enVVeno Medical Corp 10-Q

ITEM 1 – Financial Statements ENVVENO MEDICAL CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) March 31, 2025 December 31, 2024 (In thousands except par values, unless otherwise indicated) Assets Current Assets: Cash and cash equivalents $ 2,937 $ 1,754 Short-term investments 36,004 41,399 Prepaid expenses and other current assets 538 581 Total Current Assets 39,479 43,734 Property and equipment, net 142 182 Operating lease right-of-use assets, net 925 1,007 Security deposits and other assets 31 31 Total Assets $ 40,577 $ 44,954 Liabilities and Stockholders’ Equity Current Liabilities: Accounts payable, accrued expenses and other current liabilities $ 1,291 $ 1,731 Current portion of operating lease liabilities 370 364 Total Current Liabilities 1,661 2,095 Long-term operating lease liabilities 609 700 Total Liabilities 2,270 2,795 Commitments and Contingencies (Note 8) - - 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, 17,536 shares issued and outstanding as of March 31, 2025 and December 31, 2024 - - Additional paid-in capital 194,665 194,014 Accumulated deficit ( 156,358 ) ( 151,855 ) Total Stockholders’ Equity 38,307 42,159 Total Liabilities and Stockholders’ Equity $ 40,577 $ 44,954 See Notes to these Unaudited Condensed Consolidated Financial Statements 1 ENVVENO MEDICAL CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) 2025 2024 For the Three Months Ended March 31, 2025 2024 (In thousands, except per share data) Operating Expenses: Research and development expenses $ 2,557 $ 3,052 Selling, general and administrative expenses 2,397 2,451 Loss from Operations ( 4,954 ) ( 5,503 ) Other Income: Realized gain from sales of trading securities 426 408 Unrealized gain (loss) from trading securities ( 194 ) 44 Interest income, net 219 59 Total Other Income 451 511 Net Loss $ ( 4,503 ) $ ( 4,992 ) Net Loss Per Basic and Diluted Common Share: $ ( 0.22 ) $ ( 0.31 ) Weighted Average Number of Common Shares Outstanding: Basic and Diluted 20,352 16,057 See Notes to these Unaudited Condensed Consolidated Financial Statements 2 ENVVENO MEDICAL CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY) (In thousands, unless otherwise indicated) (Unaudited) Shares Amount Capital Deficit Equity Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance at January 1, 2025 17,536 $ - $ 194,014 $ ( 151,855 ) $ 42,159 Stock-based compensation - - 651 - 651 Net loss - - - ( 4,503 ) ( 4,503 ) Balance at March 31, 2025 17,536 $ - $ 194,665 $ ( 156,358 ) $ 38,307 Common Stock Additional Paid-in Accumulated Total Stockholders’ Shares Amount Capital Deficit Equity Balance at January 1, 2024 13,317 $ - $ 176,236 $ ( 130,036 ) $ 46,200 Balance 13,317 $ - $ 176,236 $ ( 130,036 ) $ 46,200 Stock-based compensation - - 1,115 - 1,115 Options exercised 13 - 46 - 46 Net loss - - - ( 4,992 ) ( 4,992 ) Balance at March 31, 2024 13,330 $ - $ 177,397 $ ( 135,028 ) $ 42,369 Balance 13,330 $ - $ 177,397 $ ( 135,028 ) $ 42,369 See Notes to these Unaudited Condensed Consolidated Financial Statements 3 ENVVENO MEDICAL CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands, unless otherwise indicated) (Unaudited) 2025 2024 For the Three Months Ended March 31, 2025 2024 Cash Flows from Operating Activities Net loss $ ( 4,503 ) $ ( 4,992 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation 651 1,115 Depreciation and amortization 40 55 Amortization of right of use assets 82 86 Unrealized gain (loss) from investments 194 ( 44 ) Changes in operating assets and liabilities: Prepaid expenses and other current assets 43 205 Accounts payable, accrued expenses and other current liabilities ( 440 ) 110 Operating lease liabilities ( 85 ) ( 85 ) Net Cash Used in Operating Activities ( 4,018 ) ( 3,550 ) Cash Flows from Investing Activities Maturities of investments 14,075 17,343 Purchase of investments ( 8,874 ) ( 15,135 ) Purchase of property and equipment - ( 10 ) Net Cash Provided by Investing Activities 5,201 2,198 Cash Flows from Financing Activities Proceeds from Stock Option Exercises - 46 Net Cash Provided by Financing Activities - 46 Net Increase (Decrease) in Cash 1,183 ( 1,306 ) Cash, cash equivalents - Beginning of period 1,754 3,620 Cash, cash equivalents - End of period $ 2,937 $ 2,314 See Notes to these Unaudited Condensed Consolidated Financial Statements 4 ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED CONSOLIDATED 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 March 31, 2025, the Company had a cash and investment balance of $ 38.9 million and working capital of $ 37.8 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 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 only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed financial statements of the Company as of March 31, 2025 and December 31, 2024, and for the three months ended March 31, 2025 and 2024. The results of operations for the three months ended March 31, 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 ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) Note 4 – Investments The components of investments were as follows at March 31, 2025 and December 31, 2024: Schedule of Components of Investments (In thousands) March 31, 2025 December 31, 2024 Cash Equivalents Short-Term Investment Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 2,619 $ 36,004 $ 1,352 $ 41,399 Total debt investments $ 2,619 $ 36,004 $ 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 our 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 $ 1.5 million and $ 0.9 million as of March 31, 2025 and December 31, 2024, respectively. Note 6 – Property and Equipment As of March 31, 2025 and December 31, 2024, property and equipment consist of the following: Schedule of Property and Equipment (In thousands) March 31, 2025 December 31, 2024 Laboratory equipment $ 566 $ 566 Computer equipment and software 500 500 Leasehold improvements, furniture and fixtures 373 373 Total property and equipment 1,439 1,439 Less: accumulated depreciation ( 1,297 ) ( 1,257 ) Property and equipment, net $ 142 $ 182 Depreciation expense amounted to $ 0.1 million for the three months ended March 31, 2025 and 2024. Depreciation expense is reflected in general and administrative expenses in the accompanying statements of operations. 6 ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) Note 7 – Accounts Payable Accrued Expenses and Other Current Liabilities As of March 31, 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) March 31, 2025 December 31, 2024 Accounts payable $ 703 $ 1,006 Accrued compensation costs 511 604 Other accrued expenses 77 121 Total accrued expenses and other current liabilities $ 1,291 $ 1,731 Note 8 – 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. 7 ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) Note 9 – Stockholders’ Equity Stock Options Stock-based compensation is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations and was $ 0.7 million and $ 1.1 million during the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, there was $ 4.2 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 1.95 years. Note 10 – 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 March 31, 2025 and 2024: Schedule of Dilutive Net Loss Per Common Share 2025 2024 (In thousands) March 31, 2025 2024 Shares of common stock issuable upon exercise of warrants 9,837 14,384 Shares of common stock issuable upon exercise of options 6,322 5,159 Potentially dilutive common stock equivalents excluded from diluted net loss per share 16,159 19,543 Note 11 – 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 our 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. 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) 2023 2024 March 31, (In thousands) 2025 2024 Research and Development: Employee expense $ 1,369 $ 1,153 Clinical 872 1,459 Product 146 303 Other 170 137 Total research and development 2,557 3,052 Selling, general and administrative expense Employee expense $ 1,234 1,463 Professional fees 580 415 Occupancy 164 153 Insurance 163 165 Other 256 255 Total selling, general and administrative expense 2,397 2,451 Loss from Operations 4,954 5,503 Adjustments and reconciling Items ( 451 ) ( 511 ) Net Loss $ 4,503 $ 4,992 Adjustments and reconciling items between loss from operations and net loss consist of interest income and realized and unrealized gains and losses related to our investments in US Treasury securities. 8