enVVeno Medical Corp
For the period ended Sep 30, 2024. Filed Oct 31, 2024.
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, 2024 · Filed Oct 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 2024-06-30; filed 2024-07-31.
0001493152-24-029737
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-09-30; filed 2024-10-31.
0001493152-24-043100
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 67 previous paragraphs and 69 current paragraphs.
36 unchanged; 19 reworded; 13 added; 10 removed; 2 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 (13)
Current report
On October 28, 2024, we announced the successful start to a six-month pre-clinical GLP study for enVVe. The first wave of implants, for the long-term subjects, was successfully completed, with the final wave for the shorter-term subjects scheduled for December. The GLP study is a prerequisite to seeking IDE approval from the FDA to begin the enVVe U.S. pivotal study. The Company expects to file for IDE approval for the enVVe pivotal study in mid 2025.
Current report
On September 30, 2024, we closed a public offering raising approximately $13.6 million net cash proceeds. Based on management’s current expectations, this capital has the potential to fund the Company through several significant milestones, including the anticipated FDA pre-market approval of the VenoValve, the beginning of preparations for VenoValve commercialization, and the initial stages of the pivotal trial for enVVe. Although we expect our quarterly cash burn rate will increase over time to support these milestones, after the additional proceeds from our offering, we believe we have sufficient cash to fund operations past what we expect will be regulatory approval of the VenoValve and the start of the enVVe pivotal trial.
Current report
For the three months ended September 30, 2024, selling, general and administrative expenses increased by $0.7 million or 27%, to $3.3 million from $2.6 million for the three months ended September 30, 2023. This increase was due to a $0.2 million increase in consulting expense related to market research for the Company’s products, and a $0.7 million increase in legal costs, partially offset by a $0.1 million decrease in share-based compensation, and a $0.1 million decrease in travel expenses due to full enrollment of the SAVVE study during 2023 resulting in less travel to study sites in 2024.
Current report
Comparison of the nine months ended September 30, 2024 and 2023
Current report
Revenues
Current report
For the nine months ended September 30, 2024, research and development expenses decreased by $1.9 million or 18%, to $8.7 million from $10.6 million for the nine months ended September 30, 2023.
Current report
This decrease resulted from a $2.7 million reduction in costs related the SAVVE study as it reached full enrollment during the 2023 period requiring less study related enrollment activity during the 2024 period, partially offset by $0.8 million higher compensation cost due to increases in staffing.
Current report
For the nine months ended September 30, 2024, selling, general and administrative expenses of $8.4 million were flat when compared to the nine months ended September 30, 2023. This is due to $1.0 million in lower share-based compensation from the reduction in expense from grants made during 2021, the cost for portions of which have been fully recognized, a $0.1 million decrease in travel expenses due to full enrollment of the SAVVE study during 2023 resulting in less travel to study sites in 2024, partially offset by $0.8 million in higher legal cost and a $0.3 million increase in consulting expense related to market research for the Company’s products.
Current report
Other Income
Current report
Our cash flows from investing activity consist of maturities and purchases of US Treasury bills from our program to invest excess cash, and purchases of property and equipment for our lab and offices. During the nine months ended September 30, 2024 we purchased $33.4 million of treasury bills and $45.8 million of them matured generating $1.4 million in realized gains and interest income. We expect to continue investing as the treasury bills mature and as allowed by the cash requirements of our operations. In the nine months ended September 30, 2024, our purchases of property and equipment consisting primarily of lab and test equipment, were less than $0.1 million.
Current report
As of October 28, 2024, we had cash and investments of $47.1 million.
Current report
Critical Accounting Policies and Estimates
Current report
For a description of our critical accounting policies, see Note 3 – Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.
Removed paragraphs (10)
Previous report
After consultation with the FDA, and as a precursor to the U.S. pivotal trial, in 2020 we conducted a small first-in-human study for the VenoValve in Colombia which included eleven (11) patients. The purpose of the first-in-human study was to provide proof of concept, and to provide feedback to make any necessary product modifications or adjustments to our surgical implantation procedure for the VenoValve prior to conducting the VenoValve pivotal trial.
Previous report
Results from the one year first-in-human study were presented at the Charing Cross International Symposium in April of 2021. Among the eleven (11) patients in the study, revised Venous Clinical Severity Scores (rVCSS) scores improved an average of 6 points, and patients also experienced significant improvements in pain (measured via visual analog scale (“VAS”) scores), and quality of life (measured by Veines sym/qol) all at one (1) year when compared to pre-surgery levels. Revised Venous Clinical Severity Scoring (rVCSS) is a validated measurement commonly used to objectively assess outcomes in the treatment of venous disease, and include ten characteristics consisting of physician assessments and patient reported outcomes including pain, inflammation, skin changes such as pigmentation and induration, the number of active ulcers, and ulcer duration. The improvement in VCSS scores was significant and indicates the VenoValve patients who had severe CVI pre-surgery, had mild CVI or the complete absence of disease at one-year post surgery. Related safety incidences during the one year first-in-human study for the VenoValve included one (1) surgical pocket hematoma (anti-coagulation related bleeding outside of the target vein within the surgical cavity), which was aspirated, intolerance from Coumadin anticoagulation therapy, three (3) minor wound infections (treated with antibiotics), and one occlusion due to patient non-compliance with anti-coagulation therapy.
Previous 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.
Previous report
Initial bench testing and acute pre-clinical testing for the enVVe valve were very successful. Adjustments to make it easier to load the enVVe valve into the enVVe delivery system are being finalized and the Company is currently manufacturing the necessary enVVe valves and enVVe delivery systems to begin a six-month chronic GLP study, which the Company expects to start in Q4 of 2024. The GLP study should be the final step necessary before filing for IDE approval to begin the enVVe pivotal study, which the Company expects to file in Q2 of 2025.
Previous report
Results of Operations
Previous 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.
Previous report
Comparison of the six months ended June 30, 2024 and 2023
Previous 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.
Previous 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.
Previous report
Other (Income) Expense
Reworded paragraphs (19)
Previous wording
The Company’s lead product is the VenoValve®, which is a potential first-in-class surgical replacement venous valve that is currently being evaluated in a U.S. pivotal study called the SAVVE trial (Surgical Anti-reflux Venous Valve Endoprosthesis). To date, patients in our SAVVE trial have indicated in testimonials to the Company that they have experienced reduced pain and enhanced quality of life as a result of the VenoValve.
Current wording
The Company’s lead product is the VenoValve®, which is a potential first-in-class surgical replacement venous valve that is currently being evaluated in a U.S. pivotal study called the SAVVE trial (Surgical Anti-reflux Venous Valve Endoprosthesis). Definitive one year data from SAVVE is expected to be released in the fourth quarter of 2024.
Previous 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.
Current wording
The Company is also developing the next generation replacement venous valve called enVVe®, which will be delivered via transcatheter as opposed to an open surgery. 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 in mid 2025.
Previous 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.
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 approximately 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
Severe CVI sufferers experience a significantly reduced quality of life. Daily activities such as preparing meals, housework, and personal hygiene (washing and bathing) become difficult due to reduced mobility. For many severe CVI sufferers, intense pain, which frequently occurs at night, prevents them from getting adequate sleep. Severe CVI sufferers are known to miss approximately 40% more workdays than the average worker. A high percentage of venous ulcer patients also experience severe itching, leg swelling, and an odorous discharge. Wound dressing changes, which occur several times a week, can be extremely painful. Venous ulcers from deep venous CVI are very difficult to heal, and a significant percentage of venous ulcers remain unhealed for more than a year. Even if healed, recurrence rates for venous ulcers are known to be high (20% to 40%) within the first year and as high as 60% after five years. Patients with severe CVI often become housebound and experience social isolation due to difficulty with ambulation. As a result, studies have shown that patients with active venous ulcers experience higher rates of anxiety and depression, with reported rates of anxiety of up to 30% and depression up to 40%. Rates of depression caused by venous ulcers among the elderly are even higher, with 48% of elderly venous ulcer patients having severe depressive symptoms.
Current wording
Severe CVI sufferers experience a significantly reduced quality of life. Daily activities such as preparing meals, housework, dressing, and personal hygiene (washing and bathing) become difficult due to reduced mobility. For many severe CVI sufferers, intense pain, which frequently occurs at night, prevents them from getting adequate sleep. Severe CVI sufferers are known to miss approximately 40% more workdays than the average worker. A high percentage of venous ulcer patients also experience severe itching, leg swelling, and an odorous discharge. Wound dressing changes, which occur several times a week, can be extremely painful. Venous ulcers from deep venous CVI are very difficult to heal, and a significant percentage of venous ulcers remain unhealed for more than a year. Even if healed, recurrence rates for venous ulcers are known to be high (20% to 40%) within the first year and as high as 60% after five years. Patients with severe CVI often become housebound and experience social isolation due to difficulty with ambulation. As a result, studies have shown that patients with active venous ulcers experience higher rates of anxiety and depression, with reported rates of anxiety of up to 30% and depression up to 40%. Rates of depression caused by venous ulcers among the elderly are even higher, with 48% of elderly venous ulcer patients having severe depressive symptoms.
Previous wording
The VenoValve is a porcine based replacement venous valve developed at enVVeno Medical to be surgically implanted in the deep venous system of the leg to treat severe CVI caused by valvular incompetence. By lowering pressure (venous hypertension) within the deep venous system of the leg, the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal recurring venous leg ulcers. The VenoValve is implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch incision in the upper thigh. As our planned initial entrant to the replacement venous valve market, we estimate that approximately 2.5 million people each year with severe deep venous CVI in the U.S. would be candidates for the VenoValve. The VenoValve has been granted Breakthrough Device designation by the FDA.
Current wording
The VenoValve is a replacement venous valve developed at enVVeno Medical to be surgically implanted in the deep venous system of the leg to treat severe CVI caused by valvular incompetence. By lowering pressure (venous hypertension) within the deep venous system of the leg, the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal recurring venous leg ulcers. The VenoValve is implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch incision in the upper thigh. As our planned initial entrant to the replacement venous valve market, we estimate that approximately 2.5 million people each year with severe deep venous CVI in the U.S. would be candidates for the VenoValve. The VenoValve has been granted Breakthrough Device designation by the FDA.
Previous wording
We achieved full enrollment of 75 subjects in the SAVVE trial on September 1, 2023, having enrolled eighteen (18) patients over the final two (2) months of the study. Full enrollment occurred approximately four (4) months earlier than expected due to increased demand for the VenoValve.
Current wording
We achieved full enrollment of 75 subjects in the SAVVE trial on September 1, 2023, having enrolled eighteen (18) patients over the final two (2) months of the study.
Previous wording
With the FDA indicating that one-year data for all 75 patients will be necessary prior to the filing of the application seeking pre-market approval (“PMA”) for the VenoValve, the Company expects to file the PMA application seeking approval in Q4 of 2024.
Current wording
The FDA has indicated that one-year data on all patients will be necessary prior to completing the application seeking pre-market approval (“PMA”) for the VenoValve. On August 14, 2024, the Company announced it had filed and the FDA had approved four of the required five modules of its PMA application. The Company expects to file the fifth and final module of its PMA application in Q4 of 2024.
Previous wording
On September 21, 2022, we announced the development of a non-surgical transcatheter based replacement venous valve called enVVe®, for the treatment of CVI of the deep veins of the leg. The enVVe system consists of the enVVe replacement venous valve, the enVVe delivery system, and the delivery system accessories. enVVe is designed to be delivered into the femoral vein of the patient via a minimally invasive procedure requiring no general anesthesia and no overnight hospital stay. Due to the minimally invasive nature of the procedure, we expect to be able to reach patients with less severe CVI or who may otherwise be poor candidates for a surgical device, and estimate the U.S. market for enVVe to be approximately 3.5 million patients.
Current wording
On September 21, 2022, we announced the development of a non-surgical transcatheter based replacement venous valve called enVVe®, for the treatment of CVI of the deep veins of the leg. enVVe is designed to be delivered into the femoral vein of the patient via a minimally invasive procedure requiring no general anesthesia and no overnight hospital stay. Due to the minimally invasive nature of the procedure, we expect to be able to reach patients with less severe CVI or who may otherwise be poor candidates for a surgical device, and estimate the U.S. market for enVVe to be approximately 3.5 million patients.
Previous 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.
Current wording
We finished 2023 with approximately $46.4 million of cash and investments and had approximately $48.4 million of cash and investments at September 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 $6.5 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.
Current wording
We reported net losses of $5.6 million and $5.0 million for the three months ended September 30, 2024 and 2023, respectively, representing an increase in net loss of $0.6 million or 12%, due to an increase in operating expenses of $0.8 million, and an increase in other income of $0.2 million.
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 lead product candidate.
Current wording
As a developmental stage Company, we are not currently generating revenue and our future revenue, if any, is expected to be diminutive in the near future and dependent on our ability to commercialize our product candidates.
Previous 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.
Current wording
For the three months ended September 30, 2024, research and development expenses increased by $0.1 million or 2%, to $2.9 million from $2.8 million for the three months ended September 30, 2023. This increase primarily resulted from $0.2 million in increased personnel costs to support the SAVVE study and enVVe development, partially offset by a $0.1 million decrease in lab costs.
Previous 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.
Current wording
For the three months ended September 30, 2024, other income increased $0.2 million or 52.0% to $0.5 million from $0.3 million for the three months ended September 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
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 wording
We reported net losses of $15.6 million and $17.9 million for the nine months ended September 30, 2024 and 2023, respectively, representing a decrease in net loss of $2.3 million, or 13%, due to a decrease in operating expenses of $1.8 million, and an increase in other income of $0.4 million.
Previous wording
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.
Current wording
For the nine months ended September 30, 2024, other income increased $0.4 million to $1.5 million from $1.1 million for the nine months ended September 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.
Previous 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.
Current wording
For the nine-months ended September 30, 2024, the Company incurred a net loss of $15.6 million and used $11.7 million cash in operating activities. Net cash used in operating activities for the period ended September 30, 2024 decreased by $2.2 million from $13.9 million for the period ended September 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 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.
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, readying for commercial development of its lead product candidate in the event of receiving PMA approval from the FDA, and 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 to complete its clinical trials, enhance products, develop new products, and operate as a public company. Although we have discretion in how we use the Company’s cash resources, we expect to continue these activities for the foreseeable future as we seek to develop and obtain regulatory approval for our product candidates. 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 do not currently have material commitments for capital expenditures or other expenditures except for our facility lease commitment of $0.4 million per year. However, we expect a modest increase in purchases of property and equipment as we continue the SAVVE study, plan for commercialization of the VenoValve and continue development of enVVe.
Current wording
We do not currently have material commitments for capital expenditures or other expenditures except for our facility lease commitment of $0.4 million per year. However, we expect a modest increase in purchases of property and equipment as we continue SAVVE, plan for commercialization of the VenoValve and continue development of enVVe. 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.
Previous 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.
Current wording
We have historically funded our operations through financing activities. On September 30, 2024, we closed an offering issuing stock and warrants and raising approximately $13.6 million net cash proceeds. Based upon our cash and working capital as of September 30, 2024 we have sufficient capital resources to meet our obligations as they become due for at least one year after the date of this Report and sustain operations, although we expect to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain our operations, pursue our product development initiatives and penetrate markets for the sale of our products. Any inability to raise additional financing in the foreseeable future would have a material adverse effect on us.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
As a developmental stage Company, we are not currently generating revenue and our future revenue, if any, is expected to be diminutive in the near future and dependent on our ability to commercialize our product candidates.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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 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 report — wording carried elsewhere
Based on our cash and working capital as of June 30, 2024, we have sufficient capital resources to meet our obligations as they become due for at least one year after the date of this Quarterly Report and sustain operations.