enVVeno Medical Corp 10-Q

ITEM 1 – Financial Statements ENVVENO MEDICAL CORPORATION CONDENSED BALANCE SHEETS (In thousands except par values, unless otherwise indicated) (Unaudited) June 30, 2025 December 31, 2024 (Unaudited) Assets Current assets: Cash and cash equivalents $ 2,044 $ 1,754 Short-term investments 33,098 41,399 Prepaid expenses and other current assets 462 581 Total current assets 35,604 43,734 Property and equipment, net 113 182 Operating lease right-of-use assets, net 829 1,007 Security deposits and other assets 31 31 Total assets $ 36,577 $ 44,954 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable, accrued expenses and other current liabilities $ 2,638 $ 1,731 Current portion of operating lease liabilities 377 364 Total current liabilities 3,015 2,095 Long-term operating lease liabilities 505 700 Total liabilities 3,520 2,795 Commitments and Contingencies - - 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, 19,247 and 17,536 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively - - Additional paid-in capital 196,109 194,014 Accumulated deficit ( 163,052 ) ( 151,855 ) Total stockholders’ equity 33,057 42,159 Total liabilities and stockholders’ equity $ 36,577 $ 44,954 See Notes to these Unaudited Condensed Financial Statements 1 ENVVENO MEDICAL CORPORATION CONDENSED STATEMENTS OF OPERATIONS (In thousands, except per share data) (Unaudited) 2025 2024 2025 2024 For the Three Months Ended June 30, For the Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development expenses $ 2,891 $ 2,825 $ 5,448 $ 5,877 Selling, general and administrative expenses 4,158 2,629 6,555 5,080 Loss from operations ( 7,049 ) ( 5,454 ) ( 12,003 ) ( 10,957 ) Other income: Realized gains from sales of trading securities 239 379 665 787 Unrealized gain (loss) from trading securities ( 79 ) 46 ( 273 ) 90 Interest income, net 195 73 414 132 Total other income 355 498 806 1,009 Net loss $ ( 6,694 ) $ ( 4,956 ) $ ( 11,197 ) $ ( 9,948 ) Net loss per basic and diluted common share: $ ( 0.33 ) $ ( 0.31 ) $ ( 0.55 ) $ ( 0.62 ) Weighted average number of common shares outstanding: Basic and Diluted 20,352 16,067 20,352 16,062 See Notes to these Unaudited Condensed Financial Statements 2 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, 2025 Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance, April 1, 2025 17,536 $ - $ 194,665 $ ( 156,358 ) $ 38,307 Common stock issued for exercise of pre-funded warrants 1,711 - - - - Stock-based compensation - - 1,444 - 1,444 Net loss - - - ( 6,694 ) ( 6,694 ) Balance, June 30, 2025 19,247 $ - $ 196,109 $ ( 163,052 ) $ 33,057 Three Months Ended June 30, 2024 Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance, April 1, 2024 13,330 $ - $ 177,397 $ ( 135,028 ) $ 42,369 Stock-based compensation - - 1,005 - 1,005 Net loss - - - ( 4,956 ) ( 4,956 ) Balance, June 30, 2024 13,330 $ - $ 178,402 $ ( 139,984 ) $ 38,418 Six Months Ended June 30, 2025 Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance, January 1, 2025 17,536 $ - $ 194,014 $ ( 151,855 ) $ 42,159 Stock-based compensation - - 2,095 - 2,095 Common stock issued for exercise of pre-funded warrants 1,711 - - - - Net loss - - - ( 11,197 ) ( 11,197 ) Balance, June 30, 2025 19,247 $ - $ 196,109 $ ( 163,052 ) $ 33,057 Six Months Ended June 30, 2024 Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance, January 1, 2024 13,317 $ - $ 176,236 $ ( 130,036 ) $ 46,200 Balance 13,317 $ - $ 176,236 $ ( 130,036 ) $ 46,200 Stock-based compensation - - 2,120 - 2,120 Options exercised 13 - 46 - 46 Net loss - - - ( 9,948 ) ( 9,948 ) Balance, June 30, 2024 13,330 $ - $ 178,402 $ ( 139,984 ) $ 38,418 Balance 13,330 $ - $ 178,402 $ ( 139,984 ) $ 38,418 See Notes to these Unaudited Condensed Financial Statements 3 ENVVENO MEDICAL CORPORATION CONDENSED STATEMENTS OF CASH FLOWS (In thousands, unless otherwise indicated) (Unaudited) 2025 2024 For the Six Months Ended June 30, 2025 2024 Cash Flows from Operating Activities Net loss $ ( 11,197 ) $ ( 9,948 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 2,095 2,120 Depreciation and amortization 74 106 Amortization of right-of-use assets 178 171 Unrealized (gain) loss from investments 273 ( 90 ) Changes in operating assets and liabilities: Prepaid expenses and other current assets 119 42 Accounts payable, accrued expenses and other current liabilities 907 311 Operating lease liabilities ( 182 ) ( 169 ) Net cash used in operating activities ( 7,733 ) ( 7,457 ) Cash Flows from Investing Activities Maturities of investments 24,835 31,263 Purchase of property and equipment ( 5 ) ( 24 ) Purchases of investments ( 16,807 ) ( 25,068 ) Net cash provided by investing activities 8,023 6,171 Cash Flows from Financing Activities Proceeds from stock option exercises - 46 Net cash provided by financing activities - 46 Net increase (decrease) in cash and cash equivalents 290 ( 1,240 ) Cash and cash equivalents - Beginning of period 1,754 3,620 Cash and cash equivalents - End of period $ 2,044 $ 2,380 See Notes to these Unaudited Condensed Financial Statements 4 ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) Note 1 – Business Organization and Nature of Operations enVVeno Medical Corporation (the “Company”) is a late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep venous disease. The Company is developing surgical and non-surgical replacement venous valves for patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the deep venous system of the leg. The Company’s lead product is the VenoValve®, a potential first of its kind surgical replacement venous valve currently in post-enrollment follow-up of its U.S. pivotal study. The Company is also developing a second product called enVVe®, a next-generation, non-surgical, transcatheter based replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system accessories. The Company is currently conducting pre-clinical testing on enVVe. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs. The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (“FDA”). We expect the VenoValve to be eligible for FDA approval first, followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option. Note 2 – Management’s Liquidity Plan As of June 30, 2025, the Company had a cash and investment balance of $ 35.1 million and working capital of $ 32.6 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 unaudited condensed financial statements of the Company as of June 30, 2025 and December 31, 2024, and for the three and six months ended June 30, 2025 and 2024. The results of operations for the three and six months ended June 30, 2025 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, 2024 included in the Company’s Annual Report on Form 10-K/A filed with the SEC on February 28, 2025. The accompanying condensed balance sheet as of December 31, 2024 has been derived from the Company’s audited financial statements. 5 Note 4 – Investments The components of investments at June 30, 2025 and December 31, 2024 were as follows: Schedule of Components of Investments June 30, 2025 December 31, 2024 (In thousands) Cash Equivalents Short-Term Investments Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 1,465 $ 33,098 $ 1,352 $ 41,399 Total debt investments $ 1,465 $ 33,098 $ 1,352 $ 41,399 Unrealized and realized gains and losses on the accompanying statement of operations result from fixed-income securities and are primarily attributable to changes in interest rates. Management does not believe any remaining unrealized losses represent impairments based on its evaluation of available evidence. 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 $ 0.7 million and $ 0.9 million as of June 30, 2025 and December 31, 2024, respectively. Note 6 – Accounts Payable Accrued Expenses and Other Current Liabilities As of June 30, 2025, and December 31, 2024, accounts payable, accrued expenses and other current liabilities consist of the following: Schedule of Accounts Payable, Accrued Expenses and Other Current Liabilities (In thousands) June 30, 2025 December 31, 2024 Accounts payable $ 1,073 $ 1,006 Accrued compensation costs 629 604 Accrued clinical costs 576 - Accrued severance 257 - Other accrued expenses 103 121 Total accounts payable, accrued expenses and other current liabilities $ 2,638 $ 1,731 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 $ 1.4 million and $ 1.0 million during the three months ended June 30, 2025 and 2024, respectively, and $ 2.1 million during the six months ended June 30, 2025 and 2024. As of June 30, 2025, there was $ 4.4 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 2.02 years. There were 600,000 and 423,000 options granted during the three and six months ended June 30, 2025 and 2024, respectively, in connection with entering into certain employment and consulting agreements. There were approximately 529,000 option grants forfeited during the three and six months ended June 30, 2025. There were 19,000 and 42,000 option grants forfeited during the three and six months ended June 30, 2024. There were no option grants exercised during the three and six months ended June 30, 2025. There were no option grants exercised during the three months ended June 30, 2024 and there were 13,000 option grants exercised during the six months ended June 30, 2024. Restricted Stock Units Restricted stock unit vesting is conditioned on achieving the Pre-Market Approval of the VenoValve milestone. During the three and six months ended June 30, 2025, there were 50,000 restricted stock units forfeited in connection with employment termination. No expense has been recorded as of June 30, 2025. Warrants Pre-funded warrants issued in 2023 and 2021 totaling approximately 861,000 and 850,000 units, respectively, were exercised during the three and six months ended June 30, 2025, at an exercise price of $ 0.0001 per share. Note 9 – Net Loss per Share The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of June 30, 2025 and 2024: Schedule of Potentially Dilutive Common Stock Equivalents Excluded From Calculation of Diluted Net Loss Per Common Share 2025 2024 (In thousands) June 30, 2025 2024 Shares of common stock issuable upon exercise of warrants 9,447 9,546 Shares of common stock issuable upon exercise of options 6,343 5,554 Potentially dilutive common stock equivalents excluded from diluted net loss per share 15,790 15,100 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/A, filed with the SEC on February 28, 2025. 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. 7 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 (In thousands) 2025 2024 For the Three Months Ended June 30, For the Six Months Ended June 30, (In thousands) 2025 2024 2025 2024 Research and Development: Employee expense $ 1,329 $ 1,211 $ 2,699 $ 2,364 Clinical 960 1,198 1,832 2,657 Product 403 273 548 576 Other 199 143 369 280 Total research and development 2,891 2,825 5,448 5,877 Selling, General and Administrative Expense: Employee expense 2,310 1,432 3,544 2,895 Professional fees 308 517 888 932 Reserve for uncollectible prepaid clinical costs 626 - 626 - Occupancy 151 156 314 309 Insurance 157 164 320 329 Other 606 360 863 615 Total selling, general and administrative expense 4,158 2,629 6,555 5,080 Loss from Operations 7,049 5,454 12,003 10,957 Adjustments and reconciling items ( 355 ) ( 498 ) ( 806 ) ( 1,009 ) Net Loss $ 6,694 $ 4,956 $ 11,197 $ 9,948 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 US Treasury securities. 8