Theralase Technologies Inc. / Earnings Calls / August 21, 2024

    Matthew Perraton

    Good morning everyone. My name is Matthew Perraton and I will be hosting Theralase Technologies Inc's Quarterly Investor Conference Call today. Today's call will focus on a presentation and discussion on the company's second quarter 2024, interim financial statements and our Phase II bladder cancer clinical study results, followed by a question-and-answer period for each. The agenda for the call today will be, first, a presentation by Kristina Hachey, Chief Financial Officer of Theralase, on the second quarter interim financial statements, followed by a question-and-answer period regarding the results. Second, once the review of the financial statements has been completed, Roger Dumoulin-White, President and Chief Executive Officer of Theralase, will provide us an update on the Phase II bladder cancer clinical study, also followed by question-and-answer period regarding the results. 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. This investor conference call audio track will be posted on our corporate website next week. Now that I have 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 second quarter ended June 30, 2024. Note, all values presented are in Canadian dollars. For the six-month period ended June 30th, 2024, Theralase’s total revenue decreased 35% year-over-year. Cost of sales was CAD186,324 or 67% of revenue resulting in a gross margin of CAD90,077 or 33% of revenue. In comparison, the cost of sales for the same period in 2023 was CAD224,947 or 53% of revenue, resulting in a gross margin of CAD201,140 or 47% of revenue. The gross margin decrease as a percentage of sales year-over-year is attributed to an increase in material costs. Selling expenses decreased to CAD145,915 from CAD147,304 for the same period in 2023, which results in a 1% decrease. administrative expensed decreased to CAD907,378 from [CAD1,100,144] (ph) for the same period in 2023, a 10% decrease. The decrease is a result of reduced spending on general and administrative expenses by 59% and stock-based compensation by 28%, due to the cumulative effect of accounting for the vesting of stock options granted in the current and previous years. Net research and development expenses for the drug division decreased to CAD1,368,333 from CAD1,594,676 for the same period in 2023, a 14% 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 CAD81,753 from CAD25,163 for the same period in 2023, a 225% increase. The increase is attributed to development of a new software program for the TLC-2000 Cool Laser Therapy System. Net loss was CAD2,400,461, which included CAD374,445 of net non-cash expenses comprised of amortization, stock-based compensation expense and foreign exchange gain or loss. This compared to a net loss in 2023 of CAD2,564,187, a 6% year-over-year reduction, which included CAD474,558 of net non-cash expenses. The Drug Division represented CAD1,938,024 of this loss, or 81% in 2024. The decrease in net 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, the company completed a CAD1.2 million financing at CAD0.18 per unit with a unit consisting of one common share and one warrant with a strike price of CAD0.25 for five years. In the second quarter, on April 24, Theralase completed a CAD750,000 financing at CAD0.18 per unit with a unit consisting of one common share and one warrant with a strike price of CAD0.25 for five years. In the third quarter on July 8, Theralase completed a CAD775,000 financing at CAD0.22 per unit with a unit consisting of one common share and one warrant with a strike price of CAD0.30 for five years. I will now like to address a few of the questions that have been submitted by shareholders. The first question is, what is the company's strategy for financing the rest of the Phase II clinical study on bladder cancer? The company estimates the cost to complete the clinical study to a range between CAD15 million and CAD30 million over the next three years. This is 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 CAD100 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 CAD100 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 CAD4.5 million. Therefore, the company plans to raise approximately CAD10 million in debt and or equity instruments this year 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 participation in future financings, it is best to contact Matthew Perraton to discuss what has been approved by the board and announced to the market, either through a press release or a Form-4A price reservation form. 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 CAD5 million. Therefore, this money would be available through the base-shelf prospectus I just mentioned. Other clinical studies would be funded through the same base-shelf prospectus. The final question is, is Theralase planning to extend the warrants that expire August 22, 2024? Unfortunately, the company is unable to extend the CAD57,499,000 warrants that are expiring on August 22, primarily because, according to exchange rules, warrants are unable to be extended beyond a five-year term. However, subject to exchange approval, the company will attempt to extend the CAD10,058,734 warrants expiring on September 22 for another three years. I believe that addresses all the 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 second quarter financial statements and your strategy to properly capitalize the drug division for both our lead asset, bladder cancer, and for the next up and coming 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 their allays. We have received many great questions and I've 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 if you've asked us a question that is not in the public domain we will not be able to answer it. I would now like to turn over to our President and CEO, Roger Dumoulin-White to discuss our Phase II bladder cancer clinical study and then address some additional questions. Theralase has received from a shareholder base.

    Roger Dumoulin-White

    Alright. 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, meaning patients who no longer have disease in their bladders, but have urothelial cancer cells detected in their urine, proving that their bladder cancer has been destroyed, but there may be other locations of cancer, such as in their ureters or prosthetic urethra, if they're men, 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 and in the majority of cases have failed numerous other treatments such as immunotherapy, chemotherapy or gene encoded oncolytic viruses. To be clear, these are 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 our secondary objective, for patients who obtained a complete response, Theralase’s clinical data is demonstrating a 44% duration of that complete response for 15-months past the primary study procedure with a total response of 46%. What this means is that almost one out of two patients, who demonstrated a complete response at any point in time continue to demonstrate that complete response at 15-months from date of first treatment, with 46% of patients demonstrating a total response. Greater than 90% of patients, who demonstrated a complete response at 450 days continue to demonstrate this response beyond 450 days. This is extremely encouraging for patients who had no other treatment options other than removal of their bladder and the morbidity and mortality risks that are associated with that life-altering surgery. For our tertiary objective of safety, patients have experienced 14 serious adverse events, or SAEs. But according to the company's review, 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 met its study objectives, subject to enrollment of additional patients and follow-up of all patients, providing a safe and effective treatment option for patients facing removal of their bladder. On commercialization, I believe Theralase’s therapy to be extremely appealing to the Uro-oncology market. Specifically, one and done. The patient doesn't have to come into the hospital repeatedly, which is extremely appealing to patients, who are typically elderly and less mobile. Uro-oncologist-led treatment Uro-oncologists are the source of all patient diagnoses. Therefore, the Uro-oncologist doesn't have to assess the patient and then refer them to a medical oncologist. They get to retain the patient under their care and hence the compensation derived from that effort. High efficacy. The patient obtains a complete response 63% of the time. If not, or they recur, they can always be treated additional times. High safety. No direct study drug or study device related SAEs. Higher insurance company reimbursement. Insurance companies are more likely to fund one treatment versus two years’ worth of treatments, therefore higher reimbursement for Uro-oncologist. The swimmer's plot is a graphical representation of the clinical results for patients, who achieved a complete response at any point in time and their response up to 1,080 days, demonstrating a patient's response over time. As can be seen, clinical data is still pending for patients who have demonstrated an initial complete response in 90-days and continue to demonstrate a duration of that response. 63% of the valuable patients, 41 out of 65, achieved a complete response at any point in time, with 44% of those patients, or 18 out of 41, who demonstrated a complete response continuing to maintain their complete response at 450-days and thus achieving the primary and secondary objectives of Study II. 41% of the valuable patients, or 17 out of 41, demonstrate a complete response beyond 450-days. In addition, a complete response was obtained by patients after only one study procedure, 57% of the time. As a note, this is interim clinical data, and clinical data is still being collected, but all indications demonstrate that the study has achieved its primary, secondary, and tertiary objectives. The Kaplan-Meier curve illustrates graphically for patients who have achieved a complete response the duration of their complete response and the probability of that complete response continuing in the future. In summary, the interim clinical data demonstrate that patients consenting to participate in the study have a 63% chance of achieving a complete response. If a complete response is obtained, then the patient has a 48.3%, 42.3% and 33.8% chance of remaining cancer-free for one, two and three years respectively. The International Bladder Cancer Group, formed by some of the world's top Uro-oncologists to provide medical guidance to Health Canada, the FDA and European Medicines Agency, have stated that a clinically meaningful response rate for BCG-unresponsive NMIBC carcinoma in situ would be 50% at six months, 30% at 12 months, and 25% at 18 months. Theralase has substantially achieved these guidelines with interim data demonstrating a 51% complete response at six months, 29% at 12-months, and 28% at 15-months. Prior to addressing questions, I would also like to comment on the press release released this morning titled, Theralase Demonstrates Ability to Activate Rutherrin with Diabetes Drug. This is an extraordinary discovery as it demonstrates that our lead drug formulation, Rutherrin, has been proven pre-clinically to be able to be activated with metformin, a common diabetes drug, without the use of light and irradiation. Even more interesting is that because Rutherrin and metformin are both scientifically proven to cross the blood-brain barrier, as well as tumor-specific blood barriers, this new discovery potentially allows the precise targeting of cancer cells by Rutherrin anywhere inside the body, including the brain, followed by their synergistic systemic activation by metformin. Why this is important is that traditionally Rutherrin is required to be activated by laser light and a radiation. But now it is envisioned that the Rutherrin can be instilled in the body via IV drip, followed by activation with metformin, taken orally. This can be accomplished virtually anywhere and, if required, can be accompanied by hospital-based radiation treatments if the disease state requires it. Based on the latest research, pending good laboratory practices, toxicology analysis of Rutherrin and regulatory approval, Theralase would be able to commence practitioner-led and Theralase-led clinical studies in the destruction of various cancers. The clear advantage is that light and a radiation equipment is no longer a prerequisite and the procedure can be completed outside of the hospital or expensive operating room time, significantly lowering the cost of providing the treatment and the burden on elderly patients with limited mobility. Now let me move to address a few of the questions that have been submitted by shareholders. The first question, we have now enrolled 72 patients versus the previously reported 68 patients. How many patients do you think we will need to complete our enrollment and finish the clinical study? Theralase continue to enroll patients over the summer months even though this is traditionally a slower time for patient recruitment as both patients and clinical staff are often enjoying their summer vacations. However, as previously press released, we have treated an additional four patients since our last update and now have enrolled 72 patients to-date, with another three to be treated in the next four to six weeks, bringing us to 75 patients. Why this is significant is in April of this year competitor received FDA approval with just 77 patients treated? With an additional three patients treated in the next several weeks and hopefully another 10 more by the end of the year, this will bring us to 85 treated patients and very close to the end of the enrollment in our study. The clinical data has been extremely strong. Our primary objective, according to FDA guidelines, is a complete response at any point in time, demonstrating 63%, meaning that almost two out of three patients, who are diagnosed with BCG-unresponsive, non-muscle invasive bladder cancer, carcinoma in situ, and were faced with having their bladder removed via radical cystectomy, we're able to save their bladder and hence their quality of life. Out of the patients that demonstrated a complete response, 44% or almost half are seeing a duration of response of 450-days or more. What's really interesting though is that beyond the 450-days, 90% of these patients are continuing to demonstrate a complete response past 450-days, for up to three years and counting. Theralase is very pleased that the technology has been so effective for these patients. Therefore, with possibly 85 patients treated by the end of 2024, we could have enough data to complete the agreement into Study II. If successful, this will allow us to achieve soft and hard data log 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 why is duration of response so important to the FDA? Duration of response is important to all stakeholders, including the regulators, specifically Health Canada and the FDA, the insurance companies, who are paying for these types of services, the practitioners and the surgeons, who are delivering the treatment, and especially to the patients, who are faced with this hard to treat, debilitating disease. One of the biggest risks of bladder cancer is that it progresses into muscle invasive bladder cancer. If it continues to progress and it spreads outside the bladder, it can spread into the peritoneal cavity and spread metastatically, severely diminishing the quality of life and lifespan of the patient. So we really want to nip it in the bud or stop it before it has an opportunity to spread. In summary, we wish to destroy the disease in its early stage and prevent it from recurring and absolutely prevent it from progressing. Due to the high recurrence rate, the FDA and Health Canada are very interested in the duration of response. So companies are required to demonstrate that the patient can obtain a complete response and in addition that they can maintain a duration of that complete response for at least 12-months after initial diagnosis of a complete response. A lot of treatments, FDA approved drugs, and even those under clinical study start out being effective, typically in the 60% to 70% range, even higher, similar to where we are, but unfortunately they decrease in effectiveness rapidly. They are down in the double, sometimes single-digits within a year's time and regress even more as the years continue. Theralase is demonstrating world-class performance, with our duration of response being comparable to any FDA-approved drugs with only one treatment, and is showing comparable results to any company currently undergoing clinical studies, who has reported out. The third question is what is the status of breakthrough designation approval? The company submitted a pre-breakthrough 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 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 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 by the end of the third quarter, then a decision should be available from the FDA in the fourth quarter 2024. Fourth question is how does Ruvidar stack up to the competition for bladder cancer? The interim clinical data of 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 a duration of response that is comparable to Theralase has a burn rate of approximately CAD500 million per year, whereas Theralase’s burn rate is less than CAD5 million. In other words, our burn rate is less than 1% of a large competitor, which has not been able to deliver a treatment more effective than Theralase has. To restate, Theralase 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 44% and a total response of 46%. Where we really stand out though is our duration of response data. If complete response is obtained, then the patient has a 48.3% one year duration, 42.3% two year duration, and 33.8% chance of remaining cancer free for three years according to the Kaplan-Meier curve. Looking at the competition for FDA-approved technologies, valrubicin, a chemotherapy drug approved by the FDA 40-years ago, has an initial complete response of 21%, falling to 7.7% at 12-months and 4% at 24 months. The first immunotherapy drug approved in this space in early 2020 was KEYTRUDA, which has an initial complete response of 41%, falling to 19% at 12-months and 9% at 24-months. The first gene-encoded adenovirus approved in this space ADSTILADRIN has an initial complete response of 51%, falling to 23.5% at 12-months and 19% at 24-months. The most recent FDA approval belongs to BCG plus N-803, which has an initial complete response of 62%, following to 36% at 12-months, and 25% at 24-months. For technologies currently under clinical evaluation, slow-release Gemcitabine, a chemotherapy drug, has an initial complete response of 83%, falling to 21% at 12-months and 5% at 36-months. Creto, an intravesical oncolytic immunotherapy, has an initial complete response of 75%, falling to 37% at 12-months, with no further data available at this time. Finally, [Indiscernible], a non-viral gene therapy, has an initial complete response of 73% with no further data available at this time. 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 response at 90-days, after only one study procedure in 57% of the patients treated. In addition, the much higher safety margin of the 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 staple 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 fifth question is, 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 a 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 hopefully 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 a 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? The non-GLP preclinical research and toxicology has been completed for glioblastoma multiform, a deadly form of brain cancer, and is currently underway for lung cancer and the blood cancer lymphoma. GLP talks is slated to be completed by end of year, pending capital funding. This would allow commencement of a Phase I/II clinical study for these diseases in 2025, subject to Health Canada and FDA pre-approval, as well as being properly capitalized to commence these clinical studies. Based on our recent press release, Theralase has demonstrated that Rutherrin is able to significantly enhance the destruction of lung cancer in a Lewis-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. The seventh question is, 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 diseases 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 $2.4 billion with an annual growth rate of almost 10%. The global market for non-small cell lung cancer was estimated at $10 billion globally. For blood-based cancers such as leukemia, lymphoma, and multiple myeloma, the global market reached $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, is there any update on the 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 for H1N5 avian influenza. This research was 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 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 in 2026. In addition, the company plans to commence Phase I clinical studies for brain cancer, lung cancer, and blood-based cancers in 2025. Two, the launch a clinical study using Rutherrin activated by metformin. Three, research and develop a topical ointment for the treatment of herpes simplex lesions. Four, development of a vaccine for avian influenza, and possibly Monkeypox. Thank you everyone for your time today and I look forward to updating our shareholders as we continue on our path towards commercializing the next standard-of-care for bladder cancer.

    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. Thank you again for your participation today and I look forward to our next quarterly call after the submission of our third quarter financials. Enjoy the rest of your summer and I look forward to seeing you all again in the fall.

    End of Q&A:

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