[PART I – FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents the company's unaudited interim financial statements and management's analysis of its financial condition [ITEM 1. Financial Statements](index=4&type=section&id=ITEM%201.%20Financial%20Statements) Presents the unaudited condensed financial statements for the three months ended March 31, 2019 and 2018 [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets%20as%20of%20March%2031%2C%202019%20(unaudited)%20and%20December%2031%2C%202018) 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](index=11&type=chunk)[46](index=46&type=chunk) - 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](index=11&type=chunk)[53](index=53&type=chunk) [Unaudited Condensed Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations%20for%20the%20three%20months%20ended%20March%2031%2C%202019%20and%202018) 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](index=13&type=chunk)[86](index=86&type=chunk)[92](index=92&type=chunk) - 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](index=13&type=chunk)[87](index=87&type=chunk) [Unaudited Condensed Statements of Changes in Stockholders' Equity (Deficiency)](index=6&type=section&id=Unaudited%20Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficiency)%20for%20the%20three%20months%20ended%20March%2031%2C%202019%20and%202018) 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](index=14&type=chunk) - Stock-based compensation, including amortization of stock options and warrants granted to consultants, added **$85,054** to additional paid-in capital[14](index=14&type=chunk) [Unaudited Condensed Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20three%20months%20ended%20March%2031%2C%202019%20and%202018) 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](index=17&type=chunk) - Financing activities were significantly boosted by **$2,317,276** from a private placement offering in 2019[17](index=17&type=chunk) - 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](index=19&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Provides detailed explanations of accounting policies, financial position, and operational activities [Note 1 – Business Organization and Nature of Operations](index=9&type=section&id=Note%201%20%E2%80%93%20Business%20Organization%20and%20Nature%20of%20Operations) 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](index=21&type=chunk) - The business model involves licensing, selling, or forming strategic alliances with medical device companies[21](index=21&type=chunk) - The company operates a **14,507 sq ft** FDA-certified manufacturing facility in Irvine, California[21](index=21&type=chunk) [Note 2 – Going Concern and Management's Liquidity Plan](index=9&type=section&id=Note%202%20%E2%80%93%20Going%20Concern%20and%20Management's%20Liquidity%20Plan) 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](index=23&type=chunk) - Inability to raise capital could force the company to **curtail or discontinue operations**[24](index=24&type=chunk) [Note 3 – Significant Accounting Policies](index=10&type=section&id=Note%203%20%E2%80%93%20Significant%20Accounting%20Policies) 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](index=27&type=chunk)[28](index=28&type=chunk) - Basic and diluted net loss per share are identical because potential common stock equivalents are **anti-dilutive**[30](index=30&type=chunk)[32](index=32&type=chunk) | 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](index=34&type=chunk)[41](index=41&type=chunk) [Note 4 – Cash, Cash Equivalents and Restricted Cash](index=13&type=section&id=Note%204%20%E2%80%93%20Cash%2C%20Cash%20Equivalents%20and%20Restricted%20Cash) 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](index=46&type=chunk) [Note 5 – Property and Equipment](index=13&type=section&id=Note%205%20%E2%80%93%20Property%20and%20Equipment) 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](index=49&type=chunk) [Note 6 – Right-of-Use Assets and Lease Liabilities](index=14&type=section&id=Note%206%20%E2%80%93%20Right-of-Use%20Assets%20and%20Lease%20Liabilities) 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](index=53&type=chunk) | 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](index=54&type=chunk) [Note 7 – Accrued Expenses and Accrued Interest – Related Party](index=15&type=section&id=Note%207%20%E2%80%93%20Accrued%20Expenses%20and%20Accrued%20Interest%20%E2%80%93%20Related%20Party) 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](index=56&type=chunk) [Note 8 – Commitments and Contingencies](index=15&type=section&id=Note%208%20%E2%80%93%20Commitments%20and%20Contingencies) 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](index=58&type=chunk) - A Right to Attach Order for **$810,055** was granted to ATSCO, which the company plans to appeal and file a cross-complaint[58](index=58&type=chunk) - Gusrae Kaplan Nusbaum PLLC is seeking **$178,926** for legal services, which the company is disputing[60](index=60&type=chunk) - The company believes it has **fully accrued** for the outstanding claims as of March 31, 2019[58](index=58&type=chunk)[60](index=60&type=chunk) [Note 9 – Stockholders' Equity (Deficiency)](index=16&type=section&id=Note%209%20%E2%80%93%20Stockholders'%20Equity%20(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](index=63&type=chunk) - Issued **85,000 restricted shares** to MZ Group for investor relations services, vesting quarterly over a year[62](index=62&type=chunk) - Granted five-year warrants to Alere Financial Partners to purchase **35,000 common shares** at $1.59[64](index=64&type=chunk) - 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](index=68&type=chunk)[69](index=69&type=chunk)[70](index=70&type=chunk) | 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](index=71&type=chunk) [ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Provides management's perspective on financial performance, product development, and liquidity challenges [Overview](index=18&type=section&id=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](index=76&type=chunk) - VenoValve is undergoing a small first-in-human study in Colombia, with **initial successful implantations** reported[82](index=82&type=chunk) - CoreoGraft aims to be an **off-the-shelf alternative** to saphenous vein grafts in CABG surgeries[83](index=83&type=chunk)[84](index=84&type=chunk) - **Significant capital** is required to complete clinical trials and obtain FDA approval for product candidates[77](index=77&type=chunk) [Comparison of the three months ended March 31, 2019 and 2018](index=20&type=section&id=Comparison%20of%20the%20three%20months%20ended%20March%2031%2C%202019%20and%202018) 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](index=86&type=chunk) [Revenues](index=20&type=section&id=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](index=87&type=chunk) - Future revenue is **dependent on the commercialization** of product candidates[88](index=88&type=chunk) [Selling, General and Administrative Expenses](index=20&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses) 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](index=89&type=chunk) - Labor and benefit expenses decreased by approximately **$98,000** as personnel shifted focus to R&D[89](index=89&type=chunk) [Research and Development Expenses](index=20&type=section&id=Research%20and%20Development%20Expenses) 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](index=90&type=chunk) [Interest Expense](index=20&type=section&id=Interest%20Expense) 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](index=91&type=chunk) [Amortization of Debt Discount](index=21&type=section&id=Amortization%20of%20Debt%20Discount) 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](index=92&type=chunk) [Gain on extinguishment of convertible notes payable](index=21&type=section&id=Gain%20on%20extinguishment%20of%20convertible%20notes%20payable) 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](index=93&type=chunk) [Change in Fair Value of Derivative Liability](index=21&type=section&id=Change%20in%20Fair%20Value%20of%20Derivative%20Liability) 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](index=94&type=chunk) [Deemed Dividend](index=21&type=section&id=Deemed%20Dividend) 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](index=95&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=96&type=chunk) - A private placement offering on March 12, 2019, raised **$2,704,000** in gross proceeds[97](index=97&type=chunk) | 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](index=100&type=chunk) - Failure to obtain additional financing could force **cessation of operations** or dilute existing stockholders[101](index=101&type=chunk) [Off-Balance Sheet Arrangements](index=22&type=section&id=Off-Balance%20Sheet%20Arrangements) The company has no off-balance sheet arrangements - The company reported **no off-balance sheet arrangements**[102](index=102&type=chunk) [Contractual Obligations](index=22&type=section&id=Contractual%20Obligations) 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](index=103&type=chunk) [Critical Accounting Policies and Estimates](index=22&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Critical accounting policies are described in Note 4 of the financial statements - Critical accounting policies are detailed in **Note 4 – Significant Accounting Policies**[104](index=104&type=chunk) [ITEM 3. Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=106&type=chunk) [ITEM 4. Controls and Procedures](index=23&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2019 [Disclosure Controls and Procedures](index=23&type=section&id=Disclosure%20Controls%20and%20Procedures) 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](index=107&type=chunk) [Changes in Internal Control over Financial Reporting](index=23&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) 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](index=108&type=chunk) [Inherent Limitations of Controls](index=23&type=section&id=Inherent%20Limitations%20of%20Controls) 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](index=109&type=chunk) [PART II – OTHER INFORMATION](index=24&type=section&id=PART%20II%20OTHER%20INFORMATION) This part covers legal proceedings, risk factors, unregistered sales of securities, and other required information [ITEM 1. Legal Proceedings](index=24&type=section&id=ITEM%201.%20Legal%20Proceedings) 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](index=112&type=chunk) - A Right to Attach Order for **$810,055** was granted to ATSCO, which the company plans to appeal[112](index=112&type=chunk) - Gusrae Kaplan Nusbaum PLLC is seeking **$178,926** for legal services, which the company is disputing[113](index=113&type=chunk) - The company believes it has numerous meritorious defenses and has **fully accrued** for these claims[112](index=112&type=chunk)[113](index=113&type=chunk) - A mandatory settlement conference is scheduled for July 26, 2019, and a jury trial for September 9, 2019, for the **ATSCO case**[112](index=112&type=chunk) [ITEM 1A. Risk Factors](index=25&type=section&id=ITEM%201A.%20Risk%20Factors) 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](index=116&type=chunk) - Current risk factors are detailed in the company's **Form 10-K filed on March 14, 2019**[116](index=116&type=chunk) [ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=117&type=chunk) - Issued **85,000 restricted shares** to MZ Group for investor relations advisory services[118](index=118&type=chunk) - Raised **$2,704,000** in gross proceeds from a private placement offering of **2,329,615 common shares** at $1.15 per share[119](index=119&type=chunk) - The **CEO participated** in the private placement, purchasing 18,382 shares at a price of $1.36 per share[119](index=119&type=chunk) - The placement agent received a cash fee and a warrant to purchase **188,108 shares**[119](index=119&type=chunk) - Proceeds will fund **VenoValve and CoreoGraft development**, working capital, and general corporate purposes[119](index=119&type=chunk) [ITEM 3. Defaults Upon Senior Securities](index=26&type=section&id=ITEM%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities - **No defaults** upon senior securities were reported[121](index=121&type=chunk) [ITEM 4. Mine Safety Disclosures](index=26&type=section&id=ITEM%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine safety disclosures are **not applicable** to the company[122](index=122&type=chunk) [ITEM 5. Other Information](index=26&type=section&id=ITEM%205.%20Other%20Information) The company reported no other information required under this item - **No other information** was reported[123](index=123&type=chunk) [ITEM 6. Exhibits](index=26&type=section&id=ITEM%206.%20Exhibits) 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](index=126&type=chunk) - Contains **XBRL Instance Document** and Taxonomy Extension documents (Exhibits 101.INS, SCH, CAL, DEF, LAB, PRE)[126](index=126&type=chunk) [Signatures](index=27&type=section&id=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](index=129&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2018 OR [ ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ___________________ Commission file number: 001-38325 Hancock Jaffe Laboratories, Inc. (Exact name of registrant as specified in its charter) Delaware 33-09361 ...