Q2 2026 Theralase Technologies Inc Earnings Call

September 3, 2026

Matthew Perraton: Good morning, and thank you for joining us today. I am Matthew Perraton, Investor Relations Manager at Theralase, and it is my pleasure to welcome all the shareholders and stakeholders to our Q2 2026 financial statements conference call. We appreciate your ongoing support as Theralase advances towards regulatory submissions and Theralase continues to develop additional opportunities in both the oncology and infectious disease fields. On 24 August 2026, Theralase closed a brokered financing under a Listed Issuer Financing Exemption for gross proceeds of CAD 3.55 million, further strengthening the company's balance sheet as it advances on its clinical, regulatory, and strategic objectives. Forward-looking statements. Before we begin, I would like to remind everyone that today's presentation may contain forward-looking statements as defined under applicable Canadian securities laws.

Speaker #2: Good morning, and thank you for joining us today. I'm Matthew Perryton, Investor Relations Manager at Theralase, and it's my pleasure to welcome all the shareholders and stakeholders to our second quarter 2026 financial statements conference call.

Speaker #2: We appreciate your ongoing support as THERALASE continues to advance toward regulatory submissions and develops additional opportunities in both the oncology and infectious disease fields.

Speaker #2: On August 24, 2026, Theralase closed a brokered financing under a listed issuer financing exemption for gross proceeds of $3.55 million, further strengthening the company's balance sheet as it advances on its clinical, regulatory, and corporate objectives.

Matthew Perraton: On 24 August 2026, Theralase closed a brokered financing under a Listed Issuer Financing Exemption for gross proceeds of CAD 3.55 million, further strengthening the company's balance sheet as it advances on its clinical, regulatory, and strategic objectives. Forward-looking statements. Before we begin, I would like to remind everyone that today's presentation may contain forward-looking statements as defined under applicable Canadian securities laws.

Speaker #2: Forward-looking statements. Before we begin, I would like to remind everyone that today's presentation may contain forward-looking statements as defined under applicable Canadian securities laws.

Speaker #2: Participants should not unduly rely on these forward-looking statements; they are not a guarantee of future performance, and there can be no assurance they will prove to be accurate in the future.

Matthew Perraton: Participants should not unduly rely on these forward-looking statements. They are not a guarantee of future performance, and there can be no assurance they will prove to be accurate in the future. These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results or future events to differ materially. Although forward-looking statements made today are based on what management believes to be reasonable assumptions, the company cannot assure investors that actual results will align with these expectations. All forward-looking statements are made as of today's date and are subject to change without notice. Except as required by law, the company assumes no obligation to update or revise them. This conference call will be posted on our corporate website in due course. Study Two has completed enrollment and treatment of 95 patients diagnosed with BCG unresponsive, non-muscle invasive bladder cancer carcinoma in situ.

Speaker #2: These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results or future events to differ materially. Although forward-looking statements made today are based on what management believes to be reasonable assumptions, the company cannot assure investors that actual results will align with these expectations.

Speaker #2: All forward-looking statements are made as of today's date and are subject to change without notice. Except as required by law, the company assumes no obligation to update or revise them.

Matthew Perraton: All forward-looking statements are made as of today's date and are subject to change without notice. Except as required by law, the company assumes no obligation to update or revise them. This conference call will be posted on our corporate website in due course. Study Two has completed enrollment and treatment of 95 patients diagnosed with BCG unresponsive, non-muscle invasive bladder cancer carcinoma in situ.

Speaker #2: This conference call will be posted on our corporate website in due course. Steady to has completed enrollment and treatment of 95 patients diagnosed with BCG-unresponsive, non-muscle-invasive bladder cancer, carcinoma in situ.

Speaker #2: Eighty-two patients have completed the study, and 13 are in late-stage follow-up. Theralase plans to submit a New Drug Submission to Health Canada and a New Drug Application to the FDA, commencing in the fourth quarter of 2026.

Matthew Perraton: 82 patients have completed the study and 13 are in late-stage follow-up. Theralase plans to submit a New Drug Submission to Health Canada and a New Drug Application to the FDA, commencing in Q4 2026 on a rolling review. Subject to requisite regulatory review and approval in both countries, marketing decisions are anticipated in 2027. If marketing approval is achieved, light-activated Ruvidar could offer BCG unresponsive, non-muscle invasive bladder cancer carcinoma in situ patients facing radical cystectomy with a bladder-preserving treatment option. Beyond the lead program in bladder cancer, new development work includes, one, commencing patient enrollment in Cohort 2, which uses Theralase's light-activated Ruvidar in combination with Ferring Pharmaceuticals' erfilnimab. Two, Good Laboratory Practice toxicology analysis for the intravenous instillation of Rutherrin for numerous oncology indications, including glioblastoma multiforme, non-small cell lung cancer, muscle-invasive bladder cancer, pancreatic cancer, and colorectal cancer.

Speaker #2: Under rolling review, and subject to requisite regulatory review and approval in both countries, marketing decisions are anticipated in 2027. If marketing approval is achieved, light-activated Ruthner R could offer BCG-unresponsive, non–muscle-invasive bladder cancer, carcinoma in situ patients facing radical cystectomy with a bladder-preserving treatment option.

Speaker #2: Beyond the lead program in bladder, this includes: 1) commencing patient enrollment in Cohort 2, which uses Theralase's light-activated Rutherrin in combination with varying pharmaceuticals; 2) Good Laboratory Practice (GLP) toxicology analysis for the intravenous instillation of Rutherrin for numerous oncology indications, including glioblastoma multiforme, non-small cell lung cancer, muscle-invasive bladder cancer, pancreatic cancer, and colorectal cancer.

Matthew Perraton: Beyond the lead program in bladder cancer, new development work includes, one, commencing patient enrollment in Cohort 2, which uses Theralase's light-activated Ruvidar in combination with Ferring Pharmaceuticals' erfilnimab. Two, Good Laboratory Practice toxicology analysis for the intravenous instillation of Rutherrin for numerous oncology indications, including glioblastoma multiforme, non-small cell lung cancer, muscle-invasive bladder cancer, pancreatic cancer, and colorectal cancer.

Speaker #2: Good laboratory practice toxicology analysis for topical Root R, intended for the treatment of herpes simplex virus 1 cold sore lesions. These programs position Theralase at an important clinical and regulatory inflection point, with both near-term milestones and meaningful mid- and long-term opportunities across numerous oncology indications, stretching into the treatment of an infectious disease.

Matthew Perraton: Good Laboratory Practice toxicology analysis for topical Ruvidar intended for the treatment of herpes simplex virus 1, cold sore lesions. These programs position Theralase at an important clinical and regulatory inflection point with both near-term milestones and meaningful mid and long-term opportunities across numerous oncology indications, stretching into the treatment of an infectious disease. Today's call will provide insights into our six-month 2026 financial performance, cash position, and recent financing initiatives, updated interim clinical data from Study Two for BCG unresponsive, non-muscle invasive bladder cancer carcinoma in situ, regulatory pathway Cohort 2 collaboration with Ferring Pharmaceuticals, and commercialization strategy. GLP toxicology for intravenous Rutherrin and topical Ruvidar for six new target indications. Now that we've covered the required disclosures and overview, I would like to introduce our Chief Financial Officer, Ms. Kristina Hachey.

Speaker #2: Today's call will provide insights into our six-month 2026 financial performance, cash position, and recent financing initiatives. Updated interim clinical data from Study 2 for BCG-unresponsive non-muscle-invasive bladder cancer, carcinoma in situ, regulatory pathway, Cohort 2, collaboration with varying pharmaceuticals, and commercialization strategy.

Matthew Perraton: Today's call will provide insights into our six-month 2026 financial performance, cash position, and recent financing initiatives, updated interim clinical data from Study Two for BCG unresponsive, non-muscle invasive bladder cancer carcinoma in situ, regulatory pathway Cohort 2 collaboration with Ferring Pharmaceuticals, and commercialization strategy. GLP toxicology for intravenous Rutherrin and topical Ruvidar for six new target indications. Now that we've covered the required disclosures and overview, I would like to introduce our Chief Financial Officer, Ms. Kristina Hachey.

Speaker #2: GLP toxicology for intravenous Rotarin and topical Root R for six new target indications. Now that we've covered the required disclosures and overview, I would like to introduce our Chief Financial Officer, Ms. Christina Hashi.

Speaker #3: Thank you, Matthew. Before we review the numbers, please note that all financial amounts I will be presenting today are rounded to the nearest thousand Canadian dollars for simplicity.

Kristina Hachey: Thank you, Matthew. Before we review the numbers, please note that all financial amounts I will be presenting today are rounded to the nearest thousand Canadian dollars for simplicity. For financial amounts accurate to the dollar, please refer to the Q2 2026 financial statements available on SEDAR Plus and our corporate website. For today's discussion, the financial results cover the six-month period ended 30 June 2026. The company's oncology programs remain pre-revenue, so reported revenue continues to be generated solely by the device division. Total revenue was CAD 297,000, compared with CAD 311,000 for the same period in 2025, a decrease of 5%. The cost of sales decreased to CAD 147,000 from CAD 179,000. As a result, gross margin increased to CAD 150,000 or 50% of revenue from CAD 132,000 or 42% of revenue. Selling expenses remained essentially unchanged at CAD 139,000 for both 2025 and 2026.

Speaker #3: For financial amounts accurate to the dollar, please refer to the second quarter 2026 financial statements available on SEDAR+ and our corporate website. For today's discussion, the financial results cover the six-month period ended June 30, 2026.

Speaker #3: The company's oncology programs remain pre-revenue, so reported revenue continues to be generated solely by the device division. Total revenue was $297,000, compared with $311,000 for the same period in 2025, a decrease of 5%.

Kristina Hachey: The company's oncology programs remain pre-revenue, so reported revenue continues to be generated solely by the device division. Total revenue was CAD 297,000, compared with CAD 311,000 for the same period in 2025, a decrease of 5%. The cost of sales decreased to CAD 147,000 from CAD 179,000. As a result, gross margin increased to CAD 150,000 or 50% of revenue from CAD 132,000 or 42% of revenue. Selling expenses remained essentially unchanged at CAD 139,000 for both 2025 and 2026.

Speaker #3: The cost of sales decreased to $147,000 from $179,000. As a result, gross margin increased to $150,000, or 50% of revenue, from $132,000, or 42% of revenue.

Speaker #3: Selling expenses remained essentially unchanged at $139,000 for both 2025 and 2026. Administrative expenses increased 1% to $1,004,000 from $995,000, primarily due to higher professional fees, investor relations, administrative salaries, and amortization and depreciation allocation, partially offset by lower stock-based compensation.

Kristina Hachey: Administrative expenses increased 1% to CAD 1,004,000 from CAD 995,000, primarily due to higher professional fees, investor relations, administrative salaries, amortization and depreciation allocation, partially offset by lower stock-based compensation. Net research and development expenses decreased 25% to CAD 1.1 million from CAD 1.46 million, primarily due to lower Study Two patient enrollment and treatment costs as the study begins to wrap up. The net loss for the period was CAD 2,094,000, which includes CAD 287,000 of net non-cash expenses, compared with a net loss of CAD 2,423,000, which includes CAD 486,000 of net non-cash expenses for the same period in 2025. Cash on hand was CAD 5,261,000 as at 30 June 2026 compared with CAD 183,000 as at 31 December 2025. Financing activities raised CAD 6,554,000 during the first six months of 2026 via various private placements. On 24 August 2026, the company closed a brokered LIFE financing for gross proceeds of CAD 3.55 million, further strengthening our balance sheet.

Speaker #3: Net research and development expenses decreased 25% to $1.1 million from $1.46 million, primarily due to lower Study 2 patient enrollment and treatment costs as the study begins to wrap up.

Speaker #3: The net loss for the period was $2,094,000, which includes $287,000 of net non-cash expenses, compared with the net loss of $2,423,000, which includes $486,000 of net non-cash expenses for the same period in 2025.

Kristina Hachey: The net loss for the period was CAD 2,094,000, which includes CAD 287,000 of net non-cash expenses, compared with a net loss of CAD 2,423,000, which includes CAD 486,000 of net non-cash expenses for the same period in 2025. Cash on hand was CAD 5,261,000 as at 30 June 2026 compared with CAD 183,000 as at 31 December 2025. Financing activities raised CAD 6,554,000 during the first six months of 2026 via various private placements. On 24 August 2026, the company closed a brokered LIFE financing for gross proceeds of CAD 3.55 million, further strengthening our balance sheet.

Speaker #3: Cash on hand was $5,261,000 as of June 30, 2026, compared with $183,000 as of December 31, 2025. Financing activities raised $6,554,000 during the first six months of 2026 via various private placements.

Speaker #3: On August 24, 2026, the company closed a brokered life financing for gross proceeds of $3.55 million, further strengthening our balance sheet. The company has raised approximately $17.9 million over the last two years through brokered and non-brokered private placements in support of its research and development programs.

Kristina Hachey: The company has raised approximately CAD 17.9 million over the last two years through brokered and non-brokered private placements in support of its research and development programs. The 30 June cash balance and recent LIFE financing provide capital for development and commercialization of our oncology programs, Cohort 2 patient enrollment, GLP toxicology for both intravenous Rutherrin and topical Ruvidar.

Speaker #3: The June 30 cash balance and recent life financing provide capital for development and commercialization of our oncology programs, cohort 2 patient enrollment, GLP toxicology for both intravenous Rutherrin and topical Rutherrin.

Speaker #2: Thank you, Christina, for Theralase’s second quarter 2026 financial update. Courtney will now provide an update on our bladder cancer clinical study.

Matthew Perraton: Thank you, Kristina Hachey, for Theralase's Q2 2026 financial update. Courtney will now provide an update on our bladder cancer clinical study.

Speaker #3: Thank you, Matthew. Study 2 remains the company's lead clinical program. This multicenter, single-arm, phase 2 registrational clinical study is evaluating the safety and efficacy of Ruthr, our light-activated small molecule, in patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ, with or without papillary disease.

[Company Representative] (Theralase): Thank you, Matthew Perraton. Study Two remains the company's lead clinical program. This multi-center, single arm, phase II registrational clinical study is evaluating the safety and efficacy of Ruvidar, our light-activated small molecule in patients with BCG unresponsive, non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease. The clinical study sites have enrolled and treated 95 patients. Of these patients, 82 have completed the study and 13 remain on study with clinical data pending. As of 28 August 2016, 89 patients had been assessed for response outcomes and were evaluable for the primary endpoint. The updated interim Study Two results include a 65.2% complete response rate at any point in time with 58 of 89 evaluable patients achieving complete response. A 73% total response rate with 65 of 89 evaluable patients achieving either complete response or indeterminate response.

Speaker #3: The clinical study sites have enrolled and treated 95 patients. Of these patients, 82 have completed the study and 13 remain on study with clinical data pending.

[Company Representative] (Theralase): Of these patients, 82 have completed the study and 13 remain on study with clinical data pending. As of 28 August 2016, 89 patients had been assessed for response outcomes and were evaluable for the primary endpoint. The updated interim Study Two results include a 65.2% complete response rate at any point in time with 58 of 89 evaluable patients achieving complete response. A 73% total response rate with 65 of 89 evaluable patients achieving either complete response or indeterminate response.

Speaker #3: As of August 28, 2016, 89 patients had been assessed for response outcomes and were evaluable for the primary endpoint. The updated interim Study 2 results include a 65.2% complete response rate at any point in time, with 58 of 89 evaluable patients achieving a complete response.

Speaker #3: A 73% total response rate, with 65 out of 89 evaluable patients achieving either complete response or indeterminate response. A 40.4% complete response rate at 12 months, with 21 out of 52 evaluable patients maintaining complete response at 450 days.

[Company Representative] (Theralase): A 40.4% complete response rate at 12 months with 21 of 52 evaluable patients maintaining complete response at 450 days. A 19.2% complete response rate at both two and three years with 10 of 52 evaluable patients maintaining complete response at each extended time point. One patient has demonstrated a complete response for seven years after one study procedure. Treatment emergent adverse events included urinary frequency, hematuria, and urinary urgency, which resolved within one month of treatment. There have been 24 serious adverse events reported. The majority were not treatment related, and none were directly related to the study drug or study device. For the tertiary safety endpoint, 82 of 82 evaluable patients met the endpoint, representing 100%. These results are interim in nature. Study Two remains ongoing, and additional clinical data may influence or alter current response trends.

Speaker #3: A 19.2% complete response rate at both 2 and 3 years, with 10 of 52 evaluable patients maintaining complete response at each extended time point.

Speaker #3: One patient has demonstrated a complete response for seven years after one study procedure. Treatment-emergent adverse events included urinary frequency, hematuria, and urinary urgency, which resolved within one month of treatment.

Speaker #3: There have been 24 serious adverse events reported. The majority were not treatment-related, and none were directly related to the study drug or study device.

[Company Representative] (Theralase): There have been 24 serious adverse events reported. The majority were not treatment related, and none were directly related to the study drug or study device. For the tertiary safety endpoint, 82 of 82 evaluable patients met the endpoint, representing 100%. These results are interim in nature. Study Two remains ongoing, and additional clinical data may influence or alter current response trends.

Speaker #3: For the tertiary safety endpoint, 82 out of 82 evaluable patients met the endpoint, representing 100%. These results are interim in nature. Study 2 remains ongoing, and additional clinical data may influence or alter current response trends.

Speaker #3: Our next milestones include completion of patient follow-up and final clinical data analysis for Study 2, as well as the planned submission of a New Drug Submission to Health Canada and a New Drug Application to the United States FDA in 2026.

[Company Representative] (Theralase): Our next milestones include completion of patient follow-up and final clinical data analysis for Study Two, as well as planned submission of a New Drug Submission to Health Canada and a New Drug Application to the United States FDA in 2026, under rolling review with regulatory decisions anticipated in 2027. In January 2026, Theralase entered a collaborative clinical development agreement with Ferring Pharmaceuticals to add a new cohort to Study Two. Cohort 2 is intended to investigate the safety and efficacy of combining light-activated Ruvidar with ADSTILADRIN in patients with BCG unresponsive, non-muscle invasive bladder cancer carcinoma in situ. Theralase will remain the study sponsor with both parties providing clinical oversight through a joint development committee. The cohort is expected to enroll initially in the United States and may expand to Canada or other jurisdictions subject to written agreement.

Speaker #3: Under rolling review, with regulatory decisions anticipated in 2027. In January 2026, Theralase entered a collaborative clinical development agreement with Faring Pharmaceuticals to add a new cohort to Study 2.

Speaker #3: Cohort 2 is intended to investigate the safety and efficacy of combining light-activated Rutherrin with Adsiltrin in patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ.

[Company Representative] (Theralase): Cohort 2 is intended to investigate the safety and efficacy of combining light-activated Ruvidar with ADSTILADRIN in patients with BCG unresponsive, non-muscle invasive bladder cancer carcinoma in situ. Theralase will remain the study sponsor with both parties providing clinical oversight through a joint development committee. The cohort is expected to enroll initially in the United States and may expand to Canada or other jurisdictions subject to written agreement.

Speaker #3: Theralase will remain the study sponsor, with both parties providing clinical oversight through a joint development committee. The cohort is expected to enroll initially in the United States and may expand to Canada or other jurisdictions, subject to written agreement.

Speaker #3: Under the protocol, patients would receive Rutherrin through one hour of drug instillation followed by one hour of light activation. At a subsequent outpatient visit, patients would receive a one-hour Adsilrhin instillation and may receive up to four Adsilrhin treatments.

[Company Representative] (Theralase): Under the protocol, patients would receive Ruvidar through one hour of drug instillation, followed by one hour of light activation. At a subsequent outpatient visit, patients would receive a one-hour ADSTILADRIN instillation and may receive up to four ADSTILADRIN treatments. The presiding uro-oncologist would have the option to deliver an additional Ruvidar reinduction study procedure if the patient recurs. Patients would be followed for 15 months after the initial study procedure and for up to three years of post-study follow-up.

Speaker #3: The presiding uro-oncologist would have the option to deliver an additional root R re-induction study procedure if the patient recurs. Patients would be followed for 15 months after the initial study procedure, and for up to 3 years of post-study follow-up.

Speaker #2: Thank you, Courtney, for the clinical study update. With the lead regulatory pathway outlined, the company is also building commercialization and partnership readiness around the platform.

Matthew Perraton: Thank you, Courtney, for the clinical study update. With the lead regulatory pathway outlined, the company is also building commercialization and partnership readiness around the platform. Commercialization and strategic partnership work is focused on licensing arrangements for Ruvidar in the treatment of BCG unresponsive, non-muscle invasive bladder cancer carcinoma in situ across geographic territories, collaborative clinical research applying light-activated Ruvidar to broader non-muscle invasive bladder cancer indications, collaborative research combining Ruvidar with other FDA-approved drugs to enhance treatment efficacy, maintaining access to capital as clinical and regulatory milestones progress, expanded pipeline indications. In parallel with the lead bladder cancer program, Theralase is advancing a focused pipeline that applies its small molecule platform across oncology and infectious disease, including glioblastoma multiforme, an aggressive form of brain cancer, non-small cell lung cancer, muscle-invasive bladder cancer, pancreatic cancer, colorectal cancer, herpes simplex virus type 1 lesions, more commonly known as cold sores.

Speaker #2: Commercialization and strategic partnership work is focused on licensing arrangements for Rutherrin in the treatment of BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ, across geographic territories; collaborative clinical research applying light-activated Rutherrin to broader non-muscle-invasive bladder cancer indications; collaborative research combining Rutherrin with other FDA-approved drugs to enhance treatment efficacy; maintaining access to capital as clinical and regulatory milestones progress; and expanded pipeline indications.

Speaker #2: In parallel with the lead bladder cancer program, Theralase is advancing a focused pipeline that applies its small molecule platform across oncology and infectious disease, including glioblastoma multiforme—an aggressive form of brain cancer.

Matthew Perraton: In parallel with the lead bladder cancer program, Theralase is advancing a focused pipeline that applies its small molecule platform across oncology and infectious disease, including glioblastoma multiforme, an aggressive form of brain cancer, non-small cell lung cancer, muscle-invasive bladder cancer, pancreatic cancer, colorectal cancer, herpes simplex virus type 1 lesions, more commonly known as cold sores.

Speaker #2: Non-small cell lung cancer, muscle-invasive bladder cancer, pancreatic cancer, colorectal cancer, herpes simplex virus 1 lesions—more commonly known as cold sores. For oncology indications, Theralase plans to complete Good Laboratory Practice toxicology studies for Rutherrian in the fourth quarter of 2026, including determination of the maximum tolerated dose and corresponding human-equivalent dose, subject to regulatory approval.

Matthew Perraton: For oncology indications, Theralase plans to complete Good Laboratory Practice toxicology studies for Rutherrin in Q4 2026, including determination of the maximum tolerated dose and corresponding human equivalent dose. Subject to regulatory approval, the company intends to commence the design and adaptive Phase 0/I/II clinical studies in 2027. The HSV program is a distinct topical Ruvidar opportunity that is currently in preclinical formulation development. Independent University of Manitoba research and Theralase studies have demonstrated that Ruvidar can inhibit HSV1 replication both with and without light activation. In preclinical mouse models, a 1% topical Ruvidar solution applied once daily for four days resulted in complete healing of well-developed HSV1 keratitis lesions. In vitro research has also demonstrated activity at lower concentrations than acyclovir, together with additive and synergistic effects when the two agents were combined.

Speaker #2: The company intends to commence the design and adaptive Phase 0, 1, and 2 clinical studies in 2027. The HSV program is a distinct topical Root R opportunity that is currently in preclinical formulation development.

Speaker #2: Independent University of Manitoba research and THERALASE studies have demonstrated that root R can inhibit HSV1 replication, both with and without light activation. In a preclinical mouse model, a 1% topical root R solution applied once daily for 4 days resulted in the complete healing of well-developed HSV1, tetanus lesions.

Matthew Perraton: Independent University of Manitoba research and Theralase studies have demonstrated that Ruvidar can inhibit HSV1 replication both with and without light activation. In preclinical mouse models, a 1% topical Ruvidar solution applied once daily for four days resulted in complete healing of well-developed HSV1 keratitis lesions. In vitro research has also demonstrated activity at lower concentrations than acyclovir, together with additive and synergistic effects when the two agents were combined.

Speaker #2: In vitro research has also demonstrated activity at lower concentrations than in Cyclovir, together with additive and synergistic effects when the two agents were combined.

Speaker #2: Preclinical data reported in March 2026 indicated that root R binds to HSV and neutralizes the virus's surface charge, impairing its ability to enter cells and proliferate.

Matthew Perraton: Preclinical data reported in March 2026 indicated that Ruvidar binds to HSV and neutralizes the virus's surface charge, impairing its ability to enter cells and proliferate. The same work reported up to an eight-log reduction in the infectious virus population in vitro. The company plans to complete GLP toxicology for topical Ruvidar early next year. Subject to regulatory authorization, the intended next steps include an adaptive Phase 1/2 clinical study to evaluate safety and efficacy in the accelerated healing of cold sore lesions. These HSV-1 findings remain preclinical and not yet been established safety or efficacy in humans. However, the program highlights the versatility of Ruvidar and provides Theralase a potentially significant infectious disease opportunity alongside its oncology portfolio. Now I'd like to transition to the question and answer portion of today's call.

Speaker #2: The same work reported up to an 8-log reduction in the infectious virus population in vitro. The company plans to complete GLP toxicology for topical Root R early next year.

Speaker #2: Subject to regulatory authorization, the intended next steps include an adaptive Phase 1/2 clinical study to evaluate safety and efficacy in the accelerated healing of cold sore lesions.

Speaker #2: These HSV-1 findings remain preclinical and have not yet established safety or efficacy in humans. However, the program highlights the versatility of Rutherrin and provides Theralase a potentially significant infectious disease opportunity alongside its oncology portfolio.

Matthew Perraton: These HSV-1 findings remain preclinical and not yet been established safety or efficacy in humans. However, the program highlights the versatility of Ruvidar and provides Theralase a potentially significant infectious disease opportunity alongside its oncology portfolio. Now I'd like to transition to the question and answer portion of today's call. To answer your questions, I would like to call upon our President and Chief Executive Officer, Roger Dumoulin-White. We have grouped the questions received in advance by theme and will address the most common shareholder topics. Roger, welcome and thank you for joining us today.

Speaker #2: Now I'd like to transition to the question-and-answer portion of today's call. To answer your questions, I would like to call upon our President and Chief Executive Officer, Roger Doomland White.

Matthew Perraton: To answer your questions, I would like to call upon our President and Chief Executive Officer, Roger Dumoulin-White. We have grouped the questions received in advance by theme and will address the most common shareholder topics. Roger, welcome and thank you for joining us today.

Speaker #2: We have grouped the questions received in advance by theme and will address the most common shareholder topics. Roger, welcome, and thank you for joining us today.

Speaker #4: Thank you, Matthew. It's a pleasure to be here today. Question one: Does the company remain on track to commence rolling NDS and NDA submissions before September 30th?

Roger Dumoulin-White: Thank you, Matthew. It's a pleasure to be here today. Question 1, does the company remain on track to commence rolling NDS and NDA submissions before 30 September? How complete is the clinical data package? More accurately, Health Canada NDS and FDA NDA submissions will commence in Q4 2026. Enrollment and treatment are complete, with 82 of 95 patients completing the study and 89 patients already assessed for the primary endpoint. 13 patients remain in follow-up to be assessed for primary, secondary, and tertiary endpoints. Question 2, what are the key milestones shareholders should watch over the next 12 to 18 months?

Roger DuMoulin-White: Thank you, Matthew. It's a pleasure to be here today. Question 1, does the company remain on track to commence rolling NDS and NDA submissions before 30 September? How complete is the clinical data package? More accurately, Health Canada NDS and FDA NDA submissions will commence in Q4 2026. Enrollment and treatment are complete, with 82 of 95 patients completing the study and 89 patients already assessed for the primary endpoint. 13 patients remain in follow-up to be assessed for primary, secondary, and tertiary endpoints. Question 2, what are the key milestones shareholders should watch over the next 12 to 18 months?

Speaker #4: And how complete is the clinical data package? More accurately, Health Canada NDS and FDA NDA submissions will commence in the fourth quarter of 2026.

Speaker #4: Enrollment and treatment are complete, with 82 of 95 patients completing the study, and 89 patients already assessed for the primary endpoint. Thirteen patients remain in follow-up to be assessed for primary, secondary, and tertiary endpoints.

Speaker #4: Question 2: What are the key milestones shareholders should watch over the next 12 to 18 months? Key milestones include: study 2 follow-up and analysis, NDS and NDA submissions under rolling review, Health Canada and FDA regulatory approvals in 2027, commencement of patient enrollment in cohort 2, GLP toxicology analysis of intravenous Rutherian and topical root R, in fourth quarter 2026, and first quarter of 2027, respectively, adaptive oncology clinical studies commenced in 2027 for 5 cancer indications and 1 viral condition, subject to regulatory approval, commercialization licensing strategic partnerships and potential United States stock listing progress.

Roger Dumoulin-White: Key milestones include Study Two follow-up and analysis, NDS and NDA submissions under rolling review, Health Canada and FDA regulatory approvals in 2027, commencement of patient enrollment in Cohort 2, GLP toxicology analysis of intravenous Rutherrin and topical Ruvidar in Q4 2026 and Q1 2027 respectively. Adaptive oncology clinical studies commenced in 2027 for five cancer indications and one viral condition subject to regulatory approval, commercialization, licensing, strategic partnerships, and potential United States stock listing progress. Question 3, how should investors interpret the patient counts, and could the remaining data materially change the reported 65.2% complete response rate? 95 patients have been enrolled and successfully treated. 89 have been evaluated for the primary endpoint. 82 patients have completed the study and have been evaluated for the primary, secondary, and tertiary endpoints. 13 patients remain in follow-up with clinical data pending.

Roger DuMoulin-White: Key milestones include Study Two follow-up and analysis, NDS and NDA submissions under rolling review, Health Canada and FDA regulatory approvals in 2027, commencement of patient enrollment in Cohort 2, GLP toxicology analysis of intravenous Rutherrin and topical Ruvidar in Q4 2026 and Q1 2027 respectively. Adaptive oncology clinical studies commenced in 2027 for five cancer indications and one viral condition subject to regulatory approval, commercialization, licensing, strategic partnerships, and potential United States stock listing progress.

Speaker #4: Question 3: How should investors interpret the patient counts, and could the remaining data materially change the reported 65.2% complete response rate? Ninety-five patients have been enrolled and successfully treated.

Roger DuMoulin-White: Question 3, how should investors interpret the patient counts, and could the remaining data materially change the reported 65.2% complete response rate? 95 patients have been enrolled and successfully treated. 89 have been evaluated for the primary endpoint. 82 patients have completed the study and have been evaluated for the primary, secondary, and tertiary endpoints. 13 patients remain in follow-up with clinical data pending.

Speaker #4: Eighty-nine have been evaluated for the primary endpoint; eighty-two patients have completed the study and have been evaluated for the primary, secondary, and tertiary endpoints.

Speaker #4: Thirteen patients remain in follow-up with clinical data pending. Since 94% of patients in the study have been evaluated for the primary endpoint, and 86% of patients have been evaluated for all three endpoints, the remaining clinical data is not expected to materially change the reported primary endpoint efficacy of a 65.2% complete response rate.

Roger Dumoulin-White: Since 94% of patients in the study have been evaluated for the primary endpoint and 86% of patients evaluated for all three endpoints, the remaining clinical data is not expected to materially change the reported primary endpoint efficacy of a 65.2% complete response rate. As all clinical data for the study is collected and evaluated, the final numbers will certainly fluctuate based on patient response, but not significantly as the majority of the clinical data has already been analyzed. As an example, only six of the 95 treated patients are not currently included in the primary endpoint calculations. Question 4, what is the current status of the HSV-1 program, and what has the preclinical research shown? Topical Ruvidar remains in preclinical and formulation development.

Roger DuMoulin-White: Since 94% of patients in the study have been evaluated for the primary endpoint and 86% of patients evaluated for all three endpoints, the remaining clinical data is not expected to materially change the reported primary endpoint efficacy of a 65.2% complete response rate. As all clinical data for the study is collected and evaluated, the final numbers will certainly fluctuate based on patient response, but not significantly as the majority of the clinical data has already been analyzed. As an example, only six of the 95 treated patients are not currently included in the primary endpoint calculations. Question 4, what is the current status of the HSV-1 program, and what has the preclinical research shown? Topical Ruvidar remains in preclinical and formulation development.

Speaker #4: As all clinical data for the study is collected and evaluated, the final numbers will certainly fluctuate based on patient response, but not significantly. As the majority of the clinical data has already been analyzed, as an example, only 6 of the 95 treated patients are not currently included in the primary endpoint calculations.

Speaker #4: Question 4: What is the current status of the HSV1 program, and what has the preclinical research shown? Topical root R remains in preclinical and formulation development.

Speaker #4: GLP toxicology completion is planned for the first quarter of 2027, which, pending regulatory approval and adaptive Phase 1/2 clinical study in patients with coarse cold sore lesions—excuse me—will commence.

Roger Dumoulin-White: GLP toxicology completion is planned for Q1 2027. Pending regulatory approval, an adaptive Phase I/II clinical study in patients with cold sore lesions, excuse me, will commence. The preclinical data is encouraging, with efficacy demonstrated both with and without light activation, including complete healing in an aggressive mouse lesion model. These findings will require confirmation in humans subject to regulatory approval. Question five. What is the status of Cohort 2 with Ferring Pharmaceuticals? Theralase has study sponsors preparing to launch Cohort 2 to evaluate light-activated Ruvidar with Ferring Pharmaceuticals' FDA-approved gene therapy, ADSTILADRIN. The combination brings together two differentiated and potentially complementary approaches in a difficult-to-treat population. Question six. Has the FDA indicated that the existing Study Two dataset could support an NDA without an additional clinical trial?

Roger DuMoulin-White: GLP toxicology completion is planned for Q1 2027. Pending regulatory approval, an adaptive Phase I/II clinical study in patients with cold sore lesions, excuse me, will commence. The preclinical data is encouraging, with efficacy demonstrated both with and without light activation, including complete healing in an aggressive mouse lesion model. These findings will require confirmation in humans subject to regulatory approval. Question five.

Speaker #4: The preclinical data is encouraging, with efficacy demonstrated both with and without light activation, including complete healing in an aggressive mouse lesion model. These findings will require confirmation in humans, subject to regulatory approval.

Speaker #4: Question 5: What is the status of cohort 2 with Ferring Pharmaceuticals? THERALASE, as study sponsor, is preparing to launch cohort 2 to evaluate light-activated Rutherrin with Ferring Pharmaceuticals' FDA-approved gene therapy, Adstiladrin.

Roger DuMoulin-White: What is the status of Cohort 2 with Ferring Pharmaceuticals? Theralase has study sponsors preparing to launch Cohort 2 to evaluate light-activated Ruvidar with Ferring Pharmaceuticals' FDA-approved gene therapy, ADSTILADRIN. The combination brings together two differentiated and potentially complementary approaches in a difficult-to-treat population. Question six. Has the FDA indicated that the existing Study Two dataset could support an NDA without an additional clinical trial?

Speaker #4: The combination brings together two differentiated and potentially complementary approaches in a difficult-to-treat population. Question 6: Has the FDA indicated that the existing Study 2 dataset can support an NDA without an additional clinical trial?

Speaker #4: Study 2 was designed as a registrational Phase 2 study, and the encouraging interim clinical data—including efficacy, durability, and safety profile—support the company's decision to submit both an NDS in Canada and an NDA in the United States.

Roger Dumoulin-White: Study Two was designed as a registrational Phase II study, and the encouraging interim clinical data, including efficacy, durability, and safety profile, supports the company's decision to submit both an NDS in Canada and an NDA in the United States. Health Canada and the FDA do not comment on marketing decisions regarding a clinical study until a full and final evaluation of all clinical data has been completed. Question seven. What are the main takeaways from the Q2 2026 financial results? For the six months that ended 30 June 2026, revenue was CAD 297,000, gross margin was CAD 150,000, or 50% of revenue, and net loss was CAD 2,094,000. The most encouraging trends were the improvement in gross margin from 42% to 50%, a 25% reduction in research and development expenses, and a 14% reduction in net loss compared with the same period in 2025.

Roger DuMoulin-White: Study Two was designed as a registrational Phase II study, and the encouraging interim clinical data, including efficacy, durability, and safety profile, supports the company's decision to submit both an NDS in Canada and an NDA in the United States. Health Canada and the FDA do not comment on marketing decisions regarding a clinical study until a full and final evaluation of all clinical data has been completed. Question seven.

Speaker #4: Health Canada and the FDA do not comment on marketing decisions regarding a clinical study until a full and final evaluation of all clinical data has been completed.

Speaker #4: Question 7: What are the main takeaways from the Q2 2026 financial results? For the six months ended June 30, 2026, revenue was $297,000; gross margin was $150,000, or 50% of revenue; and net loss was $2,094,000.

Roger DuMoulin-White: What are the main takeaways from the Q2 2026 financial results? For the six months that ended 30 June 2026, revenue was CAD 297,000, gross margin was CAD 150,000, or 50% of revenue, and net loss was CAD 2,094,000. The most encouraging trends were the improvement in gross margin from 42% to 50%, a 25% reduction in research and development expenses, and a 14% reduction in net loss compared with the same period in 2025.

Speaker #4: The most encouraging trends were the improvement in gross margin, from 42% to 50%, a 25% reduction in research and development expenses, and a 14% reduction in net loss compared with the same period in 2025.

Speaker #4: However, these are fairly nominal numbers, and as the company continues to grow both the drug and device divisions in subsequent quarters, total revenue is expected to increase.

Roger Dumoulin-White: However, these are fairly nominal numbers, and as the company continues to grow both the drug and device divisions in subsequent quarters, total revenue is expected to increase. Question eight. How does the August LIFE capital raise strengthen execution, and is the current capital position expected to fund the company through the planned submissions and anticipated 2027 regulatory decisions? As previously mentioned, on 24 August 2026, the company closed a brokered private placement under the LIFE exemption for gross proceeds of CAD 3.55 million. This is in addition to the CAD 5,261,000 cash balance reported as of 30 June, and hence it meaningfully strengthened the company's financial position. The company's capital will be used for various initiatives, including Study Two follow-up, NDS and NDA regulatory submissions, Cohort 2 patient enrollment, GLP toxicology for both intravenous Rutherrin and topical Ruvidar, and launch of various oncology programs.

Roger DuMoulin-White: However, these are fairly nominal numbers, and as the company continues to grow both the drug and device divisions in subsequent quarters, total revenue is expected to increase. Question eight. How does the August LIFE capital raise strengthen execution, and is the current capital position expected to fund the company through the planned submissions and anticipated 2027 regulatory decisions? As previously mentioned, on 24 August 2026, the company closed a brokered private placement under the LIFE exemption for gross proceeds of CAD 3.55 million.

Speaker #4: Question 8: How does the August life capital raise strengthen execution? And is the current capital position expected to fund the company through the planned submissions and anticipated 2027 regulatory decisions?

Speaker #4: As previously mentioned, on August 24, 2026, the company closed a brokered private placement under the Life Exemption for gross proceeds of $3.55 million. This is in addition to the $5,261,000 cash balance reported as of June 30.

Roger DuMoulin-White: This is in addition to the CAD 5,261,000 cash balance reported as of 30 June, and hence it meaningfully strengthened the company's financial position. The company's capital will be used for various initiatives, including Study Two follow-up, NDS and NDA regulatory submissions, Cohort 2 patient enrollment, GLP toxicology for both intravenous Rutherrin and topical Ruvidar, and launch of various oncology programs.

Speaker #4: And hence, it meaningfully strengthened the company's financial position. The company's capital will be used for various initiatives, including Study 2 follow-up, NDS and NDA regulatory submissions, cohort 2 patient enrollment, GLP toxicology for both intravenous route R and topical route R, and launch of various oncology programs.

Speaker #4: All of these programs will require additional capital at some point in their development. Therefore, additional funding will be required at strategic inflection points. However, since the company presently has 12 to 18 months of cash flow in the bank, capital raising will be completed at strategic times for the company.

Roger Dumoulin-White: All of these programs will require additional capital at some point in their development. Therefore, additional funding will be required at strategic inflection points. However, since the company presently has 12 to 18 months of cash flow in the bank, then capital raising will be completed at strategic times for the company. Management will continue to evaluate non-dilutive funding opportunities, strategic collaborations, and government support programs as equity alternatives. Question nine. Why does management view HSV-1 as an attractive opportunity for Theralase? HSV-1 is one of the world's most prevalent viral infections. The World Health Organization estimates that approximately 3.8 billion people under the age of 50 are infected globally. Recurrent oral lesions are quite often embarrassing and disruptive to an individual's role in society.

Roger DuMoulin-White: All of these programs will require additional capital at some point in their development. Therefore, additional funding will be required at strategic inflection points. However, since the company presently has 12 to 18 months of cash flow in the bank, then capital raising will be completed at strategic times for the company.

Speaker #4: Management will continue to evaluate non-dilutive funding opportunities, strategic collaborations, and government support programs as equity alternatives. Question 9: Why does management view HSV-1 as an attractive opportunity for Theralase?

Roger DuMoulin-White: Management will continue to evaluate non-dilutive funding opportunities, strategic collaborations, and government support programs as equity alternatives. Question nine. Why does management view HSV-1 as an attractive opportunity for Theralase? HSV-1 is one of the world's most prevalent viral infections. The World Health Organization estimates that approximately 3.8 billion people under the age of 50 are infected globally. Recurrent oral lesions are quite often embarrassing and disruptive to an individual's role in society.

Speaker #4: HSV-1 is one of the world's most prevalent viral infections. The World Health Organization estimates that approximately 3.8 billion people under the age of 50 are infected globally.

Speaker #4: Recurrent oral lesions are quite often embarrassing and disruptive to an individual's role in society. Existing antiviral treatments help to lessen the impact of viral outbreaks.

Roger Dumoulin-White: Existing antiviral treatments help to lessen the impact of viral outbreaks, but advancements are required to shorten the lifespan of the cold sore lesion on a patient's face, and this is what Theralase intends to do. For Theralase, the opportunity is compelling as it combines a very large international patient population with an innate need of those inflicted to shorten the healing time of their disfiguring cold sore lesions. If the preclinical results translate successfully into humans, it could provide a highly lucrative treatment approach for this condition and create an additional commercial avenue beyond oncology. Question 10. Is Theralase still pursuing a United States listing, and would it require a share consolidation?

Roger DuMoulin-White: Existing antiviral treatments help to lessen the impact of viral outbreaks, but advancements are required to shorten the lifespan of the cold sore lesion on a patient's face, and this is what Theralase intends to do. For Theralase, the opportunity is compelling as it combines a very large international patient population with an innate need of those inflicted to shorten the healing time of their disfiguring cold sore lesions. If the preclinical results translate successfully into humans, it could provide a highly lucrative treatment approach for this condition and create an additional commercial avenue beyond oncology. Question 10. Is Theralase still pursuing a United States listing, and would it require a share consolidation?

Speaker #4: But advancements are required to shorten the lifespan of the cold sore lesion on a patient's face, and this is what Theralase intends to do.

Speaker #4: For Theralase, the opportunity is compelling, as it combines a very large international patient population with an innate need for those afflicted to shorten the healing time of their disfiguring cold sore lesions.

Speaker #4: If the preclinical results translate successfully into humans, it could provide a highly lucrative treatment approach for this condition and create an additional commercial avenue beyond oncology.

Speaker #4: Question 10: Is THERALASE still pursuing a United States listing and would it require a share consolidation? The company continues to evaluate United States financing and listing opportunities, and is working with a full-service United States investment bank for strategic advice.

Roger Dumoulin-White: The company continues to evaluate United States financing and listing opportunities and is working with a full-service United States investment bank for strategic advice. As discussed previously, management has identified a potential pathway that would not require a share consolidation. A successful United States listing could broaden Theralase's visibility in the world's largest capital market, expand access to specialized biotechnology and institutional investors, and potentially improving trade liquidity. No definitive transaction or timing has been announced, and any material development would be disclosed via press release in accordance with applicable securities laws. Question 11. How does Ruvidar differentiate itself in bladder cancer? Ruvidar's interim clinical data demonstrates encouraging efficacy, durability, and safety responses, such as a 65.2% complete response rate at any point in time, a 40.4% duration of complete response in patients that respond, and 100% tertiary safety endpoint result.

Roger DuMoulin-White: The company continues to evaluate United States financing and listing opportunities and is working with a full-service United States investment bank for strategic advice. As discussed previously, management has identified a potential pathway that would not require a share consolidation. A successful United States listing could broaden Theralase's visibility in the world's largest capital market, expand access to specialized biotechnology and institutional investors, and potentially improving trade liquidity. No definitive transaction or timing has been announced, and any material development would be disclosed via press release in accordance with applicable securities laws.

Speaker #4: As discussed previously, management has identified a potential pathway that would not require a share consolidation. A successful United States listing could broaden Theralase's visibility in the world's largest capital market, expand access to specialized biotechnology and institutional investors, and potentially improve trade liquidity.

Speaker #4: No definitive transaction or timing has been announced, and any material development would be disclosed via press release in accordance with applicable securities laws. Question 11: How does Root R differentiate itself in bladder cancer?

Roger DuMoulin-White: Question 11. How does Ruvidar differentiate itself in bladder cancer? Ruvidar's interim clinical data demonstrates encouraging efficacy, durability, and safety responses, such as a 65.2% complete response rate at any point in time, a 40.4% duration of complete response in patients that respond, and 100% tertiary safety endpoint result. In the majority of cases, these results are obtained after a single procedure.

Speaker #4: Root R's interim clinical data demonstrate encouraging efficacy, durability, and safety responses, such as a 65.2% complete response rate at any point in time, a 40.4% duration of complete response in patients that respond, and a 100% tertiary safety endpoint result.

Speaker #4: In the majority of cases, these results are obtained after a single procedure. To illustrate the durability of the response, Theralase has one patient who has demonstrated a complete response after a single procedure and has maintained that complete response for seven years and counting.

Roger Dumoulin-White: In the majority of cases, these results are obtained after a single procedure. To illustrate the durability of the response, Theralase has one patient who has demonstrated a complete response after a single procedure and has maintained that complete response for seven years and counting. The localized single-procedure approach is attractive for patients, clinicians, and insurance companies. Question 12. What non-dilutive funding sources are being considered, and why pursue a base shelf prospectus and at-the-market program? The company continues to evaluate government grants, interest-free debt, and strategic collaborations that would reduce reliance on equity financing and allow the company to grow without additional stock dilution. A CAD 100 million base shelf prospectus has been successfully received by the OSC, and an at-the-market program, once available, could provide measured financing flexibility around positive clinical and regulatory milestones.

Roger DuMoulin-White: To illustrate the durability of the response, Theralase has one patient who has demonstrated a complete response after a single procedure and has maintained that complete response for seven years and counting. The localized single-procedure approach is attractive for patients, clinicians, and insurance companies.

Speaker #4: The localized single-procedure approach is attractive for insurance companies. Question 12: What non-dilutive funding sources are being considered? And why pursue a base shelf prospectus and at-the-market program?

Roger DuMoulin-White: Question 12. What non-dilutive funding sources are being considered, and why pursue a base shelf prospectus and at-the-market program? The company continues to evaluate government grants, interest-free debt, and strategic collaborations that would reduce reliance on equity financing and allow the company to grow without additional stock dilution. A CAD 100 million base shelf prospectus has been successfully received by the OSC, and an at-the-market program, once available, could provide measured financing flexibility around positive clinical and regulatory milestones.

Speaker #4: The company continues to evaluate government grants, interest-free debt, and strategic collaborations that would reduce reliance on equity financing and allow the company to grow without additional stock dilution.

Speaker #4: The $100 million base shelf prospectus has been successfully received by the OSC, and an at-the-market program, once available, could provide measured financing flexibility around positive clinical and regulatory milestones.

Speaker #4: Management remains mindful of dilution and will evaluate each financing alternative based on cost, timing, market conditions, and its potential to create long-term shareholder value.

Roger Dumoulin-White: Management remains mindful of dilution and will evaluate each financing alternative based on cost, timing, market conditions, and its potential to create long-term shareholder value. Question 13. What is the next step for Rutherrin in the oncology pipeline? The next step in the commercialization pathway for Rutherrin is GLP toxicology analysis, expected to be completed in Q4 2026. This information will be used to calculate the maximum tolerated dose and the human equivalent dose. Subject to regulatory approval, this work is intended to support adaptive Phase 0/I/II clinical studies in 2027 for various cancer indications. Question 14. How will the company prioritize which new indications advance first? The current indications include glioblastoma multiforme, a deadly form of brain cancer, non-small cell lung cancer, muscle-invasive bladder cancer, pancreatic cancer, colorectal cancer, and HSV-1. No final clinical sequence has been announced.

Roger DuMoulin-White: Management remains mindful of dilution and will evaluate each financing alternative based on cost, timing, market conditions, and its potential to create long-term shareholder value. Question 13. What is the next step for Rutherrin in the oncology pipeline? The next step in the commercialization pathway for Rutherrin is GLP toxicology analysis, expected to be completed in Q4 2026. This information will be used to calculate the maximum tolerated dose and the human equivalent dose. Subject to regulatory approval, this work is intended to support adaptive Phase 0/I/II clinical studies in 2027 for various cancer indications.

Speaker #4: Question 13: What is the next step for root R in the oncology pipeline? The next step in the commercialization pathway for root R is GLP toxicology analysis, expected to be completed in the fourth quarter of 2026.

Speaker #4: This information will be used to calculate the maximum tolerated dose and the human equivalent dose, subject to regulatory approval. This work is intended to support adaptive Phase 0, 1, and 2 clinical studies in 2027 for various cancer indications.

Speaker #4: Question 14: How will the company prioritize which new indications advance first? The current indications include glioblastoma multiforme, a deadly form of brain cancer; non-small cell lung cancer; muscle invasive bladder cancer; pancreatic cancer; colorectal cancer; and HSV-1.

Roger DuMoulin-White: Question 14. How will the company prioritize which new indications advance first? The current indications include glioblastoma multiforme, a deadly form of brain cancer, non-small cell lung cancer, muscle-invasive bladder cancer, pancreatic cancer, colorectal cancer, and HSV-1. No final clinical sequence has been announced. Management intends to prioritize programs based on clinical data, competition in the disease space, unmet clinical need, feasibility, regulatory pathway, development cost, partner interest, and commercial potential. The objective is to direct capital towards the programs with the clearest path to meaningful clinical impact and shareholder value.

Speaker #4: No final clinical sequence has been announced. Management intends to prioritize programs based on clinical data, competition in the disease space, unmet clinical need, feasibility, regulatory pathway, development cost, partner interest, and commercial potential.

Roger Dumoulin-White: Management intends to prioritize programs based on clinical data, competition in the disease space, unmet clinical need, feasibility, regulatory pathway, development cost, partner interest, and commercial potential. The objective is to direct capital towards the programs with the clearest path to meaningful clinical impact and shareholder value. Question 15. Will Ruvidar be commercialized in-house or through partnerships? The company is evaluating multiple approaches, including geographic licensing for bladder cancer, collaborative research in broader NMIBC indications, and combinations with other approved drugs. Strategic partnerships can significantly extend geographic reach, accelerate development and market access, bring specialized commercial capabilities, and reduce the capital Theralase would otherwise need to deploy on its own. The ultimate structure may vary by territory and indication, with the objective of maximizing long-term shareholder value.

Speaker #4: The objective is to direct capital towards the programs with the clearest path to meaningful clinical impact and shareholder value. Question 15: Will Root R be commercialized in-house or through partnerships?

Roger DuMoulin-White: Question 15. Will Ruvidar be commercialized in-house or through partnerships? The company is evaluating multiple approaches, including geographic licensing for bladder cancer, collaborative research in broader NMIBC indications, and combinations with other approved drugs. Strategic partnerships can significantly extend geographic reach, accelerate development and market access, bring specialized commercial capabilities, and reduce the capital Theralase would otherwise need to deploy on its own. The ultimate structure may vary by territory and indication, with the objective of maximizing long-term shareholder value.

Speaker #4: The company is evaluating multiple approaches, including geographic licensing for bladder cancer, collaborative research, broader NMIBC indications, and combinations with other approved drugs. Strategic partnerships can significantly extend geographic reach, accelerate development and market access, bring specialized commercial capabilities, and reduce the capital Theralase would otherwise need to deploy on its own.

Speaker #4: The ultimate structure may vary by territory and indication, with the objective of maximizing long-term shareholder value. At the moment, licensing Route R for bladder cancer would be the most logical path forward, versus developing an expensive sales, marketing, and distribution network.

Roger Dumoulin-White: At the moment, licensing Ruvidar for bladder cancer would be the most logical path forward versus developing an expensive sales, marketing, and distribution network. Question 16. What is the shelf life and logistical advantage of Ruvidar? Ruvidar has demonstrated a 10-year shelf life at room temperature. This is a meaningful product attribute that would simplify storage, inventory management, and distribution compared with therapies requiring complex preparation or ultra-cold storage. If approved, this stability profile could support broader clinical adoption and partnership interest. Commercial logistics, labeling, and distribution requirements will remain subject to applicable regulatory approvals. Question 17. What does the updated durability data show, and what should investors expect from the final 12 and 24-month analyses?

Roger DuMoulin-White: At the moment, licensing Ruvidar for bladder cancer would be the most logical path forward versus developing an expensive sales, marketing, and distribution network. Question 16. What is the shelf life and logistical advantage of Ruvidar? Ruvidar has demonstrated a 10-year shelf life at room temperature. This is a meaningful product attribute that would simplify storage, inventory management, and distribution compared with therapies requiring complex preparation or ultra-cold storage. If approved, this stability profile could support broader clinical adoption and partnership interest. Commercial logistics, labeling, and distribution requirements will remain subject to applicable regulatory approvals.

Speaker #4: Question 16: What is the shelf life and logistical advantage of root R? Root R is demonstrated to have a 10-year shelf life at room temperature. This is a meaningful product attribute that would simplify storage, inventory management, and distribution compared with therapies requiring complex preparation or ultra-cold storage.

Speaker #4: If approved, this stability profile could support broader clinical adoption and partnership interest. Commercial logistics, labeling, and distribution requirements will remain subject to applicable regulatory approvals.

Speaker #4: Question 17: What does the updated durability data show, and what should investors expect from the final 12- and 24-month analyses? The reported 40.4% complete response rate at 450 days, representing 21 of 52 patients, and the 19.2% rates at both 2 and 3 years, representing 10 of 52 patients, used the full population currently available for durability at those time points.

Roger DuMoulin-White: Question 17. What does the updated durability data show, and what should investors expect from the final 12 and 24-month analyses? The reported 40.4% complete response rate at 450 days, representing 21 of 52 patients, and the 19.2% rates at both 2 and 3 years, representing 10 of 52 patients, use the full population currently evaluable for durability at those time points. The Kaplan-Meier estimates are slightly different, as they are used to predict response based on the probability of remaining cancer-free once a complete response has been achieved, and are currently 48.6%, 34.5%, and 25.4% at 1, 2, and 3 years respectively.

Roger Dumoulin-White: The reported 40.4% complete response rate at 450 days, representing 21 of 52 patients, and the 19.2% rates at both 2 and 3 years, representing 10 of 52 patients, use the full population currently evaluable for durability at those time points. The Kaplan-Meier estimates are slightly different, as they are used to predict response based on the probability of remaining cancer-free once a complete response has been achieved, and are currently 48.6%, 34.5%, and 25.4% at 1, 2, and 3 years respectively. The final durability of complete response will change slightly as follow-up matures. The long-duration responses observed to date remain particularly encouraging. Question 18, how does rolling review work once the submissions begin? Rolling reviews allow Health Canada and the FDA the ability to commence reviewing completed portions of a submission as they become available, instead of waiting for every module to be filed at once.

Speaker #4: The Kaplan-Meier estimates are slightly different, as they are used to predict response based on the probability of remaining cancer-free once a complete response has been achieved and are currently 48.6% and 25.4% at 1, 2, and 3 years, respectively.

Speaker #4: The final durability of complete response will change slightly as follow-up matures. The long-duration responses observed to date remain particularly encouraging. Question 18: How does rolling review work once the submissions begin?

Roger DuMoulin-White: The final durability of complete response will change slightly as follow-up matures. The long-duration responses observed to date remain particularly encouraging. Question 18, how does rolling review work once the submissions begin? Rolling reviews allow Health Canada and the FDA the ability to commence reviewing completed portions of a submission as they become available, instead of waiting for every module to be filed at once.

Speaker #4: Rolling reviews allow healthcare and the FDA the ability to commence reviewing completed portions of a submission as they become available, instead of waiting for every module to be filed at once.

Speaker #4: This supports earlier regulatory engagement and a timelier response to a clinical submission. The company anticipates regulatory decisions in 2027, but the timing and outcome remain under the control of Health Canada and the FDA.

Roger Dumoulin-White: This supports earlier regulatory engagement and a timelier response to a clinical submission. The company anticipates regulatory decisions in 2027, but the timing and outcome remain under the control of Health Canada and the FDA. Question 19, what is the long-term strategic vision, and has the company considered dedicated business development leadership? The long-term vision is to build a global small molecule company with a lead bladder cancer opportunity and a broader platform across various oncological conditions and infectious disease. The company's research suggests that Ruvidar and Rutherrin may be activated or deployed in different ways across multiple indications, creating several potential development and partnering pathways from the core technology. Execution will require focused clinical and regulatory work, commercialization and licensing capabilities, access to capital, and experienced personnel.

Roger DuMoulin-White: This supports earlier regulatory engagement and a timelier response to a clinical submission. The company anticipates regulatory decisions in 2027, but the timing and outcome remain under the control of Health Canada and the FDA. Question 19, what is the long-term strategic vision, and has the company considered dedicated business development leadership? The long-term vision is to build a global small molecule company with a lead bladder cancer opportunity and a broader platform across various oncological conditions and infectious disease.

Speaker #4: Question 19: What is the long-term strategic vision and has the company considered dedicated business development leadership? The long-term vision is to build a global small molecule company with a lead bladder cancer opportunity and a broader platform across various oncological conditions and infectious disease.

Speaker #4: The company's research suggests that Rutherrin and Rutherrin may be activated or deployed in different ways across multiple indications, creating several potential development and partnering pathways from the core technology.

Roger DuMoulin-White: The company's research suggests that Ruvidar and Rutherrin may be activated or deployed in different ways across multiple indications, creating several potential development and partnering pathways from the core technology. Execution will require focused clinical and regulatory work, commercialization and licensing capabilities, access to capital, and experienced personnel.

Speaker #4: Execution will require focused clinical and regulatory work, commercialization and licensing capabilities, access to capital, and experienced personnel. As the balance sheet strengthens and the programs mature, management plans to build the corporate infrastructure and business development capabilities needed to support partnerships, licensing, and commercialization.

Roger Dumoulin-White: As the balance sheet strengthens and the programs mature, management plans to build the corporate infrastructure and business development capabilities needed to support partnerships, licensing, and commercialization. That concludes all the questions that we have received to date that we are able to address. Thank you for your continued support and interest in Theralase.

Roger DuMoulin-White: As the balance sheet strengthens and the programs mature, management plans to build the corporate infrastructure and business development capabilities needed to support partnerships, licensing, and commercialization. That concludes all the questions that we have received to date that we are able to address. Thank you for your continued support and interest in Theralase.

Speaker #4: That concludes all the questions that we have received to date that we are able to address. Thank you for your continued support and interest in Theralase.

Speaker #1: Thank you, Roger, for your detailed responses. And thank you to all the shareholders for your thoughtful questions and continued engagement throughout today's discussion. With the balance sheet strengthened by our August Life capital raise and Study 2 continuing to mature, the next chapter in the life of Theralase will focus on regulatory submissions and approval for the company's bladder cancer asset, launch of our Cohort 2 GLP toxicology analysis for intravenous route R and topical route R, and commencement of Phase 0-1-2 clinical studies for numerous medical conditions.

Matthew Perraton: Thank you, Roger, for your detailed responses. Thank you to all the shareholders for your thoughtful questions and continued engagement throughout today's discussion. With the balance sheet strengthened by our August LIFE capital raise and Study Two continuing to mature, the next chapter in the life of Theralase will focus on regulatory submissions and approval for the company's bladder cancer asset, launch of our Cohort 2, GLP toxicology analysis for intravenous Rutherrin and topical Ruvidar, and commencement of Phase 0/I/II clinical studies for numerous medical conditions. Thank you for your time today. A replay of this call will be available in due course on our website. Have a great day. Stay safe, and thank you again for your continued support of Theralase.

Speaker #1: Thank you for your time today. I replayed this call would be available in due course on our website. Have a great day, stay safe, and thank you again for your continued support of THERALASE.