The stenoparib Phase 2 monotherapy trial in advanced, recurrent ovarian cancer continues to show promise, prompting shift in resources to accelerate stenoparib development

在晚期复发性卵巢癌中进行的stenoparib 2期单药治疗试验继续显示出前景，促使资源转移以加速stenoparib的发展

Further development of IXEMPRA® and dovitinib is de-prioritized

IXEMPRA®和dovitinib的进一步开发被取消优先级

The Company has been able to reduce costs materially

该公司已经能够大幅降低成本

Boston (March 27, 2024) — Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments, today announced a strategic pivot aimed at advancing its clinical-stage candidate stenoparib, a novel PARP/Tankyrase dual inhibitor, toward registration in advanced recurrent ovarian cancer, leveraging its DRP® platform to identify and enroll only the patients most likely to derive clinical benefit..

波士顿（2024年3月27日）-Allarity Therapeutics，Inc.（“Allarity”或“公司”）（纳斯达克：ALLR），一家致力于开发个性化癌症治疗的临床阶段制药公司，今天宣布了一项战略重点，旨在推进其临床阶段候选药物stenoparib（一种新型PARP/Tankyrase双重抑制剂）在晚期复发性卵巢癌中的注册，利用其DRP®平台仅识别和招募最有可能获得临床益处的患者。。

This decision is the outcome of an extensive analysis of the Company’s strategic opportunities, initiated immediately after Thomas Jensen stepped into his role as Interim CEO in early December 2023. In partnership with Executive Advisor Jeremy R. Graff, PhD and in agreement with the Board of Directors, this analysis was meticulously carried out with a dual objective: to rapidly channel the Company’s proprietary DRP® technology towards benefiting a patient population with an unmet medical need while at the same time taking the clinical risk/reward balance as well as commercial and regulatory probabilities of success into consideration..

这一决定是对公司战略机遇进行广泛分析的结果，该分析是在托马斯·延森于2023年12月初担任临时首席执行官后立即启动的。与执行顾问Jeremy R.Graff博士合作，并与董事会达成一致，这项分析是精心进行的，有双重目标：快速引导公司专有的DRP®技术，使医疗需求未得到满足的患者受益，同时考虑临床风险/回报平衡以及商业和监管成功概率。。

This decisive shift in priorities is driven by the compelling initial data from the Phase 2 monotherapy trial evaluating stenoparib in advanced, recurrent ovarian cancer patients, as announced on December 5, 2023.

2023年12月5日宣布的评估晚期复发性卵巢癌患者中司托巴的2期单药治疗试验的令人信服的初始数据推动了优先事项的决定性转变。

For this trial, the patients enrolled have advanced through multiple lines of therapy, including platinum, taxanes, anti-angiogenesis inhibitors, and even the recently approved Antibody Drug Conjugate, Elahere. Importantly, all but two enrolled patients to date have been previously treated with a PARP inhibitor.

对于这项试验，入选的患者通过多种治疗方案取得了进展，包括铂类，紫杉烷，抗血管生成抑制剂，甚至是最近批准的抗体-药物偶联物Elahere。重要的是，迄今为止，除两名入选患者外，所有患者均曾接受过PARP抑制剂治疗。

These patients have few, if any, effective treatment options and typically advance through available therapies after only a few months..

这些患者几乎没有（如果有的话）有效的治疗选择，通常仅在几个月后就可以通过可用的治疗方法取得进展。。

Emerging and maturing data continue to show that the clinical benefit and duration on stenoparib are substantially exceeding expectations:

新出现的和成熟的数据继续表明，对stenoparib的临床益处和持续时间大大超过了预期：

Clinical benefit has now exceeded 20 weeks for each of the five patients originally mentioned in the December release, with the first patient on trial remaining on treatment for more than ten months.

12月发布的最初提到的5名患者中，每名患者的临床获益现已超过20周，第一名接受试验的患者仍在接受治疗10个月以上。

The Complete Responder, referenced in the December release, has confirmed continued response through multiple additional scans and remains on therapy.

12月发布的完整应答者已通过多次额外扫描证实持续应答，并仍在接受治疗。

Durable clinical benefit is evident in patients with:

以下患者具有明显的持久临床益处：

Platinum-sensitive or resistant disease.

铂敏感或耐药疾病。

Homologous repair proficient or deficient tumors; and

同源修复熟练或缺陷的肿瘤；和

both BRCA-wt or mutant cancers.

BRCA wt或突变型癌症。

These points highlight the differentiated mechanism of therapeutic action for stenoparib and accentuate the benefit of pre-selecting patients with DRP®.

这些观点突出了司妥巴利治疗作用的差异化机制，并强调了预先选择DRP®患者的益处。

These data have prompted the Company to funnel its finances and internal resources to accelerate stenoparib development for this advanced patient population.

这些数据促使该公司将其财务和内部资源用于加速这一先进患者群体的stenoparib开发。

Interim CEO of Allarity Thomas Jensen stated, “There remains a clear unmet medical need in patients with advanced ovarian cancer whose treatment options are limited to standard, older chemotherapies that provide limited benefit and come with significant toxicity. Based on the favorable tolerability with stenoparib and the emerging clinical benefit evident in our patients so far, we have decided to focus on re-tooling our company to accelerate development of stenoparib toward registration as quickly as possible for these desperately ill patients.”.

Allarity Thomas Jensen的临时首席执行官表示：“晚期卵巢癌患者的医疗需求显然尚未得到满足，其治疗选择仅限于标准的，较旧的化学疗法，这些疗法提供的益处有限且毒性显着。基于对司托巴利的良好耐受性以及迄今为止我们患者中明显出现的临床益处，我们决定专注于重新调整我们的公司，以加速司托巴利的发展，尽快为这些危重患者注册。”。

As part of this strategic shift, the Company will deprioritize the other clinical trials for dovitinib and IXEMPRA®.

作为这一战略转变的一部分，该公司将取消对多维替尼和IXEMPRA®的其他临床试验的重视。

An additional outcome of the strategic review is that Allarity Therapeutics has been able to materially reduce its ongoing costs and cash burn and still prioritize stenoparib to better align with its new strategic priorities.

战略审查的另一个结果是，Allarity Therapeutics已经能够大大降低其持续成本和现金消耗，并且仍然优先考虑斯妥巴利，以更好地符合其新的战略重点。

Several factors outside the Company have been included in the above-mentioned analysis of the Company’s strategic opportunities. This includes that the PARP inhibitor market, expected to reach $22 billion in revenue by 2028, has historically seen significant partnerships and acquisitions. A recent notable example occurred earlier this year with Merck KGaA’s agreement with Jiangsu Hengrui Pharmaceuticals, involving an upfront payment of approx.

上述对公司战略机遇的分析包括了公司外部的几个因素。这包括PARP抑制剂市场，预计到2028年将达到220亿美元的收入，历史上已经出现了重大的合作和收购。最近一个值得注意的例子发生在今年早些时候，默克公司（Merck KGaA）与江苏恒瑞制药（Jiangsu Hengrui Pharmaceuticals）达成协议，涉及预付约。

$176 million for a PARP inhibitor (HRS-1167) and an antibody-drug conjugate, potentially altogether totaling around $1.5 billion. In terms of availability of treatments, the PARP inhibitor market saw a major shift in 2022 as rucaparib, olaparib, and niraparib were withdrawn for heavily pretreated ovarian cancer patients, underscoring the need for new, effective PARP inhibitors with a more favorable safety profile.

PARP抑制剂（HRS-1167）和抗体-药物偶联物的费用为1.76亿美元，可能总计约15亿美元。就治疗的可用性而言，PARP抑制剂市场在2022年发生了重大变化，因为rucaparib，olaparib和niraparib被撤回用于严重预处理的卵巢癌患者，强调需要具有更有利安全性的新型有效PARP抑制剂。

Extensive clinical experience with stenoparib has continuously shown a favorable toxicity profile. In addition, stenoparib is unique in its mechanism of action, inhibiting PARP as well as the novel cancer target, tankyrase. Tankyrase inhibition would restrain the WNT pathway, which is commonly upregulated not only in ovarian cancers but in many other solid cancers.

广泛的临床经验表明，司托帕利具有良好的毒性。此外，司徒诺巴布的作用机制独特，可抑制PARP以及新型癌症靶标tankyrase。Tankyrase抑制会抑制WNT途径，WNT途径通常不仅在卵巢癌中而且在许多其他实体癌中上调。

Given the unique, dual mechanism of action for stenoparib—coupled with its favorable safety profile—stenoparib may represent the next-generation alternative in the evolving market for advanced ovarian cancer patients..

鉴于司托帕利独特的双重作用机制及其良好的安全性，司托帕利可能是晚期卵巢癌患者不断发展的市场中的下一代替代品。。

About stenoparib

关于stenoparib

Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and Tankyrase 1 and 2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the Wnt signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers.

Stenoparib是PARP1/2和Tankyrase 1和2的口服小分子双靶向抑制剂。目前，tankyrases作为新兴的癌症治疗靶点正在引起人们的极大关注，主要是由于它们在调节Wnt信号通路中的作用。异常的Wnt/β-连环蛋白信号传导与许多癌症的发展和进展有关。

By inhibiting PARP and blocking Wnt pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic. Allarity has exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121..

通过抑制PARP和阻断Wnt通路的激活，司汤那利独特的治疗作用显示出作为一种有前途的治疗方法的潜力。Allarity拥有stenoparib开发和商业化的独家全球权利，stenoparib最初由Eisai Co.Ltd.开发，以前的名称为E7449和2X-121。。

About the Drug Response Predictor – DRP® Companion Diagnostic

关于药物反应预测因子–DRP®伴随诊断

Allarity uses its drug-specific DRP® to select those patients who, by the expression signature of their cancer, are found to have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be significantly increased.

Allarity使用其药物特异性DRP®来选择那些通过癌症的表达特征被发现很有可能从特定药物中受益的患者。通过在治疗前筛查患者，并且仅治疗具有足够高的药物特异性DRP评分的患者，可以显着提高治疗获益率。

The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP® platform has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 37 out of 47 clinical studies that were examined (both retrospective and prospective).

DRP方法基于敏感与耐药人类癌细胞系的比较，包括来自细胞系的转录组信息，结合临床肿瘤生物学过滤器和先前的临床试验结果。DRP基于患者活检的信使RNA表达谱。DRP®平台已证明其能够在47项临床研究（回顾性和前瞻性）中的37项中提供对癌症患者药物治疗临床结果的统计学显着预测。

The DRP platform, which can be used in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in the peer-reviewed literature..

DRP平台可用于所有癌症类型，并获得70多种抗癌药物的专利，已在同行评审文献中广泛发表。。

About Allarity Therapeutics

关于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 Therapeutics，Inc.（纳斯达克股票代码：ALLR）是一家临床阶段生物制药公司，致力于开发个性化癌症治疗。该公司专注于开发用于晚期卵巢癌患者的新型PARP/Tankyrase抑制剂stenoparib，在正在进行的2期临床试验NCT03878849中使用其DRP®伴侣诊断进行患者选择。

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 www.allarity.com..

Allarity总部位于美国，在丹麦设有研究机构，致力于解决癌症治疗中未满足的重大医疗需求。有关更多信息，请访问www.allarity.com。。

Follow Allarity on Social Media

在社交媒体上关注Allarity

LinkedIn: https://www.linkedin.com/company/allaritytx/

LinkedIn: https://www.linkedin.com/company/allaritytx/

X: https://twitter.com/allaritytx

十：https://twitter.com/allaritytx

Forward-Looking Statements

前瞻性声明

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.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的“前瞻性声明”。前瞻性声明提供了公司当前对未来事件的预期或预测。“预期”、“相信”、“继续”、“可能”、“估计”、“预期”、“打算”、“可能”、“可能”、“计划”、“可能”、“潜在”、“预测”、“项目”、“应该”、“会”等词语可能会识别前瞻性陈述，但缺少这些词语并不意味着陈述不是前瞻性的。

These forward-looking statements include, but are not limited to, statements related to any statements related to the de-prioritization of the other clinical trials for dovitinib and IXEMPRA®, and any statements concerning an acceleration of the stenoparib development. 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.

这些前瞻性声明包括但不限于与dovitinib和IXEMPRA®其他临床试验取消优先级相关的任何声明，以及关于加速stenoparib发展的任何声明。本新闻稿中的任何前瞻性声明均基于管理层目前对未来事件的预期，并受到多种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此类前瞻性声明中规定或暗示的结果产生重大不利差异。

These risks and uncertainties include, but are not limited to, 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 therape.

这些风险和不确定性包括但不限于公司无法筹集足够资金来支持其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能预测最终结果的风险，以及在对数据进行更全面的审查后，一个或多个临床结果可能会发生重大变化的风险，以及随着更多患者数据的出现，可能需要对临床研究结果进行解释和额外分析的风险和/或可能与这些结果相矛盾的风险，以及获得监管部门对司托巴利或我们任何其他治疗方法的批准的风险。

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Company Contact:

公司联系人：

investorrelations@allarity.com

investorrelations@allarity.com

Media Contact:

媒体联系人：

Thomas Pedersen

托马斯·佩德森

Carrotize PR & Communications

胡萝卜化公关与沟通

+45 6062 9390

+45 6062 9390

tsp@carrotize.com

tsp@carrotize.com

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Allarity Therapeutics - Strategic Pivot to Focus Solely on Accelerating Stenoparib

Allarity Therapeutics-专注于加速Stenoparib的战略重点