Movano Inc

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 Evie Med. We believe Evie Med 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 Evie Med 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 excellent 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 and expect a decision in July 2024. We believe that FDA clearance of these metrics, sold via prescription under the brand name Evie Med, would foster clinical-level confidence in Evie Med’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. 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.

Previous wording

In addition to the Evie Ring and Evie Med 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.

Current wording

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.

Previous wording

We have incurred net losses in each year since inception. Our losses were $5.7 million and $7.1 million for the three months ended March 31, 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 $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.

Previous wording

As of March 31, 2024, we had $2.1 million in available cash and cash equivalents.

Current wording

As of June 30, 2024, we had $16.9 in available cash and cash equivalents.

Previous wording

There have been no material changes in our critical accounting policies and estimates during the three months ended March 31, 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 six months ended June 30, 2024, as compared to those disclosed in the 2023 Form 10-K.

Previous wording

Our condensed consolidated statements of operations for the three months ended March 31, 2024 and 2023 as discussed herein are presented below.

Current 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.

Previous wording

Three months ended March 31, 2024 and 2023

Current 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.

Previous wording

Revenue totaled $0.9 million and $0 for the three months ended March 31, 2024 and 2023, respectively. This increase of $0.9 million was due to recognition of revenue upon the transfer of control of the various Evie Ring Elements, which began in this quarter.

Current 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.

Previous wording

Cost of revenue totaled $1.2 million and $0 for the three months ended March 31, 2024 and 2023, respectively. This increase of $1.2 million was due to the direct costs of $1.0 million related to the transfer of control of the various Evie Ring elements, shipping and fulfillment costs of $0.1 million and inventory that was designated as scrap materials of $0.1 million.

Current 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.

Previous wording

Research and development expenses totaled $2.9 million and $3.9 million for the three months ended March 31, 2024 and 2023, respectively. This decrease of $1.0 million was due primarily to lower research and laboratory expenses and other professional fees. Research and development expenses for the three months ended March 31, 2024 included expenses related to employee compensation of $1.4 million, other professional fees of $0.7 million, research and laboratory expenses of $0.5 million, and other expenses of $0.3 million. Research and development expenses for the three months ended March 31, 2023 included expenses related to employee compensation of $1.6 million, other professional fees of $1.1 million, research and laboratory expenses of $1.0 million, and other expenses of $0.2 million.

Current 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.

Previous wording

Sales, general and administrative expenses totaled $2.5 million and $3.3 million for the three months ended March 31, 2024 and 2023, respectively. This decrease of $0.8 million was due primarily to lower Company headcount with respect to sales, general and administrative employees and related costs. Sales, general and administrative expenses for the three months ended March 31, 2024 included expenses related to employee and board of director compensation of $1.2 million, professional and consulting fees of $0.7 million, and other expenses of $0.6 million. Sales, general and administrative expenses for the three months ended March 31, 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 $1.0 million.

Current 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.

Previous wording

Other income (expense), net for the three months ended March 31, 2024 was a net other income of $34,000 as compared to a net other income of $107,000 for the three months ended March 31, 2023.

Current 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.

Previous wording

As a result of the foregoing, net loss was $5.7 million for the three months ended March 31, 2024, as compared to $7.1 million for the three months ended March 31, 2023.

Current 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.

Previous wording

At March 31, 2024, we had cash and cash equivalents totaling $2.1 million. During the three months ended March 31, 2024, we used $4.1 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”) agreement with B. Riley Securities Inc., or B. Riley, 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 under which B. Riley acts as sales agent. During the three months ended March 31, 2024, we sold an aggregate of 273,307 shares of common stock through the ATM program for proceeds of approximately $0.2 million, net of commissions paid. Approximately $44.2 million remained available on the ATM equity offering program at March 31, 2024.

Current 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.

Previous wording

During the three months ended March 31, 2024, the Company used cash of $4.1 million in operating activities, as compared to $6.1 million used in operating activities during the three months ended March 31, 2023.

Current 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.

Previous wording

The $4.1 million used in operating activities during the three months ended March 31, 2024 was primarily attributable to our net loss of $5.7 million during the period. The net loss was offset by changes in our operating assets and liabilities totaling $0.9 million and by non-cash items, including stock-based compensation, totaling $0.7 million.

Current 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.

Previous wording

The $6.1 million used in operating activities during the three months ended March 31, 2023 was primarily attributable to our net loss of $7.1 million during the period and changes in our operating assets and liabilities totaling $0.3 million. These items were offset by non-cash items, including stock-based compensation, totaling $0.7 million.

Current 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.

Previous wording

During the three months ended March 31, 2024 the Company used cash of $6,000 in investing activities, consisting of purchases of property and equipment.

Current 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.

Previous wording

During the three months ended March 31, 2023 the Company used cash of $13,000 in investing activities, consisting of purchases of property and equipment.

Current 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.

Previous wording

During the three months ended March 31, 2024, the Company was provided cash of $0.2 million which included net proceeds of $0.2 million for the issuance of common stock through the ATM activity.

Current 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.

Previous wording

During the three months ended March 31, 2023, the Company was provided cash of $9.6 million which included net proceeds of $6.7 million from the issuance of common stock, net proceeds of $2.8 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 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.