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Vivani Medical(VANI) - 2025 Q2 - Quarterly Report
2025-08-13 21:01
[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)
Dermata Therapeutics(DRMA) - 2025 Q2 - Quarterly Results
2025-08-13 21:01
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 ...
NexMetals Mining Corp(NEXM) - 2025 Q2 - Quarterly Report
2025-08-13 21:01
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 ...
LAVA Therapeutics(LVTX) - 2025 Q2 - Quarterly Report
2025-08-13 21:00
Table of Contents 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: 001-40241 LAVA Therapeutics N.V. (Exact Name of Registrant as Specified in Its Charter) The Netherlands (State or ...
DURECT (DRRX) - 2025 Q2 - Quarterly Report
2025-08-13 21:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 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 000-31615 DURECT CORPORATION (Exact name of registrant as specified in its charter) Delaware 94-3297098 (State or other jurisdiction of incorpor ...
GEE Group(JOB) - 2025 Q3 - Quarterly Results
2025-08-13 21:00
[Financial Highlights](index=1&type=section&id=Financial%20Highlights) GEE Group reported declining Q3 and YTD FY2025 revenues, improved gross margins, reduced SG&A, a net loss from continuing operations, and maintained strong liquidity Q3 & YTD FY2025 Key Financial Metrics (Continuing Operations) | Metric | Q3 2025 | Q3 2024 | YoY Change | YTD 2025 | YTD 2024 | YoY Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **Consolidated Revenues** | $24.5 million | $27.0 million | -9% | $73.0 million | $80.8 million | -10% | | **Gross Profit** | $8.7 million | $9.2 million | -5% | $25.0 million | $27.0 million | -7% | | **Gross Margin** | 35.4% | 34.1% | +1.3 percentage points | 34.2% | 33.4% | +0.8 percentage points | | **SG&A Expenses** | $9.0 million | $9.8 million | -8% | $26.7 million | $29.5 million | -9% | | **Loss from Continuing Ops** | $(0.4) million | $(18.1) million | N/A | $(34.0) million | $(20.5) million | N/A | | **Adjusted EBITDA** | $(25) thousand | $(329) thousand | N/A | $(918) thousand | $(1.0) million | N/A | - The decrease in consolidated revenues was primarily attributed to volatile macroeconomic conditions, high interest rates, and client caution, leading to elongated hiring cycles and fewer job orders; artificial intelligence (AI) replacing certain tasks contributed to a lesser extent[4](index=4&type=chunk) - Gross margins improved year-over-year for both the three and nine-month periods, mainly due to a higher mix of direct hire placement revenues, which have a **100% gross margin**[4](index=4&type=chunk) - The Industrial Staffing Services segment was sold during the quarter and its results are reclassified as discontinued operations, with the sale resulting in a net gain of **$133 thousand**[1](index=1&type=chunk)[5](index=5&type=chunk) Balance Sheet and Liquidity as of June 30, 2025 | Metric | Value | | :--- | :--- | | Cash Balances | $18.6 million | | ABL Credit Facility Availability | $6.6 million (undrawn) | | Net Working Capital | $24.1 million | | Current Ratio | 4.2 | | Long-Term Debt | Zero | | Shareholders' Equity | $50.4 million | | Net Book Value per Share | $0.46 | | Net Tangible Book Value per Share | $0.23 | [Management Commentary and Business Outlook](index=2&type=section&id=Management%20Commentary%20and%20Business%20Outlook) Management focuses on adapting the business plan with new revenue opportunities, AI tools, and expense reduction, expecting gradual demand improvement - CEO Derek E. Dewan stated the company is adjusting its business plan to navigate the challenging environment by targeting new revenue, using AI to boost efficiency, and cutting expenses[10](index=10&type=chunk) - The company has implemented and incorporated AI into its strategic plan to enhance recruiting and sales, and to support clients' own AI implementation needs[10](index=10&type=chunk) - The demand environment for the remainder of 2025 is expected to be volatile but gradually improve; the company plans to increase market share through several initiatives[12](index=12&type=chunk) - Aggressive AI-assisted sales process - Increased use of offshore recruiting to maximize fill rates - Expansion into value-added services like HR consulting, IT statement of work (SOW) projects, and resource process outsourcing (RPO) - On January 3, 2025, the company acquired Hornet Staffing, Inc. to enhance its ability to compete for business from Fortune 1000 companies, leveraging Hornet's expertise with MSPs and VMSs and its offshore recruiting team[11](index=11&type=chunk) [Non-GAAP Financial Measures and Reconciliations](index=3&type=section&id=Non-GAAP%20Financial%20Measures%20and%20Reconciliations) The company uses non-GAAP measures like Adjusted EBITDA and free cash flow for performance evaluation, with detailed GAAP reconciliations provided - The company uses non-GAAP measures like adjusted net loss, EBITDA, adjusted EBITDA, and free cash flow for internal evaluation of operating performance, financial planning, and other management purposes[15](index=15&type=chunk) Reconciliation of Net Loss to Non-GAAP Adjusted EBITDA (in thousands) | Description | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net loss from continuing operations | $(401) | $(18,105) | $(34,041) | $(20,541) | | Non-cash goodwill impairment | - | $14,201 | $22,000 | $14,201 | | **Non-GAAP EBITDA** | **$(270)** | **$(524)** | **$(1,728)** | **$(2,533)** | | **Non-GAAP Adjusted EBITDA** | **$(25)** | **$(329)** | **$(918)** | **$(1,028)** | Reconciliation to Non-GAAP Free Cash Flow (in thousands) | Description | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,884) | $(1,117) | | Acquisition of property and equipment | $(16) | $(58) | | **Non-GAAP free cash flow** | **$(1,900)** | **$(1,175)** | [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents GEE Group's unaudited consolidated financial statements, including Q3 and YTD FY2025 statements of operations and balance sheets [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) GEE Group's net revenues decreased for the nine months ended June 30, 2025, resulting in a significant loss from continuing operations due to a goodwill impairment Consolidated Statements of Operations Highlights (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Nine Months Ended June 30, 2025 | Nine Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | **Net Revenues** | **$24,523** | **$27,048** | **$73,043** | **$80,774** | | Contract staffing services | $21,301 | $23,761 | $64,310 | $71,977 | | Direct hire placement services | $3,222 | $3,287 | $8,733 | $8,797 | | **Gross Profit** | **$8,681** | **$9,229** | **$24,967** | **$26,958** | | Goodwill impairment charge | $0 | $14,201 | $22,000 | $14,201 | | **Loss from Operations** | **$(544)** | **$(20,717)** | **$(24,537)** | **$(24,303)** | | **Loss from Continuing Operations** | **$(401)** | **$(18,105)** | **$(34,041)** | **$(20,541)** | | **Consolidated Net Loss** | **$(423)** | **$(19,286)** | **$(34,234)** | **$(21,849)** | | **Diluted EPS (Continuing Ops)** | **$(0.00)** | **$(0.17)** | **$(0.31)** | **$(0.19)** | [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, GEE Group's total assets decreased to $60.6 million, primarily due to reduced goodwill, while maintaining strong cash and shareholders' equity Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | September 30, 2024 | | :--- | :--- | :--- | | **Current Assets** | | | | Cash | $18,622 | $20,735 | | Accounts receivable, net | $11,752 | $12,751 | | Total current assets | $31,678 | $35,401 | | **Non-Current Assets** | | | | Goodwill | $24,762 | $46,008 | | **Total Assets** | **$60,564** | **$95,902** | | **Current Liabilities** | | | | Total current liabilities | $7,566 | $9,322 | | **Total Liabilities** | **$10,169** | **$11,691** | | **Total Shareholders' Equity** | **$50,395** | **$84,211** | | **Total Liabilities & Equity** | **$60,564** | **$95,902** | [Corporate Information](index=2&type=section&id=Corporate%20Information) GEE Group Inc. provides specialized staffing solutions and will host an investor webcast to discuss results, with standard forward-looking statement disclaimers - GEE Group provides professional staffing services in information technology, engineering, finance, accounting, and healthcare through brands like Access Data Consulting, Agile Resources, Omni-One, Paladin Consulting, Scribe Solutions, and various SNI brands[30](index=30&type=chunk) - The company will host an investor webcast and conference call on Thursday, August 14, 2025, at 11 a.m. EDT to discuss the fiscal 2025 third quarter and YTD results[8](index=8&type=chunk) - The press release contains forward-looking statements subject to risks and uncertainties, and readers are advised to consult the company's SEC filings for a more detailed understanding of these risk factors[31](index=31&type=chunk)[32](index=32&type=chunk)
Aptose Biosciences(APTO) - 2025 Q2 - Quarterly Results
2025-08-13 21:00
EXHIBIT 99.1 Aptose Reports Second Quarter 2025 Results SAN DIEGO and TORONTO, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Aptose Biosciences Inc. ("Aptose" or the "Company") (TSX: APS and OTC: APTOF), a clinical-stage precision oncology company developing a tuspetinib (TUS)-based triple drug frontline therapy to treat patients with newly diagnosed acute myeloid leukemia (AML), today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. Report maturing data from TUS+ ...
LogicMark(LGMK) - 2025 Q2 - Quarterly Results
2025-08-13 21:00
Exhibit 99.1 LogicMark, Inc. Reports Second Quarter 2025 Results Highlighted by 22% Sales Growth Louisville, KY., August 12, 2025 -- LogicMark, Inc.(OTC: LGMK) (the Company), a provider of personal safety, personal emergency response systems (PERS), health communications devices, and technology for the growing care and safety economy, today announced financial and operational results for the quarter ended June 30, 2025. Summary: Chia-Lin Simmons, Chief Executive Officer of LogicMark, commented, "I'm pleased ...
Bullfrog AI (BFRG) - 2025 Q2 - Quarterly Report
2025-08-13 20:59
UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-41600 BULLFROG AI HOLDINGS, INC. (Exact name of registrant as specified in its charter) Washington, D.C. 20549 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 ______ Nevada 84-4786155 (State or other juri ...
Inspirato rporated(ISPO) - 2025 Q2 - Quarterly Report
2025-08-13 20:58
FORM 10-Q (Mark One) x 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 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 o 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: 001-39791 INSPIRATO INCORPORATED (Exact Name of Registrant as Specified in its Charter) Dela ...