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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 OR 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) August 15, 2022

 

Movano Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40254   26-0579295

(State or other jurisdiction

of incorporation)

  (Commission File Number)   (IRS Employer
Identification No.)

 

6800 Koll Center Parkway, Pleasanton, CA   94566
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code (415) 651-3172

 

Not applicable

(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 15, 2022, Movano Inc. announced its financial results for the quarter ended June 30, 2022. 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.

 

9.01. Financial Statements and Exhibits.

 

The exhibits to this Current Report on Form 8-K are listed below and incorporated herein by reference.

 

Exhibit No.   Description
99   Press release, dated August 15, 2022, issued by Movano Inc., furnished herewith.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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SIGNATURES

 

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.

 

  Movano Inc.
   
Date: August 15, 2022 By: /s/ Jeremy Cogan
  Name:  Jeremy Cogan
  Title: Chief Financial Officer

 

 

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Exhibit 99 

 

 

Movano Inc. Provides Business Update and Reports Second Quarter 2022 Financial Results

 

Conference call begins at 2:00 p.m. Pacific time today

 

Pleasanton, Calif. – August 15, 2022 – Today, Movano Inc. (NASDAQ:MOVE), a purpose-driven healthcare solutions company at the intersection of medtech and consumer devices, reported financial results for the three months ending June 30, 2022 and provided a business update.

 

Highlights from the second quarter and recent weeks include the following:

 

Movano plans to conduct beta test programs with several strategic partners utilizing the Movano Ring, the Company’s first commercial product designed to blend the best features of medical and wellness devices to help women better understand the correlation between how they feel and various aspects of their health. The Company named its first beta partner as Stanford University’s Applied Sports Science department. Stanford is looking to test wearable technology, like the Movano Ring, to drive innovation that facilitates the ethical enhancement of athletic performance and improve the quality of life of the Stanford athlete.

 

Further, Movano is kicking off beta programs with several other organizations including a major global pharmaceutical company, a leading global diabetes-focused medical device company, and an integrated regional health network. The beta test programs are expected to commence in the fourth quarter of 2022, and the development of these partnerships across the broader healthcare landscape is an important milestone in building the foundation for an enterprise solution.

 

Movano expects the direct-to-consumer launch of the Movano Ring to take place in the first half of 2023. To prepare for the broader launch, the Company has hired a world class go-to-market (GOTM) leadership team. Over the last several months, this team, along with leading app development partners, has continued to build on the foundational elements already in place, aiming to create a unique and valuable user experience. Further, the Company has secured leading marketing, branding, website development and consumer research partners, to ensure the brand is engaging and relevant to the target audience.

 

After recently completing an initial hypoxia study with the University of California San Francisco (UCSF) and announcing high accuracy marks for its blood oxygen saturation (SpO2) and heart rate data, the Company is eyeing its first FDA submission. The recently completed pilot study tested the accuracy of the Movano Ring on seven subjects during mild, moderate and severe hypoxia and followed the same protocol that is expected to be required by the FDA for the submission. In comparing the overall accuracy of the Ring’s data with that of the reference devices, the Movano Ring achieved a 2% margin of error, well below the FDA’s 4% requirement for SpO2. In addition, the Ring also estimated heart rate with accuracy commensurate with the FDA’s standards. This successful study demonstrates the potential for wearables to properly track sleep and heart health and detect potential illnesses, such as sleep apnea, and is a major step toward the Company’s goal of providing medically-validated data to consumers and healthcare professionals. Based on the positive results from this study, Movano plans to conduct a larger pivotal study for the FDA submission later this year.

 

 

 

 

 

 

Movano plans to conduct additional blood pressure and glucose clinical studies beginning in the third quarter of 2022, utilizing its proprietary and patented system-on-a-chip (SoC), which is the smallest ever custom mmWave integrated sensor designed specifically for non-invasive glucose and cuffless blood pressure monitoring. While the majority of current wearables on the market use off-the-shelf optical sensors, Movano spent four years developing, designing and shrinking its multi-chip architecture from four integrated circuits into a single SoC in an effort to deliver a higher level of accuracy, offer form factor flexibility and provide its technology to consumers at a lower price point. Movano is currently integrating the SoC into a new prototype system, which will be closer in size and shape to its final product, and enable the Company to conduct longer, more complex blood pressure and glucose studies.

 

Movano was recently granted two new patents centered around Movano’s SoC, marking a total of nine U.S. patents currently issued to the Company. The two new patents protect the SoC’s agile method of understanding detailed features of waveforms that aid in estimating blood pressure and other analytes.

 

“It’s an exciting time for our emerging company as we’re working toward commercialization of the Movano Ring, a smart ring designed for women. Our team has accomplished several significant milestones over a short period of time, including the development of multiple beta test programs in partnership with leaders in the healthcare space and a highly encouraging hypoxia pilot study. In parallel, we successfully completed testing of our proprietary and patented system-on-a-chip, the smallest custom mmWave integrated sensor for cuffless blood pressure and non-invasive glucose monitoring, and are now integrating it into a prototype platform for clinical evalutions,” said Dr. John Mastrototaro, CEO of Movano Inc. “We aim to move healthcare technology in a direction that’s more accessible, both in price and in experience, arming consumers with medically validated data and key insights they can trust, and packaging it into a solution that looks great and provides real value, so it becomes a seamless part of their everyday routine and helps them achieve a more well balanced and healthier life.”

 

Second Quarter 2022 Financial Results

 

Movano reported a net loss attributable to common stockholders of $6.9 million, or a loss of $(0.21) per basic and diluted share, in the second quarter of 2022, compared with a net loss attributable to common stockholders of $4.7 million, or a loss of $(0.15) per basic and diluted share, in the second quarter of 2021.

 

The Company reported an operating loss of $6.8 million in the second quarter of 2022 compared to an operating loss of $5.0 million in the second quarter of 2021.

 

Movano is a development stage company and the majority of its business activities to date and planned future activities will be devoted to research and development. As such, the Company did not generate revenue in either the second quarter of 2022 or the second quarter of 2021.

 

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The Company had $21.3 million in cash, cash equivalents and short-term investments as of June 30, 2022, compared to $33.6 million in cash, cash equivalents and short-term investments, as of December 31, 2021.

 

The total number of shares outstanding was 32,818,060 as of June 30, 2022.

 

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’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’s website approximately one hour after the completion of the event and for two years thereafter.

 

To learn more about Movano Inc., please visit www.movano.com

 

About Movano

 

Founded in 2018, Movano Inc. (NASDAQ:MOVE) 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’s wearables 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’s end-to-end solutions will soon enable a world where consumers, caretakers and healthcare professionals can utilize daily health data as a tool to proactively monitor and manage their health. For more information, visit www.movano.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 expected future operating results; product development efforts and product releases; clinical trial and regulatory initiatives; commercial partner activities; as well as 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.

 

Investor Contact:

 

J. Cogan, CFA

CFO of Movano Inc.

ir@movano.com

 

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Movano Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

(Unaudited) 

 

   June 30,   December 31, 
   2022   2021 
         
ASSETS        
Current assets:        
Cash and cash equivalents  $17,089   $17,675 
Short-term investments   4,214    15,921 
Payroll tax credit, current portion   379    166 
Prepaid expenses and other current assets   1,289    1,296 
Total current assets   22,971    35,058 
Property and equipment, net   474    529 
Payroll tax credit, noncurrent portion   417    630 
Other assets   530    48 
Total assets  $24,392   $36,265 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $753   $311 
Other current liabilities   2,635    2,907 
Total current liabilities   3,388    3,218 
Noncurrent liabilities:          
Early exercised stock option liability   205    281 
Other noncurrent liabilities   302    36 
Total noncurrent liabilities   507    317 
Total liabilities   3,895    3,535 
           
Commitments and contingencies (Note 12)          
           
Stockholders’ equity:          
Preferred stock, $0.0001 par value, 5,000,000 shares authorized at June 30, 2022 and December 31, 2021; no shares issued and outstanding at June 30, 2022 and December 31, 2021        
Common stock, $0.0001 par value, 75,000,000 shares authorized at June 30, 2022 and December 31, 2021; 32,818,060 and 32,772,060 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively   3    3 
Additional paid-in capital   99,077    97,506 
Accumulated other comprehensive loss   (15)   (11)
Accumulated deficit   (78,568)   (64,768)
Total stockholders’ equity   20,497    32,730 
Total liabilities and stockholders’ equity  $24,392   $36,265 

 

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Movano Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

(Unaudited)

 

   Three Months Ended
June 30,
   Six Months Ended
June 30,
 
   2022   2021   2022   2021 
OPERATING EXPENSES:                
Research and development  $4,112   $3,183   $8,703   $5,125 
General and administrative   2,734    1,863    5,081    3,187 
Total operating expenses   6,846    5,046    13,784    8,312 
                     
Loss from operations   (6,846)   (5,046)   (13,784)   (8,312)
                     
Other income (expense), net:                    
Interest expense               (883)
Change in fair value of warrant liability               (1,581)
Change in fair value of derivative liability               121 
Forgiveness of Paycheck Protection Program Loan       351        351 
Interest and other income (expense), net   (22)   8    (16)   9 
Other income (expense), net   (22)   359    (16)   (1,983)
                     
Net loss   (6,868)   (4,687)   (13,800)   (10,295)
                     
Accretion and dividends on redeemable convertible preferred stock               (2,489)
Net loss attributable to common stockholders  $(6,868)  $(4,687)  $(13,800)  $(12,784)
                     
Net loss  $(6,868)  $(4,687)  $(13,800)  $(10,295)
Other comprehensive loss:                    
Change in unrealized gain (loss) on available-for-sale
securities
   15    (1)   (4)   (1)
Total comprehensive loss  $(6,853)  $(4,688)  $(13,804)  $(10,296)
                     
Net loss per share attributable to common stockholders, basic and diluted  $(0.21)  $(0.15)  $(0.42)  $(0.64)
                     
Weighted average shares used in computing net loss per share attributable to common stockholders, basic and diluted   32,793,907    32,017,335    32,769,093    20,099,402 

 

 

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