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Movano(MOVE) - Prospectus
2026-01-13 22:24
As filed with the Securities and Exchange Commission on January 13, 2026. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 MOVANO INC. (Exact name of registrant as specified in its charter) Delaware 3845 82-4233771 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer incorporation or organization) Classification Code Number) Identification No.) 6800 Koll Center Parkway Pleasanton, CA 94566 (415) ...
Tivic Health (TIVC) Q2 2025 Earnings Transcript
The Motley Fool· 2025-08-14 21:02
Financial Performance - Revenue net of returns was $86,000 for the quarter, down from $140,000 in the prior year, and $156,000 for the first half of 2025 compared to $474,000 for 2024, attributed to decreased unit sales of ClearUp due to reduced marketing expenditures [24][25] - Gross margin increased to 63% for the second quarter, up from 21% a year ago, and 67% from 42% for the first half of 2025 compared to 2024, driven by reduced product support and fulfillment costs [25][26] - Operating expenses rose to $2.0 million for the second quarter from $1.3 million in the prior year, primarily due to increased research and biologics investment, while net loss was $1.9 million compared to $1.3 million in the prior year [3][26] Strategic Shift - The company plans to exit the consumer health technology business and focus exclusively on prescription-based therapeutics, citing underperformance in ClearUp sales [5][22] - An exclusive license was obtained for Sotero Biopharma's TLR5 agonist portfolio, including entolimod, which is seen as a potential growth engine with significant U.S. government contract opportunities for Acute Radiation Syndrome (ARS) [5][8] - Management is pursuing regulatory progress for entolimod, which has received fast track designation and orphan drug status, with a type B FDA meeting planned to advance a Biologic License Application (BLA) filing [5][15] Clinical Development and Manufacturing - GMP manufacturing validation for entolimod has been initiated with Scorpius Biomanufacturing, moving towards key biologics license application steps [6][16] - The company completed all study visits in an optimization study for the noninvasive cervical vagus nerve stimulation (NCVNS) device, with results expected later this year [6][21] - The potential market for neutropenia drugs is estimated between $19 billion to $24 billion, with entolimod positioned to address this market by preventing cell death during radiation treatment [17][18] Leadership and Talent Acquisition - Lisa Wolf has been confirmed as CFO, with key hires from Statera to support regulatory, clinical, and business development efforts [7][28] - The company has made significant adjustments to its staff to align with the new strategic focus, including the transition of the chief scientific officer to a consultancy role [7][28] Future Outlook - The company anticipates completing the transfer of existing INDs from Statera, cell line verification, and the first batch of GMP materials, along with reporting on the VNS trial results [30] - Management emphasizes the importance of the entolimod opportunity, with a single contract for ARS potentially totaling several hundred million dollars [9][13]