Movano, Inc. Q2 FY2023 earnings call

1. EV ring launch delayed by about two months to November due to upgrading to a new sensor for better accuracy, still planning to launch ahead of Black Friday to perfect the product and leverage holiday marketing. 2. Successfully submitted the first 510(k) application for the EV ring pulse oximeter to the FDA, which has passed initial completeness review and is under full review. 3. Preparing for the second round of beta programs, having collaborated with three partners including a global athletic apparel company, a major health insurer, and a leading remote patient monitoring company. 4. EV ring has multiple health monitoring functions like sleep stages, heart rate variability, etc., and the companion app can personalize data display. 5. Marketing team conducting all-round marketing activities, including paid brand promotion, collaborating with influencers, showcasing new features, etc. 6. Establishing a medical advisory board for professional support. 7. Operations team building supply chain and order fulfillment capabilities, advancing manufacturing process and equipment automation, etc. 8. Continuing to test the single-chip radio frequency solution, completed a three-week IRB-approved clinical study on blood pressure in May with good signals and planning follow-up studies.

Not applicable as no specific product segment financial performance details provided

1. EV ring originally planned for September launch, now delayed to November, still planning to launch ahead of Black Friday. 2. Cautiously optimistic about FDA clearance for EV ring, and if not approved, will launch as a wellness device. 3. Expect FDA clearance to be a catalyst for commercial agreements with healthcare and other enterprises. 4. Plan to perfect the end-to-end solution through beta programs to ensure commercial success.

1. Forward-looking statements are subject to inherent risks and uncertainties, actual results may differ materially, risks detailed in SEC filings. 2. Uncertainty regarding FDA clearance of EV ring. 3. Risk of product delay affecting market timing and sales expectations.

Q: Can you talk more about why you've delayed the launch date?

A: As a medical device company, data quality is essential. We had an opportunity to enhance the product by incorporating a new component. This new component is more accurate and addresses perfusion issues in our target market, especially for women with smaller fingers. The delay gives us time to test the new component, perfect the product, and leverage the holiday season for marketing.

Q: What gives you confidence in your ability to meet the new launch date?

A: We've completed all testing and documentation for the FDA submission, including environmental, biocompatibility, electrical, and cybersecurity testing. We've been pushing forward with marketing, production readiness, customer service, and have thoroughly tested the new component, seeing improved signal collection.

Q: Any concern about your ability to capitalize on holiday traffic with the launch ahead of Black Friday?

A: No, the overall launch extends beyond the fourth quarter. There's macro awareness around women's health, and the momentum we've generated will translate into purchases during and beyond the holiday season.

Q: Why did your cash burn increase in the quarter? And what will the burn rate be after launch?

A: Cash burn increased due to resources invested in raw materials, tooling, FDA and product testing, and marketing ahead of launch. We view the launch prior to Black Friday as relatively immaterial to cash burn, with lower marketing spend and other launch-related costs offsetting any delay.

Q: Can you give us some more insight to the FDA process? What are the next milestones? When do you expect to hear back from FDA?

A: The 510(k) process involves filing, FDA acknowledging receipt, assessing completeness (15-day review), then formal review. At 60 days post filing, we'll get feedback with questions, then there's back and forth to address questions. Average process is 3-6 months. We're cautiously optimistic but there are no guarantees.

Q: What were the results of your latest blood pressure study with your single-chip technology? And what are you doing to make further progress?

A: The last study using the single chip got good signals. We're optimizing the antenna and making algorithm changes, and planning a follow-up blood pressure study in a couple of weeks, with fixes applied to glucose as well.