SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) August 14, 2023
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
|(Commission File Number)||(IRS Employer |
|6800 Koll Center Parkway, Pleasanton, CA||94566|
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code (415) 651-3172
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
|☐||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|☐||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|☐||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|☐||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common stock, par value $0.0001 per share||MOVE||The Nasdaq Stock Market LLC|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 14, 2023, Movano Inc. announced its financial results for the quarter ended June 30, 2023. A copy of the press release is being furnished as Exhibit 99 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K and Exhibit 99 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
The exhibits to this Current Report on Form 8-K are listed below and incorporated herein by reference.
|99||Press release, dated August 14, 2023, issued by Movano Inc., furnished herewith.|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: August 14, 2023||By:||/s/ Jeremy Cogan|
|Title:||Chief Financial Officer|
Movano Health Provides Business Update and Reports Second Quarter 2023 Financial Results
Conference call begins at 2:00 p.m. Pacific time today
Pleasanton, Calif. – August 14, 2023 – Today, Movano Health (Nasdaq: MOVE), a purpose-driven healthcare solutions company at the intersection of medical and consumer devices and makers of the Evie Ring, reported financial results for the three months ending June 30, 2023 and provided a business update.
Key highlights from the second quarter and recent weeks include:
|●||Movano Health demonstrated significant progress with the development of the Evie Ring, as well as fulfilling the requirements of its FDA submission. The Company validated a recently released, high-performance sensor that could improve the efficacy of the ring and help position the Company’s first commercial product for success. Given expected implementation and testing of the sensor and related solution enhancements, the Company plans to launch Evie before Black Friday 2023.|
|●||The Evie Ring continues to generate strong consumer interest and has reached a major milestone through strategic paid and organic social media and email content. Year-to-date, more than 600,000 people have visited eviering.com and more than 100,000 individuals signed up to receive updates about Evie’s release, demonstrating momentum for the upcoming launch.|
|●||Movano Health successfully submitted its first 510(k) application to the FDA for the Evie Ring’s pulse oximeter, making Evie one of the first consumer wearables to seek FDA clearance as a medical device. The submission recently passed an initial review for completeness and is now under full review by the FDA.|
|●||The Company is preparing for its second round of beta programs ahead of the Evie Ring’s upcoming commercial launch. Beta partners include a global athletic apparel company, a major health insurer and a leading remote patient monitoring company.|
|●||Movano Health announced the formation of its Medical Advisory Board. The initial panel is composed of healthcare industry subject matter experts in women’s health, mental health, and sleep, who will serve as trusted advisors to the Evie team regarding the development of its medical-grade smart ring for women and provide insights to establish Evie as a highly credible health and wellness resource.|
|●||In May, the Company completed an IRB-approved clinical study on over 50 volunteers in the Movano Health Clinical Lab to test the efficacy of its proprietary, single chip prototype in estimating blood pressure. Movano Health plans to commence a study on an additional 50 volunteers in the near term with a newly modified prototype.|
“With the launch of the Evie Ring, we have an opportunity to deliver a solution that ushers in a new era of women’s health,” said John Mastrototaro, CEO of Movano Health. “Evie is not just another wearable device; it is a medical-grade smart ring designed for women that we believe meets the guidelines necessary for FDA clearance as a medical device which we are currently seeking. We’re carving out a new category of health-focused wearables by providing medical-grade accuracy, personalized insights and a customized user experience.”
Second Quarter 2023 Financial Results and Recent Capital Markets Activity
|●||Movano Health reported a net loss of $7.3 million and a loss of $(0.17) per basic and diluted share, in the second quarter of 2023, compared with a net loss of $6.9 million and a loss of $(0.21) per basic and diluted share, in the second quarter of 2022.|
|●||The Company reported an operating loss of $7.4 million in the second quarter of 2023 compared to an operating loss of $6.8 million in the second quarter of 2022.|
|●||Movano Health is a development stage company and, as such, the Company did not generate revenue in either the second quarter of 2023 or the second quarter of 2022.|
|●||The Company had $14.5 million in cash and cash equivalents as of June 30, 2023, compared to $10.8 million in cash and cash equivalents as of December 2022.|
|●||During the second quarter of 2023, Movano Health raised $9.2 million in gross proceeds ($8.1 million in net proceeds) through an underwritten public offering of 9.2 million shares of its common stock.|
|●||The total number of shares outstanding was 50,646,661 as of June 30, 2023.|
Conference Call and Webcast
Management will host a conference call and live audio webcast to discuss these results and provide a business update today at 2:00 p.m. PDT (5:00 p.m. EDT).
Attendees can access the live webcast here or on the investors section of Movano Health’s website at https://ir.movano.com. The conference call can be accessed by dialing 1-877-407-0989 (domestic) or +1- 201-389-0921 (international). Attendees can also use the Call Me link, in which they will be dialed in to the conference call instantly on the number provided with no hold time. An archived webcast will be available on Movano Health’s website approximately one hour after the completion of the event and for two years thereafter.
About Movano Health
Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health is developing a suite of purpose-driven healthcare solutions to bring medical-grade, high-quality data to the forefront of consumer health devices. Featuring modern form factors, Movano Health’s devices capture a comprehensive picture of a person’s vital health information and uniquely translate the data into personalized and intelligent insights that empower consumers to live healthier and more balanced lives. Movano Health’s end-to-end solutions will soon enable consumers and their healthcare professionals to utilize daily medical-grade data as a tool to proactively monitor and manage health outcomes. For more information on Movano Health, visit https://movanohealth.com/.
Movano Health’s Evie Ring, which is specifically designed to address women’s health concerns, will be available for purchase before Black Friday 2023. To stay up to date on Evie’s launch, visit https://eviering.com/.
Forward Looking Statements
This press release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding anticipated FDA clearance for the Evie Ring, expected future operating results; product development and features, product releases, clinical trial, and regulatory initiatives; our strategies, positioning and expectations for future events or performance. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption “Risk Factors.” Any forward-looking statement in this release speaks only as of the date of this release. 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.
J. Cogan, CFA
CONDENSED CONSOLIDATED BALANCE SHEETS
|June 30,||December 31,|
|Cash and cash equivalents||$||14,472||$||10,759|
|Payroll tax credit, current portion||271||379|
|Prepaid expenses and other current assets||1,343||508|
|Total current assets||16,086||11,646|
|Property and equipment, net||404||443|
|Payroll tax credit, noncurrent portion||667||667|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Other current liabilities||3,031||4,421|
|Total current liabilities||4,553||4,978|
|Early exercised stock option liability||71||136|
|Other noncurrent liabilities||121||214|
|Total noncurrent liabilities||192||350|
|Additional paid-in capital||122,283||103,009|
|Total stockholders’ equity||12,828||7,915|
|Total liabilities and stockholders’ equity||$||17,573||$||13,243|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
|Three Months Ended|
|Six Months Ended|
|Research and development||$||4,171||$||4,112||$||8,065||$||8,703|
|Sales, general and administrative||3,213||2,734||6,522||5,081|
|Total operating expenses||7,384||6,846||14,587||13,784|
|Loss from operations||(7,384||)||(6,846||)||(14,587||)||(13,784||)|
|Other income (expense), net:|
|Interest and other income (expense), net||117||(22||)||224||(16||)|
|Other income (expense), net||117||(22||)||224||(16||)|
|Other comprehensive income (loss):|
|Change in unrealized loss on available-for-sale securities||—||15||—||(4||)|
|Total comprehensive loss||$||(7,267||)||$||(6,853||)||$||(14,363||)||$||(13,804||)|
|Net loss per share, basic and diluted||$||(0.17||)||$||(0.21||)||$||(0.36||)||$||(0.42||)|
|Weighted average shares used in computing net loss per share, basic and diluted||43,056,785||32,793,907||40,314,164||32,769,093|