enVVeno Medical Corp 10-Q

ITEM 1 – Financial Statements ENVVENO MEDICAL CORPORATION CONDENSED BALANCE SHEETS (In thousands except par values, unless otherwise indicated) (Unaudited) September 30, 2025 December 31, 2024 (Unaudited) Assets Current assets: Cash and cash equivalents $ 1,544 $ 1,754 Short-term investments 29,408 41,399 Prepaid expenses and other current assets 547 581 Total current assets 31,499 43,734 Property and equipment, net 82 182 Operating lease right-of-use assets, net 740 1,007 Security deposits and other assets 31 31 Total assets $ 32,352 $ 44,954 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable, accrued expenses and other current liabilities $ 2,114 $ 1,731 Current portion of operating lease liabilities 286 364 Total current liabilities 2,400 2,095 Long-term operating lease liabilities 505 700 Total liabilities 2,905 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, 20,216 and 17,536 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively - - Additional paid-in capital 197,038 194,014 Accumulated deficit ( 167,591 ) ( 151,855 ) Total stockholders’ equity 29,447 42,159 Total liabilities and stockholders’ equity $ 32,352 $ 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 September 30, For the Nine Months Ended September 30, 2025 2024 2025 2024 Operating expenses: Research and development expenses $ 2,585 $ 2,859 $ 8,033 $ 8,736 Selling, general and administrative expenses 2,298 3,311 8,853 8,391 Loss from operations ( 4,883 ) ( 6,170 ) ( 16,886 ) ( 17,127 ) Other income: Realized gains from sales of trading securities 208 428 873 1,215 Unrealized gain (loss) from trading securities ( 39 ) 6 ( 312 ) 96 Interest income, net 175 94 589 226 Total other income 344 528 1,150 1,537 Net loss $ ( 4,539 ) $ ( 5,642 ) $ ( 15,736 ) $ ( 15,590 ) Net loss per basic and diluted common share: $ ( 0.23 ) $ ( 0.35 ) $ ( 0.78 ) $ ( 0.97 ) Weighted average number of common shares outstanding: Basic and Diluted 20,155 16,067 20,286 16,063 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 September 30, 2025 Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance, July 1, 2025 19,247 $ - $ 196,109 $ ( 163,052 ) $ 33,057 Common stock issued for exercise of warrants 969 - 241 - 241 Stock-based compensation - - 688 - 688 Net loss - - - ( 4,539 ) ( 4,539 ) Balance, September 30, 2025 20,216 $ - $ 197,038 ( 167,591 ) $ 29,447 Three Months Ended September 30, 2024 Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance, July 1, 2024 13,330 $ - $ 178,402 $ ( 139,984 ) $ 38,418 Common Stock and Warrants Issued in Public Offering 4,206 - 13,591 - 13,591 Stock-based compensation - - 1,003 - 1,003 Net loss - - - ( 5,642 ) ( 5,642 ) Balance, September 30, 2024 17,536 $ - $ 192,996 $ ( 145,626 ) $ 47,370 Nine Months Ended September 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 Common stock issued for exercise of warrants 2,680 - 241 - 241 Stock-based compensation - - 2,783 - 2,783 Net loss - - - ( 15,736 ) ( 15,736 ) Balance, September 30, 2025 20,216 $ - $ 197,038 $ ( 167,591 ) $ 29,447 Nine Months Ended September 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 Common Stock and Warrants Issued in Public Offering 4,206 13,591 - 13,591 Stock-based compensation - - 3,123 - 3,123 Options exercised 13 - 46 - 46 Net loss - - - ( 15,590 ) ( 15,590 ) Balance, September 30, 2024 17,536 $ - $ 192,996 $ ( 145,626 ) $ 47,370 Balance 17,536 $ - $ 192,996 $ ( 145,626 ) $ 47,370 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 Nine Months Ended September 30, 2025 2024 Cash Flows from Operating Activities Net loss $ ( 15,736 ) $ ( 15,590 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 2,783 3,123 Depreciation and amortization 105 149 Amortization of right-of-use assets 267 257 Unrealized (gain) loss from investments 312 ( 96 ) Changes in operating assets and liabilities: Prepaid expenses and other current assets 34 ( 161 ) Accounts payable, accrued expenses and other current liabilities 383 839 Operating lease liabilities ( 273 ) ( 254 ) Net cash used in operating activities ( 12,125 ) ( 11,733 ) Cash Flows from Investing Activities Maturities of investments 38,381 45,844 Purchase of property and equipment ( 5 ) ( 33 ) Purchases of investments ( 26,702 ) ( 33,420 ) Net cash provided by investing activities 11,674 12,391 Cash Flows from Financing Activities Proceeds from private placement offering - 13,591 Proceeds from warrant exercises 241 - Proceeds from stock option exercises - 46 Net cash provided by financing activities 241 13,637 Net increase (decrease) in cash and cash equivalents ( 210 ) 14,295 Cash and cash equivalents - Beginning of period 1,754 3,620 Cash and cash equivalents - End of period $ 1,544 $ 17,915 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 September 30, 2025, the Company had a cash and investment balance of $ 31.0 million and working capital of $ 29.1 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 September 30, 2025 and December 31, 2024, and for the three and nine months ended September 30, 2025 and 2024. The results of operations for the three and nine months ended September 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 as of September 30, 2025 and December 31, 2024 were as follows: Schedule of Components of Investments September 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 $ 1,180 $ 29,408 $ 1,352 $ 41,399 Total debt investments $ 1,180 $ 29,408 $ 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 $ 1.0 million and $ 0.9 million as of September 30, 2025 and December 31, 2024, 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) September 30, 2025 December 31, 2024 Accounts payable $ 626 $ 1,006 Accrued compensation costs 533 604 Accrued clinical costs 576 - Accrued severance 187 - Other accrued expenses 192 121 Total accounts payable, accrued expenses and other current liabilities $ 2,114 $ 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 $ 0.7 million and $ 1.0 million during the three months ended September 30, 2025 and 2024, respectively, and $ 2.8 million and $ 3.1 million during the nine months ended September 30, 2025 and 2024. As of September 30, 2025, there was $ 3.7 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 1.83 years. There were no options granted during the three months ended September 30, 2025 and 2024. There were 600,000 and 423,000 options granted during the nine months ended September 30, 2025 and 2024, respectively, in connection with entering into certain employment and consulting agreements. There were no option grants forfeited during the three months ended September 30, 2025. There were approximately 529,000 option grants forfeited during the nine months ended September 30, 2025. There were approximately 2,000 and 44,000 option grants forfeited during the three and nine months ended September 30, 2024, respectively. There were no option grants exercised during the three and nine months ended September 30, 2025. There were no option grants exercised during the three months ended September 30, 2024 and there were approximately 13,000 option grants exercised during the nine months ended September 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 nine months ended September 30, 2025, there were 50,000 restricted stock units forfeited in connection with employment termination. No expense has been recorded as of September 30, 2025. Warrants Pre-funded warrants issued in 2021 totaling approximately 909,000 units were exercised during the three months ended September 30, 2025, at an exercise price of $ 0.0001 per share. Pre-funded warrants issued in 2023 and 2021 totaling approximately 861,000 and 1,759,000 units, respectively, were exercised during the nine months ended September 30, 2025, at an exercise price of $ 0.0001 per share. Warrants issued in 2024 totaling 60,000 units were exercised during the three months ended September 30, 2025, at an exercise price of $ 4.025 per share. A warrant issued in 2021 was exercised during the three months ended September 30, 2025, at an exercise price of $ 7.00 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: Schedule of Potentially Dilutive Common Stock Equivalents Excluded From Calculation of Diluted Net Loss Per Common Share 2025 2024 (In thousands) September 30, 2025 2024 Shares of common stock issuable upon exercise of warrants 9,073 9,847 Shares of common stock issuable upon exercise of options 6,343 5,552 Potentially dilutive common stock equivalents excluded from diluted net loss per share 15,416 15,399 Note 10 – Segment Reporting The Company has determined that it currently operates in a single 1 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 2025 2024 For the Three Months Ended September 30, For the Nine Months Ended September 30, (In thousands) 2025 2024 2025 2024 Research and Development: Employee expense $ 1,329 $ 1,194 $ 4,028 $ 3,558 Clinical 859 1,105 2,691 3,763 Product 251 382 799 958 Other 146 178 515 457 Total research and development 2,585 2,859 8,033 8,736 Selling, General and Administrative Expense: Employee expense 1,251 1,466 4,795 4,361 Professional fees 335 1,050 1,224 1,981 Reserve for (recovery of) uncollectible prepaid clinical costs ( 291 ) - 335 - Occupancy 165 159 480 468 Insurance 146 165 466 494 Other 692 471 1,553 1,087 Total selling, general and administrative expense 2,298 3,311 8,853 8,391 Loss from Operations 4,883 6,170 16,886 17,127 Adjustments and reconciling items ( 344 ) ( 528 ) ( 1,150 ) ( 1,537 ) Net Loss $ 4,539 $ 5,642 $ 15,736 $ 15,590 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. Note 11 – Subsequent Events On October 7, 2025, the Company received notification from Nasdaq notifying the Company that, because the closing bid price for the Company’s common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price requirement for continued listing on the Nasdaq Capital Market under Rule 5550(a)(2) of Nasdaq Listing Rules. Nasdaq’s notice has no immediate effect on the listing of the Company’s common stock on the Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until April 6, 2026, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must close at or above $1.00 per share for a minimum of 10 consecutive trading days (which period may be extended to greater than 10 consecutive trading days at the sole discretion of Nasdaq) prior to April 6, 2026. In the event the Company does not regain compliance by April 6, 2026, the Company may be eligible for an additional 180 calendar day compliance period to demonstrate compliance with the bid price requirement. To qualify for the additional 180-day period, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Nasdaq staff determines that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for such additional compliance period, Nasdaq will provide notice that the Company’s common stock will be subject to delisting. The Company would have the right to appeal a determination to delist its common stock, and the common stock would remain listed on the Nasdaq Capital Market until the completion of the appeal process. 8