Movano Inc
For the period ended Sep 30, 2024. Filed Nov 14, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 14, 2024
MOVE$5.01-4.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-14.
0001213900-24-068994
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-11-14.
0001213900-24-098474
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 68 previous paragraphs and 72 current paragraphs.
38 unchanged; 28 reworded; 6 added; 2 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 21 previous and 23 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
Reverse Stock Split
Current report
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.
Current report
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.
Current report
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.
Current report
Three and nine months ended September 30, 2024 and 2023
Current report
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.
Removed paragraphs (2)
Previous report
Three and six months ended June 30, 2024 and 2023
Previous report
Loss from operations was $12.3 million for the six months ended June 30, 2024, as compared to $14.6 million for the six months ended June 30, 2023.
Reworded paragraphs (28)
Previous wording
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 SpO 2 data, following a successful pivotal hypoxia trial during the fourth quarter of 2022. The submission was reviewed by the FDA, and the Company is working with the agency to address the review commentary. 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.
Current wording
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 SpO 2 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.
Previous wording
We have incurred net losses in each year since inception. Our losses were $11.9 million and $14.4 million for the six months ended June 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.
Current wording
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.
Previous wording
As of June 30, 2024, we had $16.9 in available cash and cash equivalents.
Current wording
As of September 30, 2024, we had $11.3 million in available cash and cash equivalents.
Previous wording
There have been no material changes in our critical accounting policies and estimates during the three and six months ended June 30, 2024, as compared to those disclosed in the 2023 Form 10-K.
Current wording
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.
Previous wording
Our condensed consolidated statements of operations for the three and six months ended June 30, 2024 and 2023 as discussed herein are presented below.
Current wording
Our condensed consolidated statements of operations for the three and nine months ended September 30, 2024 and 2023 as discussed herein are presented below.
Previous wording
Revenue totaled $0 and $0 for the three months ended June 30, 2024 and 2023, respectively. The transfer of control of the Evie Ring Elements began in the first quarter of 2024 and was completed during the second quarter. However, the customer refunds and returns during the second quarter offset the recognition of revenue for that quarter.
Current wording
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.
Previous wording
Revenue totaled $0.9 million and $0 for the six months ended June 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.
Current wording
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.
Previous wording
Cost of revenue totaled $1.6 million and $0 for the six months ended June 30, 2024 and 2023, respectively. This increase of $1.6 million was due to the direct costs of $1.3 million related to the transfer of control of the various Evie Ring Elements, shipping and fulfillment costs of $0.2 million and inventory that was designated as scrap materials of $0.1 million.
Current wording
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.
Previous wording
Cost of revenue totaled $0.4 million and $0 for the three months ended June 30, 2024 and 2023, respectively. This increase of $0.4 million was due to the direct costs of $0.4 million related to the transfer of control of the various Evie Ring Elements.
Current wording
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.
Previous wording
Research and development expenses totaled $2.9 million and $4.2 million for the three months ended June 30, 2024 and 2023, respectively. This decrease of $1.3 million was due primarily to lower research and laboratory expenses and other professional fees. Research and development expenses for the three months ended June 30, 2024 included expenses related to employee compensation of $1.9 million, other professional fees of $0.7 million, research and laboratory expenses of $0.1 million, and other expenses of $0.2 million. Research and development expenses for the three months ended June 30, 2023 included expenses related to employee compensation of $1.8 million, other professional fees of $1.4 million, research and laboratory expenses of $0.8 million, and other expenses of $0.2 million.
Current wording
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.
Previous wording
Research and development expenses totaled $5.8 million and $8.1 million for the six months ended June 30, 2024 and 2023, respectively. This decrease of $2.3 million was due primarily to lower research and laboratory expenses and other professional fees. Research and development expenses for the six months ended June 30, 2024 included expenses related to employee compensation of $3.3 million, other professional fees of $1.4 million, research and laboratory expenses of $0.7 million, and other expenses of $0.4 million. Research and development expenses for the six months ended June 30, 2023 included expenses related to employee compensation of $3.3 million, other professional fees of $2.5 million, research and laboratory expenses of $1.7 million, and other expenses of $0.6 million.
Current wording
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.
Previous wording
Sales, general and administrative expenses totaled $3.1 million and $3.2 million for the three months ended June 30, 2024 and 2023, respectively. This decrease of $0.1 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 June 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 $0.5 million. Sales, general and administrative expenses for the three months ended June 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 $0.9 million.
Current wording
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.
Previous wording
Sales, general and administrative expenses totaled $5.6 million and $6.5 million for the six months ended June 30, 2024 and 2023, respectively. This decrease of $0.9 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 six months ended June 30, 2024 included expenses related to employee and board of director compensation of $3.0 million, professional and consulting fees of $1.5 million, and other expenses of $1.1 million. Sales, general and administrative expenses for the six months ended June 30, 2023 included expenses related to employee and board of director compensation of $3.4 million, professional and consulting fees of $1.2 million, and other expenses of $1.9 million.
Current wording
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.
Previous wording
Loss from operations was $6.5 million for the three months ended June 30, 2024, as compared to $7.4 million for the three months ended June 30, 2023.
Current wording
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.
Previous wording
Other income (expense), net for the six months ended June 30, 2024 was a net other income of $0.2 million as compared to a net other income of $0.2 million for the six months ended June 30, 2023.
Current wording
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.
Previous wording
As a result of the foregoing, net loss was $6.2 million for the three months ended June 30, 2024, as compared to $7.3 million for the three months ended June 30, 2023.
Current wording
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.
Previous wording
As a result of the foregoing, net loss was $11.9 million for the six months ended June 30, 2024, as compared to $14.4 million for the six months ended June 30, 2023.
Current wording
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.
Previous wording
At June 30, 2024, we had cash and cash equivalents totaling $16.9 million. During the six months ended June 30, 2024, we used $12.3 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 six months ended June 30, 2024, we sold an aggregate of 956,721 shares of common stock through the ATM program for proceeds of approximately $0.3 million, net of commissions paid. Approximately $43.9 million remained available on the ATM equity offering program at June 30, 2024.
Current wording
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.
Previous wording
On April 2, 2024, the Company entered into a securities purchase agreement for the private placement of an aggregate of 45,252,517 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 $0.533. Certain directors and officers participated and purchased 287,500 unitsat an offering price of $0.565 per share.
Current wording
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.
Previous wording
Each pre-funded warrant has an exercise price of $0.001 per share, was immediately exercisable on the date of issuance and does not expire. Each warrant has an exercise price equal to $0.4071 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 $0.44.
Current wording
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.
Previous wording
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 $1.4 million.
Current wording
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.
Previous wording
During the six months ended June 30, 2024, the Company used cash of $12.3 million in operating activities, as compared to $14.0 million used in operating activities during the six months ended June 30, 2023.
Current wording
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.
Previous wording
The $12.3 million used in operating activities during the six months ended June 30, 2024 was primarily attributable to our net loss of $11.9 million during the period. The net loss was offset by changes in our operating assets and liabilities totaling $2.8 million and by non-cash items, including stock-based compensation, totaling $2.4 million.
Current wording
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.
Previous wording
The $14.0 million used in operating activities during the six months ended June 30, 2023 was primarily attributable to our net loss of $14.4 million during the period and changes in our operating assets and liabilities totaling $1.2 million. These items were offset by non-cash items, including stock-based compensation of $1.6 million.
Current wording
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.
Previous wording
During the six months ended June 30, 2024 the Company used cash of $6,000 in investing activities, consisting of purchases of property and equipment.
Current wording
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.
Previous wording
During the six months ended June 30, 2023 the Company used cash of $39,000 in investing activities, consisting of purchases of property and equipment.
Current wording
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.
Previous wording
During the six months ended June 30, 2024, the Company was provided cash of $23.1 million which included net proceeds $22.7 million from the issuance of common stock, pre-funded warrants and common stock warrants, and net proceeds of $0.3 million for the issuance of common stock through the ATM activity and the exercise of common stock options.
Current wording
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.
Previous wording
During the six months ended June 30, 2023, the Company was provided cash of $17.7 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 $2.9 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.
Current wording
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.