enVVeno Medical Corp 10-Q

ITEM 1 – Financial Statements ENVVENO MEDICAL CORPORATION CONDENSED BALANCE SHEETS (In thousands except par values, unless otherwise indicated) (Unaudited) March 31, 2026 December 31, 2025 Assets Current assets: Cash and cash equivalents $ 2,597 $ 3,065 Short-term investments 22,333 25,147 Prepaid expenses and other current assets 559 614 Total current assets 25,489 28,826 Property and equipment, net 16 51 Operating lease right-of-use assets, net 561 654 Security deposits and other assets 31 31 Total assets $ 26,097 $ 29,562 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable, accrued expenses and other current liabilities $ 1,747 $ 1,732 Current portion of operating lease liabilities 396 390 Total current liabilities 2,143 2,122 Long-term operating lease liabilities 207 310 Total liabilities 2,350 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, 656 shares issued and outstanding as of March 31, 2026 and December 31, 2025 - - Additional paid-in capital 198,923 198,457 Accumulated deficit ( 175,176 ) ( 171,327 ) Total stockholders’ equity 23,747 27,130 Total liabilities and stockholders’ equity $ 26,097 $ 29,562 See accompanying notes to unaudited condensed financial statements. 1 ENVVENO MEDICAL CORPORATION CONDENSED STATEMENTS OF OPERATIONS (In thousands, except per share data) (Unaudited) For the Three Months Ended March 31, 2026 2025 (In thousands, except per share data) Operating expenses: Research and development expenses $ 2,111 $ 2,557 Selling, general and administrative expenses 1,951 2,397 Loss from operations ( 4,062 ) ( 4,954 ) Other income: Realized gain from sales of trading securities 238 426 Unrealized loss from trading securities ( 43 ) ( 194 ) Interest income 22 219 Loss from disposition of property and equipment ( 4 ) - Total other income 213 451 Net loss $ ( 3,849 ) $ ( 4,503 ) Net loss per basic and diluted common share: $ ( 5.89 ) $ ( 7.75 ) Weighted average number of common shares outstanding: Basic and diluted 654 581 See accompanying notes to unaudited condensed financial statements. 2 ENVVENO MEDICAL CORPORATION CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (In thousands, unless otherwise indicated) (Unaudited) Three Months Ended March 31, 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 Effect of reverse stock split - - ( 1 ) - ( 1 ) Stock-based compensation - - 467 - 467 Net loss - - - ( 3,849 ) ( 3,849 ) Balance, March 31, 2026 656 $ - $ 198,923 $ ( 175,176 ) $ 23,747 Three Months Ended March 31, 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 Balance 501 $ - $ 194,014 $ ( 151,855 ) $ 42,159 Stock-based compensation - - 651 - 651 Net loss - - - ( 4,503 ) ( 4,503 ) Balance, March 31, 2025 501 $ - $ 194,665 $ ( 156,358 ) $ 38,307 Balance 501 $ - $ 194,665 $ ( 156,358 ) $ 38,307 See accompanying notes to unaudited condensed financial statements. 3 ENVVENO MEDICAL CORPORATION CONDENSED STATEMENTS OF CASH FLOWS (In thousands, unless otherwise indicated) (Unaudited) For the Three Months Ended March 31, 2026 2025 Cash Flows from Operating Activities Net loss $ ( 3,849 ) $ ( 4,503 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 467 651 Depreciation and amortization 31 40 Loss on disposition of property and equipment 4 - Amortization of right-of-use assets 93 82 Unrealized loss from investments 43 194 Changes in operating assets and liabilities: Prepaid expenses and other current assets 55 43 Accounts payable, accrued expenses and other current liabilities 15 ( 440 ) Operating lease liabilities ( 97 ) ( 85 ) Net cash used in operating activities ( 3,238 ) ( 4,018 ) Cash Flows from Investing Activities Maturities of investments 25,012 14,075 Purchases of investments ( 22,242 ) ( 8,874 ) Net cash provided by investing activities 2,770 5,201 Net (decrease) increase in cash and cash equivalents ( 468 ) 1,183 Cash and cash equivalents, beginning of period 3,065 1,754 Cash and cash equivalents, end of period $ 2,597 $ 2,937 See accompanying notes to unaudited condensed financial statements. 4 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 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 first developed the VenoValve®, which was a potential first-in-class surgical replacement venous valve (the Company received a not-approvable letter from the U.S. Food and Drug Administration (“FDA”) in response to its PMA application for the VenoValve in August 2025). The Company is now focused on its next-generation, non-surgical venous valve product, 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, non-surgical, transcatheter based replacement venous valve being developed for the treatment of severe 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. The Company has completed pre-clinical testing on the enVVe System. The Company’s Investigational Device Exemption (“IDE”) application was approved by the FDA authorizing the Company to commence a study of a non-surgical replacement venous valve. The Transcatheter Venous Valve Endoprosthesis (“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. 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. Note 2 – Management’s Liquidity Plan As of March 31, 2026, the Company had a cash and investment balance of $ 24.9 million and working capital of $ 23.3 million. Although the Company expects to continue incurring losses for the foreseeable future and may 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 months ended March 31, 2026 and 2025, and as of December 31, 2025. 5 The results of operations for the three months ended March 31, 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: Schedule of Components of Investments March 31, 2026 December 31, 2025 (In thousands) Cash Equivalents Short-Term Investments Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 2,179 $ 22,333 $ 2,339 $ 25,147 Total debt investments $ 2,179 $ 22,333 $ 2,339 $ 25,147 Unrealized losses of $ 43,000 and $ 0.2 million for the three months ended March 31, 2026 and 2025, respectively, 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 $ 1.6 million and $ 1.1 million as of March 31, 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: Schedule of Accounts Payable, Accrued Expenses and Other Current Liabilities (In thousands) March 31, 2026 December 31, 2025 Accounts payable $ 813 $ 358 Accrued compensation costs 382 679 Accrued clinical costs 415 445 Accrued severance 56 116 Other accrued expenses 81 134 Total accounts payable, accrued expenses and other current liabilities $ 1,747 $ 1,732 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. 6 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 $ 0.5 million and $ 0.7 million during the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, there was $ 2.2 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 1.51 years. There were no options granted or exercised during the three months ended March 31, 2026 and 2025. There were 4,476 option grants forfeited during the three months ended March 31, 2026 and no option grants were forfeited during the three months ended March 31, 2025. Warrants There were no warrants issued or exercised during the three months ended March 31, 2026 and 2025. There were 85,219 and 262 warrants that expired during the three months ended March 31, 2026 and 2025, respectively. 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: Schedule of Dilutive Net Loss Per Common Share (In thousands) March 31, 2026 2025 Shares of common stock issuable upon exercise of warrants 172 281 Shares of common stock issuable upon exercise of options 182 180 Potentially dilutive common stock equivalents excluded from diluted net loss per share 354 461 Note 10 – Segment Reporting The Company has determined that it currently operates in a 1 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. Schedule of Segment Expenses For the Three Months Ended March 31, (In thousands) 2026 2025 Research and development: Employee expense $ 1,136 $ 1,369 Clinical 844 872 Product 78 146 Other 53 170 Total research and development 2,111 2,557 Selling, general and administrative expense Employee expense 1,063 1,234 Professional fees 386 580 Occupancy 161 164 Insurance 144 163 Other 197 256 Total selling, general and administrative expense 1,951 2,397 Loss from operations 4,062 4,954 Adjustments and reconciling Items ( 213 ) ( 451 ) Net loss $ 3,849 $ 4,503 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. Note 11 – Subsequent Events On April 29, 2026, the Company announced that the FDA had approved the Company’s IDE application, authorizing the Company to commence a study of a non-surgical replacement venous valve. 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. During April 2026, we raised approximately $ 0.1 million, net of expenses, through an at-the-market equity offering of 12,148 shares of common stock. Under our at-the-market equity program, which is currently effective and may remain available for us to use in the future, as of the date hereof, we may sell approximately an additional $ 48.8 million of common stock. 7