What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-08-03 compared with 2022-04-29 · 104 added, 62 removed, 173 unchanged (49% of the section changed)

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VenoValve is a porcine based valve developed at enVVeno Medical to be implanted in the deep venous system of the leg to treat severe

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 current version of the VenoValve is designed to be implanted into the femoral vein of the patient in an open surgical procedure via

a 5-to-6-inch incision in the upper thigh.

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.

version of the VenoValve is designed to be implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch

incision in the upper thigh.

are presently no FDA approved medical devices to address valvular incompetence in the deep venous system, or effective treatments for

deep venous CVI.

Current treatment options include compression garments, or constant leg elevation, and wound care for venous

These treatments are generally ineffective, as they attempt to alleviate the symptoms of CVI without addressing the underlying

causes of the disease.

In addition, we believe compliance with compression garments and leg elevation is extremely low, especially among

Current treatment options include compression garments, or constant leg elevation, and wound care for venous ulcers.

These treatments are generally ineffective, as they attempt to alleviate the symptoms of CVI without addressing the underlying causes

of the disease.

In addition, we believe compliance with compression garments and leg elevation is extremely low, especially among the

The premise behind the VenoValve is that by reducing the underlying causes of CVI, reflux and venous hypertension, the debilitating

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preparation for the VenoValve U.S.

pivotal trial, on March 5, 2021, we submitted an IDE application with the FDA.

investigational device exemption or IDE from the FDA is required before a medical device company can proceed with a pivotal trial for

a class III medical device.

On April 1, 2021, we received notification from the FDA that our IDE application was approved.

We have named

pivotal trial for the VenoValve the SAVVE (Surgical Anti-reflux Veno Valve Endoprosthesis) study.

It is a prospective, non-blinded,

single arm, multi-center study of seventy-five (75) CVI patients to be enrolled at up to twenty (20) U.S.

pivotal trial, on March 5, 2021, we submitted an investigational device exemption or IDE application

with the FDA.

IDE from the FDA is required before a medical device company can proceed with a pivotal trial for a class III medical device.

1, 2021, we received notification from the FDA that our IDE application was approved.

We have named the U.S.

pivotal trial for the VenoValve

the SAVVE (Surgical Anti-reflux Veno Valve Endoprosthesis) study.

It is a prospective, non-blinded, single arm, multi-center study of

seventy-five (75) CVI patients to be enrolled at up to twenty (20) U.S.

product modifications for the VenoValve were necessary following the first-in-human study and the SAVVE trial is evaluating the same

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staff being reassigned to cover the shortfall.

The lack of available clinical personnel both slows enrollment and impacts the speed at

which we can activate clinical sites.

This lack of available clinical personnel continues to slow enrollment at

our clinical sites.

COVID impacts our patient population.

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We finished 2021 with approximately $55 million of cash and had approximately $9.1

million of cash at March 31, 2022.

At our existing cash burn rate of approximately $4 million per quarter, we should have sufficient

cash to fund operations through the end of 2024 and into 2025.

With primary endpoints following full enrollment in the SAVVE pivotal

trial of thirty (30) days for safety, and six (6) months for effectiveness, we expect to have primary endpoint data well in advance of

the need to raise additional capital.

million of cash and $38.1 million of investments at June 30, 2022.

At our existing cash burn rate of approximately $4 million per quarter,

we should have sufficient cash to fund operations through the end of 2024 and into 2025.

With primary endpoints following full enrollment

in the SAVVE pivotal trial of thirty (30) days for safety, and six (6) months for effectiveness, we expect to have primary endpoint data

well in advance of the need to raise additional capital.

of Operations

of the three months ended March 31, 2022 and 2021

reported net losses of $5.3 million and $2.8 million for the three months ended March 31, 2022 and 2021, respectively, representing an

increase in net loss of $2.5 million, or 89%, resulting from an increase in operating expenses.

of the three months ended June 30, 2022 and 2021

We reported net losses of $7.1

million and $2.4 million for the three months ended June 30, 2022 and 2021, respectively, representing an increase in net loss of $4.7

million, or 197%, resulting from an increase in operating expenses and other expenses.

a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product

We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our

lead product candidate.

We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead

product candidate.

General and Administrative Expenses

the three months ended March 31, 2022, selling, general and administrative expenses increased by $2.6 million or 222%, to $3.8 million

from $1.2 million for the three months ended March 31, 2021.

Of this increase, $2.1 million was due to share based compensation from

grants made during 2021, which increased share-based compensation cost to $2.2 million in 2022 from $0.1 million in 2021.

the three months ended June 30, 2022, selling, general and administrative expenses increased by $2.6 million or 202%, to $3.9 million

from $1.3 million for the three months ended June 30, 2021.

Of this increase, $2.1 million was due to share based compensation from grants

made during 2021, which increased share-based compensation cost to $2.3 million in 2022 from $0.2 million in 2021.

remaining $0.5 million increase reflects $0.2 million from consulting for reimbursement codes for the Company’s product once commercially

approved, $0.1 million from higher Delaware franchise taxes in 2022 which increased due to changes in our capital structure, $0.1 million

from higher information technology and other office expense to support increases in staff, and $0.1 million in higher insurance premiums

related to our D&O, cyber security and product liability insurance coverages.

from higher information technology and other office expense to support increases in staff, and $0.1 million in compensation due to increased

and Development Expenses

the three months ended March 31, 2022, research and development expenses decreased by $0.1 million or 5%, to $1.5 million from $1.6 million

for the three months ended March 31, 2021.

This decrease primarily resulted from $0.3 million in costs related the Coreograft

product development in 2021, which we did not incur in 2022 due the change in our strategic direction and decision to focus on development

of the VenoValve, partially offset by a $0.2 million increase in lab and personnel costs to support the VenoValve pivotal trial and continued

the three months ended June 30, 2022, research and development expenses increased by $2.0 million or 182%, to $3.1 million from $1.1

million for the three months ended June 30, 2021.

This increase primarily resulted from $1.4 million in costs related the SAVVE

study, $0.4 million in lab costs to support the SAVVE study and VenoValve continued development, $0.1 million increase in personnel

costs due to additional staff, and $0.1 million in travel costs mainly to support the SAVVE study.

Other (Income) Expense

For the three months

ended June 30, 2022 other (income) expense increased $0.1 million from nil for the three months ended June 30, 2021.

This change is

primarily related to unrealized loss from investments which reflects changes in market value of the US Treasuries purchased by the

We expect the market value of these investments to fluctuate somewhat during their term, however all these Treasuries were

purchased to provide a positive yield over their term.

of the six months ended June 30, 2022 and 2021

We reported net losses of $12.4

million and $5.2 million for the six months ended June 30, 2022 and 2021, respectively, representing an increase in net loss of $7.2 million

or 141%, due to an increase in operating expenses of $7.1 million and an increase in other income and expense of $0.1 million.

General and Administrative Expenses

the six months ended June 30, 2022, selling, general and administrative expenses increased $5.2 million or 211%, to $7.7 million from

$2.5 million for the six months ended June 30, 2021.

Of this increase, $4.2 million was due to share based compensation from grants made

during 2021, which increased share-based compensation cost to $4.5 million in 2022 from $0.3 million in 2021.

The remaining $1.0 million increase

in expenses is attributable to $0.3 million of consulting costs for reimbursement codes for the Company’s product to be used once

the product is commercially approved, if ever, $0.2 million from higher legal costs mainly related to intellectual property, $0.2 million

from higher Delaware franchise taxes in 2022 which increased due to changes in our capital structure, $0.2 million from higher information

technology and other office expense to support increases in staff and $0.1 million from higher insurance costs related to increased coverages

for cyber risks and higher a D&O insurance premium.

and Development Expenses

the six months ended June 30, 2022, research and development expenses increased by $1.9 million or 70%, to $4.6 million from $2.7 million

for the six months ended June 30, 2021.

increase primarily resulted from $1.5 million in costs related the SAVVE study, $0.1 million in lab costs to support the SAVVE study

and VenoValve continued development, $0.1 million increase in personnel costs due to additional staff, $0.1 million in travel costs to

support the SAVVE study, and $0.1 million in costs for the preparing regulatory submissions related to SAVVE.

Other (Income) Expense

For the six months ended June 30, 2022 other (income) expense increased

$0.1 million from nil for the six months ended June 30, 2021.

This change is primarily related to unrealized loss from investments

which reflects changes in market value of the US Treasuries purchased by the Company.

We expect the market value of these investments

to fluctuate somewhat during their term, however all these Treasuries were purchased to provide a positive yield over their term.

and Capital Resources

the three-months ended March 31, 2022, the Company incurred losses from operations of $5.3 million and used $3.3 million cash in operating

The net cash used in operating activities during the 2022 period decreased by $0.5 from $3.8 million for the quarter ended

March 31, 2021.

the six-months ended June 30, 2022, the Company incurred losses from operations of $12.4 million and used $7.3 million cash in operating

The net cash used in operating activities during the 2022 period increased by $0.8 from $6.5 million for the six-months ended

June 30, 2021.

losses and the uses of cash are primarily due to the Company’s administrative and product research and development activities.

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Research and development activities are for continued product development and clinical trials for

the VenoValve.

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 lead product candidate.

We are not currently

generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate.

the VenoValve, currently primarily the SAVVE study.

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 lead product candidate.

We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate.

cash flows from investing activity have historically consisted of purchases of property and equipment for our lab and offices.

quarter ended March 31, 2022, we purchased $0.1 million of property and equipment consisting primarily of lab and test equipment.

We do not currently have material commitments for capital expenditures or other expenditures with the exception of 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 and plan for commercialization of the VenoValve.

during the period ending June 30, 2022, we commenced a program to invest excess cash in US Treasury bills.

In the six months ended June

30, 2022, we purchased $38.3 million of these investments and expect to continue investing as the treasury bills mature and as allowed

by the cash requirements of our operations.

Also, during the six months ending June 30, 2022, we purchased $0.1 million of property and

equipment consisting primarily of lab and test equipment.

do not currently have material commitments for capital expenditures or other expenditures with the exception of 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 and plan for

commercialization of the VenoValve.

Company has historically funded its operations through financing activities such as the capital raises completed in 2021.

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Our cash balance

as of March 31, 2022, is $51.3 million.

as of June 30, 2022, is $9.1 million.

In addition, we have $38.1 million in investments, for total cash and investments of $47.2 million.

future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials

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have a material adverse effect on us.

upon our cash and working capital as of March 31, 2022, we have sufficient capital resources to meet our obligations as they become due

upon our cash and working capital as of June 30, 2022, 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.

of April 28, 2022, we had a cash balance of $50.5 million.

As of August 1, 2022,

our cash balance was $5.5 million and our investment balance was $40.7 million.

COVID-19 pandemic continues to disrupt the global economy and has negatively impacted large populations including people and businesses

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product candidates.

The resurgence of COVID and the Omicron variant had both direct and indirect consequences on our clinical trial.

Several of our clinical sites put elective surgeries on hold and prohibited potential study subjects from coming to the hospital for

COVID with its variants continues to have both direct and indirect consequences on our clinical trial.

our clinical sites put elective surgeries on hold and prohibited potential study subjects from coming to the hospital for screening.

Further COVID resurgences put an enormous strain on all hospital resources including clinical staffs.

The lack of available

clinical personnel both slows enrollment and impacts the speed at which we can activate clinical sites.

The lack of available clinical

personnel both slows enrollment and impacts the speed at which we can activate clinical sites.

has also impacted our patient population.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis