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Movano(MOVE) - 2021 Q4 - Annual Report
2022-03-30 20:01
Part I [Business](index=6&type=section&id=Item%201.%20Business) Movano Inc. is a development-stage company creating a healthcare platform with the Movano Ring, targeting FDA clearance for non-invasive continuous glucose and cuffless blood pressure monitoring - Movano is developing a healthcare platform based on proprietary RF technology, with its initial product being the Movano Ring, a smart ring designed for women[16](index=16&type=chunk)[17](index=17&type=chunk)[18](index=18&type=chunk) - The company's long-term goal is to achieve Class II FDA clearance for its technology to provide non-invasive continuous glucose monitoring (CGM) and cuffless blood pressure monitoring[19](index=19&type=chunk)[61](index=61&type=chunk) - Movano has conducted several IRB-approved clinical trials to collect data for refining its blood pressure and glucose monitoring algorithms, completing its largest blood pressure trial on **110 participants** in December 2021[49](index=49&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) - As of December 31, 2021, the company's intellectual property portfolio includes **6 issued patents** and **42 pending U.S. patent applications**[59](index=59&type=chunk) - The company faces competition from major players in the wellness market (Apple, Samsung, Oura), CGM market (DexCom, Abbott), and blood pressure monitoring market (OMRON, Philips)[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) [Risk Factors](index=17&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including limited operating history, ongoing losses, capital needs, intense competition, regulatory hurdles, and reliance on third parties - The company is a development-stage entity with no revenue history, an accumulated deficit of approximately **$64.8 million** as of December 31, 2021, and may never achieve profitability[95](index=95&type=chunk)[96](index=96&type=chunk) - There is substantial uncertainty about the company's ability to continue as a going concern, as its current cash is insufficient to complete the development and commercialization of its proposed solution[97](index=97&type=chunk) - The business is highly dependent on the success of its proposed solution, which requires substantial clinical development and regulatory clearance or approval from the FDA, which may be difficult to achieve[113](index=113&type=chunk)[128](index=128&type=chunk) - The company expects to depend on third-party OEMs, VARs, and distributors for the design, manufacture, and sale of its products, but currently has no such relationships[114](index=114&type=chunk)[115](index=115&type=chunk) - As an "emerging growth company," Movano is subject to reduced disclosure requirements, which may make its common stock less attractive to investors[165](index=165&type=chunk) [Unresolved Staff Comments](index=36&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) There are no unresolved staff comments - Not applicable[172](index=172&type=chunk) [Properties](index=36&type=section&id=Item%202.%20Properties) The company's principal office is located in Pleasanton, California - The company's principal office is located at 6800 Koll Center Parkway, Pleasanton, California[173](index=173&type=chunk) [Legal Proceedings](index=36&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently involved in any pending legal proceedings expected to have a material adverse effect on its business[174](index=174&type=chunk) [Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company - Not applicable[175](index=175&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=37&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Movano's common stock began trading on Nasdaq in March 2021, with the company having never paid dividends and no material change in IPO proceeds use - The company's common stock has been listed on the Nasdaq Capital Market under the symbol "**MOVE**" since **March 23, 2021**[178](index=178&type=chunk) - The company has never paid cash dividends and does not plan to in the foreseeable future, retaining any future earnings for business reinvestment[180](index=180&type=chunk) - The company's Registration Statement on Form S-1 (Reg. No. 333-252671) was declared effective on **March 22, 2021**, for its IPO[182](index=182&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=38&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Movano's net loss increased to **$21.8 million** in 2021 due to higher R&D and G&A expenses, with **$33.6 million** in cash deemed sufficient for 12 months of operations but not full product commercialization | | Year Ended December 31, | Change | |---|---|---|---| | | **2021** | **2020** | **$** | | **(in thousands)** | | | | | Research and development | $13,427 | $8,373 | $5,054 | | General and administrative | $6,376 | $2,734 | $3,642 | | **Total operating expenses** | **$19,803** | **$11,107** | **$8,696** | | Loss from operations | ($19,803) | ($11,107) | ($8,696) | | **Net loss** | **($21,773)** | **($13,031)** | **($8,742)** | - The increase in R&D expenses was primarily due to a **$3.8 million** rise in employee compensation and a **$0.7 million** increase in other professional fees[218](index=218&type=chunk) - The increase in G&A expenses was mainly driven by a **$1.6 million** rise in employee and board compensation and a **$0.8 million** increase in professional and consulting fees[220](index=220&type=chunk) - As of December 31, 2021, the company had **$33.6 million** in cash, cash equivalents, and short-term investments, which it believes is sufficient to fund operations for at least **12 months**[193](index=193&type=chunk)[225](index=225&type=chunk) | | Year Ended December 31, | |---|---|---| | **(in thousands)** | **2021** | **2020** | | Net cash used in operating activities | ($16,183) | ($10,666) | | Net cash used in investing activities | ($16,699) | $0 | | Net cash provided by financing activities | $44,847 | $12,085 | [Quantitative and Qualitative Disclosures About Market Risk.](index=47&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) This section is not applicable to the company - Not applicable[239](index=239&type=chunk) [Financial Statements and Supplementary Data.](index=48&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data.) Audited consolidated financial statements for 2021 and 2020 are presented, highlighting the **March 2021 IPO** that raised **$44.3 million** and led to the conversion of preferred stock and convertible notes into common stock | | Dec 31, 2021 | Dec 31, 2020 | |---|---|---| | **(in thousands)** | | | | **Assets** | | | | Cash and cash equivalents | $17,675 | $5,710 | | Short-term investments | $15,921 | $0 | | **Total Assets** | **$36,265** | **$7,083** | | **Liabilities & Equity** | | | | Total current liabilities | $3,218 | $1,160 | | Total noncurrent liabilities | $317 | $13,985 | | **Total Liabilities** | **$3,535** | **$15,145** | | Total stockholders' equity (deficit) | $32,730 | ($40,880) | - In its **March 2021 IPO**, the company sold **9,775,000 shares** of common stock at **$5.00 per share**, raising net proceeds of **$44.3 million** after underwriting discounts and offering expenses[267](index=267&type=chunk) - Upon the IPO, all outstanding redeemable convertible preferred stock converted into **11,436,956 shares** of common stock[290](index=290&type=chunk)[336](index=336&type=chunk) - Upon the IPO, **$12.9 million** in principal and interest from convertible notes converted into **5,015,494 shares** of common stock[329](index=329&type=chunk)[341](index=341&type=chunk) - The company maintains a full valuation allowance against its net deferred tax assets of approximately **$9.0 million** due to uncertainty surrounding their realization[390](index=390&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.](index=85&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure.) There were no changes in or disagreements with accountants on accounting and financial disclosure - None[402](index=402&type=chunk) [Controls and Procedures.](index=85&type=section&id=Item%209A.%20Controls%20and%20Procedures.) As of December 31, 2021, management concluded that disclosure controls and procedures were ineffective due to a material weakness in financial close and reporting controls - Management concluded that as of **December 31, 2021**, the company's disclosure controls and procedures were ineffective[403](index=403&type=chunk) - A material weakness was identified related to the ineffective design and operation of financial close and reporting controls, though it did not result in any identified misstatements to the financial statements[404](index=404&type=chunk)[405](index=405&type=chunk) [Other Information.](index=85&type=section&id=Item%209B.%20Other%20Information.) This section is not applicable - Not applicable[408](index=408&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=85&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This section is not applicable - Not applicable[409](index=409&type=chunk) Part III [Directors, Executive Officers and Corporate Governance.](index=86&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance.) The information required for this item is incorporated by reference from the company's Proxy Statement for its 2022 annual meeting of stockholders - Information is incorporated by reference to the Proxy Statement on Schedule 14A for the **2022 annual meeting of stockholders**[412](index=412&type=chunk) [Executive Compensation](index=86&type=section&id=Item%2011.%20Executive%20Compensation) The information required for this item is incorporated by reference from the company's Proxy Statement for its 2022 annual meeting of stockholders - Information is incorporated by reference to the Proxy Statement on Schedule 14A for the **2022 annual meeting of stockholders**[413](index=413&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholders Matters.](index=86&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholders%20Matters.) The information required for this item is incorporated by reference from the company's Proxy Statement for its 2022 annual meeting of stockholders - Information is incorporated by reference to the Proxy Statement on Schedule 14A for the **2022 annual meeting of stockholders**[414](index=414&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=86&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The information required for this item is incorporated by reference from the company's Proxy Statement for its 2022 annual meeting of stockholders - Information is incorporated by reference to the Proxy Statement on Schedule 14A for the **2022 annual meeting of stockholders**[415](index=415&type=chunk) [Principal Accountant Fees and Services](index=86&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) The information required for this item is incorporated by reference from the company's Proxy Statement for its 2022 annual meeting of stockholders - Information is incorporated by reference to the Proxy Statement on Schedule 14A for the **2022 annual meeting of stockholders**[416](index=416&type=chunk) Part IV [Exhibits, Financial Statements and Schedules](index=87&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statements%20and%20Schedules) This section lists financial statements, schedules, and an index of exhibits filed with the Form 10-K report, including corporate governance documents and material contracts - This item lists the financial statements and exhibits filed with the report, including corporate governance documents, incentive plans, and material contracts[419](index=419&type=chunk)[420](index=420&type=chunk)
Movano(MOVE) - 2021 Q4 - Earnings Call Transcript
2022-03-25 00:44
Financial Data and Key Metrics Changes - Movano reported an operating loss of $6.3 million in Q4 2021, compared to an operating loss of $3.2 million in the same period last year [39] - For the full year 2021, the operating loss was $19.8 million, up from $11.1 million in 2020 [39] - The increase in losses was primarily due to team expansion, R&D initiatives, and costs associated with being a public company [40] Business Line Data and Key Metrics Changes - The company is preparing for the beta launch of its first commercial product, the Movano Ring, which is expected to be released in the second half of 2022 [12][40] - The Movano Ring will measure various health metrics and is designed specifically for women, addressing a gap in the wearable technology market [10][20] Market Data and Key Metrics Changes - Since the announcement of the Movano Ring, the company has received over 50,000 unique visitors to its website and more than 4,000 supportive messages from potential customers [17] - The media response to the Movano Ring has been overwhelmingly positive, with features in major outlets like TechCrunch and Forbes [15] Company Strategy and Development Direction - Movano aims to position itself at the intersection of medical technology and consumer devices, focusing on affordable health solutions [25][23] - The company is pursuing FDA clearances for its health monitoring capabilities, which include heart rate, blood oxygen, and respiration rate [12][54] - The strategy includes a subscription model to make the solution accessible to a wider audience while allowing for reinvestment in product features [58] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's trajectory and the market opportunity, emphasizing the importance of capital deployment and operating efficiency [42][46] - The CEO highlighted the need for healthcare to become more consumer-oriented and the potential for the Movano Ring to help a large population manage their health proactively [61][62] Other Important Information - The company has made significant progress in technology development, including the completion of critical studies for FDA clearances [26][30] - Key strategic hires have been made to strengthen the team, including individuals with experience from Google Fitbit and Medtronic [34] Q&A Session Summary Question: What is the status of cash burn rate? - The cash burn was $5.7 million in Q4, with $33.6 million in cash equivalents at year-end. The company plans to invest in R&D and team expansion as it prepares for the beta launch [45][46] Question: How did the meetings with potential strategic partners at CES go? - The Movano Ring announcement generated significant interest from potential strategic partners across healthcare, consumer, and technology sectors, exceeding expectations [47] Question: What is the status of blood pressure and glucose algorithm development? - Progress has been made, but the company is not yet ready to file for FDA clearance. The focus is on improving data accuracy and developing algorithms [48][54] Question: Can you provide details on the beta launch, including pricing and subscription model? - There is high interest in beta testing, but specific details on pricing and subscription models are not yet available. The focus will be on thorough testing before launch [55][56] Question: What are the biggest takeaways after one year as CEO? - The CEO emphasized the importance of addressing chronic health conditions and the potential for the Movano Ring to help a large audience live healthier lives [60][62]
Movano(MOVE) - 2021 Q3 - Quarterly Report
2021-11-12 21:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-40254 MOVANO INC. (Exact name of registrant as specified in its charter) (State of incorporation) (I.R.S. Employer Delaware 26-0579295 Identification No.) 68 ...
Movano(MOVE) - 2021 Q3 - Earnings Call Transcript
2021-11-11 23:51
Movano Inc. (NASDAQ:MOVE) Q3 2021 Results Earnings Conference Call November 11, 2021 5:00 PM ET Company Participants J. Cogan - Chief Financial Officer John Mastrototaro - Chief Executive Officer Conference Call Participants Operator Greetings. Welcome to the Movano 3Q 2021 earnings conference call. At this time, all participants are in a listen only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. Please note, this conference is being recorded. I will now tu ...
Movano(MOVE) - 2021 Q2 - Quarterly Report
2021-08-12 21:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-40254 MOVANO INC. (Exact name of registrant as specified in its charter) (State of incorporation) (I.R.S. Employer Delaware 26-0579295 Identification No.) 6800 Ko ...
Movano(MOVE) - 2021 Q1 - Quarterly Report
2021-05-14 00:34
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-40254 MOVANO INC. (Exact name of registrant as specified in its charter) Delaware 26-0579295 (State of incorporation) (I.R.S. Employer Identification No.) 6800 K ...