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Press Release: Galecto Reports Third Quarter Operating and Financial Results

Press Release: Galecto Reports Third Quarter Operating and Financial Results

新闻稿:Galecto公布第三季度经营和财务业绩
Dow Jones Newswires ·  2021/11/05 04:31

Galecto Reports Third Quarter Operating and Financial Results

Galecto公布第三季度运营和财务业绩

Announces clinical collaboration with Roche for first line NSCLC

宣布与罗氏在一线非小细胞肺癌方面进行临床合作

Remains on track with clinical data milestone timing

保持在临床数据里程碑时间的正轨上

BOSTON, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Galecto, Inc. (NASDAQ: GLTO), a clinical stage biotechnology company focused on the development of novel treatments for fibrosis and cancer, today announced its operating and financial results for the quarter ended September 30, 2021.

波士顿,2021年11月4日(环球通讯社)--专注于开发治疗纤维化和癌症的新型疗法的临床阶段生物技术公司Galecto,Inc.(纳斯达克代码:GLTO)今天公布了截至2021年9月30日的季度的经营和财务业绩。

"The third quarter continued to show strong execution by the Galecto team, as we initiated enrollment in two separate Phase 2 trials with different mechanisms of action -- one focused on our oral galectin-3 inhibitor, GB1211, for the treatment of liver cirrhosis, and the other focused on our collagen-cross linking enzyme, LOXL2, inhibitor, GB2064, for the treatment of myelofibrosis. We recently completed enrollment in Part 1 of the liver cirrhosis trial and remain on track to present topline data from both of these trials in the second half of 2022," said Dr. Hans Schambye, CEO of Galecto. "In addition, we recently announced a clinical trial supply agreement with Roche for our planned Phase 2 trial of GB1211 in combination with Tecentriq(R) for the treatment of non-small-cell lung cancer (NSCLC). This planned trial continues our expansion of Galecto's clinical pipeline beyond fibrosis and into oncology. We are very excited about the potential use of galectin-3 inhibitors in difficult to treat cancers, starting with NSCLC. Finally, we continue to recruit patients and open additional sites in existing and new countries in our GALACTIC-1 Phase 2b clinical trial in IPF, and we remain on track to present topline results by mid-2023."

第三季度,Galecto团队继续表现出强劲的执行力,因为我们开始了两个不同作用机制的独立的第二阶段试验--一个集中在我们口服Galectin-3抑制剂GB1211上,用于治疗肝硬化,另一个集中在我们的胶原交联酶LOXL2抑制剂GB2064上,用于治疗骨髓纤维化。我们最近完成了肝硬化试验第一部分的登记,并将继续在这两个试验中提交背线数据。此外,我们最近宣布与罗氏公司签署了一项临床试验供应协议,用于我们计划中的GB1211与Tecentriq(R)联合治疗非小细胞肺癌(NSCLC)的第二阶段试验。这项计划中的试验继续将Galecto的临床流水线从纤维化扩展到肿瘤学。我们对Galectin-3抑制剂在难以治疗的癌症(从NSCLC开始)的潜在使用感到非常兴奋。最后,我们继续招募患者,并在我们的Galecto现有和新国家开设更多网站。

Dr. Schambye continued, "With the addition of the GB1211 Phase 2a trial for the treatment of NSCLC, we expect that our fibrosis and cancer product candidates will be in four separate Phase 2 clinical trials in early 2022. We remain well-funded with cash sufficient to fund our operating expenses and capital requirements into the second half of 2024."

沙姆拜博士继续说:“随着治疗非小细胞肺癌的GB1211 2a期试验的增加,我们预计我们的纤维化和癌症候选产品将在2022年初进行4个独立的2期临床试验。我们的现金资金仍然充足,足以支付我们到2024年下半年的运营费用和资本需求。”

Recent Highlights & Developments

最近的亮点和发展


-- Announced clinical collaboration with Roche for Galecto's upcoming Phase
2a trial of GB1211 in combination with Tecentriq(R) for first line NSCLC
(GALLANT-1).
-- Announced initiation of two separate Phase 2 trials:
-- Phase 2a trial of the Oral LOXL2 Inhibitor GB2064 in Myelofibrosis
(MYLOX-1 trial)
-- Phase 1b/2a trial of Oral Galectin-3 Inhibitor GB1211 in Liver
Cirrhosis (GULLIVER-2 trial)
-- Completion of enrollment in Part 1 of the GULLIVER-2 trial
--宣布与罗氏公司就Galecto的下一阶段进行临床合作GB1211联合Tecentriq(R)治疗一线非小细胞肺癌的临床试验(GARANT-1)。-宣布启动两个独立的第二阶段试验:口服LOXL2抑制剂GB2064治疗骨髓纤维化的2a期试验(MYLOX-1试验)--口服Galectin-3抑制剂GB1211肝脏1b/2a期试验肝硬化(格列佛-2试验)--完成格列佛-2试验第一部分的登记工作

Upcoming Milestones

即将到来的里程碑


-- Completion of enrollment in MYLOX-1 trial in Q4 2021
-- Initiation of enrollment in Phase 2a trial of GB1211 in Combination with
Tecentriq(R) in First Line Non-Small-Cell Lung Cancer (GALLANT-1) in 1H
2022
-- Completion of enrollment in GALACTIC-1 Phase 2b clinical trial in IPF
patients in 1H 2022
-2021年第四季度完成MYLOX-1试验的登记工作-结合GB1211和GB1211在2a阶段开始注册Tecentriq(R)在1H一线非小细胞肺癌(GARANT-1)中的应用      2022 --IPF的银河-1期2b临床试验完成登记2022年上半年的病人

Third Quarter 2021 Financial Highlights

2021年第三季度财务亮点

Cash, cash equivalents, and marketable securities as of September 30, 2021 were approximately $128 million. The Company currently expects that its cash, cash equivalents and marketable securities to be sufficient to fund its operating expenses and capital requirements into the second half of 2024.

截至2021年9月30日,现金、现金等价物和有价证券约为1.28亿美元。该公司目前预计,其现金、现金等价物和有价证券将足以为2024年下半年的运营费用和资本需求提供资金。

Research and development expenses were $9.7 million for the three months ended September 30, 2021, compared to $7.7 million for the three months ended September 30, 2020. The increase of $2.0 million was due primarily to increased clinical spending associated with three active clinical trials.

截至2021年9月30日的三个月,研发费用为970万美元,而截至2020年9月30日的三个月的研发费用为770万美元。增加200万美元的主要原因是与三项活跃的临床试验相关的临床支出增加。

General and administrative expenses were $3.2 million for the three months ended September 30, 2021, compared to $2.5 million for the three months ended September 30, 2020. The increase of $0.7 million was primarily related to increased insurance costs as a public company, increased headcount and non-cash stock-based compensation.

截至2021年9月30日的三个月,一般和行政费用为320万美元,而截至2020年9月30日的三个月为250万美元。增加70万美元的主要原因是上市公司的保险成本增加、员工人数增加以及基于非现金股票的薪酬。

Net loss attributable to common stockholders for the three months ended September 30, 2021 was $12.7 million, or $(0.50) per basic and diluted share, compared with $14.4 million, or $(55.25) per basic and diluted share, for the prior year period.

截至2021年9月30日的三个月,普通股股东应占净亏损为1270万美元,或每股基本和稀释后亏损0.50美元,而去年同期为1440万美元,或每股基本和稀释后亏损55.25美元。

About Galecto

关于Galecto

Galecto is a clinical stage company incorporated in the U.S. that is developing small molecule-based inhibitors of galectin-3 and LOXL2. Galecto has multiple ongoing Phase 2 clinical programs in fibrosis and cancer, including (i) an inhaled galectin-3 modulator (GB0139) in a Phase 2b trial for the treatment of idiopathic pulmonary fibrosis (IPF); (ii) an orally active LOXL2 inhibitor (GB2064) in a Phase 2a trial for the treatment of myelofibrosis; (iii) an orally active galectin-3 inhibitor (GB1211) in a Phase 1b/2a trial in liver cirrhosis and a separate to-be-initiated Phase 2a trial for the treatment of NSCLC in combination with atezolizumab (Tecentriq(R) ).

Galecto是一家在美国注册成立的临床阶段公司,正在开发基于Galectin-3和LOXL2的小分子抑制剂。Galecto公司有多个正在进行的纤维化和癌症第二阶段临床计划,包括(I)治疗特发性肺纤维化(IPF)的2b期试验中的吸入型Galectin-3调节剂(GB0139);(Ii)2a期试验中治疗骨髓纤维化的口服活性LOXL2抑制剂(GB2064);(Iii)1b/2b期试验中的口服活性Galectin-3抑制剂(GB1211);以及1b/2b期的肝硬化试验和一项单独的准BE试验。

Galecto intends to use its website as a means of disclosing material non-public information. For regular updates about Galecto, visit www.galecto.com.

Galecto打算利用其网站作为披露重大非公开信息的手段。有关Galecto的定期更新,请访问www.galecto.com。

Forward-Looking Statements

前瞻性陈述

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about Galecto's ability to complete enrollment in its GALACTIC-1 Phase 2b clinical trial in IPF patients in 1H 2022 and present topline data in mid-2023; Galecto's planned initiation of enrollment in the GALLANT-1 trial (NSCLC) in the 1H 2022; Galecto's completion of enrollment of its MYLOX-1 trial in Q4 2022; Galecto's expectation that topline data for the MYLOX-1 (myelofibrosis) and GULLIVER-2 (liver cirrhosis) trials in the 2H 2022; and Galecto's expectation that it cash, cash equivalents and marketable securities will be sufficient to fund our operating expenses and capital requirements into the second half of 2024. Such forward-looking statements include statements about Galecto's focus, plans for clinical development, product candidates and pipeline. The words "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "project," "potential," "continue," "target" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements, Galecto claims the protection of the Private Securities Litigation Reform Act of 1995. Actual events or results may differ materially from Galecto's expectations. Factors that could cause actual results to differ materially from the forward-looking statements include risks and uncertainties related to the development of Galecto's product candidates and their therapeutic potential, having adequate funds and their use, and those disclosed in Galecto's filings with the Securities and Exchange Commission (SEC), including, but not limited to, Galecto's Annual Report on Form 10-K, as filed with the SEC on March 29, 2021. These forward-looking statements represent Galecto's judgment as of the time of this release. Galecto disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

本新闻稿中的某些陈述是前瞻性陈述,涉及许多风险和不确定性。这些前瞻性陈述包括有关Galecto公司有能力在2022年上半年完成其针对IPF患者的Galaxy-1期2b临床试验的登记,并在2023年年中提交背线数据;Galecto公司计划在2022年上半年启动GARANT-1试验(NSCLC)的登记工作;Galecto公司在2022年第四季度完成其MYLOX-1试验的登记工作;Galecto公司预计MYLOX-1试验的背线数据--Galecto预计,到2024年下半年,它的现金、现金等价物和有价证券将足以为我们的运营费用和资本需求提供资金。这些前瞻性陈述包括关于Galecto的重点、临床开发计划、候选产品和流水线的陈述。“可能”、“将”、“可能”、“将”、“应该”、“预期”、“计划”、“预期”、“打算”、“相信”、“估计”、“预测”、“项目”、“潜在”、“继续”、“目标”以及类似的表述旨在识别前瞻性表述,尽管并不是所有的前瞻性表述都包含这些标识性词语。对于这样的声明,Galecto声称受到1995年私人证券诉讼改革法案的保护。实际事件或结果可能与Galecto的预期大不相同。可能导致实际结果与前瞻性陈述大不相同的因素包括与Galecto公司候选产品的开发及其治疗潜力有关的风险和不确定因素,是否有足够的资金及其使用,以及Galecto公司提交给美国证券交易委员会(美国证券交易委员会)的文件中披露的那些风险和不确定性,这些文件包括但不限于Galecto公司于3月29日提交给美国证券交易委员会的10-K表格年度报告。, 2021年这些前瞻性陈述代表Galecto在本新闻稿发布时的判断。除适用法律可能要求的情况外,Galecto公司不承担任何更新这些前瞻性陈述的意图或义务。

For more information, contact:

如需更多信息,请联系:

Galecto, Inc. 
Hans Schambye, CEO
Jon Freve, CFO
+45 70 70 52 10
Investors/US Media/EU
Ashley R. Robinson Sandya von der Weid
arr@lifesciadvisors.com svonderweid@lifesciadvisors.com
+1 617 430 7577 +41 78 680 0538
Galecto,Inc.汉斯·夏姆拜,首席执行官乔恩·弗里夫(Jon Freve),首席财务官 +45 70 70 52 10 投资者/美国媒体/欧盟阿什利·R·罗宾逊·桑迪亚·冯·德·韦德邮箱:arr@lifescivisors.com svonderweid@lifescivisors.com +1 617 430 7577           +41 78 680 0538 

Financial Tables to Follow

应遵循的财务表格

GALECTO, INC.

Galecto,Inc.

Condensed Consolidated Balance Sheets

简明综合资产负债表

(in thousands)

(单位:千)

                                          September 30,     December 31, 
2021 2020
(unaudited)
Cash and cash equivalents $ 66,157 $ 163,582
Marketable securities 35,987 --
Prepaid expenses and other current
assets 4,864 5,713
Marketable securities, long-term 25,492 --
Operating lease right-of-use assets 940 885
Other assets 2,434 1,416
----------- ----------
Total assets $ 135,874 $ 171,596
=========== ==========
Current liabilities $ 5,743 $ 5,566
Operating lease liabilities, noncurrent 511 541
----------- ----------
Total liabilities 6,254 6,107
----------- ----------
Total stockholders' equity 129,620 165,489
----------- ----------
Total liabilities and stockholders'
equity $ 135,874 $ 171,596
=========== ==========
九月三十日,十二月三十一日,                                                2021             2020 (未经审计)现金及现金等价物66,157美元163,582美元有价证券35,987--预付费用和其他当期费用资产4,864,713有价证券,长期25,492--经营性租赁使用权资产940 885其他资产2,434 1,416                                             -----------      ---------- 总资产135,874美元171,596美元                                             ===========      ========== 流动负债$5,743$5,566经营性租赁负债,非流动511 541                                             -----------      ---------- 总负债6,254 6,107                                             -----------      ---------- 股东权益总额129,620 165,489                                             -----------      ---------- 总负债和股东总负债股本$135,874$171,596                                             ===========      ========== 

GALECTO, INC.

Galecto,Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

简明合并经营报表与全面亏损

(in thousands, except share and per share amounts)

(以千为单位,不包括每股和每股金额)

译文内容由第三方软件翻译。


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