SEC Form 10-Q filed by Movano Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
FOR
THE QUARTERLY PERIOD ENDED
OR
COMMISSION
FILE NUMBER:
(Exact name of registrant as specified in its charter)
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
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Indicate
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405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
| Large accelerated filer | ☐ | Accelerated filer | ☐ | |
| ☒ | Smaller reporting company | |||
| Emerging growth company |
If
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Indicate
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As of November 8, 2024, there
were
MOVANO INC.
FORM 10-Q
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024
INDEX
i
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
Movano Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(Unaudited)
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Payroll tax credit, current portion | ||||||||
| Vendor deposits | ||||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Payroll tax credit, noncurrent portion | ||||||||
| Other assets | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Deferred revenue | ||||||||
| Other current liabilities | ||||||||
| Total current liabilities | ||||||||
| Noncurrent liabilities: | ||||||||
| Early exercised stock option liability | ||||||||
| Other noncurrent liabilities | ||||||||
| Total noncurrent liabilities | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 10) | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $ | ||||||||
| Common stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities and stockholders’ equity | $ | $ | ||||||
See accompanying notes to condensed consolidated financial statements.
1
Movano Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
(Unaudited)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| COSTS AND EXPENSES: | ||||||||||||||||
| Cost of revenue | ||||||||||||||||
| Research and development | ||||||||||||||||
| Sales, general and administrative | ||||||||||||||||
| Total costs and expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest and other income, net | ||||||||||||||||
| Other income (expense), net | ||||||||||||||||
| Net loss and total comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share, basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average shares used in computing net loss per share, basic and diluted | ||||||||||||||||
See accompanying notes to condensed consolidated financial statements.
2
Movano Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(in thousands, except share data)
(Unaudited)
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||||||||
| Three Months Ended September 30, 2023 | Shares | Amount | Capital | Deficit | Equity | |||||||||||||||
| Balance at June 30, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Issuance of common stock | ||||||||||||||||||||
| Issuance of common stock warrants | — | |||||||||||||||||||
| Vesting of early exercised stock options | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balance at September 30, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||||||||
| Nine Months Ended September 30, 2023 | Shares | Amount | Capital | Deficit | Equity | |||||||||||||||
| Balance at December 31, 2022 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Issuance of common stock upon February 2023 public offering, net of issuance costs | ||||||||||||||||||||
| Issuance of warrants upon February 2023 public offering | — | |||||||||||||||||||
| Issuance of common stock upon June 2023 public offering, net of issuance costs | ||||||||||||||||||||
| Issuance of common stock | ||||||||||||||||||||
| Issuance of common stock upon exercise of options | ||||||||||||||||||||
| Issuance of common stock warrant | — | |||||||||||||||||||
| Vesting of early exercised stock options | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balance at September 30, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||||||||
| Three Months Ended September 30, 2024 | Shares | Amount | Capital | Deficit | Equity | |||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Common stock issuance costs | — | ( | ) | ( | ) | |||||||||||||||
| Issuance of common stock warrants | — | |||||||||||||||||||
| Issuance of common stock | ||||||||||||||||||||
| Vesting of early exercised stock options | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Additional | Total | |||||||||||||||||||
| Common Stock | Paid-In | Accumulated | Stockholders’ | |||||||||||||||||
| Nine Months Ended September 30, 2024 | Shares | Amount | Capital | Deficit | Equity | |||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | ( | ) | $ | ||||||||||||||
| Stock-based compensation | — | |||||||||||||||||||
| Issuance of common stock in April 2024 sale, net of issuance costs | ||||||||||||||||||||
| Issuance of pre-funded warrants in April 2024 sale | — | |||||||||||||||||||
| Issuance of common stock warrants in April 2024 sale | — | |||||||||||||||||||
| Issuance of common stock warrants | — | |||||||||||||||||||
| Issuance of common stock | — | — | ||||||||||||||||||
| Issuance of common stock upon exercise of options | ||||||||||||||||||||
| Vesting of early exercised stock options | — | |||||||||||||||||||
| Net loss | — | ( | ) | ( | ) | |||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | ( | ) | $ | ||||||||||||||
See accompanying notes to condensed consolidated financial statements.
3
Movano Inc.
Condensed Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation | ||||||||
| Noncash lease expense | ( | ) | ||||||
| Non-cash compensation related to common stock warrants issued to strategic advisory group | ||||||||
| Loss on disposal of property and equipment | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Payroll tax credit | ||||||||
| Inventory | ( | ) | ||||||
| Prepaid expenses, vendor deposits and other current assets | ( | ) | ||||||
| Other assets | ( | ) | ( | ) | ||||
| Accounts payable | ( | ) | ||||||
| Deferred revenue | ( | ) | ||||||
| Other current and noncurrent liabilities | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchases of property and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Issuance of common stock and warrants upon February 2023 public offering, net of issuance costs | ||||||||
| Issuance of common stock upon June 2023 public offering, net of issuance costs | ||||||||
| Issuance of common stock, pre-funded warrants and common stock warrants in April 2024 sale, net of issuance costs | ||||||||
| Issuance of common stock, net of issuance costs | ||||||||
| Issuance of common stock upon exercise of stock options | ||||||||
| Net cash provided by financing activities | ||||||||
| Net increase/(decrease) in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| NONCASH INVESTING AND FINANCING ACTIVITIES: | ||||||||
| Vesting of common stock issued upon early exercise | $ | $ | ||||||
| Warrants issued upon February 2023 public offering | $ | $ | ||||||
| Issuance of common stock warrant | $ | $ | ||||||
| Issuance of common stock warrants in April 2024 sale | $ | $ | ||||||
| Right of use asset recorded for operating lease liability | $ | $ | ||||||
See accompanying notes to condensed consolidated financial statements.
4
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note 1 – Business Organization, Nature of Operations
Movano Inc., dba Movano Health (the “Company”, “Movano”, “Movano Health”, “we”, “us” or “our”) was incorporated in Delaware on January 30, 2018 as Maestro Sensors Inc. and changed its name to Movano Inc. on August 3, 2018. The Company is an early-stage technology company and is developing a platform to deliver purpose-driven healthcare solutions at the intersection of medical and consumer devices. Movano is on a mission to make medical grade data more accessible and actionable for all.
The Company’s solutions provide vital health information, including heart rate, heart rate variability (HRV), sleep, respiration rate, temperature, blood oxygen saturation (SpO2), steps, and calories as well as glucose and blood pressure data, in a variety of form factors to meet individual style needs and give users actionable feedback to improve their quality of life.
On April 28, 2021, the Company established Movano Ireland Limited, organized under the laws of Ireland, as a wholly owned subsidiary of the Company. Operations and activity at the wholly owned subsidiary were not significant for the three and nine months ended September 30, 2024 and 2023, respectively.
Since inception, the Company has engaged in only
limited research and development of product candidates and underlying technology and the commercialization of the Company’s first
commercial product, the Evie Ring. For the three months and nine months ended September 30, 2024, the Company recorded revenue for
this product of $
On April 2, 2024, the Company entered into
a securities purchase agreement for the private placement (“April 2024 Private Placement”) of an aggregate of
Pre-funded warrants totaling
Warrants totaling
The gross proceeds of the April 2024 Private Placement
were approximately $
The Company has incurred losses from operations and has generated negative cash flows from operating activities since inception. The Company expects to continue to incur net losses for the foreseeable future as it continues the development of its technology. The Company’s ultimate success depends on the outcome of its research and development and commercialization activities, for which it expects to incur additional losses in the future. Through September 30, 2024, the Company has relied primarily on the proceeds from equity offerings to finance its operations. The Company expects to require additional financing to fund its future planned operations, including research and development and commercialization of its products. The Company will likely raise additional capital through the issuance of equity, borrowings, or strategic alliances with partner companies. However, if such financing is not available at adequate levels, the Company would need to reevaluate its operating plans.
Liquidity and Going Concern
The
accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred significant losses and has an
accumulated deficit of $
Adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise additional capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce, or eliminate its product or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs. The accompanying condensed consolidated financial statements do not include any adjustments that might result should the Company be unable to continue as a going concern.
5
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note 2 – Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiary and have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and in accordance with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair presentation. Intercompany transactions are eliminated in the condensed consolidated financial statements. These financial statements should be read in conjunction with the audited financial statements and notes thereto for the preceding fiscal year contained in the Company’s Annual Report on Form 10-K filed on April 16, 2024 with the United States Securities and Exchange Commission (the “SEC”) and amended on April 29, 2024.
The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024. The condensed consolidated balance sheet as of December 31, 2023 has been derived from audited financial statements at that date but does not include all the information required by GAAP for complete financial statements.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods.
Significant estimates and assumptions reflected in these condensed consolidated financial statements include but are not limited to the fair value of stock options and warrants, and income taxes. Estimates are periodically reviewed considering changes in circumstances, facts, and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates or assumptions.
Reverse Stock Split
On October 29, 2024, the Company completed a 1-for-15 reverse stock split of its issued and outstanding common stock (the “Reverse Stock Split”). As a result of the Reverse Stock Split, each share of common stock issued and outstanding immediately prior to October 29, 2024 were automatically reclassified and converted into one-fifteenth (1/15th, “Reverse Stock Split Ratio”) of a share of common stock. The Reverse Stock Split affected all common stockholders uniformly and did not alter any stockholder's percentage interest in the Company's equity, except to the extent that the Reverse Stock Split resulted in a stockholder of record owning a fractional share. Stockholders of record who were otherwise entitled to receive a fractional share, instead automatically had their fractional shares rounded up to the next whole share. No cash was issued for fractional shares as part of the Reverse Stock Split.
The Reverse Stock Split did not change the par value of the common stock or the authorized number of shares of common stock. Proportionate adjustments were made to the exercise prices and the number of shares underlying the Company’s equity plans and grants thereunder, as applicable. Additionally, proportionate adjustments were made to the exercise prices and the number of shares underlying all outstanding warrants, as required by the terms of these securities.
All common share and per-share amounts in this Form 10-Q have been retroactively restated to reflect the effect of the Reverse Stock Split.
Segment Information
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views
its operations and manages its business in
Cash and Cash Equivalents
The Company invests its excess cash primarily in money market funds. The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents.
6
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Concentrations of Credit Risk and Off-Balance Sheet Risk
Cash and cash equivalents are financial instruments
that are potentially subject to concentrations of credit risk. Substantially all cash and cash equivalents are held in United States financial
institutions. Cash equivalents consist of interest-bearing money market accounts. The amounts deposited in the money market accounts exceed
federally insured limits. Further, the Company has amounts in excess of federally insured limits as of September 30, 2024 at one
financial institution that totaled approximately $
The Company is dependent on third-party manufacturers to supply products for manufacturing as well as research and development activities. These programs could be adversely affected by a significant interruption in the supply of such materials.
The Company has no financial instruments with off-balance sheet risk of loss.
Inventory
Inventory, which consists of raw materials and finished goods, is stated at the lower of cost or net realizable value. Cost comprises purchase price and incidental expenses incurred in bringing the inventory to its present location and condition. Cost is computed using the weighted-average cost method.
The Company writes down its inventory for estimated obsolescence or unmarketable inventory equal to the difference between the cost of inventory and the estimate net realized value based upon assumptions about future demand and market conditions. If actual market conditions are less favorable than those projected by management, inventory write-downs may be required.
Software Development Costs
Costs associated with the planning and design phase of software development are classified as research and development costs and are expensed as incurred. Once technological feasibility has been established, a portion of the costs incurred in development, including coding, testing and quality assurance, are capitalized until available for general release to customers, and subsequently reported at the lower of unamortized cost or net realizable value. Amortization is calculated on a solution-by-solution basis based on the estimated lives of the underlying asset and is included in cost of revenue on the condensed consolidated statements of operations and comprehensive loss. During the three and nine months ended September 30, 2024 and 2023, no software development costs were capitalized, and no amortization was recognized.
Revenue
The Company recognizes revenue from contracts with customers upon transfer of control of promised goods or services at the transaction price which reflects the consideration the Company expects to be entitled in exchange for those goods or services. The transaction price is calculated as selling price net of variable consideration which may include estimates for future returns and sales incentives related to current period product revenue.
The Company generates revenue from the sale of Evie Rings, portable chargers, charging cables, ring sizers, and mobile applications. As part of the purchase, customers also receive customer support and future unspecified software updates. These products and services are collectively referred to as the Evie Ring Elements, each of which is distinct and a separate performance obligation.
The Company allocates the transaction price to all distinct performance obligations based on their relative stand-alone selling price (“SSP”). When available, the Company uses observable prices to determine SSP. When observable prices are not available, SSPs are established that reflect the Company’s best estimates of what the selling prices of the performance obligations would be if they were sold regularly on a stand-alone basis. The Company’s process for estimating SSPs without observable prices considers multiple factors that may vary depending upon the unique facts and circumstances related to each performance obligation including, where applicable, prices charged by the Company for similar offerings, market trends in the pricing for similar offerings, product-specific business objectives and the estimated cost to provide the performance obligation.
7
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Revenue associated with the Evie Ring, portable charger, charging cable, ring sizer, and mobile application performance obligations is recognized upon delivery to customers. The performance obligation for the embedded right to receive, on a when-and-if-available basis, customer support and future unspecified software updates, is recognized to revenue on a straight-line basis over the estimated life of the product and is not material in the periods presented. The Company allocates revenue and any related discounts to these performance obligations based on their relative SSPs. Because the Company lacks observable prices for the undelivered performance obligations, the allocation of revenue is based on the Company’s estimated SSPs.
Sales of the Evie Ring Elements include an assurance warranty.
Contract balances represent amounts presented in the condensed consolidated balance sheets when the Company has transferred goods or services to the customer, or the customer has paid consideration to the Company under the contract. Customer payments are made up-front upon the purchase of products and services. The Company has no accounts receivable as of September 30, 2024, December 31, 2023, or December 31, 2022, respectively. There were no contract assets at September 30, 2024, December 31, 2023, or December 31, 2022.
The Company records a contract liability for deferred revenue when
cash payments from customers are received prior to the transfer of control or satisfaction of the related performance obligations. Deferred
revenue at September 30, 2024, December 31, 2023, and December 31, 2022 was $
The Company offers limited rights of return for
a 30-day right of return, whereby customers may return the Evie Ring Elements. The Company’s estimate of future returns requires
significant judgement. The Company estimates reserves based on data specific to each reporting period and historical trends to date. The
estimate is adjusted each period for actual returns received. The returns reserve is recorded as a reduction of revenue and recognized
in other current liabilities. As of September 30, 2024, December 31, 2023, and December 31, 2022, the balance of product
return provisions included in other current liabilities is $
The Company collects sales taxes at the point of sale and remits the taxes to the proper state authorities. Sales tax is excluded from the measurement of the transaction price.
Shipping and handling costs are incurred as part of fulfillment activities with customers and are included as a component of cost of revenue.
Costs of Revenue
Costs of revenue consists primarily of material costs, freight charges, purchasing and receiving costs, inspection costs, royalties, customer support and other costs, which are directly attributable to the production of the Company’s product. Write-down of inventory to lower of cost or net realizable value is also recorded in cost of goods sold.
Advertising Costs
The
Company expenses advertising costs as they are incurred. Advertising expenses were $
Stock-Based Compensation
The Company measures equity classified stock-based awards granted to employees, directors, and nonemployees based on the estimated fair value on the date of grant and recognizes compensation expense of those awards on a straight-line basis over the requisite service period, which is generally the vesting period of the respective award. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model. This valuation model for stock-based compensation expense requires the Company to make assumptions and judgments about the variables used in the calculation including the expected term, the volatility of the Company’s common stock, and an assumed risk-free interest rate. The Company accounts for forfeitures as they occur.
8
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Income Taxes
The Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on differences between the financial statement and tax basis of assets and liabilities and net operating loss and credit carryforwards using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized. As the Company maintained a full valuation allowance against its deferred tax assets, the changes resulted in no provision or benefit from income taxes during the three and nine months ended September 30, 2024 and 2023, respectively.
The Company accounts for unrecognized tax benefits using a more-likely-than-not threshold for financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. The Company establishes a liability for tax-related uncertainties based on estimates of whether, and the extent to which, additional taxes will be due. The Company records an income tax liability, if any, for the difference between the benefit recognized and measured and the tax position taken or expected to be taken on the Company’s tax returns. To the extent that the assessment of such tax positions changes, the change in estimate is recorded in the period in which the determination is made. The liability is adjusted considering changing facts and circumstances, such as the outcome of a tax audit. The provision for income taxes includes the impact of liability provisions and changes to the liability that are considered appropriate. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs.
For interim periods, the Company estimates its annual effective income tax rate and applies the estimated rate to the year-to-date income or loss before income taxes. The Company computes the tax provision or benefit related to items reported separately and recognizes the items net of their related tax effect in the interim periods in which they occur. The Company recognizes the effect of changes in enacted tax laws or rates in the interim periods in which the changes occur.
Net Loss per Share
Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. The weighted average number of common shares used in calculating basic and diluted net loss per share includes the weighted-average pre-funded common stock warrants outstanding during the period as they are exercisable at any time for nominal cash consideration. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive.
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The disclosure requirements must be applied retrospectively to all prior periods presented in the financial statements. The effective date for the standard is for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the effects adoption of this guidance will have on the consolidated financial statements for fiscal year 2024.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, to require disclosure, in the notes to financial statements, of specified information about certain costs and expenses. The effective date for the standard is for fiscal years beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the effects adoption of this guidance will have on the consolidated financial statements.
Note 3 – FAIR VALUE MEASUREMENTS
Financial assets and liabilities are recorded at fair value. The Company uses a three-level hierarchy, which prioritizes, within the measurement of fair value, the use of market-based information over entity-specific information for fair value measurements based on the nature of inputs used in the valuation of an asset or liability as of the measurement date. Fair value focuses on an exit price and is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The inputs or methodology used for valuing financial instruments are not necessarily an indication of the risk associated with investing in those financial instruments.
9
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
A three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows:
| Level 1 – | Quoted prices in active markets for identical assets or liabilities. |
| Level 2 – | Quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable, either directly or indirectly. |
| Level 3 – | Significant unobservable inputs that cannot be corroborated by market data. |
The asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company’s Level 1 financial assets are money market funds whose fair values are based on quoted market prices. The carrying amounts of prepaid expenses and other current assets, payroll tax credit, vendor deposits, inventory, accounts payable, deferred revenue, and other current liabilities approximate fair value due to the short-term nature of these instruments.
The following tables provide a summary of the assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2024 and December 31, 2023 (in thousands):
| September 30, 2024 | ||||||||||||||||
| Fair Value | Level 1 | Level 2 | Level 3 | |||||||||||||
| Cash equivalents: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total cash equivalents | $ | $ | $ | $ | ||||||||||||
| December 31, 2023 | ||||||||||||||||
| Fair Value | Level 1 | Level 2 | Level 3 | |||||||||||||
| Cash equivalents: | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Total cash equivalents | $ | $ | $ | $ | ||||||||||||
Note 4 – CASH AND CASH EQUIVALENTS
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Cash and cash equivalents: | ||||||||
| Cash | $ | $ | ||||||
| Money market funds | ||||||||
| Total cash and cash equivalents | $ | $ | ||||||
10
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note 5 – BALANCE SHEET COMPONENTS
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Raw materials | $ | | $ | |||||
| Finished goods | ||||||||
| Total inventory | $ | $ | ||||||
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Office equipment and furniture | $ | $ | ||||||
| Software | ||||||||
| Test equipment | ||||||||
| Total property and equipment | ||||||||
| Less: accumulated depreciation | ( | ) | ( | ) | ||||
| Total property and equipment, net | $ | $ | ||||||
Total
depreciation and amortization expense related to property and equipment for the three and nine months ended September 30, 2024 was
approximately $
Note 6 – Other Current Liabilities
| September 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Accrued compensation | $ | $ | ||||||
| Accrued research and development | ||||||||
| Accrued inventory | ||||||||
| Accrued vacation | ||||||||
| Accrued severance payment | ||||||||
| Lease liabilities, current portion | ||||||||
| Other | ||||||||
| $ | $ | |||||||
11
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note 7 – Common Stock
As
of September 30, 2024 and December 31, 2023, the Company was authorized to issue
On July 9,
2024, the Company filed a Certificate of Amendment to its Third Amended and Restated Certificate of Incorporation increasing the number
of authorized shares of common stock from
On October 29, 2024, the Company completed a 1-for-15 reverse stock split of its issued and outstanding common stock. As a result of the Reverse Stock Split, each share of common stock issued and outstanding immediately prior to October 29, 2024 were automatically reclassified and converted into one-fifteenth (1/15th) of a share of common stock.
At-the-Market Issuance of Common Stock
On
August 15, 2022, the Company entered into an At-the-Market Issuance Agreement (the “Issuance Agreement”) with B. Riley Securities,
Inc. (the “Sales Agent”). Pursuant to the terms of the Issuance Agreement, the Company may sell from time to time through
the Sales Agent shares of the Company’s common stock having an aggregate offering price of up to $
Under the terms of the Issuance Agreement, the Company may also sell Shares to the Sales Agent as principal for its own accounts at a price to be agreed upon at the time of sale. Any sale of Shares to the Sales Agent as principal would be pursuant to the terms of a separate agreement between the Company and the Sales Agent.
The Company has no obligation to sell any of the Shares under the Issuance Agreement and may at any time suspend solicitation and offers under the Issuance Agreement.
In June 2024, the Company replaced B. Riley Securities with Jones Trading as the Sales Agent for the Issuance Agreement.
During
the three months ended September 30, 2024 and 2023, the Company issued and sold an aggregate of
Common Stock Reserved for Future Issuance
| September 30, | ||||
| 2024 | ||||
| Warrants to purchase common stock | ||||
| Stock options outstanding | ||||
| Stock options available for future grants | ||||
| Total | ||||
Early Exercised Stock Option Liability
During the three and nine months ended September 30, 2024 and 2023, no additional shares were issued upon the early exercise of common stock options. The Exercise Notice (Early Exercise) Agreement states that the Company has the option to repurchase all or a portion of the unvested shares in the event of the separation of the holder from service to the Company. The shares continue to vest in accordance with the original vesting schedules of the former option agreements.
As of September 30, 2024 and December 31,
2023, the Company has recorded a repurchase liability for approximately
12
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note 8 – Common Stock Warrants
Preferred A and B Placement Warrants
During
May 2024, the Board approved the amendment of
April 2024 Pre-funded and Common Stock Warrants
On April 2, 2024, the Company entered into
a securities purchase agreement for the private placement of an aggregate of
Pre-funded warrants totaling
Warrants totaling
The
warrants were recorded on a relative fair value basis at the date of issuance using the Black-Scholes model, which was recorded as a
debit to issuance costs and a credit to additional paid-in capital on the condensed consolidated balance sheets. The warrants are not
remeasured in future periods as the warrants meet the conditions for equity classification. The relative fair value of the April 2024
Pre-funded warrants was $
| Expected term | ||||
| Expected volatility | % | |||
| Risk-free interest rate | % | |||
| Expected dividends | % | |||
August 2024 Common Stock Warrants
On August 14, 2024, in connection with a strategic advisory agreement,
the Company issued warrants to purchase
The August 2024 Warrants had a grant-date fair value of $
| Expected term | ||||
| Expected volatility | % | |||
| Risk-free interest rate | % | |||
| Expected dividends | % |
13
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
| Warrant Issuance | Issuance | Weighted Average Exercise Price | Outstanding, December 31, 2023 | Granted | Exercised | Canceled/ Expired | Outstanding, September 30, 2024 | Expiration | ||||||||||||||||||||||
| Preferred A Placement Warrants | $ | |||||||||||||||||||||||||||||
| Preferred B Placement Warrants | $ | |||||||||||||||||||||||||||||
| Convertible Notes Placement Warrants | $ | |||||||||||||||||||||||||||||
| Underwriter Warrants | $ | |||||||||||||||||||||||||||||
| January 2023 warrants | $ | |||||||||||||||||||||||||||||
| February 2023 warrants | $ | |||||||||||||||||||||||||||||
| August 2023 warrants | $ | |||||||||||||||||||||||||||||
| April 2024 Pre-Funded warrants | $ | |||||||||||||||||||||||||||||
| April 2024 warrants | $ | |||||||||||||||||||||||||||||
| August 2024 warrants | $ | |||||||||||||||||||||||||||||
| Warrant Issuance | Issuance | Weighted Average Exercise Price | Outstanding, December 31, 2022 | Granted | Exercised | Canceled/ Expired | Outstanding, September 30, 2023 | Expiration | ||||||||||||||||||||||
| Preferred A Placement Warrants | $ | |||||||||||||||||||||||||||||
| Preferred A Lead Investor Warrants | $ | ( | ) | |||||||||||||||||||||||||||
| Preferred B Placement Warrants | $ | |||||||||||||||||||||||||||||
| Convertible Notes Placement Warrants | $ | |||||||||||||||||||||||||||||
| Underwriter Warrants | $ | |||||||||||||||||||||||||||||
| January 2023 warrants | $ | |||||||||||||||||||||||||||||
| February 2023 warrants | $ | |||||||||||||||||||||||||||||
| August 2023 warrants | $ | |||||||||||||||||||||||||||||
| ( | ) | |||||||||||||||||||||||||||||
14
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note 9 – Stock-based Compensation
On July 9, 2024, the Company amended the 2019 Equity Incentive
Plan to authorize
2019 Equity Incentive Plan
As of September 30, 2024, the Company had
2021 Employment Inducement Plan
As of September 30, 2024, the Company had
Stock Options
| Number of Options | Weighted Average Exercise Price | Weighted Average Remaining Life | Intrinsic Value | |||||||||||
| Outstanding at December 31, 2023 | $ | | $ | |||||||||||
| Granted | $ | |||||||||||||
| Exercised | ( | ) | $ | |||||||||||
| Cancelled | ( | ) | $ | |||||||||||
| Outstanding at September 30, 2024 | $ | | $ | |||||||||||
| Exercisable as of September 30, 2024 | $ | | $ | |||||||||||
| Vested and expected to vest as of September 30, 2024 | $ | | $ | |||||||||||
The weighted-average grant date fair value of options granted during
the nine months ended September 30, 2024 and 2023, was $
15
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
The
Company estimated the fair value of stock options using the Black-Scholes option pricing model.
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Dividend yield | % | — | % | |||||
| Expected volatility | % | 61.88 | % | |||||
| Risk-free interest rate | % | 3.73 | % | |||||
| Expected life | 5.97 years | |||||||
Dividend Rate—The expected dividend rate was assumed to be zero, as the Company had not previously paid dividends on common stock and has no current plans to do so.
Expected Volatility—The expected volatility was derived from the historical stock volatilities of several public companies within the Company’s industry that the Company considers to be comparable to the business over a period equivalent to the expected term of the stock option grants.
Risk-Free Interest Rate—The risk-free interest rate is based on the interest yield in effect at the date of grant for zero coupon U. S. Treasury notes with maturities approximately equal to the option’s expected term.
Expected Term—The expected term represents the period that the Company’s stock options are expected to be outstanding. The expected term of option grants that are considered to be “plain vanilla” are determined using the simplified method. The simplified method deems the term to be the average of the time-to-vesting and the contractual life of the options. For other option grants not considered to be “plain vanilla,” the Company determined the expected term to be the contractual life of the options.
Forfeiture Rate—The Company recognizes forfeitures when they occur.
| Three
Months Ended September 30, | Nine
Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Cost of revenue | $ | $ | $ | $ | ||||||||||||
| Research and development | ||||||||||||||||
| Sales, general and administrative | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
As of September 30, 2024, unamortized compensation expense related to unvested stock options was approximately $
16
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note 10 – Commitments and Contingencies
Operating and Finance Leases
On
June 19, 2024, the Company executed the third amendment to the original corporate office and facilities lease. The purpose of the amendment
was to extend the lease term of the facilities consisting of (i)
The
lease amendment was accounted for as a lease modification. The right-of-use asset and operating lease liability for the existing premises
were remeasured at the modification date, which resulted in an increase of $
| September 30, | December 31, | |||||||
| Operating and Finance leases | 2024 | 2023 | ||||||
| Right-of-use assets | $ | $ | ||||||
| Operating lease liabilities - Short-term | $ | $ | ||||||
| Operating lease liabilities - Long-term | $ | $ | ||||||
| Finance lease liabilities - Short-term | $ | $ | ||||||
| Finance lease liabilities - Long-term | $ | $ | ||||||
The short-term balances of operating and finance lease liabilities are included in other current liabilities on the Company’s condensed consolidated balance sheets. The long-term balances of operating and finance lease liabilities are included in other noncurrent liabilities on the Company’s condensed consolidated balance sheets.
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Lease Cost: | ||||||||||||||||
| Operating lease cost | $ | $ | $ | $ | ||||||||||||
| Other Information: | ||||||||||||||||
| Cash paid for amounts included in the measurement of lease liabilities for the year ended | $ | $ | $ | $ | ||||||||||||
| Weighted average remaining lease term - operating leases (in years) | ||||||||||||||||
| Average discount rate - operating leases | % | % | % | % | ||||||||||||
| Weighted average remaining lease term - financing leases (in years) | — | — | ||||||||||||||
| Average discount rate - financing leases | % | |||||||||||||||
17
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
| 2024 | $ | |||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| Total lease payments | ||||
| Less: Interest | ( | ) | ||
| Total lease liabilities | $ |
Litigation
From time to time, the Company may become involved in various litigation and administrative proceedings relating to claims arising from its operations in the normal course of business. Management is not currently aware of any matters that may have a material adverse impact on the Company’s business, financial position, results of operations or cash flows.
Indemnification
The Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to these arrangements, the Company indemnifies, holds harmless and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third party with respect to its technology. The term of these indemnification agreements is generally perpetual after the execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these agreements is not determinable because it involves claims that may be made against the Company in the future, but have not yet been made. The Company has not incurred costs to defend lawsuits or settle claims related to these indemnification agreements.
The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct of the individual.
No amounts associated with such indemnifications have been recorded as of September 30, 2024.
Non-cancelable Obligations
The Company did not have any non-cancelable contractual commitments as of September 30, 2024.
Royalty Commitments
The Company is required to make certain usage-based royalty payments
to a vendor. The royalty amount is calculated based on the number of Evie Rings shipped, as adjusted for returns and refunds to customers,
and the number of specified algorithms developed by the vendor that are included on the Evie Rings. The maximum amount of the royalty
commitment is approximately $
18
Movano Inc.
Notes to Condensed Consolidated Financial Statements
For the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note 11 – NET LOSS PER SHARE
| Three
Months Ended September 30, | Nine
Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Numerator: | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Denominator: | ||||||||||||||||
| Weighted average shares used in computing net loss per share, basic and diluted | ||||||||||||||||
| Net loss per share, basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Nine Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Shares subject to options to purchase common stock | ||||||||
| Shares subject to warrants to purchase common stock | ||||||||
| Total | ||||||||
For both the three and nine months ended September 30,
2024, there were performance-based option awards for shares of common stock. For both the three and nine months ended September 30,
2023, performance-based option awards for
Note 12 – Subsequent Events
Management of the Company evaluated events that have occurred after the balance sheet dates through the date these condensed consolidated financial statements were issued. No events required disclosure in the condensed consolidated financial statements.
19
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy”, “future”, “likely” or other comparable terms and references to future periods. All statements other than statements of historical facts included in this Form 10-Q regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expectations for revenues, cash flows and financial performance, the anticipated results of our development efforts, product features and the timing for receipt of required regulatory approvals and product launches.
Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following:
| ● | our limited operating history and our ability to achieve profitability; |
| ● | the failure of our common stock to meet the minimum requirements for continued listing on the Nasdaq Capital Market; |
| ● | our ability to continue as a going concern and our need for and ability to obtain additional capital in the future; |
| ● | our ability to demonstrate the feasibility of and develop products and their underlying technologies; |
| ● | the impact of competitive or alternative products, technologies and pricing; |
| ● | our ability to attract and retain highly qualified personnel; |
| ● | our dependence on consultants to assist in the development of our technologies; |
| ● | our ability to manage the growth of our Company and to realize the benefits from any acquisitions or strategic alliances we may enter in the future; |
| ● | the impact of macroeconomic and geopolitical conditions including increases in prices caused by rising inflation; |
| ● | our dependence on the successful commercialization of the Evie Ring; |
| ● | our dependence on third parties to design, manufacture, market and distribute our products; |
| ● | the adequacy of protections afforded to us by the patents that we own and the success we may have in, and the cost to us of, maintaining, enforcing and defending those patents; |
| ● | our need to secure required FCC, FDA and other regulatory approvals from governmental authorities in the United States; |
| ● | the impact of healthcare regulations and reform measures; |
| ● | the accuracy of our estimates of market size for our products; |
| ● | our ability to implement and maintain effective control over financial reporting and disclosure controls and procedures; and |
| ● | our success at managing the risks involved in the foregoing items. |
The risks included above are not exhaustive. Other important risks and uncertainties are described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Form 10-K”). Except as otherwise required by the federal securities laws, we undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Overview
Movano Inc., dba Movano Health, a Delaware corporation, is developing a platform to deliver purpose-driven healthcare solutions to bring medical-grade, high-quality data to the forefront of consumer health devices.
20
Our initial commercial product is the Evie Ring, a wearable designed specifically for women that was launched in November 2023. The Evie Ring combines health and wellness metrics to give a full picture of one’s health, which include resting heart rate, heart rate variability (“HRV”), blood oxygen saturation (“SpO2”), respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and calories burned, sleep stages and duration, and mood tracking. The device provides women with continuous health data distilled down to simple, yet meaningful, insights to help them make manageable lifestyle changes and take a more proactive approach that could mitigate the risks of chronic disease.
We launched the Evie Ring as a general wellness device without any FDA premarket clearances. Separately, we are planning to seek FDA clearances on our medical device, which will be sold under the brand name EvieMED. We believe EvieMED will be one of the first patient wearables with FDA clearance on the entire system, both hardware and software, differing from our competition which sometimes gets FDA clearance on an individual algorithm under “Software as a Medical Device” guidance. In July 2023, we filed our first 510(k) submission to the FDA for the EvieMED Ring’s pulse oximeter to monitor pulse and SpO2 data, following a successful pivotal hypoxia trial during the fourth quarter of 2022. With progressive changes in the device and significant additional requirements from FDA since the initial submission, we opted to withdraw the 2023 510(k). Armed with FDA’s review of the initial 510(k) and results from a second pivotal hypoxia trial using the production model ring completed in the first quarter of 2024, we re-submitted in April 2024. We believe that FDA clearance of these metrics, sold via prescription under the brand name EvieMED, would foster clinical-level confidence in EvieMED’s monitoring capabilities and could make the device attractive to clinicians and to facilities engaged in clinical trials for at-home and/or long-term patient monitoring.
In addition to the Evie Ring and EvieMED Ring, we are developing one of the smallest patented and proprietary System-on-a-Chip (“SoC”) designed specifically for blood pressure or continuous glucose monitoring systems (“GCM”). We built the integrated sensor from the ground up with multiple antennas and a variety of frequencies to achieve an unprecedented level of precision in health monitoring. We are currently conducting clinical trials with the SoC and developing algorithms that, if successful, will enable us to develop wearables that can monitor glucose non-invasively and blood pressure without a cuff. To that end, we are currently conducting a longitudinal study (n=100) to program the effects of stress on blood pressure over time, with results pending. Our end goal is to bring a Class II FDA-cleared device to the market that includes CGM and cuffless blood pressure monitoring capabilities. Over time, our technology could also enable the measurement and continuous monitoring of other health data.
On April 28, 2021, the Company established Movano Ireland Limited, organized under the laws of Ireland, as a wholly owned subsidiary of the Company.
Financial Operations Overview
We are an early-stage technology company with a limited operating history. To date, we have invested substantially all of our efforts and financial resources into (i) the research and development of the products we are developing, including conducting clinical studies and related sales, general and administrative costs, and (ii) the commercialization of our first commercial product, the Evie Ring. To date, we have funded our operations primarily from the sale of our equity securities.
We have incurred net losses in each year since inception. Our losses were $19.1 million and $23.3 million for the nine months ended September 30, 2024 and 2023, respectively. Substantially all our net losses have resulted from costs incurred in connection with our research and development programs and from sales, general and administrative costs associated with our operations.
As of September 30, 2024, we had $11.3 million in available cash and cash equivalents.
Reverse Stock Split
On October 29, 2024, we completed a 1-for-15 reverse stock split of our issued and outstanding common stock. As a result of the Reverse Stock Split, each share of common stock issued and outstanding immediately prior to October 29, 2024 were automatically reclassified and converted into one-fifteenth (1/15th) of a share of common stock. The Reverse Stock Split affected all common stockholders uniformly and did not alter any stockholder's percentage interest in our equity, except to the extent that the Reverse Stock Split resulted in a stockholder of record owning a fractional share. Stockholders of record who were otherwise entitled to receive a fractional share, instead automatically had their fractional shares rounded up to the next whole share. No cash was issued for fractional shares as part of the Reverse Stock Split.
The Reverse Stock Split did not change the par value of the common stock or the authorized number of shares of common stock. Proportionate adjustments were made to the exercise prices and the number of shares underlying our equity plans and grants thereunder, as applicable. The amount of undistributed shares of Common Stock deemed to be covered by our effective registration statements on Forms S-3 and S-8 were proportionately reduced as of the effective time of the Reverse Stock Split at the Reverse Stock Split Ratio. Additionally, proportionate adjustments were made to the exercise prices and the number of shares underlying all outstanding warrants, as required by the terms of these securities.
All common share and per-share amounts in this Form 10-Q have been retroactively restated to reflect the effect of the Reverse Stock Split.
Critical Accounting Policies and Estimates
The discussion and analysis of our condensed consolidated financial condition and results of operations are based on our condensed consolidated financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements as well as the reported revenue and expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
21
There have been no material changes in our critical accounting policies and estimates during the three and nine months ended September 30, 2024, as compared to those disclosed in the 2023 Form 10-K.
Recently Issued and Adopted Accounting Pronouncements
A description of recently adopted and recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2, Recently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements, to our audited financial statements for the year ended December 31, 2023, and notes thereto, included in the Company’s Annual Report on Form 10-K.
See Note 2 to our condensed consolidated financial statements included in Part I, Item 1, “Notes to Condensed Consolidated Financial Statements,” of this Quarterly Report on Form 10-Q for a description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations.
Results of Operations
Three and nine months ended September 30, 2024 and 2023
Our condensed consolidated statements of operations for the three and nine months ended September 30, 2024 and 2023 as discussed herein are presented below.
| Three
Months Ended September 30, | Change | Nine
Months Ended September 30, | Change | |||||||||||||||||||||||||||||
| 2024 | 2023 | $ | % | 2024 | 2023 | $ | % | |||||||||||||||||||||||||
(in thousands) | (in thousands) | |||||||||||||||||||||||||||||||
| Revenue | $ | 50 | $ | — | $ | 50 | n/a | $ | 902 | $ | — | $ | 902 | n/a | ||||||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||||||||||||||||||
| Cost of revenue | 845 | — | 845 | n/a | 2,440 | — | 2,440 | n/a | ||||||||||||||||||||||||
| Research and development | 3,404 | 5,636 | (2,232 | ) | -40% | 9,198 | 13,701 | (4,503 | ) | -33% | ||||||||||||||||||||||
| Sales, general and administrative | 3,180 | 3,443 | (263 | ) | -8% | 8,794 | 9,965 | (1,171 | ) | -12% | ||||||||||||||||||||||
| Total operating expenses | 7,429 | 9,079 | (1,650 | ) | -18% | 20,432 | 23,666 | (3,234 | ) | -14% | ||||||||||||||||||||||
| Loss from operations | (7,379 | ) | (9,079 | ) | 1,700 | 19% | (19,530 | ) | (23,666 | ) | 4,136 | 17% | ||||||||||||||||||||
| Other income (expense), net: | ||||||||||||||||||||||||||||||||
| Interest and other income, net | 178 | 117 | 61 | 52% | 419 | 341 | 78 | 23% | ||||||||||||||||||||||||
| Other income (expense), net | 178 | 117 | 61 | 52% | 419 | 341 | 78 | 23% | ||||||||||||||||||||||||
| Net loss | $ | (7,201 | ) | $ | (8,962 | ) | $ | 1,761 | 20% | $ | (19,111 | ) | $ | (23,325 | ) | $ | 4,214 | 18% | ||||||||||||||
Revenue
Revenue totaled $50,000 and $0 for the three months ended September 30, 2024 and 2023, respectively. The transfer of control of the Evie Ring Elements began in the first quarter of 2024, was completed in the second quarter of 2024, then re-started in the third quarter of 2024.
Revenue totaled $0.9 million and $0 for the nine months ended September 30, 2024 and 2023, respectively. This increase of $0.9 million was due to recognition of revenue upon the transfer of control of the Evie Ring Elements, which began in the first quarter of 2024.
Cost of revenue
Cost of revenue totaled $0.8 million and $0 for the three months ended September 30, 2024 and 2023, respectively. This increase of $0.8 million was due to the direct costs of $0.2 million related to the transfer of control of the various Evie Ring Elements, $0.1 million for labor and related stock-based compensation, and $0.5 million for inventory that was designated as scrap materials.
Cost of revenue totaled $2.4 million and $0 for the nine months ended September 30, 2024 and 2023, respectively. This increase of $2.4 million was due to the direct costs of $1.4 million related to the transfer of control of the various Evie Ring Elements, $0.3 million for labor and related stock-based compensation, $0.1 million for order processing, shipping and fulfillment costs, and $0.6 million for inventory that was designated as scrap materials.
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Research and Development
Research and development expenses totaled $3.4 million and $5.6 million for the three months ended September 30, 2024 and 2023, respectively. This decrease of $2.2 million was due primarily to lower research and laboratory expenses and other professional fees. Research and development expenses for the three months ended September 30, 2024 included expenses related to employee compensation of $1.8 million, other professional fees of $1.1 million, research and laboratory expenses of $0.3 million, and other expenses of $0.2 million. Research and development expenses for the three months ended September 30, 2023 included expenses related to employee compensation of $1.6 million, other professional fees of $1.6 million, research and laboratory expenses of $2.1 million, and other expenses of $0.3 million.
Research and development expenses totaled $9.2 million and $13.7 million for the nine months ended September 30, 2024 and 2023, respectively. This decrease of $4.4 million was due primarily to lower research and laboratory expenses and other professional fees. Research and development expenses for the nine months ended September 30, 2024 included expenses related to employee compensation of $5.0 million, other professional fees of $2.4 million, research and laboratory expenses of $1.2 million, and other expenses of $0.6 million. Research and development expenses for the nine months ended September 30, 2023 included expenses related to employee compensation of $5.0 million, other professional fees of $4.1 million, research and laboratory expenses of $3.8 million, and other expenses of $0.8 million.
Sales, General and Administrative
Sales, general and administrative expenses totaled $3.2 million and $3.4 million for the three months ended September 30, 2024 and 2023, respectively. This decrease of $0.2 million was due primarily to lower headcount with respect to sales, general and administrative employees and decreased marketing costs, offset by increased stock compensation expenses related to the issuance of new option grants. Sales, general and administrative expenses for the three months ended September 30, 2024 included expenses related to employee and board of director compensation of $1.8 million, professional and consulting fees of $0.8 million, and other expenses of $0.6 million. Sales, general and administrative expenses for the three months ended September 30, 2023 included expenses related to employee and board of director compensation of $1.7 million, professional and consulting fees of $0.6 million, and other expenses of $1.1 million.
Sales, general and administrative expenses totaled $8.8 million and $10.0 million for the nine months ended September 30, 2024 and 2023, respectively. This decrease of $1.2 million was due primarily to lower Company headcount with respect to sales, general and administrative employees and decreased marketing costs, offset by increased stock compensation expenses related to the issuance of new option grants. Sales, general and administrative expenses for the nine months ended September 30, 2024 included expenses related to employee and board of director compensation of $4.8 million, professional and consulting fees of $2.3 million, and other expenses of $1.7 million. Sales, general and administrative expenses for the nine months ended September 30, 2023 included expenses related to employee and board of director compensation of $5.1 million, professional and consulting fees of $1.8 million, and other expenses of $3.1 million.
Loss from Operations
Loss from operations was $7.4 million for the three months ended September 30, 2024, as compared to $9.1 million for the three months ended September 30, 2023.
Loss from operations was $19.5 million for the nine months ended September 30, 2024, as compared to $23.7 million for the nine months ended September 30, 2023.
Other Income (Expense), Net
Other income (expense), net for the three months ended September 30, 2024 was a net other income of $0.2 million as compared to a net other income of $0.1 million for the three months ended September 30, 2023. The increase of $0.1 million is attributable to interest income on the additional funds that were received from the April 2024 Private Placement.
Other income (expense), net for the nine months ended September 30, 2024 was a net other income of $0.4 million as compared to a net other income of $0.3 million for the nine months ended September 30, 2023. The increase of $0.1 million is attributable to interest income on the additional funds that were received from the April 2024 Private Placement.
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Net Loss
As a result of the foregoing, net loss was $7.2 million for the three months ended September 30, 2024, as compared to $9.0 million for the three months ended September 30, 2023.
As a result of the foregoing, net loss was $19.1 million for the nine months ended September 30, 2024, as compared to $23.3 million for the nine months ended September 30, 2023.
Liquidity and Capital Resources
At September 30, 2024, we had cash and cash equivalents totaling $11.3 million. During the nine months ended September 30, 2024, we used $18.0 million of cash in our operating activities. Our cash and cash equivalents are not expected to be sufficient to fund our operations for the next twelve months after the date these condensed consolidated financial statements are issued. In August 2022, we entered into an at-the-market issuance (“ATM”) to sell shares of our common stock for aggregate gross proceeds of up to $50.0 million, from time to time, through an ATM equity offering program. During the nine months ended September 30, 2024, we sold an aggregate of 99,061 shares of common stock through the ATM program for proceeds of approximately $0.6 million, net of commissions paid. Approximately $43.7 million remained available on the ATM equity offering program at September 30, 2024.
On April 2, 2024, the Company entered into a securities purchase agreement for the private placement of an aggregate of 3,015,172 units with each unit consisting of (1) one share of the Company’s common stock or at the election of the purchaser a pre-funded warrant, and (2) one warrant to purchase one share of common stock. The purchase price paid for each unit was $8.00. Certain directors and officers participated and purchased 19,168 units at an offering price of $8.48 per unit.
Each pre-funded warrant has an exercise price of $0.015 per share, was immediately exercisable on the date of issuance and does not expire. Each warrant has an exercise price equal to $6.11 per share, was exercisable immediately and expires on the fifth anniversary of the initial exercise date of the warrant. The warrants issued to the Company’s officers and directors have an exercise price equal to $6.60.
The private placement transaction closed on April 5, 2024, resulting in gross proceeds to the Company of approximately $24.1 million, before deducting offering fees and expenses of approximately $1.5 million.
We expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We anticipate that our expenses will increase substantially as we:
| ● | advance the engineering design and development of the Evie Ring and other potential products; |
| ● | prepare applications required for marketing approval of the Evie Ring in the United States; |
| ● | develop our plans for manufacturing, distributing and marketing the Evie Ring and other potential products; and |
| ● | add operational, financial and management information systems and personnel, including personnel to support our product development, planned commercialization efforts and our operation as a public company. |
Until we can generate a sufficient amount of revenue from our planned products, if ever, we expect to finance future cash needs through public or private equity offerings, debt financings or corporate collaborations and licensing arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available, we may be required to delay, reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts or it may become impossible for us to remain in operation. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience additional dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds through collaborations and licensing arrangements, it may be necessary to relinquish some rights to our technologies or applications or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time.
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These circumstances raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the condensed consolidated financial statements are issued. Our condensed consolidated financial statements do not include adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern. Our ability to continue as a going concern depends on our ability to raise additional capital as described above to support our future operations.
The following table summarizes our cash flows for the periods indicated:
| Nine
Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Net cash used in operating activities | $ | (17,978 | ) | $ | (20,928 | ) | ||
| Net cash used in investing activities | (3 | ) | (51 | ) | ||||
| Net cash provided by financing activities | 23,135 | 17,889 | ||||||
| Net increase / (decrease) in cash and cash equivalents | $ | 5,154 | $ | (3,090 | ) | |||
Operating Activities
During the nine months ended September 30, 2024, the Company used cash of $18.0 million in operating activities, as compared to $20.9 million used in operating activities during the nine months ended September 30, 2023.
The $18.0 million used in operating activities during the nine months ended September 30, 2024 was primarily attributable to our net loss of $19.1 million during the period. The net loss was offset by changes in our operating assets and liabilities totaling $1.9 million and by non-cash items, including stock-based compensation, totaling $3.0 million.
The $20.9 million used in operating activities during the nine months ended September 30, 2023 was primarily attributable to our net loss of $23.3 million during the period. The net loss was offset by non-cash items, including stock-based compensation of $2.3 million and depreciation and amortization of $0.1 million.
Investing Activities
During the nine months ended September 30, 2024 the Company used cash of $3,000 in investing activities, consisting of purchases of property and equipment.
During the nine months ended September 30, 2023 the Company used cash of $51,000 in investing activities, consisting of purchases of property and equipment.
Financing Activities
During the nine months ended September 30, 2024, the Company was provided cash of $23.1 million which included net proceeds $22.6 million from the issuance of common stock, pre-funded warrants and common stock warrants, and net proceeds of $0.5 million for the issuance of common stock through the ATM activity and the exercise of common stock options.
During the nine months ended September 30, 2023, the Company was provided cash of $17.9 million which included net proceeds of $6.7 million and $8.1 million from the issuance of common stock in public offerings in February 2023 and June 2023, respectively, net proceeds of $3.1 million for the issuance of common stock through the ATM activity and $0.1 million from the issuance of common stock upon the exercise of common stock options.
Off-Balance Sheet Transactions
At September 30, 2024, the Company did not have any transactions, obligations or relationships that could be considered off-balance sheet arrangements.
Non-cancelable Obligations
The Company did not have any non-cancelable obligations at September 30, 2024.
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Item 3. Quantitative and Qualitative Disclosure About Market Risk
As a smaller reporting company, we are not required to provide the information required by this Item 3.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We are responsible for maintaining disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Disclosure controls and procedures are controls and other procedures designed to ensure that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate to allow timely decisions regarding required disclosure.
Based on our management’s evaluation (with the participation of our principal executive officer and our principal financial officer) of our disclosure controls and procedures as required by Rule 13a-15 under the Exchange Act, our principal executive officer and our principal financial officer have concluded that, due to the previously identified material weakness in our internal controls over financial reporting that is described below, our disclosure controls and procedures were not effective as of September 30, 2024, the end of the period covered by this report.
A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented or detected on a timely basis. As previously disclosed in our 2023 Form 10-K, we identified one material weakness in our internal control over financial reporting at December 31, 2023 related to ineffective design and operation of our financial close and reporting controls. Specifically, we did not design and maintain effective controls over certain account reviews and analyses and certain information technology general controls. Although we are making efforts to remediate these issues, these efforts may not be sufficient to avoid similar material weaknesses in the future.
Inherent Limitations on Effectiveness of Controls
Our management, including our principal executive officer and our principal financial officer, do not expect that our disclosure controls or our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of a simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of control effectiveness to future periods are subject to risks. Over time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the nine months ended September 30, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently a party to any pending legal proceedings that we believe will have a material adverse effect on our business or financial condition. We may, however, be subject to various claims and legal actions arising in the ordinary course of business from time to time.
Item 1A. Risk Factors
We operate in a rapidly changing environment that involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond our control. In addition to the risk factor included below and other information set forth in this report, the risks and uncertainties that we believe are most important for you to consider are discussed in Part I, “Item 1A. Risk Factors” in the 2023 Form 10-K. Except as disclosed below, we believe that there have been no material changes to the risk factors described in the 2023 Form 10-K.
Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our common stock.
Our common stock is currently traded on the Nasdaq Stock Market (“Nasdaq”). On November 14, 2023, we were notified by Nasdaq that because the closing bid price for the Company’s common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company no longer meets the minimum bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Marketplace Rule 5550(a)(2), requiring a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”). On May 15, 2024, since the Company did not regain compliance by May 13, 2024, the Company requested, and was granted, an additional 180 calendar days to regain compliance with Bid Price Requirement expiring November 11, 2024.
On October 29, 2024, the Company completed a 1-for-15 Reverse Stock Split of its issued and outstanding common stock. On November 12, 2024, the Company was notified by Nasdaq that it had regained compliance with the Minimum Bid Price Requirement. Even though the Company is now in compliance with continued listing requirements of Nasdaq, any future failure of the Company to satisfy such requirements could result in Nasdaq taking steps to delist the Company’s common stock. Such a delisting would likely have a negative effect on the price of the Company’s common stock and would impair shareholders’ ability to sell or purchase the Company’s common stock. In the event of a delisting, the Company would take actions to restore its compliance with Nasdaq’s listing requirements, but the Company can provide no assurance that any such action taken by the Company would allow its common stock to become listed again, stabilize the market price or improve the liquidity of the Company’s common stock, prevent the Company’s common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements
Item 2. Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities
Not applicable.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
Rule 10b5-1 Trading Plans
During the third quarter of 2024, none of the
Company’s directors or executive officers
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Item 6. Exhibits
| * | Filed herewith. |
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| MOVANO INC. | ||
| Date: November 14, 2024 | By: | /s/ John Mastrototaro |
| John Mastrototaro | ||
| Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| MOVANO INC. | ||
| Date: November 14, 2024 | By: | /s/ J. Cogan |
| J. Cogan | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
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