6/9/2026

speaker
Matthew Periton
Investor Relations Manager

Good morning and thank you for joining us today. I'm Matthew Periton, Investor Relations Manager at Theralase, and it's my pleasure to welcome all shareholders and stakeholders to our first quarter 2026 Financial Statements Conference Call. We appreciate your ongoing support as Theralase executes on its strategic objectives, marking a pivotal phase in our transformation from preclinical research through clinical development to commercialization. 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. Participants should not unduly rely on these forward-looking statements. They are not a guarantee of future performance, and there can be no assurance that 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 all forward-looking statements made today are based on what management believes to be reasonable assumptions, the company cannot assure investors that actual results may 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 call will be posted on our corporate website in due course. Our Phase II cancer clinical study has now completed our target enrollment of 90 patients, enrolling 92 patients in total, although additional patients may be enrolled in 2026 in our Canadian clinical study sites. Of the 92 patients, 82 have completed the study, with the remaining 10 patients currently on study. There are plans to file a new drug application under rolling review for marketing approval with Health Canada and the FDA in third quarter of 2026. Pending Health Canada and FDA approval, Theralase estimates achieving marketing approval in Canada and the U.S. in the first half of 2027. Completion of enrollment in the Phase II Bladder Cancer Clinical Study allows the company the following new opportunities. 1. Exploring increased efficacy in the combination of light-activated Ruvidar with an FDA-approved drug, Aciladrin, in collaboration with Faring Pharmaceuticals. 2. Developing energy-activated rutharin for numerous cancers including glioblastoma multiforme, 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 rubrar for the topical treatment of herpes simplex I lesions, more commonly known as cold sores. Achieving marketing approval of light-activated Rubidor for non-muscle invasive bladder 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 healthcare practitioners focused on the treatment of bladder cancer. Theralase is thus in a transformational phase of its development, financially, clinically, and strategically. Today's call will provide insights into our First Quarter 2026 Financial Performance and Current Capital Financing Initiatives Interim Clinical Data from Study 2 for the Treatment of BCD Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma in Situ Expansion of our Drug Pipeline into 9 High Value Indications Our Strategic Vision including Institutional Financing and the 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 that we plan to take in the quarters ahead will out there lays the ability to become a fully operational, self-sustained pharmaceutical company in 2027. Now that we've covered the required disclosures and overview, I would like to introduce our Chief Financial Officer, Ms. Kristina Hachey.

speaker
Kristina Hachey
Chief Financial Officer

Thank you, Matthew. Before we review the numbers, please note that all financial amounts I will be presenting today will be rounded to the nearest thousand Canadian dollars for clarity and simplicity. For financial amounts accurate to the dollar, please refer to the first quarter 2026 financial statements available on both CDAR Plus and our corporate website. Overall, Theralase continues to demonstrate strong financial discipline, advancing our clinical platforms with a limited balance sheet, while continuing to invest in preclinical research that may unlock significant future shareholder value. Due to the fact that all of our oncological programs are pre-revenue, total revenue for the three-month period ending March 31, 2026 was derived solely from business-to-business sales and service of our cool laser therapy systems, which increased from 91,000 to 133,000, a 45% increase year-over-year. In Canada, revenue increased from 76,000 to 124,000, a 62% increase, while revenue decreased 39% from 15,000 to 9,000 in the U.S. The company's limited balance sheet required management to prioritize capital allocation toward advancing its lead bladder cancer treatment program, while maintaining a focused domestic sales strategy rather than deploying significant resources toward broader U.S. market expansion. As the company's balance sheet strengthens, management anticipates increasing investment in marketing and commercial initiatives across both the Canadian and U.S. markets. With enrollment now completed in the company's bladder cancer clinical study, Fairlace Technologies Inc. plans to reinvest across both its drug and device divisions to support current operations and future growth initiatives. Management expects that increased investment in the device division will support revenue growth, while additional investment in the drug division is expected to facilitate the advancement of multiple new clinical development programs and indications. Moving on, gross margin increased from 13,000 to 64,000, a 392% increase. Operating expenses for the period ending March 31 compared to the prior year were comprised of selling expenses of $67,000, which decreased 2%, administrative expenses of $464,000, which decreased 16%, and research and development expenses of $565,000, which decreased 36%. The net loss for the three-month period was $1,032,000, which included $172,000 in non-cash expenses, such as amortization and stock-based compensation, a 30% decrease over the prior year. In terms of capital, the company has successfully raised approximately $7.5 million year-to-date and $13.2 million over the past 24 months. with significant participation from institutional investors, insiders, and long-term shareholders. This capital has been strategically deployed to complete enrollment in our bladder cancer clinical study and advance our energy-activated Lutheran platform. To further strengthen our balance sheet, we have recently closed a $4.8 million brokered and non-brokered offering on May 20th. 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 to further expand our clinical pipeline.

speaker
Matthew Periton
Investor Relations Manager

Thank you, Kristina, for Theralase's first quarter, 2026. Financial Update Now, an investor relations summer intern of ours, Courtney, will provide an update on our bladder cancer clinical study.

speaker
Courtney
Investor Relations Summer Intern

Thank you, Matthew. As should be expected, Study 2 remains the company's top strategic objective. This multi-center, single-arm, phase 2, registrational clinical study is being used to evaluate the safety and efficacy of Rubidoc. are light-activated small molecules in patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ. To date, we have enrolled and successfully treated 92 patients, with 82 of these patients completing the study, leaving 10 patients currently undergoing assessment. To date, study 2 has achieved a 65% complete response at any point in time, with patients demonstrating no detectable cancer, A 73% total response, which includes patients who achieved a complete response as well as patients who still exhibit positive or suspicious urine cytology suggesting 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 in the clinical study. 40% 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% at both two and three years, with one patient demonstrating a complete response for seven years after only one treatment, with additional clinical data still being collected. Treatment emergent adverse events 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 one month of treatment. There were 24 reported serious adverse events, specifically 1 grade 1, 3 grade 2, 13 grade 3, 5 grade 4, which all resolved between 1 and 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 Rubidar or the TLC3200 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 one-and-done in the industry, places Rivadar in the coveted position as one of the most promising emerging therapies in bladder cancer. Our next milestones include the completion of follow-up on all patients enrolled in Study 2, and a submission of a new drug application to Health Canada and the United States FDA in the third quarter of 2026, under rolling review with regulatory decisions anticipated in the first half of 2027. In January of this year, Therlase announced a combinational clinical study with Bering Pharmaceuticals Subject to FDA approval, Theralase as a study sponsor is prepared to launch a combinational clinical study to investigate the safety and efficacy of combining light-activated Rufidart with Astilogen. It is anticipated that the complementary mechanisms of action with Rufidart targeting bladder cancer cells directly and Astilogen targeting healthy bladder cells to produce interferon, which stimulates both innate and adaptive immune system, will provide a strong additive effect in the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ patients. In the study protocol, patients will be treated with Rubrar for one hour of drug installation followed by one hour of light activation. Then, at a subsequent visit, they will be treated with Arcilogen for one hour, both delivered in outpatient procedures. Under the clinical protocol, the patient may receive up to four treatments of adstilogen. The providing uro-oncologist will have the option to deliver an additional re-induction 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 the initial study procedure and up to three years for post-study follow-up.

speaker
Matthew Periton
Investor Relations Manager

Thank you, Courtney. For the clinical study update, with strong interim clinical results, a growing shareholder base, interest from larger pharma, 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, separating the drug and device divisions from both the financial and marketing perspectives. Although they would both be 100% wholly owned by the parent company, Theralase Technologies Inc. Establishing a Canadian base shell prospectus and an at-the-market financing program to provide flexible access to capital to be better aligned with clinical and regulatory milestones. Pursuing a U.S. initial public offering and public listing. Capitalizing, clinically developing, and licensing out new clinical indications. These strategic initiatives should help position Theralase for breakout growth in the second 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 the company amongst U.S.-based investors and U.S. institutions, Leveling the playing field with competitive biotech companies who trade at significantly higher valuations with substantially less advanced technology. Ability to raise funds from specific US-based institutional investors who invest solely in pharmaceutical and biotech companies. As we approach late stage development in a treatment for bladder cancer, we are simultaneously advancing a robust pipeline across oncology and infectious disease indications, including glial bloxoma multiforme, a deadly form of 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 or extensive primodal therapy for select patients involving surgery, chemotherapy, and radiation. Colorectal cancer, the second leading cause of cancer deaths in the United States. Hermetologic cancers such as leukemia, lymphoma, and multiple myeloma, all deadly forms of blood cancers. Herpes, simplex virus, cold sores. 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 the cancer indications are expected to be completed by the third quarter of 2026. Pending completion of GLP toxicology studies for Lutheran, the company anticipates commencing 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 application. Theralase is focused on building a multifaceted pharmaceutical company capable of addressing major oncology, bacterial, and virology challenges. Now I'd like to transition us 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. Roger, welcome, and thank you for joining us today.

speaker
Roger Dumoulin-White
President and Chief Executive Officer

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 Farrelly's 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've 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 SharePoint. Question 1. 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 from the study. In addition, post-study assessment may take up to three years. However, Theralase plans to submit a new drug application to Health Canada and the U.S. FDA in the third quarter of 2026 under 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 are the key milestones shareholders should watch for over the next 12 to 18 months? In addition to the continuation of our clinical studies and data releases, shareholders should monitor several important milestones over the next 12 to 18 months, including FDA approval to commence enrolling and treating patients in a clinical study using Theralase's light-activated Ruvidar combined with Faring's drug Astilidrin. Approval of a base shelf prospectus and establishment of an at-the-market financing program. Completion of GLP toxicology studies for Rufarin to allow intravenous administration. Commencement of Phase 0, 1, and 2 adaptive clinical studies for brain cancer, lung cancer, muscle invasive bladder cancer, colorectal cancer, and pancreatic cancer. Commencement of new drug application rolling reviews with Health Canada and the United States, FDA, for the treatment of bladder cancer, targeted for the third quarter of 2026. Completion of GLP toxicology studies for the topical administration of Ruvadar to allow the commencement of Phase 1, 2, and 3 clinical studies designed to evaluate the drug for the treatment of herpes simplex virus lesions, or more commonly known as cold sores. Commencement of a TSX-Uplist and US-Crosslist IPO in late 2026, early 2027. FDA and Health Canada marketing approval decisions for light-activated Rubidar for the treatment of non-muscle-invasive bladder cancer, carcinoma in situ, anticipated in the first half of 2027. As a result, management believes the second half of 2026 and early 2027 represent a particularly catalyst-rich period for the company.

speaker
Matthew Periton
Investor Relations Manager

Question 3

speaker
Roger Dumoulin-White
President and Chief Executive Officer

What is the estimated cost to complete Study 2? We estimate approximately $50,000 to complete patient follow-up in Study 2, Cohort 1, with no additional patients enrolled. Question 4. What's the status of the combinational study with Faring? Faralase, in conjunction with Faring 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 astiladrine. It is anticipated that the complementary mechanisms of action with ruvidar targeting bladder cancer cells directly and astiladrine targeting healthy bladder cells to produce interferon to stimulate the innate and the adaptive immune system Together, we will provide a strong additive effect in the treatment of BCGM-responsive, non-muscle-invasive bladder cancer, carcinoma, and Psy-Q patients. At the moment, we are awaiting Food and Drug Administration approval to commence enrollment into Cohort 2. Question 5. Is Theralase still pursuing a U.S. listing, and would it require share consolidation? Profitably capitalizing the drug and device divisions in 2026 and 2027 is the company's main priority. As such, a U.S. listing in IPO is being investigated for late 2026, early 2027 to further capitalize the company to accelerate our clinical development for numerous cancer indications. 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 strategy for a U.S. listing. It reflects the strength of our current structure and supports shareholder continuity and confidence. Question 6 What value would a United States listing bring to shareholders and are you seeing increased interest from U.S. investors? Primarily, it would increase access to U.S. institutional investors, which represent approximately 10 times the number of Canadian institutional investors, allowing funding from specialized funds that focus solely on the pharmaceutical and biotech space. Secondarily, it could 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 data. As our interim clinical data matures, we are seeing increased interest from U.S.-based investors and organizations. We associate this with our upcoming FDA marketing submission, which could bring significant value to shareholders on both sides of the border. Question 7. How does Rubidar compare to other bladder cancer therapies, and what differentiates Theralase scientifically from other oncology companies? Rubidar delivers high complete response rates with an ultra-high safety profile using a single intravascular treatment. No serious adverse events have been directly related to Rubidar or the laser system that activates it. which differentiates it significantly from other more expensive and complex multi-dose immunotherapeutic approaches, which require dozens of treatments over years to support their efficacy. Theralase's platform combines light activation of a small molecule designed to selectively target disease cells while minimizing systemic toxicity. Paralase is advancing on the next generation formulations of Ruvidar, including Rutheran, an intravenously administered small molecule activated by various forms of energy. Unlike intravesical Ruvidar, which is localized to bladder cancer treatment, Rutheran is designed to potentially hunt and target numerous cancer types throughout the body, in combination with existing standards of care, Such as radiation therapy. In addition, the company is advancing topical Rubidar formulations targeting viral indications, including the treatment of herpes simplex virus type 1 lesions, or more commonly known as cold source. Management believes these platform expansions can significantly broaden the long-term commercial and clinical potential of the company beyond bladder cancer alone. Question 8. What non-dilutive funding sources are you pursuing and why is the company establishing a base-shelf perspective and at-the-market financing program? The company is currently pursuing interest-free debt and grant financings from both Ontario and Canadian-based government programs to help reduce shareholder dilution. We will provide more guidance on these vehicles if and when they become material. The objective of the Bay Shell prospectus and at-the-market financing program is to provide financing flexibility. These vehicles, once in place, allow the company to access capital opportunistically during periods of increased market visibility, clinical advancement, or regulatory progress, rather than relying exclusively on traditionally discounted private placements. Management remains highly conscious of shareholder dilution and continues to evaluate financing strategies designed to support long-term shareholder value. Question 9. What is the next step for the new indications to move into the clinic and why expand into new indications now? GLP Toxicology of Bruteren is the next step. Theralase plans to complete GLP toxicology studies by the third quarter of 2026, which will allow determination of the maximum tolerated dose and corresponding human equivalent dose into the unit's administration of rutharin. Subject to Health Canada and FDA regulatory approvals, the company intends to commence phase 0, 1, and 2 adaptive clinical studies in late 2026 for a number of clinical indications, including brain cancer, One Cancer, Muscle Invasive Bladder Cancer, Pancreatic Cancer, and Colorectal Cancer. Our small molecule platform has shown strong potential across numerous cancer indications. Diversifying the pipeline reduces overall risk, expands our target market, and hence increases our revenue potential. Question 10. Will Rivadar be commercialized in-house or through partnerships? or are you pursuing partnership opportunities? 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 and 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 a primary decision matrix based on what provides the greatest shareholder value in the most expedient time span. We are always pursuing potential partnership opportunities with some discussions more advanced than others. As outlined in previous communications, we are engaged in ongoing partnership discussions both for potential outlicensing opportunities and clinical collaborations. These span various geographic and therapeutic areas and reflect growing recognition of the value in our lead program and platform technologies. Question 11. What is the shelf life and logistical advantage of Rubidar? Rubidar has demonstrated 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 negative 80 degree cold storage management. Question 12. How long do you expect complete response durability to last based on current data? What we've seen in our clinical study is the complete response durability extends beyond 15 months in many cases, with 19% of patients who achieved a complete response still exhibiting this duration of response at 3 years. We also have one patient who has demonstrated a duration of complete response for over 7 years, after only one treatment. As our clinical data continues to mature, these numbers are expected to strengthen. Question 13. Are you in discussions with regulators? We continue to engage proactively with Health Canada and the FDA, as required, to ensure alignment as we move toward submission readiness. Question 14. What is your long-term strategic vision and what gives management confidence that Theralase is approaching a transformational period? Our vision is to be a global leader in energy-activated small molecules delivering innovative, safe, and effective oncology, antiviral, and antibacterial solutions to patients worldwide while preserving their quality of life. Management believes the company is entering a convergence period where late-stage clinical data, regulatory opportunities, capitalization initiatives, and broader market visibility are beginning to align simultaneously. We have a late-stage clinical asset, which is expanding shareholder awareness, both retail and institutional, while providing them a clear investment strategy and exit, greater than at any point in the company's history. Given the importance of securing partnerships and licensing deals over the next 12 to 24 months, Has the company considered hiring a dedicated VP or Director of Business Development with oncology or platform licensing experience to support these efforts? As our balance sheet strengthens, we plan to build out our corporate infrastructure to provide the company with highly skilled and experienced managers and employees to allow us to accelerate on the completion of our strategic initiatives.

speaker
Matthew Periton
Investor Relations Manager

That concludes the questions received to date.

speaker
Roger Dumoulin-White
President and Chief Executive Officer

We thank all shareholders for their continued support and interest in Theralase.

speaker
Matthew Periton
Investor Relations Manager

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 a strong momentum across our organization. This is demonstrated by the strengthening of our capital position, achievement of key milestones in our pivotal bladder cancer clinical study, and its advancement of our preclinical development of our new oncological and antiviral indications, which we believe will ultimately lead to increased long-term shareholder value. With an extended pipeline that now encompasses nine additional indications, Theralase is positioning itself to become an emerging pharmaceutical company focused on oncology and antiviral therapeutics. The steps we've taken over the past several quarters, along with the strategic initiatives we are pursuing in the quarters ahead, continue to differentiate Theralase within the biotechnology and pharmaceutical landscape. We look forward to seeing many of you at our annual, general, and special meeting of shareholders being held on June 17th at our corporate head office. 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.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-