enVVeno Medical Corp

Previous wording

The first stage of the TAVVE study, which is expected to commence in the second half of 2026, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

Current wording

The first stage of the TAVVE study, which is expected to commence in the fourth quarter of 2026, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

Previous wording

On April 29, 2026, the Company announced that the FDA had approved the Company’s IDE application, authorizing the Company to commence a pivotal study for the enVVe System. The TAVVE pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe deep CVI. The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220 th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

Current wording

As previously announced, the FDA approved the Company’s IDE application, authorizing the Company to commence a pivotal study for the enVVe System. The TAVVE pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe deep CVI. The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220 th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

Previous wording

We finished 2025 with approximately $28.2 million of cash and investments and had approximately $21.5 million of cash and investments as of June 30, 2026. Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials, related product development costs, and our ability to successfully bring products to market. We anticipate that our cash burn rate may increase from current levels of approximately $3 million to $4 million per quarter to between $4 million and $5 million per quarter in the second half of 2026. Even after considering this increase, we should have sufficient cash and investments to fund operations into the third quarter of 2027.

Current wording

We finished 2025 with approximately $28.2 million of cash and investments and had approximately $18.5 million of cash and investments as of September 30, 2026. Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials, related product development costs, and our ability to successfully bring products to market. We anticipate that our cash burn rate may increase from current levels of approximately $3 million to $4 million per quarter to between $4 million and $5 million per quarter in the first half of 2027. The timing and extent of the anticipated increase in cash burn are subject to management’s decisions regarding discretionary spending. This discretion relates to the incremental spending, rather than all operating costs. Even after considering this increase, we should have sufficient cash and investments to fund operations into the fourth quarter of 2027.

Previous wording

We reported net losses of $3.6 million and $6.7 million for the three months ended June 30, 2026 and 2025, respectively, representing a decrease in net loss of $3.1 million, or 46%, due to a decrease in operating expenses of $3.3 million, partially offset by a decrease in other income of $0.2 million, as described in further detail below.

Current wording

We reported net losses of $4.4 million and $4.5 million for the three months ended September 30, 2026 and 2025, respectively, representing a decrease in net loss of $0.2 million, or 3.8%, due to a decrease in operating expenses of $0.4 million, partially offset by a decrease in other income of $0.2 million, as described in further detail below.

Previous wording

For the three months ended June 30, 2026, research and development expenses decreased by $0.8 million or 28%, to $2.1 million from $2.9 million for the three months ended June 30, 2025. This decrease primarily resulted from $1.1 million in lower costs related to the VenoValve pivotal study as the amount of follow-up for each participant decreases over time, as well as a net decrease of $0.1 million in various other expenses. These decreases were partially offset by an increase of $0.4 million as our focus has shifted to product development, testing and other expenses related to the enVVe System being developed for approval by the FDA.

Current wording

For the three months ended September 30, 2026, research and development expenses increased by $0.3 million or 11%, to $2.9 million from $2.6 million for the three months ended September 30, 2025. This increase primarily resulted from an increase of $1.0 million associated with product development, testing and other expenses related to the enVVe System being developed for approval by the FDA, as well as the initial costs of launching the TAVVE pivotal study. These increases were partially offset by a decrease of $0.7 million related to the VenoValve pivotal study as the amount of follow-up for each participant decreases over time.

Previous wording

For the six months ended June 30, 2026, selling, general and administrative expenses decreased by $2.9 million or 44%, to $3.7 million from $6.6 million for the six months ended June 30, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest representing $1.3 million, as well as a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs and a non-recurring severance expense of $0.3 million recorded during the six months ended June 30, 2025, and a net $0.7 million related to various other expenses.

Current wording

For the three months ended September 30, 2026, selling, general and administrative expenses decreased by $0.6 million or 28%, to $1.7 million from $2.3 million for the three months ended September 30, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest representing $0.2 million and a decrease in various other non-recurring legal and consulting expenses totaling $0.7 million. These decreases were partially offset by a non-recurring recovery of a reserve totaling $0.3 million recorded during the three months ended September 30, 2025 for potentially uncollectible prepaid clinical costs totaling $0.6 million recorded during the six months ended June 30, 2025.

Previous wording

For the three months ended June 30, 2026, other income decreased $0.2 million or 45% to $0.2 million from $0.4 million for the three months ended June 30, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities.

Current wording

For the three months ended September 30, 2026, other income decreased $0.1 million or 52% to $0.2 million from $0.3 million for the three months ended September 30, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities.

Previous wording

We reported net losses of $7.4 million and $11.2 million for the six months ended June 30, 2026 and 2025, respectively, representing a decrease in net loss of $3.8 million, or 33%, due to a decrease in operating expenses of $4.2 million, partially offset by a decrease in other income of $0.4 million, as described in further detail below.

Current wording

We reported net losses of $11.8 million and $15.7 million for the nine months ended September 30, 2026 and 2025, respectively, representing a decrease in net loss of $3.9 million, or 25%, due to a decrease in operating expenses of $4.5 million, partially offset by a decrease in other income of $0.6 million, as described in further detail below.

Previous wording

For the six months ended June 30, 2026, research and development expenses decreased by $1.3 million or 23%, to $4.2 million from $5.5 million for the six months ended June 30, 2025. This decrease primarily resulted from $1.8 million in lower costs related to the VenoValve pivotal study as the amount of follow-up for each participant decreases over time, as well as a net decrease of $0.4 million in various other expenses. These decreases were partially offset by an increase of $0.9 million as our focus has shifted to product development, testing and other expenses related to the enVVe System being developed for approval by the FDA.

Current wording

For the nine months ended September 30, 2026, research and development expenses decreased by $0.9 million or 12%, to $7.1 million from $8.0 million for the nine months ended September 30, 2025. This decrease primarily resulted from $2.5 million in lower costs related to the VenoValve pivotal study as the amount of follow-up for each participant decreases over time, as well as a net decrease of $0.2 million in various other expenses. These decreases were partially offset by an increase of $1.8 million as our focus has shifted to product development, testing and other expenses related to the enVVe System being developed for approval by the FDA, as well as the initial costs of launching the TAVVE pivotal study.

Previous wording

For the three months ended June 30, 2026, selling, general and administrative expenses decreased by $2.5 million or 59%, to $1.7 million from $4.2 million for the three months ended June 30, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest representing $1.0 million, as well as a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs and a non-recurring severance expense of $0.3 million recorded during the three months ended June 30, 2025, and a net $0.6 million related to various other expenses.

Current wording

For the nine months ended September 30, 2026, selling, general and administrative expenses decreased by $3.5 million or 40%, to $5.3 million from $8.9 million for the nine months ended September 30, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest representing $1.5 million, as well as a non-recurring $0.3 million reserve for potentially uncollectible prepaid clinical costs and a non-recurring severance expense of $0.3 million recorded during the nine months ended September 30, 2025, and a net $1.4 million related to various other non-recurring legal and consulting expenses.

Previous wording

For the six months ended June 30, 2026, other income decreased $0.4 million or 49% to $0.4 million from $0.8 million for the six months ended June 30, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities.

Current wording

For the nine months ended September 30, 2026, other income decreased $0.6 million or 50% to $0.6 million from $1.2 million for the nine months ended September 30, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities.

Previous wording

For the six months ended June 30, 2026, the Company incurred losses from operations of $7.9 million and used $6.8 million cash in operating activities. The net cash used in operating activities during the 2026 period decreased by $0.9 million from $7.7 million for the six months ended June 30, 2025 primarily due to the decrease in research and development expenses from 2025 to 2026. Our cash balance as of June 30, 2026, is $2.8 million. In addition, we have $18.7 million in investments, for total cash and investments of $21.5 million.

Current wording

For the nine months ended September 30, 2026, the Company incurred losses from operations of $12.4 million and used $10.0 million cash in operating activities. The net cash used in operating activities during the 2026 period decreased by $2.1 million from $12.1 million for the nine months ended September 30, 2025 primarily due to the decrease in research and development expenses and various other non-recurring legal and consulting expenses from 2025 to 2026. Our cash balance as of September 30, 2026, is $2.6 million. In addition, we have approximately $15.8 million in investments, for total cash and investments of $18.5 million.

Previous wording

Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate may increase from current levels of approximately $3 million to $4 million per quarter to between $4 million and $5 million per quarter in the second half of 2026. Even after considering this increase, we should have sufficient cash and investments to fund operations into the third quarter of 2027.

Current wording

Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate may increase from current levels of approximately $3 million to $4 million per quarter to between $4 million and $5 million per quarter in the first half of 2027. The timing and extent of the anticipated increase in cash burn are subject to management’s decisions regarding discretionary spending. This discretion relates to the incremental spending, rather than all operating costs. Even after considering this increase, we should have sufficient cash and investments to fund operations into the fourth quarter of 2027.