Envoy Medical, Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
COCH$7.15+0.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-10.
0001213900-26-086974
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001213900-26-116117
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 116 previous paragraphs and 122 current paragraphs.
72 unchanged; 42 reworded; 8 added; 1 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 44 previous and 45 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (8)
Current report
Reverse Stock Split
Current report
On October 26, 2026, we completed a one-for-ten reverse stock split (“Reverse Stock Split”), which reduced the number of shares of our Class A Common Stock that were issued and outstanding immediately prior to the effectiveness of the Reverse Stock Split. The number of shares of our authorized Class A Common Stock was not affected by the Reverse Stock Split and the par value of our Class A Common Stock remained unchanged at $0.0001 per share. No fractional shares were issued in connection with the Reverse Stock Split.
Current report
Proportional adjustments were made to the number of shares of Class A Common Stock awarded and available for issuance under our equity incentive plans, as well as the exercise price and the number of shares issuable upon the exercise or conversion of our outstanding stock options and other equity securities under our equity incentive plans. All outstanding warrants were also adjusted in accordance with their terms.
Current report
All share and per share amounts of Class A Common Stock in this Report have been adjusted to reflect the Reverse Stock Split.
Current report
General and administrative expenses increased by $126 for the three months ended September 30, 2026, compared to the three months ended September 30, 2025, primarily due to modest increases in compensation, stock-based compensation, and professional services expenses.
Current report
The loss from the loss on offering change in fair value of the private warrant liability was $782 for the three months ended September 30, 2025. The loss on offering and change in fair value of private warrant liability was driven by $443 of direct offering expenses, including the issuance of the September 2025 Placement Agent Warrants, associated with the September 2025 Offering (both as defined in Note 9 of the accompanying unaudited condensed consolidated financial statements included elsewhere in this Report) and a $339 of loss from the change in the fair value of the private warrant liability as a result of issuing the warrants on September 23, 2025 and the subsequent remeasurement on September 30, 2025.
Current report
Comparison of the nine months ended September 30, 2026 and 2025
Current report
The loss from the loss on offering change in fair value of the private warrant liability was $782 for the nine months ended September 30, 2025. The loss on offering and change in fair value of private warrant liability was driven by $443 of direct offering expenses, including the issuance of the September 2025 Placement Agent Warrants, associated with the September 2025 Offering (both as defined in Note 9 of the accompanying unaudited condensed consolidated financial statements included elsewhere in this Report) and a $339 of loss from the change in the fair value of the private warrant liability as a result of issuing the warrants on September 23, 2025 and the subsequent remeasurement on September 30, 2025.
Removed paragraphs (1)
Previous report
Comparison of the six months ended June 30, 2026 and 2025
Reworded paragraphs (42)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements as of June 30, 2026 and December 31, 2025, and the three and six months ended June 30, 2026 and 2025, together with the notes thereto included elsewhere in this Report. It should also be read in conjunction with the audited consolidated financial statements as of and for the years ended December 31, 2025 and 2024, together with related notes thereto included in the Form 10-K, which is accessible on the SEC’s website at www.sec.gov.
Current wording
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements as of September 30, 2026 and December 31, 2025, and the three and nine months ended September 30, 2026 and 2025, together with the notes thereto included elsewhere in this Report. It should also be read in conjunction with the audited consolidated financial statements as of and for the years ended December 31, 2025 and 2024, together with related notes thereto included in the Form 10-K, which is accessible on the SEC’s website at www.sec.gov.
Previous wording
We are a hearing health company focused on development of fully implanted hearing solutions and providing innovative medical technologies across the hearing loss spectrum. Our technologies are designed to shift the paradigm within the hearing industry and bring both providers and patients the hearing devices they desire. We are dedicated to pushing beyond the status quo to provide patients with improved access, usability, independence, and quality of life. We believe leveraging the ear’s natural anatomy, rather than an external or sub-dermal artificial microphone, is the ideal way for people to hear. In recent years, we have focused almost exclusively on developing the fully implanted Acclaim® cochlear implant (the “Acclaim CI”), our lead product candidate.
Current wording
We are a hearing health and neuroprosthetics company focused on development of fully implanted hearing solutions and providing innovative technologies across the hearing loss spectrum. Our technologies are designed to shift the paradigm within the hearing industry and bring both providers and patients the hearing devices they desire. We are dedicated to pushing beyond the status quo to provide patients with improved access, usability, independence, and quality of life. We believe leveraging the ear’s natural anatomy, rather than an external or sub-dermal artificial microphone, is the ideal way for people to hear. In recent years, we have focused almost exclusively on developing the fully implanted Acclaim® cochlear implant (the “Acclaim CI”), our lead product candidate.
Previous wording
The IDE was approved as a “staged” clinical trial. The first stage allowed for enrollment of 10 study participants (“First Stage”) prior to us having to formally request FDA approval to expand enrollment to the full subject cohort of 56 patients (“Second Stage”). Once the First Stage completed their 3-month follow-up visits, we submitted this preliminary clinical data to justify study expansion into the second and final stage. The FDA agreed that this data adequately characterized device effectiveness and our expansion request to the FDA was formally approved by the FDA on October 3, 2025. We completed enrollment of all 56 patients on March 10, 2025 and all 56 patients completed their activation visits, when a patient’s device is initially turned on for the first time, by April 16, 2026. On July, 21, 2026, we announced that all 56 patients enrolled in the clinical trial have surpassed the 3-month milestone.
Current wording
The IDE was approved as a “staged” clinical trial. The first stage allowed for enrollment of 10 study participants (“First Stage”) prior to us having to formally request FDA approval to expand enrollment to the full subject cohort of 56 patients (“Second Stage”). Once the First Stage completed their 3-month follow-up visits, we submitted this preliminary clinical data to justify study expansion into the second and final stage. The FDA agreed that this data adequately characterized device effectiveness and our expansion request to the FDA was formally approved by the FDA on October 3, 2025. We completed enrollment of all 56 patients on March 10, 2026 and all 56 patients completed their activation visits, when a patient’s device is initially turned on for the first time, by April 16, 2026. On July 21, 2026, we announced that all 56 patients enrolled in the clinical trial have surpassed the 3-month milestone and on October 20, 2026 we announced that we have surpassed the six-month follow-up visit milestone for the clinical trial.
Previous wording
Each implanted study participant will be followed through their 12-month visit. After all 56 patients have been through their 12-month visits, the data will be collected and analyzed in accordance with the clinical study protocol and statistical analysis plan. Upon finalization of the results, we intend to submit a Premarket Approval (“PMA”) application to the FDA. As of June 30, 2026, the first 10 pivotal trial patients implanted at the start of 2025 have reached the 12-month follow-up evaluation point. We expect all Stage 2 participants to complete their 12-month data collection by early Q2 2027, with a PMA submission to the FDA planned to follow a few months thereafter.
Current wording
Each implanted study participant will be followed through their 12-month visit. After all 56 patients have been through their 12-month visits, the data will be collected and analyzed in accordance with the clinical study protocol and statistical analysis plan. Upon finalization of the results, we intend to submit a Premarket Approval (“PMA”) application to the FDA. The first 10 pivotal trial patients implanted at the start of 2025 reached the 12-month follow-up evaluation point during the second quarter of 2026. We expect all Stage 2 participants to complete their 12-month data collection by early Q2 2027, with a PMA submission to the FDA planned to follow a few months thereafter.
Previous wording
The FDA will have at least 180 days to review the PMA application unless a panel review is requested. If a panel review is requested, it may add several months of additional review time to the PMA application. As a result, we currently anticipate obtaining the FDA’s decision on our PMA application at some point within the second half of 2027 assuming that no panel review is requested. If a panel review is requested, the FDA’s decision could extend to the first half of 2028.
Current wording
The FDA will have at least 180 days to review the PMA application. The FDA may take longer than 180 actual calendar days for the review if it “pauses the clock” during the 180 day review period (pausing the days counted) or requests a panel review. If a panel review is requested, it may add several months of additional review time to the PMA application. As a result, the earliest we currently anticipate obtaining the FDA’s decision on our PMA application is late Q4 of 2027; however, if the FDA pauses the clock or requests a panel review, the FDA’s decision could extend to the first half of 2028.
Previous wording
Our PMA submission will occur as modular submissions so that completed sections can be provided to the FDA for review, rather than waiting to compile and submit the entire submission at once. We expect to submit a total of four modules, with the final module containing final clinical trial data. By utilizing the modular PMA pathway, we expect to engage with the FDA throughout the review process, allowing for earlier regulatory feedback while establishing a series of defined development milestones. On June 30, 2026, we announced the submission of the first module of our PMA application.
Current wording
Our PMA application will occur as four modular submissions so that completed modules can be provided to the FDA for review over time, rather than waiting to compile and submit the entire submission at once after the clinical trial is completed. We plan to submit a total of four modules, with the final module containing final clinical trial data. By utilizing the modular PMA pathway, we expect to engage with the FDA throughout the review process, allowing for earlier regulatory feedback while establishing a series of defined development milestones. On June 30, 2026, we announced the submission of the first module of our PMA application. On October 12, 2026, we announced the submission of the second module of our PMA application.
Previous wording
We had net losses of $5,982 and $5,690 for the three months ended June 30, 2026 and 2025, respectively, $10,333 and $10,688 for the six months ended June 2026 and 2025, respectively, and had an accumulated deficit of $326,369 and $313,396 as of June 30, 2026 and December 31, 2025, respectively. We have funded our operations to date primarily through the issuance of equity securities and debt. We expect to continue to incur net losses for the foreseeable future, and expect our research and development expenses, sales and marketing expenses, general and administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue the clinical trial forthe Acclaim CI and seek the necessary regulatory approvals for our product candidate. In addition, if and when we seek and obtain regulatory approval to commercialize the Acclaim CI in the United States, we will also incur increased expenses in connection with commercialization and marketing of such product. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, if any, and our expenditures on other research and development activities. We anticipate that our expenses will increase significantly in connection with our ongoing activities, if and as we:
Current wording
We had net losses of $3,932 and $6,482 for the three months ended September 30, 2026 and 2025, respectively, $14,265 and $17,170 for the nine months ended September 30, 2026 and 2025, respectively, and had an accumulated deficit of $331,609 and $313,396 as of September 30, 2026 and December 31, 2025, respectively. We have funded our operations to date primarily through the issuance of equity securities and debt. We expect to continue to incur net losses for the foreseeable future, and expect our research and development expenses, sales and marketing expenses, general and administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue the clinical trial for the Acclaim CI and seek the necessary regulatory approvals for our product candidate. In addition, if and when we seek and obtain regulatory approval to commercialize the Acclaim CI in the United States, we will also incur increased expenses in connection with commercialization and marketing of such product. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, if any, and our expenditures on other research and development activities. We anticipate that our expenses will increase significantly in connection with our ongoing activities, if and as we:
Previous wording
Upon commercialization of our Acclaim CI product, we expect that Acclaim CI revenues will more than exceed our Esteem FI-AMEI revenue. We are targeting FDA approval on our PMA application for the Acclaim CI in the second half of 2027 or first half of 2028, depending on the FDA’s review process and timeline.
Current wording
Upon commercialization of our Acclaim CI product, we expect that Acclaim CI revenues will more than exceed our Esteem FI-AMEI revenue. We are targeting FDA approval on our PMA application for the Acclaim CI late in 2027 or first half of 2028, depending on the FDA’s review process and timeline.
Previous wording
Our R&D expenses are currently tracked on a project basis. The majority of our R&D expenses incurred during the three and six months ended June 30, 2026 and 2025 were for the development of the Acclaim CI, including expenses for clinical trial activities and patient enrollment for the Acclaim CI pivotal clinical trial.
Current wording
Our R&D expenses are currently tracked on a project basis. The majority of our R&D expenses incurred during the three and nine months ended September 30, 2026 and 2025 were for the development of the Acclaim CI, including expenses for clinical trial activities and patient enrollment for the Acclaim CI pivotal clinical trial.
Previous wording
Interest expense (related party) consists of accrued interest for the term loans held by a related party (the “Term Loans”), as well as amortization of the debt discount recorded as a result of the warrants issued with the Term Loans. Amortization of the debt discount is recorded over the respective terms of the Term Loans. On August 25, 2025, the Term Loans were extinguished resulting in the Company no longer recognizing interest expense on the Term Loans.
Current wording
Interest expense (related party) consists of accrued interest for the term loans held by a related party (the “Term Loans”), as well as amortization of the debt discount recorded as a result of the warrants issued with the Term Loans. Amortization of the debt discount is recorded over the respective terms of the Term Loans. On August 25, 2025, the Term Loans were extinguished resulting in us no longer recognizing interest expense on the Term Loans.
Previous wording
Other income (expense), net consists of interest income as well interest incurred on insurance financing loans as and other expenses.
Current wording
Other income (expense), net consists of interest income as well as interest incurred on insurance financing loans and other expenses.
Previous wording
Net revenues decreased by $27 for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. Revenue was not significant to our results of operations.
Current wording
Net revenues increased by $24 for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. Revenue was not significant to our results of operations.
Previous wording
Cost of goods sold increased by $44 for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The increase was primarily attributable to higher fees paid to third parties performing work related to our products of $60 and increased scrap and materials usage of $19, partially offset by decreases in other product-related costs.
Current wording
Cost of goods sold increased by $41 for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The increase was primarily attributable to higher fees paid to third parties performing work related to our products of $26.
Previous wording
R&D expenses increased by $647 for the three months ended June 30, 2026, compared to the three months ended June 30, 2025 reflecting the expansion to the Second Stage of the clinical trial following FDA approval in the fourth quarter of 2025. Clinical trial expenses increased by $279 as activities were primarily related to follow-up visits following completion of enrollment in the first quarter of 2026, whereas the comparable 2025 period included enrollment of the final participants of the First Stage of the clinical trial. Personnel costs increased by $139, primarily due to existing personnel needed to support the clinical trial. Product costs increased by $322, primarily due to fees incurred in connection with the submission of the first module of our PMA application to the FDA. These increases were partially offset by lower other R&D expenses.
Current wording
R&D expenses increased by $377 for the three months ended September 30, 2026, compared to the three months ended September 30, 2025 reflecting the expansion to the Second Stage of the clinical trial following FDA approval in the fourth quarter of 2025. Clinical trial expenses increased by $299 as activities were primarily related to follow-up visits following completion of enrollment in the first quarter of 2026, whereas the comparable 2025 period included follow-up visits from the First Stage of the clinical trial. Personnel costs increased by $162 to support the clinical trial. Product costs decreased by $101 and other R&D costs increased by $17, neither of which was individually significant.
Previous wording
Sales and marketing expenses decreased by $180 for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The decrease was primarily attributable to the reallocation of field clinical engineers to research and development activities in support of the clinical trial. During the three months ended June 30, 2025, we incurred $188 of sales and marketing expenses related to these employees, who no longer support sales and marketing activities.
Current wording
Sales and marketing expenses decreased by $248 for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The decrease was primarily attributable to the reallocation of field clinical specialists to research and development activities in support of the clinical trial. During the three months ended September 30, 2025, we incurred $240 of sales and marketing expenses related to these employees, who no longer support sales and marketing activities.
Previous wording
The gain from the change in the fair value of the forward purchase agreement warrant liability was $23 for the three months ended June 30, 2026 compared to a gain of $37 for the three months ended June 30, 2025. The change in fair value during both periods was driven by changes in the probability of the applicable Exercise Price Floor being achieved for the Shortfall Warrants (as defined in Note 9 to the unaudited condensed consolidated financial statements). During both periods, our stock price remained below the applicable Exercise Price Floor. Additionally, the lower number of warrants outstanding during the 2026 period reduced the magnitude of the warrant liability.
Current wording
The gain from the change in the fair value of the forward purchase agreement warrant liability was $14 for the three months ended September 30, 2026 compared to a gain of $64 for the three months ended September 30, 2025. The change in fair value during both periods was driven by changes in the probability of the applicable Exercise Price Floor being achieved for the Shortfall Warrants (as defined in Note 9 to the unaudited condensed consolidated financial statements). During both periods, our stock price remained below the applicable Exercise Price Floor. Additionally, the lower number of warrants outstanding during the 2026 period reduced the magnitude of the warrant liability.
Previous wording
The gain from the change in fair value of the private warrant liability was $1,167 for the six months ended June 30, 2026. The gain resulted from the remeasurement of the Investor Warrants (as defined in Note 9 to the unaudited condensed consolidated financial statements), which were issued on September 23, 2025 and October 9, 2025. No Investor Warrants were outstanding during the six months ended June 30, 2025.
Current wording
The gain from the change in fair value of the private warrant liability was $1,201 for the three months ended September 30, 2026. The gain resulted from the remeasurement of the Investor Warrants (as defined in Note 9 to the unaudited condensed consolidated financial statements), which were issued on September 23, 2025 and October 9, 2025. The exercise price of the Investor Warrants has remained above the market price of the Class A Common Stock underlying the warrants.
Previous wording
The gain from the change in the fair value of the publicly traded warrant liability was $236 for the three months ended June 30, 2026 compared to a loss of $32 for the three months ended June 30, 2025. The change was attributable to a decrease in the trading price of the Company’s publicly traded warrants during 2026, compared to an increase during 2025.
Current wording
The gain from the change in the fair value of the publicly traded warrant liability was $259 for the three months ended September 30, 2026 compared to a loss of $33 for the three months ended September 30, 2025. The change was attributable to a decrease in the trading price of our publicly traded warrants during 2026, compared to an increase during 2025.
Previous wording
Interest expense, related party decreased by $624 for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The decrease was due to the settlement of the Term Loans on August 25, 2025, after which no further related party interest expense was incurred.
Current wording
Interest expense, related party decreased by $471 for the three months ended September 30, 2026, compared to the three months ended September 30, 2025. The decrease was due to the settlement of the Term Loans on August 25, 2025, after which no further related party interest expense was incurred.
Previous wording
Other income (expense), net increased by $167 for the three months ended June 30, 2026 compared to the three months ended June 30, 2025 primarily due to higher interest income.
Current wording
Other income (expense), net increased by $126 for the three months ended September 30, 2026 compared to the three months ended September 30, 2025 primarily due to higher interest income.
Previous wording
Net revenues decreased by $34 for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. Revenue was not significant to our results of operations.
Current wording
Net revenues decreased by $10 for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. Revenue was not significant to our results of operations.
Previous wording
Cost of goods sold increased by $131 for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The increase was primarily due to higher fees paid to third parties performing work related to our products of $93 and increased scrap and materials usage of $69, partially offset by decreases in other product-related costs.
Current wording
Cost of goods sold increased by $172 for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The increase was primarily due to higher fees paid to third parties performing work related to our products of $119 and increased scrap and materials usage of $49.
Previous wording
The following table summarizes the components of our R&D expenses for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes the components of our R&D expenses for the nine months ended September 30, 2026 and 2025:
Previous wording
R&D expenses increased by $1,541 for the six months ended June 30, 2026, compared to the six months ended June 30, 2025 reflecting the expansion of the clinical trial following FDA approval in the fourth quarter of 2025. Clinical trial expenses increased by $1,289 as activities were primarily related to completion of enrollment and follow-up visits, whereas the comparable 2025 period consisted of enrollment for the First Stage of the clinical trial. Personnel costs increased by $364, primarily due to existing personnel needed to support the clinical trial. These increases were partially offset by lower product costs of $62 and lower other R&D expenses of $50, neither of which was individually significant.
Current wording
R&D expenses increased by $1,918 for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025 reflecting the expansion of the clinical trial following FDA approval in the fourth quarter of 2025. Clinical trial expenses increased by $1,588 as activities were primarily related to completion of enrollment and follow-up visits, whereas the comparable 2025 period consisted of enrollment and follow-up visits for the First Stage of the clinical trial. Personnel costs increased by $524 to support the clinical trial. The increase of $129 in other R&D costs was primarily due to fees associated with our PMA application. These increases were partially offset by lower product costs of $323 as the product advanced in its development lifecycle during nine months ended September 30, 2026 compared to the prior period.
Previous wording
Sales and marketing expenses decreased by $374 for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The decrease was primarily due to the reallocation of field clinical engineers to research and development activities in support of the clinical trial. During the six months ended June 30, 2025, we incurred $335 of sales and marketing expenses related to these employees, who no longer support sales and marketing activities.
Current wording
Sales and marketing expenses decreased by $622 for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The decrease was primarily due to the reallocation of field clinical specialists to research and development activities in support of the clinical trial. During the nine months ended September 30, 2025, we incurred $575 of sales and marketing expenses related to these employees, who no longer support sales and marketing activities.
Previous wording
General and administrative expenses increased by $19 for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The increase reflects higher consulting and professional service fees, largely offset by a $315 severance accrual related to our former Chief Financial Officer recorded during the six months ended June 30, 2025.
Current wording
General and administrative expenses increased by $145 for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The increase is largely attributable to increased stock-based compensation of $125. Increased consulting and professional service fees of $366 in the nine months ended September 30, 2026 were largely offset by a $315 severance accrual related to our former Chief Financial Officer recorded during the nine months ended September 30, 2025.
Previous wording
The gain from the change in the fair value of the forward purchase agreement warrant liability was $10 for the six months ended June 30, 2026 compared to a gain of $458 for the six months ended June 30, 2025. The change in fair value during both periods was driven by the changes in the probability of the applicable Exercise Price Floor being achieved for the Shortfall Warrants (as defined in Note 9 to the unaudited condensed consolidated financial statements). During both periods, our stock price remained below the applicable Exercise Price Floor. Additionally, the lower number of warrants outstanding during the 2026 period reduced the magnitude of the warrant liability.
Current wording
The gain from the change in the fair value of the forward purchase agreement warrant liability was $24 for the nine months ended September 30, 2026 compared to a gain of $522 for the nine months ended September 30, 2025. The change in fair value during both periods was driven by the changes in the probability of the applicable Exercise Price Floor being achieved for the Shortfall Warrants (as defined in Note 9 to the unaudited condensed consolidated financial statements). During both periods, our stock price remained below the applicable Exercise Price Floor. Additionally, the lower number of warrants outstanding during the 2026 period reduced the magnitude of the warrant liability.
Previous wording
The loss from the change in fair value of the private warrant liability was $838 for the three months ended June 30, 2026. The loss resulted from the remeasurement of the Investor Warrants (as defined in Note 9 to the unaudited condensed consolidated financial statements), which were issued on September 23, 2025 and October 9, 2025. No Investor Warrants were outstanding during the three months ended June 30, 2025.
Current wording
The gain from the change in fair value of the private warrant liability was $2,368 for the nine months ended September 30, 2026. The gain resulted from the remeasurement of the Investor Warrants (as defined in Note 9 to the unaudited condensed consolidated financial statements), which were issued on September 23, 2025 and October 9, 2025. The exercise price of the Investor Warrants has remained above the market price of the Class A Common Stock underlying the warrants.
Previous wording
The loss from the change in the fair value of the publicly traded warrant liability was $154 for the six months ended June 30, 2026 compared to a gain of $162 for the six months ended June 30, 2025. The change was attributable to an increase in the publicly traded warrants price during the 2026 period, compared to a decrease during the 2025 period.
Current wording
The gain from the change in the fair value of the publicly traded warrant liability was $105 for the nine months ended September 30, 2026 compared to a gain of $129 for the nine months ended September 30, 2025. The change was attributable to a decrease in the publicly traded warrants price during both the 2026 and 2025 periods.
Previous wording
Interest expense (related party) decreased by $1,119 for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. The decrease was due to the settlement of the Term Loans on August 25, 2025, after which no further related party interest expense was incurred.
Current wording
Interest expense (related party) decreased by $1,590 for the nine months ended September 30, 2026, compared to the nine months ended September 30, 2025. The decrease was due to the settlement of the Term Loans on August 25, 2025, after which no further related party interest expense was incurred.
Previous wording
Other income (expense), net increased by $184 for the six months ended June 30, 2026 compared to the six months ended June 30, 2025 primarily due to higher interest income.
Current wording
Other income (expense), net increased by $310 for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 primarily due to higher interest income.
Previous wording
Since inception, we have incurred significant operating losses. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our products and fund the process of clinical FDA trials. We have funded our operations to date primarily with proceeds from issuing equity securities, term loans, convertible notes and proceeds from a 2023 business combination. As of June 30, 2026 and December 31, 2025 we had $19,679 and $3,739 of cash, respectively.
Current wording
Since inception, we have incurred significant operating losses. We expect to continue to incur significant expenses and operating losses for the foreseeable future as we advance the clinical development of our products and fund the process of clinical FDA trials. We have funded our operations to date primarily with proceeds from issuing equity securities, term loans, convertible notes and proceeds from a 2023 business combination. As of September 30, 2026 and December 31, 2025 we had $14,570 and $3,739 of cash, respectively.
Previous wording
We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us. Based on our cash position as of June 30, 2026, and assuming there is no additional funding through the exercise of any outstanding warrants and no material change to our operating expenses, we expect to have sufficient funds for our operations through the first quarter of 2027. Proceeds from the exercise of any outstanding warrants or other sources will provide us with funding beyond this timeframe. We have based our estimates as to how long we expect we will be able to fund our operations on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect, in which case we would be required to obtain additional financing sooner than currently projected, which may not be available to us on acceptable terms, or at all. If we are unable to raise sufficient financing when needed or events or circumstances occur such that we do not meet our strategic plans, we may be required to reduce certain discretionary spending, be unable to develop new or enhanced production methods, or be unable to fund capital expenditures, which could have a material adverse effect on our financial position, results of operations, cash flows, and ability to achieve our intended business objectives. These matters raise substantial doubt about our ability to continue as a going concern. To the extent that we raise additional capital through additional collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our Acclaim CI, future revenue streams, research programs or to grant licenses on terms that may not be favorable to us. If we do raise additional capital through public or private equity or convertible debt offerings, the ownership interest of our existing stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.
Current wording
We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us. Based on our cash position as of September 30, 2026, and assuming there is no additional funding through the exercise of any outstanding warrants and no material change to our operating expenses, we expect to have sufficient funds for our operations into the second quarter of 2027. Proceeds from the exercise of any outstanding warrants or other sources will provide us with funding beyond this timeframe. We have based our estimates as to how long we expect we will be able to fund our operations on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect, in which case we would be required to obtain additional financing sooner than currently projected, which may not be available to us on acceptable terms, or at all. If we are unable to raise sufficient financing when needed or events or circumstances occur such that we do not meet our strategic plans, we may be required to reduce certain discretionary spending, be unable to develop new or enhanced production methods, or be unable to fund capital expenditures, which could have a material adverse effect on our financial position, results of operations, cash flows, and ability to achieve our intended business objectives. These matters raise substantial doubt about our ability to continue as a going concern. To the extent that we raise additional capital through additional collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our Acclaim CI, future revenue streams, research programs or to grant licenses on terms that may not be favorable to us. If we do raise additional capital through public or private equity or convertible debt offerings, the ownership interest of our existing stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2026 was $11,517, primarily reflecting a net loss of $10,333 and $1,437 of cash outflows from changes in operating assets and liabilities. Non-cash expenses totaled $253.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2026 was $16,547, primarily reflecting a net loss of $14,265 and $1,775 of cash outflows from changes in operating assets and liabilities. Non-cash income totaled $507.
Previous wording
The $1,437 of cash outflows from net changes in the levels of operating assets and liabilities was primarily due to a decrease of $912 in accounts payable and a decrease in accrued expenses of $247, primarily related to the clinical trial, as well as other changes in operating assets and liabilities resulting from the timing of cash receipts and disbursements. We will continue to evaluate our capital requirements for both short-term and long-term liquidity needs, which could be affected by various risks and uncertainties, including, but not limited to, the effects of the current inflationary environment, rising interest rates, and other risks detailed in our Form 10-K detailed in the section titled “Risk Factors.”
Current wording
The $1,775 of cash outflows from net changes in the levels of operating assets and liabilities was primarily due to a decrease of $1,345 in accounts payable and a combined decrease of $349 in the operating lease liability and product warranty liability, as well as other changes in operating assets and liabilities resulting from the timing of cash receipts and disbursements. We will continue to evaluate our capital requirements for both short-term and long-term liquidity needs, which could be affected by various risks and uncertainties, including, but not limited to, the effects of the current inflationary environment, rising interest rates, and other risks detailed in our Form 10-K detailed in the section titled “Risk Factors.”
Previous wording
Net cash used in operating activities for the six months ended June 30, 2025 was $8,185. This use of cash was primarily driven by a net loss of $10,688, partially offset by $999 of cash inflows from changes in operating assets and liabilities. Non-cash expenses totaled $1,504.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2025 was $12,516. This use of cash was primarily driven by a net loss of $17,170, partially offset by $1,761 of cash inflows from changes in operating assets and liabilities. Non-cash expenses totaled $2,893.
Previous wording
The $999 of cash inflows from net changes in the levels of operating assets and liabilities was primarily due to a $760 decrease of in other receivable due to the receipt of an income tax refund, an increase to a severance accrual of $315, as well as other changes in operating assets and liabilities resulting from the timing of cash receipts and disbursements.
Current wording
The $1,761 of cash inflows from net changes in the levels of operating assets and liabilities was primarily due to a increase of $973 in accounts payable, a $761 decrease in other receivable due to the receipt of an income tax refund, an increase to a severance accrual of $315, partially offset by changes in operating assets and liabilities resulting from the timing of cash receipts and disbursements.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2026 was $6 and consisted of purchases of production equipment.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2026 was $33 and consisted of purchases of production equipment.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2025 was $7 and consisted of purchases of computer equipment.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2025 was $7 and consisted of purchases of computer equipment.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2026 was $27,465 and was primarily due to net proceeds of $27,782 from the issuance of securities in the February 2026 Offering (as defined in Note 9 of the unaudited condensed consolidated financial statements), partially offset by payments made on insurance financing loans of $421.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2026 was $27,414 and was primarily due to net proceeds of $27,782 from the issuance of securities in the February 2026 Offering (as defined in Note 9 of the unaudited condensed consolidated financial statements), partially offset by payments made on insurance financing loans of $572.
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Previous report — wording carried elsewhere
General and administrative expenses decreased by $39 for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. The decrease was primarily attributable to a $315 severance accrual related to our former Chief Financial Officer recorded during the three months ended June 30, 2025. The decrease was partially offset by higher consulting and professional service fees during the three months ended June 30, 2026.