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").
多倫多，2021年11月29日(環球通訊社)--Theralase®Technologies Inc.(“Theralase®“或”公司") (TSXV：TLT) (OTCQB：TLTFF)，一家致力於研究和開發光活性化合物及其相關藥物配方的臨牀期製藥公司，其主要目標是療效，次要目標是銷燬各種癌症、細菌和病毒的安全性。該公司公佈了未經審計的2021年第三季度簡明中期綜合財務報表(“財務報表)，提供上一財季的財務信息和季度通訊(“通訊“)，它提供了II期非肌肉浸潤性膀胱癌的中期臨牀數據分析(”NMIBC“)臨牀研究(”研究報告II").
The Financial Statements can be found on the Company's Website at www.theralase.com/financial-filings/
財務報表可在公司網站www.theralase.com/Finance-filings/上查閲。
The Newsletter can be found on the Company's website at www.theralase.com/quarterly-newsletters/
該通訊可在公司網站www.theralase.com/季度-時事通訊/上查閲。
Highlights from the Newsletter:
新聞稿中的要點：
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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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領導層換屆
自2021年10月25日起，Vera Madzarevic博士擔任臨牀開發和質量保證總監。Madzarevic博士擁有臨牀藥理學和生物化學的博士學位，並將在生物製藥和醫療器械行業超過25年的臨牀研究和質量保證方面的全球經驗帶到Theralase。®.
自2021年11月15日起，John Trikola先生同意辭去首席運營官一職(“首席運營官“)和臨時行政總裁(”首席執行官“)由於公司注意到有關Trikola先生背景的某些事實，而公司的審查程序未能發現這些事實，公司已採取措施改進對新任高級管理人員和董事的審查程序。
自2021年11月15日起，現任首席科學官的Arkady Mandel，M.D.，Ph.D.，D.Sc.CSO)接替特里科拉先生擔任臨時首席執行官。
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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財務報表要點
總收入同比增長7%，主要歸功於加拿大和美國的復甦(“我們“)經濟受到新冠肺炎大流行的影響，因為2020年大多數醫療從業者選擇暫時關閉他們的診所，並暫時或永久擱置任何購買決定。
淨虧損同比下降34%，主要歸因於以下幾個方面：
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)由於新冠肺炎大流行，患者招募和治療大幅延遲，導致研究II的研發費用減少。
2)新冠肺炎疫情導致工資下降，導致部分非必要的行政、研發和生產人員辭職或離職。
The Anti-Cancer Therapy ("ACT") division represented $2,325,340 of this loss (74%) for the nine-month period ended September 30, 2021.
抗癌治療(“施展“)分部佔截至2021年9月30日的9個月這一虧損的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個月財務摘要：
| 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 | % |
| 未經審計的合併經營報表 | 2021 | 2020 | 變化 | |
| 用加元表示 | $ | $ | % | |
| 收入 | ||||
| 加拿大 | 501,523 | 449,359 | +12 | % |
| 美國 | 52,100 | 52,074 | 0 | % |
| 國際 | 13,189 | 26,041 | -49 | % |
| 總收入 | 566,812 | 527,474 | +7 | % |
| 銷售成本 | 317,397 | 383,990 | -17 | % |
| 毛利率 | 249,415 | 143,484 | +74 | % |
| 毛利率佔銷售額的百分比 | 44% | 27% | ||
| 運營費用 | ||||
| 銷售費用 | 271,708 | 333,863 | -19 | % |
| 行政費用 | 1,211,834 | 1,522,179 | -20 | % |
| 研發費用-CLT事業部 | 254,228 | 259,507 | -2 | % |
| 研發費用-ACT部門 | 1,782,187 | 2,830,417 | -37 | % |
| 其他(1) | (140,810) | (86,711) | 62 | % |
| 總運營費用 | 3,379,146 | 4,859,255 | -30 | % |
| 淨虧損 | (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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臨牀研究網站(“CSS”)
加拿大(5個)和美國(7個)已經推出了12個CSS，用於第二項研究的患者登記和治療。
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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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研究二初步結果
截至2021年11月29日，研究II已經為總共33名患者中的30名患者(包括研究中的3名患者)進行了初步研究治療，取得了以下中期結果：
注：重要的臨牀數據在第二次研究中仍在等待，從這一臨時臨牀數據集和假設中得出結論時應謹慎行事。，因為第二項研究仍在進行中，收集的新臨牀數據可能會也可能不會繼續支持目前的趨勢。
|
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 | % |
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評估日** |
90天 | 180天 | 270天 | 360天 | 450天 | ||||||||||
| # | % | # | % | # | % | # | % | # | % | ||||||
| 完成回覆(“鉻") | 14 | 42 | % | 7 | 21 | % | 7 | 21 | % | 4 | 12 | % | 4 | 12 | % |
| 部分響應(“印刷機") | 4 | 12 | % | 5 | 15 | % | 2 | 6 | % | 4 | 12 | % | 2 | 6 | % |
| 待定 | 7 | 21 | % | 13 | 39 | % | 15 | 45 | % | 16 | 48 | % | 17 | 52 | % |
| 無響應(“天然橡膠") | 8 | 24 | % | 8 | 24 | % | 9 | 27 | % | 9 | 27 | % | 10 | 30 | % |
| 治療總數* | 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)名在治療劑形式的Ib期NMIBC臨牀研究中接受治療的患者(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:
對研究II的臨牀數據(研究Ib中的3名患者)的分析提供了以下中期評估：
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天達到完全緩解的10例患者中，有7例(70.0%)在180天時繼續表現為完全緩解。
2)在33名患者的總人口中(@90天)：
I)42.4%的人獲得了完全響應(“鉻")
Ii)12.1%的人實現了部分響應(“印刷機")
三)21.2%待定
Iv)24.2%的人無反應(“天然橡膠")
Hence, the potential for CR is up to 75.8%** for the interim clinical data analysis.
因此，在中期臨牀數據分析中，CR的可能性高達75.8%**。
Note**: Assumes both PR and Pending data are clinically determined to be CR at a later assessment date.
注**：假設PR和懸而未決的數據在臨牀上都被確定為在以後的評估日期為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)在接受優化治療的18名患者中(@90天)：
I)44.4%實現CR
Ii)實現11.1%的公關
Iii)38.9%的案件懸而未決
Iv)達到5.6%的NR
Hence, the potential for CR is up to 94.4%***
因此，CR的潛力高達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*：假設PR和待定數據在臨牀上被確定為CR，用於中期臨牀數據分析的較晚評估日期。
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.
總而言之，與最初的研究II治療(90天)相比，接受初步優化研究II治療的患者CR增加了5%，NR減少了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.
關於Theralase®技術公司
Theralase®是一家臨牀階段的製藥公司，致力於光活性化合物及其相關藥物配方的研究和開發，主要目標是療效，次要目標是銷燬各種癌症、細菌和病毒的安全性。
Additional information is available at www.theralase.com and www.sedar.com
欲瞭解更多信息，請訪問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.
本新聞稿包含“前瞻性陳述反映了公司管理層目前對未來增長、經營結果、業績、業務前景和機遇的期望。這些陳述包括但不限於關於公司提出的有關光動態化合物及其藥物配方的發展計劃的陳述。在可能的情況下，如可能", "會不會", "可能", "應該", "將要", "預期", "相信", "平面圖", "期望", "意向", "估算", "潛在的“類似的表述也被用來識別這些前瞻性陳述。這些陳述反映了管理層目前對未來事件的信念，並基於管理層目前掌握的信息。前瞻性陳述涉及重大風險、不確定因素和假設，包括公司是否有能力：提供充足的資金，獲得必要的監管批准，以便及時開始併成功完成NMIBC第二階段臨牀研究，並實施其發展計劃。許多因素可能導致公司的實際結果、業績或成就與此類前瞻性陳述可能明示或暗示的任何未來結果、業績或成就大不相同，包括但不限於公司向加拿大證券監管機構提交的文件(可在www.sedar.com查看)中列出的那些結果、業績或成就。如果這些風險或不確定性中的一個或多個成為現實，或者前瞻性陳述背後的假設被證明是不正確的，實際結果、表現或成就可能與本新聞稿中包含的前瞻性陳述所表達或暗示的大不相同。這些因素應慎重考慮，潛在投資者不應過度依賴前瞻性陳述。儘管新聞稿中包含的前瞻性陳述是基於管理層目前認為合理的假設，但公司不能向潛在投資者保證實際結果、業績或成就將與這些前瞻性陳述一致。公司不會因為新的信息而修改前瞻性陳述，也不承擔任何義務。, 除法律另有規定外，未來的發展或其他情況。所有前瞻性陳述都明確地受到本警告性聲明的全部限制。
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.
多倫多證券交易所創業板交易所及其監管服務提供商(該術語在多倫多證券交易所創業板交易所的政策中定義)均不對本新聞稿的充分性或準確性承擔責任。
For More Information:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
www.theralase.com
有關更多信息，請訪問：
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·哈奇註冊會計師，首席財務官
郵箱：khaceh@theralase.com
Www.theralase.com