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, 2024
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 | | 82-4233771 |
(State of incorporation) | | (I.R.S. Employer Identification No.) |
6800
Koll Center Parkway, Pleasanton, CA 94566
(Address
of principal executive office) (Zip code)
(415)
651-3172
(Registrant’s
telephone number, including area code)
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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company
or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
| Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| | | 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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
☒
As of November 8, 2024, there
were 6,633,511 shares of our common stock, par value $0.0001 per share, outstanding.
MOVANO
INC.
FORM
10-Q
FOR
THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024
INDEX
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements
Movano
Inc.
Condensed
Consolidated Balance Sheets
(in
thousands, except share and per share data)
(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 | |
| |
| | | |
| | |
Commitments
and contingencies (Note 10) | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’
equity: | |
| | | |
| | |
Preferred stock, $0.0001 par value, 5,000,000 shares authorized at September 30, 2024 and December 31, 2023; no shares issued and outstanding at September 30, 2024 and December 31, 2023 | |
| — | | |
| — | |
Common stock, $0.0001 par value, 500,000,000 and 150,000,000 shares authorized at September 30, 2024 and December 31, 2023, respectively; 6,633,511 and 3,723,218 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively | |
| 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 | |
See
accompanying notes to condensed consolidated financial statements.
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 | |
See
accompanying notes to condensed consolidated financial statements.
Movano Inc.
Condensed
Consolidated Statements of Stockholders’ Equity
(in
thousands, except share data)
(Unaudited)
| |
| | |
| | |
Additional | | |
| | |
Total | |
| |
Common
Stock | | |
Paid-In | | |
Accumulated | | |
Stockholders’ | |
Three Months
Ended September 30, 2023 | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance at June 30, 2023 | |
| 3,376,444 | | |
$ | 5 | | |
$ | 122,283 | | |
$ | (109,460 | ) | |
$ | 12,828 | |
Stock-based compensation | |
| — | | |
| — | | |
| 757 | | |
| — | | |
| 757 | |
Issuance of common stock | |
| 10,619 | | |
| — | | |
| 173 | | |
| — | | |
| 173 | |
Issuance of common stock
warrants | |
| — | | |
| — | | |
| 124 | | |
| — | | |
| 124 | |
Vesting of early exercised
stock options | |
| — | | |
| — | | |
| 24 | | |
| — | | |
| 24 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (8,962 | ) | |
| (8,962 | ) |
Balance at September 30, 2023 | |
| 3,387,063 | | |
$ | 5 | | |
$ | 123,361 | | |
$ | (118,422 | ) | |
$ | 4,944 | |
| |
| | |
| | |
Additional | | |
| | |
Total | |
| |
Common
Stock | | |
Paid-In | | |
Accumulated | | |
Stockholders’ | |
Nine
Months Ended September 30, 2023 | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance
at December 31, 2022 | |
| 2,243,964 | | |
$ | 3 | | |
$ | 103,009 | | |
$ | (95,097 | ) | |
$ | 7,915 | |
Stock-based
compensation | |
| — | | |
| — | | |
| 2,252 | | |
| — | | |
| 2,252 | |
Issuance
of common stock upon February 2023 public offering, net of issuance costs | |
| 356,040 | | |
| 1 | | |
| 5,179 | | |
| — | | |
| 5,180 | |
Issuance
of warrants upon February 2023 public offering | |
| — | | |
| — | | |
| 1,473 | | |
| — | | |
| 1,473 | |
Issuance
of common stock upon June 2023 public offering, net of issuance costs | |
| 613,334 | | |
| 1 | | |
| 8,065 | | |
| — | | |
| 8,066 | |
Issuance
of common stock | |
| 157,335 | | |
| — | | |
| 3,061 | | |
| — | | |
| 3,061 | |
Issuance
of common stock upon exercise of options | |
| 16,390 | | |
| — | | |
| 109 | | |
| — | | |
| 109 | |
Issuance
of common stock warrant | |
| — | | |
| — | | |
| 124 | | |
| — | | |
| 124 | |
Vesting
of early exercised stock options | |
| — | | |
| — | | |
| 89 | | |
| — | | |
| 89 | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (23,325 | ) | |
| (23,325 | ) |
Balance
at September 30, 2023 | |
| 3,387,063 | | |
$ | 5 | | |
$ | 123,361 | | |
$ | (118,422 | ) | |
$ | 4,944 | |
| |
| | |
Additional | | |
| | |
Total | |
| |
Common Stock | | |
Paid-In | | |
Accumulated | | |
Stockholders’ | |
Three Months Ended September 30, 2024 | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance at June 30, 2024 | |
| 6,596,565 | | |
$ | 10 | | |
$ | 153,058 | | |
$ | (136,290 | ) | |
$ | 16,778 | |
Stock-based compensation | |
| — | | |
| — | | |
| 534 | | |
| — | | |
| 534 | |
Common stock issuance costs | |
| — | | |
| — | | |
| (65 | ) | |
| — | | |
| (65 | ) |
Issuance of common stock warrants | |
| — | | |
| — | | |
| 60 | | |
| — | | |
| 60 | |
Issuance of common stock | |
| 36,946 | | |
| — | | |
| 141 | | |
| — | | |
| 141 | |
Vesting of early exercised stock options | |
| — | | |
| — | | |
| 4 | | |
| — | | |
| 4 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (7,201 | ) | |
| (7,201 | ) |
Balance at September 30, 2024 | |
| 6,633,511 | | |
$ | 10 | | |
$ | 153,732 | | |
$ | (143,491 | ) | |
$ | 10,251 | |
| |
| | |
Additional | | |
| | |
Total | |
| |
Common Stock | | |
Paid-In | | |
Accumulated | | |
Stockholders’ | |
Nine Months Ended September 30, 2024 | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance at December 31, 2023 | |
| 3,723,218 | | |
$ | 6 | | |
$ | 127,823 | | |
$ | (124,380 | ) | |
$ | 3,449 | |
Stock-based compensation | |
| — | | |
| — | | |
| 2,695 | | |
| — | | |
| 2,695 | |
Issuance of common stock in April 2024 sale, net of issuance costs | |
| 2,806,898 | | |
| 4 | | |
| 12,890 | | |
| — | | |
| 12,894 | |
Issuance of pre-funded warrants in April 2024 sale | |
| — | | |
| — | | |
| 980 | | |
| — | | |
| 980 | |
Issuance of common stock warrants in April 2024 sale | |
| — | | |
| — | | |
| 8,756 | | |
| — | | |
| 8,756 | |
Issuance of common stock warrants | |
| — | | |
| — | | |
| 60 | | |
| — | | |
| 60 | |
Issuance of common stock | |
| 100,728 | | |
| — | | |
| 490 | | |
| — | | |
| 490 | |
Issuance of common stock upon exercise of options | |
| 2,667 | | |
| — | | |
| 15 | | |
| — | | |
| 15 | |
Vesting of early exercised stock options | |
| — | | |
| — | | |
| 23 | | |
| — | | |
| 23 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| (19,111 | ) | |
| (19,111 | ) |
Balance at September 30, 2024 | |
| 6,633,511 | | |
$ | 10 | | |
$ | 153,732 | | |
$ | (143,491 | ) | |
$ | 10,251 | |
See
accompanying notes to condensed consolidated financial statements.
Movano Inc.
Condensed
Consolidated Statements of Cash Flows
(in
thousands)
(Unaudited)
| |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | |
| |
Net loss | |
$ | (19,111 | ) | |
$ | (23,325 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 128 | | |
| 118 | |
Stock-based compensation | |
| 2,695 | | |
| 2,252 | |
Noncash lease expense | |
| 157 | | |
| (11 | ) |
Non-cash compensation related to common stock warrants issued to strategic advisory group | |
| 60 | | |
| — | |
Loss on disposal of property and equipment | |
| 2 | | |
| 13 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Payroll tax credit | |
| 331 | | |
| 129 | |
Inventory | |
| (919 | ) | |
| — | |
Prepaid expenses, vendor deposits and other current assets | |
| 365 | | |
| (626 | ) |
Other assets | |
| (31 | ) | |
| (40 | ) |
Accounts payable | |
| (1,216 | ) | |
| 1,398 | |
Deferred revenue | |
| (1,232 | ) | |
| — | |
Other current and noncurrent liabilities | |
| 793 | | |
| (836 | ) |
Net cash used in operating activities | |
| (17,978 | ) | |
| (20,928 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Purchases of property and equipment | |
| (3 | ) | |
| (51 | ) |
Net cash used in investing activities | |
| (3 | ) | |
| (51 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Issuance of common stock and warrants upon February 2023 public offering, net of issuance costs | |
| — | | |
| 6,653 | |
Issuance of common stock upon June 2023 public offering, net of issuance costs | |
| — | | |
| 8,066 | |
Issuance of common stock, pre-funded warrants and common stock warrants in April 2024 sale, net of issuance costs | |
| 22,630 | | |
| — | |
Issuance of common stock, net of issuance costs | |
| 490 | | |
| 3,061 | |
Issuance of common stock upon exercise of stock options | |
| 15 | | |
| 109 | |
Net cash provided by financing activities | |
| 23,135 | | |
| 17,889 | |
| |
| | | |
| | |
Net increase/(decrease) in cash and cash equivalents | |
| 5,154 | | |
| (3,090 | ) |
Cash and cash equivalents at beginning of period | |
| 6,118 | | |
| 10,759 | |
Cash and cash equivalents at end of period | |
$ | 11,272 | | |
$ | 7,669 | |
| |
| | | |
| | |
NONCASH INVESTING AND FINANCING ACTIVITIES: | |
| | | |
| | |
Vesting of common stock issued upon early exercise | |
$ | 23 | | |
$ | 89 | |
Warrants issued upon February 2023 public offering | |
$ | — | | |
$ | 1,473 | |
Issuance of common stock warrant | |
$ | — | | |
$ | 124 | |
Issuance of common stock warrants in April 2024 sale | |
$ | 8,756 | | |
$ | — | |
Right of use asset recorded for operating lease liability | |
$ | 514 | | |
$ | — | |
See
accompanying notes to condensed consolidated financial statements.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note
1 – Business Organization, Nature of Operations
Movano
Inc., dba Movano Health (the “Company”, “Movano”, “Movano Health”, “we”, “us”
or “our”) was incorporated in Delaware on January 30, 2018 as Maestro Sensors Inc. and changed its name to Movano Inc. on
August 3, 2018. The Company is an early-stage technology company and is developing a platform to deliver purpose-driven healthcare solutions
at the intersection of medical and consumer devices. Movano is on a mission to make medical grade data more accessible and actionable
for all.
The
Company’s solutions provide vital health information, including heart rate, heart rate variability (HRV), sleep, respiration rate,
temperature, blood oxygen saturation (SpO2), steps, and calories as well as glucose and blood pressure data, in a variety
of form factors to meet individual style needs and give users actionable feedback to improve their quality of life.
On
April 28, 2021, the Company established Movano Ireland Limited, organized under the laws of Ireland, as a wholly owned subsidiary of
the Company. Operations and activity at the wholly owned subsidiary were not significant for the three and nine months ended September 30,
2024 and 2023, respectively.
Since inception, the Company has engaged in only
limited research and development of product candidates and underlying technology and the commercialization of the Company’s first
commercial product, the Evie Ring. For the three months and nine months ended September 30, 2024, the Company recorded revenue for
this product of $0.1 million and $0.9 million, respectively.
On April 2, 2024, the Company entered into
a securities purchase agreement for the private placement (“April 2024 Private Placement”) of an aggregate of 3,015,172 units
with each unit consisting of (1) one share of the Company’s common stock or at the election of the purchaser, a pre-funded warrant
to purchase one share of common stock, and (2) one warrant to purchase one share of common stock. The purchase price paid for each unit
was $8.00. Certain directors and officers participated in the transaction and purchased 19,168 of the units at an offering price
of $8.48 per unit.
Pre-funded warrants totaling 209,936 shares
were issued as part of the April 2024 Private Placement. Each pre-funded warrant has an exercise price equal to $0.015 per share or calculated
pursuant to the cashless exercise provision. The pre-funded warrants were immediately exercisable on the date of issuance and do not
expire.
Warrants totaling 3,015,172 shares were issued as part of the April
2024 Private Placement. Each warrant that was issued to holders other than the Company’s officers and directors has an exercise
price equal to $6.11 per share or calculated pursuant to the cashless exercise provision. The warrants issued to the Company’s officers
and directors have an exercise price equal to $6.60 or calculated pursuant to the cashless exercise provision. The warrants were exercisable
immediately and expire on the fifth anniversary of the initial exercise date of the warrant. After April 4, 2025, the warrants may be
redeemed in whole or in part at the option of the Company with at least thirty days’ notice to the holder of the warrant, which
notice may not be given before, but may be given at any time after the date on which (i) the closing price of the Company’s common
stock has equaled or exceeded $75.00 for ten consecutive trading days and (ii) the daily trading volume of the common stock has exceeded
6,667 shares on each of such ten trading days. The redemption price is $0.38 per warrant share.
The gross proceeds of the April 2024 Private Placement
were approximately $24.1 million, before deducting offering fees and expenses of approximately $1.5 million. The April 2024 Private Placement
closed on April 5, 2024. Common stock shares of 2,806,898 were issued.
The
Company has incurred losses from operations and has generated negative cash flows from operating activities since inception. The Company
expects to continue to incur net losses for the foreseeable future as it continues the development of its technology. The Company’s
ultimate success depends on the outcome of its research and development and commercialization activities, for which it expects to incur
additional losses in the future. Through September 30, 2024, the Company has relied primarily on the proceeds from equity offerings
to finance its operations. The Company expects to require additional financing to fund its future planned operations, including research
and development and commercialization of its products. The Company will likely raise additional capital through the issuance of equity,
borrowings, or strategic alliances with partner companies. However, if such financing is not available at adequate levels, the Company
would need to reevaluate its operating plans.
Liquidity
and Going Concern
The
accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization
of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred significant losses and has an
accumulated deficit of $143.5 million as of September 30, 2024. The Company anticipates incurring additional losses until such
time, if ever, that it can generate significant sales. The Company’s existence is dependent upon management’s ability to
obtain additional funding sources. These circumstances raise substantial doubt about the Company’s ability to continue as a going
concern within one year after the date that the financial statements are issued.
Adequate
additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise additional
capital and/or enter into strategic alliances when needed or on attractive terms, it would be forced to delay, reduce, or eliminate its
product or any commercialization efforts. There can be no assurance that the Company’s efforts will result in the resolution of
the Company’s liquidity needs. The accompanying condensed consolidated financial statements do not include any adjustments that
might result should the Company be unable to continue as a going concern.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note
2 – Summary of Significant Accounting Policies
Basis
of Presentation
The accompanying unaudited condensed consolidated
financial statements include the accounts of the Company and its wholly owned subsidiary and have been prepared in accordance with U.S.
generally accepted accounting principles (GAAP) for interim financial information and in accordance with the instructions to Form 10-Q
and Rule 10-01 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete
financial statements. The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial
statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments
(consisting only of normal recurring adjustments) considered necessary for a fair presentation. Intercompany transactions are eliminated
in the condensed consolidated financial statements. These financial statements should be read in conjunction with the audited financial
statements and notes thereto for the preceding fiscal year contained in the Company’s Annual Report on Form 10-K filed on April 16,
2024 with the United States Securities and Exchange Commission (the “SEC”) and amended on April 29, 2024.
The
results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results
to be expected for the year ending December 31, 2024. The condensed consolidated balance sheet as of December 31, 2023 has
been derived from audited financial statements at that date but does not include all the information required by GAAP for complete financial
statements.
Use
of Estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated
financial statements, and the reported amounts of revenues and expenses during the reporting periods.
Significant
estimates and assumptions reflected in these condensed consolidated financial statements include but are not limited to the fair value
of stock options and warrants, and income taxes. Estimates are periodically reviewed considering changes in circumstances, facts, and
experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates
or assumptions.
Reverse Stock Split
On October 29, 2024, the Company completed a 1-for-15
reverse stock split of its issued and outstanding common stock (the “Reverse Stock Split”). As a result of the Reverse Stock
Split, each share of common stock issued and outstanding immediately prior to October 29, 2024 were automatically reclassified and converted
into one-fifteenth (1/15th, “Reverse Stock Split Ratio”) of a share of common stock. The Reverse Stock Split affected
all common stockholders uniformly and did not alter any stockholder's percentage interest in the Company's equity, except to the extent
that the Reverse Stock Split resulted in a stockholder of record owning a fractional share. Stockholders of record who were otherwise
entitled to receive a fractional share, instead automatically had their fractional shares rounded up to the next whole share. No cash
was issued for fractional shares as part of the Reverse Stock Split.
The Reverse Stock Split did not change the
par value of the common stock or the authorized number of shares of common stock. Proportionate adjustments were made to the
exercise prices and the number of shares underlying the Company’s equity plans and grants thereunder, as applicable.
Additionally, proportionate adjustments were made to the exercise prices and the number of shares underlying all outstanding
warrants, as required by the terms of these securities.
All common share and per-share amounts in this
Form 10-Q have been retroactively restated to reflect the effect of the Reverse Stock Split.
Segment
Information
Operating
segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief
operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views
its operations and manages its business in one segment. The Company’s chief operating decision maker is the Chief Executive Officer.
Cash
and Cash Equivalents
The
Company invests its excess cash primarily in money market funds. The Company considers all highly liquid investments with an original
maturity of three months or less to be cash equivalents.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Concentrations
of Credit Risk and Off-Balance Sheet Risk
Cash and cash equivalents are financial instruments
that are potentially subject to concentrations of credit risk. Substantially all cash and cash equivalents are held in United States financial
institutions. Cash equivalents consist of interest-bearing money market accounts. The amounts deposited in the money market accounts exceed
federally insured limits. Further, the Company has amounts in excess of federally insured limits as of September 30, 2024 at one
financial institution that totaled approximately $0.3 million. The Company has not experienced any losses related to this account and
believes the associated credit risk to be minimal due to the financial condition of the depository institution in which those deposits
are held.
The
Company is dependent on third-party manufacturers to supply products for manufacturing as well as research and development activities.
These programs could be adversely affected by a significant interruption in the supply of such materials.
The
Company has no financial instruments with off-balance sheet risk of loss.
Inventory
Inventory,
which consists of raw materials and finished goods, is stated at the lower of cost or net realizable value. Cost comprises purchase price
and incidental expenses incurred in bringing the inventory to its present location and condition. Cost is computed using the weighted-average
cost method.
The
Company writes down its inventory for estimated obsolescence or unmarketable inventory equal to the difference between the cost of inventory
and the estimate net realized value based upon assumptions about future demand and market conditions. If actual market conditions are
less favorable than those projected by management, inventory write-downs may be required.
Software
Development Costs
Costs
associated with the planning and design phase of software development are classified as research and development costs and are expensed
as incurred. Once technological feasibility has been established, a portion of the costs incurred in development, including coding, testing
and quality assurance, are capitalized until available for general release to customers, and subsequently reported at the lower of unamortized
cost or net realizable value. Amortization is calculated on a solution-by-solution basis based on the estimated lives of the underlying
asset and is included in cost of revenue on the condensed consolidated statements of operations and comprehensive loss. During the three
and nine months ended September 30, 2024 and 2023, no software development costs were capitalized, and no amortization was recognized.
Revenue
The
Company recognizes revenue from contracts with customers upon transfer of control of promised goods or services at the transaction price
which reflects the consideration the Company expects to be entitled in exchange for those goods or services. The transaction price is
calculated as selling price net of variable consideration which may include estimates for future returns and sales incentives related
to current period product revenue.
The
Company generates revenue from the sale of Evie Rings, portable chargers, charging cables, ring sizers, and mobile applications. As part
of the purchase, customers also receive customer support and future unspecified software updates. These products and services are collectively
referred to as the Evie Ring Elements, each of which is distinct and a separate performance obligation.
The
Company allocates the transaction price to all distinct performance obligations based on their relative stand-alone selling price (“SSP”).
When available, the Company uses observable prices to determine SSP. When observable prices are not available, SSPs are established that
reflect the Company’s best estimates of what the selling prices of the performance obligations would be if they were sold regularly
on a stand-alone basis. The Company’s process for estimating SSPs without observable prices considers multiple factors that may
vary depending upon the unique facts and circumstances related to each performance obligation including, where applicable, prices charged
by the Company for similar offerings, market trends in the pricing for similar offerings, product-specific business objectives and the
estimated cost to provide the performance obligation.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Revenue
associated with the Evie Ring, portable charger, charging cable, ring sizer, and mobile application performance obligations is recognized
upon delivery to customers. The performance obligation for the embedded right to receive, on a when-and-if-available basis, customer
support and future unspecified software updates, is recognized to revenue on a straight-line basis over the estimated life of the product
and is not material in the periods presented. The Company allocates revenue and any related discounts to these performance obligations
based on their relative SSPs. Because the Company lacks observable prices for the undelivered performance obligations, the allocation
of revenue is based on the Company’s estimated SSPs.
Sales
of the Evie Ring Elements include an assurance warranty.
Contract balances represent amounts presented
in the condensed consolidated balance sheets when the Company has transferred goods or services to the customer, or the customer has paid
consideration to the Company under the contract. Customer payments are made up-front upon the purchase of products and services. The Company
has no accounts receivable as of September 30, 2024, December 31, 2023, or December 31, 2022, respectively. There were
no contract assets at September 30, 2024, December 31, 2023, or December 31, 2022.
The Company records a contract liability for deferred revenue when
cash payments from customers are received prior to the transfer of control or satisfaction of the related performance obligations. Deferred
revenue at September 30, 2024, December 31, 2023, and December 31, 2022 was $20,000, $1.3 million and $0, respectively.
During the three and nine months ended September 30, 2024, deferred revenue of $0.1 million and $1.3 million, respectively,
was recognized in revenue. However, customer refunds and returns during the three and nine months ended September 30, 2024 offset
the recognition of revenue, which resulted in $0.1 million and $0.9 million of revenue during the three and nine months ended September 30,
2024.
The Company offers limited rights of return for
a 30-day right of return, whereby customers may return the Evie Ring Elements. The Company’s estimate of future returns requires
significant judgement. The Company estimates reserves based on data specific to each reporting period and historical trends to date. The
estimate is adjusted each period for actual returns received. The returns reserve is recorded as a reduction of revenue and recognized
in other current liabilities. As of September 30, 2024, December 31, 2023, and December 31, 2022, the balance of product
return provisions included in other current liabilities is $15,000, $0 and $0, respectively.
The
Company collects sales taxes at the point of sale and remits the taxes to the proper state authorities. Sales tax is excluded from the
measurement of the transaction price.
Shipping
and handling costs are incurred as part of fulfillment activities with customers and are included as a component of cost of revenue.
Costs
of Revenue
Costs
of revenue consists primarily of material costs, freight charges, purchasing and receiving costs, inspection costs, royalties, customer
support and other costs, which are directly attributable to the production of the Company’s product. Write-down of inventory to
lower of cost or net realizable value is also recorded in cost of goods sold.
Advertising
Costs
The
Company expenses advertising costs as they are incurred. Advertising expenses were $49,000 and $0.5 million for the three months ended
September 30, 2024 and 2023, and $0.2 million and $1.0 million for the nine months ended September 30, 2024 and 2023, respectively.
These costs are included in sales, general and administrative expenses in the accompanying condensed consolidated statements of operations
and comprehensive loss.
Stock-Based
Compensation
The
Company measures equity classified stock-based awards granted to employees, directors, and nonemployees based on the estimated fair value
on the date of grant and recognizes compensation expense of those awards on a straight-line basis over the requisite service period,
which is generally the vesting period of the respective award. The fair value of each stock option grant is estimated on the date of
grant using the Black-Scholes option pricing model. This valuation model for stock-based compensation expense requires the Company to
make assumptions and judgments about the variables used in the calculation including the expected term, the volatility of the Company’s
common stock, and an assumed risk-free interest rate. The Company accounts for forfeitures as they occur.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Income
Taxes
The
Company accounts for income taxes using the asset and liability method. Under this method, deferred tax assets and liabilities are determined
based on differences between the financial statement and tax basis of assets and liabilities and net operating loss and credit carryforwards
using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are established
when necessary to reduce deferred tax assets to the amounts expected to be realized. As the Company maintained a full valuation allowance
against its deferred tax assets, the changes resulted in no provision or benefit from income taxes during the three and nine months ended
September 30, 2024 and 2023, respectively.
The
Company accounts for unrecognized tax benefits using a more-likely-than-not threshold for financial statement recognition and measurement
of tax positions taken or expected to be taken in a tax return. The Company establishes a liability for tax-related uncertainties based
on estimates of whether, and the extent to which, additional taxes will be due. The Company records an income tax liability, if any,
for the difference between the benefit recognized and measured and the tax position taken or expected to be taken on the Company’s
tax returns. To the extent that the assessment of such tax positions changes, the change in estimate is recorded in the period in which
the determination is made. The liability is adjusted considering changing facts and circumstances, such as the outcome of a tax audit.
The provision for income taxes includes the impact of liability provisions and changes to the liability that are considered appropriate.
Changes in recognition or measurement are reflected in the period in which the change in judgment occurs.
For
interim periods, the Company estimates its annual effective income tax rate and applies the estimated rate to the year-to-date income
or loss before income taxes. The Company computes the tax provision or benefit related to items reported separately and recognizes the
items net of their related tax effect in the interim periods in which they occur. The Company recognizes the effect of changes in enacted
tax laws or rates in the interim periods in which the changes occur.
Net
Loss per Share
Basic
net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during
the period, without consideration for common stock equivalents. The weighted average number of common shares used in calculating basic
and diluted net loss per share includes the weighted-average pre-funded common stock warrants outstanding during the period as they are
exercisable at any time for nominal cash consideration. Diluted net loss per share is the same as basic net loss per share, since the
effects of potentially dilutive securities are antidilutive.
Recently
Issued Accounting Pronouncements
In November
2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures,
to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The
disclosure requirements must be applied retrospectively to all prior periods presented in the financial statements. The effective date
for the standard is for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15,
2024, with early adoption permitted. The Company is currently evaluating the effects adoption of this guidance will have on the consolidated
financial statements for fiscal year 2024.
In November 2024, the FASB issued ASU 2024-03, Income
Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement
Expenses, to require disclosure, in the notes to financial statements, of specified information about certain costs and expenses.
The effective date for the standard is for fiscal years beginning after December 15, 2026 and interim periods within fiscal years
beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the effects adoption of this
guidance will have on the consolidated financial statements.
Note
3 – FAIR VALUE MEASUREMENTS
Financial
assets and liabilities are recorded at fair value. The Company uses a three-level hierarchy, which prioritizes, within the measurement
of fair value, the use of market-based information over entity-specific information for fair value measurements based on the nature of
inputs used in the valuation of an asset or liability as of the measurement date. Fair value focuses on an exit price and is defined
as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants
at the measurement date. The inputs or methodology used for valuing financial instruments are not necessarily an indication of the risk
associated with investing in those financial instruments.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
A
three-tier fair value hierarchy is used to prioritize the inputs in measuring fair value as follows:
|
Level 1 – |
Quoted prices in active
markets for identical assets or liabilities. |
|
Level 2 – |
Quoted prices for similar
assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active,
or other inputs that are observable, either directly or indirectly. |
|
Level 3 – |
Significant unobservable
inputs that cannot be corroborated by market data. |
The
asset’s or liability’s fair value measurement level within the fair value hierarchy is based on the lowest level of any input
that is significant to the fair value measurement. The Company’s Level 1 financial assets are money market funds whose fair values
are based on quoted market prices. The carrying amounts of prepaid expenses and other current assets, payroll tax credit, vendor deposits,
inventory, accounts payable, deferred revenue, and other current liabilities approximate fair value due to the short-term nature of these
instruments.
The
following tables provide a summary of the assets and liabilities that are measured at fair value on a recurring basis as of September 30,
2024 and December 31, 2023 (in thousands):
Fair
Value Measurements
| |
September
30, 2024 | |
| |
Fair
Value | | |
Level
1 | | |
Level
2 | | |
Level
3 | |
| |
| | |
| | |
| | |
| |
Cash equivalents: | |
| | |
| | |
| | |
| |
Money
market funds | |
$ | 10,659 | | |
$ | 10,659 | | |
$ | — | | |
$ | — | |
Total cash equivalents | |
$ | 10,659 | | |
$ | 10,659 | | |
$ | — | | |
$ | — | |
| |
December
31, 2023 | |
| |
Fair
Value | | |
Level
1 | | |
Level
2 | | |
Level
3 | |
Cash equivalents: | |
| | |
| | |
| | |
| |
Money
market funds | |
$ | 4,393 | | |
$ | 4,393 | | |
$ | — | | |
$ | — | |
Total cash equivalents | |
$ | 4,393 | | |
$ | 4,393 | | |
$ | — | | |
$ | — | |
Note
4 – CASH AND CASH EQUIVALENTS
Cash
and cash equivalents consist of the following (in thousands):
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Cash and cash equivalents: | |
| | |
| |
Cash | |
$ | 613 | | |
$ | 1,725 | |
Money
market funds | |
| 10,659 | | |
| 4,393 | |
Total cash and cash equivalents | |
$ | 11,272 | | |
$ | 6,118 | |
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note
5 – BALANCE SHEET COMPONENTS
Inventory
as of September 30, 2024 and December 31, 2023, consisted of the following (in thousands):
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Raw materials | |
$ | 1,852 | | |
$ | 1,114 | |
Finished goods | |
| 181 | | |
| — | |
Total inventory | |
$ | 2,033 | | |
$ | 1,114 | |
Property
and equipment, net, as of September 30, 2024 and December 31, 2023, consisted of the following (in thousands):
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Office equipment and furniture | |
$ | 255 | | |
$ | 266 | |
Software | |
| 144 | | |
| 144 | |
Test equipment | |
| 310 | | |
| 310 | |
Total property and equipment | |
| 709 | | |
| 720 | |
Less: accumulated depreciation | |
| (472 | ) | |
| (378 | ) |
Total
property and equipment, net | |
$ | 237 | | |
$ | 342 | |
Total
depreciation and amortization expense related to property and equipment for the three and nine months ended September 30, 2024 was
approximately $30,000 and $100,000, respectively. Total depreciation and amortization expense related to property and equipment for the
three and nine months ended September 30, 2023 was approximately $40,000 and $118,000, respectively.
Note
6 – Other Current Liabilities
Other
current liabilities as of September 30, 2024 and December 31, 2023 consisted of the following (in thousands):
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
Accrued compensation | |
$ | 1,184 | | |
$ | 299 | |
Accrued research and development | |
| 335 | | |
| 461 | |
Accrued inventory | |
| 148 | | |
| — | |
Accrued vacation | |
| 295 | | |
| 246 | |
Accrued severance payment | |
| — | | |
| 5 | |
Lease liabilities, current portion | |
| 102 | | |
| 217 | |
Other | |
| 253 | | |
| 301 | |
| |
$ | 2,317 | | |
$ | 1,529 | |
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note
7 – Common Stock
As
of September 30, 2024 and December 31, 2023, the Company was authorized to issue 500,000,000 and 150,000,000, shares of common stock,
respectively, with a par value of $0.0001 per share. As of September 30, 2024 and December 31, 2023, 6,633,511 and 3,723,218
shares were outstanding, respectively.
On July 9,
2024, the Company filed a Certificate of Amendment to its Third Amended and Restated Certificate of Incorporation increasing the number
of authorized shares of common stock from 150,000,000 to 500,000,000 shares.
On October 29, 2024, the Company completed a 1-for-15 reverse stock
split of its issued and outstanding common stock. As a result of the Reverse Stock Split, each share of common stock issued and outstanding
immediately prior to October 29, 2024 were automatically reclassified and converted into one-fifteenth (1/15th) of a share of common stock.
At-the-Market
Issuance of Common Stock
On
August 15, 2022, the Company entered into an At-the-Market Issuance Agreement (the “Issuance Agreement”) with B. Riley Securities,
Inc. (the “Sales Agent”). Pursuant to the terms of the Issuance Agreement, the Company may sell from time to time through
the Sales Agent shares of the Company’s common stock having an aggregate offering price of up to $50,000,000 (the “Shares”).
Sales of Shares, if any, may be made by means of transactions that are deemed to be “at the market” offerings as defined
in Rule 415 under the Securities Act, including block trades, ordinary brokers’ transactions on the Nasdaq Capital Market or otherwise
at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices or by any other
method permitted by law.
Under the terms of the Issuance Agreement, the
Company may also sell Shares to the Sales Agent as principal for its own accounts at a price to be agreed upon at the time of sale. Any
sale of Shares to the Sales Agent as principal would be pursuant to the terms of a separate agreement between the Company and the Sales
Agent.
The
Company has no obligation to sell any of the Shares under the Issuance Agreement and may at any time suspend solicitation and offers
under the Issuance Agreement.
In
June 2024, the Company replaced B. Riley Securities with Jones Trading as the Sales Agent for the Issuance Agreement.
During
the three months ended September 30, 2024 and 2023, the Company issued and sold an aggregate of 35,279 and 10,619 shares of common
stock through the Issuance Agreement at a weighted-average public offering price of $5.51 and $17.96 per share and received net
proceeds of $0.2 million and $0.2 million, respectively. During the nine months ended September 30, 2024 and 2023, the
Company issued and sold an aggregate of 99,061 and 157,335 shares of common stock through the Issuance Agreement at a weighted-average
public offering price of $6.64 and $20.14 per share and received net proceeds of $0.6 million and $3.1 million, respectively.
As of September 30, 2024, an aggregate offering price amount of approximately $43.7 million remained available to be issued
and sold under the Issuance Agreement.
Common
Stock Reserved for Future Issuance
Common
stock reserved for future issuance at September 30, 2024 is summarized as follows:
| |
September 30, | |
| |
2024 | |
Warrants to purchase common stock | |
| 3,564,375 | |
Stock options outstanding | |
| 755,105 | |
Stock options available for future grants | |
| 801,236 | |
Total | |
| 5,120,716 | |
Early
Exercised Stock Option Liability
During
the three and nine months ended September 30, 2024 and 2023, no additional shares were issued upon the early exercise of common
stock options. The Exercise Notice (Early Exercise) Agreement states that the Company has the option to repurchase all or a portion of
the unvested shares in the event of the separation of the holder from service to the Company. The shares continue to vest in accordance
with the original vesting schedules of the former option agreements.
As of September 30, 2024 and December 31,
2023, the Company has recorded a repurchase liability for approximately $0 and $23,000 for 0 and 2,917 shares that remain unvested, respectively.
As of September 30, 2024, there are no remaining unvested shares.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note
8 – Common Stock Warrants
Preferred
A and B Placement Warrants
During
May 2024, the Board approved the amendment of 19,536 Preferred A Placement Warrants and 30,920 Preferred B Placement Warrants to extend
the maturity to April 2025. The maturity of the Series A Placement Warrants were previously extended by amendment in February 2023, September
2023, and November 2023. The Company assessed the accounting treatment of the warrant amendments and determined that the amendments are
modifications for accounting purposes. The Company determined the modifications had an insignificant impact on the consolidated financial
statements.
April
2024 Pre-funded and Common Stock Warrants
On April 2, 2024, the Company entered into
a securities purchase agreement for the private placement of an aggregate of 3,015,172 units with each unit consisting of (1) one share
of the Company’s common stock or at the election of the purchaser, a pre-funded warrant to purchase one share of common stock,
and (2) one warrant to purchase one share of common stock. The purchase price paid for each unit was $8.00. Certain directors and officers
participated in the transaction and purchased 19,168 of the units at an offering price of $8.48 per unit.
Pre-funded warrants totaling 209,936 shares
were issued. Each pre-funded warrant has an exercise price equal to $0.015 per share or calculated pursuant to the cashless exercise
provision. The pre-funded warrants were immediately exercisable on the date of issuance and do not expire.
Warrants totaling 3,015,172 shares were issued. Each warrant that was
issued to holders other than the Company’s officers and directors has an exercise price equal to $6.11 per share or calculated pursuant
to the cashless exercise provision. The warrants issued to the Company’s officers and directors have an exercise price equal to
$6.60 or calculated pursuant to the cashless exercise provision. The warrants were exercisable immediately and expire on the fifth anniversary
of the initial exercise date of the warrant. After April 4, 2025, the warrants may be redeemed in whole or in part at the option of the
Company with at least thirty days’ notice to the holder of the warrant, which notice may not be given before, but may be given at
any time after the date on which (i) the closing price of the Company’s common stock has equaled or exceeded $75.00 for ten consecutive
trading days and (ii) the daily trading volume of the common stock has exceeded 6,667 shares on each of such ten trading days. The redemption
price is $0.38 per warrant share.
The
warrants were recorded on a relative fair value basis at the date of issuance using the Black-Scholes model, which was recorded as a
debit to issuance costs and a credit to additional paid-in capital on the condensed consolidated balance sheets. The warrants are not
remeasured in future periods as the warrants meet the conditions for equity classification. The relative fair value of the April 2024
Pre-funded warrants was $1.0 million and the relative fair value of the April 2024 Warrants at the issuance date was $8.8 million.
The
following assumptions were used to calculate the fair value of the pre-funded and common stock warrants at issuance date:
Expected term | | 5.0 years | |
Expected volatility | | | 59.5 | % |
Risk-free interest rate | | | 4.4 | % |
Expected dividends | | | 0.0 | % |
August
2024 Common Stock Warrants
On August 14, 2024, in connection with a strategic advisory agreement,
the Company issued warrants to purchase 22,097 shares of the Company’s common stock (the “August 2024 Warrants”). The
August 2024 Warrants have a five-year term and an exercise price of $6.11 per share. The August 2024 Warrants may be exercised at
any time prior to the expiration date of August 14, 2029. Each outstanding August 2024 Warrant not exercised on or before the expiration
date will become void. The August 2024 Warrants are not subject to restrictions on transfers and each holder is permitted to transfer
the August 2024 Warrants. The August 2024 Warrants can be exercised on a cashless basis at the option of the holder.
The August 2024 Warrants had a grant-date fair value of $2.72 at issuance and are fully vested. The Company recognized the aggregate fair
value of $0.1 million within sales, general and administrative expense in its condensed consolidated statements of operations and comprehensive
loss during the three and nine months ended September 30, 2024, respectively, and a credit to additional paid-in capital on the condensed
consolidated balance sheets as of September 30, 2024. The warrants are not remeasured in future periods as the warrants meet the conditions
for equity classification.
The following table provides quantitative information regarding inputs used in the Black-Scholes option-pricing model
to determine the fair value of the August 2024 Warrants as of August 14, 2024:
Expected term | | | 5.0 years | |
Expected volatility | | | 60.83 | % |
Risk-free interest rate | | | 3.67 | % |
Expected dividends | | | 0.0 | % |
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
The
following is a summary of the Company’s warrant activity for the nine months ended September 30, 2024:
Warrant Issuance | | Issuance | | Weighted Average Exercise Price | | | Outstanding, December 31, 2023 | | | Granted | | | Exercised | | | Canceled/ Expired | | | Outstanding, September 30, 2024 | | | Expiration | |
Preferred A Placement Warrants | | March and April 2018 and August 2019 | | $ | 21.00 | | | | 19,536 | | | | — | | | | — | | | | — | | | | 19,536 | | | | April 2025 | |
Preferred B Placement Warrants | | April 2019 | | $ | 31.50 | | | | 30,920 | | | | — | | | | — | | | | — | | | | 30,920 | | | | April 2025 | |
Convertible Notes Placement Warrants | | August 2020 | | $ | 38.55 | | | | 11,455 | | | | — | | | | — | | | | — | | | | 11,455 | | | | August 2025 | |
Underwriter Warrants | | March 2021 | | $ | 90.00 | | | | 63,798 | | | | — | | | | — | | | | — | | | | 63,798 | | | | March 2026 | |
January 2023 warrants | | January 2023 | | $ | 23.55 | | | | 154,800 | | | | — | | | | — | | | | — | | | | 154,800 | | | | January 2028 | |
February 2023 warrants | | February 2023 | | $ | 23.55 | | | | 23,220 | | | | — | | | | — | | | | — | | | | 23,220 | | | | February 2028 | |
August 2023 warrants | | August 2023 | | $ | 18.60 | | | | 13,441 | | | | — | | | | — | | | | — | | | | 13,441 | | | | August 2028 | |
April 2024 Pre-Funded warrants | | April 2024 | | $ | 0.015 | | | | — | | | | 209,936 | | | | — | | | | — | | | | 209,936 | | | | None | |
April 2024 warrants | | April 2024 | | $ | 6.11 | | | | — | | | | 3,015,172 | | | | — | | | | — | | | | 3,015,172 | | | | April 2029 | |
August 2024 warrants | | August 2024 | | $ | 6.11 | | | | — | | | | 22,097 | | | | — | | | | — | | | | 22,097 | | | | August 2029 | |
| | | | | | | | | 317,170 | | | | 3,247,205 | | | | — | | | | — | | | | 3,564,375 | | | | | |
The
following is a summary of the Company’s warrant activity for the nine months ended September 30, 2023:
Warrant Issuance | | Issuance | | Weighted Average Exercise Price | | | Outstanding, December 31, 2022 | | | Granted | | | Exercised | | | Canceled/ Expired | | | Outstanding, September 30, 2023 | | | Expiration | |
Preferred A Placement Warrants | | March and April 2018 and August 2019 | | $ | 21.00 | | | | 19,536 | | | | — | | | | — | | | | — | | | | 19,536 | | | | October 2023 | |
Preferred A Lead Investor Warrants | | February 2021 | | $ | 0.19 | | | | 3,500 | | | | — | | | | — | | | | (3,500 | ) | | | — | | | | March 2023 | |
Preferred B Placement Warrants | | April 2019 | | $ | 31.50 | | | | 30,920 | | | | — | | | | — | | | | — | | | | 30,920 | | | | April 2024 | |
Convertible Notes Placement Warrants | | August 2020 | | $ | 38.55 | | | | 11,455 | | | | — | | | | — | | | | — | | | | 11,455 | | | | August 2025 | |
Underwriter Warrants | | March 2021 | | $ | 90.00 | | | | 63,798 | | | | — | | | | — | | | | — | | | | 63,798 | | | | March 2026 | |
January 2023 warrants | | January 2023 | | $ | 23.55 | | | | — | | | | 154,800 | | | | — | | | | — | | | | 154,800 | | | | January 2028 | |
February 2023 warrants | | February 2023 | | $ | 23.55 | | | | — | | | | 23,220 | | | | — | | | | — | | | | 23,220 | | | | February 2028 | |
August 2023 warrants | | August 2023 | | $ | 18.60 | | | | — | | | | 13,441 | | | | — | | | | — | | | | 13,441 | | | | August 2028 | |
| | | | | | | | | 129,209 | | | | 191,461 | | | | — | | | | (3,500 | ) | | | 317,170 | | | | | |
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note
9 – Stock-based Compensation
On July 9, 2024, the Company amended the 2019 Equity Incentive
Plan to authorize 10,000,000 additional shares available for future grant.
2019
Equity Incentive Plan
As of September 30, 2024, the Company had 696,375 shares available
for future grant pursuant to the 2019 Plan.
2021
Employment Inducement Plan
As of September 30, 2024, the Company had 104,861 shares available
for future grant under the Inducement Plan.
Stock
Options
Stock
option activity for the nine months ended September 30, 2024 was as follows (in thousands, except share, per share, and remaining
life data):
| | Number of Options | | | Weighted Average Exercise Price | | | Weighted Average Remaining Life | | Intrinsic Value | |
Outstanding at December 31, 2023 | | | 496,561 | | | $ | 31.95 | | | 7.1 years | | $ | 726 | |
Granted | | | 291,948 | | | $ | 7.02 | | | | | | | |
Exercised | | | (2,667 | ) | | $ | 5.70 | | | | | | | |
Cancelled | | | (30,738 | ) | | $ | 29.95 | | | | | | | |
Outstanding at September 30, 2024 | | | 755,105 | | | $ | 22.58 | | | 7.3 years | | $ | 13 | |
| | | | | | | | | | | | | | |
Exercisable as of September 30, 2024 | | | 635,850 | | | $ | 21.52 | | | 7.1 years | | $ | — | |
| | | | | | | | | | | | | | |
Vested and expected to vest as of September 30, 2024 | | | 755,105 | | | $ | 22.58 | | | 7.3 years | | $ | 13 | |
The weighted-average grant date fair value of options granted during
the nine months ended September 30, 2024 and 2023, was $3.62 and $11.24, respectively. During the nine months ended September 30,
2024 and 2023, 2,667 and 16,390 options were exercised for proceeds of $15,200 and $109,000, respectively. The fair value of the 333,683
and 92,278 options that vested during the nine months ended September 30, 2024 and 2023 was approximately $2.6 million and $2.2 million,
respectively.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
The
Company estimated the fair value of stock options using the Black-Scholes option pricing model. The fair value of the stock options was
estimated using the following weighted average assumptions for the nine months ended September 30, 2024 and 2023.
| |
Nine Months Ended September 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Dividend yield | |
| — | % | |
| — | % |
Expected volatility | |
| 51.6 | % | |
| 61.88 | % |
Risk-free interest rate | |
| 4.26 | % | |
| 3.73 | % |
Expected life | |
| 5.00 years | | |
| 5.97 years | |
Dividend
Rate—The expected dividend rate was assumed to be zero, as the Company had not previously paid dividends on common stock and
has no current plans to do so.
Expected
Volatility—The expected volatility was derived from the historical stock volatilities of several public companies within the
Company’s industry that the Company considers to be comparable to the business over a period equivalent to the expected term of
the stock option grants.
Risk-Free
Interest Rate—The risk-free interest rate is based on the interest yield in effect at the date of grant for zero coupon U.
S. Treasury notes with maturities approximately equal to the option’s expected term.
Expected
Term—The expected term represents the period that the Company’s stock options are expected to be outstanding. The expected
term of option grants that are considered to be “plain vanilla” are determined using the simplified method. The simplified
method deems the term to be the average of the time-to-vesting and the contractual life of the options. For other option grants not considered
to be “plain vanilla,” the Company determined the expected term to be the contractual life of the options.
Forfeiture
Rate—The Company recognizes forfeitures when they occur.
The
Company has recorded stock-based compensation expense for the three and nine months ended September 30, 2024 and 2023 related to
the issuance of stock option awards to employees and nonemployees in the condensed consolidated statement of operations and comprehensive
loss as follows (in thousands):
| |
Three
Months Ended September 30, | | |
Nine
Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Cost of revenue | |
$ | 3 | | |
$ | — | | |
$ | 38 | | |
$ | — | |
Research and development | |
| 144 | | |
| 228 | | |
| 966 | | |
| 678 | |
Sales, general and administrative | |
| 387 | | |
| 529 | | |
| 1,691 | | |
| 1,574 | |
| |
$ | 534 | | |
$ | 757 | | |
$ | 2,695 | | |
$ | 2,252 | |
As of September 30, 2024, unamortized compensation expense related to unvested stock options was approximately $1.8 million, which is expected to be recognized over a weighted average period of 1.6 years.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note
10 – Commitments and Contingencies
Operating
and Finance Leases
On
June 19, 2024, the Company executed the third amendment to the original corporate office and facilities lease. The purpose of the amendment
was to extend the lease term of the facilities consisting of (i) 5,798 square feet and (ii) 1,890 rentable square feet within the building
located at 6800 Koll Center Parkway, Pleasanton, CA. The extended lease term commences on October 1, 2024 and ends on December 31, 2027
with one option to extend the lease for three years. The monthly base rent will be approximately $20,000, with a rent abatement for the
first three months of the lease term.
The
lease amendment was accounted for as a lease modification. The right-of-use asset and operating lease liability for the existing premises
were remeasured at the modification date, which resulted in an increase of $0.6 million to both the right-of-use asset and operating
lease liabilities.
The
balances of the operating and finance lease related accounts as of September 30, 2024 and December 31, 2023 are as follows (in thousands):
| |
September
30, | | |
December 31, | |
Operating
and Finance leases | |
2024 | | |
2023 | |
Right-of-use assets | |
$ | 636 | | |
$ | 247 | |
Operating lease liabilities - Short-term | |
$ | 90 | | |
$ | 203 | |
Operating lease liabilities - Long-term | |
$ | 557 | | |
$ | 15 | |
Finance lease liabilities - Short-term | |
$ | 16 | | |
$ | 14 | |
Finance lease liabilities - Long-term | |
$ | 22 | | |
$ | 35 | |
The short-term balances of operating and finance
lease liabilities are included in other current liabilities on the Company’s condensed consolidated balance sheets. The long-term
balances of operating and finance lease liabilities are included in other noncurrent liabilities on the Company’s condensed consolidated
balance sheets.
The
components of lease expense and supplemental cash flow information as of and for the three and nine months ended September 30, 2024
and 2023 are as follows (in thousands):
| | Three Months Ended September 30, | | | Nine Months Ended September 30, | |
| | 2024 | | | 2023 | | | 2024 | | | 2023 | |
Lease Cost: | | | | | | | | | | | | |
Operating lease cost | | $ | 57 | | | $ | 65 | | | $ | 182 | | | $ | 193 | |
| | | | | | | | | | | | | | | | |
Other Information: | | | | | | | | | | | | | | | | |
Cash paid for amounts included in the measurement of lease liabilities for the year ended | | $ | 68 | | | $ | 61 | | | $ | 195 | | | $ | 180 | |
Weighted average remaining lease term - operating leases (in years) | | | 3.3 | | | | 1.2 | | | | 3.3 | | | | 1.2 | |
Average discount rate - operating leases | | | 10.00 | % | | | 10.00 | % | | | 10.00 | % | | | 10.00 | % |
Weighted average remaining lease term - financing leases (in years) | | | 2.2 | | | | — | | | | 2.2 | | | | — | |
Average discount rate - financing leases | | | 15.08 | | | | — | | | | 15.08 | % | | | — | |
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Future
minimum lease payments for the operating and finance leases are as follows as of September 30, 2024 (in thousands):
2024 | |
$ | 5 | |
2025 | |
| 236 | |
2026 | |
| 290 | |
2027 | |
| 279 | |
Total lease payments | |
| 810 | |
Less:
Interest | |
| (125 | ) |
Total
lease liabilities | |
$ | 685 | |
Litigation
From
time to time, the Company may become involved in various litigation and administrative proceedings relating to claims arising from its
operations in the normal course of business. Management is not currently aware of any matters that may have a material adverse impact
on the Company’s business, financial position, results of operations or cash flows.
Indemnification
The
Company enters into standard indemnification agreements in the ordinary course of business. Pursuant to these arrangements, the Company
indemnifies, holds harmless and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party,
in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third party with respect
to its technology. The term of these indemnification agreements is generally perpetual after the execution of the agreement. The maximum
potential amount of future payments the Company could be required to make under these agreements is not determinable because it involves
claims that may be made against the Company in the future, but have not yet been made. The Company has not incurred costs to defend lawsuits
or settle claims related to these indemnification agreements.
The
Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors
and officers against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities
arising from willful misconduct of the individual.
No
amounts associated with such indemnifications have been recorded as of September 30, 2024.
Non-cancelable
Obligations
The
Company did not have any non-cancelable contractual commitments as of September 30, 2024.
Royalty
Commitments
The Company is required to make certain usage-based royalty payments
to a vendor. The royalty amount is calculated based on the number of Evie Rings shipped, as adjusted for returns and refunds to customers,
and the number of specified algorithms developed by the vendor that are included on the Evie Rings. The maximum amount of the royalty
commitment is approximately $6.1 million, and the amount of the research and development expenses paid to the vendor will reduce
the total royalty commitment amount. Through September 30, 2024, the Company has paid research and development expenses of approximately
$0.6 million to the vendor. The amount of the royalty calculation for the three and nine months ended September 30, 2024 and
2023 was not significant.
Movano
Inc.
Notes
to Condensed Consolidated Financial Statements
For
the three and nine months ended September 30, 2024 and 2023
(Unaudited)
Note
11 – NET LOSS PER SHARE
The
following table provides the computation of the basic and diluted net loss per share during the three and nine months ended September 30,
2024 and 2023 (in thousands, except share and per share data):
| |
Three
Months Ended September 30, | | |
Nine
Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator: | |
| | |
| | |
| | |
| |
Net
loss | |
$ | (7,201 | ) | |
$ | (8,962 | ) | |
$ | (19,111 | ) | |
$ | (23,325 | ) |
Denominator: | |
| | | |
| | | |
| | | |
| | |
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 | |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic
and diluted | |
$ | (1.06 | ) | |
$ | (2.65 | ) | |
$ | (3.33 | ) | |
$ | (7.99 | ) |
The
potential shares of common stock that were excluded from the computation of diluted net loss per share for the nine months ended September 30,
2024 and 2023 because including them would have been antidilutive are as follows:
| |
Nine Months Ended September
30, | |
| |
2024 | | |
2023 | |
Shares subject to options to purchase common stock | |
| 755,105 | | |
| 518,591 | |
Shares subject to warrants to purchase common stock | |
| 3,564,375 | | |
| 317,170 | |
Total | |
| 4,319,480 | | |
| 835,761 | |
For both the three and nine months ended September 30,
2024, there were no performance-based option awards for shares of common stock. For both the three and nine months ended September 30,
2023, performance-based option awards for 3,347 shares of common stock are not included in the table above or considered in the calculation
of diluted earnings per share because the performance conditions of the option award are not considered probable by the Company.
Note
12 – Subsequent Events
Management of the Company evaluated events that
have occurred after the balance sheet dates through the date these condensed consolidated financial statements were issued. No events
required disclosure in the condensed consolidated financial statements.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe
harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans,
strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,”
“may,” “will,” “should,” “would,” “could,” “seek,” “intend,”
“plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy”,
“future”, “likely” or other comparable terms and references to future periods. All statements other than statements
of historical facts included in this Form 10-Q regarding our strategies, prospects, financial condition, operations, costs, plans and
objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding
expectations for revenues, cash flows and financial performance, the anticipated results of our development efforts, product features
and the timing for receipt of required regulatory approvals and product launches.
Forward-looking
statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations
and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy
and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks
and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial
condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these
forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those
indicated in the forward-looking statements include, among others, the following:
|
● |
our limited operating history
and our ability to achieve profitability; |
|
● |
the failure of our common stock to meet the minimum requirements for continued listing on the Nasdaq Capital Market; |
|
● |
our ability to continue as a going concern and our
need for and ability to obtain additional capital in the future; |
|
● |
our ability to demonstrate
the feasibility of and develop products and their underlying technologies; |
|
● |
the impact of competitive
or alternative products, technologies and pricing; |
|
● |
our ability to attract
and retain highly qualified personnel; |
|
● |
our dependence on consultants
to assist in the development of our technologies; |
|
● |
our ability to manage the
growth of our Company and to realize the benefits from any acquisitions or strategic alliances we may enter in the future; |
|
● |
the impact of macroeconomic and geopolitical conditions
including increases in prices caused by rising inflation; |
|
● |
our dependence on the successful
commercialization of the Evie Ring; |
|
● |
our dependence on third
parties to design, manufacture, market and distribute our products; |
|
● |
the adequacy of protections
afforded to us by the patents that we own and the success we may have in, and the cost to us of, maintaining, enforcing and defending
those patents; |
|
● |
our need to secure required
FCC, FDA and other regulatory approvals from governmental authorities in the United States; |
|
● |
the impact of healthcare
regulations and reform measures; |
|
● |
the accuracy of our estimates
of market size for our products; |
|
● |
our ability to implement
and maintain effective control over financial reporting and disclosure controls and procedures; and |
|
● |
our success at managing
the risks involved in the foregoing items. |
The
risks included above are not exhaustive. Other important risks and uncertainties are described in the Risk Factors and in Management’s
Discussion and Analysis of Financial Condition and Results of Operations sections of our Annual Report on Form 10-K for the year ended
December 31, 2023 (the “2023 Form 10-K”). Except as otherwise required by the federal securities laws, 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.
Overview
Movano
Inc., dba Movano Health, a Delaware corporation, is developing a platform to deliver purpose-driven healthcare solutions to bring medical-grade,
high-quality data to the forefront of consumer health devices.
Our
initial commercial product is the Evie Ring, a wearable designed specifically for women that was launched in November 2023. The Evie
Ring combines health and wellness metrics to give a full picture of one’s health, which include resting heart rate, heart rate
variability (“HRV”), blood oxygen saturation (“SpO2”), respiration rate, skin temperature variability,
period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and calories burned, sleep
stages and duration, and mood tracking. The device provides women with continuous health data distilled down to simple, yet meaningful,
insights to help them make manageable lifestyle changes and take a more proactive approach that could mitigate the risks of chronic disease.
We launched the Evie Ring as a general wellness
device without any FDA premarket clearances. Separately, we are planning to seek FDA clearances on our medical device, which will be sold
under the brand name EvieMED. We believe EvieMED will be one of the first patient wearables with FDA clearance on the entire system, both
hardware and software, differing from our competition which sometimes gets FDA clearance on an individual algorithm under “Software
as a Medical Device” guidance. In July 2023, we filed our first 510(k) submission to the FDA for the EvieMED Ring’s pulse
oximeter to monitor pulse and SpO2 data, following a successful pivotal hypoxia trial during the fourth quarter of 2022. With
progressive changes in the device and significant additional requirements from FDA since the initial submission, we opted to withdraw
the 2023 510(k). Armed with FDA’s review of the initial 510(k) and results from a second pivotal hypoxia trial using the production
model ring completed in the first quarter of 2024, we re-submitted in April 2024. We believe that FDA clearance of these metrics, sold
via prescription under the brand name EvieMED, would foster clinical-level confidence in EvieMED’s monitoring capabilities and could
make the device attractive to clinicians and to facilities engaged in clinical trials for at-home and/or long-term patient monitoring.
In
addition to the Evie Ring and EvieMED Ring, we are developing one of the smallest patented and proprietary System-on-a-Chip (“SoC”)
designed specifically for blood pressure or continuous glucose monitoring systems (“GCM”). We built the integrated sensor
from the ground up with multiple antennas and a variety of frequencies to achieve an unprecedented level of precision in health monitoring.
We are currently conducting clinical trials with the SoC and developing algorithms that, if successful, will enable us to develop wearables
that can monitor glucose non-invasively and blood pressure without a cuff. To that end, we are currently conducting a longitudinal study
(n=100) to program the effects of stress on blood pressure over time, with results pending. Our end goal is to bring a Class II FDA-cleared
device to the market that includes CGM and cuffless blood pressure monitoring capabilities. Over time, our technology could also enable
the measurement and continuous monitoring of other health data.
On
April 28, 2021, the Company established Movano Ireland Limited, organized under the laws of Ireland, as a wholly owned subsidiary of
the Company.
Financial
Operations Overview
We
are an early-stage technology company with a limited operating history. To date, we have invested substantially all of our efforts and
financial resources into (i) the research and development of the products we are developing, including conducting clinical studies and
related sales, general and administrative costs, and (ii) the commercialization of our first commercial product, the Evie Ring. To date,
we have funded our operations primarily from the sale of our equity securities.
We
have incurred net losses in each year since inception. Our losses were $19.1 million and $23.3 million for the nine months
ended September 30, 2024 and 2023, respectively. Substantially all our net losses have resulted from costs incurred in connection
with our research and development programs and from sales, general and administrative costs associated with our operations.
As
of September 30, 2024, we had $11.3 million in available cash and cash equivalents.
Reverse
Stock Split
On October 29, 2024, we completed a 1-for-15 reverse
stock split of our issued and outstanding common stock. As a result of the Reverse Stock Split, each share of common stock issued and
outstanding immediately prior to October 29, 2024 were automatically reclassified and converted into one-fifteenth (1/15th) of a share
of common stock. The Reverse Stock Split affected all common stockholders uniformly and did not alter any stockholder's percentage interest
in our equity, except to the extent that the Reverse Stock Split resulted in a stockholder of record owning a fractional share. Stockholders
of record who were otherwise entitled to receive a fractional share, instead automatically had their fractional shares rounded up to the
next whole share. No cash was issued for fractional shares as part of the Reverse Stock Split.
The Reverse Stock Split did not change the
par value of the common stock or the authorized number of shares of common stock. Proportionate adjustments were made to the exercise
prices and the number of shares underlying our equity plans and grants thereunder, as applicable. The amount of undistributed shares
of Common Stock deemed to be covered by our effective registration statements on Forms S-3 and S-8 were proportionately reduced as of
the effective time of the Reverse Stock Split at the Reverse Stock Split Ratio. Additionally, proportionate adjustments were made to
the exercise prices and the number of shares underlying all outstanding warrants, as required by the terms of these securities.
All
common share and per-share amounts in this Form 10-Q have been retroactively restated to reflect the effect of the Reverse Stock Split.
Critical
Accounting Policies and Estimates
The
discussion and analysis of our condensed consolidated financial condition and results of operations are based on our condensed consolidated
financial statements, which we have prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial
statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure
of contingent assets and liabilities at the date of the condensed consolidated financial statements as well as the reported revenue and
expenses during the reporting periods. On an ongoing basis, we evaluate our estimates and judgments. We base our estimates on historical
experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results
may differ from these estimates under different assumptions or conditions.
There
have been no material changes in our critical accounting policies and estimates during the three and nine months ended September 30,
2024, as compared to those disclosed in the 2023 Form 10-K.
Recently
Issued and Adopted Accounting Pronouncements
A
description of recently adopted and recently issued accounting pronouncements that may potentially impact our financial position and
results of operations is disclosed in Note 2, Recently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements,
to our audited financial statements for the year ended December 31, 2023, and notes thereto, included in the Company’s Annual Report
on Form 10-K.
See
Note 2 to our condensed consolidated financial statements included in Part I, Item 1, “Notes to Condensed Consolidated Financial
Statements,” of this Quarterly Report on Form 10-Q for a description of recently issued accounting pronouncements that may potentially
impact our financial position and results of operations.
Results
of Operations
Three
and nine months ended September 30, 2024 and 2023
Our
condensed consolidated statements of operations for the three and nine months ended September 30, 2024 and 2023 as discussed herein
are presented below.
| |
Three
Months Ended
September 30, | | |
Change | | |
Nine
Months Ended
September 30, | | |
Change | |
| |
2024 | | |
2023 | | |
$ | | |
% | | |
2024 | | |
2023 | | |
$
| | |
% | |
| |
(in
thousands) | | |
(in thousands) | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Revenue | |
$ | 50 | $ | |
| — | | |
$ | 50 | | |
| n/a
| | |
$ | 902 | | |
$ | — | | |
$ | 902 | | |
| n/a
| |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
OPERATING
EXPENSES: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Cost
of revenue | |
| 845 | | |
| — | | |
| 845 | | |
| n/a
| | |
| 2,440 | | |
| — | | |
| 2,440 | | |
| n/a
| |
Research
and development | |
| 3,404 | | |
| 5,636 | | |
| (2,232 | ) | |
| -40% | | |
| 9,198 | | |
| 13,701 | | |
| (4,503 | ) | |
| -33% | |
Sales,
general and administrative | |
| 3,180 | | |
| 3,443 | | |
| (263 | ) | |
| -8% | | |
| 8,794 | | |
| 9,965 | | |
| (1,171 | ) | |
| -12% | |
Total
operating expenses | |
| 7,429 | | |
| 9,079 | | |
| (1,650 | ) | |
| -18% | | |
| 20,432 | | |
| 23,666 | | |
| (3,234 | ) | |
| -14% | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Loss
from operations | |
| (7,379 | ) | |
| (9,079 | ) | |
| 1,700 | | |
| 19% | | |
| (19,530 | ) | |
| (23,666 | ) | |
| 4,136 | | |
| 17% | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Other
income (expense), net: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Interest
and other income, net | |
| 178 | | |
| 117 | | |
| 61 | | |
| 52% | | |
| 419 | | |
| 341 | | |
| 78 | | |
| 23% | |
Other
income (expense), net | |
| 178 | | |
| 117 | | |
| 61 | | |
| 52% | | |
| 419 | | |
| 341 | | |
| 78 | | |
| 23% | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net
loss | |
$ | (7,201 | ) | |
$ | (8,962 | ) | |
$ | 1,761 | | |
| 20% | | |
$ | (19,111 | ) | |
$ | (23,325 | ) | |
$ | 4,214 | | |
| 18% | |
Revenue
Revenue totaled $50,000 and $0 for the three months
ended September 30, 2024 and 2023, respectively. The transfer of control of the Evie Ring Elements began in the first quarter of
2024, was completed in the second quarter of 2024, then re-started in the third quarter of 2024.
Revenue
totaled $0.9 million and $0 for the nine months ended September 30, 2024 and 2023, respectively. This increase of $0.9 million
was due to recognition of revenue upon the transfer of control of the Evie Ring Elements, which began in the first quarter of 2024.
Cost
of revenue
Cost of revenue totaled $0.8 million and
$0 for the three months ended September 30, 2024 and 2023, respectively. This increase of $0.8 million was due to the direct
costs of $0.2 million related to the transfer of control of the various Evie Ring Elements, $0.1 million for labor and related
stock-based compensation, and $0.5 million for inventory that was designated as scrap materials.
Cost of revenue totaled $2.4 million and
$0 for the nine months ended September 30, 2024 and 2023, respectively. This increase of $2.4 million was due to the direct
costs of $1.4 million related to the transfer of control of the various Evie Ring Elements, $0.3 million for labor and related
stock-based compensation, $0.1 million for order processing, shipping and fulfillment costs, and $0.6 million for inventory
that was designated as scrap materials.
Research
and Development
Research and development expenses totaled $3.4 million
and $5.6 million for the three months ended September 30, 2024 and 2023, respectively. This decrease of $2.2 million was
due primarily to lower research and laboratory expenses and other professional fees. Research and development expenses for the three months
ended September 30, 2024 included expenses related to employee compensation of $1.8 million, other professional fees of $1.1 million,
research and laboratory expenses of $0.3 million, and other expenses of $0.2 million. Research and development expenses for
the three months ended September 30, 2023 included expenses related to employee compensation of $1.6 million, other professional
fees of $1.6 million, research and laboratory expenses of $2.1 million, and other expenses of $0.3 million.
Research
and development expenses totaled $9.2 million and $13.7 million for the nine months ended September 30, 2024 and 2023,
respectively. This decrease of $4.4 million was due primarily to lower research and laboratory expenses and other professional fees.
Research and development expenses for the nine months ended September 30, 2024 included expenses related to employee compensation
of $5.0 million, other professional fees of $2.4 million, research and laboratory expenses of $1.2 million, and other
expenses of $0.6 million. Research and development expenses for the nine months ended September 30, 2023 included expenses
related to employee compensation of $5.0 million, other professional fees of $4.1 million, research and laboratory expenses
of $3.8 million, and other expenses of $0.8 million.
Sales,
General and Administrative
Sales, general and administrative expenses totaled
$3.2 million and $3.4 million for the three months ended September 30, 2024 and 2023, respectively. This decrease of $0.2 million
was due primarily to lower headcount with respect to sales, general and administrative employees and decreased marketing costs, offset
by increased stock compensation expenses related to the issuance of new option grants. Sales, general and administrative expenses for
the three months ended September 30, 2024 included expenses related to employee and board of director compensation of $1.8 million,
professional and consulting fees of $0.8 million, and other expenses of $0.6 million. Sales, general and administrative expenses
for the three months ended September 30, 2023 included expenses related to employee and board of director compensation of $1.7 million,
professional and consulting fees of $0.6 million, and other expenses of $1.1 million.
Sales,
general and administrative expenses totaled $8.8 million and $10.0 million for the nine months ended September 30, 2024
and 2023, respectively. This decrease of $1.2 million was due primarily to lower Company headcount with respect to sales, general
and administrative employees and decreased marketing costs, offset by increased stock compensation expenses related to the issuance of
new option grants. Sales, general and administrative expenses for the nine months ended September 30, 2024 included expenses related
to employee and board of director compensation of $4.8 million, professional and consulting fees of $2.3 million, and other
expenses of $1.7 million. Sales, general and administrative expenses for the nine months ended September 30, 2023 included
expenses related to employee and board of director compensation of $5.1 million, professional and consulting fees of $1.8 million,
and other expenses of $3.1 million.
Loss
from Operations
Loss
from operations was $7.4 million for the three months ended September 30, 2024, as compared to $9.1 million for the three
months ended September 30, 2023.
Loss
from operations was $19.5 million for the nine months ended September 30, 2024, as compared to $23.7 million for the nine
months ended September 30, 2023.
Other
Income (Expense), Net
Other
income (expense), net for the three months ended September 30, 2024 was a net other income of $0.2 million as compared to a
net other income of $0.1 million for the three months ended September 30, 2023. The increase of $0.1 million is attributable
to interest income on the additional funds that were received from the April 2024 Private Placement.
Other income (expense), net for the nine months
ended September 30, 2024 was a net other income of $0.4 million as compared to a net other income of $0.3 million for
the nine months ended September 30, 2023. The increase of $0.1 million is attributable to interest income on the additional
funds that were received from the April 2024 Private Placement.
Net
Loss
As
a result of the foregoing, net loss was $7.2 million for the three months ended September 30, 2024, as compared to $9.0 million
for the three months ended September 30, 2023.
As
a result of the foregoing, net loss was $19.1 million for the nine months ended September 30, 2024, as compared to $23.3 million
for the nine months ended September 30, 2023.
Liquidity
and Capital Resources
At September 30, 2024, we had cash and cash
equivalents totaling $11.3 million. During the nine months ended September 30, 2024, we used $18.0 million of cash in our
operating activities. Our cash and cash equivalents are not expected to be sufficient to fund our operations for the next twelve months
after the date these condensed consolidated financial statements are issued. In August 2022, we entered into an at-the-market issuance
(“ATM”) to sell shares of our common stock for aggregate gross proceeds of up to $50.0 million, from time to time, through
an ATM equity offering program. During the nine months ended September 30, 2024, we sold an aggregate of 99,061 shares of common
stock through the ATM program for proceeds of approximately $0.6 million, net of commissions paid. Approximately $43.7 million
remained available on the ATM equity offering program at September 30, 2024.
On April 2, 2024, the Company entered into a securities
purchase agreement for the private placement of an aggregate of 3,015,172 units with each unit consisting of (1) one share of the Company’s
common stock or at the election of the purchaser a pre-funded warrant, and (2) one warrant to purchase one share of common stock. The
purchase price paid for each unit was $8.00. Certain directors and officers participated and purchased 19,168 units at an offering
price of $8.48 per unit.
Each pre-funded warrant has an exercise price
of $0.015 per share, was immediately exercisable on the date of issuance and does not expire. Each warrant has an exercise price equal
to $6.11 per share, was exercisable immediately and expires on the fifth anniversary of the initial exercise date of the warrant. The
warrants issued to the Company’s officers and directors have an exercise price equal to $6.60.
The private placement transaction closed on April
5, 2024, resulting in gross proceeds to the Company of approximately $24.1 million, before deducting offering fees and expenses of approximately
$1.5 million.
We
expect to continue to incur significant expenses and increasing operating losses for at least the next several years. We anticipate that
our expenses will increase substantially as we:
|
● |
advance the engineering
design and development of the Evie Ring and other potential products; |
|
● |
prepare applications required
for marketing approval of the Evie Ring in the United States; |
|
● |
develop our plans for manufacturing,
distributing and marketing the Evie Ring and other potential products; and |
|
● |
add operational, financial
and management information systems and personnel, including personnel to support our product development, planned commercialization
efforts and our operation as a public company. |
Until
we can generate a sufficient amount of revenue from our planned products, if ever, we expect to finance future cash needs through public
or private equity offerings, debt financings or corporate collaborations and licensing arrangements. Additional funds may not be available
when we need them on terms that are acceptable to us, or at all. If adequate funds are not available, we may be required to delay, reduce
the scope of or eliminate one or more of our research or development programs or our commercialization efforts or it may become impossible
for us to remain in operation. To the extent that we raise additional funds by issuing equity securities, our stockholders may experience
additional dilution, and debt financing, if available, may involve restrictive covenants. To the extent that we raise additional funds
through collaborations and licensing arrangements, it may be necessary to relinquish some rights to our technologies or applications
or grant licenses on terms that may not be favorable to us. We may seek to access the public or private capital markets whenever conditions
are favorable, even if we do not have an immediate need for additional capital at that time.
These
circumstances raise substantial doubt about the Company’s ability to continue as a going concern within
one year after the date that the condensed consolidated financial statements are issued. Our condensed consolidated financial statements
do not include adjustments to the amounts and classification of assets and liabilities that may be necessary should we be unable to continue
as a going concern. Our ability to continue as a going concern depends on our ability to raise additional capital
as described above to support our future operations.
The
following table summarizes our cash flows for the periods indicated:
| |
Nine
Months Ended
September 30, | |
| |
2024 | | |
2023 | |
Net cash used in operating activities | |
$ | (17,978 | ) | |
$ | (20,928 | ) |
Net cash used in investing activities | |
| (3 | ) | |
| (51 | ) |
Net cash provided by
financing activities | |
| 23,135 | | |
| 17,889 | |
Net increase / (decrease)
in cash and cash equivalents | |
$ | 5,154 | | |
$ | (3,090 | ) |
Operating
Activities
During
the nine months ended September 30, 2024, the Company used cash of $18.0 million in operating activities, as compared to $20.9 million
used in operating activities during the nine months ended September 30, 2023.
The $18.0 million used in operating
activities during the nine months ended September 30, 2024 was primarily attributable to our net loss of $19.1 million
during the period. The net loss was offset by changes in our operating assets and liabilities totaling $1.9 million and by
non-cash items, including stock-based compensation, totaling $3.0 million.
The
$20.9 million used in operating activities during the nine months ended September 30, 2023 was primarily attributable to our
net loss of $23.3 million during the period. The net loss was offset by non-cash items, including stock-based compensation of $2.3 million
and depreciation and amortization of $0.1 million.
Investing
Activities
During
the nine months ended September 30, 2024 the Company used cash of $3,000 in investing activities, consisting of purchases of property
and equipment.
During
the nine months ended September 30, 2023 the Company used cash of $51,000 in investing activities, consisting of purchases of property
and equipment.
Financing
Activities
During
the nine months ended September 30, 2024, the Company was provided cash of $23.1 million which included net proceeds $22.6 million
from the issuance of common stock, pre-funded warrants and common stock warrants, and net proceeds of $0.5 million for the issuance
of common stock through the ATM activity and the exercise of common stock options.
During
the nine months ended September 30, 2023, the Company was provided cash of $17.9 million which included net proceeds of $6.7 million
and $8.1 million from the issuance of common stock in public offerings in February 2023 and June 2023, respectively, net proceeds
of $3.1 million for the issuance of common stock through the ATM activity and $0.1 million from the issuance of common stock
upon the exercise of common stock options.
Off-Balance
Sheet Transactions
At
September 30, 2024, the Company did not have any transactions, obligations or relationships that could be considered off-balance
sheet arrangements.
Non-cancelable
Obligations
The
Company did not have any non-cancelable obligations at September 30, 2024.
Item
3. Quantitative and Qualitative Disclosure About Market Risk
As
a smaller reporting company, we are not required to provide the information required by this Item 3.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
are responsible for maintaining disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act.
Disclosure controls and procedures are controls and other procedures designed to ensure that the information required to be disclosed
by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods
specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures
designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated
and communicated to our management, including our principal executive officer and our principal financial officer, as appropriate to
allow timely decisions regarding required disclosure.
Based
on our management’s evaluation (with the participation of our principal executive officer and our principal financial officer)
of our disclosure controls and procedures as required by Rule 13a-15 under the Exchange Act, our principal executive officer and our
principal financial officer have concluded that, due to the previously identified material weakness in our internal controls over financial
reporting that is described below, our disclosure controls and procedures were not effective as of September 30, 2024, the end of
the period covered by this report.
A
material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is
a reasonable possibility that a material misstatement of a company’s annual or interim financial statements will not be prevented
or detected on a timely basis. As previously disclosed in our 2023 Form 10-K, we identified one material weakness in our internal control
over financial reporting at December 31, 2023 related to ineffective design and operation of our financial close and reporting controls.
Specifically, we did not design and maintain effective controls over certain account reviews and analyses and certain information technology
general controls. Although we are making efforts to remediate these issues, these efforts may not be sufficient to avoid similar material
weaknesses in the future.
Inherent
Limitations on Effectiveness of Controls
Our
management, including our principal executive officer and our principal financial officer, do not expect that our disclosure controls
or our internal control over financial reporting will prevent or detect all errors and all fraud. A control system, no matter how well
designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The
design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered
relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute
assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud, if any, have been
detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur
because of a simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or
more people, or by management override of the controls. The design of any system of controls is based in part on certain assumptions
about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under
all potential future conditions. Projections of any evaluation of control effectiveness to future periods are subject to risks. Over
time, controls may become inadequate because of changes in conditions or deterioration in the degree of compliance with policies or procedures.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting during the nine months ended September 30, 2024 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings
We
are not currently a party to any pending legal proceedings that we believe will have a material adverse effect on our business or financial
condition. We may, however, be subject to various claims and legal actions arising in the ordinary course of business from time to time.
Item
1A. Risk Factors
We operate in a rapidly changing environment that
involves a number of risks that could materially affect our business, financial condition or future results, some of which are beyond
our control. In addition to the risk factor included below and other information set forth in this report, the risks and uncertainties
that we believe are most important for you to consider are discussed in Part I, “Item 1A. Risk Factors” in the 2023 Form 10-K.
Except as disclosed below, we believe that there have been no material changes to the risk factors described in the 2023 Form 10-K.
Our failure to meet the continued listing
requirements of Nasdaq could result in a de-listing of our common stock.
Our common stock is currently traded on the Nasdaq
Stock Market (“Nasdaq”). On November 14, 2023, we were notified by Nasdaq that because the closing bid price for the
Company’s common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, the Company no longer meets the minimum
bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Marketplace Rule 5550(a)(2), requiring a minimum
bid price of $1.00 per share (the “Minimum Bid Price Requirement”). On May 15, 2024, since the Company did not regain
compliance by May 13, 2024, the Company requested, and was granted, an additional 180 calendar days to regain compliance with Bid Price
Requirement expiring November 11, 2024.
On October 29, 2024, the Company completed a 1-for-15 Reverse
Stock Split of its issued and outstanding common stock. On November 12, 2024, the Company was notified by Nasdaq that it had regained
compliance with the Minimum Bid Price Requirement. Even though the Company is now in compliance with continued listing requirements of
Nasdaq, any future failure of the Company to satisfy such requirements could result in Nasdaq taking steps to delist the Company’s
common stock. Such a delisting would likely have a negative effect on the price of the Company’s common stock and would impair shareholders’
ability to sell or purchase the Company’s common stock. In the event of a delisting, the Company would take actions to restore its
compliance with Nasdaq’s listing requirements, but the Company can provide no assurance that any such action taken by the Company
would allow its common stock to become listed again, stabilize the market price or improve the liquidity of the Company’s common
stock, prevent the Company’s common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance
with Nasdaq’s listing requirements
Item
2. Recent Sales of Unregistered Securities; Use of Proceeds from Registered Securities
Not
applicable.
Item
3. Defaults Upon Senior Securities
Not
applicable.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
Rule 10b5-1 Trading Plans
During the third quarter of 2024, none of the
Company’s directors or executive officers adopted or terminated any “Rule 10b5-1 trading arrangement” or any “non-Rule
10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.
Item
6. Exhibits
Exhibit
Number |
|
Description |
3.1 |
|
Third
Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s
Current Report on Form 8-K filed on March 25, 2021) |
3.2 |
|
Certificate
of Amendment to Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1
to the Registrant’s Current Report on Form 8-K filed on July 10, 2024) |
3.3 |
|
Certificate of Amendment to Third Amended and Restated Certificate of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on October 25, 2024) |
3.4 |
|
Amended
and Restated Bylaws of the Registrant (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form
8-K filed on March 25, 2021) |
4.1 |
|
Specimen
Certificate representing shares of common stock of the Registrant (incorporated by reference to Exhibit 4.1 to the Registrant’s
Registration Statement on Form S-1 filed on March 10, 2021) |
4.2 |
|
Form
of Underwriter Warrant (incorporated by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1 filed
on March 10, 2021) |
4.3 |
|
Form
of Amended and Restated Warrant to Purchase Common Stock issued to the placement agent in the Registrant’s 2018 private placement
offering (incorporated by reference to Exhibit 4.3 to the Registrant’s Registration Statement on Form S-1 filed on February
2, 2021) |
4.4 |
|
Form
of Amended and Restated Warrant to Purchase Common Stock issued to the placement agent in the Registrant’s 2019 private placement
offering (incorporated by reference to Exhibit 4.4 to the Registrant’s Registration Statement on Form S-1 filed on February
2, 2021) |
4.6 |
|
Form
of Warrant to Purchase Common Stock issued in 2020 (incorporated by reference to Exhibit 4.6 to the Registrant’s Registration
Statement on Form S-1 filed on February 2, 2021) |
4.7 |
|
Form
of Warrant to Purchase Common Stock issued in 2023 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report
on Form 8-K filed on January 31, 2023) |
4.8 |
|
Warrant
Agent Agreement, dated January 31, 2023, by and between the Registrant and Pacific Stock Transfer Company (incorporated by reference
to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed on January 31, 2023) |
4.9 |
|
Form
of Pre-Funded Warrant issued in April 2024 (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on
Form 8-K filed on April 3, 2024) |
4.10 |
|
Form
of Warrant issued in April 2024 (incorporated by reference to Exhibit 4.2 to the Registrant’s Current Report on Form 8-K filed
on April 3, 2024) |
4.11* |
|
Form of Warrant issued in August 2024 |
31.1 |
|
Certification
of Periodic Report by Chief Executive Officer pursuant to Rule 13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002 (filed herewith) |
31.2 |
|
Certification
of Periodic Report by Chief Financial Officer pursuant to Rule 13a-14(a)/15d-14a and pursuant to Section 302 of the Sarbanes-Oxley
Act of 2002 (filed herewith) |
32.1 |
|
Certification
of Periodic Report by Chief Executive Officer and Chief Financial Officer pursuant to U.S.C Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith) |
101.INS |
|
Inline XBRL Instance Document (filed herewith) |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document (filed
herewith) |
101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase
Document (filed herewith) |
101.DEF |
|
Inline XBRL Taxonomy Extension Definition Linkbase
Document (filed herewith) |
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document
(filed herewith) |
101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase
Document (filed herewith) |
104 |
|
Cover Page Interactive Data File (formatted as Inline
XBRL and contained in Exhibit 101). |
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
|
MOVANO INC. |
|
|
|
Date: November 14, 2024 |
By: |
/s/ John
Mastrototaro |
|
|
John Mastrototaro |
|
|
Chief Executive Officer |
|
|
(Principal Executive Officer) |
|
|
|
|
MOVANO INC. |
|
|
|
Date: November 14, 2024 |
By: |
/s/ J.
Cogan |
|
|
J. Cogan |
|
|
Chief Financial Officer |
|
|
(Principal Financial and Accounting Officer) |
29
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NEITHER THESE SECURITIES NOR THE SECURITIES ISSUABLE
UPON EXERCISE OF THESE SECURITIES HAVE BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY
STATE IN RELIANCE UPON AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”)
AND APPLICABLE STATE SECURITIES LAWS AND, ACCORDINGLY, MAY NOT BE OFFERED OR SOLD EXCEPT PURSUANT TO (I) AN EFFECTIVE REGISTRATION STATEMENT
UNDER THE SECURITIES ACT OR (II) AN AVAILABLE EXEMPTION FROM, OR IN A TRANSACTION NOT SUBJECT TO, THE REGISTRATION REQUIREMENTS OF THE
SECURITIES ACT AND IN ACCORDANCE WITH APPLICABLE STATE SECURITIES LAWS OR BLUE SKY LAWS. THESE SECURITIES AND THE SECURITIES ISSUABLE
UPON EXERCISE OF THESE SECURITIES MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN SECURED BY SUCH SECURITIES.
MOVANO INC.
1. Definitions.
In addition to the terms defined elsewhere in this Warrant, capitalized terms that are not otherwise defined herein have the meanings
given to such terms in the Engagement Letter.
2. Exercise
Price. For purposes of this Warrant, the “Exercise Price” shall be equal to $0.407 (as adjusted from time
to time as provided in Section 11 herein).
3. Number
of Warrant Shares. The aggregate number of Warrant Shares acquirable upon the exercise of this Warrant shall be equal to [___] shares
of Common Stock (as adjusted from time to time as provided in Section 11 herein).
4. Registration
of Warrants. The Company shall register this Warrant, upon records to be maintained by the Company for that purpose (the “Warrant
Register”), in the name of the record Holder (which shall include the initial Holder or, as the case may be, any registered
assignee to which this Warrant is permissibly assigned hereunder) from time to time. The Company may deem and treat the registered Holder
of this Warrant as the absolute owner hereof for the purpose of any exercise hereof or any distribution to the Holder, and for all other
purposes, absent actual notice to the contrary.
5. Transfers.
The Company shall register the transfer of all or any portion of this Warrant in the Warrant Register, upon (i) surrender of this Warrant,
with the Form of Assignment attached as Schedule 2 hereto duly completed and signed, to the Company’s transfer agent or to
the Company at its address specified herein (ii) delivery, at the request of the Company, of an opinion of counsel reasonably satisfactory
to the Company to the effect that the transfer of such portion of this Warrant may be made pursuant to an available exemption from the
registration requirements of the Securities Act of 1933 (“Securities Act”) and all applicable state securities
or blue sky laws and (iii) delivery by the transferee of a written statement to the Company certifying that the transferee is an “accredited
investor” as defined in Rule 501(a) under the Securities Act and making the representations and certifications as the Company may
reasonably request to procure an exemption from Section 5 of the Securities Act. Upon any such registration or transfer, a new warrant
to purchase Common Stock in substantially the form of this Warrant (any such new warrant, a “New Warrant”) evidencing
the portion of this Warrant so transferred shall be issued to the transferee, and a New Warrant evidencing the remaining portion of this
Warrant not so transferred, if any, shall be issued to the transferring Holder. The acceptance of the New Warrant by the transferee thereof
shall be deemed the acceptance by such transferee of all of the rights and obligations of a Holder of a Warrant.
6. Exercise
and Duration of Warrants.
(a) All
or any part of this Warrant shall be exercisable by the registered Holder at any time and from time to time on or after the Trigger Date
and through and including 5:00 P.M. prevailing Pacific time on the Expiration Date. At 5:00 P.M., prevailing Pacific time, on the Expiration
Date, the portion of this Warrant not exercised prior thereto shall be and become void and of no value and this Warrant shall be terminated
and no longer outstanding.
(b) The
Holder may exercise this Warrant by delivering to the Company (i) an exercise notice, in the form attached as Schedule 1 hereto (the “Exercise
Notice”), appropriately completed and duly signed, (ii) payment of the Exercise Price for the number of Warrant Shares as
to which this Warrant is being exercised (which may take the form of a “cashless exercise” if so indicated in the Exercise
Notice and if a “cashless exercise” may occur at such time pursuant to Section 12 below), and the date such items are
delivered to the Company (as determined in accordance with the notice provisions hereof) is an “Exercise Date.” The
Holder shall not be required to deliver the original Warrant in order to effect an exercise hereunder, but shall do so reasonably shortly
thereafter. Execution and delivery of the Exercise Notice shall have the same effect as cancellation of the original Warrant and issuance
of a New Warrant evidencing the right to purchase the remaining number of Warrant Shares.
(c) The
Holder may not exercise this Warrant at any time that Holder is unable to establish to the Company’s reasonable satisfaction that
the exercise complies with an exemption from the registration provisions of Section5 of the Securities Act.
7. Delivery
of Warrant Shares. Upon exercise of this Warrant, the Company shall promptly issue or cause to be issued and cause to be delivered
to or upon the written order of the Holder and in such name or names as the Holder may designate a certificate for the Warrant Shares
issuable upon such exercise, with an appropriate restrictive legend. The Holder, or any Person permissibly so designated by the Holder
to receive Warrant Shares, shall be deemed to have become the holder of record of such Warrant Shares as of the Exercise Date.
8. Charges,
Taxes and Expenses. Issuance and delivery of certificates for shares of Common Stock upon exercise of this Warrant shall be made without
charge to the Holder for any issue or transfer tax, transfer agent fee or other incidental tax or expense in respect of the issuance of
such certificates, all of which taxes and expenses shall be paid by the Company; provided, however, that the Company shall not
be required to pay any tax which may be payable in respect of any transfer involved in the registration of any certificates for Warrant
Shares or Warrants in a name other than that of the Holder or an Affiliate thereof. The Holder shall be responsible for all other tax
liability that may arise as a result of holding or transferring this Warrant or receiving Warrant Shares upon exercise hereof.
9. Replacement
of Warrant. If this Warrant is mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and
substitution for and upon cancellation hereof, or in lieu of and substitution for this Warrant, a New Warrant, but only upon receipt of
evidence reasonably satisfactory to the Company of such loss, theft or destruction (in such case) and, in each case, a customary and reasonable
indemnity (which shall not include a surety bond), if requested. Applicants for a New Warrant under such circumstances shall also comply
with such other reasonable regulations and procedures and pay such other reasonable third-party costs as the Company may prescribe. If
a New Warrant is requested as a result of a mutilation of this Warrant, then the Holder shall deliver such mutilated Warrant to the Company
as a condition precedent to the Company’s obligation to issue the New Warrant.
10. Reservation
of Warrant Shares. The Company covenants that it will at all times reserve and keep available out of the aggregate of its authorized
but unissued and otherwise unreserved Common Stock, solely for the purpose of enabling it to issue Warrant Shares upon exercise of this
Warrant as herein provided, the number of Warrant Shares which are then issuable and deliverable upon the exercise of this entire Warrant,
free from preemptive rights or any other contingent purchase rights of persons other than the Holder (taking into account the adjustments
and restrictions of Section 11). The Company covenants that all Warrant Shares so issuable and deliverable shall, upon issuance
and the payment of the applicable Exercise Price in accordance with the terms hereof, be duly and validly authorized, issued and fully
paid and nonassessable. The Company will take all such action as may be necessary to assure that such shares of Common Stock may be issued
as provided herein without violation of any applicable law or regulation, or of any requirements of any securities exchange or automated
quotation system upon which the Common Shares may be listed.
11. Certain
Adjustments. The Exercise Price and number of Warrant Shares issuable upon exercise of this Warrant are subject to adjustment from
time to time as set forth in this Section 11.
12. Payment
of Exercise Price. The Holder shall pay the Exercise Price in immediately available funds; provided, however, that if at the
time of exercise hereof there is no effective registration statement registering, or the prospectus contained therein is not available
for the resale of the Warrant Shares by the Holder, then Holder may satisfy its obligation to pay the Exercise Price through a “cashless
exercise”, in which event the Company shall issue to the Holder the number of Warrant Shares determined as follows:
X = the number of Warrant Shares to be
issued to the Holder.
Y = the total number of Warrant Shares
with respect to which this Warrant is being exercised.
A = the average of the Closing Sale Prices
of the shares of Common Stock for the five Trading Days ending on the date immediately preceding the Exercise Date.
B = the Exercise Price then in effect
for the applicable Warrant Shares at the time of such exercise.
For purposes of Rule 144 promulgated under the
Securities Act, it is intended, understood and acknowledged that the Warrant Shares issued in a cashless exercise transaction shall be
deemed to have been acquired by the Holder, and the holding period for the Warrant Shares shall be deemed to have commenced, on the date
this Warrant was originally issued pursuant to the Engagement Letter (provided that the Commission continues to take the position that
such treatment is proper at the time of such exercise).
13. No
Settlement in Cash. Without limiting any rights of a Holder to receive Warrant Shares on a “cashless exercise” pursuant
to Section 6(b), in no event shall the Company be required to net cash settle an exercise of this Warrant.
14. No
Fractional Shares. No fractional Warrant Shares will be issued in connection with any exercise of this Warrant. In lieu of any fractional
shares which would otherwise be issuable, the number of Warrant Shares to be issued shall be rounded up to the next whole number.
15. Notices.
Any and all notices or other communications or deliveries hereunder (including, without limitation, any Exercise Notice) shall be in writing
and shall be deemed given and effective on the earliest of (i) the date of transmission, if such notice or communication is delivered
via email at the email address specified in the Engagement Agreement prior to 5:00 p.m. (prevailing Pacific time) on a Trading Day, (ii)
the next Trading Day after the date of transmission, if such notice or communication is delivered via email at the email address specified
in the Engagement Agreement t on a day that is not a Trading Day or later than 5:00 p.m. (prevailing Pacific time) on any Trading Day,
(iii) the Trading Day following the date of mailing, if sent by nationally recognized overnight courier service specifying next business
day delivery, or (iv) upon actual receipt by the party to whom such notice is required to be given, if by hand delivery. The address and
facsimile number of a party for such notices or communications shall be as set forth in the Engagement Agreement unless changed by such
party by two Trading Days’ prior notice to the other party in accordance with this Section 15.
16. Warrant
Agent. The Company shall serve as warrant agent under this Warrant. Upon thirty (30) days’ notice to the Holder, the Company
may appoint a new warrant agent. Any corporation into which the Company or any new warrant agent may be merged or any corporation resulting
from any consolidation to which the Company or any new warrant agent shall be a party or any corporation to which the Company or any new
warrant agent transfers substantially all of its corporate trust or shareholders’ services business shall be a successor warrant
agent under this Warrant without any further act. Any such successor warrant agent shall promptly cause notice of its succession as warrant
agent to be mailed (by first class mail, postage prepaid) to the Holder at the Holder’s last address as shown on the Warrant Register.
17. [Reserved].
18. Miscellaneous.
(a) The
Holder, solely in such Person’s capacity as a holder of this Warrant, shall not be entitled to vote or receive dividends or be deemed
the holder of share capital of the Company for any purpose, nor shall anything contained in this Warrant be construed to confer upon the
Holder, solely in such Person’s capacity as the Holder of this Warrant, any of the rights of a stockholder of the Company or any
right to vote, give or withhold consent to any corporate action (whether any reorganization, issue of stock, reclassification of stock,
consolidation, merger, amalgamation, conveyance or otherwise), receive notice of meetings, receive dividends or subscription rights, or
otherwise, prior to the issuance to the Holder of the Warrant Shares which such Person is then entitled to receive upon the due exercise
of this Warrant. In addition, nothing contained in this Warrant shall be construed as imposing any liabilities on the Holder to purchase
any securities (upon exercise of this Warrant or otherwise) or as a stockholder of the Company, whether such liabilities are asserted
by the Company or by creditors of the Company.
(b) Subject
to the restrictions on transfer set forth on the first page hereof, and compliance with applicable securities laws, this Warrant may be
assigned by the Holder. This Warrant may not be assigned by the Company except to a successor in the event of a Fundamental Transaction.
This Warrant shall be binding on and inure to the benefit of the parties hereto and their respective successors and assigns. Subject to
the preceding sentence, nothing in this Warrant shall be construed to give to any Person other than the Company and the Holder any legal
or equitable right, remedy or cause of action under this Warrant. This Warrant may be amended only in writing signed by the Company and
the holders of a majority of the Warrant Shares then underlying any warrants that remain outstanding and unexercised and that were issued
to the holder thereof due to the assignment of the original Warrant.
(c) GOVERNING
LAW; VENUE; WAIVER OF JURY TRIAL. ALL QUESTIONS CONCERNING THE CONSTRUCTION, VALIDITY, ENFORCEMENT AND INTERPRETATION OF THIS WARRANT
SHALL BE GOVERNED BY AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK WITHOUT REGARD TO THE PRINCIPLES
OF CONFLICTS OF LAW THEREOF. EACH PARTY HEREBY IRREVOCABLY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE STATE AND FEDERAL COURTS SITTING
IN THE CITY OF NEW YORK, BOROUGH OF MANHATTAN, FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION HEREWITH OR WITH ANY TRANSACTION
CONTEMPLATED HEREBY OR DISCUSSED HEREIN (INCLUDING WITH RESPECT TO THE ENFORCEMENT OF ANY OF THE TRANSACTION DOCUMENTS), AND HEREBY IRREVOCABLY
WAIVES, AND AGREES NOT TO ASSERT IN ANY SUIT, ACTION OR PROCEEDING, ANY CLAIM THAT IT IS NOT PERSONALLY SUBJECT TO THE JURISDICTION OF
ANY SUCH COURT, THAT SUCH SUIT, ACTION OR PROCEEDING IS IMPROPER. EACH PARTY HEREBY IRREVOCABLY WAIVES PERSONAL SERVICE OF PROCESS AND
CONSENTS TO PROCESS BEING SERVED IN ANY SUCH SUIT, ACTION OR PROCEEDING BY MAILING A COPY THEREOF VIA REGISTERED OR CERTIFIED MAIL OR
OVERNIGHT DELIVERY (WITH EVIDENCE OF DELIVERY) TO SUCH PARTY AT THE ADDRESS IN EFFECT FOR NOTICES TO IT UNDER THE ENGAGEMENT LETTER AND
AGREES THAT SUCH SERVICE SHALL CONSTITUTE GOOD AND SUFFICIENT SERVICE OF PROCESS AND NOTICE THEREOF. NOTHING CONTAINED HEREIN SHALL BE
DEEMED TO LIMIT IN ANY WAY ANY RIGHT TO SERVE PROCESS IN ANY MANNER PERMITTED BY LAW. THE COMPANY HEREBY WAIVES ALL RIGHTS TO A TRIAL
BY JURY.
(d) The
headings herein are for convenience only, do not constitute a part of this Warrant and shall not be deemed to limit or affect any of the
provisions hereof.
(e) In
case any one or more of the provisions of this Warrant shall be invalid or unenforceable in any respect, the validity and enforceability
of the remaining terms and provisions of this Warrant shall not in any way be affected or impaired thereby, and the parties will attempt
in good faith to agree upon a valid and enforceable provision which shall be a commercially reasonable substitute therefor, and upon so
agreeing, shall incorporate such substitute provision in this Warrant.
(f) Except
as otherwise set forth herein, prior to exercise of this Warrant, the Holder hereof shall not, by reason of by being a Holder, be entitled
to any rights of a stockholder with respect to the Warrant Shares.
IN WITNESS WHEREOF, the Company has caused this
Warrant to be duly executed by its authorized officer as of the date first indicated above.
(To be executed by the Holder to exercise the
right to purchase shares of Common Stock under the foregoing Warrant)
(1) The
undersigned is the Holder of Warrant No. _______ (the “Warrant”) issued by Movano Inc. (the “Company”).
Capitalized terms used herein and not otherwise defined herein have the respective meanings set forth in the Warrant.
(2) The
undersigned hereby exercises its right to purchase ________ Warrant Shares pursuant to the Warrant.
(3) The
Holder intends that payment of the Exercise Price shall be made as (check one):
(4) If
the Holder has elected a Cash Exercise, the Holder shall pay the sum of $_________ in immediately available funds to the Company in accordance
with the terms of the Warrant.
(5) Pursuant
to this Exercise Notice, the Company shall deliver to the Holder ________ Warrant Shares in accordance with the terms of the Warrant.
(Signature must conform in all respects to name
of Holder as specified on the face of the Warrant)
FOR VALUE RECEIVED, the undersigned hereby sells,
assigns and transfers unto ________ (the “Transferee” the right represented by the within Warrant to purchase
________ shares of Common Stock of Movano Inc. (the “Company”) to which the within Warrant relates and appoints
________ attorney to transfer said right on the books of the Company with full power of substitution in the premises. In connection therewith,
the undersigned represents, warrants, covenants and agrees to and with the Company that:
I, J. Cogan, certify that:
In connection with the Quarterly Report on Form
10-Q of Movano Inc. (the “Company”) for the period ended September 30, 2024 as filed with the Securities and Exchange Commission
on the date hereof (the “Report”), we, John Mastrototaro, Chief Executive Officer of the Company, and J. Cogan, Chief Financial
Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002,
to our knowledge that:
A signed original of this written statement required
by Section 906 has been provided to Movano Inc. and will be retained by Movano Inc. and furnished to the Securities and Exchange Commission
or its staff upon request.