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EnVVeno Medical Reports First Quarter 2024 Financial Results and Provides Corporate Update

EnVVeno Medical Reports First Quarter 2024 Financial Results and Provides Corporate Update

EnvVeno Medical公佈2024年第一季度財務業績並提供公司最新情況
Accesswire ·  05/09 04:15

- Ended the quarter with $42.9 million cash and investments on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025
- Positive 11-month topline efficacy data presented at the 46th Annual Charing Cross Symposium
- Company on track to file PMA Application seeking VenoValve FDA approval in Q4 2024

-本季度末,手頭有4,290萬美元的現金和投資足以爲當前業務提供資金,包括到2025年底的多個價值驅動里程碑
-在 46 屆會議上公佈了 11 個月的正面療效數據th 年度查林十字研討會
-公司有望在 2024 年第四季度提交 PMA 申請,尋求 VenoValve FDA 的批准

IRVINE, CA / ACCESSWIRE / May 8, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today reported financial results for the first quarter 2024.

加利福尼亞州爾灣/ACCESSWIRE/2024年5月8日/制定靜脈疾病治療新護理標準的公司EnvVeno Medical Corporation(納斯達克股票代碼:NVNO)(“EnvVeno” 或 “公司”)今天公佈了2024年第一季度的財務業績。

"We continue to generate and present extremely encouraging data for the VenoValve at leading vascular conferences throughout the world and are in the final stages of accumulating the data necessary to file for PMA approval later this year. We recently added Andrew Cormack to our senior management team as our Chief Commercial Officer and will continue to make changes and additions to prepare for commercialization and what we hope will be FDA approval for the VenoValve," commented Robert Berman, CEO of enVVeno Medical. "Importantly, we have maintained our strong financial position and moving forward, have the capital that we need to take the Company through several key milestones."

“我們繼續在全球領先的血管會議上生成和提供有關VenoValve的極其令人鼓舞的數據,並且正處於積累今年晚些時候申請PMA批准所需數據的最後階段。EnvVeno Medical首席執行官羅伯特·伯曼評論說:“我們最近將安德魯·科馬克加入我們的高級管理團隊,擔任首席商務官,並將繼續進行修改和補充,爲商業化做準備,我們希望VenoVelve獲得美國食品藥品管理局的批准。”“重要的是,我們保持了強勁的財務狀況,向前邁進,擁有帶領公司度過幾個關鍵里程碑所需的資金。”

Recent Corporate Highlights

近期企業要聞

  • Appointed Andrew Cormack as its Chief Commercial Officer.
  • 任命安德魯·科馬克爲其首席商務官。

Clinical Program Highlights

臨床項目亮點

VenoValve: Surgical Replacement Venous Valve

VenoValve:手術替代靜脈瓣膜

  • Positive 11-month topline efficacy data from SAVVE showing significant clinical improvement from SAVVE U.S. pivotal trial presented at the 46th Annual Charing Cross Symposium:
    • Overall, 8.46 average revised Venous Clinical Severity Score (rVCSS) Improvement per patient for patients showing Clinical Meaningful Benefit (rVCSS Improvement 3 Points) including:
      • 9.29 points for patients at the two-year milestone
      • 8.08 points for patients at the one-year milestone
      • 8.71 points for patients at the six-month milestone
    • 94% of the study patients receiving the VenoValve have shown clinical improvement as measured by rVCSS at a weighted-average patient follow-up of 11.04 months.
    • 72% of the study patients have improved the three or more rVCSS points needed to demonstrate the VenoValve's Clinical Meaningful Benefit, at a weighted-average patient follow-up of 11.64 months.
    • Total patient follow-up was 762 months and 582 months, respectively, for the two patient cohorts.
  • Company on Track to File Application Seeking VenoValve FDA Approval in Q4 2024.
  • 來自SAVVE的11個月積極的頂級療效數據顯示,與46年上發佈的SAVVE美國關鍵試驗相比,臨床效果顯著改善th 年度查林十字研討會:
    • 總體而言,對於顯示臨床有意義益處(rvCSS 改善 3 分)的患者,每位患者的經修訂的靜脈臨床嚴重程度評分 (rvCSs) 的平均改善幅度爲 8.46,包括:
      • 達到兩年裏程碑的患者得分爲9.29分
      • 達到一年裏程碑的患者獲得 8.08 分
      • 達到六個月里程碑的患者得分爲8.71分
    • 根據RVCs的測量,在接受VenoValve的研究患者中,有94%的臨床改善,加權平均患者隨訪時間爲11.04個月。
    • 72%的研究患者已經改善了證明VenoValve臨床有意義益處所需的三個或更多RVCs點,而加權平均患者隨訪時間爲11.64個月。
    • 兩組患者的總隨訪時間分別爲762個月和582個月。
  • 公司有望在2024年第四季度提交申請,尋求VenoValve FDA的批准。

enVVe:Non-surgical Transcatheter Based Replacement Venous Valve and Delivery System

envve: 基於非手術經導管的置換靜脈瓣膜和輸送系統

  • Initial bench testing and acute pre-clinical testing for the enVVe valve were very successful.
  • The Company is now making final adjustments to make it easier to load the enVVe valve into the enVVe delivery system.
  • enVVe valves and enVVe delivery systems are currently being manufactured to start a six-month chronic GLP study, which the Company expects to begin in Q3 of 2024.
  • The GLP study should be the final step necessary before filing the IDE seeking FDA approval to start the enVVe pivotal study.
  • The Company expects to file the IDE in Q2 of 2025.
  • EnvVE 閥門的初始臺架測試和急性臨床前測試非常成功。
  • 該公司現在正在進行最後的調整,以便更輕鬆地將EnvVe閥門加載到EnvVE輸送系統中。
  • 目前正在生產EnvVe閥門和EnvVe輸送系統,以啓動一項爲期六個月的慢性GLP研究,該公司預計該研究將於2024年第三季度開始。
  • GLP研究應該是提交IDE尋求美國食品藥品管理局批准以啓動EnvVE關鍵研究之前的最後一步。
  • 該公司預計將在2025年第二季度提交IDE。

Summary of Financial Results for the First Quarter 2024

2024年第一季度財務業績摘要

The Company ended the quarter with $42.9 million in cash and investments. Based on management's current expectations, this capital has the potential to fund the Company through several significant milestones, including the release of initial topline efficacy data from SAVVE, anticipated FDA pre-market approval of the VenoValve, the beginning of preparations for VenoValve commercialization and accelerated plans for the pivotal trial for enVVe.

該公司在本季度末擁有4,290萬美元的現金和投資。根據管理層目前的預期,這筆資金有可能通過幾個重要的里程碑爲公司提供資金,包括SAVVE發佈的初步主要療效數據,預計美國食品藥品管理局對VenoValve的上市前批准,開始爲VenoValve商業化做準備,以及加快EnvVE關鍵試驗的計劃。

Cash burn for the quarter was $3.5 million, better than the Company's projected cash burn rate of approximately $4-5 million per quarter.

該季度的現金消耗爲350萬美元,好於公司預計的每季度約400萬至500萬美元的現金消耗率。

The Company reported net losses of $5.0 million and $6.4 million for the three months ended March 31, 2024 and 2023, respectively, representing a decrease in net loss of $1.4 million or 22%, resulting from, as described in further detail below, a decrease in operating expenses of $1.3 million, and an increase in other income of $0.1 million.

該公司報告稱,截至2024年3月31日和2023年3月31日的三個月,淨虧損分別爲500萬美元和640萬美元,淨虧損減少了140萬美元,下降了22%,具體原因是運營費用減少了130萬美元,其他收入增加了10萬美元。

For the three months ended March 31, 2024, selling, general and administrative expenses decreased $0.7 million or 22%, to $2.5 million from $3.2 million for the three months ended March 31, 2023. This was due to share-based compensation, which decreased to $1.2 million in 2024 from $1.9 million in 2023, primarily because of the expense associated with grants made in 2021, which was $0.7 million lower in 2024 than in 2023.

在截至2024年3月31日的三個月中,銷售、一般和管理費用從截至2023年3月31日的三個月的320萬美元下降了70萬美元,下降了22%,至250萬美元。這是由於基於股份的薪酬從2023年的190萬美元降至2024年的120萬美元,這主要是由於與2021年撥款相關的支出比2023年減少了70萬美元。

For the three months ended March 31, 2024, research and development expenses decreased by $0.5 million or 14%, to $3.1 million from $3.6 million for the three months ended March 31, 2023. This decrease primarily resulted from $0.9 million in lower costs related the SAVVE study as the study was fully enrolled during 2023 resulting in the reduction of outreach and enrollment related activities and related costs. This decrease was offset by $0.3 million increase in personnel costs to support SAVVE and enVVe development, and $0.2 million in lab costs related to enVVe development.

在截至2024年3月31日的三個月中,研發費用從截至2023年3月31日的三個月的360萬美元減少了50萬美元,下降了14%,至310萬美元。減少的主要原因是與SAVVE研究相關的成本降低了90萬美元,因爲該研究在2023年已全部入學,從而減少了與外聯和招生相關的活動及相關費用。支持SAVVE和EnvVE開發的人員成本增加了30萬美元,以及與EnvVE開發相關的實驗室成本增加了20萬美元,抵消了這一減少。

About enVVeno Medical Corporation

關於 EnvVeno 醫療公司

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 potential 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 trial and the Company is currently performing the final testing necessary to seek approval for the enVVe pivotal trial.

EnvVeno Medical(納斯達克股票代碼:NVNO)是一家總部位於加利福尼亞州爾灣的臨床後期醫療器械公司,專注於開發創新的生物假體(基於組織)的解決方案,以提高靜脈疾病治療的護理標準。該公司的主要產品VenoValve是潛在的首款手術替代靜脈瓣膜,正在開發用於治療深靜脈慢性靜脈功能不全(CVI)。該公司還在開發一種名爲EnvVe的非手術、基於經導管的替代靜脈瓣膜,用於治療深靜脈CVI。CVI 發生在腿部靜脈內的瓣膜受損,導致血液向後流動(回流)、小腿血液積聚、腿部靜脈壓力增加(靜脈高血壓),嚴重時會出現難以癒合的靜脈潰瘍變爲慢性。VenoValve和EnvVe都被設計爲充當單向瓣膜,以幫助將血液推向腿部,然後流回心臟和肺部。目前正在SAVVE美國關鍵試驗中對VenoValve進行評估,該公司目前正在進行必要的最終測試,以尋求EnvVE關鍵試驗的批准。

Cautionary Note on Forward-Looking Statements

關於前瞻性陳述的警示說明

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.

本新聞稿以及與之相關的EnvVeno Medical Corporation(“公司”)股東、董事、員工、代表和合作夥伴的任何聲明都包含或可能包含1995年《私人證券訴訟改革法》所指的某些 “前瞻性陳述”。此類前瞻性陳述涉及重大風險和不確定性。此類陳述可能包括但不限於由 “項目”、“可能”、“將”、“可以”、“將”、“應該”、“相信”、“期望”、“預期”、“預期”、“估計”、“打算”、“計劃”、“潛力” 或類似表述等詞語識別的陳述。這些陳述基於公司管理層當前的信念和預期,存在重大風險和不確定性,包括公司向美國證券交易委員會提交的文件中詳述的風險和不確定性。實際結果和時間可能與前瞻性陳述中列出或暗示的結果和時機有很大不同。前瞻性陳述涉及某些風險和不確定性,這些風險和不確定性可能會因各種因素而發生變化(其中許多因素是公司無法控制的)。除非適用法律要求,否則公司沒有義務公開更新任何前瞻性陳述,無論是由於新信息、未來陳述還是其他原因。

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INVESTOR CONTACT:

投資者聯繫人:

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

JTC Team, LLC 珍妮·托馬斯
NVNO@jtcir.com
(833) 475-8247

SOURCE: enVVeno Medical Corporation

來源:envVeno Medical Corporation


譯文內容由第三人軟體翻譯。


以上內容僅用作資訊或教育之目的,不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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