STOCK TITAN
  1. Home
  2. Sec-filings
  3. NVNO
  4. [10-Q] enVVeno Medical Corp Quarterly Earnings Report

FDA IDE pivotal trial and 2027 cash runway for enVVeno Medical (NASDAQ: NVNO)

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
10-Q

Rhea-AI Filing Summary

enVVeno Medical Corporation develops the enVVe System, a first-in-class transcatheter replacement venous valve for patients with severe Chronic Venous Insufficiency. In April 2026, the FDA granted Investigational Device Exemption (IDE) approval for the TAVVE pivotal study, a two-stage trial of 230 patients at up to 40 U.S. sites that could support an FDA post-marketing submission one year after the 220th enrollment in stage two.

For the quarter ended June 30, 2026, enVVeno reported a net loss of $3.6 million, down from $6.7 million a year earlier, as operating expenses fell on lower VenoValve study costs and reduced stock-based compensation. Six-month net loss was $7.4 million versus $11.2 million. Cash and investments totaled $21.5 million with working capital of $20.2 million, and the company states these resources should fund operations into the third quarter of 2027, though it expects quarterly cash burn to rise to $4–$5 million in the second half of 2026 and acknowledges it will need additional capital over time.

Positive

  • FDA IDE approval for TAVVE pivotal study enables a 230-patient U.S. trial of the enVVe System, creating a defined clinical pathway that could support an FDA post-marketing submission after completion of enrollment and follow-up.
  • Substantially lower losses and expenses: Q2 2026 net loss fell to $3.6 million from $6.7 million (a 46% decrease), driven by a $3.3 million reduction in operating expenses versus Q2 2025.
  • Extended cash runway: With $21.5 million in cash and investments and $20.2 million in working capital as of June 30, 2026, the company projects funding sufficiency into the third quarter of 2027.

Negative

  • Continuing operating losses and no revenue: As a development-stage company, enVVeno generated no product revenue and recorded a six-month net loss of $7.4 million, with expectations of ongoing losses.
  • Rising future cash burn and financing need: Management anticipates quarterly cash use increasing to $4–$5 million in the second half of 2026 and explicitly states it will need to raise additional capital, noting failure to do so would have a material adverse effect.
Cash and investments $21.5 million Cash and investment balance as of June 30, 2026
Working capital $20.2 million Working capital as of June 30, 2026
Q2 2026 net loss $3.6 million Net loss for the three months ended June 30, 2026
Six-month 2026 net loss $7.4 million Net loss for the six months ended June 30, 2026
Q2 2026 R&D expense $2.1 million Research and development expenses for the quarter ended June 30, 2026
Q2 2026 SG&A expense $1.7 million Selling, general and administrative expenses for the quarter ended June 30, 2026
Cash used in operations $6.8 million Net cash used in operating activities for the six months ended June 30, 2026
Shares outstanding 682,722 shares Common stock outstanding as of July 28, 2026
Investigational Device Exemption regulatory
"In April 2026, the U.S. Food and Drug Administration awarded the Company an Investigational Device Exemption"
An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.
pivotal study medical
"The Transcatheter Venous Valve Endoprosthesis pivotal study will evaluate the Company’s minimally invasive enVVe System"
A pivotal study is a large, definitive clinical trial designed to show whether a medical product works and is safe enough for regulators to approve and for doctors to use. Think of it as the final exam that determines whether a drug or device moves from testing into the market; its results can dramatically change a company’s approval chances, future sales prospects, and therefore its stock value.
at-the-market equity program financial
"shares of common stock issued during the three and six months ended June 30, 2026 under our at-the-market equity program"
An at-the-market equity program lets a company sell newly issued shares directly into the open market at the current trading price through a broker, rather than in a single, prearranged block. It provides flexible, on-demand access to cash—like drawing small amounts from a credit line—but increases the number of shares outstanding, which can reduce existing shareholders’ ownership percentage and put downward pressure on the stock price, so investors monitor program size and pacing.
reverse stock split financial
"approved a one-for-thirty-five reverse stock split of the outstanding shares of our common stock"
A reverse stock split reduces a company's number of outstanding shares while raising the price per share proportionally, so the total value of each investor's holding is unchanged; a 1-for-10 split turns 100 shares worth $1 each into 10 shares worth $10 each. Companies often do this to regain compliance with an exchange's minimum price rule or to attract investors who avoid very low-priced stocks.
Chronic Venous Insufficiency medical
"developing a replacement venous valve for patients suffering from severe Chronic Venous Insufficiency"
A long-term condition in which the one-way valves in leg veins do not work properly, causing blood to pool, swelling, pain, skin changes or ulcers; think of it as a plumbing problem where backflow wears out pipes and fixtures. Investors care because it is a common, chronic market with ongoing demand for treatments, devices and wound-care products, and outcomes depend on clinical data, regulatory approvals and reimbursement decisions that affect revenue streams.
Q2 2026 net loss $3.6 million Decreased by $3.1 million, or 46%, compared with Q2 2025
Six-month 2026 net loss $7.4 million Decreased by $3.8 million, or 33%, compared with the six months ended June 30, 2025
Q2 2026 operating expenses $3.8 million Decreased by $3.3 million versus the three months ended June 30, 2025
Six-month 2026 operating expenses $7.9 million Decreased by $4.2 million versus the six months ended June 30, 2025
Guidance

The company states its cash burn rate may increase from approximately $3–$4 million per quarter to between $4 million and $5 million per quarter in the second half of 2026 and that it expects existing cash and investments to fund operations into the third quarter of 2027.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
10-Q Quarterly Reports: What Changes Quarter to Quarter →

FAQ

What was enVVeno Medical’s (NVNO) net loss for Q2 2026?
enVVeno reported a net loss of $3.6 million for the three months ended June 30, 2026, compared with $6.7 million in Q2 2025, reflecting a 46% decrease driven mainly by lower research and development and selling, general and administrative expenses.

How much cash and runway does enVVeno Medical (NVNO) have as of June 30, 2026?
As of June 30, 2026, enVVeno held $21.5 million in cash and investments and $20.2 million of working capital. The company states these resources should fund operations into the third quarter of 2027, assuming its projected spending levels.

What is the status of enVVeno Medical’s (NVNO) enVVe System and TAVVE pivotal study?
In April 2026, enVVeno received FDA IDE approval to start the TAVVE pivotal study of the enVVe System. The trial will enroll 230 patients in two stages at up to 40 U.S. sites, comparing enVVe-treated patients with a standard-of-care control arm.

Does enVVeno Medical (NVNO) generate revenue yet?
No. enVVeno is a development-stage medical device company and is not currently generating revenue. Management does not expect significant revenue until it can successfully commercialize its lead product candidate after obtaining FDA approval, if such approval is achieved.

How are enVVeno Medical’s (NVNO) operating expenses changing?
For Q2 2026, research and development expense fell to $2.1 million and selling, general and administrative expense to $1.7 million, driven by lower VenoValve study costs, reduced stock-based compensation, and non-recurring items present in 2025 but not in 2026.

What cash burn does enVVeno Medical (NVNO) expect going forward?
Management states that current cash burn is about $3–$4 million per quarter and anticipates it may rise to $4–$5 million per quarter in the second half of 2026 as the enVVe System pivotal study progresses.

How many shares of enVVeno Medical (NVNO) are outstanding?
As of June 30, 2026, the company had 673,000 shares of common stock issued and outstanding, and it reports 682,722 shares outstanding as of July 28, 2026, reflecting minor issuance under its at-the-market equity program.
false --12-31 Q2 0001661053 0001661053 2026-01-01 2026-06-30 0001661053 2026-07-28 0001661053 2026-06-30 0001661053 2025-12-31 0001661053 2026-04-01 2026-06-30 0001661053 2025-04-01 2025-06-30 0001661053 2025-01-01 2025-06-30 0001661053 us-gaap:CommonStockMember 2026-03-31 0001661053 us-gaap:AdditionalPaidInCapitalMember 2026-03-31 0001661053 us-gaap:RetainedEarningsMember 2026-03-31 0001661053 2026-03-31 0001661053 us-gaap:CommonStockMember 2025-03-31 0001661053 us-gaap:AdditionalPaidInCapitalMember 2025-03-31 0001661053 us-gaap:RetainedEarningsMember 2025-03-31 0001661053 2025-03-31 0001661053 us-gaap:CommonStockMember 2025-12-31 0001661053 us-gaap:AdditionalPaidInCapitalMember 2025-12-31 0001661053 us-gaap:RetainedEarningsMember 2025-12-31 0001661053 us-gaap:CommonStockMember 2024-12-31 0001661053 us-gaap:AdditionalPaidInCapitalMember 2024-12-31 0001661053 us-gaap:RetainedEarningsMember 2024-12-31 0001661053 2024-12-31 0001661053 us-gaap:CommonStockMember 2026-04-01 2026-06-30 0001661053 us-gaap:AdditionalPaidInCapitalMember 2026-04-01 2026-06-30 0001661053 us-gaap:RetainedEarningsMember 2026-04-01 2026-06-30 0001661053 us-gaap:CommonStockMember 2025-04-01 2025-06-30 0001661053 us-gaap:AdditionalPaidInCapitalMember 2025-04-01 2025-06-30 0001661053 us-gaap:RetainedEarningsMember 2025-04-01 2025-06-30 0001661053 us-gaap:CommonStockMember 2026-01-01 2026-06-30 0001661053 us-gaap:AdditionalPaidInCapitalMember 2026-01-01 2026-06-30 0001661053 us-gaap:RetainedEarningsMember 2026-01-01 2026-06-30 0001661053 us-gaap:CommonStockMember 2025-01-01 2025-06-30 0001661053 us-gaap:AdditionalPaidInCapitalMember 2025-01-01 2025-06-30 0001661053 us-gaap:RetainedEarningsMember 2025-01-01 2025-06-30 0001661053 us-gaap:CommonStockMember 2026-06-30 0001661053 us-gaap:AdditionalPaidInCapitalMember 2026-06-30 0001661053 us-gaap:RetainedEarningsMember 2026-06-30 0001661053 us-gaap:CommonStockMember 2025-06-30 0001661053 us-gaap:AdditionalPaidInCapitalMember 2025-06-30 0001661053 us-gaap:RetainedEarningsMember 2025-06-30 0001661053 2025-06-30 0001661053 NVNO:BoardOfDirectorsMember 2026-01-02 2026-01-02 0001661053 us-gaap:FairValueInputsLevel1Member us-gaap:USGovernmentDebtSecuritiesMember us-gaap:DebtSecuritiesMember 2026-06-30 0001661053 us-gaap:FairValueInputsLevel1Member us-gaap:USGovernmentDebtSecuritiesMember us-gaap:DebtSecuritiesMember 2025-12-31 0001661053 us-gaap:FairValueInputsLevel1Member NVNO:InsuredMoneyMarketAccountMember us-gaap:DebtSecuritiesMember 2026-06-30 0001661053 us-gaap:FairValueInputsLevel1Member NVNO:InsuredMoneyMarketAccountMember us-gaap:DebtSecuritiesMember 2025-12-31 0001661053 us-gaap:FairValueInputsLevel1Member us-gaap:DebtSecuritiesMember 2026-06-30 0001661053 us-gaap:FairValueInputsLevel1Member us-gaap:DebtSecuritiesMember 2025-12-31 0001661053 us-gaap:EmployeeStockOptionMember 2026-04-01 2026-06-30 0001661053 us-gaap:EmployeeStockOptionMember 2025-04-01 2025-06-30 0001661053 us-gaap:EmployeeStockOptionMember 2026-01-01 2026-06-30 0001661053 us-gaap:EmployeeStockOptionMember 2025-01-01 2025-06-30 0001661053 us-gaap:EmployeeStockOptionMember 2026-06-30 0001661053 us-gaap:WarrantMember 2026-04-01 2026-06-30 0001661053 us-gaap:WarrantMember 2026-01-01 2026-06-30 0001661053 us-gaap:WarrantMember 2025-04-01 2025-06-30 0001661053 us-gaap:WarrantMember 2025-01-01 2025-06-30 0001661053 us-gaap:WarrantMember 2026-01-01 2026-06-30 0001661053 us-gaap:WarrantMember 2025-01-01 2025-06-30 0001661053 us-gaap:EmployeeStockOptionMember 2026-01-01 2026-06-30 0001661053 us-gaap:EmployeeStockOptionMember 2025-01-01 2025-06-30 0001661053 NVNO:EmployeeExpenseMember 2026-04-01 2026-06-30 0001661053 NVNO:EmployeeExpenseMember 2025-04-01 2025-06-30 0001661053 NVNO:EmployeeExpenseMember 2026-01-01 2026-06-30 0001661053 NVNO:EmployeeExpenseMember 2025-01-01 2025-06-30 0001661053 NVNO:ClinicalMember 2026-04-01 2026-06-30 0001661053 NVNO:ClinicalMember 2025-04-01 2025-06-30 0001661053 NVNO:ClinicalMember 2026-01-01 2026-06-30 0001661053 NVNO:ClinicalMember 2025-01-01 2025-06-30 0001661053 NVNO:ProductsMember 2026-04-01 2026-06-30 0001661053 NVNO:ProductsMember 2025-04-01 2025-06-30 0001661053 NVNO:ProductsMember 2026-01-01 2026-06-30 0001661053 NVNO:ProductsMember 2025-01-01 2025-06-30 0001661053 NVNO:OtherMember 2026-04-01 2026-06-30 0001661053 NVNO:OtherMember 2025-04-01 2025-06-30 0001661053 NVNO:OtherMember 2026-01-01 2026-06-30 0001661053 NVNO:OtherMember 2025-01-01 2025-06-30 0001661053 NVNO:ProfessionalFeesMember 2026-04-01 2026-06-30 0001661053 NVNO:ProfessionalFeesMember 2025-04-01 2025-06-30 0001661053 NVNO:ProfessionalFeesMember 2026-01-01 2026-06-30 0001661053 NVNO:ProfessionalFeesMember 2025-01-01 2025-06-30 0001661053 NVNO:ReserveForUncollectiblePrepaidClinicalCostsMember 2026-04-01 2026-06-30 0001661053 NVNO:ReserveForUncollectiblePrepaidClinicalCostsMember 2025-04-01 2025-06-30 0001661053 NVNO:ReserveForUncollectiblePrepaidClinicalCostsMember 2026-01-01 2026-06-30 0001661053 NVNO:ReserveForUncollectiblePrepaidClinicalCostsMember 2025-01-01 2025-06-30 0001661053 NVNO:OccupanciesMember 2026-04-01 2026-06-30 0001661053 NVNO:OccupanciesMember 2025-04-01 2025-06-30 0001661053 NVNO:OccupanciesMember 2026-01-01 2026-06-30 0001661053 NVNO:OccupanciesMember 2025-01-01 2025-06-30 0001661053 NVNO:InsuranceMember 2026-04-01 2026-06-30 0001661053 NVNO:InsuranceMember 2025-04-01 2025-06-30 0001661053 NVNO:InsuranceMember 2026-01-01 2026-06-30 0001661053 NVNO:InsuranceMember 2025-01-01 2025-06-30 iso4217:USD xbrli:shares iso4217:USD xbrli:shares xbrli:pure NVNO:Integer

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2026

 

OR

 

☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from to ___________________

 

Commission file number: 001-38325

 

enVVeno Medical Corporation

(Exact name of registrant as specified in its charter)

 

Delaware   33-0936180

(State or other jurisdiction of

incorporation or organization)

  

(I.R.S. Employer

Identification No.)

 

70 Doppler

Irvine, California 92618

(Address of principal executive offices)

 

(949) 261-2900

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class:   Name of Each Exchange on Which Registered:   Ticker Symbol
Common Stock, $0.00001 par value   The NASDAQ Stock Market LLC   NVNO

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

  Large accelerated filer ☐   Accelerated filer ☐
  Non-accelerated filer ☒   Smaller reporting company ☒
        Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

As of July 28, 2026, there were 682,722 shares of common stock outstanding.

 

 

 

 

 

 

ENVVENO MEDICAL CORPORATION

TABLE OF CONTENTS

 

PART I  
   
FINANCIAL INFORMATION  
   
ITEM 1. Financial Statements (unaudited) 3
   
Condensed Balance Sheets as of June 30, 2026 and December 31, 2025 3
   
Condensed Statements of Operations for the three and six months ended June 30, 2026 and 2025 4
   
Condensed Statements of Changes in Stockholders’ Equity for three and the six months ended June 30, 2026 and 2025 5
   
Condensed Statements of Cash Flows for the six months ended June 30, 2026 and 2025 6
   
Notes to Condensed Financial Statements 7
   
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 11
   
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 16
   
ITEM 4. Controls and Procedures 16
   
PART II  
   
OTHER INFORMATION 17
   
ITEM 1. Legal Proceedings 17
   
ITEM 1A. Risk Factors 17
   
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 17
   
ITEM 3. Defaults Upon Senior Securities 17
   
ITEM 4. Mine Safety Disclosures 17
   
ITEM 5. Other Information 17
   
ITEM 6. Exhibits 18
   
Signatures 19

 

2

 

 

PART I – FINANCIAL INFORMATION

 

ITEM 1 – Financial Statements

 

ENVVENO MEDICAL CORPORATION

CONDENSED BALANCE SHEETS

(In thousands except par values, unless otherwise indicated)

(Unaudited)

 

  

June 30,

2026

  

December 31,

2025

 
         
Assets          
Current assets:          
Cash and cash equivalents  $2,841   $3,065 
Short-term investments   18,645    25,147 
Prepaid expenses and other current assets   596    614 
Total current assets   22,082    28,826 
Property and equipment, net   78    51 
Operating lease right-of-use assets, net   469    654 
Security deposits and other assets   31    31 
Total assets  $22,660   $29,562 
           
Liabilities and Stockholders’ Equity          
Current liabilities:          
Accounts payable, accrued expenses and other current liabilities  $1,485   $1,732 
Current portion of operating lease liabilities   402    390 
Total current liabilities   1,887    2,122 
Long-term operating lease liabilities   103    310 
Total liabilities   1,990    2,432 
           
Commitments and Contingencies – Note 7   -    - 
           
Stockholders’ Equity:          
Preferred stock, par value $0.00001, 10,000 shares authorized, no shares issued or outstanding   -    - 
Common stock, par value $0.00001, 250,000 shares authorized, 673 and 656 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively   -    - 
Additional paid-in capital   199,446    198,457 
Accumulated deficit   (178,776)   (171,327)
Total stockholders’ equity   20,670    27,130 
Total liabilities and stockholders’ equity  $22,660   $29,562 

 

See accompanying notes to unaudited condensed financial statements.

 

3

 

 

ENVVENO MEDICAL CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(Unaudited)

 

   2026   2025   2026   2025 
  

For the Three Months Ended

June 30,

  

For the Six Months Ended

June 30,

 
   2026   2025   2026   2025 
Operating expenses:                    
Research and development expenses  $2,076   $2,891   $4,187   $5,448 
Selling, general and administrative expenses   1,720    4,158    3,671    6,555 
Loss from operations   (3,796)   (7,049)   (7,858)   (12,003)
                     
Other income:                    
Realized gains from sales of trading securities   209    239    447    665 
Unrealized loss from trading securities   (22)   (79)   (65)   (273)
Interest income   9    195    31    414 
Loss from disposition of property and equipment   -    -    (4)   - 
Total other income   196    355    409    806 
                     
Net loss  $(3,600)  $(6,694)  $(7,449)  $(11,197)
                     

Net loss per basic and diluted

common share:

  $(5.37)  $(11.52)  $(11.18)  $(19.27)
                     

Weighted average number of

common shares outstanding:

                    
Basic and Diluted   671    581    666    581 

 

See accompanying notes to unaudited condensed financial statements.

 

4

 

 

ENVVENO MEDICAL CORPORATION

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(In thousands, unless otherwise indicated)

(Unaudited)

 

   Shares   Amount   Capital   Deficit   Equity 
   Three Months Ended June 30, 2026 
   Common Stock  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

 
   Shares   Amount   Capital   Deficit   Equity 
Balance, April 1, 2026   656   $-   $198,923   $(175,176)  $23,747 
Issuance of common stock from At-the-Market offering (ATM), net of fees   17    -    126    -    126 
Stock-based compensation   -    -    397    -    397 
Net loss   -    -    -    (3,600)   (3,600)
Balance, June 30, 2026   673   $-   $199,446   $(178,776)  $20,670 

 

   Three Months Ended June 30, 2025 
   Common Stock  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

 
   Shares   Amount   Capital   Deficit   Equity 
Balance, April 1, 2025   501   $-   $194,665   $(156,358)  $38,307 
Exercise of common stock warrants   49    -    -    -    - 
Stock-based compensation   -    -    1,444    -    1,444 
Net loss   -    -    -    (6,694)   (6,694)
Balance, June 30, 2025   550   $-   $196,109   $(163,052)  $33,057 

 

   Six Months Ended June 30, 2026 
   Common Stock  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

 
   Shares   Amount   Capital   Deficit   Equity 
Balance, January 1, 2026   656   $-   $198,457   $(171,327)  $27,130 
Issuance of common stock from At-the-Market offering (ATM), net of fees   17    -    126    -    126 
Effect of reverse stock split   -    -    (1)   -    (1)
Stock-based compensation   -    -    864    -    864 
Net loss   -    -    -    (7,449)   (7,449)
Balance, June 30, 2026   673   $-   $199,446   $(178,776)  $20,670 

 

   Six Months Ended June 30, 2025 
   Common Stock  

Additional

Paid-in

   Accumulated  

Total

Stockholders’

 
   Shares   Amount   Capital   Deficit   Equity 
Balance, January 1, 2025   501   $-   $194,014   $(151,855)  $42,159 
Stock-based compensation   -    -    2,095    -    2,095 
Common stock issued for exercise of pre-funded warrants   49    -    -    -    - 
Net loss   -    -    -    (11,197)   (11,197)
Balance, June 30, 2025   550   $-   $196,109   $(163,052)  $33,057 

 

See accompanying notes to unaudited condensed financial statements.

 

5

 

 

ENVVENO MEDICAL CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(In thousands, unless otherwise indicated)

(Unaudited)

 

   2026   2025 
  

For the Six Months Ended

June 30,

 
   2026   2025 
Cash Flows from Operating Activities          
Net loss  $(7,449)  $(11,197)
Adjustments to reconcile net loss to net cash used in operating activities:          
Stock-based compensation   864    2,095 
Depreciation and amortization   (32)   74 
Loss on disposition of property and equipment   4    - 
Amortization of right-of-use assets   185    178 
Unrealized loss from investments   65    273 
Changes in operating assets and liabilities:          
Prepaid expenses and other current assets   18    119 
Accounts payable, accrued expenses and other current liabilities   (247)   907 
Operating lease liabilities   (195)   (182)
Net cash used in operating activities   (6,787)   (7,733)
           
Cash Flows from Investing Activities          
Maturities of investments   47,253    24,835 
Purchases of investments   (40,816)   (16,807)
Purchases of property and equipment   -    (5)
Net cash provided by investing activities   6,437    8,023 
           
Cash Flows from Financing Activities          
Proceeds from sale of common stock in At-the-Market offering, net of fees   126    - 
Net cash provided by financing activities   126    - 
           
Net (decrease) increase in cash and cash equivalents   (224)   290 
Cash and cash equivalents, beginning of period   3,065    1,754 
Cash and cash equivalents, end of period  $2,841   $2,044 

 

See accompanying notes to unaudited condensed financial statements.

 

6

 

 

ENVVENO MEDICAL CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 1 – Business Organization and Nature of Operations

 

The Company

 

enVVeno Medical Corporation (the “Company”) is a late-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company is developing a replacement venous valve for patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the deep venous system of the leg.

 

The Company is focused on its next-generation, non-surgical replacement venous valve, called the enVVe® System. The enVVe System consists of the enVVe Valve, enVVe Delivery System, enVVe Nose Cone, the enVVe Delivery System Accessories, and the enVVe Crimping System. The enVVe Valve is a first-in-class transcatheter based replacement venous valve being developed for the treatment of severe, deep venous CVI. The enVVe Valve is designed to act as a one-way valve, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs.

 

In April 2026, the U.S. Food and Drug Administration (“FDA”) awarded the Company an Investigational Device Exemption (“IDE”) approval to proceed with a U.S. pivotal study of the enVVe System. The Transcatheter Venous Valve Endoprosthesis (“TAVVE”) pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe CVI.

 

The IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million U.S. patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg.

 

The first stage of the TAVVE® study, which is expected to commence in the second half of 2026, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

 

2026 Reverse Stock Split

 

On January 2, 2026, the Company’s board of directors (the “Board”) approved a one-for-thirty-five (1:35) reverse stock split of the outstanding shares of our common stock (the “Reverse Stock Split”). On January 16, 2026, the Company filed an amendment to the Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the Reverse Stock Split, which became effective on January 20, 2026. The amendment did not change the number of authorized shares of our common stock.

 

Except as the context otherwise requires, all common stock share numbers, share price amounts (including exercise prices, conversion prices, and closing market prices) and shares issued upon the exercise of warrants contained in the unaudited condensed financial statements and notes hereto have been retroactively adjusted to reflect the Reverse Stock Split.

 

7

 

 

Note 2 – Management’s Liquidity Plan

 

As of June 30, 2026, the Company had a cash and investment balance of $21.5 million and working capital of $20.2 million. Although the Company expects to continue incurring losses for the foreseeable future and will need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products, management believes that the Company’s capital resources are sufficient to meet its obligations as they become due within one year after the date of this Quarterly Report, and sustain operations.

 

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 United States of America (“GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, such statements include all adjustments (consisting of normal recurring items) which are considered necessary for a fair presentation of the Company’s unaudited condensed financial statements of the Company as of and for the three and six months ended June 30, 2026 and 2025, and as of December 31, 2025.

 

The results of operations for the three and six months ended June 30, 2026 are not necessarily indicative of the operating results for the full year. These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2026. The accompanying condensed balance sheet as of December 31, 2025 has been derived from the Company’s audited financial statements.

 

Note 4 – Investments

 

The components of investments were as follows:

 

   June 30, 2026   December 31, 2025 
(In thousands) 

Cash

Equivalents

  

Short-Term

Investments

  

Cash

Equivalents

  

Short-Term

Investments

 
Fair Value Level 1                
U.S. Government Securities  $1,402   $18,645   $626   $25,147 
Insured Money Market Account   757    -    1,713    - 
Total investments  $2,159   $18,645   $2,339   $25,147 

 

Unrealized losses of $22,000 and $0.1 million for the three months ended June 30, 2026 and 2025, respectively, and $0.1 million and $0.3 million for the six months ended June 30, 2026 and 2025, respectively, are from fixed-income securities and are primarily attributable to changes in interest rates.

 

Note 5 – Concentrations

 

The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 at each institution. There were aggregate uninsured cash balances of $1.8 million and $1.1 million as of June 30, 2026 and December 31, 2025, respectively.

 

Note 6 – Accounts Payable Accrued Expenses and Other Current Liabilities

 

Accounts payable, accrued expenses and other current liabilities consist of the following:

 

(In thousands) 

June 30,

2026

  

December 31,

2025

 
Accounts payable  $540   $358 
Accrued compensation costs   441    679 
Accrued clinical costs   392    445 
Accrued severance   -    116 
Other accrued expenses   112    134 
Total accounts payable, accrued expenses and other current liabilities  $1,485   $1,732 

 

8

 

 

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.

 

Note 8 –Stockholders’ Equity

 

Omnibus Incentive Plan

 

Stock Options

 

Stock-based compensation expense is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations and was $0.4 million and $1.4 million during the three months ended June 30, 2026 and 2025, respectively, and $0.9 million and $2.1 million during the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, there was $1.7 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 1.36 years.

 

There were no options granted during the three and six months ended June 30, 2026. There were 17,142 options granted during the three and six months ended June 30, 2025 in connection with entering into certain employment and consulting agreements.

 

There were no options exercised during the three and six months ended June 30, 2026 and 2025.

 

There were 7,850 and 12,316 option grants forfeited during the three and six months ended June 30, 2026, respectively. There were 15,110 option grants forfeited during the three and six months ended June 30, 2025.

 

Warrants

 

There were no warrants issued or exercised during the three and six months ended June 30, 2026. Pre-funded warrants issued in 2023 and 2021 were exercised for 48,890 shares of common stock during the three and six months ended June 30, 2025 at an exercise price of $0.0001 per pre-funded warrant.

 

There were no warrants that expired during the three months ended June 30, 2026. There were warrants exercisable for 11,128 shares of common stock that expired during the three months ended June 30, 2025. There were warrants exercisable for 85,219 and 11,390 shares of common stock that expired during the six months ended June 30, 2026 and 2025, respectively.

 

Equity Issuances

 

There were approximately 17,000 shares of common stock issued during the three and six months ended June 30, 2026 under our at-the-market equity program resulting in proceeds of $0.1 million, net of transaction fees.

 

9

 

 

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:

 

   2026   2025 
(In thousands)  June 30, 
   2026   2025 
Shares of common stock issuable upon exercise of warrants   172    281 
Shares of common stock issuable upon exercise of options   174    180 
Potentially dilutive common stock equivalents excluded from diluted net loss per share   346    461 

 

Note 10 – Segment Reporting

 

The Company has determined that it currently operates in a single segment, Medical Device development, located in a single geographic location, the United States. The accounting policies of the segment are the same as those described in the summary of significant accounting policies set forth in the Company’s Form 10-K, filed with the SEC on March 26, 2026. Since the Company operates in a single segment, the measure of segment total assets and loss from operations is the same as that reported on the accompanying balance sheets as total assets, and the accompanying statement of operations as loss from operations, respectively.

 

The Company’s chief operating decision maker (“CODM”) is the chief executive officer. The CODM uses operating expenses to measure performance against progress in its clinical trials and its product development. The following table sets forth segment expenses.

 

(In thousands)  2026   2025   2026   2025 
   For the Three Months Ended
June 30,		   For the Six Months Ended
June 30,		 
(In thousands)  2026   2025   2026   2025 
Research and Development:                    
Employee expense  $1,211   $1,329   $2,347   $2,699 
Clinical   670    960    1,514    1,832 
Product   112    403    190    548 
Other   83    199    136    369 
Total research and development   2,076    2,891    4,187    5,448 
Selling, General and Administrative Expense:                    
Employee expense   897    2,310    1,960    3,544 
Professional fees   362    308    749    888 
Reserve for uncollectible prepaid clinical costs   -    626    -    626 
Occupancy   158    151    319    314 
Insurance   146    157    290    320 
Other   157    606    353    863 
Total selling, general and administrative expense   1,720    4,158    3,671    6,555 
Loss from Operations   3,796    7,049    7,858    12,003 
Adjustments and reconciling items   (196)   (355)   (409)   (806)
Net Loss  $3,600   $6,694   $7,449   $11,197 

 

Adjustments and reconciling items between loss from operations and net loss consist of interest income and realized and unrealized gains and losses related to the Company’s investments in U.S. Treasury securities.

 

10

 

 

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 Quarterly Report and in any other statement made by, or on our behalf, whether or not in future filings with the Securities and Exchange Commission. Forward-looking statements are statements not based on historical information and which relate to future operations, strategies, financial results or other developments. Such forward-looking statements involve significant risks and uncertainties. Forward looking statements are necessarily based upon estimates and assumptions that are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are beyond our control and many of which, with respect to future business decisions, are subject to change. These uncertainties and contingencies can affect actual results and could cause actual results to differ materially from those expressed in any forward-looking statements made by, or on our behalf. Words such as “anticipate,” “estimate,” “plan,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions are used to identify forward-looking statements. Such forward-looking statements also involve other factors which may cause our actual results, performance or achievements to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements and to vary significantly from reporting period to reporting period. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual future results will not be different from the expectations expressed in this Quarterly Report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

Unless the context requires otherwise, references in this document to “NVNO”, “we”, “our”, “us” or the “Company” are to enVVeno Medical Corporation

 

Overview

 

enVVeno Medical Corporation is a late-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. Chronic Venous Disease (“CVD”) is the world’s most prevalent chronic disease, impacting approximately 70% of the adult population of the U.S. Chronic Venous Insufficiency (“CVI”), is a large subset of CVD, which most often occurs when valves inside of the veins of the leg become permanently damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal. The Company is developing a non-surgical replacement venous valve for patients suffering from severe CVI of the deep venous system of the leg.

 

The Company is focused on its next-generation, non-surgical replacement venous valve, called the enVVe® System. The enVVe System consists of the enVVe Valve, enVVe Delivery System, enVVe Nose Cone, the enVVe Delivery System Accessories, and the enVVe Crimping System. The enVVe Valve is a first-in-class transcatheter based replacement venous valve being developed for the treatment of severe, deep venous CVI. The enVVe Valve is designed to act as a one-way valve, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs.

 

In April 2026, the U.S. Food and Drug Administration (“FDA”) awarded the Company an Investigational Device Exemption (“IDE”) approval to proceed with a U.S. pivotal study of the enVVe System. The Transcatheter Venous Valve Endoprosthesis (“TAVVE”) pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe CVI.

 

11

 

 

The IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million U.S. patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg.

 

The first stage of the TAVVE study, which is expected to commence in the second half of 2026, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

 

We develop and manufacture our products 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.

 

CVI Background

 

Chronic venous disease (“CVD”) is the world’s most prevalent chronic disease. CVD is clinically 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 permanently damaged. 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 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.

 

12

 

 

We estimate that there are approximately 3 million patients with severe deep venous CVI in the U.S. including approximately 1.5 million patients that develop venous leg ulcers (C6 patients). The average patient seeking treatment of a venous ulcer spends as much as $30,000 a year on wound care, and the total direct medical costs from venous ulcer sufferers in the U.S. has been estimated to exceed $20 billion a year.

 

enVVe System

 

The enVVe System is designed to treat severe deep CVI through a minimally invasive, catheter-based procedure. The procedure is performed without the need for open surgery or an overnight hospital stay. Built on the clinical foundation of the VenoValve® surgical replacement venous valve program, which demonstrated significant clinical improvement in severe CVI patients, the enVVe System seeks to address prior FDA concerns related to the VenoValve’s open surgical implantation procedure. In addition to eliminating open surgical complications, the enVVe System’s transcatheter approach is expected to broaden adoption by appealing to a wider range of implanting physicians including vascular surgeons, interventional radiologists, and interventional cardiologists.

 

On April 29, 2026, the Company announced that the FDA had approved the Company’s IDE application, authorizing the Company to commence a pivotal study for the enVVe System. The TAVVE pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe deep CVI. The first stage of the TAVVE study, which is expected to commence later this year, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

 

Key features of the enVVe System include:

 

  ● Minimally invasive procedure requiring no general anesthesia or overnight hospital stay;
  ● Self-expanding frame made from a specially formulated biocompatible nickel and titanium alloy;
  ● Frame geometry that accommodates the natural dilation and contraction of the vein;
  ● 3 enVVe valve sizes to ensure a proper fit across a broad range of vein sizes;
  ● Unique, mono-cusp leaflet design that is laser cut from porcine pericardium tissue;
  ● Delivery profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement valve currently in use for the cardiovascular system; and
  ● Delivery via an over-the-wire, coaxial, single-stage pull system for ease of use.

 

Capital

 

We finished 2025 with approximately $28.2 million of cash and investments and had approximately $21.5 million of cash and investments as of June 30, 2026. 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 may increase from current levels of approximately $3 million to $4 million per quarter to between $4 million and $5 million per quarter in the second half of 2026. Even after considering this increase, we should have sufficient cash and investments to fund operations into the third quarter of 2027.

 

We have historically funded our operations through financing activities such as capital raises and an at-the-market equity program. We will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.

 

Based upon our cash and working capital as of June 30, 2026, we have sufficient capital resources to meet our obligations as they become due within at least one year after the date of this Quarterly Report and sustain operations.

 

13

 

 

Results of Operations

 

Comparison of the three months ended June 30, 2026 and 2025

 

Overview

 

We reported net losses of $3.6 million and $6.7 million for the three months ended June 30, 2026 and 2025, respectively, representing a decrease in net loss of $3.1 million, or 46%, due to a decrease in operating expenses of $3.3 million, partially offset by a decrease in other income of $0.2 million, as described in further detail below.

 

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 after receiving FDA approval, if ever.

 

Research and Development Expenses

 

For the three months ended June 30, 2026, research and development expenses decreased by $0.8 million or 28%, to $2.1 million from $2.9 million for the three months ended June 30, 2025. This decrease primarily resulted from $1.1 million in lower costs related to the VenoValve pivotal study as the amount of follow-up for each participant decreases over time, as well as a net decrease of $0.1 million in various other expenses. These decreases were partially offset by an increase of $0.4 million as our focus has shifted to product development, testing and other expenses related to the enVVe System being developed for approval by the FDA.

 

Selling, General and Administrative Expenses

 

For the three months ended June 30, 2026, selling, general and administrative expenses decreased by $2.5 million or 59%, to $1.7 million from $4.2 million for the three months ended June 30, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest representing $1.0 million, as well as a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs and a non-recurring severance expense of $0.3 million recorded during the three months ended June 30, 2025, and a net $0.6 million related to various other expenses.

 

Other Income

 

For the three months ended June 30, 2026, other income decreased $0.2 million or 45% to $0.2 million from $0.4 million for the three months ended June 30, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities.

 

Comparison of the six months ended June 30, 2026 and 2025

 

Overview

 

We reported net losses of $7.4 million and $11.2 million for the six months ended June 30, 2026 and 2025, respectively, representing a decrease in net loss of $3.8 million, or 33%, due to a decrease in operating expenses of $4.2 million, partially offset by a decrease in other income of $0.4 million, as described in further detail below.

 

14

 

 

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 after receiving FDA approval, if ever.

 

Research and Development Expenses

 

For the six months ended June 30, 2026, research and development expenses decreased by $1.3 million or 23%, to $4.2 million from $5.5 million for the six months ended June 30, 2025. This decrease primarily resulted from $1.8 million in lower costs related to the VenoValve pivotal study as the amount of follow-up for each participant decreases over time, as well as a net decrease of $0.4 million in various other expenses. These decreases were partially offset by an increase of $0.9 million as our focus has shifted to product development, testing and other expenses related to the enVVe System being developed for approval by the FDA.

 

Selling, General and Administrative Expenses

 

For the six months ended June 30, 2026, selling, general and administrative expenses decreased by $2.9 million or 44%, to $3.7 million from $6.6 million for the six months ended June 30, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest representing $1.3 million, as well as a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs and a non-recurring severance expense of $0.3 million recorded during the six months ended June 30, 2025, and a net $0.7 million related to various other expenses.

 

Other Income

 

For the six months ended June 30, 2026, other income decreased $0.4 million or 49% to $0.4 million from $0.8 million for the six months ended June 30, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities.

 

Liquidity and Capital Resources

 

For the six months ended June 30, 2026, the Company incurred losses from operations of $7.9 million and used $6.8 million cash in operating activities. The net cash used in operating activities during the 2026 period decreased by $0.9 million from $7.7 million for the six months ended June 30, 2025 primarily due to the decrease in research and development expenses from 2025 to 2026. Our cash balance as of June 30, 2026, is $2.8 million. In addition, we have $18.7 million in investments, for total cash and investments of $21.5 million.

 

The operating losses and the uses of cash are primarily due to the Company’s product research and development and administrative 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 were for product development and clinical trials for the VenoValve and for the enVVe System. The Company will continue to incur these costs to complete its clinical trials for the VenoValve and the enVVe System, enhance products, develop new products, and operate as a public company for the foreseeable future as we seek to obtain regulatory approval for our studies and product candidates.

 

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. We expect a nominal increase in purchases of property and equipment and in facility lease costs as we commence the enVVe System pivotal study.

 

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 may increase from current levels of approximately $3 million to $4 million per quarter to between $4 million and $5 million per quarter in the second half of 2026. Even after considering this increase, we should have sufficient cash and investments to fund operations into the third quarter of 2027.

 

15

 

 

We have historically funded our operations through financing activities such as capital raises and an at-the-market equity program. We will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.

 

Based upon our cash and working capital as of June 30, 2026, we have sufficient capital resources to meet our obligations as they become due within at least one year after the date of this Quarterly Report and sustain operations.

 

Critical Accounting Estimates

 

The preparation of our condensed financial statements requires management to make judgments, estimates and assumptions that affect the reported amounts of expenses, assets and liabilities, and the accompanying disclosures, and the disclosure of contingent liabilities, if any. Critical accounting estimates are those for which uncertainty about the assumptions and estimates could result in outcomes that require a material adjustment to the carrying amount of assets or liabilities in future periods if the actual outcomes differ from estimates.

 

We do not have any matters that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next fiscal year.

 

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.

 

Item 3. Quantitative and Qualitative Disclosure About Market Risk

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required by this Item.

 

Item 4: Controls and Procedures

 

Disclosure Controls and Procedures

 

Our management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer (who is our Principal Executive Officer) and our Chief Financial Officer (who is our Principal Financial Officer and Principal Accounting Officer), of the effectiveness of the design of our disclosure controls and procedures (as defined by Exchange Act Rules 13a-15(e) or 15d-15(e)) as of June 30, 2026, pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2026.

 

Changes in Internal Control over Financial Reporting

 

During the six months ended June 30, 2026, there were no changes in our internal controls over financial reporting, or in other factors that could significantly affect these controls, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

16

 

 

Inherent Limitations of Controls

 

Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and all fraud. Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings

 

None.

 

Item 1A. Risk Factors

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required by this Item. Our current risk factors are set forth in our Form 10-K, filed with the SEC on March 26, 2026.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults upon Senior Securities

 

None.

 

Item 4. Mine and Safety Disclosure

 

Not applicable.

 

Item 5. Other Information

 

None.

 

17

 

 

Item 6. Exhibits

 

The following is a complete list of exhibits filed as part of this Form 10-Q. Exhibit numbers correspond to the numbers in the Exhibit Table of Item 601 of Regulation S-K.

 

Exhibit   Description
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act*
31.2   Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Sarbanes-Oxley Act*
32   Certification of Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act**
101.INS   Inline XBRL Instance Document*
101.SCH   Inline XBRL Taxonomy Extension Schema Document*
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document*
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document*
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Filed herewith.
** These certifications are furnished to the SEC pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and are deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

 

18

 

 

SIGNATURES

 

Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Date: July 30, 2026 ENVVENO MEDICAL CORPORATION
     
  By: /s/ Robert Berman
    Robert Berman
    Chief Executive Officer
    (Principal Executive Officer)
     
  By: /s/ Jennifer Bright
    Jennifer Bright
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

19

 

Source: View Original Filing on SEC EDGAR