0001213900-24-069021.txt : 20240814 0001213900-24-069021.hdr.sgml : 20240814 20240814161301 ACCESSION NUMBER: 0001213900-24-069021 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240814 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240814 DATE AS OF CHANGE: 20240814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Movano Inc. CENTRAL INDEX KEY: 0001734750 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 824233771 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40254 FILM NUMBER: 241207890 BUSINESS ADDRESS: STREET 1: 6800 KOLL CENTER PARKWAY CITY: PLEASANTON STATE: CA ZIP: 94566 BUSINESS PHONE: 408-393-1209 MAIL ADDRESS: STREET 1: 6800 KOLL CENTER PARKWAY CITY: PLEASANTON STATE: CA ZIP: 94566 FORMER COMPANY: FORMER CONFORMED NAME: Maestro Sensors Inc. DATE OF NAME CHANGE: 20180315 8-K 1 ea0211408-8k_movano.htm CURRENT REPORT
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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 14, 2024

 

Movano Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40254   82-4233771
(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 14, 2024, Movano Inc. announced its financial results for the quarter ended June 30, 2024. 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.

 

Exhibit No.   Description
99   Press Release, dated August 14, 2024, issued by Movano Inc., furnished herewith.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

 

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 14, 2024 By: /s/ Jeremy Cogan
  Name:  Jeremy Cogan
  Title: Chief Financial Officer

 

 

2

 
EX-99 2 ea021140801ex99_movano.htm PRESS RELEASE, DATED AUGUST 14, 2024, ISSUED BY MOVANO INC

Exhibit 99

 

 

Movano Health Reports Q2 2024 Financial Results and

Provides Business Update

 

Prepares for September 17, 2024, Evie Ring back in stock date

Announces brand partnership with digital creator Heidi D’Amelio

Focuses on launch of EvieMED and securing B2B opportunities

Conference Call at 2:00 PM PT/ 5:00 PM ET Today

 

PLEASANTON, Calif. – August 14, 2024 – Movano Health (Nasdaq: MOVE), a pioneer in health technology, reported second quarter 2024 results and provided a business update.

 

Following the successful close of the Company’s April 2024 $24.1 million private placement that included a seed investment from a tier 1 multi-billion dollar medical device company, Movano Health has been focused on three key initiatives:

 

Preparing for the September 17th back in stock date for the Evie Ring, including an enhanced product experience, improved operations processes, and bolstered customer service.

 

Today, the Company announced an Evie Ring brand partnership with digital creator, wife, mom, and entrepreneur Heidi D’Amelio.

 

Securing FDA 510(k) clearance for the EvieMED Ring and pursuing initial business-to-business (B2B) commercial agreements across the healthcare sector. The Company is scheduled to meet live with its FDA counterparts in mid-August.

 

Advancing cuffless blood pressure and noninvasive glucose monitoring clinical studies with Movano Health’s proprietary and patented System-on-a-Chip (SoC).

 

“We are excited to be back in stock on the Evie Ring and have been laser focused over the past quarter on improving the consumer experience across product, delivery and customer service in order to maximize our sales potential,” said John Mastrototaro, CEO and President of Movano Health. “Additionally, we are committed to working collaboratively with the FDA to obtain a 510(k) clearance for EvieMED, the cornerstone of our enterprise initiative.”

 

Recent Operating Highlights and Milestones

 

On April 4, 2024, Movano Health closed a $24.1 million private placement, totaling 45.3 million units, with each unit consisting of one share of the Company’s common stock (or pre-funded warrant in lieu thereof) and one warrant to purchase a share of common stock, to a select group of investors that included a tier-one multi-billion dollar medical device company, institutional and accredited investors, and members of the Company’s management team and board of directors.

 

 

 

 

On April 21, 2024, Movano Health successfully submitted updated pivotal clinical trial results as well as proof of enhanced medical device usability to the U.S. Food and Drug Administration (FDA) as part of its 510(k) filing for the Company’s first commercial medical device, the EvieMED Ring pulse oximeter. The Company recently announced that it will be meeting live with the FDA in mid-August to discuss the wellness aspects of EvieMED and to move forward with the review process.

 

On June 10, 2024, Movano Health announced a clinical study partnership with the Massachusetts Institute of Technology (MIT)’s MAESTRO study of the long term effects of Chronic Lyme and Long Covid, using the continuous health monitoring capabilities of the Evie Ring.

 

In the second quarter, Movano Health made important progress with three additional B2B commercial opportunities that could leverage EvieMED in building unique solutions for both clinical and consumer applications. In the first case, the Company is in the agreement phase with a global pharmaceutical company for a program that could begin in late-2024, and, assuming success, would be expected to develop into a larger commercial opportunity in 2025. In the second case, EvieMED is expected to be evaluated this Fall by a tier 1 global pharmaceutical company for a clinical trial that is scheduled to commence in 2025. Finally, Movano Health is engaged with a large payor looking to better manage high risk populations utilizing EvieMED. This opportunity is expected to commence in late-2024/early-2025 and could develop further into calendar 2025.

 

In June 2024, Movano Health completed a cuffless blood pressure clinical study that included the use of an arterial blood pressure line. The Company plans to execute another cuffless blood pressure clinical study in the fourth quarter of 2024.

 

Second Quarter 2024 and Recent Financial Highlights

 

In Q2 2024, Movano Health shipped 1,837 Evie Rings. The Company did not report revenue in the period, as previously deferred revenue was offset by customer refunds.

 

The Company reported an operating loss of $6.4 million in Q2 2024, compared to an operating loss of $7.4 million in Q2 2023.

 

Total cash and cash equivalents at June 30, 2024 were $16.9 million.

 

Conference Call

 

Management will host a conference call and live audio webcast to discuss these results and provide a business update today at 2:00 pm PT/5:00 pm ET.

 

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.

 

2

 

 

About Movano Health

 

Founded in 2018, Movano Inc. (Nasdaq: MOVE) dba Movano Health, maker of the Evie Ring (www.eviering.com), is developing a suite of purpose-driven healthcare solutions to bring medical-grade data to the forefront of wearables. Featuring modern and flexible form factors, Movano Health’s devices offer an innovative approach to delivering trusted data to both customers and enterprises, capturing a comprehensive picture of an individual’s health data and uniquely translating it into personalized and intelligent insights.

 

Movano Health’s proprietary technologies and wearable medical device solutions will soon enable the use of data as a tool to proactively monitor and manage health outcomes across a number of patient populations that exist in healthcare. For more information on Movano Health, visit https://movanohealth.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 plans with respect to the commercial launches of the Evie Ring and EvieMED; our expectations regarding potential commercial opportunities; planned cost-cutting initiatives; anticipated FDA clearance decisions with respect to our products; expected future operating results; product development and features, product releases, clinical trials 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.

 

Investor Relations

 

Jill Schmidt PR

t: 847-904-2806

e: jill@jillschmidtpr.com

 

3

 

 

Movano Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

   June 30,   December 31, 
   2024   2023 
         
ASSETS        
Current assets:        
Cash and cash equivalents  $16,868   $6,118 
Payroll tax credit, current portion   233    450 
Vendor deposits   22    399 
Inventory   1,790    1,114 
Prepaid expenses and other current assets   776    442 
Total current assets   19,689    8,523 
Property and equipment, net   272    342 
Payroll tax credit, noncurrent portion   55    169 
Other assets   810    387 
Total assets  $20,826   $9,421 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities:          
Accounts payable  $1,538   $3,118 
Deferred revenue       1,252 
Other current liabilities   1,883    1,529 
Total current liabilities   3,421    5,899 
Noncurrent liabilities:          
Early exercised stock option liability   4    23 
Other noncurrent liabilities   623    50 
Total noncurrent liabilities   627    73 
Total liabilities   4,048    5,972 
           
Stockholders’ equity:          
Common stock   10    6 
Additional paid-in capital   153,058    127,823 
Accumulated deficit   (136,290)   (124,380)
Total stockholders’ equity   16,778    3,449 
Total liabilities and stockholders’ equity  $20,826   $9,421 

 

4

 

 

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, 
   2024   2023   2024   2023 
                 
Revenue  $   $   $852   $ 
                     
COSTS AND EXPENSES:                    
Cost of revenue   380        1,595     
Research and development   2,907    4,171    5,794    8,065 
Sales, general and administrative   3,110    3,213    5,614    6,522 
Total costs and expenses   6,397    7,384    13,003    14,587 
Loss from operations   (6,397)   (7,384)   (12,151)   (14,587)
                     
Other income (expense), net:                    
Interest and other income, net   207    117    241    224 
Other income (expense), net   207    117    241    224 
                     
Net loss and total comprehensive loss  $(6,190)  $(7,267)  $(11,910)  $(14,363)
                     
Net loss per share, basic and diluted  $(0.06)  $(0.17)  $(0.15)  $(0.36)
                     
Weighted average shares used in computing net loss per share, basic and diluted   99,538,371    43,056,785    77,780,822    40,314,164 

 

 

 

5

 
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Cover
Aug. 14, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 14, 2024
Entity File Number 001-40254
Entity Registrant Name Movano Inc.
Entity Central Index Key 0001734750
Entity Tax Identification Number 82-4233771
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 6800 Koll Center Parkway
Entity Address, City or Town Pleasanton
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94566
City Area Code 415
Local Phone Number 651-3172
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common stock, par value $0.0001 per share
Trading Symbol MOVE
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Elected Not To Use the Extended Transition Period false
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