Denali Therapeutics (NASDAQ: NASDAQ: DNLI ) is changing the neurodegenerative disease landscape - one traditionally characterized by failed trials and a grim outlook. While almost all investors remain focused on large pharmaceutical players or are wary because of past disappointmentsI have a strong inclination towards high-growth companies, often treading in sectors poised for exponential expansion. My expertise lies in understanding and investing in disruptive technologies and forward-thinking enterprises. ...

Shares of Denali Therapeutics (DNLI) rose marginally yesterday after the company reported third-quarter results on Wednesday.Denali incurred a third-quarter 2024 loss of 63 cents per share, wider than the Zacks Consensus Estimate of a loss of 60 cents. The company reported a loss of 72 cents in the year-ago quarter.The bottom line improved year over year despite a rise in operating expenses, mainly due to an increase in the number of shares outstanding.In the absence of a marketed product, the company only ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38311 Denali Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 46-3872213 ...

新型治疗药物开发 - 丹纳利治疗公司正在开发一系列跨越血脑屏障的新型治疗药物[2] - 公司正在开发针对阿尔茨海默病和帕金森病的OTV:MAPT和OTV:SNCA两个寡核苷酸运载体(OTV)项目,处于IND前期阶段[11] - 公司正在开发针对阿尔茨海默病的ATV:Abeta项目,前期数据显示可能具有更好的疗效和安全性[12] 加速审批申请 - 公司正在为MPS II(亨廷顿综合征)的治疗药物tividenofusp alfa(DNL310)申请加速审批,预计于2025年初提交生物制品许可申请[3] - DNL126(MPS IIIA治疗药物)的临床前期数据显示CSF HS水平大幅降低,包括正常化,公司正在评估加速审批的可能性[9] 财务预测 - 公司2024年全年现金经营支出预计将增加5-10%,主要用于支持tividenofusp alfa的BLA申报和商业化准备,以及加速其他TV平台项目的开发[15]

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today reported financial results for the third quarter ended September 30, 2024, and provided business highlights. "As leaders in pioneering a new class of therapeutics that cross the blood-brain barrier, we are making significant progress across our Transport Vehicle (TV)-enabled portfolio,” said Ryan Watts, Ph.D., Chief Executive Officer of Denali Therapeutics. “Within our Enzyme TV (ETV) franchise, we a ...

Wall Street expects a year-over-year increase in earnings on higher revenues when Denali Therapeutics Inc. (DNLI) reports results for the quarter ended September 2024. While this widely-known consensus outlook is important in gauging the company's earnings picture, a powerful factor that could impact its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss ...

Denali Therapeutics Inc. (DNLI) shares ended the last trading session 10.1% higher at $30.77. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 18.1% gain over the past four weeks. Denali is developing a broad portfolio of product candidates engineered to cross the blood-brain barrier for the treatment of neurodegenerative and lysosomal storage diseases. The recent upward price trajectory can be attributed to positiv ...

Denali Therapeutics Inc. (DNLI) announced that its meeting with the Center for Drug Evaluation and Research ("CDER") division of the FDA for the advancement of pipeline candidate tividenofusp alfa (DNL310) was successful. Tividenofusp alfa (DNL310) is being evaluated for the treatment of MPS II (Hunter syndrome). The meeting with CDER outlined a path for Denali to file a biologics license application (BLA) seeking accelerated approval of tividenofusp alfa (DNL310) for the treatment of MPS II and its subsequ ...

Denali Therapeutics Inc. (DNLI) closed the last trading session at $21.64, gaining 2.1% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $38.87 indicates a 79.6% upside potential. The mean estimate comprises 15 short-term price targets with a standard deviation of $16.35. While the lowest estimate of $22 indicates a 1.7% increase from the current price level, the most optimistic ana ...

公司概况 - 公司的目标是发现、开发和提供治疗方案来战胜神经退行性疾病[126] - 公司的发现和开发策略以三个指导原则为依归,包括针对遗传验证的分子靶点或生物通路、利用自有的血脑屏障运载平台技术以及生物标志物驱动的开发和审批[127,128,129] - 公司的主要临床阶段项目包括tividenofusp alfa (MPS II)、DNL343 (ALS和FTD)、BIIB122/DNL151 (帕金森病)、SAR443820/DNL788 (多发性硬化和阿尔茨海默病)以及eclitasertib (溃疡性结肠炎)[129,130] 重要里程碑 - 公司在2024年取得了一系列重要的临床和运营里程碑,包括tividenofusp alfa的III期COMPASS研究持续推进、DNL126 I/II期临床启动、BIIB122/DNL151二期临床合作协议签署等[133,134,135,136] - 公司在2024年2月完成了4.99亿美元的PIPE融资,并与第三方就BIIB122/DNL151二期临床合作达成协议,获得7500万美元的资金支持[136,137] 财务状况 - 公司尚未获得任何产品销售批准，自成立以来未产生任何产品收入[138] - 公司主要通过发行和出售可转换优先股、在公开发行和私募配售中出售普通股和预付款认股权证以及与Takeda、Sanofi、Biogen和其他第三方的合作和资助协议获得资金[138] - 公司至今一直亏损，预计未来一段时间内仍将持续亏损,截至2024年6月30日累计亏损132亿美元[139] - 公司收入主要来自与Takeda、Sanofi和Biogen的合作协议,未来可能来自产品销售、里程碑付款、版税和利润分成[140,141] - 研发费用占公司营业支出的大部分,包括外部研发费用、人员相关费用和其他费用[142-144] - 研发费用主要用于推进临床阶段项目、完善BBB平台技术、获取和开发新的产品候选药物等[146-148] - 公司预计未来几年内研发费用将继续增加[148] - 2024年第二季度和上半年研发费用分别下降6%和12%,主要由于人员相关费用和成本分摊付款的减少[158-163] - 研发费用减少约2790万美元,主要原因包括ETV:IDS项目外部费用减少1650万美元、TV平台和其他项目外部费用减少[165][166] - 一般及行政费用减少290万美元,主要由于人员相关费用减少[168][169] - 出售小分子项目产生收益[170] - 截至2024年6月30日,公司现金、现金等价物和有价证券总额为13.5亿美元[171][172][173][174][175] - 公司预计未来会持续亏损,需要通过股权或债务融资来满足资金需求[176][177][178][179] - 公司现有承诺主要包括租赁协议和制造协议,截至2024年6月30日总额为56.5亿美元[180] - 未来资金需求取决于临床试验进度、新项目启动、合作伙伴进展等多方面因素[181][182][183] - 2024年上半年经营活动净现金流出2.048亿美元,投资活动净现金流出3.546亿美元,筹资活动净现金流入5.07亿美元[184][185][186][187] - 公司现金、现金等价物和有价证券总额为13.5亿美元,主要由货币市场基金和投资级短期和中期固定收益证券组成[191] - 公司投资活动的主要目标是保护资本以维持公司运营,同时也力求在不承担重大风险的情况下最大化投资收益[192] 内部控制 - 公司管理层对公司披露控制和程序的设计和运行有效性进行了评估,认为截至2024年6月30日,公司的披露控制和程序在合理保证水平上是有效的[195] - 公司在2024年第二季度没有发生任何重大影响或可能重大影响公司内部财务报告控制的变化[196]