Envoy Medical — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net revenue for the three months ended September 30, 2026, was $66,000, compared to $42,000 in the same period in 2025.
• Net loss attributable to common stockholders was $5,240,000 ($0.50 per share) for the quarter, compared to $7,747,000 ($3.55 per share) in the prior year period.
• Research and development expenses were $3,077,000 for the quarter, an increase from $2,700,000 in the prior year period, driven by clinical trial follow-up and regulatory submission costs.
• Sales and marketing expenses decreased to $157,000 from $405,000 in the prior year period, primarily due to reallocating field clinical specialists to R&D.
• General and administrative expenses were $2,125,000, up from $1,999,000 in the prior year period, due to increases in compensation, stock-based compensation, and professional services.
• Cash on hand as of September 30, 2026, was approximately $14,570,000, up from $3,739,000 at the end of 2025.
• Total liabilities were $20,298,000 as of September 30, 2026, compared to $20,325,000 at the end of 2025.
• Stockholders' deficit was $1,531,000 as of September 30, 2026, compared to a deficit of $12,158,000 at the end of 2025.

Guidance and Future Outlook:

• The Company expects all participants in the pivotal clinical trial to complete their 12-month visits by early in the second quarter of 2027.
• Stage 2 participants are expected to complete 12-month data collection by early in the second quarter of 2027.
• The Company plans to submit the final module of its Modular PMA application to the FDA a few months after the completion of Stage 2 data collection.
• The Company anticipates continued progress toward offering a fully implanted cochlear implant option to candidates in 2027.

Business Segments and Product Lines:

• The Acclaim® cochlear implant, an investigational fully implanted device, received Breakthrough Device Designation from the FDA in 2019.
• Positive 12-month data from the first 10 participants in Stage 1 of the pivotal trial showed a mean CNC word recognition score of 53.2%, a 38.0 percentage point improvement from a baseline of 15.2%.
• The Company completed the three-month follow-up window for the full cohort of the pivotal clinical trial.
• The Company surpassed the six-month follow-up visit milestone for all 56 patients in the pivotal trial, marking the first time a U.S. pivotal trial of a fully implanted cochlear implant has reached this milestone.
• The Company submitted the second module of its Modular PMA application to the FDA, with a total of four modules planned for submission.
• The Esteem® active middle ear implant remains commercially available in the U.S. since 2010.
• The global intellectual property portfolio expanded to 97 granted patents (40 U.S. and 57 foreign) with 35 applications pending.

Market and Competitive Landscape:

• The Company is the first to reach the six-month follow-up milestone in a U.S. pivotal clinical trial of a fully implanted cochlear implant.
• The Acclaim CI is designed to address severe to profound sensorineural hearing loss not adequately addressed by hearing aids.

Risks and Challenges:

• The Acclaim Cochlear Implant is an investigational device limited by Federal law to investigational use.
• Forward-looking statements regarding clinical trial results, FDA approval timing, and market acceptance are subject to risks including regulatory uncertainty, clinical trial outcomes, and competition.
• Risks include potential changes in reimbursement policies, supply chain disruptions, and the need for additional capital.

Management Commentary and Tone:

• CEO Brent Lucas stated the Company is making significant progress with the investigational fully implanted cochlear implant and approaches an "extremely exciting 2027."
• Management highlighted that each clinical milestone brings the Company closer to offering cochlear implant candidates a fully implanted option they have wanted for decades.

Other Key Points:

• On October 6, 2026, the Company entered into a dismissal agreement with Atlas Merchant Capital SPAC Fund I LP, terminating litigation filed in the Delaware Court of Chancery without any payment by the Company.
• The Company raised $29,997,000 in proceeds from the issuance of Class A Common Stock, Issued Pre-Funded Warrants, and Series A Warrants during the nine months ended September 30, 2026.
• Offering costs for the aforementioned issuance totaled $2,215,000.
• The Company paid $19,000 in cash interest during the nine months ended September 30, 2026.
• Accrued and unpaid dividends on Series A Preferred Stock totaled $3,948,000 as of September 30, 2026.