The following discussion of our financial condition and results of operations should be read in conjunction with the financial statements and the related notes thereto included elsewhere in this Annual Report. This discussion and analysis contains forward-looking statements that are based on our management's current beliefs and assumptions, which statements are subject to substantial risks and uncertainties. Our actual results may differ materially from those expressed or implied by these forward-looking statements as a result of many factors, including those discussed in "Risk Factors" in Item 1A of this Annual Report. Please also see "Cautionary Note Regarding Forward-Looking Statements" at the beginning of this Annual Report. Overview
The Company's initial commercial product in development is the Evie Ring which is a wearable designed specifically for women. The Evie Ring combines health and wellness metrics to give a full picture of one's health, including resting heart rate, heart rate variability ("HRV"), 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. In addition to the Evie Ring, we are developing one of the smallest patented and proprietary SoC designed specifically for blood pressure or CGM systems.Movano Health 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 will enable us to develop wearables that can monitor glucose non-invasively and blood pressure without a cuff. 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
Financial Operations Overview
We are a development stage company with a limited operating history. To date, we have invested substantially all of our efforts and financial resources into the research and development of the products we are developing, including conducting clinical studies and related sales, general and administrative costs. 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 net losses were$30.3 million and$21.8 million for the years endedDecember 31, 2022 and 2021, 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
Adoption of New Accounting Pronouncement - Leases
InFebruary 2016 , the FASB issued ASU 2016-02, Leases (ASC 842) which requires lessees to recognize leases on the balance sheet by recording a right-of-use asset and lease liability. We adopted this new guidance as ofJanuary 1, 2022 and applied the modified retrospective approach, whereby prior comparative periods will not be retrospectively presented in the consolidated financial statements. We elected the package of practical expedients not to reassess prior conclusions related to contracts containing leases and lease classification and the lessee practical expedient to combine lease and non-lease components for all asset classes. We made a policy election to not recognize right-of-use assets and lease liabilities for short-term leases for all asset classes. See Note 13 Commitments and Contingencies of our consolidated financial statements for further details. Upon adoption onJanuary 1, 2022 , we recognized right-of-use assets and lease liabilities for operating leases of$380,000 and$429,000 , respectively. The difference between the right-of-use asset and lease liability primarily represents the net book value of deferred rent recognized as ofDecember 31, 2021 , which was adjusted against the right-of-use asset upon adoption. 33
Critical Accounting Policies and Estimates
Our consolidated financial statements are prepared in accordance withU.S. generally accepted accounting principles, or GAAP, which requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses. These estimates require the use of judgment as future events, and the effect of these events cannot be predicted with certainty. Liquidity In accordance with Accounting Standard Codification ("ASC") 205-40, "Presentation of Financial Statements - Going Concern", the Company continually evaluates whether there are conditions or events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. We have incurred operating losses and negative cash flows from operating activities in each year since its inception. We believe that our cash and cash equivalents as ofDecember 31, 2022 with the addition of the$6.85 million raised in ourFebruary 2023 public offering will not be sufficient to fund our projected operating requirements for at least the next 12 months from the filing date of this annual report.
Redeemable Convertible Preferred Stock
We recorded all shares of redeemable convertible preferred stock at their respective issuance price less issuance costs on the dates of issuance. Under certain circumstances, we would have been required to redeem the Series A and Series B redeemable convertible preferred stock unless an Initial Public Offering ("IPO") had been consummated prior toApril 1, 2021 , or an extension or waiver was obtained upon approval of a majority of the holders of such preferred stock. As the preferred stock became redeemable due to the passage of time, we considered the preferred stock to be redeemable as ofApril 1, 2021 . We record the accretion of the Series A and B preferred stock balances to their respective redemption amounts using the effective interest method. Upon the IPO, the redeemable convertible preferred stock converted in to 11,436,956 shares of common stock.
Paycheck Protection Program Loan
We accounted for funds received from the Paycheck Protection Program as a financial liability with interest accrued and expensed over the term of the loan under the effective interest method. The loan remained recorded as a liability until the Company was legally released from the liability. The amount that was ultimately forgiven by the lender was recognized in the consolidated statement of operations and comprehensive loss as a gain extinguishment.
Convertible Financial Instruments
We bifurcate embedded redemption and conversion options from their host instruments and account for them as freestanding derivative financial instruments at fair value, if certain criteria are met. The criteria include circumstances in which (a) the economic characteristics and risks of the embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b) the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under otherwise applicable GAAP with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded derivative instrument would be considered a derivative instrument. Debt discounts under these arrangements are amortized to interest expense using the interest method over the earlier of the term of the related debt or their earliest date of redemption. We may retain a third-party appraiser to estimate the fair value of the derivative financial instruments. These fair value estimates are subjective in nature and require careful consideration and judgement. Management reviews the third-party reports for reasonableness of the assigned values. We believe that the appraised values represent the fair value of the freestanding derivative financial instruments, and we have not had to modify the assumptions. From time to time, we issue convertible financial instruments to nonemployees in payment for services that are provided. Until the services are completely rendered, we will expense the principal and any interest earned prior to the service completion to the representative expense account for the services performed and will record a noncurrent liability for the expected amount of the principal balance. Upon completion of the services, we will reclassify the noncurrent liability balance to the balance of an outstanding convertible financial instrument and assess the embedded redemption and conversion options that are applicable at that time. Common Stock Warrants
During the normal course of business, from time to time, we issue warrants to purchase common stock as part of a debt or equity financing or to vendors as consideration to perform services. We assess each warrant to determine if it meets the characteristics of a liability or a derivative, and if the warrant does meet the characteristics of a liability or a derivative, we classify the warrant as a liability measured at fair value. The derivative liabilities are remeasured at each period end, on a recurring basis, to the estimated fair value with the changes in fair value reflected as current period income or loss until the warrant is exercised, extinguished, or expires. If the warrant does not meet the characteristics of a liability or a derivative, we classify the warrant as equity, and record the warrant at its fair value on the date of issuance. The fair value of our warrants is estimated using the Black-Scholes option pricing model which contains estimates and assumptions that require careful consideration and judgment. To date, we have not experienced changes in these estimates and have not had to modify our assumptions. 34 Stock-Based Compensation We measure 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 us 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. As a result, if we revise our assumptions and estimates, our stock-based compensation expense could change. These assumptions include: Dividend Rate - The expected dividend rate was assumed to be zero, as we have not previously paid dividends on common stock and have no current plans to
do so.
Expected Volatility - The expected volatility was derived from the historical stock volatilities of several public companies within our industry that we consider to be comparable to our 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 couponU.S. Treasury notes with maturities approximately equal to the option's expected term. Expected Term - The expected term represents the period that our 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," we determined the expected term to be the contractual life of the options.
Forfeitures - We made the one-time policy election to recognize forfeitures when they occur.
Fair Value of Common Stock Prior to our IPO inMarch 2021 , the fair values of the shares of our common stock underlying our share-based awards and warrant grants were estimated on each grant date by our board of directors. In order to determine the fair value of our common stock, our board of directors considered, among other things, valuations of our common stock prepared by an independent third-party valuation firm in accordance with the guidance provided by theAmerican Institute of Certified Public Accountants Practice Guide , Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The fair value of our common stock was estimated using a two-step process. First, our enterprise value was established using generally accepted valuation methodologies, such as comparable public company and market adjusted option pricing analysis as well as consideration of company financing transactions. Second, the enterprise value was allocated among the securities that comprise our capital structure using the option-pricing method. The option-pricing method treats all levels of the capital structure as call options on the enterprise's value, with exercise price based on the "breakpoints" between each of the different claims on the securities. The inputs necessary for the option-pricing model include the current equity value (the enterprise value as previously calculated), breakpoints (the various characteristics for each class of equity, including liquidation preferences and priority distributions, in accordance with our certificate of incorporation, as amended and restated), term, risk-free
rate, and volatility. 35 Given the absence of a public trading market for our common stock, our board of directors exercised their judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of our common stock, including valuations performed by an independent third party, developments in our operations, sales of preferred stock, the prices, rights, preferences and privileges of our preferred stock relative to the common stock, actual operating results and financial performance and capital resources, the conditions in the our industry and the economy and capital markets in general, the stock price performance and volatility of comparable public companies, the likelihood of achieving a liquidity event for shares of our common stock underlying these stock options, such as an initial public offering or sale of our company, and the lack of liquidity of our common stock, among other factors. The assumptions underlying these valuations were highly complex and subjective and represented management's best estimates, which involved inherent uncertainties and the application of management's judgment. As a result, if we had used significantly different assumptions or estimates, the fair value of our common stock and our stock-based compensation expense could be materially different. The fair value of the underlying common stock was determined by the board of directors until the IPO when our common stock started trading on The Nasdaq Capital Market under the ticker symbol MOVE onMarch 23, 2021 . Consequently, after our IPO the fair value of the shares of common stock underlying the stock options is the closing market price on the option grant date. Income Taxes We account 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. We account 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. We establish a liability for tax-related uncertainties based on estimates of whether, and the extent to which, additional taxes will be due. We record 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 our 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. 36 Results of Operations
Years Ended
Our consolidated statements of operations for the years ended
Year Ended December 31, Change 2022 2021 $ % (in thousands) OPERATING EXPENSES: Research and development$ 18,994 $ 13,427 $ 5,567 41 %
Sales, general and administrative 11,468 6,376
5,092 80 % Total operating expenses 30,462 19,803 10,659 54 % Loss from operations (30,462 ) (19,803 ) (10,659 ) (54 )% Other income (expense), net: Interest expense - (883 ) 883 100 % Change in fair value of warrant liability - (1,581 ) 1,581 100 % Change in fair value of derivative liability - 121 (121 ) (100 )% Forgiveness of Paycheck Protection Program Loan - 351 (351 ) (100 )% Interest and other income, net 133 22
111 505 % Other income (expense), net 133 (1,970 ) 2,103 107 % Net loss$ (30,329 ) $ (21,773 ) $ (8,556 ) (39 )% Research and Development Research and development expenses totaled$19.0 million and$13.4 million for the years endedDecember 31, 2022 and 2021, respectively. This increase of$5.6 million was due primarily to the growth of the Company and its activities. Research and development expenses for the year endedDecember 31, 2022 included expenses related to employee compensation of$9.4 million , other professional fees of$6.7 million , tools and equipment expenses of$2.0 million , rent of$0.2 million , depreciation and amortization of$0.1 million , and other expenses of$0.6 million . Research and development expenses for the year endedDecember 31, 2021 included expenses related to employee compensation of$6.0 million , tools and equipment expenses of$1.0 million , other professional fees of$5.9 million , rent of$0.1 million , depreciation and amortization of$0.1 million , and other expenses of$0.3 million . 37
Sales, General and Administrative
Sales, general and administrative expenses totaled$11.5 million and$6.4 million for the years endedDecember 31, 2022 and 2021, respectively. This increase of$5.1 million was due primarily to the growth of the Company and its activities. Sales, general and administrative expenses for the year endedDecember 31, 2022 included expenses related to employee and board of director compensation of$6.1 million , professional and consulting fees of$2.5 million , rent of$0.1 million , insurance of$1.3 million , and other expenses of$1.5 million . Sales, general and administrative expenses for the year endedDecember 31, 2021 included expenses related to employee and board of director compensation of$3.2 million , professional and consulting fees of$1.7 million , and other expenses of$1.5 million . Loss from Operations
Loss from operations was
Other Income (Expense), Net
Other income (expense), net for the year endedDecember 31, 2022 was a net other income of$0.1 million as compared to a net other expense of$2.0 million for the year endedDecember 31, 2021 . Other income (expense), net for the year endedDecember 31, 2022 reflected the net interest income on short-term investments. Other income (expense), net for the year endedDecember 31, 2021 included interest expense of$0.9 million related to the accrual of interest and amortization of debt discounts on the convertible promissory notes and$1.6 million related to the change in the fair value of warrant liability, which were partially offset by$0.1 million related to the change in fair value of the derivative liability and forgiveness of the Paycheck Protection Program Loan of$0.4 million . Net Loss
As a result of the foregoing, net loss was
Liquidity and Capital Resources
AtDecember 31, 2022 , we had cash, cash equivalents$10.8 million . During the year endedDecember 31, 2022 , the Company used$24.9 million of cash in our operating activities. Our cash and short-term investments are not expected to be sufficient to enable us to complete the development and commercialization of our first proposed commercial product, the Evie Ring. InAugust 2022 , we entered into an at-the-market issuance ("ATM") agreement withB. Riley Securities Inc. , orB. Riley , 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 under whichB. Riley acts as sales agent. During the year endedDecember 31, 2022 , the Company sold an aggregate of 810,400 shares of common stock through the ATM program for proceeds of approximately$2.2 million , net of commissions paid. Approximately$47.7 million remains available on the ATM equity offering program atDecember 31, 2022 . 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. 38
Until we can generate a sufficient amount of revenue from our 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. These circumstances raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. Our 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 through the sale of equity or debt securities to support
our future operations. The following table summarizes our cash flows for the periods indicated (in thousands): Year EndedDecember 31, 2022 2021
Net cash used in operating activities$ (24,902 ) $ (16,183 ) Net cash provided by/(used in) investing activities 15,724 (16,699 ) Net cash used in financing activities 2,262
44,847
Net increase/(decrease) in cash and cash equivalents
11,965 Operating Activities
During the year ended
The$24.9 million used in operating activities during the year endedDecember 31, 2022 was primarily attributable to our net loss of$30.3 million and changes in our operating assets and liabilities totaling$2.1 million . These items were offset by non-cash items, including stock-based compensation of$3.1 million , depreciation of$0.1 million and accretion of discount on short-term investments of$0.1 million . The$16.2 million used in operating activities during the year endedDecember 31, 2021 was primarily attributable to our net loss of$21.8 million during the year and changes in our operating assets and liabilities totaling$1.3 million . These items were offset by non-cash items, including depreciation and amortization of$0.1 million , stock-based compensation of$1.9 million , accretion of the debt discount on our convertible promissory notes of$0.8 million , the forgiveness of our PPP loan of$0.4 million , accrued interest on our convertible promissory notes of$0.1 million , accretion of discount on short-term investments of$0.2 million , compensation of nonemployee services upon the issuance of common stock of$0.1 million , the change in the fair value of the derivative liability of$0.1 million and the change in the fair value of the warrant liability of$1.6 million . 39 Investing Activities During the year endedDecember 31, 2022 the Company was provided cash of$15.7 million in investing activities, consisting of$15.8 million in maturities of short-term investments and offset by$0.1 million for the purchase of office and laboratory equipment. During the year endedDecember 31, 2021 the Company used cash of$16.7 million in investing activities, consisting of$23.6 million in purchases of marketable securities and$0.6 million for the purchase of office and laboratory equipment, offset by maturities of short-term investments of$7.5 million . Financing Activities During the year endedDecember 31, 2022 , the Company was provided cash of$2.3 million from financing activities, comprised of$2.3 million from the issuance of common stock. During the year endedDecember 31, 2021 , the Company was provided cash of$44.8 million from financing activities, comprised of$44.7 million from the net proceeds of our initial public offering and$0.1 million from the issuance
of common stock. Funding Requirements We anticipate that, excluding non-recurring items, we will continue to generate annual losses for the foreseeable future as we continue the development of ourEvie Ring and other products in development. We will require additional capital to fund our operations, to complete our ongoing and planned clinical studies, to commercialize our products, to continue investing in and to further develop our general infrastructure, and such funding may not be available to us on acceptable terms or at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may be required to delay, limit, reduce the scope of, or terminate one or more of our clinical studies, research and development programs, or our future commercialization efforts.
Our future funding requirements will depend on many factors, including the following:
? the scope, rate of progress, results and cost of our product development
and clinical testing;
? the cost of manufacturing our products in development and any products
that we may develop in the future;
? the number and characteristics of the potential products that we pursue;
? the cost, timing, and outcomes of regulatory approvals; and
? the magnitude and extent to which the COVID-19 pandemic impacts our
business operations and operating results, as described in "Risk Factors -
Risks Related to Our Business."
We expect to satisfy future cash needs through existing capital balances, through some combination of public or private equity offerings, debt financings, licensing arrangements, and other marketing and distribution arrangements. Please see "Risk Factors-Risks Related to Our Business."
Contractual Obligations
Material contractual obligations arising in the normal course of business
primarily consist of operating leases. See Note 13 to the consolidated financial
statements for amounts outstanding for operating leases on
Off-Balance Sheet Transactions
At
Non-cancelable Obligations
The Company also had approximately
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