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MiNK Reports Second Quarter 2024 Results and Business Update

MiNK Reports Second Quarter 2024 Results and Business Update

MiNk报告了2024年第二季度的业绩和业务更新
MiNK Therapeutics ·  08/13 00:00

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  • Expanded Access to AgenT-797 in Severe ARDS Reinforces Clinical Efficacy; Data Highlighted at ATS 2024 Annual Meeting

  • Phase 2 Study in 2L Gastric Cancer Advances; Early Clinical Data to be Presented at Upcoming Medical Conference

  • Phase 1 Study in GvHD on Track for Activation in 2Q 2024

  • 扩大重度急性呼吸综合征患者获得Agent-797的机会增强了临床疗效;ATS 2024年年会上重点介绍了数据

  • 2L 胃癌的二期研究进展;早期临床数据将在即将举行的医学会议上公布

  • GvHD 的 1 期研究有望在 2024 年第二季度启动

NEW YORK, Aug.  13, 2024  (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced results for the second quarter 2024. MiNK executives will host a conference call and webcast at 8:30 a.m. ET to discuss the results and provide a corporate update.

纽约,2024年8月13日(GLOBE NEWSWIRE)——MinK Therapeutics, Inc.(纳斯达克股票代码:INKT)是一家临床阶段的生物制药公司,率先发现、开发和商业化治疗癌症和其他免疫介导疾病的异基因、现成、不变自然杀手t(inKT)细胞疗法,今天公布了2024年第二季度的业绩。MinK高管将在美国东部时间上午 8:30 主持电话会议和网络直播,讨论结果并提供公司最新情况。

"MiNK is making significant strides in advancing our iNKT programs as we pioneer this next generation of cell therapies for patients," said Dr. Jennifer Buell, CEO of MiNK Therapeutics. "Our lead program, agenT-797, is moving forward in a Phase 2 study for second-line gastric cancer, and we are fast-tracking IND-enabling activities for our FAP-expressing CAR-iNKT therapy, MiNK-215. Additionally, the expanded findings presented at the ATS annual meeting underscore the significant potential of agenT-797 in treating severe respiratory conditions in immune-compromised patients. We are committed to expanding the development of agenT-797 in a non-dilutive manner, particularly in the areas of ARDS and GvHD, where unmet needs are critical."

MinK Therapeutics首席执行官詹妮弗·比尔博士表示:“随着我们率先为患者开发下一代细胞疗法,MinK在推进我们的inKT项目方面取得了长足的进步。”“我们的主导项目agent-797正在推进一项针对二线胃癌的2期研究,我们正在加快推进表达FAP的CAR-Inkt疗法mink-215的IND支持活动。此外,在苯丙胺类兴奋剂年会上公布的扩大研究结果突显了agent-797在治疗免疫功能低下患者严重呼吸系统疾病方面的巨大潜力。我们致力于以非稀释的方式扩大agent-797的开发,特别是在ARDS和GvHD领域,在这些领域,未得到满足的需求至关重要。”

Business Updates:

业务更新:

  • In May 2024, MiNK successfully closed a private placement financing (PIPE) agreement, raising $5.8 million at a 25% premium to a new investor. Increased efficiency and progress of externally funded trials enable cash runway into 2025.

  • 2024年5月,MinK成功完成了私募融资(PIPE)协议,以25%的溢价向新投资者筹集了580万美元。外部资助试验的效率和进展的提高使现金流进入2025年。

Clinical Programs:

临床项目:

  • Acute Respiratory Distress (ARDS): Expanded access to agenT-797 in ARDS has deepened observations of clinical benefit. MiNK's recent presentation at the American Thoracic Society (ATS) 2024 annual meeting highlighted the activity of agenT-797 in treating ARDS. In a clinical case involving a renal transplant patient with severe COVID-19-induced respiratory distress, agenT-797 led to rapid cytokine reduction, successful extubation, and rapid discharge after just a single dose. These results underscore the potential of agenT-797 for severe respiratory conditions in immune-compromised patients. MiNK is committed to advancing agenT-797 in ARDS through a predominantly externally funded, large-scale platform trial.

  • 2L Gastric Cancer: A Phase 2 Investigator-Sponsored Study of agenT-797 is progressing rapidly at Memorial Sloan Kettering Cancer Center (NCT06251973). The study's swift advancement and early signals of activity highlight the promising potential of agenT-797 in treating challenging cancers, with initial data at an upcoming conference.

  • MiNK is preparing to initiate a Phase 1 study of agenT-797 in Graft-versus-Host Disease (GvHD), with activation planned for 2Q 2024. This study aims to explore the potential of agenT-797 in mitigating GvHD, a severe and life-threatening complication following allogeneic stem cell transplantation. The unique immunomodulatory properties of iNKT cells offer a novel therapeutic approach to controlling GvHD by reducing inflammation and promoting immune tolerance - furthering MiNK's commitment to the application of agenT-797 beyond cancer.

  • 急性呼吸窘迫(ARDS):扩大急性呼吸窘迫综合征中797药物的可及性,加深了对临床益处的观察。MinK最近在美国胸科学会(ATS)2024年年会上发表的演讲重点介绍了797药物在治疗急性呼吸综合征方面的活动。在涉及一名患有严重COVID-19诱发的呼吸窘迫的肾移植患者的临床病例中,agent-797导致细胞因子迅速减少,成功拔管,并在仅服用单剂量后迅速排出。这些结果突显了agent-797在免疫受损患者中治疗严重呼吸系统疾病的潜力。MinK致力于通过一项主要由外部资助的大规模平台试验,推进ARDS中的agent-797的发展。

  • 2L 胃癌:纪念斯隆·凯特琳癌症中心(NCT06251973)一项由研究人员赞助的针对agent-797的2期研究正在迅速取得进展。该研究的迅速进展和早期的活动信号凸显了agent-797在治疗具有挑战性的癌症方面的巨大潜力,初步数据将在即将举行的会议上公布。

  • MinK正准备启动一项针对移植物抗宿主病(GvHD)的797药物的1期研究,计划于2024年第二季度激活。这项研究旨在探讨agent-797在缓解GvHD方面的潜力,GvHD是一种在异基因干细胞移植后出现的严重且危及生命的并发症。inKT细胞独特的免疫调节特性为通过减少炎症和促进免疫耐受性来控制移植物抗宿主病提供了一种新的治疗方法,进一步推动了MinK对在癌症以外使用agent-797的承诺。

Preclinical Programs Advancing:

临床前项目进展情况:

  • MiNK-215 is an investigational IL-15 armored fibroblast activation protein (FAP) targeting CAR-iNKT cell therapy, that has demonstrated robust preclinical activity in solid tumor cancers, including MSS colorectal cancer liver metastases, and non-small-cell-lung cancer. Plans are in place to fast-track the IND filing to early 2025.

  • mink-215 是一种靶向 CAR-INKT 细胞疗法的在研的 IL-15 装甲成纤维细胞激活蛋白 (FAP),已在实体瘤癌中显示出强大的临床前活性,包括MSS结直肠癌肝转移和非小细胞肺癌。已经制定了将IND申请快速推迟到2025年初的计划。

Financial Results

财务业绩

MiNK ended the quarter with a cash balance of $9.3 million reflecting cash used in operations for the quarter of $2.3 million, reduced from $2.6 million for the first quarter 2024.

MinK在本季度末的现金余额为930万美元,反映了该季度运营中使用的现金为230万美元,低于2024年第一季度的260万美元。

Net loss for the three and six months ended June 30, 2024, was $2.7 million, or $0.07 per share, and $6.5 million, or $0.18 per share, respectively. This compares to $6.2 million, or $0.18 per share, and $11.9 million, or $0.35 per share, for the same periods in 2023.

截至2024年6月30日的三个月和六个月中,净亏损分别为270万美元,合每股亏损0.07美元,净亏损650万美元,合每股亏损0.18美元。相比之下,2023年同期为620万美元,合每股0.18美元,合1190万美元,合每股0.35美元。

Summary Consolidated Financial Information

Condensed Consolidated Balance Sheet Data

(in thousands)

(unaudited)

June 30, 2024

December 31, 2023

Cash and cash equivalents

$

9,314

$

3,367

Total assets

10,324

4,552

Other Financial Information

(in thousands)

(unaudited)

Three months ended June 30,

Six months ended June 30,

2024

2023

2024

2023

Cash used in operations

$

2,291

$

4,151

$

4,833

$

8,517

Non-cash operating expenses

491

683

1,141

1,650

Condensed Consolidated Statements of Operations Data

(in thousands, except per share data)

(unaudited)

Three months ended June 30,

Six months ended June 30,

2024

2023

2024

2023

Operating expenses:

Research and development

$

1,840

$

4,558

$

4,389

$

8,752

General and administrative

1,062

1,785

2,343

3,445

Change in fair value of related party note

169

-

169

-

Operating loss

3,071

6,343

6,901

12,197

Other income, net

(369)

(146)

(386)

(314)

Net loss

$

2,702

$

6,197

$

6,515

$

11,883

Per common share data, basic and diluted:

Net loss

$

(0.07)

$

(0.18)

$

(0.18)

$

(0.35)

Weighted average number of common shares outstanding, basic and diluted

37,142

34,409

35,892

34,189

合并财务信息摘要

简明的合并资产负债表数据

(以千计)

(未经审计)

2024年6月30日

2023 年 12 月 31 日

现金和现金等价物

$

9,314

$

3,367

总资产

10,324

4,552

其他财务信息

(以千计)

(未经审计)

截至6月30日的三个月

截至6月30日的六个月

2024

2023

2024

2023

运营中使用的现金

$

2,291

$

4,151

$

4,833

$

8,517

非现金运营费用

491

683

1,141

1,650

简明合并运营报表数据

(以千计,每股数据除外)

(未经审计)

截至6月30日的三个月

截至6月30日的六个月

2024

2023

2024

2023

运营费用:

研究和开发

$

1,840

$

4,558

$

4,389

$

8,752

一般和行政

1,062

1,785

2,343

3,445

关联方票据公允价值的变动

169

-

169

-

营业亏损

3,071

6,343

6,901

12,197

其他收入,净额

(369)

(146)

(386)

(314)

净亏损

$

2,702

$

6,197

$

6,515

$

11,883

每股普通股数据,基本数据和摊薄后的数据:

净亏损

$

(0.07)

$

(0.18)

$

(0.18)

$

(0.35)

已发行普通股、基本股和摊薄后普通股的加权平均数

37,142

34,409

35,892

34,189

Conference Call

电话会议

Dial-in numbers: 646-307-1963 (New York), 800-715-9871 (USA & Canada).
Conference ID: 4021545

拨入号码:646-307-1963(纽约)、800-715-9871(美国和加拿大)。
会议 ID:4021545

Webcast

网络直播

A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company's website at  and via .

电话会议的网络直播和重播可从公司网站的活动和演示页面上观看。

About MiNK Therapeutics

关于 MinK Therapeut

MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit  or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels.

MinK Therapeutics 是一家临床阶段的生物制药公司,率先发现、开发和商业化用于治疗癌症和其他免疫介导疾病的异基因不变自然杀伤 t (inKT) 细胞疗法。MinK正在推进原生和下一代工程InKT程序的管道,其平台旨在促进可扩展和可重复的制造,以实现现成交付。该公司总部位于纽约州纽约。欲了解更多信息,请访问或 @MiNK_iNKt。可能对投资者很重要的信息将定期发布在我们的网站和社交媒体渠道上。

Forward Looking Statements

前瞻性陈述

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic and curative potential of agenT-797 and iNKT cells the mechanism of action, potency and safety, interim or top-line data, including statements regarding clinical data of agenT-797, the anticipated benefits of agenT-797 and clinical development plans and timelines. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K filed with the SEC. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

本新闻稿包含根据联邦证券法安全港条款做出的前瞻性陈述,包括有关Agent-797和inKT细胞的治疗和治疗潜力、作用机制、效力和安全性、中期或主要数据,包括有关Agent-797临床数据、Agent-797的预期益处以及临床开发计划和时间表的声明。这些前瞻性陈述受风险和不确定性的影响,可能导致实际结果出现重大差异。这些前瞻性陈述受风险和不确定性的影响,包括向美国证券交易委员会提交的最新10-K表中 “风险因素” 部分中描述的因素。MinK提醒投资者不要过分依赖本新闻稿中包含的前瞻性陈述。这些声明仅代表截至本新闻稿发布之日,除法律要求外,MinK没有义务更新或修改声明。本警示性陈述对所有前瞻性陈述进行了明确的完整限定。

Investor Contact

投资者联系人

917-362-1370

917-362-1370

investor@minktherapeutics.com

investor@minktherapeutics.com

Media Contact

媒体联系人

781-674-4428

781-674-4428

communications@minktherapeutics.com

communications@minktherapeutics.com

Source: MiNK Therapeutics

来源:MinK Therapeutics

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