Latest news with #ArkadyMandel
Yahoo
29-05-2025
- Business
- Yahoo
CORRECTION FROM SOURCE: Theralase to Present Groundbreaking Research at ASTRO 2025
Radiation-Activated Rutherrin(R) Versus Radiation Alone in Preclinical Cancer Models to be Presented at ASTRO 2025 This Press Release removes references to preclinical data that has not yet been presented. Toronto, Ontario--(Newsfile Corp. - May 29, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses will present promising new preclinical results at the 2025 American Society for Radiation Oncology ("ASTRO") 67th Annual Meeting. The Company's latest research evaluates radiation-activated Rutherrin® versus radiation alone in the destruction of cancer cells in a number of preclinical cancer models. This data will be showcased at the 2025 ASTRO 67th Annual Meeting, the world's largest gathering of radiation oncology professionals, taking place in late September in San Francisco, California. ASTRO has selected the Theralase® abstract titled, "Rutherrin® Activated by Radiation Therapy Evaluated for Synergistic Tumor Regression through Direct Destruction and Immune Activation in Multiple Preclinical Cancer Models", for presentation in a scientific poster session. The study explores the potent anti-cancer effects of Rutherrin®—a ruthenium-based small molecule drug formulated with recombinant human transferrin for intravenous administration. Once activated by ionizing radiation through a process known as Radio Dynamic Therapy ("RDT"), Rutherrin® initiates a two-phase cancer-killing response: the generation of Reactive Oxygen Species ("ROS") for immediate cytotoxicity, followed by Immunogenic Cell Death ("ICD") to stimulate a durable immune response. The Preclinical Data Presented Will Evaluate: Selective Tumor Targeting: Rutherrin®'s accumulation in tumor tissues versus healthy cells. Blood-Brain Barrier Penetration: Concentrations in Glio Blastoma Multiforme ("GBM") tumors versus healthy brain tissue. Synergistic Mechanism: Combination of direct tumor cell destruction with immune activation. Survival Rates: Survival benefits compared to radiation therapy alone. Resistance: Inhibition of mechanisms associated with multidrug and radiation resistance. Adaptive Immune Activation: Induction of long-term immunity, based on resistance to tumor rechallenge. Mark Roufaiel, Ph.D., research scientist at Theralase® commented, "Results are expected to be highly encouraging. Rutherrin® is hypothesized to enhance the effectiveness of radiation therapy, but also activate a sustained immune response, offering a powerful, dual-action strategy against aggressive and treatment-resistant cancers." Arkady Mandel, M.D., Ph.D., Chief Scientific Officer of Theralase®, added, "Our focus is to bring this innovative platform to clinical application. Rutherrin® may represent a major advancement in oncologic treatment, potentially enabling radiation oncologists to dramatically improve patient outcomes. This research may provide a strong foundation for integrating Rutherrin® with existing cancer therapies to deliver more effective, long-lasting solutions." Roger DuMoulin-White, President and Chief Executive Officer of Theralase®, stated, "Based on the release of this compelling data in the fall, we are fully committed to completing GLP toxicology studies in 2025. This critical milestone will support the launch of clinical studies in early 2026 targeting GBM, lung, pancreatic, lymphoma and colorectal cancers. We're excited to continue advancing Rutherrin® toward commercialization and transforming cancer care." About Rutherrin® Rutherrin® is a patented formulation of Theralase®'s lead ruthenium-based small molecule (Ruvidar®) combined with recombinant human transferrin making it suitable for intravenous delivery. It has the ability to selectively accumulate in cancer cells versus healthy cells and when radiation-activated provide a one-two punch to cancer, by first destroying the cancer cell through oxidative stress and then activating the immune system for destruction of residual cancer cells. Rutherrin® is slated to enter clinical studies in early 2026 for the destruction of deadly cancers; including: brain, lung, pancreatic, colorectal and lymphoma. About Theralase® Technologies Inc. Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their associated formulations, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses, with minimal impact on surrounding healthy tissue. Additional information is available at and Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Statements This news release contains Forward-Looking Statements ("FLS") within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words "may, "should", "will", "anticipates", "believes", "plans", "expects", "estimate", "potential for" and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals. These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure the regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; the risk that access to sufficient capital to fund the Company's operations may not be available on terms that are commercially favorable to the Company or at all; the risk that the Company's small molecule and drug formulations may not be effective against the diseases tested in its clinical studies; the risk that the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict. Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS. Although the FLS 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 FLS. All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS. For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies. For More Information: (843-5273) (5273) Kristina Hachey, CPAChief Financial Officer X 224khachey@ To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
28-05-2025
- Business
- Yahoo
Theralase to Present Groundbreaking Research at ASTRO 2025
Radiation-Activated Rutherrin(R) Shown to Be 100 Times More Effective Than Radiation Alone in Preclinical Cancer Models Toronto, Ontario--(Newsfile Corp. - May 28, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses is proud to announce promising new preclinical results. The Company's latest research demonstrates that radiation-activated Rutherrin® is up to 100 times more effective at destroying cancer cells than radiation therapy alone in comparable models. This data will be showcased at the 2025 American Society for Radiation Oncology ("ASTRO") 67th Annual Meeting, the world's largest gathering of radiation oncology professionals, taking place in late September in San Francisco, California. ASTRO has selected the Theralase® abstract titled, "Rutherrin® Activated by Radiation Therapy Induces Synergistic Tumor Regression through Direct Destruction and Immune Activation in Multiple Preclinical Cancer Models", for presentation in a scientific poster session. The study highlights the potent anti-cancer effects of Rutherrin®—a ruthenium-based small molecule drug formulated with recombinant human transferrin for intravenous administration. Once activated by ionizing radiation through a process known as Radio Dynamic Therapy ("RDT"), Rutherrin® initiates a two-phase cancer-killing response: the generation of Reactive Oxygen Species ("ROS") for immediate cytotoxicity, followed by Immunogenic Cell Death ("ICD") to stimulate a durable immune response. Key Findings from the Preclinical Research: Selective Tumor Targeting: Rutherrin® preferentially accumulates in tumor tissues, sparing healthy cells. Blood-Brain Barrier Penetration: Demonstrated 10x higher concentrations in Glio Blastoma Multiforme ("GBM") tumors than in healthy brain tissue. Synergistic Mechanism: Combines direct tumor cell destruction with robust immune activation. Improved Survival Rates: Statistically significant survival benefits compared to radiation therapy alone. Resistance Overcoming: Effectively inhibits mechanisms associated with multidrug and radiation resistance. Adaptive Immune Activation: Induces long-term immunity, as evidenced by resistance to tumor rechallenge. Mark Roufaiel, Ph.D., research scientist at Theralase® commented, "These results are highly encouraging. Rutherrin® not only enhances the effectiveness of radiation therapy, but also activates a sustained immune response, offering a powerful, dual-action strategy against aggressive and treatment-resistant cancers." Arkady Mandel, M.D., Ph.D., Chief Scientific Officer of Theralase®, added, "Our focus is to bring this innovative platform to clinical application. Rutherrin® represents a major advancement in oncologic treatment, potentially enabling radiation oncologists to dramatically improve patient outcomes. This research provides a strong foundation for integrating Rutherrin® with existing cancer therapies to deliver more effective, long-lasting solutions." Roger DuMoulin-White, President and Chief Executive Officer of Theralase®, stated, "Based on this compelling data, we are fully committed to completing GLP toxicology studies in 2025. This critical milestone will support the launch of clinical studies in early 2026 targeting GBM, lung, pancreatic, lymphoma and colorectal cancers. We're excited to continue advancing Rutherrin® toward commercialization and transforming cancer care." About ASTRO Founded in 1958, ASTRO's mission is to advance the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research, disseminating research results and representing radiation oncology in a rapidly evolving health care environment. The ASTRO Annual Meeting is the premier event in radiation oncology, bringing together leading scientists, clinicians and industry partners to share groundbreaking research and technological innovations. The 2025 meeting in San Francisco will showcase cutting-edge advances in radiation biology, translational medicine and cancer therapeutics. About Rutherrin® Rutherrin® is a patented formulation of Theralase®'s lead ruthenium-based small molecule (Ruvidar®) combined with recombinant human transferrin making it suitable for intravenous delivery. It has the ability to selectively accumulate in cancer cells versus healthy cells and when radiation-activated provide a one-two punch to cancer, by first destroying the cancer cell through oxidative stress and then activating the immune system for destruction of residual cancer cells. Rutherrin® is slated to enter clinical studies in early 2026 for the destruction of deadly cancers; including: brain, lung, pancreatic, colorectal and lymphoma. About Theralase® Technologies Inc. Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their associated formulations, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses, with minimal impact on surrounding healthy tissue. Additional information is available at and Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Statements This news release contains Forward-Looking Statements ("FLS") within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words "may, "should", "will", "anticipates", "believes", "plans", "expects", "estimate", "potential for" and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals. These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure the regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; the risk that access to sufficient capital to fund the Company's operations may not be available on terms that are commercially favorable to the Company or at all; the risk that the Company's small molecule and drug formulations may not be effective against the diseases tested in its clinical studies; the risk that the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict. Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS. Although the FLS 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 FLS. All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS. For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies. For More Information: (843-5273) (5273) Kristina Hachey, CPAChief Financial Officer X 224khachey@ To view the source version of this press release, please visit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
28-05-2025
- Business
- Associated Press
Theralase to Present Groundbreaking Research at ASTRO 2025
Radiation-Activated Rutherrin(R) Shown to Be 100 Times More Effective Than Radiation Alone in Preclinical Cancer Models Toronto, Ontario--(Newsfile Corp. - May 28, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ('Theralase®" or the 'Company'), a clinical stage pharmaceutical company pioneering light, radiation, sound and drug-activated therapeutics for the treatment of cancer, bacteria and viruses is proud to announce promising new preclinical results. The Company's latest research demonstrates that radiation-activated Rutherrin® is up to 100 times more effective at destroying cancer cells than radiation therapy alone in comparable models. This data will be showcased at the 2025 American Society for Radiation Oncology ('ASTRO') 67 th Annual Meeting, the world's largest gathering of radiation oncology professionals, taking place in late September in San Francisco, California. ASTRO has selected the Theralase® abstract titled, " Rutherrin® Activated by Radiation Therapy Induces Synergistic Tumor Regression through Direct Destruction and Immune Activation in Multiple Preclinical Cancer Models ", for presentation in a scientific poster session. The study highlights the potent anti-cancer effects of Rutherrin®—a ruthenium-based small molecule drug formulated with recombinant human transferrin for intravenous administration. Once activated by ionizing radiation through a process known as Radio Dynamic Therapy ('RDT'), Rutherrin® initiates a two-phase cancer-killing response: the generation of Reactive Oxygen Species ('ROS') for immediate cytotoxicity, followed by Immunogenic Cell Death ('ICD') to stimulate a durable immune response. Key Findings from the Preclinical Research: Mark Roufaiel, Ph.D., research scientist at Theralase® commented, 'These results are highly encouraging. Rutherrin® not only enhances the effectiveness of radiation therapy, but also activates a sustained immune response, offering a powerful, dual-action strategy against aggressive and treatment-resistant cancers.' Arkady Mandel, M.D., Ph.D., Chief Scientific Officer of Theralase®, added, 'Our focus is to bring this innovative platform to clinical application. Rutherrin® represents a major advancement in oncologic treatment, potentially enabling radiation oncologists to dramatically improve patient outcomes. This research provides a strong foundation for integrating Rutherrin® with existing cancer therapies to deliver more effective, long-lasting solutions.' Roger DuMoulin-White, President and Chief Executive Officer of Theralase®, stated, 'Based on this compelling data, we are fully committed to completing GLP toxicology studies in 2025. This critical milestone will support the launch of clinical studies in early 2026 targeting GBM, lung, pancreatic, lymphoma and colorectal cancers. We're excited to continue advancing Rutherrin® toward commercialization and transforming cancer care.' About ASTRO Founded in 1958, ASTRO's mission is to advance the practice of radiation oncology by promoting excellence in patient care, providing opportunities for educational and professional development, promoting research, disseminating research results and representing radiation oncology in a rapidly evolving health care environment. The ASTRO Annual Meeting is the premier event in radiation oncology, bringing together leading scientists, clinicians and industry partners to share groundbreaking research and technological innovations. The 2025 meeting in San Francisco will showcase cutting-edge advances in radiation biology, translational medicine and cancer therapeutics. About Rutherrin® Rutherrin® is a patented formulation of Theralase®'s lead ruthenium-based small molecule (Ruvidar®) combined with recombinant human transferrin making it suitable for intravenous delivery. It has the ability to selectively accumulate in cancer cells versus healthy cells and when radiation-activated provide a one-two punch to cancer, by first destroying the cancer cell through oxidative stress and then activating the immune system for destruction of residual cancer cells. Rutherrin® is slated to enter clinical studies in early 2026 for the destruction of deadly cancers; including: brain, lung, pancreatic, colorectal and lymphoma. About Theralase® Technologies Inc. Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their associated formulations, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses, with minimal impact on surrounding healthy tissue. Additional information is available at and Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Statements This news release contains Forward-Looking Statements ('FLS') within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words 'may, 'should', 'will', 'anticipates', 'believes', 'plans', 'expects', 'estimate', 'potential for' and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals. These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure the regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; the risk that access to sufficient capital to fund the Company's operations may not be available on terms that are commercially favorable to the Company or at all; the risk that the Company's small molecule and drug formulations may not be effective against the diseases tested in its clinical studies; the risk that the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict. Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS. For investor information on the Company, please feel to reach outInvestor Inquiries - Theralase Technologies. For More Information: (843-5273) (5273) Kristina Hachey, CPA Chief Financial Officer X 224 [email protected] To view the source version of this press release, please visit
The Market Online
28-04-2025
- Business
- The Market Online
Theralase uncovers new use-case for flagship drug
Healthcare stock Theralase Technologies (TSXV:TLT) recently discovered that its lead drug candidate, Ruvidar, has the potential to inhibit deubiquitinating enzymes, which are linked to certain cancers and neurodegenerative diseases Theralase is a clinical-stage pharmaceutical company dedicated to developing light, radiation, sound and/or drug-activated small molecule compounds, associated drug formulations and the systems that activate them to destroy various cancers, bacteria and viruses Theralase stock has added 18.75 per cent year-over-year but remains down by 9.52 per cent since 2020 Theralase Technologies (TSXV:TLT), a healthcare stock focused on treating select cancers, bacteria and viruses, recently discovered that its lead drug candidate, Ruvidar, has the potential to inhibit deubiquitinating enzymes (DUBs), which are linked to certain cancers and neurodegenerative diseases. Ruvidar has been shown to induce oxidative stress in cancer cells through the production of Reactive Oxygen Species (ROS), facilitating their destruction without affecting healthy cells. The drug – alone and/or in combination with Transferrin to produce the compound Rutherrin -has delivered promising results against bladder cancer, lung cancer, as well as various viruses, including recent breakthroughs in the treatment of herpes. The chart below depicts Ruvidar's latest potential use-case as a DUBs inhibitor: Correlation between administration of Ruvidar and reduction in DUBs activity. According to Monday's news release, 'DUBs cause cellular damage by removing ubiquitin or ubiquitin-like molecules from target proteins.' These molecules are found in all eukaryotic cells – encompassing animals, plants and humans – playing 'an essential role in regulating gene expression, DNA repair, cytokine signaling, cell metabolism, cell cycle and cell death.' Theralase's study looks to build upon recent evidence that the alteration of DUBs is a key cause behind cancer drug resistance. Leadership insights 'Our latest research provides compelling evidence that Ruvidar not only induces oxidative stress through the production of ROS to destroy cancer cells, but also directly inhibits DUBs activity – a key host mechanism exploited by the cancer cell to evade immune defenses,' Mark Roufaiel, research scientist at Theralase, said in a statement. 'This dual mechanism positions Ruvidar as a promising therapeutic candidate, particularly against cancers, where traditional chemotherapeutics demonstrate limited effectiveness.' 'With the increasing prevalence of chemoradiotherapy-resistant cancers, Ruvidar, as an effective DUBs inhibitor, may be indispensable clinically to be used as a combinational therapy with various chemotherapy drugs and/or radiotherapy to provide a safe and effective treatment against various forms of chemoradiotherapy-resistant cancers,' commented Arkady Mandel, Theralase's chief scientific officer. 'The discovery of Ruvidar's effectiveness against DUBs is a notable milestone in the development of Theralase's small-molecule program and can be used for treating cancer, but could be expanded far beyond this to the treatment of age-associated medical conditions, various neurodegenerative diseases, such as Alzheimer's, Parkinson's and Multiple Sclerosis, as well as to effectively combat various infectious diseases.' 'According to recent peer-reviewed research, reducing DUBs plays a very important role in the war against cancer and its innate ability to build up drug resistance,' added Roger DuMoulin-White, Theralase's president and chief executive officer. 'This latest research reinforces an additional mechanism of action beyond direct cancer destruction and indirect immune stimulation, stripping away one of cancer's final defence mechanisms. As Theralase pursues clinical development of Ruvidar for numerous cancers, such as brain and lung cancer, I look forward to reporting out on the clinical safety and efficacy of these programs.' About Theralase Technologies Theralase is a clinical-stage pharmaceutical company dedicated to developing light, radiation, sound and/or drug-activated small molecule compounds, associated drug formulations and the systems that activate them to destroy various cancers, bacteria and viruses. Theralase stock (TSXV:TLT) last traded at C$0.19 per share. The stock has added 18.75 per cent year-over-year but remains down by 9.52 per cent since 2020. Join the discussion: Find out what everybody's saying about this healthcare stock on the Theralase Technologies Inc. Bullboard and check out Stockhouse's stock forums and message boards. The material provided in this article is for information only and should not be treated as investment advice. For full disclaimer information, please click here. (Top image, generated by AI: Adobe Stock)
Associated Press
07-04-2025
- Health
- Associated Press
Ruvidar Demonstrates 7 Year Complete Response
Patient Diagnosed with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ Treated Once with Light-Activated Ruvidar(TM) Demonstrates 7 Year Complete Response Toronto, Ontario--(Newsfile Corp. - April 7, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ('Theralase®" or the 'Company'), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses, is pleased to announce that a patient enrolled in the Phase Ib Non-Muscle Invasive Bladder Cancer ('NMIBC') clinical study ( A Phase 1b Clinical Study of Intravesical Photodynamic Therapy in Patients with Bacillus Calmette-Guérin-unresponsive Non-muscle-invasive Bladder Cancer - ScienceDirect) has demonstrated a sustained Complete Response ('CR') (negative cystoscopy and negative urine cytology) lasting over 7 years. The patient was diagnosed with Bacillus Calmette-Guérin ('BCG')-Unresponsive NMIBC Carcinoma In-Situ ('CIS') and was treated once with the therapeutic dose of Theralase®'s lead small molecule Ruvidar TM, which was subsequently activated with the TLC-3200 medical laser system. CIS of the bladder is an aggressive type of NMIBC characterized as a flat, high-grade tumour confined to the urothelial layer. NMIBC comprises approximately 75% to 80% of all bladder cancers, with CIS found in about 10% of cases. 1 Management of CIS of the bladder remains a complex and challenging endeavor due to its high rate of recurrence and progression. Although it is typically grouped with other NMIBCs, its higher grade and aggressiveness make it a unique clinical entity. Intravesical BCG is the standard first-line treatment given its superiority to other agents; however, high rates of BCG failure highlight the need for additional therapies. 2 CIS in the bladder is associated with a less favourable prognosis. It is more likely to recur after treatment. There is also a greater risk of CIS developing into Muscle Invasive Bladder Cancer ('MIBC'). 3 Arkady Mandel, M.D., Ph.D., Chief Scientific Officer, Theralase® stated, " As a physician and a scientific researcher, I am delighted that this patient was able to achieve and maintain a complete response for 7 years after only 1 treatment. BCG-Unresponsive NMIBC CIS is a difficult to treat disease, with a very high probability of recurrence and progression. Theralase®'s light-activated Ruvidar® small molecule, based on my team's preclinical research, is able to destroy cancer through the production of reactive oxygen species and subsequently prevent its recurrence through the activation of the immune system. ' Roger DuMoulin-White, President and Chief Executive Officer, Theralase® stated, " Ruvidar TM has certainly proven to be a versatile small molecule, with its ability to destroy cancer, bacteria and viruses, when activated by light, radiation, sound or even other drugs. I am excited that it has now been proven to be safe and effective in BCG-Unresponsive NMIBC CIS for over 7 years, a very difficult to treat condition. As Theralase® wraps up the Phase II NMIBC clinical study in 2025 with a Health Canada and FDA regulatory submission in 2026, I look forward to working with our world-class scientists, researchers and medical doctors in the commencement of numerous new clinical studies, focused on hard to treat viral infections, such as herpes simplex virus lesions (cold sores), through to some of the deadliest and most difficult to treat cancers in the world, such as: glioblastoma multiforme, non-small cell lung cancer, pancreatic cancer and MIBC. ' 1 Llano A, Chan A, Kuk C, Kassouf W, Zlotta AR. Carcinoma In Situ (CIS): Is There a Difference in Efficacy between Various BCG Strains? A Comprehensive Review of the Literature. Cancers (Basel). 2024 Jan 5;16(2):245. doi: 10.3390/cancers16020245. PMID: 38254736; PMCID: PMC10813486. 2 Tang DH, Chang SS. Management of carcinoma in situ of the bladder: best practice and recent developments. Ther Adv Urol. 2015 Dec;7(6):351-64. doi: 10.1177/1756287215599694. PMID: 26622320; PMCID: PMC4647140. 3 Prognosis and survival for bladder cancer | Canadian Cancer Society. About Theralase® Technologies Inc.: Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecule compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses. Additional information is available at and Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Forward-Looking Statements: This news release contains Forward-Looking Statements ('FLS') within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words 'may, 'should', 'will', 'anticipates', 'believes', 'plans', 'expects', 'estimate', 'potential for' and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals. These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure regulatory approval to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; the risk that access to sufficient capital to fund the Company's operations may not be available on terms that are commercially favorable to the Company or at all; the risk that the Company's small molecule and drug formulations may not be effective against the diseases tested in its clinical studies; the risk that the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict. Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS. Although the FLS 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 FLS. (5273) Kristina Hachey, CPA Chief Financial Officer X 224
