Ended the quarter with $47.2 million in cash and investments - expected to fund operations through the end of 2024, including release of topline SAVVE pivotal trial data
IRVINE, CA / ACCESSWIRE / August 3, 2022 / enVVeno Medical Corporation (NASDAQ:NVNO) ('enVVeno' or the 'Company'), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the second quarter ended June 30, 2022. The Company ended the quarter with $47.2 million of cash and investments which is expected to fund the Company through at least the end of 2024.
'We continue to be in a very strong cash position as we progress through the SAVVE pivotal trial for the VenoValve,' commented Robert Berman, CEO of enVVeno Medical. 'As a late-stage clinical, pre-revenue company, we are always mindful of our cash spend and seek to achieve the right balance between conserving our cash and advancing the Company. In this past quarter, our burn of approximately $4.0 million of cash was well within our previous guidance, which includes the SAVVE study, preparations for commercialization, and the development of a second product for the treatment of venous disease.'
Clinical Program Update
The SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial is a prospective, non-blinded, single arm, multi-center trial designed to evaluate the safety and efficacy of the VenoValve as a treatment for deep venous Chronic Venous Insufficiency (CVI). The study will enroll seventy-five (75) patients at top research institutions and vascular practices across the U.S.
CVI occurs when the natural valves inside of the veins fail, causing blood to flow in the wrong direction (reflux), and creating increased pressure inside of the veins of the leg (venous hypertension). CVI can cause the leg to swell, and blood vessels to break, resulting in discoloration, pain, and the breakdown of the skin leading to venous ulcers (open sores) which are difficult to treat. The Company estimates that approximately 2.4 million people in the U.S. have the type of CVI for which the VenoValve is being evaluated. There are currently no effective treatments for patients with deep venous CVI resulting from malfunctioning valves.
Patients suffering from lower leg swelling, pain, non-healing leg sores, enlarged veins, and/or brownish or blueish skin discoloration - who may also have leg pain when standing or walking - may be candidates for the SAVVE trial. Interested patients can learn more about the SAVVE trial and fill out a pre-qualification questionnaire by visiting www.VenoValve.com.
Summary of Financial Results for the Second Quarter 2022
- The Company ended the quarter with $47.2 million in cash and cash equivalents, and investments. Based on management's current expectations, the Company believes it has sufficient cash to sustain operations through the end of 2024.
- The Company's burn rate for the second quarter was $4.0 million, in line with previous guidance of $4.0 - $5.0 million expected cash burn per quarter.
- The Company reported net losses of $7.1 and $2.4 million for the three months ended June 30, 2022 and 2021, respectively, representing an increase in net loss of $4.7 million, or 197%, resulting from an increase in operating expenses.
- For the three months ended June 30, 2022, selling, general and administrative expenses increased by $2.6 million to $3.9 million, compared with $1.3 million for the three months ended June 30, 2021. Of this increase, $2.1 million was due to share based compensation from grants made during 2021, which increased share-based compensation cost to $2.3 million in 2022 from $0.2 million in 2021.
- For the three months ended June 30, 2022, research and development expenses increased by $2.0 million to $3.1 million, compared with $1.1 million for the three months ended June 30, 2021. This increase primarily resulted from $1.4 million in costs related to the SAVVE study, $0.4 million in lab costs to support the SAVVE study and VenoValve continued development, $0.1 million increase in personnel costs due to additional staff, and $0.1 million in travel costs mainly to support the SAVVE study.
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 in the treatment of venous disease. The Company's lead product, the VenoValve®, is a first-in-class implant being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). In healthy patients, valves inside the veins of the leg assist in propelling blood up the leg, and back to the heart and lungs. Affecting approximately 2.4 million people in the United States, 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. Implanted into the femoral vein, the VenoValve is designed to act as a one-way valve, to help restore proper blood flow in the leg. The VenoValve is currently being evaluated in the SAVVE pivotal study.
Cautionary Note on Forward-Looking Statements
This press release and any statements of stockholders, directors, employees, representatives and partners 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 may include, without limitation, 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 those 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.
Jenene Thomas, JTC Team, LLC
SOURCE: enVVeno Medical Corporation
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