Up to an additional $34 million of capital may become available from milestone-driven warrants in Q2, 2024 upon the release of initial topline efficacy data from the VenoValve pivotal trial

Up to an additional $41 million of capital may become available from milestone-driven warrants upon expected FDA pre-market approval of the VenoValve

IRVINE, CA / ACCESSWIRE / October 6, 2023 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today announced that it has entered into a securities purchase agreement with certain healthcare focused institutional investors for approximately $28 million of gross proceeds. The private placement is being conducted as an at-the-market offering under Nasdaq rules at a purchase price per share of common stock and warrants of $5.806.

The transaction was led by Perceptive Advisors with participation from Nantahala Capital, Kingdon Capital Management, Velan Capital, L1 Capital and other new and existing institutional investors.

"We are pleased to secure funding from well-respected, institutional healthcare investors in order to significantly reduce our capital risk through the end of 2025," commented Robert Berman, CEO of enVVeno Medical. "This financing has the potential to fund the Company well past several significant milestones, including the release of initial topline efficacy data from SAVVE, what we anticipate will be FDA pre-market approval of the VenoValve, the beginning of preparations for VenoValve commercialization, and our plans to fast-track and begin the pivotal trial for enVVe, our transcatheter based replacement venous valve."

Milestone-driven warrants that were issued as part of the transaction could bring in up to approximately $34 million of additional capital within 30 days of the release of initial topline efficacy data from the SAVVE U.S. pivotal trial for the VenoValve, expected in Q2 of 2024, and up to approximately $40 million of additional capital within 30 days of FDA pre-market approval for the VenoValve, expected in Q2 of 2025. With the full exercise of both sets of milestone-driven warrants, the financing has the potential to generate $103 million of gross proceeds.

The two subsequent potential financing tranches in the form of milestone-driven warrants are priced at $6.945 and $8.334, respectively, and will expire on the 1-year and 3-year anniversary of the date of issuance, respectively, if the milestones above are not achieved.

Ladenburg Thalman Co. Inc. is acting as exclusive placement agent in connection with the offering.

The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. enVVeno has agreed to file a registration statement with the Securities and Exchange Commission within 15 days of closing to register the resale of the shares of common stock and the shares of common stock underlying the warrants issued in this private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About enVVeno Medical Corporation
enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, 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 venous disease. The Company's lead product, the VenoValve®, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter-based replacement venous valve for the treatment of deep venous CVI called enVVe™. CVI occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal study and the company is currently waiting for regulatory approval to begin the TAVVE early feasibility study for enVVe.

Cautionary Note on Forward-Looking Statements
This press release and any statements of officers and directors of enVVeno Medical Corporation (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 include, without limitation, statements related to the closing of this offering, the exercise of the warrants and receipt the proceeds therefrom, the ability for the Company to utilize the financing to fund operations well past several significant milestones, the Company's ability to achieve the various milestones indicated herein and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including, but not limited, to market conditions and those other risks detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.

INVESTOR CONTACT:
Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(833) 475-8247

SOURCE: enVVeno Medical Corporation