Theralase Technologies Inc. (TLT) Earnings Call Transcript & Summary

Good morning, everyone. My name is Matthew Perraton, and I'll be hosting Theralase's quarterly investment conference call today. The focus of today's call will be a presentation and discussion of the company's annual 2024 audited financial statements and a corporate update. [Operator Instructions] The agenda for today's call is as follows: Kristina Hachey, Chief Financial Officer, will present the fourth quarter audited financial statements, along with the Q&A session on the results. Next, Matthew Perraton will provide an update on the Phase II bladder cancer clinical study. Finally, Roger Dumoulin-White, President and CEO, will cover our other indications and wrap up with a Q&A session. Before we begin, I would like to remind everybody that today's presentation may contain forward-looking statements defined within the meaning of the applicable securities laws. Participants should not unduly rely on these forward-looking statements which are not a guarantee of future performance as there can be no assurance that these statements will prove to be accurate as they may involve known and unknown risks, uncertainties and other factors, which may cause actual results or future events to differ materially from the forward-looking statements. Although the forward-looking statements contained in the call today are based upon what management currently believes to be reasonable assumptions, the company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. All forward-looking statements are made as of the date hereof and are subject to change without prior notification. Except as required by law, the company assumes no obligation to update such statements. The investor conference call audio track will be posted to our corporate website next week. Now that we've dispensed with the legal disclosure, let me introduce the Chief Financial Officer of the company, Ms. Kristina Hachey.

Thank you, Matt. Good morning, everyone. Let's start with an overview of the key highlights for the year ending December 31, 2024. Please note, all values presented are in Canadian dollars, and I have rounded to the nearest thousand. Theralase's total revenue in 2024 decreased to $1,033,000 from $1,070,000 in 2023 or a 3% decrease year-over-year. In comparison, the cost of sales in 2023 was $508,000 or 47% of revenue, resulting in a gross margin of $562,000 or 53% of revenue. The gross margin increase as a percentage of sales year-over-year is attributed to a write-down of obsolete inventory of $89,000 in 2023. Selling expense increased in 2024 to $354,000 from $279,000 in 2023, a 27% increase. The increase in selling expense is primarily a result of increased spending for sales salaries and advertising. Administrative expenses in 2024 decreased to $1,734,000 from $1,895,000 in 2023, a 9% decrease. The decrease is a result of reduced spending on general and administrative expenses and professional fees. Stock-based compensation expense decreased by 12% in 2024 due to the cumulative effect of accounting for vesting of stock options granted in the current and prior years. The drug division represented $989,000 of administrative expenses or 58% in 2024. Net research and development expenses in 2024 decreased to $2,750,000 from $2,982,000 in 2023, an 8% decrease. Net research and development expenses for the drug division decreased in 2024 to $2,578,000 from $2,938,000 in 2023, a 12% decrease. The decrease is primarily attributed to a decrease in cost for Study II patient enrollment treatment. Net research and development expenses for the device division increased in 2024 to $175,000 from $44,000 in 2023, a 400% increase. The increase is attributed to development of a new software program for the TLC-2000 Cool Laser Therapy system. Net loss for the year ended December 31, 2024, was $4,256,000, which included $827,000 of net noncash expenses. These include amortization, stock-based compensation expense and foreign exchange gain or loss. This compared to a net loss in 2023 of $4,570,000, which included $934,000 of net noncash expenses. The drug division represented $3,585,000 of this loss or 84% in 2024. The decrease in net loss is primarily attributed to decreased spending on research and development expenses in Study II. The company completed 5 nonbrokered private placements in 2024 and 1 in 2025, raising gross proceeds of approximately $4,245,800, issuing 20,332,513 units at various prices between $0.18 and $0.30. Each unit consisted of 1 common share of the company and 1 nontransferable warrant. All warrants entitled the holder to acquire an additional common share at a price between $0.25 and $0.45 for a period of 5 years following the date of issuance. I would now like to address a few of the questions that have been submitted by shareholders. The first question is how much is it going to cost to complete the Phase II clinical study for bladder cancer? And how do you plan to finance it? The company estimates the cost to complete the clinical study to range between $15 million and $30 million over the next 3 years, dependent on patient recruitment rate and the number of clinical study sites required to successfully complete it. The company's primary mandate is to be properly capitalized by securing funding to complete the Phase II clinical study through receipt from the Ontario Securities Commission to register a $100 million base shelf prospectus. If granted, this would allow the company 25 months from date of approval to access funds from the base shelf up to a maximum amount of $100 million. These funds would be raised in various tranches based on need. In order to be base shelf eligible, the company is required to demonstrate 12 months' worth of cash flow, which according to our latest financial statements is approximately $5 million. Therefore, the company plans to raise approximately $10 million in debt and/or equity instruments and government programs in the form of grants and loans to become base shelf eligible. The second question is, are there any plans for private placements or capital raises in the near future? To discuss future financings, it's best to contact Matthew Perraton to discuss what we have coming down the pipe. His e-mail is posted on the screen to connect with him. The third question is how does the company plan to fund the brain cancer and lung cancer clinical studies? A Phase Ib clinical study for both brain and lung cancer is estimated to cost approximately $5 million. Therefore, this money would be available through the base shelf prospectus I just mentioned. I believe that addresses all the questions I have received about the company's financial statements, and I will now turn it back over to Matt.

Thank you, Kristina, for your thorough overview of the company's fourth quarter annual financials and your strategy to appropriately fund the drug division focusing on [ lead asset ] bladder cancer as well as emerging assets targeting brain, lung and blood cancers. We also extend our gratitude to all shareholders who submitted questions for this call. Your engagement and continued support for Theralase is greatly appreciated. To make the discussion as efficient as possible, we've consolidated questions with similar themes to avoid redundancy. If we don't address your specific question during the call due to time limitations, we apologize and encourage you to reach out to me directly for further clarification. As a reminder, as a publicly traded company, we are restricted to discussing only information already available to the public domain. We cannot address inquiries regarding nonpublic information. I'll provide a brief overview of the recently released Phase II bladder cancer clinical study. Today, Theralase has enrolled and treated 79 patients in Study II who have been provided primary study procedure by the clinical study sites. Theralase added 4 new clinical study sites in the fourth quarter of 2024 as well as increased enrollment to an existing 10 clinical study sites to complete Study II enrollment in 2025. 95% of the 79 patients treated have been evaluated at the 90-day assessment for treatment of safety and efficacy according to the clinical study protocol. 81% of the 79 patients have completed the clinical study. Primary endpoint, which is complete response at any time, primarily defined as negative cystoscopy and negative cytology, 62.5% of patients demonstrated a complete response. If we include patients who demonstrated an indeterminate response defined as negative cystoscopy and positive urine cytology without a confirmatory negative bladder biopsy, the total response increases to 68.8%. This means that greater than 2 out of 3 BCG unresponsive nonmuscle invasive bladder cancer patients facing a radical cystectomy treated with Theralase's unique study procedure are experiencing complete restructuring of the cancer in their bladder. For secondary endpoint, which is duration of complete response, 45% of patients who achieved a complete response maintained their complete response for at least 12 months or 450 days from the point from the date of the primary study procedure. What this means is that almost 1 of 2 patients who demonstrated a complete response at any point in time continue to demonstrate a complete response at 15 months from the date of the study procedure. For tertiary endpoint, which is safety of the study procedure, 100% of patients experienced no serious adverse events directly related to the study drug or study device. In addition, 25% of patients who demonstrated a complete response at 450 days continue to demonstrate a complete response at 24 months, and 20% of patients continue to demonstrate a complete response at 36 months. These are tremendous results with increases in every category, including the long-term duration. The swimmers plot is a graphical representation of a patient's response to a treatment over time, specifically the clinical results for patients who achieved a complete or indeterminant response at any point in time and how they responded over time. As you can see, in the plot, clinical data is still pending for patients, who have demonstrated an initial complete response at 90 days and continue to demonstrate a duration of response. The Kaplan-Meier curve illustrates graphically for patients who have achieved a complete response, the estimate of the duration of that complete response and probability that the complete response will continue in the future when all clinical data of Study II is analyzed. According to the Kaplan-Meier curve, if the patient obtains a complete response, then the patient has a greater than or equal chance of 53% of remaining cancer-free for 1 year, greater and equal or equal chance of 35.9% for 2 years and greater than or equal chance of 26.1% for 3 years. The 79 patients treated in Study II, there have been 15 serious adverse events reported with all except the Grade 5 fully resolving within 90 days and oftentimes within a few days. Theralase believes all serious adverse events reported to date are unrelated to the study drug or a study device. This is a very strong clinical data for patients that have been diagnosed with high-grade bladder cancer disease specifically Carcinoma In-Situ as they have failed standard of care treatment with the BCG and in the majority of cases have failed other treatments, such as immunotherapy or gene encoded oncolytic viruses. To be clear, these patients are facing radical cystectomy or complete removal of their bladder and associated tissues. In 68% of the cases or approximately 7 out of 10 patients, Theralase has been able to completely destroy the cancer in the bladder. This is extremely encouraging for patients who have no other treatment options as the removal of their bladder and the morbidity, mortality risks associated with the significant surgery. Clinical data is still being collected, but all indications demonstrate that [ 72 ] has achieved its primary secondary and tertiary objectives. I'll now hand things over to our President and CEO, Roger Dumoulin-White, to respond to additional shareholder questions.

Thank you, Matt. Good morning, everyone. Now let me move to address a few of the questions that have been submitted by shareholders. The first question is, how many patients are required to complete enrollment and finish the clinical study? Based on new clinical data, Theralase has updated its statistical analysis plan to arrive at a total number of patients required to be enrolled and treated in the Phase II clinical study at 90 patients. This will provide a confidence level of 95% and a margin of error of plus or minus 10%. Today, Theralase has enrolled 79 patients with additional study procedures scheduled so an additional 11 patients are required to complete the clinical study. As a result, Theralase expects to complete enrollment into the study by this summer. If successful, this would allow us to report out on the completion of 75 patients in December of this year and completion of 90 patients by September 2026. Theralase will then lock its database and complete its biostatistical review to complete a new drug application for submission to the FDA and Health Canada in the fourth quarter of 2026. This would allow a marketing decision by Health Canada and the FDA by early to mid-2027. The clinical data to date is very strong, demonstrating a complete response rate of 62.5% at any point in time, a 45% complete response at 1 year; 25% at 2 years; and 20% at 3 years after only 1 to 2 treatments. Question number two, accelerated approval status. Fast track approval, breakthrough designation, accelerated approval and priority review are all programs that the FDA has created to bring further attention to a drug, but they do not allow any company to skip any of the steps required for commercialization. In this regard, they are nice to have recognitions, but are certainly not must-have recognitions. The undisputed prize is FDA and Health Canada marketing approval, allowing commercialization of the company's technology which is what the company is focused on. The company has already been awarded fast track approval. So if we are lucky enough to be awarded breakthrough designation, accelerated approval or a priority review, we will certainly be delighted. But at the end of the day, our focus should be and remains on FDA and Health Canada marketing approval. Question number three, can you tell us about the Herpes Simplex Virus negotiations? Are you seeking a development JV partnership for Herpes Simplex? Over the next 1 to 2 years, Theralase's plans to research and develop the technology required to safely and effectively treat Herpes Simplex Virus, number one. The virus, which is responsible for the development of unsightly cold source. These steps involve formulation of a compound, GLP toxicology testing and completion of adaptive Phase I/II clinical study to support safety and efficacy in a patient population. Once safety and efficacy have been demonstrated in patients, Theralase plans to license this technology to a larger organization to complete a Phase III registration clinical study and in addition, provide the sales, marketing and distribution of the technology across Canada, the United States and internationally upon Health Canada, FDA and international approvals. Question number four, for almost 2 years, Theralase has been compiling data clarification identified by the FDA for the pre-BTD and BTD. Why is it that those data clarification updates have not been completed 2 years later. Why is it taking so long? It has been approximately 20 months since we first spoke to the FDA about breakthrough designation through the submission of a pre-BTD application. At that time, the FDA declined to approve our pre-BTD application, raising questions about various aspects of the clinical data reported. Specifically, how did patients respond past 1 year and the need for central pathology review. Theralase undertook to address these questions to the FDA's satisfaction. Between July 2023 and today, the company has submitted 2 additional pre-BTD applications. With each one being refused by the FDA, based on various clarifications to the clinical data. The process of addressing FDA data clarification is complex and requires a thorough analysis to ensure compliance with their regulatory requests. The delays encountered have primarily been due to 2 primary reasons. Specifically, a clarification of the clinical data presented and the further collection of pending clinical data to demonstrate patient responses past 1 year. While it has taken longer than initially expected, families has compiled what it believes to be a strong, well-supported pre-BTD submission, to maximize the likelihood of FDA approval that will be submitted to the FDA before month end. If successful, Theralase will submit a BTD submission, which will take 60 days for the FDA to approve. If unsuccessful, then the company will wait until the end of the year when it has the complete data set on 75 patients before resubmitting. Question number five. Is there any chance the Parkinson's study will expand to additional sites and that British-Columbia could possibly be included at some point? The clinical study site currently conducting the Parkinson's disease study is located in Windsor, Ontario. Theralase plans to open another clinical study site possibly in London, Ontario or Toronto, Ontario later this year. Unfortunately, at this point, there is no intent to open a clinical study site in Vancouver, British-Columbia. But as the clinical study progresses, Vancouver would be a great location due to the large cosmopolitan population. Question number six. Why is it so difficult to raise funds when we have such promising anticancer technologies on the market? What is being done to address this? Raising funds in the biotechnology sector has been extremely challenging over the last 5 years, even with promising anticancer technologies due to several key factors: One, the global pandemic, which dramatically curtailed investments in things that were not COVID-19 related; two, the broader economic climate, such as high inflation rates, followed by high interest rates and now followed by international and reciprocal tariffs have been extremely challenging for the stock markets, making it harder to secure funding even for high-potential technologies; three, in times of uncertainty, investors often seek shorter-term returns, whereas drug development requires years of clinical studies and regulatory approvals before commercialization, leading to investors wishing to wait on the sidelines; number four, despite fast track designation and strong preliminary data, there is still regulatory uncertainty which some investors see as excessive risk; five, while Theralase's technology is unique, competition from established pharmaceutical companies with larger resources can make investors hesitant; six, a lot of attention has been paid to IAI in the last few years, making it difficult to attract the attention of investors. The steps being taken by the company to address these issues include Theralase raised funds over the last few years through non-brokered private placements. In 2025, Theralase will seek to raise funds through brokered private placements and life financings. If successful, Theralase will seek receipt of $100 million base shelf prospectus that Theralase can use to raise funds through over 25 months from date of receipt. Theralase is actively seeking collaborations with biotech and pharmaceutical companies to secure licensing agreements for our various technologies, providing nondilutive financing, which can aid the company in this commercialization strategic objectives. Management is increasingly -- sorry, management is increasing engagement with institutional investors, analysts and strategic partners to highlight the strong clinical data and market potential [indiscernible] in various applications, including bladder cancer and herpes simplex. Theralase continues to optimize its study execution and operational spending to extend its runway while focusing on achieving critical clinical milestones to successfully commercialize its various technologies. With inflation and interest rates under control by the central banks and tariffs not directly affecting our drug development business. The investment climate is shaping up for increased investment in biotechnology companies. In summary, with its strong clinical data and systematic development process, Theralase remains committed to securing the necessary funding to bring its various technologies to market efficiently. And question number seven, will you be considering a reverse split? Theralase is not currently considering a reverse split as it is not required to achieve our strategic objectives. We believe that based on our strong technology pipeline, we can achieve the requisite stock price to enter into larger national exchanges like TSX and NASDAQ organically. While stock price management is always under review, the company remains focused on advancing its clinical programs, securing strategic funding, and increasing shareholder value through strong operational performance rather than structural stock adjustments, which often do little to help a company or its shareholders.

Thank you for your detailed responses Roger. If any participants have any additional questions that were not addressed today, please feel free to send an e-mail directly to myself. My e-mail address is displayed on the screen. Thank you to everyone for your time today, and I look forward to seeing everyone in-person or virtually at the Annual General and Special Meeting later this year. Have a good day. Thanks.