepSolar solution is new and unproven, with potential limited growth and risks associated with AI technology adoption[50]. - The company may face intense competition in the AI software market, which could hinder the development of a customer base and revenue generation[50]. - The pharmaceutical industry is highly competitive, and the company faces challenges from competitors with greater resources and experience in drug development[96]. - The company faces significant competition from established players in the solar energy market, which may hinder its ability to develop a customer base and generate revenue[142]. Operational Risks and Management - The company has identified a material weakness in internal control over financial reporting, which could impair the ability to produce timely and accurate financial statements[55]. - The company must establish effective financial and management controls to support its growth; failure to do so may lead to increased expenses and hinder revenue generation[138]. - The company is dependent on the retention of key personnel for its success, with potential negative impacts if key management is lost[78]. - The company is currently facing challenges in identifying and executing strategic alliances, which may limit future growth opportunities[193]. Legal and Compliance Issues - Regulatory compliance is critical, and failure to meet requirements could result in penalties, withdrawal of products from the market, or other enforcement actions[97]. - The company is subject to anti-bribery and anti-corruption laws, with violations potentially leading to significant penalties and adverse effects on operations[195]. - The company is subject to the Sarbanes-Oxley Act, specifically Section 404, which requires a comprehensive evaluation of internal controls over financial reporting[218]. Geopolitical and Economic Factors - The ongoing military conflict in Israel, including recent escalations, poses risks to the company's operations and financial condition due to potential disruptions and economic instability[170]. - The company faces potential material adverse effects on its business and financial condition due to political instability and hostilities in Israel, which could negatively impact operations and market share[176]. - Currency exchange rate fluctuations and inflation in Israel could materially affect the company's financial results, particularly due to costs incurred in NIS[201]. Cybersecurity and IT Risks - The company has experienced a cybersecurity incident resulting in a loss of $165,000 due to a fraudulent payment request, highlighting vulnerabilities in its IT systems[191]. - The company has not experienced any material IT system failures or cybersecurity attacks to date, but acknowledges the increasing sophistication of cyber threats[192]. Intellectual Property and Patent Issues - The company relies on a combination of patent, copyright, and trademark laws, as well as trade secrets, to protect its proprietary technology, but faces risks of infringement and piracy[152]. - The company has patent protection for PRF-110 and OcuRingTM, but its DeepSolar business lacks any patents or patent applications, which could adversely affect its competitive position[155]. - The patent prosecution process is complex and costly, and failure to maintain patent protection could lead to significant competition from similar products[157].

Financial Performance - Net sales for Q4 2025 were $30.3 million, a 5.9% increase from $28.6 million in Q4 2024[5] - Net income for Q4 2025 was $897 thousand, or $0.32 per basic share, compared to a net loss of $1,478 thousand, or $(0.54) per basic share in Q4 2024, representing a 160.7% improvement[6] - Adjusted EBITDA for Q4 2025 was $1.2 million, a significant recovery from a loss of $585 thousand in Q4 2024, marking a 305.6% increase[6] - Nortech achieved a gross profit of $5.1 million in Q4 2025, a 79.5% increase from $2.8 million in Q4 2024[5] - EBITDA for 2025 was $2.263 million, up from $1.543 million in 2024, reflecting operational improvements[17] - Adjusted EBITDA for 2025 reached $2.529 million, compared to $2.114 million in 2024, showing enhanced profitability[17] - Net loss improved to $(252) thousand in 2025 from $(1,295) thousand in 2024, indicating a positive trend in financial performance[16] Operational Metrics - The company reported a 90-day backlog of $27.3 million as of December 31, 2025, up from $26.5 million a year earlier[6] - Operating expenses increased by 2.9% to $4.2 million in Q4 2025, compared to $4.0 million in Q4 2024[5] - The company reported a gross profit margin of 15.3% in Q4 2024, which improved to 15.8% in Q4 2025[18] Financial Position - The company closed on $17.2 million in debt financing, enhancing its financial position[6] - Total assets decreased slightly to $71.919 billion in 2025 from $72.435 billion in 2024[14] - Current liabilities increased significantly to $29.844 billion in 2025 from $21.428 billion in 2024, primarily due to a new line of credit of $7 billion[14] - Cash at the end of 2025 increased to $1.655 million from $916 thousand in 2024, indicating better liquidity[16] - Accounts receivable rose to $16.998 billion in 2025 from $14.875 billion in 2024, suggesting increased sales activity[14] - Inventories decreased to $20.695 billion in 2025 from $21.638 billion in 2024, reflecting improved inventory management[14] - Proceeds from the line of credit amounted to $101.785 million in 2025, down from $129.793 million in 2024, indicating a reduction in reliance on external financing[16] Strategic Initiatives - Nortech's gross margin improved significantly, reflecting the successful execution of strategic restructuring initiatives[2] - The AS9100:D certification achieved at the Monterrey facility enhances competitiveness in aerospace and high-reliability markets[3] - The company is optimistic about future performance, supported by a strong North American and Asian footprint and a growing customer backlog[3]

Exhibit 99.1 Sanuwave Announces Record Revenues and Financial Results for Q4 and Full Year 2025 Q4 2025 revenues were $13.4 million, up 29.7% from Q4 2024. This was an all-time quarterly record for the Company. Full year 2025 revenues were $44.1 million up 35.0% from full year 2024 revenues. This was an all-time annual record for the Company. Q4 2025 gross margin was 74.7%, versus 77.9% in Q4 2024 and 77.6% in Q3 2025. Full year 2025 gross margin was 77.1% versus 75.2% in 2024. GAAP Operating Income was $2. ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 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 001-42383 Oaktree Acquisition Corp. III Life Sciences (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1799512 State or othe ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 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 001-42383 Oaktree Acquisition Corp. III Life Sciences (Exact Name of Registrant as Specified in Its Charter) Cayman Islands 98-1799512 State or othe ...

Clinical Development and Trials - Azenosertib (ZN-c3) is a clinical-stage biopharmaceutical company developing a potentially first-in-class WEE1 inhibitor for ovarian cancer, with a focus on Cyclin E1-positive platinum-resistant ovarian cancer (PROC) [23]. - The DENALI Part 2 clinical trial aims to enroll approximately 100 patients with Cyclin E1-positive PROC, with a topline readout anticipated by the end of 2026; the trial has the potential to support accelerated approval from the FDA [26]. - In January 2025, clinical data from DENALI Part 1b showed an objective response rate (ORR) of 34.9% in response-evaluable patients with Cyclin E1-positive PROC [32]. - Azenosertib is also being evaluated in combination with bevacizumab in a Phase 1b clinical trial for ovarian cancer, with ongoing patient enrollment [30]. - The company plans to initiate a Phase 3 trial (ASPENOVA) in the first half of 2026 to compare azenosertib against standard-of-care chemotherapy for Cyclin E1-positive PROC [30]. - The median duration of response (mDOR) for the intent-to-treat population in DENALI Part 1b was approximately 6.3 months as of January 13, 2025 [35]. - A total of 193 patients were involved in the ZN-c3-001 study, with a daily dose of ≥300 mg, showing a 5.2% discontinuation rate due to treatment-related adverse events [42]. - The safety profile of azenosertib showed treatment-related serious adverse events in 21.6% of patients, with common adverse events including nausea (65.7%) and fatigue (59.8%) [33]. - Patient enrollment is critical for clinical trials, and difficulties in this area could lead to significant delays or abandonment of trials [192]. Market Opportunity and Competition - The global ovarian cancer market was approximately $3 billion in 2022, with an estimated 21,500 PROC patients in the U.S. and EU4 who overexpress Cyclin E1, indicating a significant market opportunity for azenosertib [28]. - Approximately 50% of PROC patients are estimated to overexpress Cyclin E1, highlighting the unmet need for targeted therapies in this patient population [28]. - The biotechnology and pharmaceutical industries are characterized by significant competition, with potential competitors having greater financial resources and expertise [45]. - There are currently no FDA-approved WEE1 inhibitors, but several companies are evaluating various WEE1 inhibitors in clinical trials [49]. - The company faces intense competition in oncology, with numerous established and emerging companies developing similar therapies [205]. - Competitors may develop safer, more effective products, potentially reducing the company's market opportunity [208]. Regulatory Environment - Azenosertib has received Fast Track Designation from the FDA for treating PROC patients who are positive for Cyclin E1 protein levels [30]. - The FDA regulates the drug approval process, requiring substantial time and financial resources for compliance [60]. - The FDA aims to review a standard New Drug Application (NDA) within ten months from the date of filing, with a typical review taking twelve months [72]. - The FDA may issue a Complete Response Letter if the NDA/BLA has deficiencies, requiring resubmission or withdrawal of the application [75]. - Approval of an NDA/BLA may include conditions such as changes to proposed labeling or the development of Risk Evaluation and Mitigation Strategies (REMS) [76]. - The FDA offers expedited programs like Fast Track and Breakthrough Therapy Designation to facilitate the review of products addressing serious conditions [80][81]. - The FDA requires approval of companion diagnostics at the same time as therapeutic products, which may complicate the approval process for new treatments [122]. - The FDA may deny PMA approval based on application deficiencies, which could delay the approval process significantly [128]. - The FDA requires pediatric assessments for most drugs under the Pediatric Research Equity Act (PREA) unless a deferral or waiver is granted [78]. - The FDA grants orphan drug designation to products intended for rare diseases affecting fewer than 200,000 individuals in the U.S. or those with no reasonable expectation of recovering development costs [87]. Financial Performance and Projections - Zentalis incurred net losses of $137.1 million and $165.9 million for the years ended December 31, 2025, and December 31, 2024, respectively, with an accumulated deficit of $1.2 billion as of December 31, 2025 [140]. - The company has no products approved for commercial sale and has not generated any revenue from product sales to date [138]. - The company expects to continue incurring significant expenses and increasing operating losses as it advances research and development efforts for azenosertib and future product candidates [141]. - The company anticipates substantial additional capital will be required to finance operations and support the commercialization of any approved product candidates [145]. - The company does not have any committed external funding sources and may need to seek additional financing through equity offerings or collaborations, which could dilute stockholder value [148]. - The company has incurred significant costs related to the development of a companion diagnostic and may face additional unanticipated costs in the future [145]. Strategic Focus and Governance - Zentalis completed a strategic restructuring in 2025, which included a workforce reduction of approximately 40% to support late-stage development for azenosertib [131]. - The company is primarily focused on the late-stage clinical development of azenosertib following a strategic restructuring in January 2025, but long-term success may depend on developing additional product candidates [157]. - The company aims to maintain a strong governance framework, including regular employee training on data privacy and cybersecurity [136]. - The company is committed to enhancing diversity and inclusivity within its workforce and has implemented various employee development opportunities [132]. Risks and Challenges - The regulatory approval process for azenosertib is lengthy and unpredictable, and failure to obtain approval would significantly harm the company's business [161]. - The company faces risks related to the timely completion of clinical trials and the successful commercialization of azenosertib, which are essential for generating revenue [152]. - Collaborators may not commit sufficient resources to the marketing and distribution of products, which could hinder commercialization efforts [158]. - The company may need additional capital to pursue further development or commercialization of product candidates if collaborations are terminated or not successful [155]. - Changes in manufacturing methods during product development could increase costs and delay clinical trials [210]. - Product liability risks could adversely affect the company's business and financial condition if sufficient insurance coverage is not obtained [211]. - Coverage and reimbursement from third-party payors are essential for the commercialization of product candidates [212]. - The reimbursement process is time-consuming and costly, with no guarantee of consistent coverage across payors [213]. - Third-party payors are increasingly challenging drug prices and may require discounts, impacting revenue [214]. - International operations face extensive price controls and regulations, potentially limiting revenue from product candidates [215]. Manufacturing and Supply Chain - The company currently relies on third-party contract manufacturing organizations (CMOs) for the production of product candidates, with no plans to establish its own manufacturing facilities [43]. - Clinical trial supplies for azenosertib are obtained from CMOs on a purchase order basis, with no long-term supply arrangements in place [44]. - Delays in developing a sustainable manufacturing process for companion diagnostics may hinder the timely commercialization of azenosertib and future product candidates [184].

Financial Performance - Research and development expenses for the years ended December 31, 2025, and 2024 were approximately $18.3 million and $15.1 million, respectively, indicating a year-over-year increase of 15.5%[151]. - The company may face increased competition that could lead to price reductions and revenue shortfalls, impacting its financial condition and operating results[168]. - Legislative changes, such as the Budget Control Act of 2011, have reduced Medicare payments to providers, which may adversely affect revenue and commercial prospects[208]. - The overall escalating cost of medical products has led to increased pressures on the healthcare industry to reduce costs, impacting demand for products[204]. Supply Chain Management - The company has established long-term relationships with key suppliers, including Largan for lens modules (over 17 years), Toshiba for CMOS image sensors (over 11 years), and Moai/Speedbridge for ASICs (over 6 years), ensuring favorable terms and reasonable lead times[152]. - The company is actively planning mitigation measures to address supply chain risks, including qualifying backup suppliers and building reserve supplies of critical components[158]. - The company has entered into multiple memorandums of understanding and agreements with suppliers to secure critical components for its products, ensuring a stable supply chain[153][155][156]. Product Development and Innovation - CapsoCam Plus captures a full 360° panoramic video, providing superior diagnostic yield compared to competitor systems that offer limited views and require wired data recorders[162]. - CapsoCam Colon, once FDA cleared, is expected to outperform existing colorectal cancer detection methods, which suffer from poor sensitivity and high costs, with colonoscopy having only a 74% detection rate for cancer[164]. - The CapsoCloud platform allows providers to remotely access data and stream in vivo videos, enhancing workflow efficiency and patient data management[166]. - The company has developed a comprehensive intellectual property portfolio related to its capsule camera products, including over 140 issued patents worldwide as of December 31, 2025[220]. - The company is focusing on enhancing image quality with patents for image enhancement methods for dark areas of capsule images, with Patent No. 8150123 expiring on September 3, 2030[222]. - The company is actively pursuing advancements in endoscopic imaging, with multiple patents related to structured light and physiological feature size measurement, all expiring in 2035[223]. Regulatory Compliance - The FDA regulates the company's products as medical devices, requiring either 510(k) clearance or PMA approval for commercial distribution in the U.S.[171]. - The FDA's 510(k) clearance process allows devices to be marketed if deemed substantially equivalent to existing devices, while non-equivalent devices require a more rigorous PMA process[176]. - Clinical trials for medical devices must comply with FDA regulations, and significant risk devices require an IDE application before human trials can commence[181]. - Post-market regulations include stringent quality management system requirements and mandatory reporting of device-related adverse events to the FDA[186]. - Manufacturers are subject to periodic inspections by the FDA, and non-compliance with QMSR requirements can lead to production shutdowns or product recalls[187]. - The FDA has broad enforcement powers, including the ability to impose fines, withdraw approvals, or initiate criminal prosecutions for regulatory violations[188]. Competition and Market Landscape - Competitors in the market include well-established companies like Medtronic, which have significant resources and brand recognition, posing challenges for market share[161]. - Future healthcare reform measures could limit government payments for healthcare products and services, resulting in reduced demand and pricing pressure[209]. Employee Relations - As of December 31, 2025, the company had approximately 99 full-time employees, with no employees represented by a labor union[228]. - The company maintains a good relationship with its employees and focuses on recruiting, retaining, and incentivizing talent[229]. Legal and Corporate Governance - The company is not currently involved in any litigation or legal proceedings that are likely to have a material adverse effect on its business[230]. - The corporate headquarters is located at 18805 Cox Avenue, Suite 250, Saratoga, California 95070[231]. - The company provides access to its Annual Report, Quarterly Reports, and Current Reports on its website, free of charge[232]. - The SEC maintains a website that contains reports and information filed by the company electronically[232]. - The company encourages investors and the media to follow its disclosure channels for material information[233]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[570].