Financial Data and Key Metrics Changes - The company reported revenue of $852,000 for the first quarter of 2024, with 5,305 Evie Rings shipped during the period [68] - Operating loss for Q1 2024 was $5.8 million, an improvement from an operating loss of $7.2 million in the same period last year [68] - Cash burn in Q1 2024 was $4.1 million, which included costs related to the Evie Ring launch and FDA submission [10] Business Line Data and Key Metrics Changes - The Evie Ring was launched during the Black Friday 2023 holiday period, with revenue tied to the timing of ring shipments starting in January 2024 [9] - The company ceased all paid marketing as of December 1, 2023, and temporarily halted taking orders in February 2024 due to capital constraints [9] Market Data and Key Metrics Changes - The company is preparing for a re-launch of the Evie Ring and anticipates a significant demand increase once orders are resumed [21] - The market opportunity identified for chronic management of cardiovascular, metabolic, obesity, and pulmonary patients is estimated at $20 billion per year [54] Company Strategy and Development Direction - The company is focused on three priorities: preparing to take direct-to-consumer orders for the Evie Ring, securing FDA 510(k) clearance for the Evie Med brand, and refining the wrist-worn prototype for additional studies [36] - The company is enhancing automation and production processes to increase yield and efficiency in preparation for the re-launch [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming FDA decision regarding the 510(k) clearance, expected in July 2024, which is seen as a significant milestone [7][38] - The company is confident that recent funding and operational improvements will act as a catalyst for success throughout the year [69] Other Important Information - The company has implemented an AI-powered customer response chatbot and onboarded a new Head of Customer Service to enhance customer experience [53] - The company is in discussions with a strategic investor and has received positive feedback on its strategic plan [28] Q&A Session All Questions and Answers Question: Can you provide any updates as it relates to the 510(k) process? - The company has had ongoing communication with the FDA and is working closely to ideally get the product cleared for market [72] Question: Can you provide more detail on your plans for the launch of Evie Med with B2B partners? - The company is engaged with strategic partners in the pharmaceutical and medical device sectors, focusing on continuous and secure medical-grade data [61] Question: What progress has been seen with blood pressure monitoring? - The company is preparing for pivotal studies and is focused on improving algorithms and production processes for blood pressure monitoring [46]

Financial Performance - Movano Health generated $852,000 in revenue for Q1 2024, shipping 5,305 Evie Rings during the period[8] - The company reported an operating loss of $5.8 million in Q1 2024, an improvement from a loss of $7.2 million in Q1 2023[8] - Total cash and cash equivalents decreased to $2.1 million as of March 31, 2024, down from $6.1 million at the end of 2023[8] - Research and development expenses decreased to $2.9 million in Q1 2024 from $3.9 million in Q1 2023[15] Clinical and Regulatory Developments - Movano Health successfully submitted clinical trial results showing a pooled root mean square error (RMSE) of 2.46% for the Evie Med Ring, below the FDA guidance of 3.5%[4] - The company expects a decision on its FDA 510(k) clearance for the Evie Med Ring in July 2024[4] - The company plans to conduct an arterial blood pressure study in June 2024, which will provide continuous data on patients[5] Business Strategy and Initiatives - Movano Health closed a $24.1 million private placement on April 4, 2024, to fund working capital and corporate purposes[8] - The company is enhancing the Evie product experience and preparing to resume direct-to-consumer orders[4] - Movano Health is pursuing key business-to-business partnerships as part of its enterprise initiative[2]

Unlocking business-to-business opportunities with Evie Med, Movano Health's ring pulse oximeter, remains a key priority for the Company. PLEASANTON, Calif., May 9, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) announced that it successfully submitted updated pivotal clinical trial results as well as proof of enhanced medical device usability on April 22, 2024 to the U.S. Food and Drug Administration (FDA) as part of its 510(k) filing for the Company's first commercial medical device, the Evie Med Ring p ...

Financial Performance - Movano Health incurred net losses of $29.3 million and $30.3 million for the years ended December 31, 2023 and 2022, respectively, reflecting a decrease of 3% in net loss year-over-year [185][214]. - Total operating expenses for 2023 were $29.7 million, a decrease of 3% from $30.5 million in 2022, primarily due to reduced research and development costs [208][212]. - Research and development expenses decreased to $16.9 million in 2023 from $19.0 million in 2022, a reduction of $2.1 million attributed to lower design costs [209]. - Sales, general and administrative expenses increased to $12.8 million in 2023 from $11.5 million in 2022, an increase of 12% driven by company growth and preparations for the Evie Ring launch [211]. - Interest income increased significantly to $0.4 million in 2023 from $0.1 million in 2022, a growth of 206% due to higher prevailing interest rates [213]. - The company reported a net loss of $29.3 million for the year ended December 31, 2023, compared to a net loss of $30.3 million in 2022 [225]. Product Development - The Evie Ring, launched in November 2023, is designed to provide comprehensive health metrics for women, including heart rate, SpO2, and menstrual tracking [181]. - Movano Health is developing a proprietary System on Chip (SoC) for non-invasive glucose and cuffless blood pressure monitoring, with clinical trials currently underway [182]. - Movano Health plans to bring a Class II FDA-cleared device to market that includes continuous glucose monitoring and cuffless blood pressure monitoring capabilities [182]. Cash and Financing Activities - As of December 31, 2023, Movano Health had $6.1 million in available cash and cash equivalents [186]. - As of December 31, 2023, the company had cash and cash equivalents of $6.1 million, with an expected cash usage of $26.2 million in operating activities for the year [215]. - The company sold 2,531,757 shares through an at-the-market equity offering program in 2023, generating approximately $3.2 million in proceeds, with $44.4 million remaining available under the program [216]. - Financing activities provided cash of $21.6 million in 2023, including net proceeds from equity securities issued in public offerings totaling $18.4 million [229]. - The company entered into a securities purchase agreement for a private placement of 45,252,517 units at a purchase price of $0.533 per unit, generating gross proceeds of approximately $24.1 million [218][220]. - The company expects to finance future cash needs through public or private equity offerings, debt financings, or corporate collaborations [221]. Future Outlook and Concerns - The company anticipates ongoing annual losses as it continues the commercialization and development of the Evie Ring and other products, requiring additional capital [233]. - The company faces substantial doubt about its ability to continue as a going concern within one year after the issuance of its consolidated financial statements [222]. - The company plans to satisfy future cash needs through existing capital balances and a combination of financing options, but may face challenges in raising additional capital [236]. - Cash used in investing activities was $64,000 in 2023, a significant decrease from cash provided of $15.7 million in 2022 [228].

Financial Data and Key Metrics Changes - For Q4 2023, the company reported an operating loss of $6 million, an improvement from an operating loss of $8 million in the same period last year [30] - Cash burn for Q4 2023 was $5.4 million, which included costs related to the Evie Ring launch and FDA submission [30] - As of December 31, 2023, the company had $6.1 million in cash and cash equivalents, and recently closed a $24 million private placement [30][54] Business Line Data and Key Metrics Changes - The Evie Ring launched in November 2023, generating over $1 million in sales during the Black Friday period, but order intake was paused in mid-February due to production constraints [29][18] - The company has amassed a waitlist of over 8,000 potential buyers without paid marketing, indicating strong consumer interest [11] Market Data and Key Metrics Changes - The clinical trial market for FDA-cleared wearables is valued at $2 billion annually, with the company positioned to dominate this space with minimal competition [15] - The payer market represents over 130 million patients with chronic diseases, and the company has traction with a top U.S. payer covering approximately 50 million lives [23] Company Strategy and Development Direction - The company aims to achieve FDA clearance for pulse rate and blood oxygen monitoring, which will facilitate the launch of Evie Med, a medical device version of the Evie Ring [12] - Plans include developing an Android app, improving production capabilities, and enhancing customer service [13][55] - The company is focused on expanding its product offerings and exploring B2B opportunities, particularly in remote patient monitoring and chronic disease management [24][49] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the FDA clearance process and the potential for partnerships with pharmaceutical companies [36][21] - The company is committed to improving user experience and addressing operational challenges faced during the product launch [38] Other Important Information - The company has made software updates to enhance user experience, including improvements in sleep tracking accuracy [20] - The recent clinical study results for blood pressure monitoring showed promising accuracy, which is critical for future product development [26][68] Q&A Session Summary Question: Updates on the first 510(k) application - Management reported significant progress with clinical work on the Evie Ring and expects a decision from the FDA in July 2024 [56] Question: Comparison between Evie Med and Evie Ring - Evie Med will have a different app experience, separating wellness metrics from medical metrics, and will undergo detailed FDA review [57] Question: Status of strategic partnerships - The company is engaged with multiple strategic partners in beta testing and is optimistic about upcoming FDA clearance [36] Question: Customer response to the Evie Ring - Early feedback has been positive, and the company is focused on enhancing customer service and engagement [61] Question: Timeline for resuming Evie Ring orders - Orders will resume once the company ensures sufficient inventory to meet demand, with a focus on optimizing production processes [67] Question: Blood pressure clinical trial results - The results demonstrated that the chip used for blood pressure monitoring met FDA accuracy criteria, which is crucial for future investments [68] Question: Glucose monitoring product development - The company is exploring various methods for glucose monitoring and is optimistic about its potential [73]

Financial Data and Key Metrics Changes - Movano Health reported an operating loss of $9.1 million in Q3 2023, compared to an operating loss of $8.7 million in the same period last year, primarily due to accelerated commercialization initiatives [25] - The company had a cash burn of $7 million during the period, consistent with the previous seven quarters, influenced by pre-launch costs for the Evie Ring and expenses related to the FDA submission [25] - At the end of Q3 2023, Movano Health had $7.7 million in cash and cash equivalents, which is expected to increase to $10.8 million post-capital raise [49] Business Line Data and Key Metrics Changes - The Evie Ring, which combines health tracking features with a focus on women's health, is set to launch on November 20, 2023, priced at $269 [16] - The company is in the final stages of testing the Evie Ring and app, ensuring a smooth user experience upon launch [4][6] - Movano Health is also developing cuffless blood pressure and non-invasive glucose monitoring solutions, with significant progress reported in clinical trials [21][22] Market Data and Key Metrics Changes - The company has seen increased interest in medical-grade technologies for home use, particularly in women's health [5] - Movano Health's marketing campaign has generated over 200,000 site visits since the launch of its new commercial website [19] - The company is actively engaging with a major health insurer and a remote patient monitoring company for potential B2B partnerships [7] Company Strategy and Development Direction - Movano Health aims to empower women through the Evie Ring, which provides trusted health information and insights tailored to women's health needs [6][14] - The company is focusing on a comprehensive marketing strategy to drive awareness and excitement for the Evie Ring, particularly during the holiday season [8][42] - Future product enhancements and new features are planned for 2024, ensuring ongoing engagement with early adopters [56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of the Evie Ring, citing strong consumer interest and engagement [28] - The company is optimistic about the FDA submission process for the Evie Ring, with ongoing dialogue and collaboration with the agency [17][55] - Management highlighted the potential for significant growth in the women's health sector and the importance of the Evie Ring in addressing unmet needs [45][47] Other Important Information - Movano Health completed a $3.6 million underwritten public offering of common stock, with a 30-day option for underwriters to purchase additional shares [49] - The company is preparing for its first exhibition at the Consumer Electronics Show in January, showcasing the Evie Ring and its features [44] Q&A Session All Questions and Answers Question: What are your expectations of sales for the Evie Ring this year? - Management noted a highly engaged leads list of over 120,000 consumers and significant traffic to the website, indicating a healthy response to the launch [28] Question: Can you provide more detail on your interaction with the FDA? - Management discussed the FDA's heightened scrutiny of new pulse oximeters and the company's proactive measures to address these concerns in their clinical trials [55] Question: What is your trial result, and how long will it be before blood pressure finds its way into a commercial device? - Management explained the ongoing clinical trials for blood pressure monitoring and the need for further studies before commercialization [66] Question: How will early adopters access upgrades for the Evie Ring? - Management confirmed that users will receive software updates through the app, ensuring continued engagement with new features [62] Question: Is the company positioned well to invest behind the Evie launch? - Management expressed confidence in the company's position to invest in the launch, supported by strong consumer interest and anticipated revenue generation [69]

Financial Performance - The company reported a net loss of $9.0 million for the three months ended September 30, 2023, compared to a net loss of $8.6 million for the same period in 2022, representing a 4% increase in loss [138]. - The company incurred a net loss of $23.3 million during the nine months ended September 30, 2023, compared to a net loss of $22.4 million in the same period of 2022 [145][146]. - Cash used in operating activities increased to $20.9 million for the nine months ended September 30, 2023, from $18.6 million in the prior year, reflecting a year-over-year increase of approximately 7% [144][145]. - The company expects to continue incurring significant expenses and increasing operating losses for at least the next several years [141]. - There is substantial doubt about the company's ability to continue as a going concern within one year after the issuance of the financial statements [142]. Research and Development - Research and development expenses for the three months ended September 30, 2023, totaled $5.6 million, a 10% increase from $5.1 million in the same period in 2022 [132]. - Research and development expenses for the nine months ended September 30, 2023, were $13.7 million, a slight decrease of 1% from $13.8 million in the same period in 2022 [133]. - The company is developing a patented System-on-a-Chip (SoC) for non-invasive glucose and cuffless blood pressure monitoring, with clinical trials currently underway [127]. - The Evie Ring is expected to launch as a general wellness device without FDA premarket clearances, with plans to seek FDA clearances for its vital signs monitoring capabilities [126]. - The company plans to advance the engineering design and development of the Evie Ring and other potential products [148]. Expenses and Cash Flow - Sales, general and administrative expenses for the nine months ended September 30, 2023, were $10.0 million, a 16% increase from $8.6 million in the same period in 2022 [135]. - The total operating expenses for the three months ended September 30, 2023, were $9.1 million, a 5% increase from $8.7 million in the same period in 2022 [131]. - Other income for the nine months ended September 30, 2023, was $341,000, a significant increase of 774% from $39,000 in the same period in 2022 [137]. - Cash provided by investing activities was $14.9 million in the nine months ended September 30, 2022, compared to a cash outflow of $51,000 in the same period of 2023 [147]. - The company has approximately $10,000 in non-cancelable contractual commitments as of September 30, 2023, primarily related to vendor arrangements [153]. Financing Activities - The company sold 2,360,036 shares of common stock through an at-the-market issuance program for proceeds of approximately $3.1 million during the nine months ended September 30, 2023 [140]. - The company raised $17.9 million in financing activities during the nine months ended September 30, 2023, primarily from public offerings and an ATM equity offering program [150]. - Future cash needs may be financed through public or private equity offerings, debt financings, or corporate collaborations and licensing arrangements [141]. - The company does not have any off-balance sheet transactions as of September 30, 2023 [152].

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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 JUNE 30, 2023 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) (State of incorporation) (I.R.S. Employer Delaware 82-4233771 Identification No.) 6800 Ko ...

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 MARCH 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-40254 MOVANO INC. (State of incorporation) (I.R.S. Employer Delaware 26-0579295 Identification No.) 6800 Koll Center Parkway, Pleasanton, CA 94566 (Address of pr ...