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Movano(MOVE) - 2025 Q1 - Quarterly Report
2025-09-24 21:02
PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Movano Inc.'s unaudited condensed consolidated financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of stockholders' equity (deficit), and statements of cash flows, along with detailed notes explaining the accounting policies and specific financial components for the three months ended March 31, 2025, and 2024 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This table presents Movano Inc.'s condensed consolidated balance sheets, detailing assets, liabilities, and stockholders' equity as of March 31, 2025, and December 31, 2024 | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | --- | --- | --- | | ASSETS | | | | Current assets: | | | | Cash and cash equivalents | $4,357 | $7,902 | | Payroll tax credit, current portion | $52 | $52 | | Vendor deposits | $2 | $28 | | Inventory | $2,258 | $2,046 | | Prepaid expenses and other current assets | $246 | $362 | | Total current assets | $6,915 | $10,390 | | Property and equipment, net | $184 | $213 | | Right-of-use asset | $555 | $600 | | Other assets | $112 | $117 | | Total assets | $7,766 | $11,320 | | LIABILITIES AND STOCKHOLDERS' EQUITY | | | | Current liabilities: | | | | Accounts payable | $2,525 | $2,016 | | Deferred revenue | $18 | $36 | | Other current liabilities | $1,530 | $1,393 | | Total current liabilities | $4,073 | $3,445 | | Noncurrent liabilities: | | | | Other noncurrent liabilities | $459 | $520 | | Total noncurrent liabilities | $459 | $520 | | Total liabilities | $4,532 | $3,965 | | Commitments and contingencies (Note 10) | | | | Stockholders' equity: | | | | Preferred stock, $0.0001 par value, 5,000,000 shares authorized at March 31, 2025 and December 31, 2024; no shares issued and outstanding at March 31, 2025 and December 31, 2024 | — | — | | Common stock, $0.0001 par value, 500,000,000 shares authorized at March 31, 2025 and December 31, 2024; 7,036,475 and 6,840,291 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively | $10 | $10 | | Additional paid-in capital | $156,509 | $155,452 | | Accumulated deficit | $(153,285) | $(148,107) | | Total stockholders' equity | $3,234 | $7,355 | | Total liabilities and stockholders' equity | $7,766 | $11,320 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This table outlines Movano Inc.'s condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025, and 2024, showing revenue, expenses, and net loss | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | --- | --- | --- | | Revenue | $206 | $852 | | COSTS AND EXPENSES: | | | | Cost of revenue | $642 | $1,215 | | Research and development | $2,383 | $2,887 | | Sales, general and administrative | $2,419 | $2,504 | | Total costs and expenses | $5,444 | $6,606 | | Loss from operations | $(5,238) | $(5,754) | | Other income (expense), net: | | | | Interest and other income, net | $60 | $34 | | Other income (expense), net | $60 | $34 | | Net loss and total comprehensive loss | $(5,178) | $(5,720) | | Net loss per share, basic and diluted | $(0.73) | $(1.53) | | Weighted average shares used in computing net loss per share, basic and diluted | 7,123,191 | 3,734,885 | [Condensed Consolidated Statements of Stockholders' Equity (Deficit)](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) This table details changes in Movano Inc.'s stockholders' equity (deficit) for the three months ended March 31, 2025, and 2024, including common stock, additional paid-in capital, and accumulated deficit | | Shares | Common Stock Amount (in thousands) | Additional Paid-In Capital (in thousands) | Accumulated Deficit (in thousands) | Total Stockholders' Equity (in thousands) | | --- | --- | --- | --- | --- | --- | | **Three Months Ended March 31, 2025** | | | | | | | Balance at December 31, 2024 | 6,840,291 | $10 | $155,452 | $(148,107) | $7,355 | | Stock-based compensation | — | — | $299 | — | $299 | | Issuance of common stock | 196,184 | — | $758 | — | $758 | | Net loss | — | — | — | $(5,178) | $(5,178) | | Balance at March 31, 2025 | 7,036,475 | $10 | $156,509 | $(153,285) | $3,234 | | **Three Months Ended March 31, 2024** | | | | | | | Balance at December 31, 2023 | 3,723,218 | $6 | $127,823 | $(124,380) | $3,449 | | Stock-based compensation | — | — | $617 | — | $617 | | Issuance of common stock | 18,221 | — | $164 | — | $164 | | Vesting of early exercised stock options | — | — | $12 | — | $12 | | Net loss | — | — | — | $(5,720) | $(5,720) | | Balance at March 31, 2024 | 3,741,439 | $6 | $128,616 | $(130,100) | $(1,478) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This table presents Movano Inc.'s condensed consolidated statements of cash flows, categorizing cash movements from operating, investing, and financing activities for the three months ended March 31, 2025, and 2024 | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | --- | --- | --- | | CASH FLOWS FROM OPERATING ACTIVITIES: | | | | Net loss | $(5,178) | $(5,720) | | Adjustments to reconcile net loss to net cash used in operating activities: | | | | Depreciation and amortization | $38 | $52 | | Stock-based compensation | $299 | $617 | | Noncash lease expense | $8 | $56 | | Changes in operating assets and liabilities: | | | | Payroll tax credit | — | $41 | | Inventory | $(212) | $50 | | Prepaid expenses, vendor deposits and other current assets | $142 | $256 | | Other assets | $(4) | — | | Accounts payable | $509 | $865 | | Deferred revenue | $(18) | $(1,001) | | Other current and noncurrent liabilities | $113 | $653 | | Net cash used in operating activities | $(4,303) | $(4,131) | | CASH FLOWS FROM INVESTING ACTIVITIES: | | | | Purchases of property and equipment | — | $(6) | | Net cash used in investing activities | — | $(6) | | CASH FLOWS FROM FINANCING ACTIVITIES: | | | | Issuance of common stock, net of issuance costs | $758 | $164 | | Net cash provided by financing activities | $758 | $164 | | Net (decrease) in cash and cash equivalents | $(3,545) | $(3,973) | | Cash and cash equivalents at beginning of period | $7,902 | $6,118 | | Cash and cash equivalents at end of period | $4,357 | $2,145 | | NONCASH INVESTING AND FINANCING ACTIVITIES: | | | | Vesting of common stock issued upon early exercise | — | $12 | | Unpaid issuance costs recorded in other current liabilities | — | $137 | [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed notes explaining the accounting policies and specific financial components underlying Movano Inc.'s condensed consolidated financial statements [NOTE 1 – BUSINESS ORGANIZATION, NATURE OF OPERATIONS](index=7&type=section&id=NOTE%201%20%E2%80%93%20BUSINESS%20ORGANIZATION%2C%20NATURE%20OF%20OPERATIONS) Movano Inc. develops healthcare solutions, has incurred significant losses, and faces going concern doubts due to insufficient cash to fund operations beyond 2025 - Movano Health develops purpose-driven healthcare solutions like the Evie Ring and EvieMED Ring, offering vital health metrics[19](index=19&type=chunk)[20](index=20&type=chunk) - The company has incurred significant losses and negative cash flows since inception, with an accumulated deficit of **$153.3 million** as of March 31, 2025[22](index=22&type=chunk)[24](index=24&type=chunk) - Cash and cash equivalents as of March 31, 2025, are not sufficient to fund projected operating requirements beyond 2025, raising substantial doubt about the company's ability to continue as a going concern[24](index=24&type=chunk) - The company expects to require additional financing through equity issuance, borrowings, or strategic alliances to fund future planned operations[23](index=23&type=chunk) [NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=7&type=section&id=NOTE%202%20%E2%80%93%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) This note outlines Movano Inc.'s significant accounting policies, including its basis of presentation, use of estimates, segment information, revenue recognition, and income tax treatment - The company operates and manages its business as a single operating and reportable segment, with the Chief Executive Officer allocating resources and assessing performance based on consolidated financial information[31](index=31&type=chunk) - Revenue is recognized from the sale of Evie Rings and related elements upon transfer of control, with future unspecified software updates and customer support recognized on a straight-line basis over the product's estimated life[45](index=45&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) - The company maintains a full valuation allowance against its deferred tax assets, resulting in no provision or benefit from income taxes for the three months ended March 31, 2025, and 2024[63](index=63&type=chunk) Segment Reporting | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | --- | --- | --- | | Revenue | $206 | $852 | | Less: | | | | Cost of revenue | $641 | $1,160 | | Research and development | $2,288 | $2,704 | | Sales, general and administrative | $2,216 | $2,125 | | Other segment expenses | $239 | $583 | | Consolidated net loss | $(5,178) | $(5,720) | [NOTE 3 – FAIR VALUE MEASUREMENTS](index=14&type=section&id=NOTE%203%20%E2%80%93%20FAIR%20VALUE%20MEASUREMENTS) This note describes the company's fair value measurements, categorizing money market funds as Level 1 financial assets valued based on quoted market prices Fair Value Measurements | | Fair Value (in thousands) | Level 1 (in thousands) | Level 2 (in thousands) | Level 3 (in thousands) | | --- | --- | --- | --- | --- | | **March 31, 2025** | | | | | | Cash equivalents: | | | | | | Money market funds | $3,673 | $3,673 | $— | $— | | Total cash equivalents | $3,673 | $3,673 | $— | $— | | **December 31, 2024** | | | | | | Cash equivalents: | | | | | | Money market funds | $7,158 | $7,158 | $— | $— | | Total cash equivalents | $7,158 | $7,158 | $— | $— | [NOTE 4 – CASH AND CASH EQUIVALENTS](index=15&type=section&id=NOTE%204%20%E2%80%93%20CASH%20AND%20CASH%20EQUIVALENTS) This note provides a breakdown of the company's cash and cash equivalents, primarily consisting of cash and money market funds, as of March 31, 2025, and December 31, 2024 Cash and Cash Equivalents Breakdown | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | --- | --- | --- | | Cash and cash equivalents: | | | | Cash | $684 | $744 | | Money market funds | $3,673 | $7,158 | | Total cash and cash equivalents | $4,357 | $7,902 | [NOTE 5 – BALANCE SHEET COMPONENTS](index=16&type=section&id=NOTE%205%20%E2%80%93%20BALANCE%20SHEET%20COMPONENTS) This note details the composition of inventory, consisting of raw materials and finished goods, and property and equipment, net, including office equipment, software, and test equipment, as of March 31, 2025, and December 31, 2024 Inventory Composition | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | --- | --- | --- | | Raw materials | $2,015 | $1,845 | | Finished goods | $243 | $201 | | Total inventory | $2,258 | $2,046 | Property and Equipment, Net | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | --- | --- | --- | | Office equipment and furniture | $260 | $260 | | Software | $144 | $144 | | Test equipment | $310 | $310 | | Total property and equipment | $714 | $714 | | Less: accumulated depreciation | $(530) | $(501) | | Total property and equipment, net | $184 | $213 | [NOTE 6 – OTHER CURRENT LIABILITIES](index=16&type=section&id=NOTE%206%20%E2%80%93%20OTHER%20CURRENT%20LIABILITIES) This note provides a detailed breakdown of other current liabilities, including accrued compensation, accrued research and development, accrued vacation, current portion of lease liabilities, and other miscellaneous liabilities, as of March 31, 2025, and December 31, 2024 Other Current Liabilities Breakdown | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | --- | --- | --- | | Accrued compensation | $309 | $324 | | Accrued research and development | $313 | $235 | | Accrued vacation | $263 | $307 | | Lease liabilities, current portion | $206 | $186 | | Other | $439 | $341 | | Total | $1,530 | $1,393 | [NOTE 7 – COMMON STOCK](index=17&type=section&id=NOTE%207%20%E2%80%93%20COMMON%20STOCK) This note outlines the company's common stock authorization and outstanding shares, details the At-the-Market (ATM) Issuance Agreement for selling common stock, and lists shares reserved for future issuance, including warrants and stock options - As of March 31, 2025, Movano Inc. had **7,036,475 shares** of common stock outstanding, compared to 6,840,291 shares at December 31, 2024[81](index=81&type=chunk) - During the three months ended March 31, 2025, the company issued **196,184 shares** of common stock through its ATM program, generating net proceeds of **$0.8 million**[85](index=85&type=chunk) - Approximately **$41.7 million** remained available to be issued and sold under the ATM Issuance Agreement as of March 31, 2025[85](index=85&type=chunk) Shares Reserved for Future Issuance | | March 31, 2025 (Number of Shares) | | --- | --- | | Warrants to purchase common stock | 3,564,375 | | Stock options outstanding | 773,699 | | Stock options available for future grants | 782,641 | | Total | 5,120,715 | [NOTE 8 – COMMON STOCK WARRANTS](index=18&type=section&id=NOTE%208%20%E2%80%93%20COMMON%20STOCK%20WARRANTS) This note provides a summary of the company's common stock warrant activity for the three months ended March 31, 2025, and 2024, detailing various warrant issuances, their exercise prices, and expiration dates Common Stock Warrant Activity (March 31, 2025) | Warrant Issuance | Issuance Date | Weighted Average Exercise Price ($) | Outstanding, December 31, 2024 (Shares) | Granted (Shares) | Exercised (Shares) | Canceled/Expired (Shares) | Outstanding, March 31, 2025 (Shares) | Expiration | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Preferred A Placement Warrants | March and April 2018 and August 2019 | $21.00 | 19,536 | — | — | — | 19,536 | April 2025 | | Preferred B Placement Warrants | April 2019 | $31.50 | 30,920 | — | — | — | 30,920 | April 2025 | | Convertible Notes Placement Warrants | August 2020 | $38.55 | 11,455 | — | — | — | 11,455 | August 2025 | | Underwriter Warrants | March 2021 | $90.00 | 63,798 | — | — | — | 63,798 | March 2026 | | January 2023 warrants | January 2023 | $23.55 | 154,800 | — | — | — | 154,800 | January 2028 | | February 2023 warrants | February 2023 | $23.55 | 23,220 | — | — | — | 23,220 | February 2028 | | August 2023 warrants | August 2023 | $18.60 | 13,441 | — | — | — | 13,441 | August 2028 | | April 2024 Pre Funded warrants | April 2024 | $0.02 | 209,936 | — | — | — | 209,936 | None | | April 2024 warrants | April 2024 | $6.11 | 3,015,172 | — | — | — | 3,015,172 | April 2029 | | August 2024 warrants | August 2024 | $6.11 | 22,097 | — | — | — | 22,097 | August 2029 | | Total | | | 3,564,375 | — | — | — | 3,564,375 | | Common Stock Warrant Activity (March 31, 2024) | Warrant Issuance | Issuance Date | Exercise Price ($) | Outstanding, December 31, 2023 (Shares) | Granted (Shares) | Exercised (Shares) | Canceled/Expired (Shares) | Variable Settlement Provision Adjustment | Outstanding, March 31, 2024 (Shares) | Expiration | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Preferred A Placement Warrants | March and April 2018 and August 2019 | $21.00 | 19,536 | — | — | — | — | 19,536 | April 2024 | | Preferred B Placement Warrants | April 2019 | $31.50 | 30,920 | — | — | — | — | 30,920 | April 2024 | | Convertible Notes Placement Warrants | August 2020 | $38.55 | 11,455 | — | — | — | — | 11,455 | August 2025 | | Underwriter Warrants | March 2021 | $90.00 | 63,798 | — | — | — | — | 63,798 | March 2026 | | January 2023 warrants | January 2023 | $23.55 | 154,800 | — | — | — | — | 154,800 | January 2028 | | February 2023 warrants | February 2023 | $23.55 | 23,220 | — | — | — | — | 23,220 | February 2028 | | August 2023 warrants | August 2023 | $18.60 | 13,441 | — | — | — | — | 13,441 | August 2028 | | Total | | | 317,170 | — | — | — | — | 317,170 | | [NOTE 9 – STOCK-BASED COMPENSATION](index=20&type=section&id=NOTE%209%20%E2%80%93%20STOCK-BASED%20COMPENSATION) This note details the company's stock-based compensation, including shares available under the 2019 Equity Incentive Plan and 2021 Employment Inducement Plan, stock option activity, and the fair value estimation using the Black-Scholes option pricing model. It also presents the allocation of stock-based compensation expense across different cost categories Stock Option Activity | | Number of Options | Weighted Average Exercise Price ($) | Weighted Average Remaining Life | Intrinsic Value (in thousands) | | --- | --- | --- | --- | --- | | Outstanding at December 31, 2024 | 721,399 | $21.98 | 7.2 years | $11 | | Granted | 53,300 | $5.28 | | | | Exercised | — | $— | | | | Cancelled | (1,000) | $34.81 | | | | Outstanding at March 31, 2025 | 773,699 | $20.81 | 6.8 years | $9,141 | | Exercisable as of March 31, 2025 | 646,260 | $21.69 | 6.7 years | $8,493 | | Vested and expected to vest as of March 31, 2025 | 773,699 | $20.81 | 6.8 years | $9,141 | Stock-Based Compensation Expense Allocation | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | --- | --- | --- | | Cost of revenue | $1 | $55 | | Research and development | $95 | $183 | | Sales, general and administrative | $203 | $379 | | Total | $299 | $617 | - As of March 31, 2025, unamortized compensation expense related to unvested stock options was approximately **$1.1 million**, expected to be recognized over a weighted average period of **1.5 years**[99](index=99&type=chunk) [NOTE 10 – COMMITMENTS AND CONTINGENCIES](index=22&type=section&id=NOTE%2010%20%E2%80%93%20COMMITMENTS%20AND%20CONTINGENCIES) This note details Movano Inc.'s commitments and contingencies, including operating and finance lease agreements for its headquarters and laboratory space, future minimum lease payments, and information on potential litigation, indemnification agreements, non-cancelable obligations for raw materials, and royalty commitments to a vendor Operating and Finance Lease Liabilities | | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | --- | --- | --- | | Right-of-use assets | $555 | $600 | | Operating lease liabilities - Short-term | $188 | $169 | | Operating lease liabilities - Long-term | $445 | $502 | | Finance lease liabilities - Short-term | $18 | $17 | | Finance lease liabilities - Long-term | $14 | $18 | Future Minimum Lease Payments | Year | Amount (in thousands) | | --- | --- | | 2025 remaining | $212 | | 2026 | $290 | | 2027 | $280 | | Total lease payments | $782 | | Less: Interest | $(117) | | Total lease liabilities | $665 | - The company has a maximum royalty commitment of approximately **$6.1 million** to a vendor, which is reduced by research and development expenses paid (approximately **$0.8 million** through March 31, 2025)[110](index=110&type=chunk) [NOTE 11 – NET LOSS PER SHARE](index=24&type=section&id=NOTE%2011%20%E2%80%93%20NET%20LOSS%20PER%20SHARE) This note provides the computation of basic and diluted net loss per share for the three months ended March 31, 2025, and 2024, indicating that potentially dilutive securities were excluded as their inclusion would have been antidilutive Net Loss Per Share Computation | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | --- | --- | --- | | Numerator: | | | | Net loss (in thousands) | $(5,178) | $(5,720) | | Denominator: | | | | Weighted average shares used in computing net loss per share, basic and diluted | 7,123,191 | 3,734,885 | | Net loss per share, basic and diluted | $(0.73) | $(1.53) | Potentially Dilutive Securities | | Three Months Ended March 31, 2025 (Number of Shares) | Three Months Ended March 31, 2024 (Number of Shares) | | --- | --- | --- | | Shares subject to options to purchase common stock | 773,699 | 496,561 | | Shares subject to warrants to purchase common stock | 3,354,439 | 317,170 | | Total | 4,128,138 | 813,731 | [NOTE 12 – SUBSEQUENT EVENTS](index=24&type=section&id=NOTE%2012%20%E2%80%93%20SUBSEQUENT%20EVENTS) This note discloses significant events that occurred after March 31, 2025, including the Board's initiation of a strategic alternatives exploration process, grants of Restricted Stock Units (RSUs) to employees and directors, the securing of a $1.5 million bridge loan, and Nasdaq's decision to grant continued listing subject to compliance with filing and bid price rules - On May 15, 2025, the Board of Directors initiated a process to explore strategic alternatives to maximize shareholder value[114](index=114&type=chunk) - The company granted **408,090 Employee RSUs** and **207,849 Director RSUs** during Q2 2025, and **797,387 Employee RSUs** and **95,149 Director RSUs** during Q3 2025, in lieu of salary and cash compensation, respectively[115](index=115&type=chunk) - On August 6, 2025, Movano Inc. obtained a **$1.5 million** bridge loan at a **12.0% annual interest rate**, maturing on November 4, 2025, secured by all company assets, including intellectual property[116](index=116&type=chunk) - On August 27, 2025, Nasdaq granted the company's request for continued listing, conditional on filing Q1 and Q2 2025 10-Qs by September 30, 2025, and demonstrating **$1.00 bid price** compliance by October 30, 2025[117](index=117&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on Movano Inc.'s financial condition and results of operations for the three months ended March 31, 2025, and 2024. It includes forward-looking statements, an overview of the business and products, a summary of financial operations, critical accounting policies, and a detailed analysis of revenue, expenses, net loss, and liquidity and capital resources [Forward-Looking Statements](index=26&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements, which are subject to inherent uncertainties and risks that may cause actual results to differ materially - This report contains forward-looking statements, identifiable by terms like 'believe,' 'expect,' 'may,' 'will,' and 'should,' which describe future plans, strategies, and expectations[118](index=118&type=chunk) - Actual results and financial conditions may differ materially from forward-looking statements due to inherent uncertainties, risks, and changes in circumstances, including limited operating history, ability to achieve profitability, Nasdaq listing compliance, and need for additional capital[119](index=119&type=chunk) [Overview](index=27&type=section&id=Overview) Movano Health launched the Evie Ring as a general wellness wearable and received FDA clearance for the EvieMED Ring's pulse oximetry feature, while developing a SoC for CGM and blood pressure monitoring - Movano Health launched the Evie Ring in November 2023 as a general wellness wearable for women, providing health and wellness metrics such as heart rate, sleep, and activity[122](index=122&type=chunk)[123](index=123&type=chunk) - The EvieMED Ring received FDA 510(k) clearance for its pulse oximetry feature in November 2024, making it a medical device for clinical applications like remote patient monitoring[124](index=124&type=chunk) - The company is developing a patented System-on-a-Chip (SoC) for non-invasive continuous glucose monitoring (CGM) and cuffless blood pressure monitoring, aiming for Class II FDA clearance[125](index=125&type=chunk) [Financial Operations Overview](index=28&type=section&id=Financial%20Operations%20Overview) Movano Inc. has a limited operating history, incurring net losses since inception, with $4.4 million in cash and cash equivalents as of March 31, 2025 - Movano Inc. has a limited operating history since January 2018, generating only limited revenue and incurring net losses since inception, primarily from research and development and sales, general and administrative costs[127](index=127&type=chunk)[128](index=128&type=chunk) - Net losses were **$5.2 million** for the three months ended March 31, 2025, compared to **$5.7 million** for the same period in 2024[128](index=128&type=chunk) - As of March 31, 2025, the company had **$4.4 million** in available cash and cash equivalents[129](index=129&type=chunk) [Critical Accounting Policies and Estimates](index=28&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) There have been no material changes in the company's critical accounting policies and estimates during the three months ended March 31, 2025 - There have been no material changes in the company's critical accounting policies and estimates during the three months ended March 31, 2025, compared to those disclosed in the 2024 Form 10-K[131](index=131&type=chunk) [Recently Issued and Adopted Accounting Pronouncements](index=28&type=section&id=Recently%20Issued%20and%20Adopted%20Accounting%20Pronouncements) The company adopted ASU 2023-07 (Segment Reporting) with no financial impact and will adopt ASU 2024-03 and ASU 2023-09 in 2025 - The company adopted ASU 2023-07 (Segment Reporting) on December 31, 2024, with no impact on its financial statements[68](index=68&type=chunk) - ASU 2024-03 (Expense Disaggregation) and ASU 2023-09 (Income Tax Disclosures) will be adopted prospectively in the annual financial statements for the year ending December 31, 2025, requiring additional disclosures but not significantly impacting financial condition or results of operations[68](index=68&type=chunk)[69](index=69&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of Movano Inc.'s financial performance for the three months ended March 31, 2025, and 2024, highlighting changes in revenue, cost of revenue, research and development, sales, general and administrative expenses, loss from operations, other income, and net loss Comparative Results of Operations | | March 31, 2025 (in thousands) | March 31, 2024 (in thousands) | Change (in thousands) | Change (%) | | --- | --- | --- | --- | --- | | Revenue | $206 | $852 | $(646) | -76% | | OPERATING EXPENSES: | | | | | | Cost of revenue | $642 | $1,215 | $(573) | -47% | | Research and development | $2,383 | $2,887 | $(504) | -17% | | Sales, general and administrative | $2,419 | $2,504 | $(85) | -3% | | Total operating expenses | $5,444 | $6,606 | $(1,162) | -18% | | Loss from operations | $(5,238) | $(5,754) | $516 | 9% | | Other income (expense), net: | | | | | | Interest and other income, net | $60 | $34 | $26 | 76% | | Other income (expense), net | $60 | $34 | $26 | 76% | | Net loss | $(5,178) | $(5,720) | $542 | 9% | [Revenue](index=29&type=section&id=Revenue) Revenue decreased by $0.6 million, or 76%, to $0.2 million for the three months ended March 31, 2025, primarily due to timing of Evie Ring Elements transfer of control - Revenue decreased by **$0.6 million**, or **76%**, to **$0.2 million** for the three months ended March 31, 2025, from $0.9 million for the same period in 2024, primarily due to the timing of Evie Ring Elements transfer of control[136](index=136&type=chunk)[135](index=135&type=chunk) [Cost of revenue](index=29&type=section&id=Cost%20of%20revenue) Cost of revenue decreased by $0.6 million, or 47%, to $0.6 million for the three months ended March 31, 2025, mainly attributable to lower revenue - Cost of revenue decreased by **$0.6 million**, or **47%**, to **$0.6 million** for the three months ended March 31, 2025, from $1.2 million for the same period in 2024, mainly attributable to lower revenue[137](index=137&type=chunk)[135](index=135&type=chunk) [Research and Development](index=29&type=section&id=Research%20and%20Development) Research and development expenses decreased by $0.5 million, or 17%, to $2.4 million for the three months ended March 31, 2025, due to lower research and laboratory expenses - Research and development expenses decreased by **$0.5 million**, or **17%**, to **$2.4 million** for the three months ended March 31, 2025, from $2.9 million for the same period in 2024, primarily due to lower research and laboratory expenses and other professional fees[138](index=138&type=chunk)[135](index=135&type=chunk) [Sales, General and Administrative](index=29&type=section&id=Sales%2C%20General%20and%20Administrative) Sales, general and administrative expenses decreased by $0.1 million, or 3%, to $2.4 million for the three months ended March 31, 2025, due to lower headcount and marketing costs - Sales, general and administrative expenses decreased by **$0.1 million**, or **3%**, to **$2.4 million** for the three months ended March 31, 2025, from $2.5 million for the same period in 2024, mainly due to lower headcount and marketing costs, partially offset by increased stock compensation expenses[139](index=139&type=chunk)[140](index=140&type=chunk)[135](index=135&type=chunk) [Loss from Operations](index=31&type=section&id=Loss%20from%20Operations) Loss from operations improved by $0.5 million, or 9%, to $5.2 million for the three months ended March 31, 2025, compared to the prior year - Loss from operations improved by **$0.5 million**, or **9%**, to **$5.2 million** for the three months ended March 31, 2025, compared to $5.8 million for the same period in 2024[141](index=141&type=chunk)[135](index=135&type=chunk) [Other Income (Expense), Net](index=31&type=section&id=Other%20Income%20(Expense)%2C%20Net) Other income (expense), net increased by $26,000, or 76%, to $60,000 for the three months ended March 31, 2025 - Other income (expense), net increased by **$26,000**, or **76%**, to **$60,000** for the three months ended March 31, 2025, from $34,000 for the same period in 2024[142](index=142&type=chunk)[135](index=135&type=chunk) [Net Loss](index=31&type=section&id=Net%20Loss) Net loss decreased by $0.5 million, or 9%, to $5.2 million for the three months ended March 31, 2025, compared to the prior year - Net loss decreased by **$0.5 million**, or **9%**, to **$5.2 million** for the three months ended March 31, 2025, compared to $5.7 million for the same period in 2024[143](index=143&type=chunk)[135](index=135&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, Movano Inc. had $4.4 million in cash and cash equivalents, which are not expected to fund operations beyond 2025, raising substantial doubt about its ability to continue as a going concern - At March 31, 2025, the company had **$4.4 million** in cash and cash equivalents, which are not expected to be sufficient to fund operations beyond 2025[144](index=144&type=chunk) - The company used **$4.3 million** of cash in operating activities during the three months ended March 31, 2025[144](index=144&type=chunk) - On August 6, 2025, the company obtained **$1.5 million** in bridge financing to continue its pursuit of strategic alternatives[144](index=144&type=chunk) - These circumstances raise substantial doubt about the company's ability to continue as a going concern within one year after the financial statements are issued[148](index=148&type=chunk) Cash Flow Summary | | Three Months Ended March 31, 2025 (in thousands) | Three Months Ended March 31, 2024 (in thousands) | | --- | --- | --- | | Net cash used in operating activities | $(4,303) | $(4,131) | | Net cash used in investing activities | — | $(6) | | Net cash provided by financing activities | $758 | $164 | | Net decrease in cash and cash equivalents | $(3,545) | $(3,973) | [Operating Activities](index=32&type=section&id=Operating%20Activities) Net cash used in operating activities was $4.3 million for the three months ended March 31, 2025, primarily due to net loss, partially offset by non-cash items - Net cash used in operating activities was **$4.3 million** for the three months ended March 31, 2025, primarily due to a net loss of $5.2 million, partially offset by non-cash items and changes in operating assets and liabilities[150](index=150&type=chunk)[151](index=151&type=chunk) [Investing Activities](index=32&type=section&id=Investing%20Activities) The company used no cash in investing activities during the three months ended March 31, 2025, compared to $6,000 in the prior year - The company used **no cash** in investing activities during the three months ended March 31, 2025, compared to **$6,000** used in the prior year for property and equipment purchases[153](index=153&type=chunk) [Financing Activities](index=32&type=section&id=Financing%20Activities) Net cash provided by financing activities was $0.8 million for the three months ended March 31, 2025, primarily from common stock issuance through the At-the-Market (ATM) program - Net cash provided by financing activities was **$0.8 million** for the three months ended March 31, 2025, primarily from the issuance of common stock through the At-the-Market (ATM) program[154](index=154&type=chunk) [Off-Balance Sheet Transactions](index=32&type=section&id=Off-Balance%20Sheet%20Transactions) As of March 31, 2025, the company did not have any off-balance sheet arrangements - As of March 31, 2025, the company did not have any off-balance sheet arrangements[155](index=155&type=chunk) [Non-cancelable Obligations](index=32&type=section&id=Non-cancelable%20Obligations) As of March 31, 2025, the company had $0.4 million in non-cancelable obligations for raw materials purchased by a contract manufacturer - As of March 31, 2025, the company had **$0.4 million** in non-cancelable obligations for raw materials purchased by a contract manufacturer, for which title had not yet transferred[156](index=156&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, Movano Inc. is not required to provide quantitative and qualitative disclosures about market risk - Movano Inc. is exempt from providing quantitative and qualitative disclosures about market risk as it qualifies as a smaller reporting company[157](index=157&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) This section addresses Movano Inc.'s disclosure controls and procedures and internal control over financial reporting. Management concluded that disclosure controls were not effective as of March 31, 2025, due to identified material weaknesses in internal controls, and acknowledges the inherent limitations of control systems [Evaluation of Disclosure Controls and Procedures](index=33&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management concluded that Movano Inc.'s disclosure controls and procedures were not effective as of March 31, 2025, due to identified material weaknesses - Management concluded that Movano Inc.'s disclosure controls and procedures were **not effective** as of March 31, 2025, due to previously identified material weaknesses in internal controls over financial reporting[159](index=159&type=chunk) - Material weaknesses include an ineffective control environment (insufficient personnel, lack of proper risk assessment, control activities, information/communication, and monitoring), ineffective IT general controls (change management, access controls, segregation of duties, operations controls), and ineffective process-level controls affecting financial statement balances[160](index=160&type=chunk) [Inherent Limitations on Effectiveness of Controls](index=33&type=section&id=Inherent%20Limitations%20on%20Effectiveness%20of%20Controls) Management acknowledges that control systems provide only reasonable assurance and are subject to inherent limitations, including human error and circumvention - Management acknowledges that control systems provide only reasonable, not absolute, assurance and are subject to inherent limitations, such as resource constraints, faulty judgments, simple errors, circumvention by individuals, collusion, or management override[161](index=161&type=chunk) [Changes in Internal Control over Financial Reporting](index=33&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) There were no material changes in Movano Inc.'s internal control over financial reporting during the three months ended March 31, 2025 - There were no changes in Movano Inc.'s internal control over financial reporting during the three months ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, these controls[162](index=162&type=chunk) PART II – OTHER INFORMATION [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) Movano Inc. is not currently involved in any pending legal proceedings that are expected to have a material adverse effect on its business or financial condition, although it may encounter various claims in the ordinary course of business - The company is not currently a party to any pending legal proceedings that are believed to have a material adverse effect on its business or financial condition[165](index=165&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section highlights significant risks, including substantial doubt about Movano Inc.'s ability to continue as a going concern due to a lack of revenue, history of losses, and insufficient liquidity to fund operations beyond 2025. The company's ability to remain in business depends on successfully raising additional capital, and failure to do so could lead to curtailment of operations or liquidation. Additionally, the company faces risks related to maintaining its Nasdaq listing - Substantial doubt exists about the company's ability to continue as a going concern due to lack of revenue, history of losses, and insufficient liquidity, with cash and cash equivalents not expected to fund operations beyond 2025[167](index=167&type=chunk) - Failure to raise sufficient additional capital on acceptable terms could force the company to curtail technology development, materially reduce operations, or potentially lead to business failure and liquidation[169](index=169&type=chunk) - The company faces risks related to meeting Nasdaq's continued listing requirements, specifically the Minimum Bid Price Requirement and timely filing of periodic reports, which could result in delisting[175](index=175&type=chunk) [Item 2. Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities](index=36&type=section&id=Item%202.%20Recent%20Sales%20of%20Unregistered%20Securities%3B%20Use%20of%20Proceeds%20from%20Registered%20Securities) This item is not applicable to Movano Inc. for the reporting period - This item is not applicable to the company[176](index=176&type=chunk) [Item 3. Defaults Upon Senior Securities](index=36&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to Movano Inc. for the reporting period - This item is not applicable to the company[177](index=177&type=chunk) [Item 4. Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to Movano Inc. for the reporting period - This item is not applicable to the company[178](index=178&type=chunk) [Item 5. Other Information](index=36&type=section&id=Item%205.%20Other%20Information) This section provides other information, specifically regarding Rule 10b5-1 trading plans [Rule 10b5-1 Trading Plans](index=36&type=section&id=Rule%2010b5-1%20Trading%20Plans) None of Movano Inc.'s directors or executive officers adopted or terminated any Rule 10b5-1 trading arrangements during the first quarter of 2025 - None of Movano Inc.'s directors or executive officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the first quarter of 2025[179](index=179&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including various corporate documents, warrant forms, and certifications Exhibits List | Number | Description | | --- | --- | | 3.1 | Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed on March 25, 2021) | | 3.2 | Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed on June 21, 2023) | | 3.3 | Certificate of Amendment to Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed on July 10, 2024) | | 3.4 | Certificate of Amendment to Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant's Current Report on Form 8-K filed on October 25, 2024) | | 3.5 | Amended and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant's Current Report on Form 8-K filed on March 25, 2021) | | 4.1 | Specimen Certificate representing shares of common stock of the Registrant (incorporated by reference to Exhibit 4.1 to the Registrant's Registration Statement on Form S-1 filed on March 10, 2021) | | 4.2 | Form of Underwriter Warrant (incorporated by reference to Exhibit 4.2 to the Registrant's Registration Statement on Form S-1 filed on March 10, 2021) | | 4.3 | Form of Amended and Restated Warrant to Purchase Common Stock issued to the placement agent in the Registrant's 2018 private placement offering (incorporated by reference to Exhibit 4.3 to the Registrant's Registration Statement on Form S-1 filed on February 2, 2021) | | 4.4 | Form of Amended and Restated Warrant to Purchase Common Stock issued to the placement agent in the Registrant's 2019 private placement offering (incorporated by reference to Exhibit 4.4 to the Registrant's Registration Statement on Form S-1 filed on February 2, 2021) | | 4.5 | Form of Warrant to Purchase Common Stock issued in 2020 (incorporated by reference to Exhibit 4.6 to the Registrant's Registration Statement on Form S-1 filed on February 2, 2021) | | 4.6 | Form of Warrant to Purchase Common Stock issued in 2023 (incorporated by reference to Exhibit 4.1 to the Registrant's Current Report on Form 8-K filed on January 31, 2023) | | 4.7 | Warrant Agent Agreement, dated January 31, 2023, by and between the Registrant and Pacific Stock Transfer Company (incorporated by reference to Exhibit 4.2 to the Registrant's Current Report on Form 8-K filed on January 31, 2023) | | 4.8 | Form of Pre-Funded Warrant issued in April 2024 (incorporated by reference to Exhibit 4.1 to the Registrant's Current Report on Form 8-K filed on April 3, 2024) | | 4.9 | Form of Warrant issued in April 2024 (incorporated by reference to Exhibit 4.2 to the Registrant's Current Report on Form 8-K filed on April 3, 2024) | | 4.10 | Form of Warrant issued in August 2024 (incorporated by reference to Exhibit 4.11 to the Registrant's Quarterly Report on Form 10-Q filed on November 14, 2024) | | 31.1 | Certification of Periodic Report by Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith) | | 31.2 | Certification of Periodic Report by Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith) | | 32.1 | Certification of Periodic Report by Chief Executive Officer and Chief Financial Officer pursuant to U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith) | | 101.INS | Inline XBRL Instance Document (filed herewith) | | 101.SCH | Inline XBRL Taxonomy Extension Schema Document (filed herewith) | | 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document (filed herewith) | | 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document (filed herewith) | | 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document (filed herewith) | | 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document (filed herewith) | | 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) | SIGNATURES [SIGNATURES](index=38&type=section&id=SIGNATURES) The report was duly signed on behalf of Movano Inc. by its Chief Executive Officer and Chief Financial Officer on September 24, 2025 - The report was duly signed on behalf of Movano Inc. by John Mastrototaro, Chief Executive Officer, and J. Cogan, Chief Financial Officer, on September 24, 2025[184](index=184&type=chunk)
Movano Health Granted Listing Extension by Nasdaq
Prnewswire· 2025-08-28 20:30
Core Points - Movano Health has received approval from the Nasdaq Hearings Panel to continue its listing on Nasdaq, contingent upon regaining compliance with specific listing rules by set deadlines [1][2] - The company must file its Quarterly Reports on Form 10-Q for the quarters ended March 31, 2025, and June 30, 2025, by September 30, 2025, and maintain a bid price of at least $1.00 per share by October 30, 2025 [1][2] - Movano Health is actively working with a new auditor to complete the necessary filings and has filed a Preliminary Proxy Statement for a reverse stock split proposal to help meet the bid price requirement [2] Company Overview - Movano Health, founded in 2018, focuses on developing healthcare solutions that provide medical-grade data through wearable devices [3] - The company's flagship product, the Evie Ring, aims to deliver personalized health insights by capturing comprehensive health data [3][4] - Movano Health's proprietary technologies are designed to proactively monitor and manage health outcomes across various patient populations [4]
Movano Health Plans to Timely Request a Hearing Before a Nasdaq Hearings Panel
Prnewswire· 2025-07-11 21:30
Core Viewpoint - Movano Health has received a delisting notice from Nasdaq due to non-compliance with the minimum bid price requirement and late filing of its Form 10-Q for the quarter ended March 31, 2025 [1][2]. Group 1: Delisting Notice Details - The company was notified on July 7, 2025, that its common stock's closing bid price had fallen below $1.00 per share for 30 consecutive trading days, violating the Bid Price Requirement [2]. - The company is not eligible for any compliance period due to a reverse stock split that occurred within the prior year [2]. - Movano Health plans to request a hearing before a Nasdaq Hearings Panel to contest the delisting and intends to seek an extended stay of suspension during the hearings process [1][3]. Group 2: Company Background - Movano Health, founded in 2018, focuses on developing healthcare solutions that provide medical-grade data through wearable devices [4]. - The company's technologies aim to proactively monitor and manage health outcomes across various patient populations [5].
Movano Health Receives Notification of Deficiency from Nasdaq Related to Delayed Filing of Quarterly Report on Form 10-Q
Prnewswire· 2025-05-23 20:05
Core Viewpoint - Movano Health has received a notice from Nasdaq regarding non-compliance with listing rules due to the failure to file its Form 10-Q for the quarter ended March 31, 2025, which was due on May 15, 2025 [1][2]. Group 1: Compliance and Regulatory Actions - The company has 60 calendar days, until July 21, 2025, to submit a plan to regain compliance with Nasdaq's Listing Rule [2]. - If Nasdaq accepts the compliance plan, the company may have up to 180 additional days, until November 11, 2025, to file the Form 10-Q [2]. Group 2: Company Overview - Movano Health, founded in 2018, is focused on developing healthcare solutions that provide medical-grade data through wearable devices [3]. - The company's devices aim to deliver trusted health data and insights to both consumers and enterprises, enhancing health monitoring and management [4].
Movano Health's Board of Directors Initiates Process to Maximize Shareholder Value
Prnewswire· 2025-05-16 20:30
Core Viewpoint - Movano Health has initiated a process to explore strategic alternatives, including a potential sale or merger, to maximize shareholder value [1]. Company Overview - Movano Health, founded in 2018, is focused on developing healthcare solutions that provide medical-grade data through wearable technology [3]. - The company's devices are designed to deliver trusted health data and insights, capturing a comprehensive picture of individual health [3][4]. Strategic Actions - The Board of Directors has engaged Aquilo Partners as a financial advisor and K&L Gates LLP as legal counsel to assist in exploring strategic alternatives [1]. - There is no assurance that this process will lead to a transaction or strategic change, and the company does not plan to disclose further developments until a specific course of action is approved [2]. Financial Reporting - Movano Health has indicated that due to resource constraints, it will not timely file its quarterly report on Form 10-Q for the quarter ended March 31, 2025 [2].
Movano(MOVE) - 2024 Q4 - Annual Report
2025-04-09 21:09
Product Launch and Features - Movano Inc. launched the Evie Ring, a wearable device for women, in November 2023, designed to provide health and wellness metrics without FDA premarket clearances[17]. - The Evie Ring tracks various health metrics including resting heart rate, HRV, SpO2, and menstrual symptom tracking, aiming to help women make proactive lifestyle changes[18]. - The EvieMED Ring's FDA clearance positions it as a unique offering in the market, combining both hardware and software approvals[44]. - The EvieMED Ring is expected to enhance clinical-level confidence in monitoring capabilities, making it appealing to healthcare providers and facilities involved in clinical trials[214]. - Movano is developing a patented SoC for blood pressure and CGM systems, aiming to create wearables that can monitor glucose non-invasively and blood pressure without a cuff[215]. - The goal is to bring a Class II FDA-cleared device to market that includes CGM and cuffless blood pressure monitoring capabilities[215]. Regulatory Approvals and Compliance - In November 2024, Movano received FDA 510(k) clearance for the pulse oximetry feature in the EvieMED Ring, enabling its use in clinical trials and remote patient monitoring[19]. - The Evie Ring is classified as a general wellness device and does not require FDA premarket clearance, while EvieMED is a medical device requiring FDA clearance[56]. - The company plans to seek FDA clearance for additional monitoring capabilities and a continuous glucose monitoring (CGM) solution, which may face regulatory challenges[140]. - The typical duration to receive a 510(k) clearance is approximately nine to twelve months, while PMA approval can take about two years[141]. - Regulatory compliance costs could adversely affect the company's financial results, especially if new laws impose additional obligations[148]. - The company must comply with healthcare regulations, including the federal Anti-Kickback Statute, which could expose it to substantial penalties if violated[156]. Financial Performance and Projections - As of December 31, 2024, the company had an accumulated deficit of approximately $148.1 million and expects losses to continue for the foreseeable future due to significant investments in product commercialization and R&D[98]. - The company had total assets of approximately $11.3 million and total liabilities of approximately $4.0 million as of December 31, 2024, raising substantial doubt about its ability to continue as a going concern[99]. - The company may need to raise additional capital under unfavorable terms, resulting in substantial dilution for existing shareholders[164]. - The company has not paid dividends in the past and has no immediate plans to do so, intending to reinvest all earnings to develop technology and cover operating costs[183]. Market Demand and Competition - Demand for continuous glucose monitors (CGMs) is increasing, with approximately 9 million users worldwide and industry sales estimated at over $6.3 billion in 2023[27]. - The blood pressure monitoring device market is projected to reach approximately $5.0 billion in 2024, indicating a growing demand for non-invasive solutions[31]. - The company faces intense competition in the technology industry, particularly in the wellness, continuous glucose monitoring, and blood pressure monitoring markets, from established players like Apple, Samsung, and DexCom[78][79][80]. - The company may face increased competition from other companies utilizing AI technologies, which could adversely affect its business and financial condition[124]. Strategic Partnerships and Distribution - The company plans to sell products directly to consumers and enterprise customers through its website and retail channels, and to partner with OEMs and VARs to enhance product distribution[76]. - The company has formed a strategic partnership with a leading specialty foundry to strengthen its supply chain for manufacturing and supplying integrated circuits (ICs)[77]. - The company is exploring new distribution channels for the EvieMED Ring, including partnerships with healthcare institutions and durable medical equipment distributors[139]. Intellectual Property and Technology Risks - The company owns 32 issued patents and has exclusive rights to 5 pending U.S. patent applications as of December 31, 2024[54]. - The company may face challenges in protecting its intellectual property, as competitors may develop similar technologies or challenge its patents[128]. - The company relies on unpatented proprietary technology and trade secrets, and any unauthorized disclosure could harm its competitive position[129]. - The company may incur significant costs and distractions from potential intellectual property litigation or administrative proceedings[131]. Employee and Operational Considerations - The company has 32 full-time employees as of December 31, 2024, and focuses on recruiting and retaining talent to support its business strategy[84][85]. - The company’s ability to attract and retain qualified personnel is critical for executing its business strategy, but competition for skilled workers is intense[108]. Cybersecurity and Risk Management - The company operates in sectors subject to various cybersecurity risks, including intellectual property theft and fraud, and has implemented a risk-based approach to manage these threats[193]. - The board of directors oversees cybersecurity risk management and employs third-party consultants to maintain security controls[195]. - The company has not identified any cybersecurity threats that have materially affected its business strategy or financial position as of the report date[197]. Stock Performance and Market Listing - The company's stock price fluctuated between a high of $12.45 and a low of $3.01 in the twelve-month period ended December 31, 2024, adjusted for a 1-for-15 reverse stock split[173]. - On November 14, 2023, the company was notified by Nasdaq that it no longer met the minimum bid price requirement of $1.00 per share for continued listing[177]. - The company completed a 1-for-15 reverse stock split on October 29, 2024, and regained compliance with Nasdaq's minimum bid price requirement on November 12, 2024[178]. - Any future failure to satisfy Nasdaq's listing requirements could lead to delisting, negatively impacting the stock price and liquidity[178].
Movano's Evie Ring Adds New Personalization and Trend Tracking to Support Women's Wellness Journey
Prnewswire· 2025-03-10 12:00
Core Insights - Movano Health has announced new features for the Evie Ring's companion app, enhancing support for women's wellness journeys through data personalization and trend tracking [1][2] - The Evie Ring is priced at $269 with no subscription fees, making it accessible for users, and is eligible for HSA/FSA reimbursement [2] Product Features - Integration with Apple Health allows automatic import of Evie data, enabling users to view information from both platforms in one location [5] - The app now includes 7- and 30-day trend graphs for sleep metrics, helping users understand their health patterns over time [5] - Daily basal body temperature logging has been added to assist users in tracking their menstrual cycles [5] - Heart rate mapping provides a visual representation of users' heart rates throughout the day, categorized by activity levels [5] - The expansion of workout tracking allows users to manually log past workouts, ensuring they receive credit for calories burned [5] - The Daily Summary home screen now includes menstrual cycle day and phase, enhancing the app's one-stop value for tracking health metrics [5] Company Overview - Movano Health, founded in 2018, focuses on developing healthcare solutions that provide medical-grade data through wearables [3] - The company's Evie and EvieMED devices aim to deliver trusted health data and personalized insights to users [3]
Movano Health Commences Clinical Study with New Cuffless Blood Pressure Device
Prnewswire· 2025-02-04 13:00
Core Insights - Movano Health has initiated a clinical trial for its new cuffless blood pressure wrist wearable, aiming to enhance signal fidelity and monitor various vital signs [1][2] - The trial will involve at least 70 participants and is expected to be completed by mid-February 2025, comparing the new device's data with that from a hospital-grade blood pressure device [1][2] - The company has previously conducted three clinical trials in late 2024 and 2023, gathering data from over 60 participants to refine its technology [2] Company Overview - Movano Health, founded in 2018, focuses on developing healthcare solutions that provide medical-grade data through innovative wearable devices [3] - The company's products aim to deliver comprehensive health data and personalized insights to users, enhancing proactive health management [3][4] - Movano Health is committed to advancing its proprietary technologies to improve health outcomes across diverse patient populations [4]
ITALIAN TRADE AGENCY TO HOST "ITALY ON THE MOVE 2025" SIDE EVENT DURING J.P. MORGAN HEALTHCARE CONFERENCE
Prnewswire· 2025-01-08 20:17
Event Overview - The 8th edition of "Italy on the Move" will be hosted by the Italian Trade Agency (ITA) and the Ministry of Foreign Affairs and International Cooperation during the 43rd annual J P Morgan Healthcare Conference 2025 [1] - The event aims to promote investment opportunities in Italy's €270 billion life sciences sector, including biotech, healthcare, medical devices, and pharmaceuticals [1] - It will take place at INNOVIT, San Francisco's Italian Innovation and Culture Hub, on January 15, 2025, starting at 5:00 PM [1] Key Speakers and Participants - Opening remarks will be delivered by the Ambassador of Italy to the U S, H E Mariangela Zappia, and the Consul General of Italy in San Francisco, Sergio Strozzi [2] - Mauro Battocchi, Director General for the Promotion of the Italy System, will provide an overview of the Italian life sciences ecosystem [3] - A panel discussion titled "Navigating Transatlantic Partnerships in Life Sciences" will be moderated by Audrey Greenberg, Founder of the Center for Breakthrough Medicines and CEO of AG Capital Advisors [3] - Five Italian startups—Aavantgarde, Butterfly Decisions, Cellply, Medlea, and Sibylla Biotech—will present pitch presentations [4] Italian Life Sciences Sector Highlights - The Italian life sciences sector has a turnover of €270 billion, equivalent to 11% of the country's GDP [3] - Italy ranks 1st among EU economies in pharma CDMO manufacturing value and 4th worldwide in patents productivity in Life Sciences [3] - Nearly 50 life science multinationals have established production and R&D bases in Italy [3] - Pharmaceuticals and medical devices are the third most significant Italian export globally, surpassing iconic "Made in Italy" goods like apparel and wines [3] Event Objectives and Opportunities - The event serves as a platform for U S healthcare companies and investors to meet Italian companies for partnerships or investments [3] - It highlights Italy's potential as a competitive hub for international scientists, researchers, companies, and investors in the life sciences sector [3] - The event will showcase innovative SMEs and startups, offering opportunities for collaboration and investment [3] About the Organizers - The Italian Trade Agency (ITA) is a government agency that promotes the globalization of Italian firms and facilitates economic and trade relations with foreign countries, focusing on SMEs and partnerships [5] - INNOVIT, the Italian Innovation and Culture Hub, is a strategic initiative by the Italian Government to connect Italian innovative companies and startups with Silicon Valley and U S ecosystems [6]
Movano Health Launches EvieAI Virtual Wellness Assistant
Prnewswire· 2025-01-08 13:00
Core Insights - Movano Health has launched EvieAI, the first wearable-based virtual wellness assistant trained exclusively with data from medical journals, enhancing the Evie smart ring for women [1][3] - The EvieAI feature allows users to receive personalized health responses based on their individual health metrics captured by the ring's sensors [2] - EvieAI ensures data accuracy by utilizing information from over 100,000 medical journals, differentiating it from general-purpose digital assistants [3] Product Features - The Evie smart ring is designed to accommodate daily fluctuations in finger size, ensuring a comfortable fit, and has a battery life of over 4 days, recharging in 60 minutes [5] - The ring is available in gold, rose gold, and silver finishes, with sizes ranging from 5 to 12, and is priced at $269 with no subscription fees [5] - The beta version of EvieAI is currently available for iOS users at no cost for existing Evie Ring customers [6] Company Overview - Movano Health, founded in 2018, focuses on developing healthcare solutions that provide medical-grade data through wearable technology [7] - The company aims to proactively monitor and manage health outcomes across various patient populations using its proprietary technologies [8]