ENVVENO MEDICAL CORPORATION As of
Note 3 - Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements have been prepared in
accordance with accounting principles generally accepted in
The results of operations for the three months ended
5
ENVVENO MEDICAL CORPORATION
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
Note 4 - Concentrations
The Company maintains cash with major financial institutions. Cash held in
Note 5 - Property and Equipment
As of
Schedule of Property and Equipment
(In thousands) March 31, December 31,
2023 2022
Laboratory equipment $ 524 $ 524
Furniture and fixtures 160 160
Computer equipment 227 222
Leasehold improvements 213 213
Software 251 251
Total property and equipment 1,375 1,370
Less: accumulated depreciation (903 ) (849 )
Property and equipment, net $ 472 $ 521
Depreciation expense amounted to
6
ENVVENO MEDICAL CORPORATION
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
Note 6 - Accounts Payable Accrued Expenses and Other Current Liabilities
As of
Schedule of Accrued Expenses and Other Current Liabilities
(In thousands) March 31, December 31,
2023 2022
Accounts payable $ 380 $ 648
Accrued compensation costs 362 391
Accrued professional fees 22 62
Accrued research and development - 56
Other accrued expenses 83 59
Total accrued expenses and other current liabilities
Note 7 - Commitments and Contingencies
Litigations Claims and Assessments
In the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.
Robert Rankin Complaints
On
The complaints assert several causes of action including a cause of action for
failure to timely pay
The Company has denied all claims in both matters (which have now been
consolidated) and has filed a counterclaim asserting that Rankin has breached
his employment agreement with the Company to the Company's damage. The Company
continues to believe it has meritorious defenses to both matters which are
currently set for trial on
As of the date of these financial statements, the amount of loss associated with
these complaints, if any, cannot be reasonably estimated. Accordingly, no
amounts related to these complaints are accrued as of
7
ENVVENO MEDICAL CORPORATION
NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)
Note 8 -Stockholders' Equity
Stock Options
From time to time, the Company issues options for the purchase of its common
stock to employees and others. The Company recognized
Note 9 - Net Loss per Share
The following table summarizes the number of potentially dilutive common stock
equivalents excluded from the calculation of diluted net loss per common share
as of
Schedule of Dilutive Net Loss Per Common Share
2023 2022
(In thousands) March 31,
2023 2022
Shares of common stock issuable upon exercise of
warrants 4,589 4,553
Shares of common stock issuable upon exercise of
options 4,206 3,454
Potentially dilutive common stock equivalents
excluded from diluted net loss per share 8,795 8,007
8
Item 2: MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion should be read in conjunction with our unaudited
condensed financial statements and notes thereto included herein. In connection
with, and because we desire to take advantage of, the "safe harbor" provisions
of the Private Securities Litigation Reform Act of 1995, we caution readers
regarding certain forward-looking statements in the following discussion and
elsewhere in this report and in any other statement made by, or on our behalf,
whether or not in future filings with the
Unless the context requires otherwise, references in this document to "NVNO",
"we", "our", "us" or the "Company" are to
Overview
The Company's lead product is the VenoValve®, which is a first-in-class surgical
replacement venous valve that is currently being evaluated in a
The VenoValve and enVVe are being developed first for approval by the
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 our products in a 14,507 sq.
ft. leased manufacturing facility in
9 CVI Background
Chronic venous disease ("CVD") is the world's most prevalent chronic disease. CVD is generally classified using a standardized system known as CEAP (clinical, etiological, anatomical, and pathophysiological). The CEAP system consists of seven clinical classifications (C0 to C6) with C4, C5 and C6 being the most severe categories of CVD.
Chronic Venous Insufficiency ("CVI") is a large subset of CVD and is generally used to describe patients with C4 to C6 CVD. CVI is a debilitating condition that affects the venous system of the leg causing pain, swelling, edema, skin changes, and ulcerations.
The human leg contains three vein systems: the deep vein system, the superficial vein system, and the perforator vein system which connects the deep system to the superficial system. The deep venous system is located below the muscle and facia in the center portion of the leg and is responsible for approximately 90% of the blood flow. In order for blood to return to the heart from the foot, ankle, and lower leg, the calf muscle serves as a pump and pushes the blood up the veins of the leg against gravity and through a series of one-way valves. Each valve is supposed to open as blood passes through, and then close as blood progresses up the veins of the leg to the next valve. CVI occurs when the one-way valves in the veins of the leg fail and become incompetent. When the valves fail, gravity causes the blood to flow backwards and in the wrong direction (reflux). As blood pools in the lower leg, pressure inside the veins increases (venous hypertension). Reflux, and the resulting venous hypertension, causes the leg to swell, resulting in debilitating pain, and in the most severe cases, venous ulcers.
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 patients 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.
Prevalence is generally defined as the portion of the population that has a
given condition. Estimates indicate that the prevalence of people in the
VenoValve
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. By reducing reflux and 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 with
severe deep venous CVI in the
VenoValve Clinical Status
After consultation with the FDA, and as a precursor to the
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, reflux improved an average of 54%, Venous Clinical Severity Scores ("VCSSs") improved an average of 56%, and visual analog scale (VAS) scores, which are used by patients to measure pain, improved an average of 76%, all at one (1) year when compared to pre-surgery levels. VCSS scores are commonly used by clinicians in practice and in clinical trials to objectively assess outcomes in the treatment of venous disease, and include ten characteristics including pain, inflammation, skin changes such as pigmentation and induration, the number of active ulcers, and ulcer duration. The improvement in VCSS scores is 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) fluid pocket (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.
On
In
At the end of the VenoValve first-in-human study, eight (8) study participants
agreed to additional monitoring. In November of 2022, three-year follow-up data
was presented at the 49th Annual VEITH Symposium in
10
In November of 2022, we announced we had passed a preliminary safety review by the FDA for the first twenty (20) patients enrolled in the SAVVE trial. The FDA had requested that we submit preliminary safety data at thirty (30) days post VenoValve implantation for the first twenty (20) patients enrolled in the study. The preliminary safety data included one (1) device related (mild) and two (2) procedure related (moderate) adverse events. After review by the FDA, the study was cleared to continue without modification or interruption.
As widely reported in the media, the lasting impact from the COVID-19 pandemic
has put an enormous strain on hospital resources including their clinical staff.
Hospitals continue to be severely understaffed, which impacts the rate at which
clinical trials enroll and progress. We have taken several steps to help address
the hospital staffing shortages, including our hiring of 4 Clinical
Technologists, with extensive and specialized experience in duplex sonography of
the deep venous system, to assist in training site personnel, proctoring
enVVe
On
Several parameters will be evaluated over the course of the study including safety and technical success of the enVVe venous valve delivery system, and the safety and clinical performance of the enVVe venous valve. enVVe is 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 are otherwise not good candidates for a surgical device, and estimate the U.S. market for enVVe to be approximately 3.5 million patients.
Capital
We finished 2022 with approximately
Intellectual Property
We possess an extensive proprietary processing and manufacturing methodology
specifically applicable to the design, processing, manufacturing and
sterilization of biologic devices. This includes FDA compliant quality control
and assurance programs, proprietary tissue processing technologies demonstrated
to eliminate recipient immune responses, trusted relationship with abattoir
suppliers, and a combination of tissue preservation and gamma irradiation that
enhances device functions and guarantees sterility. We have filed numerous
patent applications for the VenoValve with the
11 Results of Operations
Comparison of the three months ended
Overview
We reported net losses of
Revenues
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.
Selling, General and Administrative Expenses
For the three months ended
Research and Development Expenses
For the three months ended
Other Income
For the three months ended
Liquidity and Capital Resources
For the three-months ended
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 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 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.
Our cash flows from investing activity consist of maturities and purchases of
We do not currently have material commitments for capital expenditures or other
expenditures except for our facility lease commitment of
The Company has historically funded its operations through financing activities
such as the capital raises completed in 2021. Our cash and investments balances
as of
Based upon our cash and working capital as of
As of
The lasting impact from the COVID-19 pandemic has put an enormous strain on
hospital resources including their clinical staff. Hospitals continue to be
severely understaffed, which impacts the rate at which clinical trials enroll
and progress. We have taken several steps to help address the hospital staffing
shortages, including our hiring of 4 Clinical Technologists, with extensive and
specialized experience in duplex sonography of the deep venous system, to assist
in training site personnel, proctoring
12
Off-Balance Sheet Arrangements
None. Contractual Obligations
As a smaller reporting company, we are not required to provide the information requested by paragraph (a)(5) of this Item.
Critical Accounting Policies and Estimates
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.
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