Theralase Releases 3Q21 Financial Statements and Newsletter
Theralase Releases 3Q21 Financial Statements and Newsletter
TORONTO, Nov. 29, 2021 (GLOBE NEWSWIRE) -- Theralase® Technologies Inc. ("Theralase®" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds and their associated drug formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses has released the Company's unaudited 3Q2021 condensed interim consolidated Financial Statements ("Financial Statements"), which provides financial information on the previous fiscal quarter and the quarterly Newsletter ("Newsletter") which provides an interim clinical data analysis on the Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study ("Study II").
多伦多，2021年11月29日(环球通讯社)--Theralase®Technologies Inc.(“Theralase®“或”公司") (TSXV：TLT) (OTCQB：TLTFF)，一家致力于研究和开发光活性化合物及其相关药物配方的临床期制药公司，其主要目标是疗效，次要目标是销毁各种癌症、细菌和病毒的安全性。该公司公布了未经审计的2021年第三季度简明中期综合财务报表(“财务报表)，提供上一财季的财务信息和季度通讯(“通讯“)，它提供了II期非肌肉浸润性膀胱癌的中期临床数据分析(”NMIBC“)临床研究(”研究报告II").
The Financial Statements can be found on the Company's Website at www.theralase.com/financial-filings/
财务报表可在公司网站www.theralase.com/Finance-filings/上查阅。
The Newsletter can be found on the Company's website at www.theralase.com/quarterly-newsletters/
该通讯可在公司网站www.theralase.com/季度-时事通讯/上查阅。
Highlights from the Newsletter:
新闻稿中的要点：
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Leadership Transition
Effective October 25, 2021, Vera Madzarevic, Ph.D. assumed the role of Director of Clinical Development and Quality Assurance. Dr. Madzarevic holds a Ph.D. in both clinical pharmacology and biochemistry and brings over 25 years of global experience in clinical research and quality assurance from the biopharmaceutical and medical device industry to Theralase®.
Effective, November 15, 2021, Mr. John Trikola agreed to resign from his positions as the Chief Operating Officer ("COO") and interim Chief Executive Officer ("CEO") of the Company, as a result of certain facts that came to the Company's attention concerning Mr. Trikola's background that the Company's vetting process failed to detect. The Company has taken steps to improve its vetting process for incoming officers and directors.
Effective November 15, 2021, Arkady Mandel, M.D., Ph.D., D.Sc., who is currently the Chief Scientific Officer ("CSO") of the Company, assumed the role of interim CEO, replacing Mr. Trikola.
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领导层换届
自2021年10月25日起，Vera Madzarevic博士担任临床开发和质量保证总监。Madzarevic博士拥有临床药理学和生物化学的博士学位，并将在生物制药和医疗器械行业超过25年的临床研究和质量保证方面的全球经验带到Theralase。®.
自2021年11月15日起，John Trikola先生同意辞去首席运营官一职(“首席运营官“)和临时行政总裁(”首席执行官“)由于公司注意到有关Trikola先生背景的某些事实，而公司的审查程序未能发现这些事实，公司已采取措施改进对新任高级管理人员和董事的审查程序。
自2021年11月15日起，现任首席科学官的Arkady Mandel，M.D.，Ph.D.，D.Sc.CSO)接替特里科拉先生担任临时首席执行官。
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3Q21 Financial Statement Highlights
Total revenue increased 7%, year over year and is primarily attributed to a recovery in the Canadian and United States ("US") economies from the COVID-19 pandemic, as a majority of healthcare practitioners in 2020 elected to temporarily close their practices and place any purchasing decisions on temporary or permanent hold.
Net loss decreased 34%, year over year and is primarily attributed to the following:
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3Q21财务报表要点
总收入同比增长7%，主要归功于加拿大和美国的复苏(“我们“)经济受到新冠肺炎大流行的影响，因为2020年大多数医疗从业者选择暂时关闭他们的诊所，并暂时或永久搁置任何购买决定。
净亏损同比下降34%，主要归因于以下几个方面：
1) Significant delay in patient enrollment and treatment due to the COVID-19 pandemic, resulting in decreased research and development expenses in Study II.
2) Decreased salaries due to the COVID-19 pandemic, resulting in the resignation or termination of certain non-essential administrative, research and production personnel.
1)由于新冠肺炎大流行，患者招募和治疗大幅延迟，导致研究II的研发费用减少。
2)新冠肺炎疫情导致工资下降，导致部分非必要的行政、研发和生产人员辞职或离职。
The Anti-Cancer Therapy ("ACT") division represented $2,325,340 of this loss (74%) for the nine-month period ended September 30, 2021.
抗癌治疗(“施展“)分部占截至2021年9月30日的9个月这一亏损的2325340美元(74%)。
Financial highlights for the 9 month period ended September 30, 2021:
截至2021年9月30日的9个月财务摘要：
| Unaudited Consolidated Statements of Operations | 2021 | 2020 | Change | |
| In Canadian Dollars | $ | $ | % | |
| Revenue | ||||
| Canada | 501,523 | 449,359 | +12 | % |
| United States | 52,100 | 52,074 | 0 | % |
| International | 13,189 | 26,041 | -49 | % |
| Total Revenue | 566,812 | 527,474 | +7 | % |
| Cost of Sales | 317,397 | 383,990 | -17 | % |
| Gross Margin | 249,415 | 143,484 | +74 | % |
| Gross Margin as a percentage of sales | 44% | 27% | ||
| Operating Expenses | ||||
| Selling Expenses | 271,708 | 333,863 | -19 | % |
| Administrative Expenses | 1,211,834 | 1,522,179 | -20 | % |
| Research and Development Expenses – CLT Division | 254,228 | 259,507 | -2 | % |
| Research and Development Expenses – ACT Division | 1,782,187 | 2,830,417 | -37 | % |
| Other(1) | (140,810) | (86,711) | 62 | % |
| Total Operating Expenses | 3,379,146 | 4,859,255 | -30 | % |
| Net Loss | (3,129,731) | (4,715,771 | -34 | % |
| 未经审计的合并经营报表 | 2021 | 2020 | 变化 | |
| 用加元表示 | $ | $ | % | |
| 收入 | ||||
| 加拿大 | 501,523 | 449,359 | +12 | % |
| 美国 | 52,100 | 52,074 | 0 | % |
| 国际 | 13,189 | 26,041 | -49 | % |
| 总收入 | 566,812 | 527,474 | +7 | % |
| 销售成本 | 317,397 | 383,990 | -17 | % |
| 毛利率 | 249,415 | 143,484 | +74 | % |
| 毛利率占销售额的百分比 | 44% | 27% | ||
| 运营费用 | ||||
| 销售费用 | 271,708 | 333,863 | -19 | % |
| 行政费用 | 1,211,834 | 1,522,179 | -20 | % |
| 研发费用-CLT事业部 | 254,228 | 259,507 | -2 | % |
| 研发费用-ACT部门 | 1,782,187 | 2,830,417 | -37 | % |
| 其他(1) | (140,810) | (86,711) | 62 | % |
| 总运营费用 | 3,379,146 | 4,859,255 | -30 | % |
| 净亏损 | (3,129,731) | (4,715,771 | -34 | % |
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Clinical Study Sites ("CSS")
12 CSS's have been launched in Canada (5) and the US (7) for patient enrollment and treatment for Study II.
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临床研究网站(“CSS”)
加拿大(5个)和美国(7个)已经推出了12个CSS，用于第二项研究的患者登记和治疗。
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Study II Preliminary Results
As of November 29, 2021, Study II has enrolled and provided the primary study treatment for 30 patients (including three patients from the Study treated at the Therapeutic Dose) for a total of 33 patients, demonstrating the following interim results:
Note: Significant clinical data is still pending in Study II and drawing conclusions from this interim clinical data set and assumptions should be done with caution, as Study II is still ongoing and new clinical data collected may or may not continue to support the current trend.
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研究二初步结果
截至2021年11月29日，研究II已经为总共33名患者中的30名患者(包括研究中的3名患者)进行了初步研究治疗，取得了以下中期结果：
注：重要的临床数据在第二次研究中仍在等待，从这一临时临床数据集和假设中得出结论时应谨慎行事。，因为第二项研究仍在进行中，收集的新临床数据可能会也可能不会继续支持目前的趋势。
|
Assessment Day* |
90 Days | 180 Days | 270 Days | 360 Days | 450 Days | ||||||||||
| # | % | # | % | # | % | # | % | # | % | ||||||
| Complete Response ("CR") | 14 | 42 | % | 7 | 21 | % | 7 | 21 | % | 4 | 12 | % | 4 | 12 | % |
| Partial Response ("PR") | 4 | 12 | % | 5 | 15 | % | 2 | 6 | % | 4 | 12 | % | 2 | 6 | % |
| Pending | 7 | 21 | % | 13 | 39 | % | 15 | 45 | % | 16 | 48 | % | 17 | 52 | % |
| No Response ("NR") | 8 | 24 | % | 8 | 24 | % | 9 | 27 | % | 9 | 27 | % | 10 | 30 | % |
| Total Treated* | 33 | 100 | % | 33 | 100 | % | 33 | 100 | % | 33 | 100 | % | 33 | 100 | % |
|
评估日** |
90天 | 180天 | 270天 | 360天 | 450天 | ||||||||||
| # | % | # | % | # | % | # | % | # | % | ||||||
| 完成回复(“铬") | 14 | 42 | % | 7 | 21 | % | 7 | 21 | % | 4 | 12 | % | 4 | 12 | % |
| 部分响应(“印刷机") | 4 | 12 | % | 5 | 15 | % | 2 | 6 | % | 4 | 12 | % | 2 | 6 | % |
| 待定 | 7 | 21 | % | 13 | 39 | % | 15 | 45 | % | 16 | 48 | % | 17 | 52 | % |
| 无响应(“天然橡胶") | 8 | 24 | % | 8 | 24 | % | 9 | 27 | % | 9 | 27 | % | 10 | 30 | % |
| 治疗总数* | 33 | 100 | % | 33 | 100 | % | 33 | 100 | % | 33 | 100 | % | 33 | 100 | % |
*Includes three (3) patients treated at the Therapeutic Dose form Phase Ib NMIBC Clinical Study (2-CR and 1- NR at 90, 180, 270, 360, 450 days)
*包括三(3)名在治疗剂形式的Ib期NMIBC临床研究中接受治疗的患者(90、180、270、360、450天的2-CR和1-NR)
An analysis of the Study II clinical data (with 3 patients from Study Ib) provides the following interim assessments:
对研究II的临床数据(研究Ib中的3名患者)的分析提供了以下中期评估：
1) 7/10 patients (70.0%), who achieved a CR at 90 days continue to demonstrate CR at 180 days
2) In the total population of 33 patients (@ 90 days):
i) 42.4% achieved Complete Response ("CR")
ii) 12.1% achieved Partial Response ("PR")
iii) 21.2% are Pending
iv) 24.2% achieved No Response ("NR")
1)在90天达到完全缓解的10例患者中，有7例(70.0%)在180天时继续表现为完全缓解。
2)在33名患者的总人口中(@90天)：
I)42.4%的人获得了完全响应(“铬")
Ii)12.1%的人实现了部分响应(“印刷机")
三)21.2%待定
Iv)24.2%的人无反应(“天然橡胶")
Hence, the potential for CR is up to 75.8%** for the interim clinical data analysis.
因此，在中期临床数据分析中，CR的可能性高达75.8%**。
Note**: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date.
注**：假设PR和悬而未决的数据在临床上都被确定为在以后的评估日期为CR。
3) In the total population of 18 patients (@ 90 days), who received the optimized treatment:
i) 44.4% achieved CR
ii) 11.1% achieved PR
iii) 38.9% are Pending
iv) 5.6% achieved NR
3)在接受优化治疗的18名患者中(@90天)：
I)44.4%实现CR
Ii)实现11.1%的公关
Iii)38.9%的案件悬而未决
Iv)达到5.6%的NR
Hence, the potential for CR is up to 94.4%***
因此，CR的潜力高达94.4%*
Note***: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date for the interim clinical data analysis.
注*：假设PR和待定数据在临床上被确定为CR，用于中期临床数据分析的较晚评估日期。
In summary, for patients who received the primary optimized Study II Treatment versus the original Study II Treatment (90 days), there is a 5% increase in CR and a 77% decrease in NR.
总而言之，与最初的研究II治疗(90天)相比，接受初步优化研究II治疗的患者CR增加了5%，NR减少了77%。
About Theralase® Technologies Inc.
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light activated compounds and their associated drug formulations with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.
关于Theralase®技术公司
Theralase®是一家临床阶段的制药公司，致力于光活性化合物及其相关药物配方的研究和开发，主要目标是疗效，次要目标是销毁各种癌症、细菌和病毒的安全性。
Additional information is available at www.theralase.com and www.sedar.com
欲了解更多信息，请访问www.theralase.com和www.sedar.com。
This news release contains "forward-looking statements" which reflect the current expectations of Company's management for future growth, results of operations, performance and business prospects and opportunities. Such statements include, but are not limited to, statements regarding the Company's proposed development plans with respect to Photo Dynamic Compounds and their drug formulations. Wherever possible, words such as "may", "would", "could", "should", "will", "anticipate", "believe", "plan", "expect", "intend", "estimate", "potential for" and similar expressions have been used to identify these forward-looking statements. These statements reflect management's current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions including with respect to the ability of the Company to: adequately fund, secure the requisite regulatory approvals to commence and successfully complete a Phase II NMIBC clinical study in a timely fashion and implement its development plans. Many factors could cause the Company's actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements; including, without limitation, those listed in the filings made by the Company with the Canadian securities regulatory authorities (which may be viewed at www.sedar.com). Should one or more of these risks or uncertainties materialize or should assumptions underlying the forward looking statements prove incorrect, actual results, performance or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the press release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. The Company disclaims any intention or obligation to revise forward-looking statements whether as a result of new information, future developments or otherwise except as required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.
本新闻稿包含“前瞻性陈述反映了公司管理层目前对未来增长、经营结果、业绩、业务前景和机遇的期望。这些陈述包括但不限于关于公司提出的有关光动态化合物及其药物配方的发展计划的陈述。在可能的情况下，如可能", "会不会", "可能", "应该", "将要", "预期", "相信", "平面图", "期望", "意向", "估算", "潜在的“类似的表述也被用来识别这些前瞻性陈述。这些陈述反映了管理层目前对未来事件的信念，并基于管理层目前掌握的信息。前瞻性陈述涉及重大风险、不确定因素和假设，包括公司是否有能力：提供充足的资金，获得必要的监管批准，以便及时开始并成功完成NMIBC第二阶段临床研究，并实施其发展计划。许多因素可能导致公司的实际结果、业绩或成就与此类前瞻性陈述可能明示或暗示的任何未来结果、业绩或成就大不相同，包括但不限于公司向加拿大证券监管机构提交的文件(可在www.sedar.com查看)中列出的那些结果、业绩或成就。如果这些风险或不确定性中的一个或多个成为现实，或者前瞻性陈述背后的假设被证明是不正确的，实际结果、表现或成就可能与本新闻稿中包含的前瞻性陈述所表达或暗示的大不相同。这些因素应慎重考虑，潜在投资者不应过度依赖前瞻性陈述。尽管新闻稿中包含的前瞻性陈述是基于管理层目前认为合理的假设，但公司不能向潜在投资者保证实际结果、业绩或成就将与这些前瞻性陈述一致。公司不会因为新的信息而修改前瞻性陈述，也不承担任何义务。, 除法律另有规定外，未来的发展或其他情况。所有前瞻性陈述都明确地受到本警告性声明的全部限制。
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchanges) accepts responsibility for the adequacy or accuracy of this release.
多伦多证券交易所创业板交易所及其监管服务提供商(该术语在多伦多证券交易所创业板交易所的政策中定义)均不对本新闻稿的充分性或准确性承担责任。
For More Information:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
www.theralase.com
有关更多信息，请访问：
1.866.THE.LASE(843-5273)
416.699.LASE(5273)
Www.theralase.com
Kristina Hachey CPA, Chief Financial Officer
khachey@theralase.com
www.theralase.com
克里斯蒂娜·哈奇注册会计师，首席财务官
邮箱：khaceh@theralase.com
Www.theralase.com