Theralase(R) Releases 2024 Annual Financial Statements

Toronto, Ontario--(Newsfile Corp. - March 12, 2025) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecules and their formulations, intended for the safe and effective destruction of various cancers, bacteria and viruses has released the Company's audited consolidated financial statements for the twelve-month period ended December 31^st, 2024. ("Financial Statements").

Theralase® will be hosting a conference call on March 19^th at 11:00 am ET, which will include a presentation of the financial and operational results for the fiscal year ending December 31^st, 2024.

To ensure Theralase® has time to address questions during the call, please e-mail them in advance to mperraton@theralase.com.

 
An archived version will be available on the website following the conference call.

Financial Summary for the year ended December 31^st:

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¹ Other represents foreign exchange, interest accretion on lease liabilities and / or interest income

Financial Highlights:

For the year ended December 31^st, 2024 (All funds in Canadian Dollars):

• Total revenue decreased to $1,033,431 from $1,070,307 for the same period in 2023, a 3% decrease.

• Cost of sales was $479,406 (46% of revenue) resulting in a gross margin of $554,026 (54% of revenue). In comparison, the cost of sales for the same period in 2023 was $508,173 (47% of revenue) resulting in a gross margin of $562,144 (53% of revenue). Cost of sales is represented by the following costs: raw materials, subcontracting, direct and indirect labour and the applicable share of manufacturing overhead. The gross margin increase, as a percentage of sales, year over year, is attributed to a write-down of obsolete inventory of $89,325 in 2023.

• Selling expenses increased to $354,636, from $278,866 for the same period in 2023, a 27% increase. The increase in selling expenses is a result of increased spending for sales salaries (39%), and advertising (65%).

• Administrative expenses decreased to $1,734,066 from $1,895,460 for the same period in 2023, a 9% decrease. The decrease in administrative expenses is a result of reduced spending on professional fees (28%) and general and administrative expenses (22%). Stock based compensation expense decreased 12% in 2024, due to the cumulative effect of accounting for vesting of stock options granted in the current and prior years.

• Net research and development expenses decreased to $2,735,674 from $2,982,073 for the same period in 2023, an 8% decrease. The decrease in research and development expenses is attributed to the decrease in costs for Study II patient enrollment and treatment. Research and development expenses represented 57% of the Company's operating expenses and represent investment into the research and development of the Company's Drug Division.

• The net loss for the year was $4,256,114, which included $827,397 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss in 2023 of $4,570,879, which included $933,790 of net non-cash expenses. The Drug Division represented $3,584,871 of this loss (84%) in 2024. The decrease in net loss is attributed to decreased spending on research and development expenses in Study II.

Operational Highlights:

Research Collaboration for Treatment for Parkinson's Disease:

Theralase® is working in collaboration with researchers at the University of Windsor, Faculty of Human Kinetics and a Windsor based chiropractor to conduct a groundbreaking clinical study into how Theralase® Cool Laser Therapy ("CLT") can be used as a treatment for Parkinson's Disease, a brain disorder that causes unintended or uncontrollable movements, such as shaking, stiffness and difficulty with balance and coordination. Theralase®'s CLT, with its super-pulsed laser technology, is one of the few technologies in the world able to make an impact on this disease and improve the outcomes of Parkinson's Disease.

Break Through Designation Update:

The Company submitted pre-Break Through Designation ("BTD") submissions to the FDA and based on the FDA's feedback the Company is currently working with the Clinical Study Sites ("CSSs") and a regulatory organization to update the pre-BTD submission with clinical data clarifications identified by the FDA. The Company plans to resubmit the pre-BTD submission to the FDA in 1Q2025 for FDA review of these clarifications. Once the pre-BTD submission has been accepted by the FDA, the Company plans to compile a BTD submission for review by the FDA in support of the grant of a BTD approval.

Theralase® has received the majority of the clinical data from the CSSs with a high percentage of patients demonstrating a duration of their Complete Response ("CR") beyond 450 days, with some patients demonstrating CR for ≥ 3 years, post receiving the primary Study Procedure.

Study II Interim Clinical Data:

To date, Theralase® has enrolled and treated 79 patients in Study II, who have been provided the primary Study Procedure by the CSSs.

Theralase® plans to complete Study II enrollment by mid 2025.

95% (75/79) of treated patients have been evaluated at the 90 days assessment for treatment safety and efficacy according to the clinical study protocol.

81% (64/79) of treated patients have completed the clinical study for treatment safety and efficacy or have been prematurely removed by the PI according to the clinical study protocol.

Performance to Primary Objective:

For the primary endpoint of Study II (CR at any point in time) 62.5% (40/64) [43.1, 81.9] of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a CR. Including patients, who demonstrated an IR (negative cystoscopy and positive or suspicious urine cytology), the TR increases to 68.8% (44/64) [48.5, 89.1].

Performance to Secondary Objective:

For the secondary endpoint of Study II (duration of CR) 45.0% (18/40) [24.2, 65.8] of treated patients who achieved a CR, maintained their CR response for at least 12 months (450 days from date of Study Procedure).

Performance to Tertiary Objective:

For the tertiary endpoint of Study II (safety of Study Procedure) 100% (64/64) experienced no Serious Adverse Events ("SAEs") directly related to the Study Drug or Study Device.

25.0% (10/40) [9.5, 40.5] of patients who demonstrated a CR, continue to demonstrate a CR at 24 months from date of first treatment and 20.0% (8/40) [6.1, 33.9] of patients continue to demonstrate a CR at 36 months from date of first treatment.

Note: For patients to be included in the statistical clinical analysis they must be enrolled in Study II, provided the primary Study Procedure and evaluated by a PI at the 90 days assessment through to 450 days assessment (cystoscopy and urine cytology) or have been removed from Study II, after the 90 day assessment and prior to the 450 day assessment. There are 64 patients that have completed Study II and have been statistically analyzed for efficacy.

Patient Response Chart:

To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/244252_41cd55ccb43a1bb4_002full.jpgThe Swimmer's plot is a graphical representation of the interim clinical results (n=64) for patients who achieved a CR at any point in time and their response up to and including 1170 days.

As can be seen in the plot, clinical data is still pending for patients (indicated by arrows), who have demonstrated an initial CR at 90 days and continue to demonstrate a duration of that response.

Kaplan-Meier Curve:

The Kaplan-Meier ("KM") Curve illustrates graphically, for patients who have achieved a CR, the duration of CR and probability of that CR continuing in the future, when all clinical data of the Study II is analyzed.

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According to the KM Curve, if CR is obtained, then the patient has a ≥ 53.0%, ≥ 35.9% and ≥ 26.1% chance of remaining cancer free for 1, 2, and 3 years, respectively.

Serious Adverse Events

For 79 patients treated in Study II, there have been 15 Serious Adverse Events ("SAEs") reported:

• 1 - Grade 1 (resolved within 9 days)

• 3 - Grade 2 (resolved within 1, 1 and 33 days, respectively)

• 7 - Grade 3 (resolved within 1, 2, 3, 4, 4, 82 and unknown days, respectively)

• 3 - Grade 4 (resolved within 3, 6 and 8 days, respectively)

• 1 - Grade 5

Theralase® believes all SAEs reported to date are unrelated to the Study II Drug or Study II Device.

Additional Oncology Targets:

Theralase® has been granted international patents supporting a comprehensive Intellectual Property ("IP") platform of its small molecules. The scientific and preclinical research and development of these small molecules has been optimized by fine-tuning the photophysical and photochemical properties of the small molecules, allowing them to demonstrate both Type I (oxygen limited) and Type II (oxygen dependent) photoreactions and activation in hypoxia.

By combining these small molecules with transferrin (human glycoprotein), as a delivery system it has been preclinically demonstrated that transferrin is able to significantly:

• Increase the resistance of Ruvidar^TM, the lead drug candidate, to photobleaching (loss of potency of the small molecule over time)

• Increase Reactive Oxygen Species ("ROS") production (ability to destroy cancer cells quickly and effectively)

• Increase selective tumour uptake (destruction of cancer cells, while sparing healthy cells) through the Transferrin Receptor ("TfR")

• Increase anti-cancer efficacy (efficiency in cancer cell destruction)

• Decrease systemic toxicity (damage to healthy cells and/or organs)

This allows Rutherrin® (Ruvidar^TM + transferrin) to be a strong candidate for the systemic treatment of recurrent, deep seated and/or progressive cancers.

Once Rutherrin®'s Maximum Tolerated Dose ("MTD") and hence Human Equivalent Dose ("HED") limits have been determined through Good Laboratory Practices ("GLP") toxicology studies, Theralase®, subject to regulatory approvals, plans to intravenously inject Rutherrin® into patients via a Phase 0/I/II adaptive clinical study design, to first determine localization to various cancer cells, including Glio Blastoma Multiforme ("GBM"), Non-Small Cell Lung Cancer ("NSCLC"), pancreatic cancer and Muscle Invasive Bladder Cancer ("MIBC") and then in an adaptive design activate Rutherrin®, in single and multiple doses, with radiation with the intent of safely and effectively destroying the cancer of interest.

Rutherrin®, if proven successful, would thus be able to "hunt" and "localize" into cancer cells and when activated by radiation "destroy" them; wherever, they may reside in the body.

GlioBlastoma Multiforme:

Theralase® completed experiments in GBM demonstrating an ability of Rutherrin® to localize to GBM.

Transferrin in the Rutherrin® product significantly increased both the total drug uptake and the specificity (> 20 times) compared to normal brain samples, while Ruvidar^TM alone does not show any selectivity. The selective uptake remains for at least 24 hours after injection, and the drug is gradually cleared overtime, which suggests a need for a second Rutherrin® injection after 48-72 hours

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In the below experiment, tumours were more resistant to radiation and grew faster than the previous experiment. None of the radiation alone treated mice showed complete response. The combination of Rutherrin® with radiation treatment significantly delayed tumour progression and improved overall survival compared to radiation alone, with 25% of Rutherrin® and radiation groups demonstrating complete response. Mice with complete response were re-challenged with fresh tumour cells and none developed tumours, which suggests an immunity rate of 100%. In addition, strong efficacy was observed with a 3 mg/kg Rutherrin® dose, suggesting that radio-enhancement can be achieved with lower drug doses and lower uptake. There was no difference in response between the small animal irradiator (XRAD at 0.225 MeV) and clinical irradiator (LINAC at 6 MeV), suggesting that equivalent efficacy is anticipated when translating these animal efficacy studies into clinical studies.

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Herpes Simplex Virus

Infectious agents account for millions of deaths every year.¹ Currently, the most effective way to protect against infection involve the use of vaccines and anti-microbials. Vaccines are known to be useful, when administered prior to infection; whereas, antibiotics and anti-virals are most useful after infection or before immunity to a vaccine has had time to develop.

In previous work, Dr. Kevin Coombs, a professor of virology at the University of Manitoba demonstrated that the small molecule, Ruvidar^TM could inhibit numerous pathogenic human viruses, when added to solutions of viruses, both with and without light-activation. In these latest experiments, Dr. Coombs evaluated the ability of Ruvidar^TM to restrict HSV-1 replication in Vero cells, both by itself and in combination with acyclovir in the absence of light-activation to mimic deep tissue application.

Light-activated Ruvidar^TM has been previously demonstrated to be even more effective in the inactivation of HSV versus non-light-activated Ruvidar^TM.

Ruvidar^TM successfully inhibited HSV-1 replication at significantly lower concentrations and more effectively than did the gold standard acyclovir alone. Dr. Coombs also discovered additive and synergistic, anti-HSV-1 effects, when combinational therapy was tested.

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Herpes Simplex Virus ("HSV"), known as herpes, is a common infection that can cause painful blisters or ulcers. It primarily spreads by skin-to-skin contact. It is treatable but not curable.²

There are two types of HSV:

Type 1 ("HSV-1") mostly spreads by oral contact and causes infections in or around the mouth (oral herpes or cold sores). It can also cause genital herpes. Most adults are infected with HSV-1.

Type 2 ("HSV-2") spreads by sexual contact and causes genital herpes.

An estimated 3.8 billion people under age 50 (64%) globally have HSV-1, the main cause of oral herpes.

An estimated 520 million people aged 15 to 49 (13%) globally have HSV-2, the main cause of genital herpes.²

The global HSV treatment market size was estimated at $USD 2.5 billion in 2023 and is expected to grow at a Compound Annual Growth Rate ("CAGR") of 8.1% from 2024 to 2030.

The market growth can be attributed to the growing concerns over HSV infection, including, oral and genital herpes. Moreover, the infection is highly contagious, spreading via saliva, vaginal secretion or semen and is acquired unknowingly. These factors highlight the increasing need for treatment throughout the projected period.³

Despite longstanding attempts at therapy and prevention, HSV remains among the most prevalent human infectious viral pathogens; therefore, it's imperative to keep HSV from replicating by implementing advanced vaccines and more effective drugs to combat and defeat this pervasive scourge to the human race.

In the latest Theralase® research, Balb/C mice were infected with human HSV-1 virus. On day 6 post-infection, 20 uL of 1% Ruvidar® solution was applied topically over the area of well-developed lesions, once daily for 4 days.

Four days of Ruvidar® treatment resulted in complete healing of the HSV-1 cutaneous lesions.

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The results support the safety and efficacy of topically applied non-light activated Ruvidar® against cutaneous HSV-1 lesions in a mouse model.

Non-Hodgkin's Lymphoma:

Rutherrin® is the Company's lead compound currently under development for Intra Venous ("IV") administration to treat numerous cancers; including: brain, lung, pancreatic and muscle invasive bladder cancer.

NHL is a cancer that starts in lymphocytes, a type of white blood cell, located in the bone marrow, blood and lymphatic system. Lymphocytes help protect the body against germs and abnormal cells; including, cancer cells.⁴

NHL ranked as the 5^th to 9^th most common cancer in most countries globally, with an estimated 544,000 new cancer cases and 260,000 cancer deaths in 2020.⁵

The global market for NHL is estimated to reach $USD 16.5 billion by 2031.⁶

In the latest research, mice were inoculated with A20 mouse lymphoma cells subcutaneously ("SQ") on day 0. At day 10, tumours reached 3 to 5 mm in size.

To simulate proposed human treatments, mice were treated for 3 weeks with:

• Rutherrin® IV (3 times per week)

• Metformin intraperitoneally (daily)

• Radiation (5 times per week)

All treatments were stopped after 3 weeks of treatment and tumour volumes were assessed.

The results support the use of Rutherrin®, activated by both Metformin and radiation, in the effective treatment of NHL in a SQ mouse model.

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To view an enhanced version of this graphic, please visit:
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References:

¹ www.who.int/data/gho/data/ themes/mortality-and-global-health-estimates/ghe-leading-causes-of-death
² Herpes simplex virus
³ Herpes Simplex Virus Treatment Market Size, Share & Trends Analysis Report By Type (HSV-1, HSV-2), By Drug (Acyclovir, Valacyclovir, Famciclovir), By Vaccine (Simplirix, Others), By Route of Administration, By End-use, By Region, And Segment Forecasts, 2024 - 2030
⁴ What is non-Hodgkin lymphoma? | Canadian Cancer Society. October 2023
⁵ Epidemiology of Non-Hodgkin Lymphoma: Global Patterns of Incidence, Mortality, and Trends | Blood | American Society of Hematology. November 2022
⁶ Global Non-Hodgkin Lymphoma Market $16.5 Billion by 2031. December 2024

About Study II:

Study II utilizes the therapeutic dose of the patented Study II Drug ("Ruvidar^TM" or "TLD-1433") (0.70 mg/cm²) activated by the proprietary Study II Device (TLC-3200 Medical Laser System or "TLC-3200"). Study II is focused on enrolling and treating 90 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.

About Theralase® Technologies Inc.:

Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecule compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.

Additional information is available at www.theralase.com and www.sedarplus.ca Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements:

This news release contains Forward-Looking Statements ("FLS") within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words "may, "should", "will", "anticipates", "believes", "plans", "expects", "estimate", "potential for" and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals.

These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure the regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; the risk that access to sufficient capital to fund the Company's operations may not be available on terms that are commercially favorable to the Company or at all; the risk that the Company's small molecule and drug formulations may not be effective against the diseases tested in its clinical studies; the risk that the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict.

Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS.

Although the FLS contained in the press release 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 FLS.

All FLS are made as of the date hereof and are subject to change. Except as required by law, the Company assumes no obligation to update such FLS.

For investor information on the Company, please feel to reach out Investor Inquiries - Theralase Technologies.

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