MOVE Movano Inc

 

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) November 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 November 14, 2024, Movano Inc. announced its financial results for the quarter ended September 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 November 14, 2024, issued by Movano Inc., furnished herewith.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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

 

 

2

Exhibit 99

 

 

 

Movano Health Reports Q3 2024 Financial Results and

Provides Business Update

 

Highlights successful Evie Ring back-in-stock execution

Updates status of EvieMED 510(k) application review

Focuses on launch of EvieMED and securing B2B opportunities

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

 

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

 

The Company continues to remain focused on three key business initiatives.

 

●

Successful execution of the Evie Ring direct-to-consumer business (D2C) following the September 17th back-in-stock launch, bolstered by an enhanced product experience and improved operations across manufacturing, logistics and customer service.

 

●

Securing FDA 510(k) clearance for the EvieMED Ring and pursuing initial business-to-business (B2B) commercial agreements across the healthcare sector.

 

●

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

 

“We are pleased with our Evie Ring D2C performance and continue to be laser focused on improving the consumer experience, including the upcoming launch of our Android app, as we head into the holiday period in order to maximize our sales potential,” said John Mastrototaro, President and CEO of Movano Health. “Additionally, we look forward to the successful completion of the 510(k) application review process of the EvieMED Ring and continue to focus on the game changing opportunities that we believe EvieMED could unlock for our healthcare partners.”

 

Recent Operating Highlights and Milestones

 

●

On September 17, 2024, Movano Health successfully launched a back-in-stock campaign for the Evie Ring D2C business. On October 30, 2024, the Company also shared the official announcement of its first brand partnership with content creator Heidi D’Amelio.

 

●

The Company continues to work collaboratively with the FDA and remains in the final stage of its FDA 510(k) application review process for the EvieMED Ring. The EvieMED Ring is designed to not only provide medical device functionality with its pulse oximetry feature, but also offer numerous wellness metrics related to sleep, activity and logging of mood, energy and health symptoms. This summer, Movano Health secured a positive resolution after responding to initial FDA questions related to EvieMED’s wellness features and metrics. During the week of October 28, 2024, the Company submitted a complete response package to additional clarifying questions related to the medical aspects of EvieMED.

 

 

●

Movano Health continues to make important progress on the B2B front in anticipation of an expected 510(k) clearance, re-engaging with a number of potential partners across the full spectrum of healthcare use cases. For example, the Company has entered into the agreement phase with a large healthcare company for a pilot program in Q1 2025 using the EvieMed Ring as part of an overall metabolic solution to address chronic disease.

 

●

Movano Health tested its newly developed blood pressure wrist wearable as part of a November 5th and 6th hypoxia clinical trial that took place at the University of California, San Francisco. The updated device features an additional 12 mmWave antennas, which together with the Company’s custom RF chip, delivers enhanced data collection with less impact of placement while also featuring a slimmer design, making it easier and more comfortable to wear. In addition, the new wearable monitors a host of other vital signs including pulse rate, blood oxygen saturation (Sp02), respiration rate and ECG waveforms.

 

Third Quarter 2024 and Recent Financial Highlights

 

●

In Q3 2024, Movano Health shipped 339 Evie Rings.

 

●

The Company reported an operating loss of $7.4 million in Q3 2024, compared to an operating loss of $9.1 million in Q3 2023.

 

●

Total cash and cash equivalents at September 30, 2024 were $11.3 million.

 

●

On October 29, 2024, the Company implemented a 1-for-15 reverse stock split of the issued shares of its common stock. The reverse stock split was intended to increase the bid price of the common stock to enable the Company to regain compliance for continued listing on The Nasdaq Capital Market. On November 12, 2024, the Company was informed by Nasdaq that it had regained compliance with the minimum bid price requirement.

 

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.

 

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 is developing its proprietary technologies and wearable medical device solutions to enable the future 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

 

 

Movano Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

		September 30,				December 31,
		2024				2023
ASSETS
Current assets:
Cash and cash equivalents		$	11,272			$	6,118
Payroll tax credit, current portion			233				450
Vendor deposits			9				399
Inventory			2,033				1,114
Prepaid expenses and other current assets			467				442
Total current assets			14,014				8,523
Property and equipment, net			237				342
Payroll tax credit, noncurrent portion			55				169
Other assets			761				387
Total assets		$	15,067			$	9,421
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	1,896			$	3,118
Deferred revenue			20				1,252
Other current liabilities			2,317				1,529
Total current liabilities			4,233				5,899
Noncurrent liabilities:
Early exercised stock option liability			—				23
Other noncurrent liabilities			583				50
Total noncurrent liabilities			583				73
Total liabilities			4,816				5,972
Stockholders’ equity:
Common stock			10				6
Additional paid-in capital			153,732				127,823
Accumulated deficit			(143,491	)			(124,380	)
Total stockholders’ equity			10,251				3,449
Total liabilities and stockholders’ equity		$	15,067			$	9,421

 

 

Movano Inc.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

(Unaudited)

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2024				2023				2024				2023
Revenue		$	50			$	—			$	902			$	—
COSTS AND EXPENSES:
Cost of revenue			845				—				2,440				—
Research and development			3,404				5,636				9,198				13,701
Sales, general and administrative			3,180				3,443				8,794				9,965
Total costs and expenses			7,429				9,079				20,432				23,666
Loss from operations			(7,379	)			(9,079	)			(19,530	)			(23,666	)
Other income (expense), net:
Interest and other income, net			178				117				419				341
Other income (expense), net			178				117				419				341
Net loss and total comprehensive loss		$	(7,201	)		$	(8,962	)		$	(19,111	)		$	(23,325	)
Net loss per share, basic and diluted		$	(1.06	)		$	(2.65	)		$	(3.33	)		$	(7.99	)
Weighted average shares used in computing net loss per share, basic and diluted			6,816,339				3,380,763				5,733,007				2,921,201

 

 

v3.24.3

Cover	Nov. 14, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 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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