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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

截至2025年底,現金和投資可滿足當前運營和多個價值創造里程碑,總額達到$42.9百萬。
- 在第46屆年度查令十字圓桌研討會上,宣佈了爲期11個月的前線療效數據。th第46屆年度查令十字圓桌研討會介紹的前11個月前線療效數據呈陽性。
公司將於2024年第四季度提出PMA申請,尋求VenoValve獲得FDA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.

2024年第一季度,總部位於IRVINE、上市編碼爲Nasdaq:NVNO的enVVeno醫療公司(以下簡稱"enVVeno"或"公司")報道了財務業績。enVVeno公司正在爲緩解靜脈病的治療制定新的醫療標準。

"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."

enVVeno Medical的CEO Robert Berman評論道:"我們持續在世界範圍內的主流血管會議上展示VenoValve非常鼓舞人心的數據,並處於累積必要數據的最後階段,以便今年晚些時候申請PMA批准。我們最近聘請Andrew Cormack作爲首席商業官加入高級管理團隊,並將繼續進行變革和增加以準備商業化以及希望VenoValve獲得FDA批准的未來。重要的是,我們保持了強勁的財務狀況,並在未來前進過程中具備了需要推動公司發展的資本。"

Recent Corporate Highlights

最新公司亮點

  • Appointed Andrew Cormack as its Chief Commercial Officer.
  • 任命Andrew Cormack爲首席商業官。

Clinical Program Highlights

臨床項目亮點

VenoValve: Surgical Replacement Venous Valve

VenoValve:手術替換靜脈瓣膜。

  • 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.
  • 在SAVVE的正向11個月前線療效數據中,46屆年度查令十字圓桌研討會上宣佈其在SAVVE的臨床試驗中取得了顯著的臨床改善,表明具有臨床意義的患者(靜脈臨床嚴重度評分改良3分)的平均靜脈臨床嚴重度評分改良爲8.46分,其中包括:th- 年度查令十字圓桌研討會上宣佈。
    • - 每位患者的療效改善,其臨床意義顯著(靜脈臨床嚴重度評分改良3分),平均改善9.29分(2年)、8.08分(1年)和8.71分(6個月)。
      • - 平均相對於治療前每位患者的靜脈臨床嚴重度評分改善爲8.71分,並且94%的研究患者接受了VenoValve治療後顯示出療效改善。
      • - 在不堪重壓的兩個病人隊列中的研究,72%的病人具有靜脈臨床嚴重度評分改善3分或更多,並且其患者隨訪時間加權平均值爲11.64月。
      • 總患者隨訪時間分別爲762個月和582個月。
    • 公司正在按計劃準備在2024年第四季度申請VenoValve獲得FDA批准。
    • 在加權平均患者隨訪11.64個月的時間裏,研究患者中有72%的人改善了需要證明VenoValve的臨床顯着益處的三個或更多的rVCSS分數。
    • 兩個病人隊列的總體患者隨訪時間分別爲762個月和582個月。
  • 公司計劃在2024年第四季度申請尋求VenoValve獲得FDA批准。

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

enVVe:無手術介入替換靜脈瓣和輸送系統

  • 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瓣的初始臺架和急性臨床前測試非常成功。
  • 該公司現在正在進行最後調整,以使enVVe瓣更容易裝入enVVe輸送系統。
  • enVVe瓣和enVVe輸送系統目前正在進行製造,以啓動爲期六個月的慢性GLP研究,該公司預計將於2024年第三季度開始。
  • GLP研究應該是在提交IDE尋求FDA批准開始enVVe關鍵研究之前必需的最後一步。
  • 公司預計將於2025年第二季度提交IDE申請。

Summary of Financial Results for the First Quarter 2024

2024年第一季度財務業績總結

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.

公司以4290萬美元的現金和投資收入結束了本季度。根據管理層的當前預期,該資本有可能爲公司提供數個重要階段的資金支持,包括SAVVE初期有效性數據的發佈、預計的VenoValve獲得FDA前市場批准、爲VenoValve商業化做準備,並加速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.

本季度現金燃盡率爲350萬美元,好於公司預計的每個季度400-500萬美元的現金燃盡率。

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.

公司報告2024年3月31日和2023年3月31日的淨虧損額分別爲500萬美元和640萬美元,相較於以往淨虧損額減少了140萬美元或22%。這是由於營業費用減少了130萬美元,而其他收入增加了0.1萬美元造成的,具體內容將在下面詳細描述。

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.

截至2024年3月31日的三個月內,銷售、一般和管理費用下降了0.7萬美元或22%,從2023年3月31日的320萬美元降至2024年3月31日的250萬美元。這是由於股份補償下降,2024年股份補償爲120萬美元,2023年股份補償爲190萬美元,主要是由於2021年授予的股份授予費用在2024年比2023年低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.

截至2024年3月31日的三個月內,研究和開發費用下降了0.5萬美元或14%,從2023年3月31日的360萬美元降至2024年3月31日的310萬美元。這主要是由於SAVVE研究的相關成本降低了0.9萬美元,因爲研究在2023年已全額招募,導致招募和相關費用的減少,抵消了0.3萬美元的人事成本增加,以支持SAVVE和enVVe的開發,以及0.2萬美元與enVVe開發相關的實驗室成本的增加。

About enVVeno Medical Corporation

關於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 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晚期臨床階段醫療器械公司,專注於推進創新的生物義肢(基於組織的)解決方案,以改善治療靜脈疾病的標準。該公司的主要產品VenoValve是一種潛在的首創外科替代靜脈瓣膜,用於治療深靜脈慢性靜脈功能不全(CVI)。該公司還開發基於非手術的介入替換靜脈瓣:enVVe,用於治療深靜脈CVI。當腿部的靜脈內瓣膜損壞時,CVI會發生,導致血液回流(反流)、血液滯留於下肢,靜脈高壓以及在嚴重情況下難以癒合並變爲慢性的靜脈潰瘍。VenoValve和enVVe都設計爲單向閥門,以幫助推動血液上行到腿部,並返回心臟和肺部。目前,VenoValve正處於SAVVE美國關鍵試驗中的評估階段,該公司正在進行最終測試,以尋求enVVe關鍵試驗的批准。

Cautionary Note on Forward-Looking Statements

前瞻性聲明的警示說明

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enVVeno Medical Corporation(以下簡稱“公司”)的股東、董事、員工、代表和合作夥伴有關的任何聲明可能包含或可能包含其他內容,除此之外,還包含某些《1995年私人證券訴訟改革法》規定的重要風險和不確定性。這種前瞻性聲明可能包括無關語句,例如“計劃”、“可能”、“將”,“可能”,“應該”,“相信”、“期望”、“預期”、“估計”、“意圖”、“計劃”、“潛力”或類似表達。這些聲明基於公司管理層的當前信仰和期望,並且受到重大的風險和不確定性的影響,包括那些在公司向證券交易委員會提交的文件中詳細描述的風險和不確定性。實際結果和時間可能會與前瞻性聲明所設定或暗示的結果和時間顯著不同。前瞻性聲明涉及某些風險和不確定性,這些風險和不確定性可能基於各種因素髮生變化(其中許多因素超出了公司的控制範圍)。公司無需公開更新任何前瞻性聲明,無論是因爲新的信息,還是由於未來的報告或其他原因,除非法律規定。

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INVESTOR CONTACT:

投資者聯繫方式:

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

Jenene Thomas,JTC團隊LLC
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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