Movano Inc.

Previous wording

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 (“SpO 2”), 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.

Current wording

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 (“SpO 2”), 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.

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. 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

Separately, in November 2024, we received FDA 510(k) clearance for the pulse oximetry feature in our EvieMED Ring, making it a medical device. The clearance enables us to pursue health solutions needed for applications such as clinical trials, post-clinical trial management, and remote patient spot check monitoring for both healthcare providers and payors. We believe EvieMED is 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. The FDA clearance of these metrics, including pulse rate and SpO 2, will be sold via prescription under the brand name EvieMED, and will help to ensure clinical-level confidence in EvieMED’s monitoring capabilities and make the device attractive to clinicians and to facilities engaged in clinical trials for at-home and/or long-term patient monitoring. This unique competitive advantage is not only a key pillar in building brand trust and loyalty but will also redefine the expectations of wearable devices.

Previous 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.

Current wording

In addition to the Evie Ring and EvieMED Ring, we are developing the smallest ever patented and proprietary System-on-a-Chip (“SoC”) designed specifically for blood pressure or continuous glucose monitoring (“CGM”) systems. 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. 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 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.

Current wording

We are a technology company that was formed in January 2018. We have a limited operating history and have generated only limited revenue to-date. We have largely focused our efforts and resources towards research and development activities relating to our development of the Evie Ring, EvieMED Ring and the SoC, the commercial launch of the Evie Ring and the FDA 510(k) clearance for the pulse oximeter feature of the EvieMED Ring. To date, we have funded our operations primarily from the sale of our equity securities.

Previous 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.

Current wording

We have incurred net losses in each year since inception. Our losses were $5.2 million and $5.7 million for the three months ended March 31, 2025 and 2024, 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 September 30, 2024, we had $11.3 million in available cash and cash equivalents.

Current wording

As of March 31, 2025, we had $4.4 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 nine months ended September 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 months ended March 31, 2025, as compared to those disclosed in the 2024 Form 10-K.

Previous wording

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.

Current wording

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,Summary of Significant Accounting Policies,underRecently Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements, to our audited financial statements for the year ended December 31, 2024, and notes thereto, included in the Company’s Annual Report on Form 10-K.

Previous wording

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.

Current wording

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 recent accounting pronouncements that may potentially impact our financial position and results of operations.

Previous 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.

Current wording

Our condensed consolidated statements of operations for the three months ended March 31, 2025 and 2024 as discussed herein are presented below.

Previous 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.

Current wording

Revenue totaled $0.2 million and $0.9 million for the three months ended March 31, 2025 and 2024, 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

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.

Current wording

Cost of revenue totaled $0.6 million and $1.2 million for the three months ended March 31, 2025 and 2024, respectively. This decrease of $0.6 million was primarily due to lower revenue for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. Cost of revenue for the three months ended March 31, 2025 included direct costs of $0.4 million related to the transfer of control of the various Evie Ring Elements, $0.2 million for labor and related stock-based compensation. Cost of revenue for the three months ended March 31, 2024 included direct costs of $1.0 million related to the transfer of control of the various Evie Ring Elements, $0.1 million for labor and related stock-based compensation, $0.1 million of order processing, shipping and fulfillment costs, and $0.1 million for inventory that was designated as scrap materials.

Previous 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.

Current wording

Research and development expenses totaled $2.4 million and $2.9 million for the three months ended March 31, 2025 and 2024, respectively. This decrease of $0.5 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, 2025 included expenses related to employee compensation of $1.2 million, other professional fees of $0.9 million, research and laboratory expenses of $0.2 million, and other expenses of $0.1 million. 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.

Previous 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.

Current wording

Sales, general and administrative expenses totaled $2.4 million and $2.5 million for the three months ended March 31, 2025 and 2024, 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 March 31, 2025 included expenses related to employee and board of director compensation of $0.8 million, professional and consulting fees of $0.9 million, and other expenses of $0.6 million. 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.

Previous wording

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.

Current wording

Other income (expense), net for the three months ended March 31, 2025 was a net other income of $60,000 as compared to a net other income of $34,000 for the three months ended March 31, 2024.

Previous 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.

Current wording

As a result of the foregoing, net loss was $5.2 million for the three months ended March 31, 2025, as compared to $5.7 million for the three months ended March 13, 2024.

Previous 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.

Current wording

In August 2022, we entered into an at-the-market issuance (“ATM”) agreement 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 three months ended March 31, 2025, we sold an aggregate of 196,184 shares of common stock through the ATM program for proceeds of approximately $0.8 million, net of commissions paid. Approximately $41.7 million remained available on the ATM equity offering program at March 31, 2025.

Previous wording

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:

Current wording

We expect to continue to incur significant expenses and increasing operating losses for at least the next several years.

Previous wording

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.

Current wording

Until we can generate a sufficient amount of revenue from our 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.

Previous 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.

Current wording

During the three months ended March 31, 2025, the Company used cash of $4.3 million in operating activities, as compared to $4.1 million used in operating activities during the three months ended March 31, 2024.

Previous 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.

Current wording

The $4.3 million used in operating activities during the three months ended March 31, 2025 was primarily attributable to our net loss of $5.2 million during the period. The net loss was offset by changes in our operating assets and liabilities totaling $0.5 million and by non-cash items, including stock-based compensation, totaling $0.3 million.

Previous 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.

Current 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 of $0.7 million.

Previous 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.

Current 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.

Previous 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.

Current wording

During the three months ended March 31, 2025, the Company was provided cash of $0.8 million which included net proceeds of $0.8 million for the issuance of common stock through the ATM activity.