On August 12, 2024 Theralase Technologies Inc. ("Theralase" or the "Company") (TSXV: TLT) (OTCQB: TLTFF), a clinical stage pharmaceutical company dedicated to the research and development of light and/or radiation activated small molecules for the safe and effective destruction of various cancers, bacteria and viruses reported the Company’s unaudited condensed consolidated interim financial statements for the six-month period ended June 30, 2024. ("Financial Statements") (Press release, Theralase, AUG 12, 2024, View Source [SID1234645739]).
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Theralase will be hosting a conference call on Wednesday August 21st, 2024 at 11:00 am ET, which will include a presentation of the financial and operational results for the six-month period ended June 30, 2024. Questions are welcome. To ensure Theralase has time to review and properly address them during the call, please send them in advance to [email protected].
Zoom Meeting Link: View Source
Conference Call in: 1-647-558-0588 (Canada) / 1-646-558-8656 (US) – not required for those attending by Zoom.
An archived version will be available on the website following the conference call.
Financial Summary:
For the six-month period ended June 30th:
1 Other represents foreign exchange, interest accretion on lease liabilities and / or interest income
Financial Highlights
For the six-month period ended June 30, 2024;
Total revenue decreased 35%, year over year.
Cost of sales was $186,324 (67% of revenue) resulting in a gross margin of $90,077 (33% of revenue). In comparison, the cost of sales for the same period in 2023 was $224,947 (53% of revenue) resulting in a gross margin of $201,140 (47% of revenue). The gross margin decrease, as a percentage of sales year over year, is attributed to an increase in material costs.
$145,915, from $147,304 for the same period in 2023, a 1% decrease.
The decrease is a result of reduced spending on general and administrative expenses (59%) and stock-based compensation (28%) (due to the cumulative effect of accounting for the vesting of stock options granted in the current and previous years).
for the Drug Division decreased to $1,368,333 from $1,594,676 for the same period in 2023, a 10% decrease. The decrease is primarily attributed to a decrease in costs for Study II patient enrollment and treatment.
The increase is attributed to development of a new software program for the TLC-2000 Cool Laser Therapy system.
Net loss was $2,400,461, which included $374,445 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 $2,564,187, a 6% year-over-year reduction, which included $474,558 of net non-cash expenses. The Drug Division represented $1,938,024 of this loss (81%). The decrease in net loss is primarily attributed to decreased spending on research and development expenses in Study II.
Operational Highlights:
Non-Brokered Private Placement:
On February 5, 2024, the Company closed a non-brokered private placement of units. On closing, the Company issued an aggregate of 6,666,670 units at a price of $CAN 0.18 per Unit for aggregate gross proceeds of approximately $CAN 1,200,000 of which 1,310,502 units were purchased by certain insiders of the Corporation, representing gross proceeds of $235,890. Each Unit consisted of one common share of the Company and one non-transferable warrant. Each Warrant entitles the holder to acquire an additional Common Share at a price of $CAN 0.25 for a period of 5 years following the date of issuance.
On April 24, 2024, the Company closed a non-brokered private placement of units. On closing, the Company issued an aggregate of 4,167,778 units at a price of $0.18 per Unit for aggregate gross proceeds of approximately $750,200. Each Unit consisted of one common share of the Company and one non-transferable common share purchase warrant. Each Warrant entitles the holder to acquire an additional Common Share at a price of $0.25 for a period of 5 years following the date of issuance.
On July 8, 2024, the Company closed a non-brokered private placement of units. On closing, the Company issued an aggregate of 3,522,729 units at a price of $0.22 per Unit for aggregate gross proceeds of approximately $775,000. Each Unit consisted of one common share of the Company and one non-transferable common share purchase warrant. Each Warrant entitles the holder to acquire an additional Common Share at a price of $0.30 for a period of 5 years following the date of issuance.
In 2024, the Company plans to secure funding through various equity and debt instruments to allow the Company the ability to become base shelf eligible. This will allow the Company sufficient funding to complete enrollment into Study II by year end, data lock in mid 2026 and position the Company for FDA and Health Canada approval by the end of 2026, subject to achieving FDA Priority Review."
Study II Update:
On February 8th, 2024, Dr. Michael Jewett joined the Company in the role of an independent consultant, to assist the Company in the accruement of patients into Study II. Under the terms of the consulting agreement, Dr. Jewett will be responsible for working with existing clinical study sites and helping to onboard new clinical study sites to assist Theralase to complete enrollment and provide the primary study treatment to 75 to 100 patients in Study II, preferably by December 31, 2024.
To date, Theralase has enrolled and treated 72 patients in Study II, who have been provided the primary Study II Procedure. The clinical study sites have screened an additional 3 patients, who they are planning to enroll and treat over the next 4 to 6 weeks, bringing the total to 75 treated patients.
Theralase plans to add up to 5 new CSSs in 2024, as well as increase enrollment at the existing 10 Clinical Study Sites ("CSSs") to complete Study II accruement by the end of 2024 / beginning of 2025.
90% (65/72) of treated patients have been evaluated at the 90 days assessment visit for treatment safety and efficacy according to the clinical study protocol.
For the primary endpoint of Study II (Complete Response ("CR") at any point in time) 63% (41/65) of treated patients achieved a CR.
For the secondary endpoint of Study II (duration of CR) 44% (18/41) of treated patients, who achieved a CR, maintained their CR response for at least 12 months.
For the tertiary endpoint of Study II (safety of Study Procedure) 100% (65/65) experienced no Serious Adverse Events ("SAEs") directly related to the Study Drug or Study Device.
Break Through Designation Update:
In 2020, the FDA granted Theralase Fast Track Designation ("FTD") for Study II. As a Fast Track designee, Theralase has access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure the timely collection of clinical data to support the approval process. The accelerated communication with the FDA potentially allows, the Study Procedure, to be the first intravesical, patient-specific, light-activated, Ruthenium-based small molecule for the treatment of patients diagnosed with BCG-Unresponsive NMIBC CIS, (with or without recurrent / resected papillary Ta/T1 tumours). FTD can also lead to Break Through Designation ("BTD"), Accelerated Approval ("AA") and/or Priority Review, if certain criteria are met, which the FDA previously defined to the Company for BTD as clinical data on approximately 20 to 25 patients enrolled and provided the primary Study Procedure, who demonstrate significant safety and efficacy clinical outcomes.
To this list, the FDA has added: Post Study II Monitoring of Response and Central Pathology Laboratory Review.
The Company is currently working with the CSSs, a biostatistics organization 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 3Q2024 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 3Q2024 in support of the grant of a BTD approval.
Theralase has commenced receiving clinical data from the CSSs with a significant number of patients, who achieved CR, continuing to experience a duration of their CR beyond 450 days, with some patients demonstrating CR for up to 3 years and counting, post the primary Study Procedure.
Study II Preliminary Clinical Data:
Performance to Primary, Secondary and Tertiary Objectives:
The interim clinical data above demonstrates that:
For the primary objective, 63% of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a Complete Response ("CR") (negative cystoscopy and negative urine cytology, among other definitions). Including patients, who demonstrated an Indeterminate Response ("IR") (negative cystoscopy and positive or suspicious urine cytology), the Total Response ("TR") increases to 71%. This represents almost 3 out of 4 Bacillus Calmette Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") patients treated with Theralase’s unique Study Procedure are demonstrating complete destruction of their CIS bladder cancer within their bladders.
For the secondary objective, 44% (almost 1 out of 2) patients, who demonstrated a CR at any point in time continued to demonstrate a CR at 15 months from date of first treatment with 46% of patients demonstrating a TR.
> 90% of patients who demonstrated a CR at 450 days continue to demonstrate this response beyond 450 days.
For the tertiary objective, no patients have been diagnosed with a Serious Adverse Event ("SAE") directly related to the Study Drug or Study Device 100% (65/65).
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 Principal Investigator ("PI") at the 90 days assessment visit (cystoscopy and urine cytology)
One patient passed away prior to their 90 days assessment and is therefore not included in the efficacy statistical analysis, only in the safety statistical analysis; therefore, there are 65 patients that have been statistically analyzed for efficacy.
Evaluable Patients are defined as patients who have been evaluated by a PI and thus excludes a patient’s clinical data at specific assessment days, if that clinical data is pending.
7 patients have been enrolled and provided the primary Study Procedure but, have not been evaluated at their 90 day assessment; therefore, 65 patients are considered Evaluable Patients at 90 days, with 41 patients considered Evaluable Patients at 450 days.
The data analysis presented above, should be read with caution, as the clinical data is interim in its presentation, as Study II is ongoing and new clinical data collected may or may not continue to support the current trends, with clinical data still pending.
Patient Response Chart:
The Swimmer’s plot below is a graphical representation of the interim clinical results (n=41) for patients who achieved a CR at any point in time and their response over 1080 days, graphically demonstrating a patient’s response to a treatment over time. As can be seen in the plot, clinical data is still pending for patients, who have demonstrated an initial CR at 90 days and continue to demonstrate a duration of that response.
The Swimmer’s Plot illustrates:
63% (41/65) Evaluable Patients achieved CR at any point in time, with 44% (18/41) patients, who demonstrated CR, continuing to demonstrate CR at 450 days and thus achieving the primary and secondary objectives of Study II.
41% (17/41) Evaluable Patients demonstrate CR beyond 450 days.
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.
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.
Note: The information on the time-to-outcome event is not available for all patients in this analysis, as not all patients have been assessed at all available assessment visits. Only patients that achieved the primary objective (CR at any point in time) have been analyzed and data is plotted relative to the date at which their first CR was observed. The "X" denotes censored observations (subjects who achieved CR at their last assessment visit and are currently on-study or have been removed from study). Thus, the KM Curve estimates the risk of a patient failing to maintain a CR over time, according to currently available interim data.
In summary, the interim clinical data demonstrates that patients consenting to participate in Study II have a 63% chance of achieving CR.
If CR is obtained, then the patient has a 48.3%, 42.3% and 33.8% chance of remaining cancer free for 1, 2 and 3 years, respectively.
Serious Adverse Events
For 72 patients treated in Study II, there have been 14 Serious Adverse Events ("SAEs") reported:
3 – Grade 2 (resolved within 1, 1 and unknown 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.
Note: A SAE is defined as any untoward medical occurrence that at any dose: Is serious or life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or results in death.
Dr. Arkady Mandel, M.D., Ph.D., D.Sc., Chief Scientific Officer of Theralase stated, "The interim clinical data of Study II, to date, has proven to be world-class. Study II has demonstrated an ability to destroy urothelial cell carcinoma in a patient’s bladder for a Total Response ("TR") of 71% and a duration of that TR of 46%, at 450 days. The primary benefits of the Theralase technology versus competitive technologies are: a urologist-led treatment, a single out-patient procedure, high efficacy rates (patients achieve a CR in 63% of the cases with a 44% duration of that CR at 450 days), high probability of the ongoing duration of that complete response (34% ≥ 3 years, based on the Kaplan-Meier Curve analysis of the interim clinical data) and high safety profile (no SAEs directly associated with the Study Drug or Study Device); therefore, the Theralase technology presents a safe, effective alternative therapy for patients, who are at high risk of having their bladder removed."
Roger DuMoulin-White, B.E.Sc., P.Eng., Pro.Dir., President and Chief Executive Officer of Theralase stated, "Based on the interim clinical data accumulated to date, Study II has achieved its primary, secondary and tertiary endpoints and requires only a few additional patients enrolled and follow-up on all patients to complete the study. Theralase expects to complete patient follow-up by mid 2026 with review by Health Canada and the FDA on a marketing approval by end of 2026. The Theralase bladder cancer treatment has been proven clinically to be safe and effective in the treatment of BCG-Unresponsive NMIBC CIS, fulfilling an unmet need of the medical community."
About Study II:
Study II utilizes the therapeutic dose of the patented Study II Drug ("RuvidarTM" 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 approximately 75 to 100 BCG-Unresponsive NMIBC Carcinoma In-Situ ("CIS") patients in up to 15 Clinical Study Sites ("CSS") located in Canada and the United States.
About RuvidarTM:
RuvidarTM is a peer reviewed, patented PDC currently under investigation in Study II.