enVVeno Medical Corp
For the period ended Jun 30, 2024. Filed Jul 31, 2024.
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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, 2024 · Filed Jul 31, 2024
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 2024-03-31; filed 2024-05-08.
0001493152-24-018225
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-07-31.
0001493152-24-029737
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 57 previous paragraphs and 67 current paragraphs.
44 unchanged; 11 reworded; 11 added; 2 removed; 0 previous and 1 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 (11)
Current report
Three (3) year results from eight (8) first-in-human study participants who agreed to additional monitoring were presented at the February 2023 annual meeting of the American Venous Forum in San Antonio, Texas. Patients continued to show significant clinical improvement (average 8 point rVCSS improvement compared to baseline) at three (3) years post-VenoValve surgery, with no venous ulcer recurrences for C6 patients.
Current report
On June 21, 2024, the Company presented data showing significant improvement for patients with venous ulcers enrolled in the SAVVE study at the Society for Vascular Surgery 2024 Vascular Annual Meeting in Chicago. The data presented included twenty-one venous ulcer patients who had reached their one-year milestone, representing thirty venous ulcers. Overall, 91% of venous ulcer patients evaluated at one year either had fully healed ulcers or ulcers that had improved. Of that group, 100% of venous ulcers with a duration of one year or less prior to VenoValve surgery were fully healed, with the majority (67%) fully healed 90 days after VenoValve surgery. For those with venous ulcers with a duration of more than one year prior to VenoValve surgery, 89% were either fully healed or improved at one year, representing a decrease in average of total ulcers of 85%. In addition, none of the patients with a fully healed venous ulcer had experienced an ulcer recurrence.
Current report
For the three months ended June 30, 2024, selling, general and administrative expenses were $2.6 million, flat from the three months ended June 30, 2023, which was also $2.6 million. This was due to the net effect of a $0.1 million decrease in share-based compensation, offset by a $0.1 million increase in legal costs.
Current report
Comparison of the six months ended June 30, 2024 and 2023
Current report
Overview
Current report
We reported net losses of $10.0 million and $12.9 million for the six months ended June 30, 2024 and 2023, respectively, representing a decrease in net loss of $2.9 million or 22.5%, due to a decrease in operating expenses of $2.6 million and an increase in other income of $0.3 million.
Current report
Research and Development Expenses
Current report
For the six months ended June 30, 2024, research and development expenses decreased by $1.9 million or 24.4%, to $5.9 million from $7.8 million for the six months ended June 30, 2023. This decrease resulted from $2.6 million in lower costs related the SAVVE study as it was fully enrolled during 2023 resulting in the elimination of costs related to enrolling patients in the study, partially offset by a $0.6 million increase in personnel costs due to increased payments to additional staff to support ENVVE product development and the SAVVE study, and $0.1 million in higher lab related costs.
Current report
Selling, General and Administrative Expenses
Current report
For the six months ended June 30, 2024, selling, general and administrative expenses decreased $0.7 million or 12.1%, to $5.1 million from $5.8 million for the six months ended June 30, 2023. Of this decrease, $0.9 million was due to share based compensation from grants made during 2021 because the expense related to portions of grants made during 2021 has been fully amortized and subsequent grants have been of lower value. This decrease in stock-based compensation expense was partially offset by a $0.2 million increase in legal costs.
Current report
Other (Income) Expense
Removed paragraphs (2)
Previous report
At the end of the VenoValve first-in-human study, eight (8) study participants agreed to additional monitoring. In November of 2022, three-year, positive follow-up data was presented for this cohort of patients at the 49th Annual VEITH Symposium in New York city, showing that patients continued to experience the benefits from the VenoValve reported at one (1) year.
Previous report
For the three months ended March 31, 2024, selling, general and administrative expenses decreased $0.7 million or 22%, to $2.5 million from $3.2 million for the three months ended March 31, 2023. The decrease was due to a decrease in share based compensation, which decreased to $1.2 million in 2024 from $1.9 million in 2023, primarily because of the decrease in the expense associated with grants made in 2021, which was $0.7 million lower in 2024 than in 2023.
Reworded paragraphs (11)
Previous wording
The Company is also developing a second product called enVVe®, which is a potential first-in-class, non-surgical, transcatheter based replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system accessories. The Company is conducting pre-clinical testing on enVVe and currently expects to be ready to file for IDE approval for the enVVe pivotal trial (the Transcatheter Anti-Thrombotic, Venous Valve Endoprosthesis or TAVVE) in Q2 of 2025.
Current wording
The Company is also developing a second product called enVVe®, which is a potential, non-surgical, transcatheter based replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system accessories. The Company is conducting pre-clinical testing on enVVe and currently expects to be ready to file for IDE approval for the enVVe pivotal trial (the Transcatheter Anti-Thrombotic, Venous Valve Endoprosthesis or TAVVE) in Q2 of 2025.
Previous wording
The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (“FDA”). We expect the VenoValve to be eligible for FDA approval in the fourth quarter of 2024 followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA. There are currently no devices approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.
Current wording
The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (“FDA”). We expect to be eligible to file for FDA approval of the VenoValve in the fourth quarter of 2024 followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA. There are currently no devices approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.
Previous wording
Our team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful. We develop and manufacture both the VenoValve and EnVVe in a 14,507 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.
Current wording
Our team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful. We develop and manufacture both the VenoValve and EnVVe in a 14,000 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.
Previous wording
Efficacy endpoints for the SAVVE pivotal study include rVCSS scores, which will be used to provide evidence of clinically meaningful benefit, as well as reflux time measurements, VAS pain scores, quality of life measurements, ulcer healing (for CEAP class C6 patients), and intra-operative and one-year vein patency and valve functionality. Safety endpoints include device related events and procedure related events including mortality, pulmonary embolism, ipsilateral deep vein thrombosis, infection and bleeding.
Current wording
Efficacy endpoints for the SAVVE pivotal study include rVCSS scores, which are used to provide evidence of clinically meaningful benefit, as well as reflux time measurements, VAS pain scores, quality of life measurements, ulcer healing (for CEAP class C6 patients), and intra-operative and one-year vein patency and valve functionality. Safety endpoints include device related events and procedure related events including mortality, pulmonary embolism, ipsilateral deep vein thrombosis, infection and bleeding.
Previous wording
We finished 2023 with approximately $46.4 million of cash and investments and had approximately $42.9 million of cash and investments at March 31, 2024. 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 2023 with approximately $46.4 million of cash and investments and had approximately $39.1 million of cash and investments at June 30, 2024. 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.
Previous wording
We reported net losses of $5.0 million and $6.4 million for the three months ended March 31, 2024 and 2023, respectively, representing a decrease in net loss of $1.4 million, or 22%, resulting from a decrease in operating expenses and an increase in other income.
Current wording
We reported net losses of $5.0 million and $6.5 million for the three months ended June 30, 2024 and 2023, respectively, representing a decrease in net loss of $1.5 million, or 23.1%, resulting from a decrease in operating expenses and an increase in other income, as described in further detail below.
Previous wording
For the three months ended March 31, 2024, research and development expenses decreased by $0.5 million or 14%, to $3.1 million from $3.6 million for the three months ended March 31, 2023. This decrease primarily resulted from $0.9 million in lower costs related the SAVVE study as the study was fully enrolled during 2023 resulting in the reduction of outreach and enrollment related activities and related costs. This decrease was offset by a $0.3 million increase in personnel costs to support the SAVVE study and enVVe development, and $0.2 million in lab costs related to enVVe development.
Current wording
For the three months ended June 30, 2024, research and development expenses decreased by $1.4 million or 33.3%, to $2.8 million from $4.2 million for the three months ended June 30, 2023. This decrease primarily resulted from $1.7 million in lower costs related the SAVVE study as the study was fully enrolled during 2023 resulting in the reduction of outreach and enrollment related activities and related costs, partially offset by a $0.3 million increase in personnel costs to support the SAVVE study and enVVe development.
Previous wording
For the three months ended March 31, 2024, other income increased $0.1 million or 25% to $0.5 million from $0.4 million for the three months ended March 31, 2023. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in US Treasury bills.
Current wording
For the three months ended June 30, 2024, other income increased $0.1 million or 25.0% to $0.5 million from $0.4 million for the three months ended June 30, 2023. 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, 2024, the Company incurred losses from operations of $5.5 million and used $3.6 million cash in operating activities. The net cash used in operating activities during the 2024 period decreased by $1.5 million from $5.1 million for the quarter ended March 31, 2023.
Current wording
For the six-months ended June 30, 2024, the Company incurred a net loss of $9.9 million and used $7.5 million cash in operating activities. The net cash used in operating activities during the 2024 period decreased by $2.2 million from $9.7 million for the six months ended June 30, 2023.
Previous wording
The losses and the uses of cash are primarily due to the Company’s administrative and product research and development activities. Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as internal administrative functions. Research and development activities are for continued product development and clinical trials for our product candidates, currently the VenoValve and enVVe. The Company will continue to incur these costs, and anticipates these costs will increase, as the Company works to complete its clinical trials, enhance products, develop new products, bring those products to market, and operate as a public company. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize one or more of our product candidates.
Current wording
The losses and the uses of cash are primarily due to the Company’s administrative and product research and development activities. Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as internal administrative functions. Research and development activities are for continued product development and clinical trials for our product candidates, currently the VenoValve and enVVe. The Company will continue to incur these costs, and expects costs will increase, as the Company works to complete its clinical trials, enhance products, develop new products, expand its organization to bring those products to market, and operate as a public company. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize one or more of our product candidates.
Previous wording
We have historically funded our operations through financing activities, such as the capital raise completed in 2023, and will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.
Current wording
We have historically funded our operations through financing activities and will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
For the six months ended June 30, 2024, other income increased $0.3 million to $1.0 million from $0.7 million for the six months ended June 30, 2023. Other income in both periods reflects realized gains, interest, and unrealized gains from our program to invest excess cash in U.S. bills.