The Phase 3 clinical trial will evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant

这项3期临床试验将评估吉达托利西联合CDK4/6抑制剂和氟维司群作为内分泌治疗耐药的HR+/HER2晚期乳腺癌患者的一线治疗

Received an additional term loan of approximately $62 million in conjunction with an amendment to an existing debt facility agreement

收到了约6200万美元的额外定期贷款，以及对现有债务融资协议的修订

MINNEAPOLIS, May 30, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it plans to initiate a Phase 3 clinical trial to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer (“ABC”) who are endocrine therapy resistant.

明尼阿波利斯，2024年5月30日（环球通讯社）--Celcuity Inc.（纳斯达克：CELC），一家致力于开发肿瘤靶向治疗的临床阶段生物技术公司，今天宣布，它计划启动一项3期临床试验，以评估吉达托利西加CDK4/6抑制剂和氟维司群作为内分泌治疗耐药的HR+/HER2晚期乳腺癌（“ABC”）患者的一线治疗。

In conjunction with its plan to conduct this study, Celcuity today entered into an amendment to an existing debt facility agreement and received an additional term loan of approximately $62 million..

结合进行这项研究的计划，Celcuity今天对现有债务融资协议进行了修订，并获得了约6200万美元的额外定期贷款。。

“There is an urgent need for better first-line treatment options for HR+/HER2- advanced breast cancer patients whose disease progressed while on or within 12 months of completing adjuvant endocrine for early breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “We are very encouraged by the preliminary clinical data for gedatolisib as first-line treatment in patients with advanced breast cancer.

Celcuity首席医疗官Igor Gorbatchevsky医学博士说：“对于HR+/HER2晚期乳腺癌患者，迫切需要更好的一线治疗选择，这些患者的疾病在完成早期乳腺癌辅助内分泌治疗的12个月内或12个月内进展。”。“我们对吉达托利西作为晚期乳腺癌患者一线治疗的初步临床数据感到非常鼓舞。

In our Phase 1b trial that evaluated gedatolisib in combination with palbociclib and letrozole, median progression free survival was 48.6 months, and the ORR was 79%. These results highlighted the potential benefit of inhibiting the PI3K/AKT/mTOR pathway in treatment naïve patients.”.

在我们的1b期临床试验中，评估了吉达托西联合palbociclib和来曲唑，中位无进展生存期为48.6个月，ORR为79%。这些结果突出了在未接受治疗的患者中抑制PI3K/AKT/mTOR途径的潜在益处。”。

Phase 3 VIKTORIA-2 Clinical Trial

3期VIKTORIA-2临床试验

The Phase 3 VIKTORIA-2 clinical trial will be an open-label, randomized study to evaluate the efficacy and safety of gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor in comparison to fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+/HER2- ABC who are endocrine therapy resistant.

3期VIKTORIA-2临床试验将是一项开放标签的随机研究，用于评估吉达托利西联合氟维司群加CDK4/6抑制剂与氟维司群加CDK4/6抑制剂作为HR+/HER2患者的一线治疗的疗效和安全性。ABC是内分泌治疗耐药的。

For the CDK4/6 inhibitor, investigators may choose either ribociclib or palbociclib. The safety profile of gedatolisib combined with fulvestrant and palbociclib is well described, but the investigational combination of gedatolisib with ribociclib has not yet been clinically tested. Therefore, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib combined with ribociclib and fulvestrant.

对于CDK4/6抑制剂，研究人员可以选择ribociclib或palbociclib。gedatolisib联合氟维司群和palbociclib的安全性已得到很好的描述，但gedatolisib与ribociclib的研究组合尚未进行临床测试。因此，大约12-36名受试者的安全性磨合将评估gedatolisib联合ribociclib和氟维司群的安全性。

The safety run-in will be completed, and gedatolisib’s Phase 3 dose confirmed, before enrolling patients in the Phase 3 portion of the study..

在将患者纳入研究的第三阶段之前，将完成安全试运行，并确认gedatolisib的第三阶段剂量。。

For the Phase 3 study, approximately 638 subjects who meet the eligibility criteria will be assigned to a cohort based on their PIK3CA mutation status. After the investigator selects the CDK4/6 inhibitor for a subject, the subject will then be randomly assigned on a 1:1 basis to either Arm A (gedatolisib, fulvestrant, and Investigator’s choice of ribociclib or palbociclib) or Arm B (fulvestrant and Investigator’s choice of ribociclib or palbociclib)..

对于第三阶段研究，将根据其PIK3CA突变状态将大约638名符合资格标准的受试者分配到队列中。在研究者为受试者选择CDK4/6抑制剂后，受试者将以1:1的比例随机分配到a组（gedatolisib，氟维司群和研究者选择的ribociclib或palbociclib）或B组（氟维司群和研究者选择的ribociclib或palbociclib）。。

The clinical trial primary endpoints are progression free survival ('PFS'), per RECIST 1.1 criteria, as assessed by blinded independent central review. The primary PFS endpoints will be evaluated separately in subjects who are PI3KCA wild type and PI3KCA mutant.

根据RECIST 1.1标准，临床试验的主要终点是无进展生存期（“PFS”），由盲法独立中央评估评估。将在PI3KCA野生型和PI3KCA突变型受试者中分别评估主要PFS终点。

The study’s design was reviewed and discussed with the U.S. Food and Drug Administration ('FDA') during a Type C meeting.

该研究的设计在C型会议期间与美国食品和药物管理局（“FDA”）进行了审查和讨论。

This global trial is expected to enroll subjects at up to 200 clinical sites across North America, Europe, Latin America, and Asia. Celcuity expects to enroll the first patient in the second quarter of 2025.

这项全球试验预计将在北美，欧洲，拉丁美洲和亚洲的多达200个临床地点招募受试者。Celcuity预计在2025年第二季度招收第一名患者。

“We are excited to have secured the additional capital so we could accelerate initiation of our second Phase 3 study,” said Brian Sullivan, CEO and co-founder of Celcuity. “Allowing investigators to choose between ribociclib or palbociclib as the CDK4/6 inhibitor for their patients, and separately randomizing patients according to their PIK3CA status, are important elements of the trial design.

Celcuity首席执行官兼联合创始人布莱恩·沙利文（BrianSullivan）表示：“我们很高兴能够获得额外的资金，以便加快第二阶段3研究的启动。”。“允许研究人员选择ribociclib或palbociclib作为患者的CDK4/6抑制剂，并根据患者的PIK3CA状态分别随机分组，这是试验设计的重要组成部分。

We are pleased that the FDA concurred with our approach.”.

我们很高兴FDA同意我们的方法。”。

Amended debt financing agreement with Innovatus Capital Partners, LLC and Oxford Finance LLC

与Innovatus Capital Partners，LLC和Oxford Finance LLC修订的债务融资协议

Today, Celcuity also amended its existing debt financing agreement with an affiliate of Innovatus Capital Partners, LLC (“Innovatus”) and added Oxford Finance LLC (“Oxford”) as a new lender to provide Celcuity with up to $180 million in term loans, a $105 million increase from the current debt financing agreement.

今天，Celcuity还修改了其与Innovatus Capital Partners，LLC（“Innovatus”）附属公司的现有债务融资协议，并增加了Oxford Finance LLC（“Oxford”）作为新贷款人，为Celcuity提供高达1.8亿美元的定期贷款，比目前的债务融资协议增加了1.05亿美元。

At the closing of this amendment to the debt financing agreement, Celcuity will receive $61.7 million and will have $100 million of total debt outstanding. Celcuity will be able to draw an additional tranche of $30 million and an additional tranche of $50 million upon achievement of certain clinical trial and regulatory milestones.

在债务融资协议修正案结束时，Celcuity将获得6170万美元，总未偿债务将达到1亿美元。在完成某些临床试验和监管里程碑后，Celcuity将能够提取3000万美元的额外部分和5000万美元的额外部分。

The amended debt facility has a 36-month interest only period, which can be extended to a 48-month period if certain conditions are met. The loans will mature on the fifth anniversary of the amended agreement date. The loan agreement includes customary warrant coverage and is secured by all of Celcuity’s assets.

修订后的债务融资有36个月的计息期，如果满足某些条件，可以延长至48个月。贷款将在修订协议日期的第五周年到期。贷款协议包括惯常的认股权证覆盖范围，并由Celcuity的所有资产担保。

Armentum Partners LLC acted as sole advisor to Celcuity on this transaction..

Armentum Partners LLC是Celcuity在此次交易中的唯一顾问。。

About Celcuity

关于Celcuity

Celcuity is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.

Celcuity是一家临床阶段生物技术公司，专注于开发用于治疗多种实体瘤适应症的靶向疗法。该公司的主要治疗候选药物是gedatolisib，一种有效的泛PI3K和mTOR抑制剂。其作用机制和药代动力学特性与单独或共同靶向PI3K或mTOR的其他目前批准的和研究性疗法高度不同。

A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is enrolling patients.

目前正在招募患者进行一项3期临床试验VIKTORIA-1，该试验评估了吉达托利西联合氟维司群联合或不联合palbociclib治疗HR+/HER2晚期乳腺癌患者。关于VIKTORIA-1研究的更多详细信息可以在ClinicalTrials.gov上找到。一项1b/2期临床试验CELC-G-201正在招募患者，该试验评估了吉达托利西联合达洛他胺治疗转移性去势抵抗性前列腺癌患者。

A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. The company’s CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.

一项3期临床试验VIKTORIA-2评估了吉达托利西联合CDK4/6抑制剂和氟维司群作为HR+/HER2晚期乳腺癌患者的一线治疗，预计将于2025年第二季度开始招募患者。该公司的CELsignia companion诊断平台能够独特地分析活的患者肿瘤细胞，以确定可能从已经批准的靶向治疗中受益的新癌症患者群体。

Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and Twitter..

Celcuity总部位于明尼阿波利斯。有关Celcuity的更多信息，请访问www.Celcuity.com。在LinkedIn和Twitter上关注我们。。

About Innovatus Capital Partners, LLC

关于Innovatus Capital Partners，LLC

Innovatus Capital Partners, LLC, is an independent adviser and portfolio management firm with approximately $1.7B in assets under management. Innovatus adheres to an investment strategy that identifies disruptive and growth opportunities across multiple asset categories with a unifying theme of capital preservation, income generation, and upside optionality.

Innovatus Capital Partners，LLC是一家独立顾问和投资组合管理公司，管理资产约17亿美元。Innovatus坚持一项投资战略，以资本保全、创收和上行可选性为统一主题，识别多个资产类别的颠覆性和增长机会。

The firm has a dedicated team of life sciences investment professionals with deep experience in healthcare, including life sciences. Innovatus and its principals have significant experience providing debt financing to medical device, diagnostics, and biotechnology companies that address unmet medical needs, improve patient outcomes, and reduce overall healthcare expenditures..

该公司拥有一支专门的生命科学投资专业团队，在包括生命科学在内的医疗保健领域拥有丰富经验。Innovatus及其负责人拥有丰富的经验，为医疗设备、诊断和生物技术公司提供债务融资，以满足未满足的医疗需求，改善患者预后，减少整体医疗支出。。

About Oxford Finance

关于牛津金融

Oxford Finance LLC is a specialty finance firm providing senior secured loans to public and private life sciences and healthcare services companies worldwide. For over 20 years, Oxford has delivered flexible financing solutions to over 700 companies, allowing borrowers to maximize their equity by leveraging their assets.

牛津金融有限责任公司是一家专业金融公司，为全球公共和私人生命科学和医疗保健服务公司提供高级担保贷款。20多年来，牛津大学为700多家公司提供了灵活的融资解决方案，使借款人能够通过杠杆化资产来最大程度地提高股本。

Since 2002, Oxford has originated more than $11 billion in loans. Oxford is headquartered in Alexandria, Virginia, with additional offices serving the greater San Diego, San Francisco, Boston and New York City metropolitan areas..

自2002年以来，牛津大学已经发放了超过110亿美元的贷款。牛津大学总部位于弗吉尼亚州亚历山大市，在大圣地亚哥、旧金山、波士顿和纽约市都设有办事处。。

Cautionary Note Regarding Forward-Looking Statements

关于前瞻性声明的警示说明

This press release contains statements that constitute “forward-looking statements” including, but not limited to, the design of our clinical trials; the timing of initiating and enrolling patients in, and receiving results and data from, our clinical trials; the costs and expected results from any ongoing or planned clinical trials; the market opportunity for gedatolisib; other expectations with respect to gedatolisib and our CELsignia platform; the expected use of proceeds from our recent financing activities; and the strength of our balance sheet.

本新闻稿包含构成“前瞻性声明”的声明，包括但不限于我们临床试验的设计；开始和招募患者以及从我们的临床试验中获得结果和数据的时间；任何正在进行或计划进行的临床试验的成本和预期结果；gedatolisib的市场机会；对gedatolisib和我们的CELsignia平台的其他期望；我们近期融资活动所得收益的预期用途；以及我们资产负债表的实力。

In some cases, you can identify forward-looking statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends” or “continue,” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.

在某些情况下，您可以通过术语来识别前瞻性陈述，例如“可能”、“应该”、“预期”、“计划”、“预期”、“相信”、“估计”、“预测”、“潜在”、“打算”或“继续”，以及其他类似的表达，这些表达是对未来事件和未来趋势的预测或指示，或者这些术语或其他类似术语的负面影响。

Forward-looking statements are subject to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited to, unforeseen delays in our clinical trials, our ability to obtain and maintain regulatory approvals to commercialize our products, and the market acceptance of such products, the development of therapies and tools competitive with our products, and those risks set forth in the Risk Factors section in Celcuity’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 27, 2024.

前瞻性陈述受到许多风险、不确定性和条件的影响，其中许多超出了Celcuity的控制范围。这些包括但不限于我们的临床试验出现不可预见的延迟，我们获得和维持监管部门批准以使我们的产品商业化的能力，以及这些产品的市场接受程度，与我们的产品竞争的疗法和工具的开发，以及Celcuity于2024年3月27日向证券交易委员会提交的截至2023年12月31日的年度报告10-K表中风险因素部分所述的风险。

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date of this press release.

提醒读者不要过度依赖这些前瞻性声明，这些声明仅在本协议签署之日起生效。Celcuity没有义务在本新闻稿发布之日后更新这些声明的修订或更改。

View source version of release on GlobeNewswire.com

在GlobeNewswire.com上查看版本的源版本

Contacts:

联系人：

Celcuity Inc.

Celcuity股份有限公司。

Brian Sullivan, bsullivan@celcuity.com

Brian Sullivan，bsullivan@celcuity.com

Vicky Hahne, vhahne@celcuity.com

Vicky Hahn，vhahne@celcuity.com

763-392-0123

763-392-0123

ICR Westwicke

ICR Westwicke

Maria Yonkoski, maria.yonkoski@westwicke.com

Maria Yonkoski，maria.yonkoski@westwicke.com

(619) 228-5886

(619) 228-5886

SOURCE: Celcuity Inc.

资料来源：Celcuity Inc。