Theralase Technologies Inc. / Earnings Calls / June 6, 2024

    Matthew Perraton

    Today's call will focus on a presentation and discussion of the Company's First Quarter 2024 Interim Financial Statements and an update on our Phase II bladder cancer clinical study followed by a question-and-answer period for each. The agenda for the call today will be a presentation by Kristina Hachey, Chief Financial Officer of Theralase, on the first quarter interim financial statements. This will be followed by a question-and-answer period regarding the results. Once Kristina has completed her discussion on the first quarter interim results, Roger Dumoulin-White, President and Chief Executive Officer of Theralase, will provide us an update on the Phase II bladder cancer clinical study. On completion of the presentation, Roger will also provide answers to questions we've received regarding the results and the clinical study. Before we begin, I would like to remind everyone that today's presentation may contain forward-looking statements defined within the meaning of applicable Canadian 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. Please note, if you would like to hear the call again or refer someone to listen to it, this investor conference call audio track will be posted on our corporate website next week. Now that we've dispensed with the legal disclosure, let me introduce the CFO of the Company, Ms. Kristina Hachey.

    Kristina Hachey

    Thank you, Matt. Good morning, everyone. Let's start with an overview of the key highlights for the first quarter ended March 31, 2024. All values presented are in Canadian dollars. For the three-month period ended March 31, 2024, Theralase's total revenue decreased 15% year-over-year. Cost of sales was a $113,440 or 65% of revenue resulting in a gross margin of $62,114 or 35% of revenue. In comparison, the cost of sales for the same period in 2023 was a $114,638 or 55% of revenue, resulting in a gross margin of $92,523 or 45% of revenue. The gross margin decrease as a percentage of sales year-over-year is attributed to a low volume of revenue and an increase in material costs. Selling expenses decreased to $67,552 from $74,671 for the same period in 2023, a 10% decrease. The decrease is result of reduced spending on commissions by 26% and travel expenses by 74%. Administrative expenses decreased to $511,495 from $522,695 for the same period in 2023, a 2% decrease. The decrease is a result of reduced spending on general and administrative expenses by 43%, insurance cost by 8%, and stock-based compensation by 10%. Net research and development expenses for the Drug Division decreased to $725,017 from $907,099 for the same period in 2023, a 20% decrease. The decrease is primarily attributed to a decrease in cost for Study II patient enrollment and treatments. Net research and development expenses for the Device Division increased to $31,363 from $3,181 for the same period in 2022 and 886% increase. The increase is attributed to development of a new software program for the TLC-2000 Cool Laser system. Net loss was $1,266,711, which included $220,919 of net non-cash expenses comprised of amortization, stock-based compensation expense, and foreign exchange gain loss. This compared to a net loss in 2023 of $1,408,953, a 10% year-over-year reduction, which included $244,787 of net non-cash expenses. The Drug Division represented $1,011,762 of this loss or 80% in 2024. The decrease in that loss is primarily attributed to decreased spending on research and development expenses in Study II. In the first quarter of 2024, the Company completed one non-brokered private placement. On February 5, 2024, the Company completed a $1.2 million financing at $0.18 per unit with the unit consisting of one common share and one warrant with a strike price of $0.25 for five years. In this quarter, on April 24, 2024, Theralase completed a 750,000 financing at $0.18 per unit with a unit consisting of one common share and one warrant with a strike price of $0.25 for five years.

    A - Kristina Hachey

    I will now like to address a few of the questions that have been submitted by shareholders. The first question is, how does the Company plan to fund the remainder of the Phase II bladder cancer clinical study? The Company estimates the cost to complete the clinical study to arrange between $15 million and $30 million over the next three 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 a $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 $4.5 million. Therefore, the Company plan plans to raise approximately $5 million in debt and/or equity instruments this year to become base shelf eligible. The second question is, are there any private placement or raises planned in the near future? To discuss future financing, it's best to contact Matthew Perraton to discuss what we have coming down the pipe. His email 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.

    Matthew Perraton

    Thank you, Kristina, for the detailed explanation of the Company's first quarter financial statements and your strategy to properly capitalize the Drug Division for both our lead asset, bladder cancer, and for the next upcoming assets, brain cancer and lung cancer. Thank you to all the shareholders who submitted questions for this call, as we have a very engaged shareholder base and appreciate your ongoing interest and support of Theralase. We have received many great questions and have taken the liberty of combining similar themed questions into a single question to prevent duplication. If we don't get to your question during this call, based on our allotted time, we apologize in advance. But feel free to contact me directly to address your question if it wasn't addressed today. Lastly, as I'm sure everyone is aware, as a publicly traded company, we can only provide information that is already available in the market. So, we'll keep ask those questions that are not in a public domain, we will not be able to answer them. I would now like to turn it over to our President and CEO, Roger Dumoulin-White to discuss our Phase II bladder cancer clinical study and then address some of the initial questions that Theralase has received from shareholders.

    Roger Dumoulin-White

    Thank you, Matt. Good morning, everyone. To begin, I would like to present the latest clinical data from the Phase II bladder cancer clinical study. Overall, the clinical data has been extremely successful, with 63% of patients demonstrating a complete response at any point in time in support of our primary objective. If we take into account the total response of patients, which are patients who no longer have disease in their bladders, but have exhibited urothelial cancer cells in their urine, meaning that their bladder cancer has been destroyed, but there may be other locations of the cancer, such as in their ureters or prosthetic urethra, the total response increases to 71%. This is 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 Bacillus Calmette Guérin or BCG, and in the majority of cases have failed other treatments, such as immunotherapy or gene encoded oncolytic viruses, to be clear, these patients that are facing radical cystectomy or complete removal of their bladder and associated tissues. In 71% of cases or seven out of 10 patients, Theralase has been able to completely destroy the cancer in their bladder. For the secondary objective, Theralase's clinical data is demonstrating a 33% duration of that complete response for 15 months past the primary study procedure with a total response of 35%. What this means is that one out of three patients who are facing radical cystectomy have been able to maintain the use of their bladder, and as a result, have received a higher quality of life. If we look at patients who received the optimized study procedure, these numbers increased moderately to a complete response of 34%, and a total response of 36%. This is extremely encouraging for patients who had no other treatment options other than removal of their bladder and the morbidity and mortality risk that come with that significant surgery. For our tertiary objective of safety, patients have experienced 13 serious adverse events, or SAEs. But according to our Data Safety Monitoring Board, none of these SAEs are directly related to the Theralase Study Drug or Study Device used in the study procedure. So overall, the Company's technology has delivered on expectations in the study design, and provided a safe and effective alternative treatment for patients facing removal of their bladder. In addition, a complete response was obtained by patients after only one study procedure 58% of the time. The International Bladder Cancer Group formed by some of the world's top year oncologists to provide medical guidance to Health Canada, the FDA, and European Medicines Agency have stated that a cleaning clinically meaningful response rate for BCG unresponsive, non-muscle invasive bladder cancer, carcinoma in situ, would be 50% at six months, 30% at 12 months and 25% at 18 months. Theralase has exceeded these guidelines, demonstrating a 57% complete response at 6 months, 35% at 12 months and 34% at 15 months. Now let me move to address a few of the questions that have been submitted by shareholders. First question is, when does the Company expect to complete Study II? Valid question. The Company plans to complete accruement into the Study II, which is the enrollment and provision of the primary study procedure to the remaining patients by the end of 2024. If we are successful, this will allow us to achieve soft and hard data lock on a majority of the clinical data by mid-2026, and subject to receiving priority review by the FDA, a determination for marketing approval by Health Canada and the FDA by the end of 2026. The second question is, how does Ruvidar stack up to the competition for bladder cancer? The interim clinical data Study II to-date has proven to be world class and very competitive to big pharma's clinical data, who, as you well know, are significantly larger and much better financed than Theralase. As an example, one of our competitors who recently received FDA approval and has clinical data inferior to Theralase has a burn rate of approximately $500 million per year whereas Theralase's burn rate is less than 5 million. In other words, our burn rate is less than 1% of a large competitor, which has not been able to deliver as effective in a treatment as Theralase has. To restate, Theralase's technology has demonstrated an ability to destroy urothelial cell carcinoma in a patient's bladder for a complete response of 63%, and a total response of 71% at any point in time. The duration of this response for 450 days after the study procedure has been a complete response of 34%, and a total response of 36% for the optimized treatment. Looking at the competition for FDA approved technologies, valrubicin, a chemotherapy drug approved by the FDA 40 years ago, has an initial complete response rate of 21%, falling to 7.7% at 15 months. The first immunotherapy drug approved in this space in early 2020, KEYTRUDA, has an initial complete response of 40%, falling to 18.9% at 15 months. The first gene encoded adenovirus approved in this space, ADSTILADRIN has an initial complete response of 51%, falling to 23.5% at 15 months and subsequently to 3.9% at 24 months. The most recent FDA approval belongs to BCG plus N-803, which has an initial complete response of 62%, falling to 25% at 24 months. This was achieved by using their drug in combination with the current standard of care, BCG. For technologies currently under clinical evaluation, slow-release gemcitabine, a chemotherapy drug, has an initial complete response of 76.7%, falling to 26% at 15 months. Creto, an intravesical oncolytic immunotherapy, has an initial complete response of 75%, falling to 27.6% at 12 months. Finally, [indiscernible] a non-viral gene therapy has an initial complete response of 73%, with no reported response at 15 months. Therefore, the data is very early stage and expected to be reported out at the end of the year. In comparison to these FDA approved therapies and for therapies undergoing clinical evaluation, the primary benefit of the Theralase technology, are the high initial response by patients, but more importantly, the high duration of that response at 450 days after only one study procedure, with 50% of the patients treated receiving that benefit. In addition, the much higher safety margin of Theralase therapy is extremely beneficial for the patients being treated. From a clinical perspective, the Theralase therapy is urologist led and is able to be provided under general anesthetic. From a manufacturing perspective, the Theralase small molecule is much easier to manufacture versus a biologic and has been proven stable for up to eight years at room temperature, a significant advantage for the clinical sites that provide the Theralase therapy to their patients. Therefore, the Theralase technology presents a safe, effective alternative therapy for patients who are at risk of having their bladder removed. The third question, we now enrolled 68 patients versus the previously reported 63 patients. What do you believe was the reason for low patient enrollment from late last year to today? In discussion with the FDA in July 2023, the FDA strongly recommended investigating the patient's duration of response after 450 days and also the inclusion of central pathology to validate the results obtained from local pathology. As a result, Theralase updated their clinical protocol to include these requests and to commence collecting this information on existing patients. This resulted in numerous documents that were required to be sent to the clinical study sites and approved by both central and local research ethics boards. As the clinical study sites were using their resources to comply with the FDA's request, new patient enrollment suffered as a result. Almost all clinical study sites have now had their research ethics boards approve the required documentation for the request, with the remaining clinical study sites expecting approval within the next three to four weeks, and have started to focus on patient recruitment. This is evidenced by the enrollment of five new patients over the last quarter. Theralase is expecting more patients enrolled prior to the summer; however, the summer months are typically slow for patient recruitment as both patients and clinical staff are often enjoying their summer vacations. Patient recruitment will resume in September after the summer holidays. In order to complete accruement into Study II by the end of 2024, Theralase has implemented three strategic initiatives. Specifically, the retention of Dr. Michael Jewett to work directly with the clinical study site principal investigators to increase enrollment. The hiring of two new clinical research associates at Theralase to interact with their counterparts at the clinical study sites to increase enrollment and prepare the clinical data for regulatory review, launch of up to five new clinical study sites in Canada and the United States over the summer to assist in patient enrollment. Fourth question. What is the status of Break Through Designation approval? The Company submitted a pre-Break Through Designation submission to the FDA in July 2023. And based on the FDA's feedback, the Company is currently working with the clinical study sites, a central pathology laboratory, a biostatistics organization, and a regulatory organization to update the pre-BTD with clinical data clarifications requested by the FDA. Specifically, the patient's duration of response after 450 days and also the inclusion of central pathology to validate the results obtained from local pathology. The Company has been collecting this clinical data and hopes to accumulate all available clinical data by the end of second quarter 2024, beginning of third quarter 2024. However, this is subject to the clinical study sites providing the requested clinical data. If this goes according to plan, then Theralase should be in a position to resubmit the pre-BTD submission to the FDA in the early third quarter of 2024 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company will compile a BTD submission for review by the FDA in third quarter in support of the grant of a BTD approval. Once the BTD submission has been made, the FDA has 60 days to review the documentation and provide their decision. If the BTD submission is made by the Company in mid third quarter, then a decision should be available from the FDA by the end of third quarter, beginning of fourth quarter. Fifth question. What is the status of any licensing, acquisition, partnering or distribution agreements? The Company's guidance in our corporate PowerPoint presentation on our website is that the Company commenced the commercialization phase at the beginning of 2024. These negotiations with various strategic partners can take up to two to three years to come to fruition. So, the corporate strategy is to have an acquisition or distribution partner in place by mid to end of 2026. Just as the Company is completing the follow-up on its Phase II bladder cancer clinical study and preparing for submission to Health Canada and the FDA for regulatory marketing approval or preferably has already achieved regulatory marketing approval. Based on the strong interim clinical data compiled to-date, the Company believes that these are realistic timelines for potential partnership agreement. When deemed material by the board of directors, any licensing, acquisition, partnering, or distribution agreements would be announced via press release. The sixth question is, can you provide any updates on brain cancer, lung cancer, or blood cancer clinical studies? Yes, we can. The non-good laboratory practices or GLP preclinical research and toxicology has been completed for glioblastoma multiforme brain cancer and is currently underway for lung cancer and the blood cancer lymphoma. GLP talks is slated to be completed this summer, pending capital funding. This would allow commencement of a Phase I/II clinical study for these diseases in '24, 2025. Subject of course the Health Canada and FDA preapproval as well as being properly capitalized to commence these clinical studies. Based on our recent press release this morning, Theralase has demonstrated that Rutherrin is able to significantly enhance the destruction of lung cancer in a Lewis lung model. This is a very aggressive lung model. When combined with radiation versus radiation alone, this demonstrates that Rutherrin is effective as a radio enhancer significantly improving the efficacy of radiation with no additional side effects. This now provides the thoracic oncologist with a very powerful tool to help destroy lung cancer, one of the leading causes of cancer related death worldwide. Seventh question. What do these new indications mean to Theralase? The impact of Theralase is believed to be significant. Any opportunity for a pharmaceutical company to increase its pipeline for therapies able to safely and effectively treat major disease stage, such as brain cancer, lung cancer or blood-based cancers, would be considered materially significant to both potential revenues and the stock price. As an example, the global market in 2022 for glioblastoma multiforme was US$2.4 billion with an annual growth rate of almost 10%. The global market for non-small cell lung cancer was estimated at US$10 billion globally. For blood-based cancers such as leukemia, lymphoma, and multiple myeloma, the global market reached US$63 billion in 2022. Theralase is excited about the possibility of developing safe and effective treatments for the millions of patients inflicted with these cancers annually. The last question is, any updates on the COVID-19 vaccine? The Company has been diligently working with the University of Manitoba and the National Microbiology Laboratory to complete this work. All petri dish work has been completed by the University of Manitoba, and we are currently working with the National Microbiology Laboratory to complete a challenge animal model. This research was recently published in a peer reviewed journal, Heliyon, detailing the ability of Ruvidar to inactivate numerous enveloped and non-enveloped viruses, both with and without light activation. As a result of this research, Theralase is currently in development of a topical ointment made with Ruvidar that can be used to treat herpes simplex lesions. In addition, Theralase has gained consensus from the National Microbiology Laboratory to shift their focus from a COVID-19 vaccine to an avian influenza vaccine. We plan to report out on the animal challenge animal model for avian influenza by year-end. In closing, I would like to state that the Company remains focused on commercializing the next standard of care treatment for BCG-unresponsive non-muscle invasive bladder cancer, which includes. One, being properly capitalized using various equity and debt instruments. Two, completing patient enrollment and provision of the primary study procedure by year-end. Three, achieving BTD status from the FDA in 2024. Four, achieving Health Canada and FDA regulatory marketing approval by the end of 2026. Five, successfully partnering the technology by 2026. In addition, the Company plans to commence Phase I clinical studies for brain cancer, lung cancer, and blood-based cancers in 2024 and 2025. Research and develop a topical ointment for the treatment of herpes simplex lesions. Three, develop a vaccine for avian influenza. Thank you, everyone, for your time today, and I look forward to seeing everyone in person at the annual general and special meeting or AGSM on June 19th later this month. Thank you.

    Matthew Perraton

    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 email directly to myself. My email address is posted on the screen. Lastly, the AGSM is scheduled for Wednesday, June 19th at 4

    30 pm at our Toronto corporate head office. In order to help make the AGSM more interactive for those shareholders who are unable to attend, after the formal part of the AGSM has concluded at 5

    30 pm, there will be an opportunity for non-attending shareholders to view the live corporate PowerPoint presentation via Zoom and also submit their questions to the live question and answer period to follow. The corporate PowerPoint presentation and question-and-answer period will end at 6

    30 pm. Thank you again for your participation. And I look forward to seeing you in a few weeks.

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