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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提供公司最新情况并公布2024年第一季度财务业绩
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.

宾夕法尼亚州马尔文,2024年5月13日(GLOBE NEWSWIRE)——开发神经退行性疾病新疗法的临床阶段药物平台公司Annovis Bio, Inc.(纽约证券交易所代码:ANVS)(“Annovis” 或 “公司”)提供了整个组织的最新情况,并公布了第一季度财务业绩。

Clinical Updates

临床更新

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公布了具有统计意义的早期阿尔茨海默氏病(AD)患者的II/III期数据。
    • 与安慰剂相比,轻度 AD 患者每次治疗剂量的 ADAS-Cog 11 评分改善率明显更高;
    • ADAS-Cog 11在三个月时测得的认知改善为3.3个百分点,而安慰剂的认知改善为0.3个百分点,这与先前的II期AD/PD和Discovery研究一致;
    • 血浆Tau蛋白水平降低,与先前的II期生物标志物数据一致。
  • 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.
  • 根据这项短期研究的结果,Annovis计划对生物标志物阳性的早期AD患者进行一项为期18个月的关键性疾病改善III期试验。

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)三期数据公布的时间表,该时间表原定于1月底发布,这是因为需要进行必要的清洁工作才能提供可靠和准确的结果。
  • 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宣布对第三阶段数据进行解盲,并打算在2024年6月发布头条结果。
  • 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期试验是一项随机、双盲、安慰剂对照试验,在现有护理标准的基础上,研究buntanetap对早期PD患者的疗效、安全性和耐受性。患者接受了为期 6 个月的 10 mg、20 mg 或安慰剂的治疗。在筛查的616名患者中,有523名患者被随机分组,471名在67个地点(43个在美国,24个在欧盟)完成了研究。

Patents

专利

  • 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于2024年1月30日宣布提交一项专利申请,涵盖使用buntanetap及其类似物治疗神经精神适应症。
  • This patent follows the U.S. Provisional Application No. 63/440,890, which was filed on January 24, 2023.
  • 该专利是在2023年1月24日提交的美国临时申请编号为63/440,890号之后提交的。
  • 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.
  • 该专利申请涉及自闭症、注意力缺陷多动障碍、躁郁症、重度抑郁症、焦虑和精神分裂症等精神疾病,这些疾病已被证明与某些神经退行性疾病有类似的病理异常,包括神经毒性蛋白合成中断、轴突转运受损、炎症和神经细胞死亡。

First Quarter 2024 Financial Results

2024 年第一季度财务业绩

  • 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,该公司的现金及现金等价物总额为310万美元,而截至2023年12月31日为580万美元。该公司估计,积极管理其现金和营运资金状况,加上与先前宣布的ELOC收购协议相关的80万美元现金,将为其2024年第四季度的运营提供资金。截至2024年3月31日,该公司的已发行普通股为1,100万股。
  • 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日的三个月,总运营支出为780万美元,其中包括650万美元的研发费用以及130万美元的一般和管理费用。相比之下,截至2023年3月31日的三个月的总运营支出为1,000万美元,其中包括780万美元的研发费用以及220万美元的一般和管理费用。
  • 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日的三个月,其他收入为670万美元,其中包括负债分类认股权证公允价值变动产生的670万美元非现金收益。相比之下,截至2023年3月31日的三个月的其他收入为20万美元,其中包括20万美元的利息收入。
  • 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报告称,截至2024年3月31日的三个月,普通股每股基本净亏损为0.10美元,摊薄后的每股普通股净亏损为0.72美元。相比之下,截至2023年3月31日的三个月,普通股每股基本净亏损为1.19美元,摊薄净亏损为1.19美元。

Conferences

会议

  • 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.
  • 安诺维斯参加了2024年3月5日至9日在葡萄牙里斯本举行的阿尔茨海默氏症和帕金森氏病国际会议(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,玛丽亚·马切基尼参加了一场题为 “α-突触核蛋白、LRKK2 和大湾区病理学生物标志物、成像和治疗开发的新见解” 的论坛讨论。

Message from Dr. Maria Maccecchini

来自 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."

“事实证明,第一季度对我们公司至关重要,因为我们继续结束最近的两项临床试验——帕金森氏症的III期和阿尔茨海默氏症的II/III期。在去年年底结束的PD研究中,我们正在努力精心准备数据,预计将于今年6月公布主要结果。在这项AD研究中,我们成功地清理了数据,并自豪地宣布ADAS-Cog 11对早期ADAS患者的认知能力进行了改善,这为我们指出了buntanetap持续临床开发的途径。我们衷心感谢患者及其家属,他们的贡献是我们旨在将新疗法推向市场的研究的推动力。”

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

-Maria L. Maccecchini,博士,Annovis 创始人、总裁兼首席执行官

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.

关于 Buntanetap
Buntanetap(以前称为 Posiphen 或 ANVS401)通过减少多种神经毒性蛋白来攻击神经变性,从而改善突触传递和轴突转运,这是神经细胞的信息高速公路。突触传递和轴突转运功能障碍已被证明是神经细胞退化乃至死亡的原因。与其他正在开发的仅试图去除一种毒性蛋白质的药物不同,buntanetap在几种有毒蛋白质形成之前会抑制它们,从而防止形成所有导致PD和AD的主要神经毒性蛋白。

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).

关于 Annovis Bio, Inc.
Annovis Bio, Inc. 总部位于宾夕法尼亚州马尔文,是一家临床阶段的药物平台公司,致力于治疗神经变性,例如阿尔茨海默氏病(AD)、帕金森氏病(PD)和其他慢性神经退行性疾病。据信它是唯一一家同时开发AD和PD药物的公司,该药物旨在抑制一种以上的神经毒性蛋白质,以恢复轴突和突触活性。通过改善大脑功能,该公司的目标是治疗与AD相关的记忆力减退和痴呆以及与PD相关的身体和大脑功能障碍。有关Annovis Bio的更多信息,请访问该公司的网站 www.annovisbio.co 然后关注我们 领英X(以前称为 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.

前瞻性陈述
本新闻稿包含经修订的1933年《证券法》第27A条和经修订的1934年《证券交易法》第21E条所指的 “前瞻性” 陈述。除历史事实陈述以外的所有陈述均可被视为前瞻性陈述。该公司建议谨慎对待前瞻性陈述。前瞻性陈述包括但不限于公司与临床试验相关的计划。这些陈述涉及已知和未知的风险、不确定性和其他因素,这些因素可能导致实际结果与前瞻性陈述所暗示的结果存在重大差异,包括患者入组、Buntanetap的有效性以及公司评估buntanetap疗效、安全性和耐受性的临床试验的时机、有效性和预期结果。另请参阅公司向美国证券交易委员会提交的定期文件中列出的其他风险因素,包括但不限于公司向美国证券交易委员会提交的10-K表年度报告和10-Q表季度报告中 “风险因素” 部分中列出的风险和不确定性。本新闻稿中的所有前瞻性陈述均基于公司截至本申报之日获得的信息。除非适用法律要求,否则公司明确表示不承担任何更新或修改其前瞻性陈述的义务,无论是由于新信息、未来事件还是其他原因。

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

投资者联系人:
玛丽亚·马切基尼博士
maccecchini@annovisbio.com

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Source: Annovis Bio Inc.

资料来源:Annovis Bio Inc.

译文内容由第三方软件翻译。


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