share_log

Annovis Bio Provides Corporate Updates and Announces First Quarter 2024 Financial Results

Annovis Bio Provides Corporate Updates and Announces First Quarter 2024 Financial Results

Annovis Bio提供公司最新情況並公佈2024年第一季度財務業績
Annovis Bio ·  05/13 12:00

Mon, 13 May 2024

2024 年 5 月 13 日星期一

MALVERN, Pa., May 13, 2024 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company developing novel therapies for neurodegenerative diseases, provided updates from across the organization and announced first quarter financial results.

賓夕法尼亞州馬爾文,2024年5月13日(GLOBE NEWSWIRE)——開發神經退行性疾病新療法的臨床階段藥物平台公司Annovis Bio, Inc.(紐約證券交易所代碼:ANVS)(“Annovis” 或 “公司”)提供了整個組織的最新情況,並公佈了第一季度財務業績。

Clinical Updates

臨床更新

AD Phase II/III Study

AD II/III 期研究

  • On April 29, Annovis announced statistically significant Phase II/III data in patients with early Alzheimer's disease (AD).
    • Significantly higher rate of improvement in ADAS-Cog 11 scores in each treatment dose relative to placebo for patients with mild AD;
    • Improvement in cognition measured by ADAS-Cog 11 at three months was 3.3 points as compared to 0.3 for placebo, consistent with previous Phase II AD/PD and Discovery studies;
    • Plasma Tau protein levels were reduced, consistent with previous Phase II biomarker data.
  • 4月29日,Annovis公佈了具有統計意義的早期阿爾茨海默氏病(AD)患者的II/III期數據。
    • 與安慰劑相比,輕度 AD 患者每次治療劑量的 ADAS-Cog 11 評分改善率明顯更高;
    • ADAS-Cog 11在三個月時測得的認知改善爲3.3個百分點,而安慰劑的認知改善爲0.3個百分點,這與先前的II期AD/PD和Discovery研究一致;
    • 血漿Tau蛋白水平降低,與先前的II期生物標誌物數據一致。
  • Based on the findings of this short study, Annovis plans to conduct a pivotal 18-month disease-modifying Phase III trial in biomarker-positive early AD patients.
  • 根據這項短期研究的結果,Annovis計劃對生物標誌物陽性的早期AD患者進行一項爲期18個月的關鍵性疾病改善III期試驗。

PD Phase III Study

PD III 期研究

  • On January 24, Annovis refined the timeline for Parkinson's disease (PD) Phase III data announcement, originally set for the end of January, due to necessary cleaning efforts required to deliver reliable and accurate results.
  • 1月24日,Annovis完善了帕金森氏病(PD)三期數據公佈的時間表,該時間表原定於1月底發佈,這是因爲需要進行必要的清潔工作才能提供可靠和準確的結果。
  • On May 9, Annovis announced unblinding of the Phase III data and intends to release topline results in June of 2024.
  • 5月9日,Annovis宣佈對第三階段數據進行解盲,並打算在2024年6月發佈頭條結果。
  • The Phase III trial was a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for early PD patients, on top of their existing standard of care. Patients were treated with 10 mg, 20 mg, or placebo for 6 months. Out of 616 patients screened, 523 were randomized and 471 completed the study across 67 sites (43 in the United States and 24 in the European Union).
  • III期試驗是一項隨機、雙盲、安慰劑對照試驗,在現有護理標準的基礎上,研究buntanetap對早期PD患者的療效、安全性和耐受性。患者接受了爲期 6 個月的 10 mg、20 mg 或安慰劑的治療。在篩查的616名患者中,有523名患者被隨機分組,471名在67個地點(43個在美國,24個在歐盟)完成了研究。

Patents

專利

  • Annovis announced on January 30, 2024 the filing of a patent application covering the use of buntanetap and its analogues for the treatment of neuropsychiatric indications.
  • Annovis於2024年1月30日宣佈提交一項專利申請,涵蓋使用buntanetap及其類似物治療神經精神適應症。
  • This patent follows the U.S. Provisional Application No. 63/440,890, which was filed on January 24, 2023.
  • 該專利是在2023年1月24日提交的美國臨時申請編號爲63/440,890號之後提交的。
  • This patent application addresses mental illnesses such as autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder, anxiety and schizophrenia, which have been shown to share similar pathological abnormalities with certain neurodegenerative diseases, including disruptions in synthesis of neurotoxic proteins, impairment of axonal transport, inflammation, and nerve cell death.
  • 該專利申請涉及自閉症、注意力缺陷多動障礙、躁鬱症、重度抑鬱症、焦慮和精神分裂症等精神疾病,這些疾病已被證明與某些神經退行性疾病有類似的病理異常,包括神經毒性蛋白合成中斷、軸突轉運受損、炎症和神經細胞死亡。

First Quarter 2024 Financial Results

2024 年第一季度財務業績

  • The Company's cash and cash equivalents totaled $3.1 million as of March 31, 2024, compared to $5.8 million as of December 31, 2023. The Company estimates that active management of its cash and working capital positions, combined with the $0.8 million cash received in connection with its previously announced ELOC Purchase Agreement, will fund its operations into the fourth quarter of 2024. The Company had 11.0 million shares of common stock outstanding as of March 31, 2024.
  • 截至2024年3月31日,該公司的現金及現金等價物總額爲310萬美元,而截至2023年12月31日爲580萬美元。該公司估計,積極管理其現金和營運資金狀況,加上與先前宣佈的ELOC收購協議相關的80萬美元現金,將爲其2024年第四季度的運營提供資金。截至2024年3月31日,該公司的已發行普通股爲1,100萬股。
  • Total operating expenses for the three months ended March 31, 2024 were $7.8 million, which included research and development expenses of $6.5 million and general and administrative expenses of $1.3 million. This compares to total operating expenses for the three months ended March 31, 2023 of $10.0 million, which included research and development expenses of $7.8 million and general and administrative expenses of $2.2 million.
  • 截至2024年3月31日的三個月,總運營支出爲780萬美元,其中包括650萬美元的研發費用以及130萬美元的一般和管理費用。相比之下,截至2023年3月31日的三個月的總運營支出爲1,000萬美元,其中包括780萬美元的研發費用以及220萬美元的一般和管理費用。
  • Other income for the three months ended March 31, 2024 was $6.7 million, which included a $6.7 million non-cash gain from change in fair value of liability-classified warrants. This compares to other income for the three months ended March 31, 2023 of $0.2 million, which included $0.2 million of interest income.
  • 截至2024年3月31日的三個月,其他收入爲670萬美元,其中包括負債分類認股權證公允價值變動產生的670萬美元非現金收益。相比之下,截至2023年3月31日的三個月的其他收入爲20萬美元,其中包括20萬美元的利息收入。
  • Annovis reported basic net loss per common share of $0.10 and diluted net loss per common share of $0.72 for the three months ended March 31, 2024. This compares to a basic net loss per common share of $1.19 and diluted net loss of $1.19 for the three months ended March 31, 2023.
  • Annovis報告稱,截至2024年3月31日的三個月,普通股每股基本淨虧損爲0.10美元,攤薄後的每股普通股淨虧損爲0.72美元。相比之下,截至2023年3月31日的三個月,普通股每股基本淨虧損爲1.19美元,攤薄淨虧損爲1.19美元。

Conferences

會議

  • Annovis participated in the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD 2024), which took place in Lisbon, Portugal from March 5-9, 2024.
  • 安諾維斯參加了2024年3月5日至9日在葡萄牙里斯本舉行的阿爾茨海默氏症和帕金森氏病國際會議(AD/PD 2024)。
  • On March 7, Maria Maccecchini participated in a forum discussion titled "New Insights in the Development of Biomarkers, Imaging, and Therapy of Alpha-Synuclein, LRKK2, and GBA Pathologies".
  • 3月7日,瑪麗亞·馬切基尼參加了一場題爲 “α-突觸核蛋白、LRKK2 和大灣區病理學生物標誌物、成像和治療開發的新見解” 的論壇討論。

Message from Dr. Maria Maccecchini

來自 Maria Maccecchini 博士的消息

"The first quarter proved to be pivotal for our company as we continued to wind down our two recent clinical trials - Phase III in Parkinson's and Phase II/III in Alzheimer's. For our PD study, which concluded late last year, diligent efforts are underway to meticulously prepare the data, with expected delivery of topline results in June of this year. For the AD study, we successfully cleaned the data and were proud to announce cognitive improvements as measured by ADAS-Cog 11 in patients with early AD, showing us a pathway for continued clinical development of buntanetap. We extend our heartfelt gratitude to the patients and their families whose contribution was the driving force of our research aimed to bring new treatments to the market."

“事實證明,第一季度對我們公司至關重要,因爲我們繼續結束最近的兩項臨床試驗——帕金森氏症的III期和阿爾茨海默氏症的II/III期。在去年年底結束的PD研究中,我們正在努力精心準備數據,預計將於今年6月公佈主要結果。在這項AD研究中,我們成功地清理了數據,並自豪地宣佈ADAS-Cog 11對早期ADAS患者的認知能力進行了改善,這爲我們指出了buntanetap持續臨床開發的途徑。我們衷心感謝患者及其家屬,他們的貢獻是我們旨在將新療法推向市場的研究的推動力。”

- Maria L. Maccecchini, Ph.D., Annovis Founder, President, and CEO

-Maria L. Maccecchini,博士,Annovis 創始人、總裁兼首席執行官

About Buntanetap
Buntanetap (formerly known as Posiphen or ANVS401) attacks neurodegeneration by reducing multiple neurotoxic proteins, thereby improving synaptic transmission and axonal transport, which is the information highway of the nerve cell. Dysfunction of synaptic transmission and axonal transport has been shown to be the cause of nerve cell degeneration and ultimately death. Unlike other drugs in development which attempt to remove only one toxic protein, buntanetap inhibits several toxic proteins before they can form, thereby preventing the formation of all the major neurotoxic proteins responsible for PD and AD.

關於 Buntanetap
Buntanetap(以前稱爲 Posiphen 或 ANVS401)通過減少多種神經毒性蛋白來攻擊神經變性,從而改善突觸傳遞和軸突轉運,這是神經細胞的信息高速公路。突觸傳遞和軸突轉運功能障礙已被證明是神經細胞退化乃至死亡的原因。與其他正在開發的僅試圖去除一種毒性蛋白質的藥物不同,buntanetap在幾種有毒蛋白質形成之前會抑制它們,從而防止形成所有導致PD和AD的主要神經毒性蛋白。

About Annovis Bio, Inc.
Headquartered in Malvern, Pennsylvania, Annovis Bio, Inc. is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer's disease (AD), Parkinson's disease (PD), and other chronic neurodegenerative diseases. It is believed to be the only company developing a drug for both AD and PD designed to inhibit more than one neurotoxic protein to restore axonal and synaptic activity. By improving brain function, the company's goal is to treat memory loss and dementia associated with AD as well as body and brain dysfunction associated with PD. For more information on Annovis Bio, please visit the Company's website www.annovisbio.com and follow us on LinkedIn and X (formerly known as Twitter).

關於 Annovis Bio, Inc.
Annovis Bio, Inc. 總部位於賓夕法尼亞州馬爾文,是一家臨床階段的藥物平台公司,致力於治療神經變性,例如阿爾茨海默氏病(AD)、帕金森氏病(PD)和其他慢性神經退行性疾病。據信它是唯一一家同時開發AD和PD藥物的公司,該藥物旨在抑制一種以上的神經毒性蛋白質,以恢復軸突和突觸活性。通過改善大腦功能,該公司的目標是治療與AD相關的記憶力減退和癡呆以及與PD相關的身體和大腦功能障礙。有關Annovis Bio的更多信息,請訪問該公司的網站 www.annovisbio.co 然後關注我們 領英X(以前稱爲 Twitter)。

Forward-Looking Statements
This press release 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. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The Company advises caution in reliance on forward-looking statements. Forward-looking statements include, without limitation, the Company's plans related to clinical trials. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those implied by forward-looking statements, including regarding patient enrollment, the effectiveness of Buntanetap and the timing, effectiveness, and anticipated results of the Company's clinical trials evaluating the efficacy, safety and tolerability of buntanetap. See also additional risk factors set forth in the Company's periodic filings with the SEC, including, but not limited to, those risks and uncertainties listed in the section entitled "Risk Factors," in the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the SEC. All forward-looking statements in this press release are based on information available to the Company as of the date of this filing. The Company expressly disclaims any obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

前瞻性陳述
本新聞稿包含經修訂的1933年《證券法》第27A條和經修訂的1934年《證券交易法》第21E條所指的 “前瞻性” 陳述。除歷史事實陳述以外的所有陳述均可被視爲前瞻性陳述。該公司建議謹慎對待前瞻性陳述。前瞻性陳述包括但不限於公司與臨床試驗相關的計劃。這些陳述涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致實際結果與前瞻性陳述所暗示的結果存在重大差異,包括患者入組、Buntanetap的有效性以及公司評估buntanetap療效、安全性和耐受性的臨床試驗的時機、有效性和預期結果。另請參閱公司向美國證券交易委員會提交的定期文件中列出的其他風險因素,包括但不限於公司向美國證券交易委員會提交的10-K表年度報告和10-Q表季度報告中 “風險因素” 部分中列出的風險和不確定性。本新聞稿中的所有前瞻性陳述均基於公司截至本申報之日獲得的信息。除非適用法律要求,否則公司明確表示不承擔任何更新或修改其前瞻性陳述的義務,無論是由於新信息、未來事件還是其他原因。

Investor Contact:
Maria Maccecchini, Ph.D.
maccecchini@annovisbio.com

投資者聯繫人:
瑪麗亞·馬切基尼博士
maccecchini@annovisbio.com

Primary Logo

Source: Annovis Bio Inc.

資料來源:Annovis Bio Inc.

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。
    搶先評論