Theralase Technologies Inc. ($TLT)

Good morning, and thank you for joining us today. I'm Matthew Perraton, Investor Relations Manager at Theralase Technologies, Inc., and it's my pleasure to welcome all our shareholders and stakeholders to our 2025 Annual Financial Statements Conference Call. We appreciate your ongoing support as Sterilize executes on its strategic objectives, marking a pivotal phase of our transformation from [Audio Gap]. 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. Participants should not unduly rely on these forward-looking statements. They are not a guarantee of future performance, and there could be no assurance that they will prove accurate in the future. These forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause actual results or future events to differ materially. Although the forward-looking statements made today are based on what management believes to be reasonable assumptions, the company cannot guarantee 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 them or revise them. This call will be posted on the corporate website in due course. Our Phase II bladder cancer clinical study has exceeded our targeted enrollment of 90 patients, enrolling 91 patients in total. Although additional patients may be enrolled in 2026 in our Canadian clinical study sites. Of the 91 patients, 82 have completed the study with the remaining 9 patients currently on study. Theralase plans to file a new drug application under rolling review for marketing approval with Health Canada and the FDA in the third quarter of 2026. Pending Health Canada and FDA approval, Theralase estimates achieving marketing approval in Canada and the United States in the first half of 2027. Completion of enrollment in the Phase II bladder cancer clinical study allows the company the following new opportunities. one, exploring increased efficacy in the combination of light activated rubidar with the FDA-approved drug estilidrin in collaboration with Ferring Pharmaceuticals. 2, developing radiation activated rutherin for numerous cancers, including glioblastoma, multiform, a deadly form of brain cancer, non-small cell lung cancer, pancreatic cancer, colorectal cancer, muscle invasive bladder cancer, leukemia, lymphoma and multiple myeloma. 3, developing Rubidar for topical treatment of Herpes Simplex 1, more commonly known as cold sores. achieving marketing approval of like activated Ruvidar for non-muscle basoblatic cancer would allow the company the opportunity to generate significant revenues both in Canada and the United States from the commercialization of this technology to health care practitioners on the treatment of bladder cancer. Theralase thus in a transformational phase in its development, financially, clinically and strategically. The agenda. Today's call will provide updates on annual 2025 financial performance and current capital financing initiatives. interim clinical data from Study 2 for BCG unresponsive nonmuscle basolbladder cancer carcinoma in Situ, expansion of our drug pipeline into 9 high-value indications. Our strategic vision, including institutional financing and a potential U.S. initial public offering with concurrent U.S. institutional financing. We believe that the progress that we've made over the last few quarters and the steps we plan to take into the quarters ahead will alter late the ability to become a fully operational, self-sustained pharmaceutical company in 2027. Now that I've covered the required disclosures and overview, I would like to introduce our Chief Financial Officer, Ms. Kristina Hachey.

Thank you, Matthew. Before I present the numbers, please note that all financial amounts presented today will be rounded to the nearest CAD 1000 for clarity and simplicity. For financial amounts accurate to the dollar, please refer to the 2025 annual financial statements available on both SEDAR+ and our corporate website. Overall, Theralase continues to demonstrate strong financial discipline, advancing our clinical platforms with a very limited balance sheet while continuing to invest in preclinical research that may unlock significant future shareholder value. [Audio Gap] Due to the fact that all of our oncological programs are pre-revenue total revenue for the year ending December 31, 2025, was $816,000, with all revenues derived from the business-to-business sales and service of our cool laser therapy systems. In Canada, revenue decreased 15% to $764,000 from $896,000. In the U.S., revenue decreased 60% to $47,000 from $116,000. International sales decreased 71% to $6, 000 from $22,000. The tariff situation and exchange rate south of the border has forced the company to focus primarily on completing sales within Canada versus expanding capital into the U.S. market as the Canadian economy improves, hopefully, over the next few years, the company expects to increase spending in the U.S. market. Now that our bladder cancer clinical study has completed enrollment, Theralase plans to reinvest in both the drug and device divisions to increase current and future revenue. With this investment, revenues in the device division are expected to grow, while investment in the drug division will allow the commencement of clinical development for a number of new clinical study indications. Moving on. Gross margin decreased 8% to $507,000 from $554,000. Operating expenses for the year ending December 31 compared to the prior year were comprised of selling expenses of $287,000, which decreased 20%. Administrative expenses of $1.943,000, which increased 12% and research and development expenses of $2.5 million, which decreased 11%. The net loss for the year was $4.1 million, which included $840,000 in noncash expenses, such as amortization and stock-based compensation, a 3.2% decrease over the prior year. This resulted in a $3.26 million cash loss a small amount, in my opinion, to advance a potential multibillion-dollar drug platform. In terms of capital, the company has successfully closed non-broker private placements of approximately $2.8 million year-to-date and $8.8 million over the past 24 months. with significant participation from insiders and long-term shareholders. This capital has been strategically deployed to complete enrollment in our bladder cancer clinical study and advance our X-ray activated with Theralase platform. To further strengthen our balance sheet, we have recently commenced a $4 million life offering expanding pipeline. In addition, Theralase is exploring an initial public offering in the United States. later in the year or early next year in the hopes of significantly broadening our shareholder base, improving stock liquidity and providing the company with additional capital required to further expand our expanding pipeline.

Thank you, Christina, for Theralase's 2025 Annual Financial Update. Now and Investor Relations summer student of ours Courtney, will provide an update on our bladder cancer clinical study.

Thank you, Matthew. As should be expected, Study 2 remains the company's top strategic objective. This multicenter single arm Phase II registrational clinical study is being used to evaluate the efficacy and safety of Rivada. or light activated small molecule in patients with BCG unresponsive nonmuscle invasive bladder cancer, carcinoma in situ. To date, we have enrolled and successfully treated 91 patients with 82 of these patients completing the study, leaving 9 patients currently undergoing assessment. To date, Study 2 has achieved a 65.2% complete response at any point in time with patients demonstrating no detectable cancer, 73% total response, which includes patients who have achieved a complete response as well as patients who still exhibit positive or suspicious urine cytology testing upper tract disease, which is outside the design of our clinical study. In other words, approximately 3 out of 4 patients demonstrated no disease detected in their bladder at any point in time. 40.4% of patients who achieved a complete response continue to show a durability of that response at 15 months and beyond. In assessing patients outside the defined endpoints of the study, the company has demonstrated a duration of complete response of 19.2% at both 2 and 3 years with 1 patient demonstrating a complete response for 7 years. after only 1 treatment with additional clinical data still being collected. Treatment emergent adverse effects were noted but did not meet the serious adverse event criteria. These included urinary frequency of 65%, hematuria 62.5% and urinary urgency 53.8%, which usually resolved in 1 month of treatment. There were 24 reported serious adverse events, specifically 1 grade 1, 3 grade 2, 13 grade 3 and 5 Grade 4, which all resolved between 1 to 82 days and 2 Grade 5, most of which were not treatment emergent. As a result, there have been no serious adverse events directly related to RuVidar or the TLC-3200 medical laser system used to activate it, confirming an exceptionally high safety and tolerability profile. This level of safety, efficacy and durability, particularly from a single intravascular treatment known as 1 and done in the industry, places Rubitar in a coveted position as 1 of the most promising emerging therapies in bladder cancer. Our next milestones include completion of follow-up on all patients enrolled in Study 2. and a submission of new drug application to help Canada and the United States Food and Drug Administration in the third quarter of 2026. under rolling review with regulatory decisions anticipated in the first half of 2027. In January of this year, Theralase announced a combination of clinical study with Ferring Pharmaceutical, Subject to FDA approval, Theralase as a study sponsor is preparing to launch a combinational clinical study to investigate the safety and efficacy of combining light-activated Ruvidar with ads. it is anticipated that the complementary mechanisms of action with Rubadar-targeting bladder cancer cells directly and astiligen targeting healthy bladder cells to produce interferon stimulating the innate and adaptive immune system will provide a strong additive effect in the treatment of BCG unresponsive nonmuscle invasive bladder cancer patients. [Audio Gap] in the study protocol, patients will be treated with RUVIDAR, 1 hour of drug installation followed by 1 hour of light activation. Then at a subsequent visit, they will be treated with estiligen for 1 hour both delivered and outpatient procedures. Under the clinical protocol, the patient may receive up to 4 treatments of estrolegin. The presiding uro-oncologist will have the option to deliver an additional reinduction study procedure if the patient recurs. In alignment with the assessment schedule of our current clinical study, the patient will be followed for 15 months after initial study procedure and up to 3 years for post-study follow-up.

Thank you, Courtney, for the clinical study update. With strong interim clinical results, a growing shareholder base, interest from partnerships from larger pharmaceutical companies and new clinical indications in oncology and virology, on the horizon, the company is undertaking a number of strategic initiatives for long-term growth as a publicly listed pharmaceutical company. specifically, separate profit and loss reporting and funding for our drug and device divisions, potential institutional raise in Canada, a U.S. initial public offering. capitalizing, expanding and partnering new clinical indications. These strategic initiatives should help position Theralase for breakout growth for the first half of 2026 and beyond. A U.S. public listing could potentially provide a number of clear advantages, including a much larger shareholder base that could provide increased daily trading volume and hence, increased shareholder liquidity. visibility and positioning of our company amongst U.S.-based investors, equal footing with competitive biotech companies who trade at significantly higher valuations with substantially less advanced technology. ability to raise funds from U.S.-based institutional investors who invest solely in pharmaceutical and biotech companies. expanded indications pipeline. As we approach late-stage development in bladder cancer, we are simultaneously advancing a robust pipeline across oncology, infectious disease indications, including glioblastoma multiform, a deadly former brain cancer. non-small cell lung cancer, the leading cause of deaths worldwide. pancreatic cancer, a cancer which is often diagnosed late in stage, leading to low survival rates, muscle invasive bladder cancer. a disease where the standard of care is bladder removal. colorectal cancer, the second leading cause of cancer deaths in the United States. Hermatologic cancers, such as leukemia, lymphoma, multiple myeloma, all deadly forms of blood cancers. Herpes simplex virus cold source a condition with no cure that affects more than 64% of the world's population under 50%. Good laboratory practice or GLP toxicology studies for these indications are expected to be complete in the third quarter of 2026, subject to capital funding. Pending completion of GLP toxicology studies, the company anticipates initiating adaptive Phase 012 clinical studies in 2026 for various clinical indications. These studies will be designed to provide early validation of safety and efficacy, providing Theralase the opportunity to efficiently move from preclinical research to clinical development in high need therapeutic areas. The strength of our technology platform lies in its versatility, targeted approach, minimally invasive administration, ultra high safety profile, high efficacy and broad therapeutic applications. Theralase is building a multifaceted pharmaceutical company capable of addressing major oncology and virology challenges.

Now I'd like to transition us to the question-and-answer period of today's call. To answer your questions, I would like to now call upon our President and Chief Executive Officer, Roger Dumoulin-White. Roger, welcome, and thank you for joining us.

Thank you, Matthew. It's a pleasure to be here today. Hello, everyone, and thank you for joining us. We sincerely appreciate your time, questions and continued support of Theralase. As we enter an inflection point, in the evolution of our company. We've received a number of questions in advance of today's call, and I have taken the liberty of combining them based on their theme. I would now like to take some time to address some of the most commonly asked questions from shareholders. Question one, when will Study 2 be complete? The study will officially be completed following the assessment of all patients at 15 months or earlier if they are prematurely removed in the study. In addition, post study assessment may take up to 3 years. However, Theralase plans to submit a new drug application to Health Canada and the United States Food and Drug Administration in third quarter 2026 under a rolling review. With the clinical data collected to date at that time with regulatory decisions anticipated in the first half of 2027. Question 2, what is the estimated cost to complete Study 2? We estimate approximately CAD 5 million to CAD 10 million to complete enrollment in the next combinational clinical study, follow-up, data lock and regulatory submissions over the next 2 years for both cohorts. Question 3, what's the status of the combinational study with FERI? Perlas, in conjunction with Ferring Pharmaceutical, subject to FDA approval is preparing to launch a combinational clinical study to investigate the safety and efficacy of combining light-activated Ruvidar with Estelar. It is anticipated that the complementary mechanisms of action with RUVIDAR targeting bladder cancer cells directly and estelidrin targeting healthy bladder cells to produce interferon which stimulates the innate and adaptive immune system will provide a strong additive effect in the treatment of BCG-unresponsive NMIBC CIS patients. At the moment, we are awaiting FDA approval to commence enrollment in to Cohort 2. Question 4, is Theralase still pursuing a U.S. listing? Yes, properly capitalizing the drug and device divisions in 2026 and 2027 is the company's main priority. As such, a U.S. IPO is being investigated for late 2026, early 2027, to further capitalize the company to accelerate our clinical development for numerous cancer indications. Question 5, how does Ruvidar compare to other bladder cancer therapies? Ruvidar delivers high complete response rates with an ultra-high safety profile using a single intravesical treatment. No serious adverse events have been directly related to Ruvidar or the laser system that activates it, which differentiates it significantly from other more expensive and complex multi-dose immunotherapeutic approaches. which provides dozens of treatments over years. Question 6, what value does the U.S. listing bring to shareholders? Primarily, it would increase access to U.S. institutional investors which represent approximately 10x the number of Canadian institutional investors, allowing funding from specialized funds that focus solely on the pharmaceutical and biotech space. Secondarily, it would potentially improve trading volumes and hence, liquidity, which would level the playing field and allow the company to better align with U.S. biotech peers that trade at significantly higher valuations despite less compelling clinical data. Question 7, are you seeing increased interest from U.S. investors. Yes. As our interim clinical data matures, we are seeing increased interest from U.S.-based investors and institutions. We associate this with our planned FDA marketing submission which could bring significant value to shareholders on both sides of the border. Question 8, what nondilutive funding sources are you pursuing? We are pursuing interest-free debt and grant financings from both Ontario and Canadian-based government programs to help produce shareholder dilution. We will provide more guidance on these vehicles if and when they become material. Question 9, what is the next step for the new indications to move into the clinic? Good laboratory practices or GLP toxicology is the next step. Theralase's plans to complete GLP tox studies by third quarter 2026 which will allow determination of the maximum tolerated dose and corresponding human equivalent dose for rutherin. Subject to Health Canada and FDA regulatory approvals, the company intends to commence design of Phase 012 adaptive clinical studies in late 2026 for a number of clinical indications. Question 10, Will Ruvidar be commercialized in-house or through partnerships. Various options are being discussed at the moment. As our discussions and negotiations continue, Theralase will decide based on a number of factors such as cost, time to develop, potential revenue, geographic territories and market penetration, what technologies would be best to partner and what technologies would be best to develop in-house. With the primary decision matrix based on what provides the greatest shareholder value in the most expedient time span. Question 11. What is the shelf life and logistical advantage of Ruida? Ruvidar has demonstrated a 10-year shelf life at room temperature, which offers significant logistical and cost advantages for global distribution, especially since the biologically proposed solutions of our competitors require complex drug preparation and administration along with expensive and time-consuming negative 80-degree cold storage management. Question 12. How long do you expect complete response to your ability to last based on current data? We've seen complete response durability extend beyond 15 months in most cases. with 19% of patients who achieved a complete response still exhibiting this duration of response at 3 years with 1 patient demonstrating a duration of complete response for over 7 years. after only 1 treatment. As our clinical data continues to mature, these numbers are expected to strengthen. Question 13. Why expanding the new indications now? Our small molecule platform has shown strong potential across numerous cancer cell lines. Diversifying the pipeline reduces overall risk, expands our target markets and hence increases our market revenue potential. Question 14, are you in discussions with regulators? Yes, we continue to engage proactively with Health Canada and the FDA as required to ensure alignment as we move toward submission readiness. Question 15. What is your long-term strategic vision? Theralase intends to be a global leader in energy activated small molecules, delivering innovative, safe and effective oncology and antiviral solutions to patients worldwide while preserving their quality of life. Question 16, will Theralase require a share consolidation to list in the U.S. No. We are pleased to confirm that we've identified a pathway to list in the U.S. that does not require a share consolidation. This removes a major hurdle and simplifies our road map to listing. It also reflects the strength of our current structure and support shareholder continuity and confidence. Question 17, are you pursuing any partnership opportunities? Yes, we are always pursuing potential partnership opportunities with some discussions more advanced than others. As outlined in previous communications, we are engaged [Audio Gap] various geographic and therapeutic areas and reflect growing recognition of the value in our lead program and platform technologies. Question 18. Given the importance of securing partnerships and licensing deals over the next 12 to 24 months, as the company considered hiring a dedicated VP or Director of Business Development, with oncology or platform licensing experience to support these efforts. Yes, as our balance street -- excuse me, as our balance sheet strengthens, we plan to build out our corporate infrastructure to allow us to accelerate on the completion of our strategic initiatives. That seems to be all the questions the company has received to date. I look forward to answering additional questions in the future. Thank you.

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. We truly appreciate your interest and continued support as Theralase advances its clinical, financial and strategic objectives. As we move through this pivotal phase of our development, the progress that we have achieved to date reflects the strong momentum achieved across our organization. This is reflected by the strengthening of our capital position, achievement of key milestones in our pivotal bladder cancer clinical study and in the preclinical development of new oncological conditions, all of which have been -- all have the potential of significantly increasing shareholder value. With an expanded pipeline that now encompasses 9 additional indications, Theralase is well positioned to become the next up-and-coming pharmaceutical company. The steps we've taken over the past few quarters and those that we are focused on in the quarters ahead, continue to differentiate Theralase within the biotech and pharmaceutical landscape. Thank you again for your time today. A replay of this call will be available in due course on our website. Have a great day and be safe.