share_log

Allarity Therapeutics Outlines Company's 2024 Progress and Objectives

Allarity Therapeutics Outlines Company's 2024 Progress and Objectives

Allarity Therapeutics概述了公司的2024年进展和目标
GlobeNewswire ·  07/22 06:30
  • Current Cash Balance of $20 million Expected to Provide Runway Into 2026
  • Allarity to Pause Use of ATM
  • Cap Table Successfully Cleaned Up
  • Allarity's Stenoparib Shows Extended Duration of Phase 2 Clinical Benefit
  • 当前现金余额达2000万美元,预计可为公司提供到2026年的资金支持。
  • Allarity暂停ATM的使用。
  • 股本结构成功清理。
  • Allarity的Stenoparib在2期临床试验中展现出了持久的临床益处。

Boston (July 22, 2024)—Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today outlines the Company's progress in 2024 and future objectives.

Allarity Therapeutics公司(“Allarity”或“公司”)(纳斯达克:ALLR)是一家致力于开发个性化癌症治疗的2期临床药物公司,今天概述了公司在2024年的进展和未来目标。

Led by New Management Allarity has Materially Strengthened its Finances

在新管理层的领导下,Allarity的财务状况得到了显著的加强。

The Company's overall financial situation significantly improved as the Company today announced a new, strong cash balance and pausing of At-The-Market (ATM) offering:

Allarity公司的整体财务状况得到了显著的改善,公司今天宣布拥有新的强劲现金余额并暂停市场股票(ATM)认购计划:

  • New Strong Cash Balance: Allarity Therapeutics is pleased to announce that the Company now has a financial runway extending into 2026 at its current burn rate with a cash balance of $20M as of July 19, 2024.
  • Pausing the ATM: In line with this newly achieved financial position, Allarity plans to pause its ATM offering program for the foreseeable future.
  • Allarity Therapeutics很高兴宣布,截至2024年7月19日,公司现有的现金余额为2000万美元,可以支持到2026年公司当前的资金消耗率。
  • 暂停市场股票(ATM)认购计划:随着新的财务状况的确立,Allarity计划在可预见的未来暂停ATM认购计划。

This new financial situation led by a new management that, throughout 2024, has implemented several key actions to improve Allarity's future outlook:

由新管理层领导的财务状况得到了改善,全年实施了多项关键性措施以改善Allarity的未来表现:

  • Cleaning Up the Capitalization Table: Consolidated to a single class of common stock, eliminating variable-priced convertible securities, including both warrants and Series A Preferred Stock.
  • Streamlining Operations and Cutting Costs: Enhancing operational efficiency and reducing the cost base.
  • Focusing Resources on Stenoparib: Concentrating all company efforts on advancing stenoparib, a novel dual PARP and Tankyrase inhibitor, the Company's promising clinical asset.
  • 股本结构清理:整合为一类普通股,排除包括认股证和A类优先股在内的按变量定价的可转换证券。
  • 精简运营和削减成本:提高运营效率和降低成本基础。
  • 资源集中在Stenoparib上:全力推进Stenoparib,Novel Dual PARP和Tankyrase抑制剂,这是该公司的一项备受期待的临床资产。

Stenoparib Continues To Show Extended Duration of Clinical Benefit in Phase 2 Trial

Stenoparib在2期试验中持续表现出临床益处。

Earlier this year, Allarity Therapeutics made a strategic pivot away from a multi-asset pipeline strategy to accelerate and focus solely on stenoparib.

今年早些时候,Allarity Therapeutics采取了战略转变,从多项目管线战略转向加速并专注于Stenoparib。

As previously announced, in its Phase 2 clinical trial in advanced, recurrent ovarian cancer patients, stenoparib continues to show durable clinical benefit when given twice daily as monotherapy, with multiple patients remaining on treatment more than 30 weeks.

如之前所宣布的,在妇科晚期复发性卵巢癌患者的2期临床试验中,当单独用药每日两次时,Stenoparib仍然表现出持久的临床益处,多个患者仍在治疗30多周后继续服用。

These results provided clinical proof of concept for stenoparib, prompting Allarity to focus its resources on developing a follow-on clinical trial to accelerate potential regulatory approval by the FDA of stenoparib.

这些结果为Stenoparib提供了临床概念验证,促使Allarity集中资源开展后续的临床试验,以加快FDA对Stenoparib的潜在审批。

Company Receives Wells Notice

公司收到Wells Notice。

As Allarity disclosed today in a Form 8-K filing, on July 18, 2024, Allarity received a "Wells Notice" from the Staff of the Securities and Exchange Commission (the "SEC"), relating to the previously disclosed SEC investigation. The Wells Notice relates to the Company's disclosures regarding meetings with the United States Food and Drug Administration (the "FDA") regarding our NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021. Allarity also understands that three of its former officers received Wells Notices from the SEC relating to the same conduct.

正如Allarity今天在提交的8-k文件中披露的那样,于2024年7月18日,Allarity收到了来自证券交易委员会(SEC)的“Wells Notice”,涉及先前披露的SEC调查。Wells Notice涉及到公司关于与美国食品药品监督管理局(FDA)会面有关Dovitinib或Dovitinib-DRP NDA的披露,该NDA于2021年提交给FDA。Allarity还了解到,其前三位高管因同样的行为收到了SEC的Wells Notice。

The Company understands that all of the conduct relating to the SEC Staff's Wells Notice occurred during or prior to fiscal year 2022. A Wells Notice is neither a formal charge of wrongdoing nor a final determination that the recipient has violated any law. The Wells Notice informed the Company that the SEC Staff has made a preliminary determination to recommend that the SEC file an enforcement action against the Company that would allege certain violations of the federal securities laws. The Company is continuing to cooperate with the SEC and maintains that its actions were appropriate and intends to pursue the Wells Notice process, including submitting a formal response to the SEC.

公司了解到,与SEC工作人员的Wells Notice相关的所有行为发生在2022财年期内或之前。Wells Notice既不是不当行为的正式指控,也不是最后确定收件人已违反任何法律。Wells Notice通知公司,SEC工作人员已作出初步决定,建议SEC提起行政诉讼,指控公司违反了联邦证券法的某些规定。公司将继续配合SEC,并坚持认为其行为是适当的,打算继续进行Wells Notice过程,包括向SEC提交正式回应。

Proposed Reverse Stock Split Necessary to Maintain NASDAQ Listing

提议进行逆向股票拆分是为了维持纳斯达克上市。

The Company's board of directors has put a proposal before shareholders for a reverse stock split. Allarity has requested approval of the reverse stock split to regain and sustain compliance with NASDAQ requirements. The reverse split is essential to enabling compliance with this objective. If the Reverse Stock Split is not approved by the Company's stockholders, the Company's common stock may be delisted from NASDAQ. Maintaining a NASDAQ listing is crucial for investor confidence and to maintain liquidity in the Company's common stock. Put simply, a NASDAQ delisting could complicate stockholder's ability to trade the Company's common stock, impact its stock price and affect stockholder's ability to buy or sell when desired. Failure to secure approval for the reverse stock split may hinder management's ability to execute its strategy, to the detriment of shareholders. Additionally, it may impede strategic initiatives dependent on the issuance of common stock. It is essential to understand that a reverse stock split consolidates existing shares, preserving the Company's overall value and each shareholder's respective ownership percentage.

公司董事会向股东提出了进行逆向股票拆分的提议。 Allarity已请求批准逆向股票拆分以恢复并维持符合纳斯达克要求。进行股票逆向拆分对于实现此目标至关重要。如果公司股东未批准逆向股票拆分,公司的普通股可能会被纳斯达克强制下市。保持纳斯达克上市对于投资者信心和维持公司普通股的流动性至关重要。简而言之,纳斯达克退市可能会使股东在期望时买入或卖出公司普通股时的交易变得更加复杂,影响其股票价格和股东的交易能力。未能获得逆向股票拆分的批准可能会妨碍管理层执行其策略,对股东不利。此外,它可能会阻碍依赖发行普通股的战略计划的实施。 了解到,逆向股票拆分会合并现有的股份,维护公司的整体价值和每个股东相应的所有权比例非常重要。

We respectfully request that you vote in favor of the reverse split proposal. If you have already voted, it is not too late to change your vote should you wish to do so. If you have any questions or need help voting, please call Allarity's proxy solicitor, Sodali & Co, at +1 212 300 2470.

我们恭请您赞成逆向拆分提案。如果您已经投票,如果您希望更改投票,现在还来得及。如果您有任何问题或需要投票协助,请致电Allarity的委托代理人Sodali & Co,电话号码为+1 212 300 2470。

About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/Tankyrase inhibitor for advanced ovarian cancer patients, using its DRP companion diagnostic for patient selection in the ongoing phase 2 clinical trial, NCT03878849. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit .

关于Allarity Therapeutics
Allarity Therapeutics公司(纳斯达克:ALLR)是一家临床阶段的生物制药公司,致力于开发用于爱文思控股卵巢癌患者的新型PARP/Tankyrase抑制剂stenoparib,使用其DRP伴随诊断进行病人选择,并正在进行第2期临床试验NCT03878849。Allarity Therapeutics公司总部位于美国,在丹麦拥有一个研究设施,致力于解决癌症治疗中重大的未满足的医疗需求。欲了解更多信息,敬请访问。

Follow Allarity on Social Media
LinkedIn:
X:

本新闻稿包含根据1995年《私人证券诉讼改革法案》发布的“前瞻性声明”。前瞻性声明提供了公司对未来事件的当前期望或预测。诸如“预计”,“相信”,“继续”,“可能”,“估计”,“期望”,“打算”,“可以”,“可能”,“计划”,“潜在”,“预测”,“项目”,“应该”,“将”等表达方式可能会识别前瞻性声明,但缺乏这些词并不意味着一个声明不是前瞻性的。本新闻稿中的前瞻性声明包括但不限于最近的临床和运营成就对未来试验设计的影响,潜在的商业伙伴关系,计划和进行注册意向临床试验,研究第2临床试验提前结束后stenoparib的预期监管进展以及可能不会在科学活动中进行任何展示的可能性。本新闻稿中任何前瞻性声明都基于管理层对未来事件的当前期望,并且容易有多重风险和不确定性,这些风险和不确定性可能导致实际结果与该前瞻性声明所述的结果实现实际结果相比,不利地发生变化。这些风险和不确定性包括但不限于与继续遵守纳斯达克持续上市要求相关的风险,Allarity的普通股交易价格可能存在波动,以及Allarity业务中固有的其他风险,包括公司无法筹集足够资本支持其当前和预期的临床试验,临床研究的初步结果不一定预示最终结果,并且在对数据进行更全面的评审和更多的患者数据可用性之后,一项或多项临床结果可能发生实质性变化,临床试验的结果面临解释的风险,需要进行其他分析和/或可能与这种结果矛盾的分析,为steno批准或其它治疗方案和伴侣诊断,或者如果获批准,成功商业化这些产品的风险,中止或延迟任何正在进行或计划的临床试验和/或我们的产品候选开发的风险,以及先前进行的研究的结果可能不会在我们的疗法候选开发的进行的正在进行的或未来的研究中重复或观察到。关于其他风险和不确定性以及其他重要因素的讨论,其中任何一个都可能导致我们的实际结果与前瞻性声明中所述的结果不同,请参见2017年4月所提交的S-1登记声明中的“风险因素”一节以及文件名为SEC网站(www.sec.gov)上的Form 10-K年度报告,以及在公司随后提交的文件中可能涉及的潜在风险,不确定性和其他重要因素的讨论。本新闻稿中的所有信息均截至发布日期,除非法律另有规定,否则本公司不承担更新此信息的责任。
领英:
博客

Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's current expectations or forecasts of future events. The words "anticipates," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predicts," "project," "should," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, the impact of recent clinical and operational achievements on future trial designs and regulatory progress, potential commercial partnerships, planning and execution of registrational intent clinical trials, the anticipated progress of stenoparib following its Phase 2 clinical trial, the potential outcomes of ongoing SEC investigations, the proposal and potential approval of a reverse stock split, and the possibility of Nasdaq listing compliance issues or changes. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks associated with maintaining compliance with Nasdaq's continued listing requirements, the trading price of Allarity's shares of common stock may be volatile and other risks inherent in Allarity's business including, the risk that the Company is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the receipt of regulatory approval for stenoparib or any of our other therapeutic candidates and companion diagnostics or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, and the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our therapeutic candidates, and the possible impact of SEC investigations and Wells Notices, and the possibility of Nasdaq delisting. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our Form S-1 registration statement filed on April 17, 2024, and our Form 10-K annual report on file with the Securities and Exchange Commission (the "SEC"), available at the SEC's website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

前瞻性声明
本新闻稿包含《1995年私人证券诉讼改革法案》中的“前瞻性陈述”。前瞻性陈述提供公司对未来事件的当前期望或预测。“期望”,“相信”,“继续”,“可能”,“估计”,“预计”,“打算”,“可能”,“计划”,“潜在”,“预测”,“项目”,“应该”和类似表达式可能识别出前瞻性陈述,但没有这些词意味着一种声明不是前瞻性的。这些前瞻性陈述包括,但不限于,最近的临床和运营成就对未来试验设计和监管进程的影响,潜在的商业伙伴关系,注册意图临床试验的规划和执行,stenoparib在其第2期临床试验后的预期进展,正在进行的证券交易委员会(SEC)调查的结果和提案以及潜在的纳斯达克上市合规性问题或变更。本新闻稿中任何前瞻性陈述均基于管理层对未来事件的当前预期,并且可能受到多重风险和不确定性的影响,这些风险和不确定性可能导致实际结果与前瞻性陈述所述的结果有所不同或产生不利影响。这些风险和不确定性包括,但不限于,与维持纳斯达克持续上市要求的合规性有关的风险,Allarity普通股的交易价格可能会波动和Allarity业务中固有的风险,包括公司无法筹集足够的资金支持当前和预期的临床试验的风险,临床研究的早期结果不一定预示着最终结果,并且一个或多个临床结果可能会在对数据进行更全面的评估之后产生重大变化,并且随着更多患者数据的可获得,临床研究结果存在解释风险,需要进行其他分析和/或可能与此类结果相矛盾,获得stenoparib或我们其他治疗候选药物和伴侣诊断工具的监管批准,或者如果获得批准,则成功商业化此类产品的风险,可能会停止或延迟任何正在进行或计划进行的临床试验和/或我们的产品候选开发,并且把以前进行的研究结果重复或观察到这些共同目标的风险,以及SEC调查和Wells通知的可能影响,以及可能被纳斯达克强制下市的风险。有关此类风险和不确定性的讨论以及其他重要因素,其中任何一个都可能导致我们的实际结果不同于前瞻性陈述中所述的结果,请参阅我们于2024年4月17日提交的S-1注册声明中的“风险因素”部分,以及我们在与证券交易委员会(SEC)提交的Form 10-k 年度报告,可在SEC网站www.sec.gov上获得,以及在公司随后向SEC提交的文件中讨论的潜在风险、不确定性和其他重要因素。本新闻稿中的所有信息均截至发布日期,除非法律要求,否则公司不负责更新此信息。

###

###

Company Contact:
investorrelations@allarity.com

公司联系人: investorrelations@allarity.com Thomas Pedersen Carrotize PR&Communications + 45 6062 9390 tsp@carrotize.com
investorrelations@allarity.com


Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com


媒体联系人:
Thomas Pedersen
Carrotize公关和传播
+ 45 6062 9390
tsp@carrotize.com

Attachment

附件

  • Allarity Therapeutics Press Release - Allarity Outlines Company's 2024 Progress and Objectives
  • Allarity Therapeutics新闻稿- Allarity概述公司的2024年进展和目标

声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    抢沙发