enVVeno Medical Corp
For the period ended Jun 30, 2025. Filed Jul 31, 2025.
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.
Jun 30, 2025 · Filed Jul 31, 2025
NVNO$6.73-3.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-04-30.
0001641172-25-007908
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-07-31.
0001493152-25-011521
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 53 previous paragraphs and 65 current paragraphs.
45 unchanged; 7 reworded; 10 added; 1 removed; 0 previous and 3 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 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 (10)
Current report
In June 2025, the Company announced that interim two-year follow-up data on forty-two (42) subjects from the seventy-five (75) patient VenoValve U.S. pivotal trial at the Society for Vascular Surgery 2025 Vascular Annual Meeting. The data indicated that eighty-three percent (83.3%) of patients enrolled in the trial (n=35/42) maintained a clinically meaningful benefit from the VenoValve, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS), at year two, compared to baseline. The average rVCSS improvement in the clinically meaningful responder cohort was 9.1 points. Patients in the study also experienced a seventy-four percent (74%) median reduction in leg pain, as measured by the Visual Analog Scale (VAS). For patients with venous ulcers, wound healing outcomes in seventeen (17) patients with twenty-five (25) ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size. Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym). Among the patients (n=30), a 100% valve patency rate was observed at the two-year follow up. All values were calculated comparing each patient’s baseline levels to the reported values at the patient’s 24-month visit. The Revised Venous Clinical Severity Score (rVCSS) is a clinically validated scoring system used to track the progression or regression of venous diseases.
Current report
For the three months ended June 30, 2025, selling, general and administrative expenses increased by $1.6 million or 58%, to $4.2 million from $2.6 million for the three months ended June 30, 2024. Of this increase, $0.4 million was due to compensation costs from the net effect of higher stock-based compensation from the issuance of additional option grants, a non-recurring severance expense of $0.3 million recorded in 2025, and $0.2 million related to higher compensation costs from additional personnel. This increase was also due to a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs resulting from payments made to a vendor that were not passed through from the vendor to clinical sites, as contractually required, and a net $0.1 million increase related to various other expenses.
Current report
Comparison of the six months ended June 30, 2025 and 2024
Current report
Overview
Current report
We reported net losses of $11.2 million and $10.0 million for the six months ended June 30, 2025 and 2024, respectively, representing an increase in net loss of $1.2 million or 13%, due to an increase in operating expenses of $1.0 million and a decrease in other income of $0.2 million, as described in further detail below.
Current report
Revenues
Current report
Research and Development Expenses
Current report
Selling, General and Administrative Expenses
Current report
For the six months ended June 30, 2025, selling, general and administrative expenses increased $1.5 million or 29%, to $6.6 million from $5.1 million for the six months ended June 30, 2024. Of this increase, $0.3 million was due to a non-recurring severance expense recorded in 2025 and $0.4 million related to higher compensation costs from additional personnel. This increase was also due to a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs resulting from payments made to a vendor that were not passed through from the vendor to clinical sites, as contractually required, and a net $0.2 million increase related to various other expenses.
Current report
Other (Income) Expense
Removed paragraphs (1)
Previous report
For the three months ended March 31, 2025, selling, general and administrative expenses decreased $0.1 million or 4%, to $2.4 million from $2.5 million for the three months ended March 31, 2024. The decrease was due to a $0.4 million decrease in share-based compensation, partially offset by $0.2 million in higher other compensation costs, and $0.1 million in higher consulting costs, both related to activities to prepare for potential commercialization of the VenoValve.
Reworded paragraphs (7)
Previous wording
We finished 2024 with approximately $43.2 million of cash and investments and had approximately $38.9 million of cash and investments at March 31, 2025. 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 will increase from current levels of approximately $4 million to $5 million per quarter as we conduct our clinical trials and work toward bringing our product candidates to market.
Current wording
We finished 2024 with approximately $43.2 million of cash and investments and had approximately $35.1 million of cash and investments as of June 30, 2025. 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 will increase from current levels of approximately $4 million per quarter to between $5 million and $7 million per quarter as we conduct our clinical trials and work toward bringing our product candidates to market.
Previous wording
We reported net losses of $4.5 million and $5.0 million for the three months ended March 31, 2025 and 2024, respectively, representing a decrease in net loss of $0.5 million, or 10%, resulting from a decrease in operating expenses, partially offset by a decrease in other income.
Current wording
We reported net losses of $6.7 million and $5.0 million for the three months ended June 30, 2025 and 2024, respectively, representing an increase in net loss of $1.7 million, or 35%, due to an increase in operating expenses of $1.6 million and a decrease in other income of $0.1 million, as described in further detail below.
Previous wording
As a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product candidates. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our product candidates after receiving FDA approval, if ever.
Current wording
As a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product candidates. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate after receiving FDA approval, if ever.
Previous wording
For the three months ended March 31, 2025, research and development expenses decreased by $0.5 million or 19%, to $2.6 million from $3.1 million for the three months ended March 31, 2024. This decrease primarily resulted from $0.5 million in lower costs related to the VenoValve pivotal study and $0.3 million in lower lab related costs. VenoValve pivotal study costs were lower as the amount of follow-up for each participant decreases over time. Lab costs were lower due to less assembly and test activity for the VenoValve once the VenoValve pivotal study reached full enrollment. These decreases were partially offset by a $0.3 million increase in personnel costs resulting from additional personnel.
Current wording
For the three months ended June 30, 2025, research and development expenses increased by $0.1 million or 2%, to $2.9 million from $2.8 million for the three months ended June 30, 2024. This increase primarily resulted from $0.2 million in higher compensation costs from additional personnel, as well as higher professional fees, partially offset by $0.1 million in lower costs related the VenoValve pivotal study as the amount of follow-up for each participant decreases over time.
Previous wording
For the three months ended March 31, 2025, other income decreased $0.1 million or 25% to $0.4 million from $0.5 million for the three months ended March 31, 2024. Other income in both periods reflects realized gains, interest, and unrealized gains and losses from our program to invest excess cash in US Treasury bills.
Current wording
For the three months ended June 30, 2025, other income decreased $0.1 million or 29% to $0.4 million from $0.5 million for the three months ended June 30, 2024. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in US Treasury bills.
Previous wording
For the three months ended March 31, 2025, the Company incurred losses from operations of $5.0 million and used $4.0 million cash in operating activities. The net cash used in operating activities during the 2025 period increased by $0.4 million from $3.6 million for the quarter ended March 31, 2024.
Current wording
For the six months ended June 30, 2025, the Company incurred losses from operations of $12.0 million and used $7.7 million cash in operating activities. The net cash used in operating activities during the 2025 period increased by $0.2 million from $7.5 million for the period ended June 30, 2024.
Previous wording
Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical studies and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter as we conduct our clinical studies and work toward bringing our product candidates to market.
Current wording
Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical studies and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate will increase from current levels of approximately $4 million to between $5 million and $7 million per quarter as we conduct our clinical studies and work toward bringing our product candidates to market.
Rearranged current paragraphs (3)
Current report — wording carried from elsewhere
As a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product candidates. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate after receiving FDA approval, if ever.
Current report — wording carried from elsewhere
For the six months ended June 30, 2025, research and development expenses decreased by $0.5 million or 7%, to $5.4 million from $5.9 million for the six months ended June 30, 2024. This decrease primarily resulted from $0.9 million in lower costs related to the VenoValve study as the amount of follow-up for each participant decreases over time, partially offset by $0.4 million in higher compensation costs from additional personnel, as well as higher professional fees.
Current report — wording carried from elsewhere
For the six months ended June 30, 2025, other income decreased $0.2 million to $0.8 million from $1.0 million for the six months ended June 30, 2024. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in U.S. bills.