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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年進展和目標
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
  • 目前的現金餘額爲2000萬美元,預計將爲2026年提供跑道
  • 呼籲暫停使用自動櫃員機
  • 上限表已成功清理
  • Alarity 的 Stenoparib 顯示 2 期臨床療效的持續時間延長

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.

波士頓(2024年7月22日)——致力於開發個性化癌症治療的二期臨床階段製藥公司Allarity Therapeutics, Inc.(“Allarity” 或 “公司”)(納斯達克股票代碼:ALLR)今天概述了該公司在2024年的進展和未來目標。

Led by New Management Allarity has Materially Strengthened its Finances

在新管理層的領導下,Allarity大幅加強了其財務狀況

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:

隨着公司今天宣佈新的強勁現金餘額並暫停At-The-Market(ATM)發行,公司的整體財務狀況顯著改善:

  • 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.
  • 新的強勁現金餘額:Allarity Therapeutics高興地宣佈,按目前的消耗率,該公司現在的財務狀況將延長至2026年,截至2024年7月19日,現金餘額爲2000萬美元。
  • 暫停自動櫃員機:根據這一新實現的財務狀況,Alarity計劃在可預見的將來暫停其自動櫃員機發行計劃。

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

這種新的財務狀況是由新管理層領導的,該管理層在整個2024年實施了多項關鍵行動,以改善Alarity的未來前景:

  • 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.
  • 清理市值表:合併爲單一類別的普通股,取消可變價格的可轉換證券,包括認股權證和A系列優先股。
  • 簡化運營和削減成本:提高運營效率並降低成本基礎。
  • 將資源集中在Stenoparib上:將公司所有精力集中在推進stenoparib上,這是一種新型的雙重PARP和Tankyrase抑制劑,該公司前景光明的臨床資產。

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

Stenoparib在2期試驗中繼續顯示出更長的臨床療效

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

今年早些時候,Allarity Therapeutics制定了戰略重點,從多資產管道戰略轉向加速發展,只專注於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.

正如先前宣佈的那樣,在針對晚期、複發性卵巢癌患者的2期臨床試驗中,stenoparib每天作爲單一療法給予兩次,多名患者的治療時間超過30周,繼續顯示出持久的臨床益處。

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.

這些結果爲stenoparib的概念提供了臨床驗證,促使Alarity將其資源集中在開發後續臨床試驗上,以加快美國食品藥品管理局對stenoparib的潛在監管批准。

Company Receives Wells Notice

公司收到富國銀行的通知

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Alarity今天在2024年7月18日提交的8-k表中披露的那樣,Alarity於2024年7月18日收到了美國證券交易委員會(“SEC”)工作人員發來的與先前披露的美國證券交易委員會調查有關的 “Wells通知”。富國集團的通知涉及公司就我們的多維替尼或多維替尼-DRP保密協議與美國食品藥品監督管理局(“FDA”)會晤的披露,該保密協議已於2021年提交給美國食品藥品監督管理局。Allarity還了解到,其三名前高管收到了美國證券交易委員會就相同行爲發出的富國銀行通知。

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,與美國證券交易委員會工作人員富國通知有關的所有行爲都發生在2022財年或之前。Wells 通知既不是對不當行爲的正式指控,也不是對收件人違反任何法律的最終裁定。富國銀行通知告知公司,美國證券交易委員會工作人員已做出初步決定,建議美國證券交易委員會對該公司提起執法行動,指控該公司存在某些違反聯邦證券法的行爲。該公司將繼續與美國證券交易委員會合作,並堅稱其行動是適當的,並打算繼續執行富國銀行通知程序,包括向美國證券交易委員會提交正式答覆。

Proposed Reverse Stock Split Necessary to Maintain NASDAQ Listing

提議的反向股票拆分是維持納斯達克上市所必需的

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.

公司董事會已向股東提出了反向股票拆分的提案。Alarity已要求批准反向股票拆分,以恢復和維持對納斯達克要求的合規性。反向拆分對於實現這一目標至關重要。如果反向股票拆分未獲得公司股東的批准,則公司的普通股可能會從納斯達克退市。維持在納斯達克上市對於投資者的信心和維持公司普通股的流動性至關重要。簡而言之,納斯達克退市可能會使股東交易公司普通股的能力複雜化,影響其股價並影響股東在需要時買入或賣出的能力。未能獲得反向股票拆分的批准可能會阻礙管理層執行其戰略的能力,從而損害股東的利益。此外,它可能會阻礙依賴普通股發行的戰略舉措。必須明白,反向股票拆分會合並現有股份,從而保持公司的整體價值和每位股東各自的所有權百分比。

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.

我們恭敬地請你對反向拆分提案投贊成票。如果您已經投票,那麼如果您願意,現在更改投票還爲時不晚。如果你有任何疑問或需要幫助投票,請致電Alarity的代理律師Sodali & Co,電話:+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 .

關於 Alarity 療法
Allarity Therapeutics, Inc.(納斯達克股票代碼:ALLR)是一家臨床階段的生物製藥公司,致力於開發個性化癌症治療方法。該公司專注於開發用於晚期卵巢癌患者的新型PARP/Tankyrase抑制劑stenoparib,在正在進行的2期臨床試驗 NCT03878849 中使用其DRP伴隨診斷進行患者選擇。Allarity 總部位於美國,在丹麥設有研究機構,致力於解決癌症治療中未滿足的重大醫療需求。欲了解更多信息,請訪問。

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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.

前瞻性陳述
本新聞稿包含1995年《私人證券訴訟改革法》所指的 “前瞻性陳述”。前瞻性陳述提供了公司當前的預期或對未來事件的預測。“預期”、“相信”、“繼續”、“可能”、“估計”、“預期”、“打算”、“可能”、“計劃”、“可能”、“潛在”、“預測”、“項目”、“應該”、“將” 等詞語以及類似的表述可以識別前瞻性陳述,但沒有這些詞語並不意味着陳述不是前瞻性的。這些前瞻性陳述包括但不限於最近的臨床和運營成就對未來試驗設計和監管進展的影響、潛在的商業夥伴關係、註冊意向臨床試驗的規劃和執行、stenoparib在2期臨床試驗後的預期進展、美國證券交易委員會正在進行的調查的潛在結果、反向股票拆分的提案和可能的批准,以及納斯達克上市合規問題或變更的可能性。本新聞稿中的任何前瞻性陳述均基於管理層當前對未來事件的預期,並受到多種風險和不確定性的影響,這些風險和不確定性可能導致實際業績與此類前瞻性陳述中列出或暗示的業績存在重大不利差異。這些風險和不確定性包括但不限於與維持納斯達克持續上市要求相關的風險、Alarity普通股的交易價格可能波動以及Alarity業務固有的其他風險,包括公司無法籌集足夠資金來支持其當前和預期的臨床試驗的風險、臨床研究的早期結果不一定能預測最終結果以及一項或多項臨床結果的風險可能會發生實質性變化在對數據進行更全面的審查之後,隨着更多患者數據的出現,可能需要對臨床研究結果進行解釋和/或可能與此類結果相矛盾的風險、stenoparib或我們的任何其他候選療法和伴隨診斷的監管批准,或此類產品的成功商業化如果獲得批准,則存在停止或推遲任何正在進行或計劃中的臨床試驗和/或我們產品開發的風險候選人和風險在涉及我們的候選療法、美國證券交易委員會調查和富國銀行通知可能產生的影響以及納斯達克退市可能性的研究中,不會重複或觀察到先前進行的研究的結果。有關其他風險和不確定性以及其他重要因素的討論,其中任何一個都可能導致我們的實際業績與前瞻性陳述中包含的有所不同,請參閱我們於2024年4月17日提交的S-1表格註冊聲明中標題爲 “風險因素” 的部分,以及我們向美國證券交易委員會(“SEC”)提交的10-k表年度報告(可在美國證券交易委員會網站www.sec.gov上查閱),以及相關討論公司隨後向其提交的文件中的潛在風險、不確定性和其他重要因素美國證券交易委員會。本新聞稿中的所有信息均截至發佈之日,除非法律要求,否則公司沒有義務更新這些信息。

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Company Contact:
investorrelations@allarity.com

公司聯繫人:
investorrelations@allarity.com


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


媒體聯繫人:
托馬斯·佩德森
開展公關與傳播
+45 6062 9390
tsp@carrotize.com

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  • Allarity Therapeutics Press Release - Allarity Outlines Company's 2024 Progress and Objectives
  • Alarity Therapeutics 新聞稿-Alarity 概述了公司 2024 年的進展和目標

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