enVVeno Medical (NVNO) - 2019 Q1 - Quarterly Report

PART I – FINANCIAL INFORMATION This part presents the company's unaudited interim financial statements and management's analysis of its financial condition ITEM 1. Financial Statements Presents the unaudited condensed financial statements for the three months ended March 31, 2019 and 2018 Condensed Balance Sheets Details the company's financial position, highlighting changes in assets, liabilities, and equity | Metric | March 31, 2019 (unaudited) | December 31, 2018 | | :--------------------------------- | :------------------------- | :------------------ | | Total Current Assets | $2,945,640 | $2,836,973 | | Restricted cash | $810,055 | $- | | Operating lease right-of-use assets, net | $1,030,527 | $- | | Total Assets | $5,488,010 | $3,559,436 | | Total Current Liabilities | $1,838,501 | $1,522,993 | | Total Liabilities | $2,622,963 | $1,522,993 | | Total Stockholders' Equity | $2,865,047 | $2,036,443 | - The increase in restricted cash is due to a court-granted Right to Attach Order for $810,055 related to a legal dispute[11][46] - The adoption of ASC Topic 842 (Leases) effective January 1, 2019, led to the recognition of operating lease right-of-use assets and corresponding lease liabilities[11][53] Unaudited Condensed Statements of Operations Reports a significantly reduced net loss year-over-year due to changes in non-cash financing expenses | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Royalty income | $31,243 | $31,065 | | Selling, general and administrative expenses | $1,300,571 | $1,247,008 | | Research and development expenses | $313,013 | $240,493 | | Loss from Operations | $(1,582,341) | $(1,456,436) | | Amortization of debt discount | $- | $4,569,757 | | Gain on extinguishment of convertible notes payable | $- | $(1,524,791) | | Interest (income) expense, net | $(8,615) | $210,462 | | Net Loss | $(1,573,726) | $(4,747,487) | | Net Loss Per Basic and Diluted Common Share | $(0.13) | $(0.80) | - Net loss decreased by 67% primarily due to the absence of amortization of debt discount and a gain on extinguishment of convertible notes payable in the prior period[13][86][92] - Royalty income remained flat, and the three-year royalty agreement ended on March 18, 2019, indicating future royalty revenue will cease until new product commercialization[13][87] Unaudited Condensed Statements of Changes in Stockholders' Equity (Deficiency) Stockholders' equity increased significantly due to a private placement offering and stock-based compensation | Metric | January 1, 2019 | March 31, 2019 | | :--------------------------------- | :-------------- | :------------- | | Common Stock Shares | 11,722,647 | 14,155,644 | | Common Stock Amount | $117 | $141 | | Additional Paid-in Capital | $50,598,854 | $53,001,160 | | Accumulated Deficit | $(48,562,528) | $(50,136,254) | | Total Stockholders' Equity | $2,036,443 | $2,865,047 | - The company issued 2,347,997 shares of common stock through a private placement offering, contributing $2,317,276 to additional paid-in capital[14] - Stock-based compensation, including amortization of stock options and warrants granted to consultants, added $85,054 to additional paid-in capital[14] Unaudited Condensed Statements of Cash Flows Net cash increased due to proceeds from a private placement offering offsetting cash used in operations | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Net Cash Used in Operating Activities | $(1,493,555) | $(1,625,419) | | Net Cash Used in Investing Activities | $(1,800) | $- | | Net Cash Provided by Financing Activities | $2,317,276 | $1,856,860 | | Net Increase in Cash, Cash Equivalent, and Restricted Cash | $821,921 | $231,441 | | Cash, cash equivalents and restricted cash - End of period | $3,562,566 | $309,129 | - Operating cash outflow improved by $131,864 year-over-year, despite ongoing net losses[17] - Financing activities were significantly boosted by $2,317,276 from a private placement offering in 2019[17] - Non-cash financing activities in 2018 included $1,942,362 for warrants issued with convertible debt and $1,232,199 for embedded conversion options[19] Notes to Unaudited Condensed Financial Statements Provides detailed explanations of accounting policies, financial position, and operational activities Note 1 – Business Organization and Nature of Operations The company develops tissue-based solutions for cardiovascular and peripheral vascular diseases - The company is developing VenoValve (for chronic venous insufficiency) and CoreoGraft (for coronary artery bypass graft surgeries)[21] - The business model involves licensing, selling, or forming strategic alliances with medical device companies[21] - The company operates a 14,507 sq ft FDA-certified manufacturing facility in Irvine, California[21] Note 2 – Going Concern and Management's Liquidity Plan Recurring losses and negative cash flows raise substantial doubt about the company's ability to continue as a going concern | Metric | Three Months Ended March 31, 2019 | March 31, 2019 | | :--------------------------------- | :-------------------------------- | :------------- | | Net Loss | $(1,573,726) | N/A | | Accumulated Deficit | N/A | $(50,136,254) | | Cash Used in Operating Activities | $(1,493,555) | N/A | | Cash Balance | N/A | $2,752,511 | | Restricted Cash | N/A | $810,055 | | Working Capital | N/A | $1,107,139 | - The company expects to continue incurring losses and requires additional capital to sustain operations and product development[23] - Inability to raise capital could force the company to curtail or discontinue operations[24] Note 3 – Significant Accounting Policies Financial statements are prepared under GAAP for interim reporting and rely on management estimates - Financial statements are unaudited and prepared under GAAP for interim reporting, relying on management estimates[27][28] - Basic and diluted net loss per share are identical because potential common stock equivalents are anti-dilutive[30][32] | Revenue Source | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :------------- | :-------------------------------- | :-------------------------------- | | Royalty income | $31,243 | $31,065 | - All revenue for the periods presented was from royalty income, which ceased after March 18, 2019[34][41] Note 4 – Cash, Cash Equivalents and Restricted Cash Total cash, cash equivalents, and restricted cash was $3,562,566, with a significant portion restricted by a court order | Category | March 31, 2019 | December 31, 2018 | | :----------------------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $2,752,511 | $2,740,645 | | Restricted cash | $810,055 | $- | | Total cash, cash equivalents, and restricted cash | $3,562,566 | $2,740,645 | - Restricted cash of $810,055 was due to a Right to Attach Order granted to ATSCO, Inc, which the company plans to appeal[46] Note 5 – Property and Equipment Net property and equipment decreased slightly due to depreciation expense | Category | March 31, 2019 | December 31, 2018 | | :------------------------ | :------------- | :---------------- | | Total property and equipment | $375,043 | $373,244 | | Less: accumulated depreciation | $(350,156) | $(347,091) | | Property and equipment, net | $24,887 | $26,153 | - Depreciation expense for the three months ended March 31, 2019, was $3,065[49] Note 6 – Right-of-Use Assets and Lease Liabilities The adoption of ASC Topic 842 resulted in the recognition of right-of-use assets and lease liabilities - Adoption of ASC Topic 842 on January 1, 2019, led to recording $1,099,400 in right-of-use assets and $1,121,873 in lease liabilities[53] | Metric | Value | | :----------------------------------------- | :------ | | Operating lease cost (3 months ended Mar 31, 2019) | $84,492 | | Cash paid for lease liabilities (3 months ended Mar 31, 2019) | $82,929 | | Remaining lease term (as of Mar 31, 2019) | 4 years | | Discount rate | 8.5% | - The present value of lease liability as of March 31, 2019, is $1,055,563[54] Note 7 – Accrued Expenses and Accrued Interest – Related Party Accrued expenses increased primarily due to higher accrued professional and stock compensation fees | Category | March 31, 2019 | December 31, 2018 | | :-------------------------- | :------------- | :---------------- | | Accrued compensation costs | $274,035 | $288,549 | | Accrued professional fees | $118,138 | $55,300 | | Accrued stock compensation expense | $19,254 | $- | | Accrued expenses (Total) | $438,534 | $412,871 | - Accrued severance expense for the former CFO decreased from $166,154 at year-end 2018 to $92,308 at March 31, 2019[56] Note 8 – Commitments and Contingencies The company is involved in several legal disputes for which it has accrued liabilities - ATSCO, Inc filed a complaint seeking $1,606,820 for disputed invoices related to a tissue supply agreement[58] - A Right to Attach Order for $810,055 was granted to ATSCO, which the company plans to appeal and file a cross-complaint[58] - Gusrae Kaplan Nusbaum PLLC is seeking $178,926 for legal services, which the company is disputing[60] - The company believes it has fully accrued for the outstanding claims as of March 31, 2019[58][60] Note 9 – Stockholders' Equity (Deficiency) The company issued common stock and granted stock-based compensation during the quarter - The company raised $2,704,000 in gross proceeds from a private placement offering of 2,329,615 common shares at $1.15 per share[63] - Issued 85,000 restricted shares to MZ Group for investor relations services, vesting quarterly over a year[62] - Granted five-year warrants to Alere Financial Partners to purchase 35,000 common shares at $1.59[64] - Granted 150,000 non-qualified stock options to VP Regulatory Affairs and Quality Assurances, 30,000 to a Primary Investigator, and 20,000 to a Medical Advisory Board member[68][69][70] | Period | Stock-Based Compensation Expense | | :--------------------------------- | :------------------------------- | | Three months ended March 31, 2019 | $82,720 | | Three months ended March 31, 2018 | $137,376 | - Unrecognized stock-based compensation expense for outstanding stock options was $680,246 as of March 31, 2019, to be recognized over 1.4 years[71] ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Provides management's perspective on financial performance, product development, and liquidity challenges Overview The company is a development-stage entity creating biologic solutions for cardiovascular diseases - The company is developing VenoValve (for chronic venous insufficiency) and CoreoGraft (for coronary artery bypass graft surgeries)[76] - VenoValve is undergoing a small first-in-human study in Colombia, with initial successful implantations reported[82] - CoreoGraft aims to be an off-the-shelf alternative to saphenous vein grafts in CABG surgeries[83][84] - Significant capital is required to complete clinical trials and obtain FDA approval for product candidates[77] Comparison of the three months ended March 31, 2019 and 2018 The company significantly reduced its net loss by 67% year-over-year due to non-cash financing items | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :------- | :-------------------------------- | :-------------------------------- | | Net Loss | $(1,573,726) | $(4,747,487) | - The decrease in net loss was primarily driven by a $4,569,757 decrease in amortization of debt discount and a $219,077 decrease in net interest expense[86] Revenues Royalty income remained flat, but the underlying agreement expired, ceasing this revenue stream | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :------------- | :-------------------------------- | :-------------------------------- | | Royalty income | $31,243 | $31,065 | - All revenue was from a royalty agreement that expired on March 18, 2019[87] - Future revenue is dependent on the commercialization of product candidates[88] Selling, General and Administrative Expenses SG&A expenses increased by 4% due to higher insurance and legal fees, offset by lower labor costs | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | SG&A Expenses | $1,300,571 | $1,247,008 | - Key drivers of the increase were approximately $66,000 in D&O insurance and $86,000 in legal and professional fees[89] - Labor and benefit expenses decreased by approximately $98,000 as personnel shifted focus to R&D[89] Research and Development Expenses R&D expenses increased by 30% to support the VenoValve first-in-human clinical trials | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | R&D Expenses | $313,013 | $240,493 | - The increase is primarily due to costs associated with the VenoValve first-in-human trials in Colombia[90] Interest Expense Net interest expense decreased by 104% following the conversion of all convertible notes in June 2018 | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Interest (income) expense, net | $(8,615) | $210,462 | - The conversion of convertible notes into common stock during the June 2018 IPO eliminated interest expense[91] Amortization of Debt Discount Amortization of debt discount was eliminated following the conversion of convertible notes in June 2018 | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Amortization of debt discount | $- | $4,569,757 | - The absence of this expense is due to the conversion of all convertible notes into common stock during the IPO on June 4, 2018[92] Gain on extinguishment of convertible notes payable No gain was recognized as the notes were converted in June 2018, eliminating extinguishment accounting | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Gain on extinguishment of convertible notes payable | $- | $1,524,791 | - The gain in 2018 resulted from an amendment to the convertible notes, which was deemed a debt extinguishment[93] Change in Fair Value of Derivative Liability No change was recorded as all related derivative liabilities were converted during the June 2018 IPO | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Change in fair value of derivative liabilities | $- | $35,623 | - Derivative liabilities were related to warrants and embedded conversion options, all converted in the June 2018 IPO[94] Deemed Dividend No deemed dividend was recorded as the related preferred stock was converted during the June 2018 IPO | Metric | Three Months Ended March 31, 2019 | Three Months Ended March 31, 2018 | | :--------------------------------- | :-------------------------------- | :-------------------------------- | | Deemed dividend to preferred stockholders | $- | $129,141 | - The deemed dividend in 2018 resulted from the 8% cumulative dividend on Series A and B Preferred Stock, which were converted in the June 2018 IPO[95] Liquidity and Capital Resources The company has a history of losses and requires substantial additional capital to fund operations - As of March 31, 2019, the company had an accumulated deficit of $50,136,254 and negative operating cash flows[96] - A private placement offering on March 12, 2019, raised $2,704,000 in gross proceeds[97] | Metric | March 31, 2019 (unaudited) | December 31, 2018 | | :------------------------ | :------------------------- | :---------------- | | Cash and cash equivalents | $2,752,511 | $2,740,645 | | Restricted Cash | $810,055 | $- | | Working capital | $1,107,139 | $1,313,980 | - The company requires additional capital within one year, indicating substantial doubt about its going concern ability[100] - Failure to obtain additional financing could force cessation of operations or dilute existing stockholders[101] Off-Balance Sheet Arrangements The company has no off-balance sheet arrangements - The company reported no off-balance sheet arrangements[102] Contractual Obligations The company is not required to provide detailed contractual obligations information - The company is exempt from providing detailed contractual obligations as a smaller reporting company[103] Critical Accounting Policies and Estimates Critical accounting policies are described in Note 4 of the financial statements - Critical accounting policies are detailed in Note 4 – Significant Accounting Policies[104] ITEM 3. Quantitative and Qualitative Disclosures About Market Risk The company is not required to provide market risk disclosures - The company is exempt from providing market risk disclosures as a smaller reporting company[106] ITEM 4. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of March 31, 2019 Disclosure Controls and Procedures Management assessed disclosure controls and procedures and concluded they were effective - Disclosure controls and procedures were evaluated and deemed effective as of March 31, 2019[107] Changes in Internal Control over Financial Reporting No material changes to internal control over financial reporting occurred during the quarter - No material changes in internal control over financial reporting occurred during the quarter[108] Inherent Limitations of Controls All control systems have inherent limitations and provide only reasonable assurance - Controls provide only reasonable assurance and are subject to inherent limitations, including human error and circumvention[109] PART II – OTHER INFORMATION This part covers legal proceedings, risk factors, unregistered sales of securities, and other required information ITEM 1. Legal Proceedings The company is actively disputing significant legal claims from a supplier and a legal firm - ATSCO, Inc filed a complaint seeking $1,606,820 for disputed invoices related to a tissue supply agreement[112] - A Right to Attach Order for $810,055 was granted to ATSCO, which the company plans to appeal[112] - Gusrae Kaplan Nusbaum PLLC is seeking $178,926 for legal services, which the company is disputing[113] - The company believes it has numerous meritorious defenses and has fully accrued for these claims[112][113] - A mandatory settlement conference is scheduled for July 26, 2019, and a jury trial for September 9, 2019, for the ATSCO case[112] ITEM 1A. Risk Factors The company is not required to provide risk factor information in this Form 10-Q - The company is exempt from providing risk factor disclosures in this 10-Q as a smaller reporting company[116] - Current risk factors are detailed in the company's Form 10-K filed on March 14, 2019[116] ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds The company engaged in several unregistered sales of equity securities to raise capital and for services - Issued five-year warrants to Alere Financial Partners to purchase 35,000 common shares at $1.59[117] - Issued 85,000 restricted shares to MZ Group for investor relations advisory services[118] - Raised $2,704,000 in gross proceeds from a private placement offering of 2,329,615 common shares at $1.15 per share[119] - The CEO participated in the private placement, purchasing 18,382 shares at a price of $1.36 per share[119] - The placement agent received a cash fee and a warrant to purchase 188,108 shares[119] - Proceeds will fund VenoValve and CoreoGraft development, working capital, and general corporate purposes[119] ITEM 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities - No defaults upon senior securities were reported[121] ITEM 4. Mine Safety Disclosures This item is not applicable to the company - Mine safety disclosures are not applicable to the company[122] ITEM 5. Other Information The company reported no other information required under this item - No other information was reported[123] ITEM 6. Exhibits This section lists the exhibits filed as part of this Form 10-Q - Includes certifications from the CEO and CFO (Exhibits 31.1, 31.2, 32)[126] - Contains XBRL Instance Document and Taxonomy Extension documents (Exhibits 101.INS, SCH, CAL, DEF, LAB, PRE)[126] Signatures The report is certified and signed by the Chief Executive Officer and Chief Financial Officer - The report was signed by the CEO and CFO on May 9, 2019[129]