[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1: Financial Statements](index=5&type=section&id=Item%201%3A%20Financial%20Statements) This section presents unaudited condensed consolidated financial statements for periods ended June 30, 2025, covering financial position, operations, comprehensive income, equity changes, cash flows, and detailed notes on accounting policies, investments, and segment reporting [Condensed Consolidated Statements of Financial Position](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Financial%20Position) Total assets increased to **$126.3 billion** by June 30, 2025, from **$121.2 billion** at year-end 2024, driven by investments, while total liabilities and equity also saw growth Condensed Consolidated Statements of Financial Position (Unaudited) | Account | June 30, 2025 (in millions) | December 31, 2024 (in millions) | | :--- | :--- | :--- | | **Total investments** | **$84,848** | **$80,755** | | Cash and cash equivalents | $12,104 | $11,330 | | **Total assets** | **$126,345** | **$121,221** | | Policyholders' account balances | $86,934 | $83,079 | | **Total liabilities** | **$116,128** | **$111,193** | | **Total equity** | **$10,217** | **$10,028** | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q2 2025 net income attributable to common stockholders decreased to **$141 million** from **$244 million** in Q2 2024, with H1 2025 showing a net loss of **$95 million** due to lower premiums, derivative changes, and non-recurring tax benefits Condensed Consolidated Statements of Operations (Unaudited) | Metric (in millions) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Total revenues | $2,186 | $2,115 | $4,525 | $3,785 | | Total benefits and expenses | $1,994 | $2,157 | $4,591 | $3,684 | | Net income (loss) before income taxes | $192 | $(42) | $(66) | $101 | | Income tax expense (benefit) | $38 | $(289) | $(17) | $(260) | | Net income (loss) | $154 | $247 | $(49) | $361 | | **Net income (loss) attributable to common stockholder** | **$141** | **$244** | **$(95)** | **$357** | [Condensed Consolidated Statements of Comprehensive Income](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Income) Comprehensive income attributable to the company significantly decreased to **$146 million** in Q2 2025 from **$759 million** in Q2 2024, mainly due to smaller unrealized investment gains Condensed Consolidated Statements of Comprehensive Income (Unaudited) | Metric (in millions) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Net income (loss) | $154 | $247 | $(49) | $361 | | Total other comprehensive income (loss) | $(6) | $503 | $324 | $554 | | **Comprehensive income attributable to American National Group Inc.** | **$146** | **$759** | **$270** | **$922** | [Condensed Consolidated Statements of Changes in Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) Total equity increased to **$10.22 billion** by June 30, 2025, from **$10.03 billion** at year-end 2024, driven by other comprehensive income despite a net loss and preferred stock redemptions - Total equity increased by **$189 million** during the first six months of 2025, primarily due to positive other comprehensive income of **$324 million**, which more than offset the net loss of **$49 million**[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash from operations was **$1.2 billion** for H1 2025, with **$3.1 billion** used in investing and **$2.7 billion** provided by financing, resulting in a **$774 million** net increase in cash and cash equivalents Six Months Ended June 30 Cash Flow Summary (Unaudited) | Activity (in millions) | 2025 | 2024 | | :--- | :--- | :--- | | Cash flows provided by operating activities | $1,206 | $1,377 | | Cash flows (used in) provided by investing activities | $(3,138) | $7,675 | | Cash flows provided by financing activities | $2,706 | $1,651 | | **Net change in cash and cash equivalents** | **$774** | **$10,703** | [Notes to Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed disclosures on the company's organization post-AEL merger, significant accounting policies, investment portfolios, fair value measurements, reinsurance, insurance liabilities, the AEL acquisition, segment performance, and commitments - On May 7, 2024, American National Group, LLC merged with American Equity Investment Life Holding Company (AEL), with AEL surviving and being renamed American National Group Inc. Financial statements prior to this date represent American National as the accounting acquirer[35](index=35&type=chunk)[36](index=36&type=chunk) - The company's available-for-sale fixed maturity securities portfolio grew to a fair value of **$48.9 billion** as of June 30, 2025, up from **$47.3 billion** at year-end 2024, with corporate debt securities comprising the largest portion[45](index=45&type=chunk) - The acquisition of AEL on May 2, 2024, involved a total consideration of **$4.53 billion**, resulting in the recognition of **$7.24 billion** in Value of Business Acquired (VOBA) and **$662 million** in goodwill[134](index=134&type=chunk)[140](index=140&type=chunk) - The company operates through three segments: Annuities, Property and Casualty (P&C), and Life Insurance. As of June 30, 2025, the Annuities segment held the vast majority of assets (**$112.3 billion**) and liabilities (**$102.8 billion**)[189](index=189&type=chunk)[195](index=195&type=chunk)[201](index=201&type=chunk) [Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations](index=67&type=section&id=Item%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance for Q2 and H1 2025, highlighting decreased net income due to tax changes and derivative valuations, strong annuity sales, and a solid financial condition with increased assets and liquidity [Results of Operations](index=68&type=section&id=Results%20of%20Operations) Q2 2025 net income decreased to **$152 million** from **$255 million** year-over-year, primarily due to tax expense and derivative valuations, while H1 2025 reported a net loss of **$54 million** amid declining net premiums - The decrease in Q2 2025 net income was primarily due to tax expense compared to a significant tax benefit in 2024 related to the Bermuda corporate income tax, along with increased amortization of VOBA and unfavorable movements in insurance-related derivatives[225](index=225&type=chunk) Gross Annuity Sales (in millions) | Annuity Type | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Retail | $3,622 | $3,077 | $6,546 | $3,897 | | Institutional | $662 | $272 | $1,544 | $944 | | **Total** | **$4,284** | **$3,349** | **$8,090** | **$4,841** | [Distributable Operating Earnings](index=72&type=section&id=Distributable%20Operating%20Earnings) Total Segment Distributable Operating Earnings (DOE) grew to **$408 million** in Q2 2025 from **$289 million** in Q2 2024, driven by Annuities segment growth, despite a decrease in Life Insurance DOE Segment Distributable Operating Earnings (DOE) (in millions) | Segment | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Annuities | $372 | $246 | $779 | $351 | | Life Insurance | $40 | $63 | $72 | $120 | | Property and Casualty | $(4) | $(20) | $60 | $29 | | **Total Segment DOE** | **$408** | **$289** | **$911** | **$500** | [Financial Condition](index=73&type=section&id=Financial%20Condition) Total assets increased by **$5.1 billion** to **$126.3 billion** by June 30, 2025, driven by annuity inflows and investment fair value movements, strengthening the company's financial condition - Total assets increased by **$5.1 billion** in the first half of 2025, driven by net annuity inflows, investment purchases, and favorable fair value movements on the equity securities portfolio[254](index=254&type=chunk) [Liquidity and Capital Resources](index=75&type=section&id=Liquidity%20and%20Capital%20Resources) Total liquidity increased to **$49.9 billion** by June 30, 2025, with cash and cash equivalents rising by **$774 million**, maintaining a strong capital position and compliance with NAIC RBC standards Total Liquidity (Non-GAAP, in millions) | Component | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $12,104 | $11,330 | | Liquid financial assets | $36,398 | $32,947 | | Undrawn credit facilities | $1,351 | $881 | | **Total liquidity** | **$49,853** | **$45,158** | - The company is in compliance with all capital requirements as of June 30, 2025, including the NAIC's Risk Based Capital (RBC) standards[276](index=276&type=chunk) [Item 3: Quantitative and Qualitative Disclosures About Market Risk](index=79&type=section&id=Item%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company manages primary market risks, including interest rate, foreign currency, and credit risk, through an ALM framework, diversification, derivatives, and mitigates insurance and operational risks via reinsurance and internal controls - The company's significant market risks are primarily associated with interest rates, foreign currency exchange rates, and credit risk. These are managed through an asset liability management (ALM) framework and the use of derivatives[285](index=285&type=chunk)[290](index=290&type=chunk) - Insurance risk related to mortality, longevity, and policyholder behavior is managed through underwriting and the use of reinsurance[295](index=295&type=chunk)[296](index=296&type=chunk) [Item 4: Controls and Procedures](index=82&type=section&id=Item%204%3A%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[301](index=301&type=chunk) - No material changes were made to the company's internal control over financial reporting during the quarter ended June 30, 2025[302](index=302&type=chunk) [PART II - OTHER INFORMATION](index=82&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1: Legal Proceedings](index=82&type=section&id=Item%201%3A%20Legal%20Proceedings) The company is involved in various ordinary course lawsuits, but management anticipates no material adverse effect on financial condition or results of operations from their ultimate liability - The company is a defendant in various lawsuits arising from the ordinary course of business, but management does not expect the outcomes to have a material adverse effect on its financial statements[206](index=206&type=chunk)[303](index=303&type=chunk) [Item 1A: Risk Factors](index=82&type=section&id=Item%201A%3A%20Risk%20Factors) This section refers to the detailed discussion of risk factors presented in the company's 2024 Annual Report on Form 10-K - For a discussion of factors that may affect the company's business, this report refers to the 'Risk Factors' section in the 2024 Annual Report on Form 10-K[304](index=304&type=chunk) [Item 2: Unregistered Sales of Equity Securities and Use of Proceeds](index=82&type=section&id=Item%202%3A%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or use of proceeds during the period - None reported[305](index=305&type=chunk) [Item 3: Defaults Upon Senior Securities](index=82&type=section&id=Item%203%3A%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - None reported[306](index=306&type=chunk) [Item 5: Other Information](index=82&type=section&id=Item%205%3A%20Other%20Information) No directors or officers adopted or terminated any Rule 10b5-1 trading plans or other non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted or terminated any Rule 10b5-1 trading plans during the three months ended June 30, 2025[308](index=308&type=chunk) [Item 6: Exhibits](index=83&type=section&id=Item%206%3A%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, indentures, and officer certifications required by the Sarbanes-Oxley Act - The report includes exhibits such as corporate governance documents, indentures for senior notes, and certifications from the CEO and CFO as required by Sections 302 and 906 of the Sarbanes-Oxley Act[310](index=310&type=chunk)

[PART I – FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=2&type=section&id=Item%201.%20Financial%20Statements) This section presents American Shared Hospital Services' unaudited condensed consolidated financial statements as of June 30, 2025, including balance sheets, statements of operations, shareholders' equity, and cash flows, with detailed notes on presentation basis, significant accounting policies, acquisitions, debt, leases, and other financial details Condensed Consolidated Balance Sheets Summary (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $24,433 | $26,258 | | **Total Assets** | $63,494 | $60,197 | | **Total Current Liabilities** | $20,860 | $10,405 | | **Total Liabilities** | $34,646 | $30,170 | | **Total Shareholders' Equity** | $28,848 | $30,027 | Condensed Consolidated Statements of Operations Summary (in thousands, except per share data) | | Three Months Ended June 30 | Six Months Ended June 30 | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Total Revenue** | $7,071 | $7,056 | $13,183 | $12,272 | | **Gross Profit** | $1,630 | $2,468 | $2,572 | $4,611 | | **Operating Loss** | ($544) | ($1) | ($1,843) | ($86) | | **Net (Loss) Income Attributable to ASHS** | ($280) | $3,602 | ($905) | $3,721 | | **Diluted (Loss) Earnings Per Share** | ($0.04) | $0.55 | ($0.14) | $0.57 | Condensed Consolidated Statements of Cash Flows Summary (in thousands) | | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | **Net Cash Provided by (Used in) Operating Activities** | $2,131 | ($579) | | **Net Cash Used in Investing Activities** | ($5,916) | ($2,036) | | **Net Cash Provided by Financing Activities** | $3,841 | $3,293 | | **Net Change in Cash, Cash Equivalents, and Restricted Cash** | $56 | $678 | - The company identified two reportable segments: leasing and direct patient services, with the latter expanding through the Rhode Island (RI) acquisition and operations of a new facility in Mexico[37](index=37&type=chunk)[38](index=38&type=chunk) - In Q2 2024, a net bargain purchase gain of **$3.679 million** related to the RI acquisition significantly impacted current period earnings[9](index=9&type=chunk)[86](index=86&type=chunk)[126](index=126&type=chunk) - A new tax law, the One Big Beautiful Bill Act (OBBBA), was enacted on July 4, 2025 (post-reporting period), and the company is evaluating its impact, with adjustments to be reflected in Q3 2025[88](index=88&type=chunk)[91](index=91&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q2 2025 financial performance, noting a slight increase in total revenue driven by the direct patient services segment, offsetting a decline in the leasing segment, and covers revenue drivers, cost fluctuations, RI acquisition impact, liquidity, capital resources, debt obligations, and significant new equipment commitments [Second Quarter 2025 Results](index=29&type=section&id=Second%20Quarter%202025%20Results) Total revenue for Q2 2025 remained flat year-over-year at **$7.1 million**, with direct patient services revenue increasing by **$0.343 million** offsetting a **$0.328 million** decrease in leasing revenue, resulting in a net loss of **$0.28 million** or **($0.04)** per share, contrasting sharply with Q2 2024's **$3.6 million** net income primarily due to a one-time RI acquisition bargain purchase gain recognized in the prior year Segment Revenue (in millions) | Revenue Segment | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Leasing | $3.57 | $3.90 | $6.56 | $8.15 | | Direct Patient Services | $3.50 | $3.16 | $6.62 | $4.12 | | **Total** | **$7.07** | **$7.06** | **$13.18** | **$12.27** | Key Operating Metrics (Number of Treatments) | Operating Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | PBRT Fractions | 1,114 | 1,236 | 1,945 | 2,512 | | Gamma Knife Treatments | 264 | 340 | 472 | 613 | | Radiation Therapy (RI & Puebla) | 6,320 | 2,599 | 13,046 | 2,599 | - The decline in leasing revenue was primarily due to reduced Gamma Knife and PBRT treatment volumes, partly attributable to expiring customer contracts[112](index=112&type=chunk) - Growth in direct patient services revenue was driven by the full-period contribution from RI (acquired May 2024) and the new Puebla facility in Mexico[112](index=112&type=chunk) - Net loss for Q2 2025 was **$0.28 million**, compared to a net income of **$3.602 million** in the prior-year period, with the latter including a **$3.679 million** bargain purchase gain[9](index=9&type=chunk)[130](index=130&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company held **$11.3 million** in cash, cash equivalents, and restricted cash, with working capital significantly decreasing from **$15.9 million** at year-end 2024 to **$3.6 million**, primarily due to revolving credit line utilization and increased current portion of long-term debt, though the company believes existing cash, operating cash flow, and available credit are sufficient for the next 12 months' debt and operating needs - As of June 30, 2025, total cash, cash equivalents, and restricted cash amounted to **$11.331 million**[131](index=131&type=chunk) - Working capital decreased by **$12.28 million** from December 31, 2024, to **$3.573 million**, primarily due to a **$5 million** revolving credit line draw and reclassification of long-term debt to current liabilities[132](index=132&type=chunk) - As of June 30, 2025, the company was not in compliance with its maximum financed debt to EBITDA ratio covenant but regained compliance on July 1, 2025[50](index=50&type=chunk)[137](index=137&type=chunk) [Commitments](index=35&type=section&id=Commitments) As of June 30, 2025, the company had significant commitments totaling **$8.4 million** for the purchase and installation of three Gamma Knife Esprit systems and two LINAC systems, in addition to **$11.9 million** in equipment service and maintenance commitments, with plans to finance these purchases and confidence in cash flow and available credit to cover service fees - The company has **$8.385 million** in commitments for the purchase of three Esprit systems and two LINAC systems[73](index=73&type=chunk)[145](index=145&type=chunk) - Total service and maintenance commitments for equipment amount to **$11.928 million**[75](index=75&type=chunk)[147](index=147&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company states that as of June 30, 2025, it does not hold or issue derivative instruments for trading purposes, nor does it have significant long-term market-sensitive investments, and has no exposure to entities designed to facilitate off-balance sheet financial transactions or similar arrangements - As of June 30, 2025, the company does not use derivative instruments for trading purposes and has no significant market-sensitive investments[151](index=151&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were ineffective as of June 30, 2025, due to previously disclosed material weaknesses in internal control over financial reporting, specifically the lack of a sufficient number of experienced personnel, with a remediation plan underway including hiring a new CFO and accounting manager, and internalizing outsourced billing processes - Disclosure controls and procedures were deemed ineffective as of June 30, 2025, due to material weaknesses in internal control[152](index=152&type=chunk) - The material weakness relates to the lack of a sufficient number of personnel with the necessary experience to maintain an appropriate control environment[152](index=152&type=chunk) - Remediation efforts include the appointment of a new CFO (December 2024), hiring an accounting manager (March 2025), and plans to internalize the billing cycle for the Rhode Island facility by Q4 2025[154](index=154&type=chunk) [PART II – OTHER INFORMATION](index=38&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings.) The company reported no legal proceedings during this period - The company reported no legal proceedings[158](index=158&type=chunk) [Item 1A. Risk Factors](index=38&type=page&id=Item%201A.%20Risk%20Factors) The company stated that no material changes occurred to the risk factors previously disclosed in its annual report on Form 10-K for the year ended December 31, 2024, during this reporting period - No material changes to risk factors occurred during this reporting period[159](index=159&type=chunk)

Exhibit 99.1 Brazil Potash Corp. CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS For the six months ended June 30, 2025 and 2024 – Stated in United States ("U.S.") dollars – Unaudited Brazil Potash Corp. Condensed Interim Consolidated Statements of Financial Position (Expressed in U.S. dollars) (Unaudited) | | June 30, | December 31, | | --- | --- | --- | | As at: | 2025 | 2024 | | ASSETS | | | | Current | | | | Cash and cash equivalents | $ 8,546,279 | $ 18,861,029 | | Amounts receivable (Note 3) | 470 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-41293 ASPIRE BIOPHARMA HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 33-3467744 (State or other jurisd ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No. 001-41293 ASPIRE BIOPHARMA HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 33-3467744 (State or other jurisd ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 3525 Del Mar Heights Rd., #322, San Diego, CA 92130 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, 2025 ☐ 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: 001-40739 DERMATA THERAPEUTICS, INC. (Exact name of registrant as spec ...

[PART I FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements of Akari Therapeutics, Plc for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheets (Amounts in thousands) | ASSETS | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash | $2,711 | $2,599 | | Total current assets | $3,301 | $2,952 | | Goodwill | $8,430 | $8,430 | | Other intangible assets | $39,180 | $39,180 | | Total assets | $50,911 | $50,562 | | LIABILITIES AND SHAREHOLDERS' EQUITY | | | | Accounts payable | $11,607 | $12,407 | | Accrued expenses | $2,468 | $3,137 | | Total current liabilities | $17,138 | $19,910 | | Total liabilities | $25,306 | $28,333 | | Total shareholders' equity | $25,605 | $22,229 | | Total liabilities and shareholders' equity | $50,911 | $50,562 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Condensed Consolidated Statements of Operations and Comprehensive Loss (Amounts in thousands) | Operating Expenses | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $667 | $3,314 | $1,480 | $5,593 | | General and administrative | $2,452 | $2,241 | $5,164 | $4,907 | | Merger-related costs | $0 | $254 | $0 | $1,298 | | Restructuring and other costs | $0 | $1,640 | $0 | $1,640 | | Loss from operations | $(3,119) | $(7,449) | $(6,644) | $(13,438) | | Total other income (expense), net | $1,224 | $(109) | $1,044 | $314 | | Net loss | $(1,895) | $(7,558) | $(5,600) | $(13,124) | | Net loss per share –– basic and diluted | $(0.00) | $(0.00) | $(0.00) | $(0.00) | | Total comprehensive loss | $(2,228) | $(7,546) | $(5,968) | $(12,833) | [Condensed Consolidated Statements of Shareholders' Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity%20(Deficit)) Condensed Consolidated Statements of Shareholders' Equity (Deficit) (Amounts in thousands) | Item | Balance, Dec 31, 2024 | Issuance of share capital related to financing, net of issuance costs | Stock-based compensation | Foreign currency translation | Net loss | Balance, June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Share Capital $0.0001 par value (Amount) | $5,319 | $457 (Mar 31) + $575 (Jun 30) | — | — | — | $6,523 | | Additional Paid-in Capital | $212,706 | $1,785 (Mar 31) + $3,829 (Jun 30) | $1,015 (Mar 31) + $719 (Jun 30) | — | — | $220,846 | | Capital Redemption Reserve | $52,194 | — | — | — | — | $52,194 | | Accumulated Other Comprehensive Loss | $(738) | — | — | $(35) (Mar 31) + $(333) (Jun 30) | — | $(1,106) | | Accumulated Deficit | $(247,252) | — | — | — | $(3,705) (Mar 31) + $(1,895) (Jun 30) | $(252,852) | | Total Shareholders' Equity | $22,229 | $2,242 (Mar 31) + $4,404 (Jun 30) | $1,015 (Mar 31) + $719 (Jun 30) | $(35) (Mar 31) + $(333) (Jun 30) | $(3,705) (Mar 31) + $(1,895) (Jun 30) | $25,605 | - **Total shareholders' equity increased** from $22,229 thousand at December 31, 2024, to **$25,605 thousand at June 30, 2025**, primarily due to issuance of share capital related to financing and stock-based compensation, partially offset by net loss and foreign currency translation adjustments[24](index=24&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Condensed Consolidated Statements of Cash Flows (Amounts in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,406) | $(8,938) | | Net cash provided by financing activities | $5,514 | $9,277 | | Effect of exchange rates on cash | $4 | $(7) | | Net change in cash | $112 | $332 | | Cash and restricted cash at beginning of period | $2,659 | $3,845 | | Cash and restricted cash at end of period | $2,771 | $4,177 | - Net cash used in operating activities **decreased by $3,532 thousand** (from $(8,938) thousand in 2024 to $(5,406) thousand in 2025) for the six months ended June 30, primarily due to reduced R&D and restructuring costs[28](index=28&type=chunk)[193](index=193&type=chunk) - Net cash provided by financing activities **decreased by $3,763 thousand** (from $9,277 thousand in 2024 to $5,514 thousand in 2025) for the six months ended June 30, reflecting lower proceeds from share issuances and convertible notes[28](index=28&type=chunk)[198](index=198&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) [Note 1. Description of Business](index=11&type=section&id=Note%201.%20Description%20of%20Business) - Akari Therapeutics, Plc is developing next-generation antibody-drug conjugates (ADCs) through its proprietary technology platform, focusing on novel payloads to target a range of cancers[30](index=30&type=chunk) - The company completed a strategic business combination with Peak Bio, Inc in November 2024, shifting its focus to the ADC platform utilizing a novel anti-cancer payload called PH1[30](index=30&type=chunk)[31](index=31&type=chunk) - Akari has incurred substantial losses and negative cash flows since inception, with an **accumulated deficit of $252.9 million** as of June 30, 2025, raising substantial doubt about its ability to continue as a going concern[37](index=37&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=13&type=section&id=Note%202.%20Summary%20of%20Significant%20Accounting%20Policies) - The unaudited condensed consolidated financial statements are prepared in accordance with U.S GAAP for interim financial information and SEC rules, reflecting management's estimates and assumptions[34](index=34&type=chunk)[35](index=35&type=chunk) - No new accounting pronouncements issued or effective in the first six months of 2025 are expected to have a material impact on the financial statements[40](index=40&type=chunk) [Note 3. Agreement and Plan of Merger](index=13&type=section&id=Note%203.%20Agreement%20and%20Plan%20of%20Merger) - On November 14, 2024, Akari completed the acquisition of Peak Bio, issuing 12,613,942 Akari ADSs to Peak Bio shareholders, representing approximately **48.4% of Akari's outstanding shares** on a fully diluted basis[30](index=30&type=chunk)[41](index=41&type=chunk) Total Consideration Paid for Peak Bio Acquisition (in thousands) | Item | Consideration | | :--- | :--- | | Company ADSs issued to Peak Bio Inc shareholders | $28,129 | | Company ADSs issuable on exercise of November 2022 Peak Investor Warrants and April 2023 Peak Investor Warrants | $1,844 | | Total consideration | $29,973 | Fair Values of Assets Acquired and Liabilities Assumed (in thousands) | Assets Acquired | Amount | | :--- | :--- | | Cash and restricted cash | $382 | | Prepaid expenses and other current assets | $10 | | Acquired in-process research and development | $39,180 | | Total assets acquired | $39,572 | | Liabilities Assumed | Amount | | Accounts payable and accrued expenses | $6,979 | | Convertible notes | $700 | | Notes payable | $659 | | Notes payable, related party | $1,651 | | Deferred tax liability | $8,040 | | Total liabilities assumed | $18,029 | | Goodwill | $8,430 | | Net assets acquired | $29,973 | - The acquisition resulted in the recognition of **$39.2 million in IPR&D intangible assets** (AKTX-101: $34.0 million, PHP-303: $5.18 million) and **$8.4 million in goodwill**[48](index=48&type=chunk)[50](index=50&type=chunk) [Note 4. Fair Value Measurements](index=16&type=section&id=Note%204.%20Fair%20Value%20Measurements) Fair Value of Warrant Liabilities (in thousands) | Warrant Liability | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | November 2022 Peak Warrants | $63 | $95 | | April 2023 Peak Warrants | $689 | $736 | | September 2022 Series B Warrants | $114 | $181 | | Total liabilities | $866 | $1,012 | - The fair value of warrant liabilities **decreased from $1,012 thousand** at December 31, 2024, to **$866 thousand at June 30, 2025**, primarily due to a decrease in the Company's stock price during the reporting period[53](index=53&type=chunk)[164](index=164&type=chunk) - All liability-classified warrants (November 2022 Peak, April 2023 Peak, and September 2022 Series B) are **Level 3 measurements**, determined using the Black-Scholes Option Pricing Model with unobservable inputs[53](index=53&type=chunk)[55](index=55&type=chunk) [Note 5. Accrued Expenses](index=17&type=section&id=Note%205.%20Accrued%20Expenses) Accrued Expenses (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Employee compensation and benefits | $775 | $473 | | External research and development expenses | $134 | $178 | | Professional and consulting fees | $1,249 | $1,305 | | Restructuring | $50 | $450 | | Other | $260 | $731 | | Total accrued expenses | $2,468 | $3,137 | - Total accrued expenses **decreased from $3,137 thousand** at December 31, 2024, to **$2,468 thousand at June 30, 2025**, driven by reductions in restructuring accruals and other liabilities[57](index=57&type=chunk) [Note 6. Convertible Notes and Notes Payable](index=17&type=section&id=Note%206.%20Convertible%20Notes%20and%20Notes%20Payable) - The Company assumed several notes from Peak Bio in November 2024, including the September 2024 Note ($0.2 million outstanding at June 30, 2025) and the April 2023 Convertible Notes (**$0.7 million outstanding and in default** at June 30, 2025)[58](index=58&type=chunk)[59](index=59&type=chunk)[63](index=63&type=chunk) - The November 2023 Note ($0.4 million principal) was settled for $325,000 on March 6, 2025, resulting in a gain on debt extinguishment[60](index=60&type=chunk)[61](index=61&type=chunk) [Note 7. Shareholders' Equity (Deficit)](index=19&type=section&id=Note%207.%20Shareholders'%20Equity%20(Deficit)) - Shareholders approved an increase in authorized ordinary shares to 330,854,276,210 as of June 30, 2025[67](index=67&type=chunk) - In March and April 2025, the Company completed a private placement, issuing 4,942,626 ADSs (or pre-funded warrants) and various Series A and Series B warrants, generating approximately **$5.6 million in net proceeds** (net of $1.0 million note termination)[69](index=69&type=chunk)[71](index=71&type=chunk)[72](index=72&type=chunk) Outstanding Warrant ADSs | Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Equity-classified Warrants | 23,253,769 | 6,788,070 | | Liability-classified Warrants | 3,284,272 | 3,519,566 | | Total outstanding warrants | 26,538,041 | 10,307,636 | - Total outstanding warrants **increased significantly from 10,307,636** at December 31, 2024, to **26,538,041 at June 30, 2025**, primarily due to new issuances in the March/April 2025 private placement[75](index=75&type=chunk)[76](index=76&type=chunk) [Note 8. Stock-Based Compensation](index=21&type=section&id=Note%208.%20Stock-Based%20Compensation) Stock Option ADSs Activity (Six Months Ended June 30, 2025) | Item | Number of Stock Option ADSs | Weighted Average Exercise Price per ADS | | :--- | :--- | :--- | | Outstanding at December 31, 2024 | 1,981,982 | $8.21 | | Granted | 5,391,336 | $1.49 | | Forfeited | (87,130) | $26.50 | | Expired | (116,569) | $20.78 | | Outstanding at June 30, 2025 | 7,169,619 | $2.73 | | Exercisable at June 30, 2025 | 1,041,615 | $8.38 | Total Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $184 | $13 | $375 | $56 | | General and administrative | $535 | $147 | $1,359 | $400 | | Restructuring and other costs | $0 | $285 | $0 | $285 | | Total stock-based compensation expense | $719 | $445 | $1,734 | $741 | - Total stock-based compensation expense **increased significantly to $1,734 thousand** for the six months ended June 30, 2025, from $741 thousand in the prior year, primarily due to increased grants and non-cash compensation[84](index=84&type=chunk) - As of June 30, 2025, unrecognized compensation cost for unvested stock options was **$5.6 million**, expected to be recognized over a weighted average period of 2.8 years[85](index=85&type=chunk) [Note 9. Net Loss per Share](index=23&type=section&id=Note%209.%20Net%20Loss%20per%20Share) Potential Dilutive Securities Excluded from Diluted Net Loss per Share Calculation | Security Type | As at June 30, 2025 (Ordinary Shares) | As at June 30, 2024 (Ordinary Shares) | | :--- | :--- | :--- | | Stock options | 14,339,239,000 | 351,934,688 | | Restricted stock units | — | 251,823,915 | | Warrants | 49,679,308,000 | 13,191,074,600 | | Convertible notes | 749,192,000 | 1,257,860,000 | | Total | 64,767,739,000 | 15,052,693,203 | - All potential dilutive securities were excluded from diluted net loss per share calculations for both periods due to their **anti-dilutive impact**[86](index=86&type=chunk) [Note 10. Income Taxes](index=23&type=section&id=Note%2010.%20Income%20Taxes) - The Company recorded **no tax expense or benefit** for the three and six months ended June 30, 2025 and 2024, due to expected current year losses and historical losses[87](index=87&type=chunk) - A **full valuation allowance** is maintained against all deferred tax assets as of June 30, 2025, and December 31, 2024, as management has determined that it is not more likely than not that the Company will realize these future tax benefits[87](index=87&type=chunk) [Note 11. Segment Information](index=23&type=section&id=Note%2011.%20Segment%20Information) - The Company operates as a **single operating segment**, with the CEO serving as the Chief Operating Decision Maker (CODM), reviewing consolidated financial information and net loss to allocate resources[88](index=88&type=chunk)[91](index=91&type=chunk) - Akari has **not generated any revenue since inception** and primarily incurs expenses in research and development of pre-clinical product candidates (next-generation precision bifunctional ADCs for cancer) and general and administrative costs[89](index=89&type=chunk) [Note 12. Related Party Transactions](index=24&type=section&id=Note%2012.%20Related%20Party%20Transactions) - Dr Samir Patel, former Interim CEO, received non-cash stock-based compensation (NQSOs) and accrued professional fees for his services[95](index=95&type=chunk)[96](index=96&type=chunk) - The Company assumed notes payable to Dr Hoyoung Huh (Chairman) from the Peak Bio acquisition, including 2021 Notes and a January 2024 Note; **$1.0 million of these notes were cancelled** and extinguished in connection with the March 2025 Private Placement for ordinary shares and warrants[97](index=97&type=chunk)[99](index=99&type=chunk)[101](index=101&type=chunk) - May 2024 Convertible Notes with Dr Ray Prudo and Dr Samir Patel for $1.0 million were partially repaid in cash ($750,000) and partially converted into ADSs ($250,000 principal and accrued interest) in October 2024[103](index=103&type=chunk) [Note 13. Commitments and Contingencies](index=26&type=section&id=Note%2013.%20Commitments%20and%20Contingencies) - The Company leases office and laboratory space on a short-term basis, incurring less than $0.1 million in lease costs for the three and six months ended June 30, 2025[107](index=107&type=chunk)[108](index=108&type=chunk) - Under the Bayer Acquisition Agreement (assumed in November 2024), Akari is committed to pay up to **$23.5 million in development and regulatory milestones** and high single-digit royalties for PHP-303, with no expenses incurred to date[111](index=111&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) - Legal proceedings include a claim for discretionary bonuses from a former Peak Bio employee, and settlements with former consultants totaling $0.4 million, leading to the issuance of 251,822,000 ordinary shares[115](index=115&type=chunk)[116](index=116&type=chunk) - A lawsuit with 'Sabby' Volatility Warrant Master Fund Ltd was settled in May 2025, with Akari agreeing to issue 272,450 ADSs (544,900,000 ordinary shares)[117](index=117&type=chunk) - The Company recognized a **$1.2 million gain on settlement** of current liabilities with a former vendor during the six months ended June 30, 2025[118](index=118&type=chunk)[161](index=161&type=chunk) [Note 14. Restructuring](index=27&type=section&id=Note%2014.%20Restructuring) - In May 2024, the Company implemented a reduction-in-force (RIF) of approximately **67% of its workforce** and suspended the nomacopan HSCT-TMA program, completing the restructuring plan in Q3 2024[120](index=120&type=chunk) Restructuring Reserve and Activity (in thousands) | Category | Balance at Dec 31, 2024 | Restructuring adjustment | Cash payments | Balance at June 30, 2025 | | :--- | :--- | :--- | :--- | :--- | | Severance and Employee Benefit Costs | $450 | $(50) | $(350) | $50 | [Note 15. Subsequent Events](index=28&type=section&id=Note%2015.%20Subsequent%20Events) - In August 2025, the Company entered into Note Purchase Agreements with certain investors and directors for a private placement of unsecured promissory notes totaling **$3 million** (aggregate principal $3.8 million), with a 20% original issuance discount, expected to close in two tranches in August and September 2025[122](index=122&type=chunk)[217](index=217&type=chunk) - The Chairman, Dr Hoyoung Huh, agreed to purchase a $1.25 million note for $1.0 million, satisfied by cancelling $837,433 of outstanding debt and $162,567 in cash[122](index=122&type=chunk)[217](index=217&type=chunk) - Series A Warrants previously issued in the March 2025 Private Placement will have their expiration date extended from 2026 to 2030 for certain August 2025 Note Investors[122](index=122&type=chunk)[217](index=217&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Akari's financial condition and operational results, highlighting the strategic shift to an ADC platform and recent financing activities [Overview](index=29&type=section&id=Overview) - Akari is an oncology company focused on developing next-generation antibody-drug conjugates (ADCs) using novel proprietary cancer-killing toxins (payloads), aiming to improve efficacy and safety[125](index=125&type=chunk) - The lead product candidate, AKTX-101, is a pre-clinical stage Trop2-targeting ADC combining the novel PH1 payload (spliceosome modulator) with the Trop2 antibody, targeting various solid tumors[127](index=127&type=chunk) - Following the Peak Bio acquisition in November 2024, Akari has **suspended internal development of legacy programs** (nomacopan and PAS-nomacopan) and PHP-303, focusing efforts on the ADC platform and seeking external partners for legacy assets[130](index=130&type=chunk) [Recent Developments](index=30&type=section&id=Recent%20Developments) - In August 2025, the Company entered into Note Purchase Agreements for a private placement of unsecured promissory notes totaling **$3 million** (aggregate principal $3.8 million), with a 20% original issuance discount[133](index=133&type=chunk) - Mr Abizer Gaslightwala was appointed President and Chief Executive Officer, effective April 21, 2025, with compensation including base salary, annual cash bonus, and share-based payments[135](index=135&type=chunk) - The March 2025 Private Placement generated approximately **$5.6 million in net proceeds**, involving the issuance of ADSs, pre-funded warrants, and Series A and B warrants[136](index=136&type=chunk)[139](index=139&type=chunk) - The Company completed a portfolio prioritization review in May 2024, suspending the nomacopan HSCT-TMA program and pre-clinical PAS-nomacopan program to focus on Peak Bio's ADC platform technology[140](index=140&type=chunk) - A reduction-in-force (RIF) of approximately **67% of the total workforce** was implemented in May 2024 as part of an operational restructuring plan[141](index=141&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Operating Expenses and Net Loss (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $667 | $3,314 | $1,480 | $5,593 | | General and administrative | $2,452 | $2,241 | $5,164 | $4,907 | | Merger-related costs | $0 | $254 | $0 | $1,298 | | Restructuring and other costs | $0 | $1,640 | $0 | $1,640 | | Total operating expenses | $3,119 | $7,449 | $6,644 | $13,438 | | Loss from operations | $(3,119) | $(7,449) | $(6,644) | $(13,438) | | Net loss | $(1,895) | $(7,558) | $(5,600) | $(13,124) | - **Loss from operations decreased by 58%** to $3.1 million for Q2 2025 (from $7.4 million in Q2 2024) and by **51% to $6.6 million** for H1 2025 (from $13.4 million in H1 2024)[144](index=144&type=chunk) - **Research and development expenses decreased by 80%** ($2.6 million) for Q2 2025 and **74%** ($4.1 million) for H1 2025, primarily due to the suspension of legacy programs (nomacopan and PHP-303) and prioritization of the ADC platform[146](index=146&type=chunk) - General and administrative costs increased by 9% ($0.2 million) for Q2 2025 and 5% ($0.3 million) for H1 2025, mainly due to higher non-cash stock-based compensation, partially offset by lower insurance premiums and cash-based salaries[153](index=153&type=chunk)[154](index=154&type=chunk) - Merger-related costs and restructuring costs were zero for Q2 and H1 2025, compared to $0.3 million and $1.6 million respectively in Q2 2024, reflecting the completion of the merger and restructuring activities[155](index=155&type=chunk)[156](index=156&type=chunk) - A **gain on settlement of current liabilities of $1.2 million** was recognized in both Q2 and H1 2025, primarily from a settlement with a former vendor and a debt extinguishment[160](index=160&type=chunk)[161](index=161&type=chunk) - **Net loss decreased to $1.9 million** for Q2 2025 (from $7.6 million in Q2 2024) and to **$5.6 million** for H1 2025 (from $13.1 million in H1 2024)[168](index=168&type=chunk) [Financial Condition, Liquidity and Capital Resources](index=37&type=section&id=Financial%20Condition,%20Liquidity%20and%20Capital%20Resources) - As of June 30, 2025, the Company had **$2.7 million in cash** and an **accumulated deficit of $252.9 million**, with existing cash and committed funds from the August 2025 Financing sufficient to fund operations only into October 2025[170](index=170&type=chunk)[187](index=187&type=chunk) - The Company has incurred substantial losses and negative cash flows since inception and will require significant additional financing to fund future operations, raising **substantial doubt about its ability to continue as a going concern**[170](index=170&type=chunk)[172](index=172&type=chunk)[191](index=191&type=chunk) - Future capital requirements depend on factors such as R&D progress, merger integration costs, clinical trial scope, revenues from licensing, operational infrastructure expansion, regulatory approval costs, and intellectual property protection[171](index=171&type=chunk)[173](index=173&type=chunk) - **Net cash used in operating activities decreased to $(5.4) million** for the six months ended June 30, 2025, from $(8.9) million in the prior year, primarily due to reduced R&D and restructuring costs[193](index=193&type=chunk) - **Net cash provided by financing activities was $5.5 million** for the six months ended June 30, 2025, primarily from the March 2025 Private Placement ($5.9 million net proceeds) and pre-funded warrants ($0.3 million), offset by debt repayments[198](index=198&type=chunk) - Debt obligations assumed from the Peak Bio Merger are expected to result in approximately **$1.6 million in principal payments** as of June 30, 2025[196](index=196&type=chunk) [Critical Accounting Estimates](index=43&type=section&id=Critical%20Accounting%20Estimates) - Key critical accounting estimates include stock-based compensation, fair value of warrants classified as liabilities, research and development prepayments/accruals, income taxes, and intangible assets impairment[199](index=199&type=chunk) - There have been **no material changes** to critical accounting policies and estimates since December 31, 2024[200](index=200&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=43&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Akari Therapeutics, Plc is not required to provide detailed quantitative and qualitative disclosures about market risk - Akari Therapeutics, Plc is a **smaller reporting company** and is exempt from providing detailed quantitative and qualitative disclosures about market risk[201](index=201&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) This section addresses the effectiveness of Akari's disclosure controls and procedures, noting that material weaknesses identified in the previous annual report persist - Management concluded that internal control over financial reporting was **not effective** as of December 31, 2024, due to material weaknesses, and disclosure controls and procedures were not effective as of June 30, 2025[203](index=203&type=chunk)[205](index=205&type=chunk) - Remediation efforts to address the material weaknesses have not yet commenced but are expected to begin in Q3 2025 and continue through fiscal year 2025[204](index=204&type=chunk)[206](index=206&type=chunk) - No changes in internal control over financial reporting occurred during the fiscal quarter ended June 30, 2025, that materially affected or are reasonably likely to materially affect internal control over financial reporting[208](index=208&type=chunk) [PART II OTHER INFORMATION](index=45&type=section&id=PART%20II%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) This section refers to the legal proceedings detailed in the notes to the financial statements, indicating routine litigation may arise from normal business operations - The Company may become involved in routine litigation related to claims arising out of normal business operations[210](index=210&type=chunk) - Specific legal proceedings and settlements are detailed in Note 13 of the financial statements[210](index=210&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) This section advises investors to consider the risks outlined in the company's Annual Report on Form 10-K, noting no material changes to these risk factors - Investing in Akari's securities involves a **high degree of risk**, and investors should review the risk factors in the Annual Report on Form 10-K[211](index=211&type=chunk) - There have been **no material changes** to the risk factors previously disclosed in the Form 10-K[212](index=212&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section states there were no unregistered sales of equity securities during the period other than those previously disclosed in a Current Report on Form 8-K - No unregistered sales of equity securities occurred during the three and six months ended June 30, 2025, beyond those previously reported in a Form 8-K[213](index=213&type=chunk) [Item 3. Defaults Upon Senior Securities](index=45&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section confirms that there were no defaults upon senior securities during the reporting period - There were **no defaults** upon senior securities[214](index=214&type=chunk) [Item 4. Mine Safety Disclosures](index=45&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that there are no mine safety disclosures to report - No mine safety disclosures are applicable or required[215](index=215&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) This section details the August 2025 Financing, including the issuance of unsecured promissory notes and the amendment of Series A Warrants - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the fiscal quarter[216](index=216&type=chunk) - In August 2025, the Company entered into Note Purchase Agreements for a private placement of unsecured promissory notes totaling approximately **$3 million** (aggregate principal $3.8 million), with a 20% original issuance discount[217](index=217&type=chunk) - The Chairman, Dr Hoyoung Huh, purchased a $1.25 million note for $1.0 million, satisfied by cancelling $837,433 of outstanding debt and $162,567 in cash[217](index=217&type=chunk) - Series A Warrants from the March 2025 Private Placement will have their expiration date **extended from 2026 to 2030** for certain August 2025 Note Investors[217](index=217&type=chunk) [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including merger agreements, incentive plan amendments, and certifications - Exhibits include the Agreement and Plan of Merger, Amendment No 2 to the 2023 Equity Incentive Plan, Form of August 2025 Note Purchase Agreement, Form of 20% Original Issue Discount Promissory Note, Form of Amendment No 1 to Series A Warrant, and various certifications[221](index=221&type=chunk) [SIGNATURES](index=48&type=section&id=SIGNATURES) - The report is signed by Abizer Gaslightwala, President and Chief Executive Officer, and Torsten Hombeck, Ph.D, Chief Financial Officer, on August 13, 2025[225](index=225&type=chunk)

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This section presents Vivani Medical, Inc.'s unaudited condensed consolidated financial statements and related disclosures [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents Vivani Medical, Inc.'s unaudited condensed consolidated financial statements and detailed notes for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) This section presents Vivani Medical, Inc.'s condensed consolidated balance sheets, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 **Condensed Consolidated Balance Sheet Highlights (in thousands):** | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------- | :------------ | :---------------- | | Cash and cash equivalents | $6,794 | $18,352 | | Total current assets | $8,715 | $20,442 | | Total assets | $28,905 | $41,561 | | Total current liabilities | $6,716 | $5,986 | | Total liabilities | $23,995 | $23,951 | | Total stockholders' equity | $4,910 | $17,610 | [Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This section presents Vivani Medical, Inc.'s condensed consolidated statements of operations, detailing revenues, expenses, and net loss for the specified periods **Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data):** | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development, net of grants | $4,759 | $3,513 | $8,976 | $7,239 | | General and administrative, net of grants | $2,703 | $2,168 | $5,044 | $4,669 | | Total operating expenses | $7,462 | $5,681 | $14,020 | $11,908 | | Net loss | $(7,144) | $(5,356) | $(13,446) | $(11,395) | | Net loss per common share - basic and diluted | $(0.12) | $(0.10) | $(0.23) | $(0.21) | [Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2025 and 2024](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This section presents Vivani Medical, Inc.'s condensed consolidated statements of comprehensive loss, including net loss and other comprehensive income items **Condensed Consolidated Statements of Comprehensive Loss Highlights (in thousands):** | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(7,144) | $(5,356) | $(13,446) | $(11,395) | | Foreign currency translation adjustments | $39 | $(25) | $33 | $(77) | | Comprehensive loss | $(7,105) | $(5,381) | $(13,413) | $(11,472) | [Condensed Consolidated Statements of Stockholders' Equity for each three month period ended during the six months ended June 30, 2025 and 2024](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20each%20three%20month%20period%20ended%20during%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This section presents Vivani Medical, Inc.'s condensed consolidated statements of stockholders' equity, detailing changes in equity components for the specified periods **Condensed Consolidated Statements of Stockholders' Equity Highlights (in thousands):** | Metric | Balance, January 1, 2025 ($) | Balance, June 30, 2025 ($) | | :-------------------------- | :----------------------- | :--------------------- | | Common Stock (Amount) | $6 | $6 | | Additional Paid-in Capital | $139,480 | $140,193 | | Accumulated Other Comprehensive Income | $48 | $81 | | Accumulated Deficit | $(121,924) | $(135,370) | | Total Stockholders' Equity | $17,610 | $4,910 | [Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) This section presents Vivani Medical, Inc.'s condensed consolidated statements of cash flows, detailing cash movements from operating, investing, and financing activities **Condensed Consolidated Statements of Cash Flows Highlights (in thousands):** | Metric | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :----------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(11,250) | $(9,313) | | Net cash used in investing activities | $(76) | $(219) | | Net cash (used in) provided by financing activities | $(265) | $13,799 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(11,558) | $4,265 | | Cash, cash equivalents and restricted cash balance at end of period | $8,132 | $26,257 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures for the condensed consolidated financial statements, covering accounting policies, equity, debt, and contingencies [Note 1. Organization and Business Operations](index=8&type=section&id=Note%201.%20Organization%20and%20Business%20Operations) This note describes Vivani Medical, Inc.'s core business, product pipeline, and recent corporate developments, including the Cortigent spin-off - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company developing miniature, ultra long-acting subdermal drug implants using its proprietary NanoPortal™ technology to treat chronic diseases by improving medication adherence and tolerability[23](index=23&type=chunk)[24](index=24&type=chunk) - The company's lead program, NPM-139 (semaglutide implant), is in development for chronic weight management, showing encouraging preclinical data with approximately **20% maintained weight loss over six months** and potential for annual dosing[25](index=25&type=chunk)[40](index=40&type=chunk) - Other programs include NPM-115 (high-dose exenatide implant) for chronic weight management, NPM-119 (exenatide implant) for type 2 diabetes, and OKV-119 (GLP-1 based implant) for animal health in collaboration with Okava Pharmaceuticals, Inc[25](index=25&type=chunk) - The FDA cleared the Investigational New Drug (IND) application and lifted the clinical hold for NPM-119 on **June 13, 2024**[35](index=35&type=chunk) - The LIBERATE-1 clinical trial for NPM-115 (exenatide implant) in obese and overweight individuals was initiated in Australia at the end of 2024, with the first implant successfully administered on **March 13, 2025**, and top-line results anticipated in mid-2025[37](index=37&type=chunk)[38](index=38&type=chunk)[39](index=39&type=chunk) - Vivani announced plans on **August 5, 2025**, to prioritize the advancement of NPM-139, with clinical development expected to begin in 2026, based on positive LIBERATE-1 data and new NPM-139 preclinical feasibility data[40](index=40&type=chunk) - Cortigent, Inc., a wholly-owned subsidiary focused on neurostimulation, filed a Form 10 registration statement on **May 29, 2025**, to spin off as an independent, publicly traded company, with completion planned for Q3 or Q4 2025[41](index=41&type=chunk)[43](index=43&type=chunk) [Note 2. Basis of Presentation and Significant Accounting Policies](index=11&type=section&id=Note%202.%20Basis%20of%20Presentation%20and%20Significant%20Accounting%20Policies) This note outlines the basis of financial statement preparation, significant accounting policies, and segment reporting - The unaudited interim financial statements are prepared in accordance with GAAP and SEC requirements for interim reporting, consolidating the accounts of the Company and its wholly owned subsidiaries[48](index=48&type=chunk)[49](index=49&type=chunk) - The Company has two non-revenue-producing operating segments: the Biopharm Division and the Neurostimulation Division[50](index=50&type=chunk) - Recently issued accounting pronouncements, ASU 2024-03 and ASU 2023-09, are not expected to have a material effect on the consolidated financial statements, though additional disclosures will be required upon adoption[53](index=53&type=chunk)[54](index=54&type=chunk) [Note 3. Concentration of Risk](index=12&type=section&id=Note%203.%20Concentration%20of%20Risk) This note discusses the company's exposure to credit risk from financial instruments and risks associated with foreign operations - Financial instruments are primarily exposed to credit risk through cash, certificates of deposit, and money market funds maintained with reputable financial institutions[55](index=55&type=chunk) - Foreign operations in Switzerland and Australia carry inherent risks, with assets amounting to approximately **$24,000** and **$642,000**, respectively, as of June 30, 2025[56](index=56&type=chunk) [Note 4. Fair Value Measurements](index=13&type=section&id=Note%204.%20Fair%20Value%20Measurements) This note explains the fair value hierarchy used for financial instruments and details the valuation of cash equivalents - The company uses a three-level fair value hierarchy for financial instruments, with Level 1 inputs for quoted prices in active markets, Level 2 for observable inputs, and Level 3 for unobservable inputs[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk) - Cash equivalents (certificates of deposit and money market funds) are the only financial instruments measured at fair value on a recurring basis and are classified as **Level 1 inputs**[62](index=62&type=chunk) **Fair Value of Cash Equivalents (in thousands):** | Asset Category | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------- | :------------ | :---------------- | | Certificates of deposit | $3,000 | $9,996 | | Money market funds | $2,812 | $7,441 | | **Total** | **$5,812** | **$17,437** | [Note 5. Insurance Premium Financing](index=13&type=section&id=Note%205.%20Insurance%20Premium%20Financing) This note details the company's insurance premium financing agreement, including its repayment status - The company entered a finance agreement in **September 2024** for approximately **$426,000** to fund insurance premiums, incurring **7.2% interest**[64](index=64&type=chunk) - The loan was fully repaid, with no outstanding balance as of **June 30, 2025**[64](index=64&type=chunk) [Note 6. Selected Balance Sheet Detail](index=14&type=section&id=Note%206.%20Selected%20Balance%20Sheet%20Detail) This note provides a detailed breakdown of selected balance sheet items, specifically property and equipment, net **Property and Equipment, Net (in thousands):** | Category | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------- | :------------ | :---------------- | | Total property and equipment at cost | $4,422 | $4,334 | | Accumulated depreciation and amortization | $(2,845) | $(2,641) | | **Property and equipment, net** | **$1,577** | **$1,693** | [Note 7. Equity Securities](index=14&type=section&id=Note%207.%20Equity%20Securities) This note details the company's common stock, registered direct offerings, and private sale transactions - As of **June 30, 2025**, the company had **300,000,000** authorized common shares with **59,243,903** shares issued and outstanding, and no preferred stock outstanding[66](index=66&type=chunk) - In **March 2024**, the company completed a registered direct offering, issuing **3,947,368** common shares and warrants for **$3.80 per share**, generating **$13.7 million** in net proceeds[67](index=67&type=chunk) - An Open Market Sale Agreement with Jefferies LLC allows the company to sell up to **$75.0 million** in common stock; during the six months ended June 30, 2025, **9,215** shares were issued for **$10,000** gross proceeds, resulting in negative net proceeds of **$28,000** after expenses[68](index=68&type=chunk)[71](index=71&type=chunk) - Private sale transactions include **$5.0 million** gross proceeds from a **November 2024** sale, and agreements for approximately **$8.25 million** (**March 2025**) and **$3.0 million** (**May 2025**) in gross proceeds from affiliated entities[72](index=72&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk) [Note 8. Warrants](index=15&type=section&id=Note%208.%20Warrants) This note provides information on warrant activity, including outstanding warrants, exercise prices, and contractual lives **Warrant Activity (in thousands, except per share and contractual life data):** | Metric | As of December 31, 2024 | As of June 30, 2025 | | :-------------------------------- | :---------------------- | :-------------------- | | Warrants outstanding (shares) | 9,340 | 8,248 | | Weighted Average Exercise Price Per Share ($) | $3.42 | $3.46 | | Weighted Average Remaining Contractual Life (in Years) | 1.6 | 1.3 | | Forfeited or expired (shares) | - | (1,092) | | Warrants exercisable (shares) | 9,340 | 8,248 | - Warrants outstanding as of **June 30, 2025**, had no intrinsic value[78](index=78&type=chunk) [Note 9. Stock-Based Compensation](index=16&type=section&id=Note%209.%20Stock-Based%20Compensation) This note details stock option and RSU activity, along with the total stock-based compensation expense recognized - As of **June 30, 2025**, **275,401** shares of common stock were available for future issuance under the Vivani Medical, Inc. 2022 Omnibus Incentive Plan[79](index=79&type=chunk) **Stock Option Activity (in thousands, except per share and contractual life data):** | Metric | As of December 31, 2024 | As of June 30, 2025 | | :-------------------------------- | :---------------------- | :-------------------- | | Options outstanding (shares) | 6,809 | 8,407 | | Weighted Average Exercise Price Per Share ($) | $2.52 | $2.25 | | Weighted Average Remaining Contractual Life (in Years) | 6.55 | 6.79 | | Granted (shares) | - | 1,617 | | Options exercisable (shares) | 5,454 | 5,454 | **Restricted Stock Units (RSUs) Activity (in thousands, except per share data):** | Metric | As of December 31, 2024 | As of June 30, 2025 | | :-------------------------------- | :---------------------- | :-------------------- | | Outstanding (shares) | 695 | 988 | | Weighted Average Grant Date Fair Value Per Share ($) | $1.25 | $1.14 | | Granted (shares) | - | 293 | **Total Stock-Based Compensation Expense (in thousands):** | Period | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $215 | $248 | $411 | $483 | | General and administrative | $176 | $135 | $330 | $253 | | **Total stock-based compensation expense** | **$391** | **$383** | **$741** | **$736** | - As of **June 30, 2025**, total unrecognized stock-based compensation expense was **$2.7 million** for stock options (weighted average period of **1.5 years**) and **$0.4 million** for RSUs (weighted average period of **1.5 years**)[84](index=84&type=chunk) [Note 10. Net Loss Per Share](index=19&type=section&id=Note%2010.%20Net%20Loss%20Per%20Share) This note presents the calculation of basic and diluted net loss per common share and lists excluded common stock equivalents **Net Loss Per Common Share (in thousands, except per share amounts):** | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(7,144) | $(5,356) | $(13,446) | $(11,395) | | Weighted average common shares outstanding - basic and diluted | 59,244 | 55,021 | 59,240 | 53,612 | | **Net loss per common share, basic and diluted** | **$(0.12)** | **$(0.10)** | **$(0.23)** | **$(0.21)** | - Basic and diluted net loss per share are the same for all periods presented because the company was in a loss position, making all potential common stock equivalents anti-dilutive[95](index=95&type=chunk) **Common Stock Equivalents Excluded from Diluted Net Loss Per Share (in thousands):** | Category | June 30, 2025 (shares) | June 30, 2024 (shares) | | :-------------------------------- | :------------ | :------------ | | Stock options issued and outstanding | 8,407 | 6,616 | | Unvested restricted stock units issued and outstanding | 988 | 695 | | Warrants to purchase common stock | 8,248 | 10,484 | | **Total** | **17,643** | **17,795** | [Note 11. Right-of-use Assets and Operating Lease Liabilities](index=19&type=section&id=Note%2011.%20Right-of-use%20Assets%20and%20Operating%20Lease%20Liabilities) This note details the company's operating lease arrangements, including right-of-use assets and lease liabilities - The company leases office, laboratory, and R&D space, including a significant triple net lease in Alameda, California, with a term ending **September 30, 2033**[98](index=98&type=chunk)[99](index=99&type=chunk) **Operating Lease Information (in thousands):** | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :-------------------------------- | :------------ | :---------------- | | Right-of-use assets, non-current | $17,146 | $17,957 | | Current operating lease liabilities | $1,337 | $1,348 | | Long-term operating lease liabilities | $17,279 | $17,965 | | Total lease liabilities (June 30, 2025) | $18,616 | N/A | | Weighted average remaining lease term (June 30, 2025) | 8.25 years | N/A | | Weighted average discount rate (June 30, 2025) | 8.38% | N/A | **Operating Lease Costs (in thousands):** | Metric | Three Months Ended June 30, 2025 ($) | Three Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating lease cost | $800 | $800 | $1,600 | $1,700 | | Variable lease cost | $200 | $100 | $400 | $200 | [Note 12. Commitments and Contingencies](index=21&type=section&id=Note%2012.%20Commitments%20and%20Contingencies) This note outlines the company's legal proceedings and potential financial obligations arising from various commitments and contingencies - An opposition filed by Pixium Vision SA challenging a European patent owned by Cortigent was abandoned in **February 2025**, with no material effect expected on Cortigent's operations[105](index=105&type=chunk) - The company is appealing a Paris Commercial Court judgment ordering it to pay Pixium Vision SA approximately **€1.55 million (net)** related to a terminated MOU; Vivani's appeal was struck out on **October 23, 2024**, for failure to enforce the decision[106](index=106&type=chunk)[107](index=107&type=chunk) - Oppenheimer & Co. Inc. filed a breach of contract claim seeking at least **$1.625 million**; the court dismissed all claims except for breach of contract, and both the company and Oppenheimer have filed notices of appeal[108](index=108&type=chunk) [Note 13. Segment Information](index=22&type=section&id=Note%2013.%20Segment%20Information) This note provides financial information for the company's two non-revenue-producing operating segments: Biopharm and Neurostimulation - The company operates in two non-revenue-producing segments: the Biopharm Division (primary focus) and the Neurostimulation Division (planned spin-off)[110](index=110&type=chunk)[111](index=111&type=chunk) **Segment Operating Expenses and Net Loss (in thousands):** | Metric | Biopharm Division (3M Ended June 30, 2025) ($) | Neurostimulation Division (3M Ended June 30, 2025) ($) | Biopharm Division (6M Ended June 30, 2025) ($) | Neurostimulation Division (6M Ended June 30, 2025) ($) | | :-------------------------- | :--------------------------------------- | :--------------------------------------------- | :--------------------------------------- | :--------------------------------------------- | | Operating expenses | $6,700 | $700 | $12,700 | $1,300 | | Segment net loss | $6,366 | $778 | $12,011 | $1,435 | **Segment Total Assets (in thousands):** | Metric | As of June 30, 2025 ($) | | :-------------------------- | :------------------ | | Biopharm Division | $28,200 | | Neurostimulation Division | $700 | [Note 14. Subsequent Event](index=23&type=section&id=Note%2014.%20Subsequent%20Event) This note discloses significant events occurring after the reporting period, including new legislation and a share purchase agreement - The One Big Beautiful Bill Act (OBBBA) was signed into law on **July 4, 2025**, permanently eliminating the requirement to capitalize and amortize U.S. R&D expenditures and returning interest limitation rules to tax basis EBITDA[116](index=116&type=chunk) - On **August 11, 2025**, the company entered into a share purchase agreement to sell **7,936,507** common shares for approximately **$10.0 million** in gross proceeds[117](index=117&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Vivani Medical's financial condition, liquidity, capital resources, and operational results [Business Overview](index=24&type=section&id=Business%20Overview) This section provides an overview of Vivani Medical, Inc.'s biopharmaceutical focus, product pipeline, and corporate developments - Vivani Medical, Inc. is a clinical-stage biopharmaceutical company focused on developing miniature, ultra long-acting subdermal drug implants using its NanoPortal™ technology to address medication non-adherence and improve drug tolerability for chronic diseases[119](index=119&type=chunk)[120](index=120&type=chunk) - The company's priority program, NPM-139 (semaglutide implant), is in development for chronic weight management, with preclinical data showing approximately **20% weight loss maintained for over six months** and potential for annual dosing; clinical development is expected to begin in **2026**[121](index=121&type=chunk)[135](index=135&type=chunk) - The LIBERATE-1 clinical trial for NPM-115 (exenatide implant) in obese and overweight patients was initiated in Australia, with the first implant administered on **March 13, 2025**, and top-line results anticipated in mid-2025[132](index=132&type=chunk)[134](index=134&type=chunk) - Cortigent, Inc., the neurostimulation subsidiary, filed a Form 10 registration statement on **May 29, 2025**, to spin off as an independent, publicly traded company, with the spin-off planned for **Q3 or Q4 2025**[136](index=136&type=chunk)[138](index=138&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's cash position, working capital, and ongoing need for substantial additional funding - The company has experienced recurring operating losses and negative operating cash flows since inception and expects to continue incurring them for the foreseeable future[145](index=145&type=chunk) - Equity purchase agreements in **March, May, and August 2025** are expected to provide an additional **$21.25 million** in committed capital from **September 2025 through July 2026**[46](index=46&type=chunk) - Currently available cash is estimated to provide sufficient funds to meet planned obligations for at least the next **twelve months**[146](index=146&type=chunk) **Liquidity Metrics (in millions):** | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :----------------------------------- | :------------ | :---------------- | | Cash, cash equivalents and restricted cash | $8.1 | $19.7 | | Working capital | $2.0 | $14.5 | | Decrease in cash, cash equivalents and restricted cash | $(11.6) | N/A | | Decrease in working capital | $(12.5) | N/A | - The company will require substantial additional funding to pursue its business objectives and commercialize products, with no assurance of obtaining it on favorable terms or at all[147](index=147&type=chunk)[149](index=149&type=chunk) [Critical Accounting Policies and Estimates](index=29&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section outlines the key accounting policies and estimates that require significant management judgment - Financial statement preparation requires management estimates and assumptions, particularly for accruals, equity instrument valuation, stock-based compensation, and going concern assessment[151](index=151&type=chunk) - No material changes to critical accounting policies were reported during the three months ended **June 30, 2025**, compared to the Form 10-K for **December 31, 2024**[152](index=152&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section analyzes the company's operating expenses and cash flow activities for the reported periods **Operating Expenses Comparison (in millions):** | Expense Category | 3 Months Ended June 30, 2025 ($) | 3 Months Ended June 30, 2024 ($) | Change ($) | Change (%) | | :----------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $4.8 | $3.5 | $1.3 | 35% | | General and administrative | $2.7 | $2.2 | $0.5 | 25% | | | | | | | | Expense Category | 6 Months Ended June 30, 2025 ($) | 6 Months Ended June 30, 2024 ($) | Change ($) | Change (%) | | :----------------------- | :--------------------------- | :--------------------------- | :--------- | :--------- | | Research and development | $9.0 | $7.2 | $1.8 | 24% | | General and administrative | $5.0 | $4.7 | $0.3 | 8% | **Cash Flow Activities (in millions):** | Activity | 6 Months Ended June 30, 2025 ($) | 6 Months Ended June 30, 2024 ($) | | :-------------------------------- | :--------------------------- | :--------------------------- | | Net cash used in operating activities | $(11.3) | $(9.3) | | Net cash used in investing activities | $(0.1) | $(0.2) | | Net cash (used in) provided by financing activities | $(0.3) | $13.8 | [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of any off-balance sheet arrangements as of June 30, 2025 - As of **June 30, 2025**, the company did not have any off-balance sheet arrangements[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section outlines the company's exposure to market risks, primarily focusing on interest rate and foreign exchange rate sensitivities - The primary objective of investment activities is to maintain principal safety and liquidity, with cash in excess of current needs invested in money market funds and short-term certificates of deposit (CDs)[165](index=165&type=chunk) - The majority of operating expenses are denominated in U.S. dollars, and the company has not entered into foreign currency forward contracts to hedge exchange rate exposure, though it may do so in the future[166](index=166&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details management's evaluation of the company's disclosure controls and procedures, concluding their effectiveness - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of **June 30, 2025**[167](index=167&type=chunk) - There were no material changes in internal control over financial reporting during the quarter ended **June 30, 2025**, though the internal control environment is being updated to address changes in financial reporting risks[168](index=168&type=chunk) - The company acknowledges the inherent limitations of internal control over financial reporting, including the possibility of collusion or management override, which may prevent timely detection of material misstatements[169](index=169&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II%20OTHER%20INFORMATION) This section provides additional information, including legal proceedings, risk factors, equity sales, and other disclosures [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) This section details the company's ongoing legal proceedings, including patent opposition, a terminated MOU, and a breach of contract claim - An opposition filed by Pixium Vision SA against a European patent owned by Cortigent was abandoned in **February 2025**, and this is not expected to materially affect Cortigent's operations[171](index=171&type=chunk) - The company's appeal in the Paris Commercial Court regarding a terminated Memorandum of Understanding (MOU) with Pixium Vision SA was struck out on **October 23, 2024**, for failure to enforce the judgment, requiring reinstatement within two years[172](index=172&type=chunk) - Oppenheimer & Co. Inc. filed a breach of contract claim seeking no less than **$1,625,000** in damages; the court dismissed all claims except for breach of contract, and both the company and Oppenheimer have filed notices of appeal[174](index=174&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section highlights significant risks to the company's business, including the critical need for additional financing and global economic impacts - The company will require substantial additional financing to pursue its business objectives, including preclinical studies and clinical trials, and there is no assurance that such capital will be available on acceptable terms or at all[177](index=177&type=chunk) - Global economic and political developments, including inflation, capital market disruption, geopolitical conflicts (e.g., Ukraine, Israel-Hamas war), and potential global health crises, could materially and adversely affect the company's business, results of operations, and future growth prospects[178](index=178&type=chunk) - Risks associated with tariffs and other trade restrictions, including those imposed by the U.S. or other countries, could lead to increased costs and operational disruptions for raw materials, active pharmaceutical ingredients (APIs), and other components used in product development and production[179](index=179&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section reports on a private sale transaction involving common stock to an affiliated entity on May 12, 2025 - On **May 12, 2025**, the company entered into a private sale transaction to sell **2,912,621** shares of common stock to an entity affiliated with one of its directors for approximately **$3.0 million** in gross proceeds[180](index=180&type=chunk) [Item 3. Defaults upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) This section confirms that the company had no defaults upon senior securities during the reported period - The company reported no defaults upon senior securities[181](index=181&type=chunk) [Item 4. Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company's operations - Mine Safety Disclosures are not applicable to the company[182](index=182&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) This section confirms no Rule 10b5-1 trading plans or non-Rule 10b5-1 arrangements were adopted, modified, or terminated - No Rule 10b5-1 trading plans or non-Rule 10b5-1 trading arrangements were adopted, modified, or terminated by officers or directors during the quarter ended **June 30, 2025**[183](index=183&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section provides a list of all exhibits filed as part of the Form 10-Q, including various agreements and certifications - Exhibits include the Agreement and Plan of Merger (2.1), Certificate of Incorporation (3.1), Bylaws (3.2), Share Purchase Agreement (10.1), and certifications (31.1, 31.2, 32.1)[187](index=187&type=chunk) [SIGNATURES](index=37&type=section&id=SIGNATURES) This section contains the required signatures for the Form 10-Q, certifying its submission by the principal executive and financial officers [SIGNATURES](index=37&type=section&id=SIGNATURES) This section contains the required signatures for the Form 10-Q, certifying its submission by the principal executive and financial officers - The report was signed by Adam Mendelsohn, Chief Executive Officer, and Anthony Baldor, Chief Financial Officer, on **August 13, 2025**[190](index=190&type=chunk)

Exhibit 99.1 Dermata Therapeutics Provides Corporate Update and Reports Second Quarter 2025 Financial Results - Dermata announced additional positive data from its XYNGARI™ Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical trial– - Raised $8.8 million in gross proceeds from a private placement and warrant inducement financings during the first half of 2025 - SAN DIEGO, CA, August 13, 2025 – Dermata Therapeutics, Inc. (Nasdaq: DRMA; DRMAW) ("Dermata," or the "Company"), a late-stage biotechnolog ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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: 001-42750 NEXMETALS MINING CORP. (Exact name of registrant as specified in its charter) Province of Ontario, Canada ...