Financial Performance - The company reported a net loss of $24.7 million for the year ended December 31, 2022, compared to a net loss of $16.5 million in 2021, representing an increase of 50% or $8.2 million [183]. - Selling, general and administrative expenses rose by 34% to $15.0 million in 2022 from $11.2 million in 2021, with share-based compensation costs increasing to $9.0 million from $6.0 million [184]. - The company has not generated any revenue and does not expect to do so in the near term, as future revenue depends on the commercialization of product candidates [182]. Research and Development - Research and development expenses increased by 74% to $9.9 million in 2022 from $5.7 million in 2021, primarily due to costs associated with the SAVVE trial and preparation for the enVVe first-in-human trial [187]. Cash and Investments - The company has a cash balance of $4.6 million and $34.5 million in investments, totaling $39.1 million in cash and investments as of December 31, 2022 [194]. - The company expects to have sufficient cash to fund operations through the end of 2024 and into 2025, with a cash burn rate of approximately $4 million to $5 million per quarter [195]. - The company plans to continue investing in U.S. Treasury bills, having purchased $48.1 million in 2022, generating $0.2 million in realized gains and interest income [192]. Product Development - The lead product, VenoValve®, is currently being evaluated in a U.S. pivotal study, with expectations for FDA approval ahead of the enVVe product [179]. - The company anticipates that the VenoValve and enVVe will co-exist post-approval, addressing a significant unmet need in the treatment of deep venous chronic venous insufficiency [180]. Operations - The company operates from a 14,507 sq. ft. ISO 13485-2020 certified facility in Irvine, California, focused on the design and manufacturing of tissue-based implantable medical devices [181].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 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 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-09361 ...

| --- | --- | --- | --- | |-------|-------|-------|-------| | | | | | | | | | | Legal Disclaimers This presentation and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements m ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 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 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) (State or other jurisdiction of inco ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38325 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-0936180 (State or other jurisdiction of incorporation or organization) Identification No.) For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANG ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 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 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-0936180 (State ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 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 enVVeno Medical Corporation (Exact name of registrant as specified in its charter) Delaware 33-09361 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 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) | 33-0936180 | | ...

HANCOCK JAFFE L A B O R A T O R I E S Nasdaq: HJLI May 2021 Setting New Standards for Venous Care Ladenburg Thalmann 2021 Healthcare Conference July 13, 2021 Robert Berman, Chief Executive Officer Legal Disclaimers This presentation contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements are not statements of historical facts, but rather reflect HJLI's curre ...

[ ] 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 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR Hancock Jaffe Laboratories, Inc. (Exact name of registrant as specified in its charter) Delaware 33- ...