CA Market News
1週前
Theralase(R) Releases Q1 2026 Financial StatementsMay 29, 2026 5:04 PM
NewsfileTheralase(R) Provides an Update on its Phase II Bladder Cancer Clinical StudyToronto, Ontario--(Newsfile Corp. - May 29, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of various cancer, bacteria and viruses has released the Company's unaudited interim consolidated financial statements for the three-month period ended March 31st, 2026 ("Financial Statements").Theralase® will be hosting a conference call on June 9th at 11:00 am ET, which will include a presentation of the financial and operational results for the quarter ended March 31st, 2026. To ensure Theralase® has time to address questions during the call, please e-mail them in advance to mperraton@theralase.com.Zoom Meeting Link:https://us02web.zoom.us/j/83115432624Conference 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 An archived version will be available on the website following the conference call.Table 1: Financial Summary for the Quarter Ended March 31stTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/299492_1988af03149dd9a6_001full.jpgFinancial Highlights:For the Quarter ended March 31st, 2026 (All funds in Canadian Dollars):Total revenue increased to $132,634 from $91,190 for the same period in 2025, a 45% increase.Cost of sales for the three-month period ended March 31st, 2026, was $68,250 (51% of revenue) resulting in a gross margin of $64,382 (49% of revenue). In comparison, the cost of sales for the same period in 2025 was $77,896 (85% of revenue) resulting in a gross margin of $13,294 (15% of revenue). Selling expenses decreased to $66,534 from $68,143 for the same period in 2025, a 2% decrease. The decrease in selling expenses is primarily a result of decreased spending on advertising (64%) and travel (38%).Administrative expenses for three-month period ended March 31st, 2026, decreased to $463,553 from $555,074 for the same period in 2025, a 16% decrease. The decrease in administrative expenses is primarily a result of decreased spending on insurance (20%) and professional fees (45%). Net research and development expenses for the three-month period ended March 31st, 2026, decreased to $564,724 from $877,670 for the same period in 2025, a 36% decrease. The decrease in research and development expenses is attributed to a decrease in costs for Study II patient enrollment and treatment, as the clinical study reaches completion. Research and development expenses represented 52% 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 three-month period ended March 31st, 2026, was $1,031,785, which included $172,118 of net non-cash expenses (i.e.: amortization, stock-based compensation expense). This compared to a net loss for the same period in 2025 of $1,471,250, which included $254,523 of net non-cash expenses. The Drug Division represented $803,352 (78%) of this loss. The decrease in net loss is primarily attributed to decreased spending on research and development expenses in Study II, as the clinical study reaches completion. Operational Highlights: Collaborative Clinical Development AgreementOn January 12th, 2026, the Company announced that it had entered into a collaborative clinical development agreement dated January 9th, 2026 with Ferring Pharmaceuticals, expanding the Company's existing Phase II NMIBC clinical program (NCT03945162) through the addition of a new cohort evaluating Ruvidar® (TLD-1433) in combination with Adstiladrin® (nadofaragene firadenovec-vncg) for adult patients diagnosed with high-risk Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") with or without papillary disease (±Ta/T1) ("Study II"). Under the terms of the agreement, the Company will remain the sponsor of the study, with both parties providing clinical oversight through a joint development committee. The new cohort is expected to be enrolled and treated initially in the United States and, subject to written agreement, may expand into Canada or other jurisdictions.Study II Interim Clinical DataCohort 1Theralase® has completed enrollment in Study II, with the Clinical Study Sites ("CSSs") enrolling and providing the primary Study Procedure to 92 patients. Additional patients may be enrolled, until all CSSs have been closed to enrollment.According to the clinical study design, a patient is considered to have completed Study II, if they received the Study Procedure and have been assessed by the Principal Investigator ("PI") for up to 15 months or they have been prematurely removed from the clinical study by the PI for failure to respond or failure to comply with the clinical study design. According to this definition, 82 patients have completed Study II (with 10 patients on study pending clinical data), resulting in the following interim clinical data in support of the Study II endpoints:A total of 92 patients have been enrolled and treated in the study. Of these patients, 81% were ≥ 65 years of age, 81% male and 83% white. Tumour stage was distributed as follows: pure 81% CIS; 12% CIS + T1; and 7% CIS + Ta. 98% were classified as BCG-Unresponsive with 2% BCG-Intolerant. The median number of BCG instillations was 15.5.As of May 29th, 2026, 89 patients have been assessed for response outcomes, evaluable for the primary endpoint analysis.Primary Endpoint Performance (Complete Response at any Point in Time)The primary endpoint of Study II is the achievement of Complete Response ("CR") at any point in time following administration of the Study Procedure. Interim analysis demonstrates that 65.2% (58 out of 89) evaluable patients achieved CR.Primary Endpoint Performance (CR at any Point in Time)
#%Confidence Interval (95%)Complete Response ("CR")58/8965.2%[49.4, 80.9]Total Response (CR and IR)65/8973.0%[56.4, 89.7] Table 2: Primary Endpoint PerformanceApproximately, 2 out of 3 patients diagnosed with BCG-Unresponsive NMIBC CIS (with or without Ta/T1) achieved a CR following treatment with the Theralase® Study Procedure.Secondary Endpoint Performance (Duration of CR - 12 Months)The secondary endpoint evaluates the sustainability of CR at 12 months, after initial CR determination (450 days post-treatment). Among patients evaluable for durability of response, 40.4% (21 of 52 evaluable patients) maintained a CR at 450 days.Secondary Endpoint Performance (Duration of CR) (450 Days)
#%Confidence Interval (95%)Complete Response (CR)21/5240.4%[24.0, 56.7]Total Response (CR and IR)22/5242.3%[26.5, 58.1] Table 3: Secondary Endpoint PerformanceTertiary Endpoint Performance (Safety)The tertiary endpoint is defined as patients who have a Serious Adverse Event ("SAE") ≥ 4 directly caused by the Study Drug or Study Device, which did not resolve within 450 days. Theralase® and the independent Data Safety Monitoring Board believes all SAEs reported to date are unrelated or unlikely related to the Study Drug or Study Device.The tertiary endpoint assesses the safety profile of the Study Procedure.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. Treatment Emergent Adverse Events ("TEAEs") were noted, but did not meet the SAE criteria. TEAEs included urinary frequency (65%), hematuria (62.5%) and urinary urgency (53.8%), which resolved within 1 month of treatment. There have been 24 SAEs reported: 1 x Grade I, 3 x Grade II, 13 x Grade III, 5 x Grade IV (all resolved between 1 to 82 days) and 2 x Grade V (Unlikely Related to the Study Drug, Study Device or Study Procedure). A high majority of SAEs were not treatment related and none were directly related to the Study Drug or Study Device.Tertiary Endpoint Performance (Safety) (450 Days)
#%Safety82/82100.0% Table 4: Tertiary Endpoint PerformanceDuration of CR - Extended Time PointsPatients who have completed the study were followed for up to 3 years after initial treatment at extended time points.Duration of CRTime#%Confidence Interval (95%)2 Years10/5219.2%[7.9, 30.5]3 Years10/5219.2%[7.9, 30.5] Table 5: Duration of CR at Extended Time PointsOne patient demonstrated CR for 7 years, after one Study Procedure.On Kaplan-Meier analysis, if CR is obtained, the long term estimated probability of remaining cancer free at 1, 2 and 3 years is 48.6%, 34.5% and 25.4%, respectively.Figure 1: Kaplan-Meier CurveTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/299492_1988af03149dd9a6_003full.jpgFigure 2: Swimmer's PlotTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/299492_figure2.jpgFigure 3: Patient PopulationTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/299492_1988af03149dd9a6_007full.jpgNote: These clinical results are interim in nature. Study II remains ongoing. Additional clinical data may influence or alter current response trends. Regulatory Pathway, Commercialization Strategy and FDA GuidanceIf approved by Health Canada and the FDA, the clinical data collected from Study II represents a transformative therapeutic option for patients diagnosed with BCG-Unresponsive NMIBC CIS, who would otherwise face radical cystectomy (surgical removal of the bladder). The Theralase® procedure has demonstrated a robust CR and sustained durability of that response, with the majority of patients receiving only a single procedure.Following the completion of patient follow-up and final clinical data analysis, Theralase® intends to submit a New Drug Application ("NDA") to Health Canada and the United States Food and Drug Administration ("FDA") in 3Q2026, under a rolling review, with regulatory decisions anticipated in 1H2027.Cohort 2Theralase®, in conjunction with Ferring Pharmaceutical, subject to FDA approval, is preparing to launch a combinational clinical study to investigate the safety and efficacy of combining light-activated Ruvidar® with Adstiladrin.It is anticipated that the complementary mechanisms of action (Ruvidar® targets bladder cancer cells directly, Adstiladrin® targets health bladder cells to produce Interferon to stimulate the innate and adaptive immune system) will provide a strong additive effect in the treatment of patients being treated for BCG-Unresponsive NMIBC CIS.In the procedure, patients will be treated with Ruvidar® (1 hour of drug instillation, approximately 1 hour of light activation), then at another visit, they will be treated with Adstiladrin® (1 hour procedure), both in outpatient procedures. Under the clinical protocol, the patient may receive up to 4 treatments of Adstiladrin®.The presiding uro-oncologist will have the option to deliver an additional re-induction Study Procedure, if the patient recurs.The patient will be followed for 15 months after initial Study Procedure and up to 3 years for post-study follow-up.Commercialization and Strategic PartnershipsIn parallel with the finalization of Study II, Theralase® is actively pursuing commercialization opportunities and strategic partnerships to support the global marketing and distribution of Ruvidar®. The Company is interested in engaging in discussions with pharmaceutical companies across multiple geographic regions regarding:Licensing arrangements for Ruvidar® in the treatment of BCG-Unresponsive NMIBC CIS in various geographic territoriesCollaborative clinical research initiatives focused on the application of light-activated Ruvidar® for broader NMIBC indicationsCollaborative clinical research combining Ruvidar®, with other FDA-approved drugs to enhance treatment efficacyAbout Study II:
Study II utilizes the therapeutic dose of the patented drug, Ruvidar® (TLD-1433) activated by the patented study device, the TLC-3200 Medical Laser System. Study II has enrolled and treated 92 BCG-Unresponsive NMIBC CIS patients in 11 clinical study sites 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 energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.Additional information is available at www.theralase.com and www.sedarplus.caNeither 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 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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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.For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/299492 Original: Theralase(R) Releases Q1 2026 Financial Statements
CA Market News
3週前
Theralase(R) Closes C$4.8 Million OfferingMay 20, 2026 11:06 AM
NewsfileToronto, Ontario--(Newsfile Corp. - May 20, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses is pleased to announce that it has closed its previously announced brokered private placement offering ("Brokered Offering") of 19,166,667 units ("Units") of the Company at a price of C$0.24 per Unit ("Offering Price") for gross proceeds of C$4,600,000; including, the full exercise of the over-allotment option. The Brokered Offering was led by Research Capital Corporation as sole agent and sole bookrunner ("Agent").In addition, the Company is pleased to announce it has closed a concurrent non-brokered private placement offering pursuant to which the Company issued 673,624 Units at the Offering Price for gross proceeds of C$161,669 ("Non-Brokered Offering", together with the Brokered Offering, the "Offering"). In aggregate, the Company raised gross proceeds of C$4,761,669 under the Offering.Each Unit consists of one common share of the Company ("Common Share") and one common share purchase warrant ("Warrant"). Each Warrant entitles the holder thereof to purchase one Common Share ("Warrant Share") at an exercise price of C$0.32 per Warrant Share at any time until May 20, 2031. The Company has applied to the TSX Venture Exchange ("TSXV") for the listing of the Warrants and the Warrant Shares pursuant to the Brokered Offering. Listing of the Warrants is subject to the approval of the TSXV and there can be no assurance that such approval will be obtained or that the Warrants will be listed.The Company plans to use the proceeds of the financing to further the Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") clinical study ("Study II") currently underway, commencement of Good Laboratory Practice ("GLP") toxicology analysis for Rutherrin®, working capital and general corporate purposes.The Brokered Offering was completed pursuant to the listed issuer financing exemption and the Non-Brokered Offering was completed by way of private placement pursuant to applicable exemptions from the prospectus requirements, under applicable Canadian securities laws. All securities issued under the Brokered Offering will become free trading on closing and the securities issued under the Non-Brokered Offering are subject to a hold period under applicable Canadian securities laws, which will expire on September 21, 2026. The Offering is subject to final acceptance of the TSX Venture Exchange.In consideration for their services, the Agent received an aggregate cash commission of C$295,772. The Company also issued 1,232,383 non-transferable compensation options to the Agent ("Compensation Options"), with each Compensation Option exercisable to acquire one Unit at an exercise price of C$0.24 per Unit until May 20, 2031.Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President, Chief Executive Officer and Chairman of the Board of Theralase®, stated that "The Company has successfully raised approximately C$7,500,000 is equity and C$1,000,000 under a recurring line of credit over the last 5 months, in order to strengthen our balance sheet and provide the Company with additional capital to fund our strategic initiatives. In 2026, the Company plans to complete follow-up assessments on the remaining patients in Study II, in order to file new drug applications to both Health Canada and the FDA, under rolling review, seeking Canadian and US marketing approval of its light-activated drug, Ruvidar® for bladder cancer. In addition, the Company plans to commence GLP toxicology studies on Rutherrin® to allow clinical development, subject to regulatory approval, for a number of cancer indications; including, brain cancer, lung cancer, pancreatic cancer, colorectal cancer and muscle invasive bladder cancer."Finder's Fee
In connection with the Non-Brokered Offering, the Company paid a finder's fee of C$3,000 (payable through the issuance of 12,500 Common Shares) and 6,250 Warrants.Related Party Transactions
An aggregate of 155,289 Units, representing gross proceeds of C$37,269 were issued to certain insiders of the Corporation. Pursuant to Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101") and TSX Venture Exchange Policy 5.9, such insider subscriptions are a "related party transaction." The Corporation is exempt from the formal valuation requirement of MI 61-101 in connection with the insider subscriptions in reliance on section 5.5(b) of MI 61-101, as no securities of the Corporation are listed or quoted for trading on the Toronto Stock Exchange, the New York Stock Exchange, the American Stock Exchange, the NASDAQ stock market or any other stock exchange outside of Canada or the United States. Additionally, the Corporation is exempt from obtaining minority shareholder approval in connection with the insider subscriptions in reliance on section 5.7(1)(a) of MI 61-101 as the aggregate value of the insider subscriptions does not exceed 25% of the market capitalization of the Corporation. Due to the limited time between the launch and the close of the Offering, there will be less than 21 days between the date the Corporation files its material change report in respect of the Offering and the completion date of the Offering.The securities referred to in this news release have not been, and will not be, registered under the United States Securities Act of 1933, as amended ("U.S. Securities Act"), or any applicable securities laws of any state of the United States, and may not be offered or sold within the United States or to, or for, the account or benefit of, U.S. persons (as such term is defined in Regulation S under the U.S. Securities Act) or persons in the United States. unless registered under the U.S. Securities Act and any other applicable securities laws of the United States or an exemption from such registration requirement is available. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation or sale would be unlawful; including, the United States.About Theralase® Technologies Inc.:
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.Additional information is available at www.theralase.com and www.sedarplus.caNeither 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 and forward-looking information (collectively, "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 use of proceeds of the Offering; the timing for closing of the Offering; 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 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 energy-activated small molecule and drug formulations; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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.For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/298205 Original: Theralase(R) Closes C$4.8 Million Offering
CA Market News
1月前
Theralase(R) Announces $4 Million Brokered LIFE OfferingMay 5, 2026 7:10 PM
NewsfileTHIS NEWS RELEASE IS NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATESToronto, Ontario--(Newsfile Corp. - May 5, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses is pleased to announce that it has entered into an agreement with Research Capital Corporation ("RCC" or the "Agent") to act as the sole agent and sole bookrunner on a commercially reasonable "best efforts" agency basis for a brokered private placement offering ("Offering") of units of the Company ("Units") at a price of C$0.24 per Unit, to raise a minimum of C$3,000,000 and up to a maximum of C$4,000,000 in aggregate gross proceeds. Each Unit will consist of one common share of the Company ("Common Share") and one Common Share purchase warrant ("Warrant"). Each Warrant shall entitle the holder thereof to purchase one Common Share ("Warrant Share") at an exercise price of C$0.32 per Warrant Share at any time for a period of 60 months following the closing of the Offering. The Company will use commercial reasonable efforts to obtain the necessary approvals to list the Warrants on the TSX Venture Exchange ("TSXV").The Company will grant the Agent an option (the "Agent's Option") to increase the size of the Offering by up to 15% in Units by giving written notice of the exercise of the Agent's Option, or a part thereof, to the Company exercisable at any time up to 48 hours prior to closing of the Offering.The Company plans to use the minimum proceeds of the financing for:1) Completion of the Phase II non-muscle invasive bladder cancer clinical study;2) Furtherance of Good Laboratory Practice ("GLP") toxicology studies to support clinical development of the intravenous use of Rutherrin® (Ruvidar® + transferrin) in the treatment of various cancers; and3) Working capital and general corporate purposes.If the maximum proceeds are achieved, then the following strategic initiatives will be added:1) Furtherance of GLP toxicology studies to support clinical development for the topical use of Ruvidar® in the treatment of herpes simplex virus induced cold sores.The Offering is scheduled to close on May 20th, 2026, or such other date as the Company and the Agent may agree upon and is subject to the receipt of all necessary approvals; including, the approval of the TSXV.The Offering will take place by way of:1) a private placement pursuant to National Instrument 45-106 - Prospectus Exemptions under Part 5A, as amended by CSA Coordinated Blanket Order 45-935 - Exemptions from Certain Conditions of the Listed Issuer Financing Exemption ("Listed Issuer Financing Exemption" or "LIFE"), to qualified investors in all the provinces of Canada, except Québec and2) in other jurisdictions where the Offering can lawfully be made; including, the United States under applicable private placement exemptions. Sales to investors in the United States will be subject to applicable United States securities laws and restrictions on securities purchased.The Units issued under the Listed Issuer Financing Exemption will not be subject to resale restrictions pursuant to applicable Canadian securities laws.The LIFE offering document ("Offering Document") related to the Offering can be accessed under the Company's profile at www.sedarplus.ca or on the Company's website at: www.theralase.com. Prospective investors should read this Offering Document before making an investment decision.Upon closing of the Offering, the Company shall pay to RCC: i) a cash commission equal to 7% of the aggregate gross proceeds of the Offering payable in cash (subject to a reduction for orders on the "President's List"); andii) broker warrants of the Company exercisable to acquire that number of Units equal to 7% of the number of Units issued under the Offering (subject to a reduction for orders on the "President's List"), with each broker warrant being exercisable to acquire one Unit at an exercise price of C$0.24 per Unit, expiring 60 months after the date of the closing of the Offering.THIS PRESS RELEASE SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY SECURITIES IN THE UNITED STATES, NOR SHALL THERE BE ANY SALE OF THE SECURITIES IN ANY JURISDICTION IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL. THE SECURITIES BEING OFFERED HAVE NOT BEEN, NOR WILL THEY BE, REGISTERED UNDER THE 1933 ACT OR UNDER ANY U.S. STATE SECURITIES LAWS, AND MAY NOT BE OFFERED OR SOLD IN THE UNITED STATES ABSENT REGISTRATION OR AN APPLICABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THE 1933 ACT, AS AMENDED, AND APPLICABLE STATE SECURITIES LAWS.About Theralase® Technologies Inc.:Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.Additional information is available at www.theralase.com and www.sedarplus.caNeither 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 StatementsThis news release contains forward-looking statements and forward-looking information (collectively, "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 use of proceeds of the Offering; the timing for closing of the Offering; 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 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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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.For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/296124 Original: Theralase(R) Announces $4 Million Brokered LIFE Offering
CA Market News
1月前
Theralase(R) Releases 2025 Annual Financial Statements and Provides Clinical Study UpdateMay 4, 2026 5:22 PM
NewsfileToronto, Ontario--(Newsfile Corp. - May 4, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of various cancer, bacteria and viruses has released the Company's audited consolidated financial statements for the twelve-month period ended December 31st, 2025 ("Financial Statements").Theralase® will be hosting a conference call on May 12th at 11:00 am ET, which will include a presentation of the financial and operational results for the fiscal year ending December 31st, 2025. To ensure Theralase® has time to address questions during the call, please e-mail them in advance to mperraton@theralase.com.Zoom Meeting Link: https://us02web.zoom.us/j/82405815948 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.Table 1: Financial Summary for the year ended December 31stTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/295879_0ea03f92e40a1b12_001full.jpgFinancial Highlights:For the year ended December 31st, 2025 (All funds in Canadian Dollars):Total revenue decreased to $816,468 from $1,033,431 for the same period in 2024, a 21% decrease.Cost of sales for the year ended December 31, 2025, was $309,337 (38% of revenue) resulting in a gross margin of $507,131 (62% of revenue). In comparison, the cost of sales for the same period in 2024 was $479,405 (46% of revenue) resulting in a gross margin of $554,026 (54% of revenue). Selling expenses decreased to $287,012 from $354,636 for the same period in 2024, a 19% decrease. The decrease in selling expenses is primarily a result of decreased spending on salaries (17%) and commissions (38%).Administrative expenses for year ended December 31, 2025, increased to $1,943,014 from $1,734,065 for the same period in 2024, a 12% increase. The increase in administrative expenses is primarily a result of increased spending on general and administrative expenses (17%) and professional fees (70%). Net research and development expenses for the year ended December 31, 2025, decreased to $2,452,445 from $2,753,674 for the same period in 2024, a 9% decrease. The decrease in research and development expenses is attributed to a decrease in costs for Study II patient enrollment and treatment. Research and development expenses represented 53% 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 ended December 31, 2025, was $4,120,817, which included $840,227 of net non-cash expenses (i.e.: amortization, stock-based compensation expense and foreign exchange gain/loss). This compared to a net loss for the same period in 2024 of $4,256,114, which included $793,181 of net non-cash expenses. The Drug Division represented $3,400,303 (83%) of this loss. The decrease in net loss is primarily attributed to decreased spending on research and development expenses in Study II. Operational Highlights: Collaborative Clinical Development AgreementOn January 12, 2026, the Company announced that it had entered into a collaborative clinical development agreement dated January 9, 2026 with Ferring Pharmaceuticals, expanding the Company's existing Phase II NMIBC clinical program (NCT03945162) through the addition of a new cohort evaluating Ruvidar® (TLD-1433) in combination with Adstiladrin® (nadofaragene firadenovec-vncg) for adult patients diagnosed with high-risk Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") with or without papillary disease (±Ta/T1) ("Study II"). Under the terms of the agreement, the Company will remain the sponsor of the study, with both parties providing clinical oversight through a joint development committee. The new cohort is expected to be enrolled and treated initially in the United States and, subject to written agreement, may expand into Canada or other jurisdictions.Study II Interim Clinical DataCohort 1
Theralase® has successfully completed its targeted enrollment for Study II, exceeding expectations with 91 patients treated by Clinical Study Sites ("CSSs") and may continue to enroll additional patients as remaining sites finalize and close to enrollment.According to the clinical study design, a patient is considered to have completed Study II, if they received the Study Procedure and have been assessed by the Principal Investigator ("PI") for up to 15 months or upon earlier withdrawal by the PI due to non-response or non-compliance.Based on this definition, 82 patients have completed Study II, while 9 remain active with pending clinical data. Interim results supporting the Study II endpoints are summarized below.A total of 91 patients have been enrolled and treated. The cohort was predominantly ≥65 years of age (81%), male (81%), and white (83%). Tumour staging was distributed as follows: 81% carcinoma in situ ("CIS") only, 12% CIS + T1, and 7% CIS + Ta. In addition, 98% of patients were classified as BCG-unresponsive and 2% as BCG-intolerant. The median number of prior BCG instillations was 15.5.As of April 30, 2026, 89 patients have been assessed for response outcomes and are evaluable for the primary endpoint analysis.Primary Endpoint Performance (Complete Response at any Point in Time)
The primary endpoint of Study II is the achievement of Complete Response ("CR") at any point in time following administration of the Study Procedure. Interim analysis demonstrates that 65.2% (58 out of 89) evaluable patients achieved CR.Primary Endpoint Performance (CR at any Point in Time)
#%Confidence Interval (95%)Complete Response ("CR")58/8965.2%[49.4, 80.9]Total Response (CR and IR)65/8973.0%[56.4, 89.7] Table 2: Primary Endpoint PerformanceApproximately, 2 out of 3 patients diagnosed with BCG-Unresponsive NMIBC CIS (with or without Ta/T1) achieved a CR following treatment with the Theralase® Study Procedure.Secondary Endpoint Performance (Duration of CR - 12 Months)
The secondary endpoint evaluates the sustainability of CR at 12 months, after initial CR determination (450 days post-treatment). Among patients evaluable for durability of response, 40.4% (21 of 52 evaluable patients) maintained a CR at 450 days.Secondary Endpoint Performance (Duration of CR) (450 Days)
#%Confidence Interval (95%)Complete Response (CR)21/5240.4%[24.0, 56.7]Total Response (CR and IR)22/5242.3%[26.5, 58.1] Table 3: Secondary Endpoint PerformanceTertiary Endpoint Performance (Safety)
The tertiary endpoint is defined as patients who are diagnosed with a Serious Adverse Event ("SAE") ≥ 4 directly caused by the Study Drug or Study Device, which did not resolve within 450 days.Theralase® and the independent Data Safety Monitoring Board believe all SAEs reported to date are unrelated or unlikely related to the Study Drug or Study Device.The tertiary endpoint assesses the safety profile of the Study Procedure.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. Treatment Emergent Adverse Events ("TEAEs") were noted, but did not meet the SAE criteria. TEAEs included urinary frequency (65%), hematuria (62.5%) and urinary urgency (53.8%), which resolved within 1 month of treatment. There have been 24 SAEs reported: 1 x Grade I, 3 x Grade II, 13 x Grade III, 5 x Grade IV (all resolved between 1 to 82 days) and 2 x Grade V. A high majority of SAEs were not treatment related and none were directly related to the Study Drug or Study Device.Tertiary Endpoint Performance (Safety) (450 Days)
#%Safety82/82100.0% Table 4: Tertiary Endpoint PerformanceDuration of CR - Extended Time Points
Patients who have completed the study are followed for up to 3 years after initial treatment at extended time points.Duration of CRTime#%Confidence Interval (95%)2 Years10/5219.2%[7.9, 30.5]3 Years10/5219.2%[7.9, 30.5] Table 5: Duration of CR at Extended Time PointsOne patient demonstrated CR for 7 years, after one Study Procedure.Based on Kaplan-Meier analysis, if CR is obtained, the long term estimated probability of remaining cancer free at 1, 2 and 3 years is 48.6%, 34.5% and 25.4%, respectively.Figure 1: Kaplan-Meier CurveTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/295879_0ea03f92e40a1b12_002full.jpgFigure 2: Swimmer's PlotTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/295879_figure2.jpgNote: These clinical results are interim in nature. Study II remains ongoing. Additional clinical data may influence or alter current response trends. Regulatory Pathway, Commercialization Strategy and FDA Guidance
If approved by Health Canada and the FDA, the clinical data collected from Study II represents a transformative therapeutic option for patients diagnosed with BCG-Unresponsive NMIBC CIS, who would otherwise face radical cystectomy (surgical removal of the bladder). The Theralase® Study Procedure has demonstrated a robust CR and sustained durability of that response, with the majority of patients receiving only a single Study Procedure.Following the completion of patient follow-up and final clinical data analysis, Theralase® intends to submit a New Drug Submission ("NDS") to Health Canada and a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") in 3Q2026, under a rolling review, with regulatory decisions anticipated in 1H2027.Cohort 2
Theralase®, in conjunction with Ferring Pharmaceutical, subject to FDA approval, is preparing to launch a combinational clinical study to investigate the safety and efficacy of combining light-activated Ruvidar® with Adstiladrin.It is anticipated that the complementary mechanisms of action (Ruvidar® targets bladder cancer cells directly, while Adstiladrin® targets health bladder cells to produce Interferon to stimulate the innate and adaptive immune system) will provide an additive effect in the treatment of patients being treated for BCG-Unresponsive NMIBC CIS.In the Study Procedure, patients will be treated with Ruvidar® (1 hour of drug instillation, 1 hour of light activation), then at another visit, they will be instilled with Adstiladrin® (1 hour procedure), both in outpatient procedures. Under the clinical protocol, the patient may receive up to 4 treatments of Adstiladrin®.The presiding uro-oncologist will have the option to deliver an additional re-induction Study Procedure, if the patient recurs.The patient will be followed for 15 months after initial Study Procedure and up to 3 years for post-study follow-up.Commercialization and Strategic Partnerships
In parallel with the finalization of Study II, Theralase® is actively pursuing commercialization opportunities and strategic partnerships to support the global marketing and distribution of Ruvidar®. The Company is pursuing discussions with pharmaceutical companies across multiple geographic regions regarding:Licensing arrangements for Ruvidar® in the treatment of BCG-Unresponsive NMIBC CIS in various geographic territoriesCollaborative clinical research initiatives focused on the application of light-activated Ruvidar® for broader NMIBC indicationsCollaborative clinical research combining Ruvidar®, with other FDA-approved drugs to enhance treatment efficacyAbout Study II:
Study II utilizes the therapeutic dose of the patented drug, Ruvidar® (TLD-1433) activated by the patented study device, the TLC-3200 Medical Laser System. Study II has enrolled and treated 91 BCG-Unresponsive NMIBC CIS patients in 11 clinical study sites 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 energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.Additional information is available at www.theralase.com and www.sedarplus.caNeither 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 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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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.For More Information:1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/295879 Original: Theralase(R) Releases 2025 Annual Financial Statements and Provides Clinical Study Update
CA Market News
2月前
Theralase(R) Closes $CAN 2.66 Million FinancingApril 10, 2026 7:00 AM
NewsfileToronto, Ontario--(Newsfile Corp. - April 10, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses is pleased to announce that it has successfully closed both a non-brokered private placement offering ("Offering") of units ("Units") and a Line Of Credit ("LOC"). On closing of the Offering, the Corporation issued an aggregate of 6,404,700 Units at a price of $CAN 0.26 per Unit for aggregate gross proceeds of $CAN 1,665,222.Each Unit consisted of one common share of the Company ("Common Share") and one common share purchase warrant ("Warrant"). Each Warrant entitles the holder to acquire an additional Common Share at an exercise price of $CAN 0.36 per share for a period of 5 years following the date of closing.The $CAN 1,000,000 revolving LOC was secured through an agreement with Desjardins.The Company plans to use the proceeds of both financings to further the Phase II BCG-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") clinical study currently underway, commencement of Good Laboratory Practice ("GLP") toxicology analysis for Rutherrin®, working capital and general corporate purposes.Related Party Transactions
An aggregate of 937,400 Units, representing gross proceeds of $243,724 were issued to certain insiders of the Corporation. Pursuant to Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101") and TSX Venture Exchange Policy 5.9, such insider subscriptions are a "related party transaction." The Corporation is exempt from the formal valuation requirement of MI 61-101 in connection with the insider subscriptions in reliance on section 5.5(b) of MI 61-101, as no securities of the Corporation are listed or quoted for trading on the Toronto Stock Exchange, the New York Stock Exchange, the American Stock Exchange, the NASDAQ stock market or any other stock exchange outside of Canada or the United States. Additionally, the Corporation is exempt from obtaining minority shareholder approval in connection with the insider subscriptions in reliance on section 5.7(1)(a) of MI 61-101 as the aggregate value of the insider subscriptions does not exceed 25% of the market capitalization of the Corporation. Due to the limited time between the launch and the close of the Offering, there will be less than 21 days between the date the Corporation files its material change report in respect of the Offering and the completion date of the Offering.Finder's Fee
In connection with the Offering, the Company paid a finder's fee of $15,241, through the issuance of 58,620 common shares. In addition, the Company issued 29,310 non-transferable finder warrants. Each finder warrant is exercisable into one common share at an exercise price of $0.36 per share for a period of 5 years following the date of closing.The securities referred to in this news release have not been, and will not be, registered under the United States Securities Act of 1933, as amended ("U.S. Securities Act"), or any applicable securities laws of any state of the United States, and may not be offered or sold within the United States or to, or for, the account or benefit of, U.S. persons (as such term is defined in Regulation S under the U.S. Securities Act) or persons in the United States. unless registered under the U.S. Securities Act and any other applicable securities laws of the United States or an exemption from such registration requirement is available. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation or sale would be unlawful; including, the United States.All securities issued under the Offering will be subject to a four month and one day hold period from the closing date under applicable Canadian securities laws, which expires on August 11, 2026. The Offering is subject to receipt of final acceptance from the TSX Venture Exchange.Roger DuMoulin-White, B.Sc, P.Eng, Pro.Dir, President, Chief Executive Officer and Chairman of the Board of Theralase®, stated, "Closing of the $CAN 2.66 million financing, in conjunction with the previously announced $CAN 1.1 million equity financing completed on March 10th, strengthens our balance sheet and provides the Company with additional capital to execute on its strategic initiatives. In 2026, the Company plans to file new drug applications to Health Canada and the FDA seeking marketing approval of its light-activated drug, Ruvidar®, in the treatment of BCG-Unresponsive NMIBC CIS."About Theralase® Technologies Inc.:
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, 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 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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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.For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/291828
Original: Theralase(R) Closes $CAN 2.66 Million Financing
CA Market News
3月前
Theralase(R) Closes $1.1 M Non-Brokered Private PlacementMarch 10, 2026 7:00 AM
NewsfileToronto, Ontario--(Newsfile Corp. - March 10, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses is pleased to announce that it has successfully closed a non-brokered private placement offering ("Offering") of units ("Units"). On closing, the Corporation issued an aggregate of 4,230,770 Units at a price of $CAN 0.26 per Unit for aggregate gross proceeds of $CAN 1,100,000.Each Unit consisted of one common share of the Company ("Common Share") and one common share purchase warrant ("Warrant"). Each Warrant entitles the holder to acquire an additional Common Share at an exercise price of $CAN 0.36 per share for a period of 5 years following the date of closing.The Company plans to use the proceeds of the financing to further the Phase II Non-Muscle Invasive Bladder Cancer ("NMIBC") clinical study currently underway, working capital and general corporate purposes.The securities referred to in this news release have not been, and will not be, registered under the United States Securities Act of 1933, as amended ("U.S. Securities Act"), or any applicable securities laws of any state of the United States, and may not be offered or sold within the United States or to, or for, the account or benefit of, U.S. persons (as such term is defined in Regulation S under the U.S. Securities Act) or persons in the United States. unless registered under the U.S. Securities Act and any other applicable securities laws of the United States or an exemption from such registration requirement is available. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of the securities offered in any jurisdiction in which such offer, solicitation or sale would be unlawful; including, the United States.All securities issued under the Offering will be subject to a four month and one day hold period from the closing date under applicable Canadian securities laws, which expires on July 11, 2026. The Offering is subject to receipt of final acceptance from the TSX Venture Exchange. Related Party TransactionsAn aggregate of 100,000 Units, representing gross proceeds of $26,000 were issued to certain insiders of the Corporation. Pursuant to Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions ("MI 61-101") and TSX Venture Exchange Policy 5.9, such insider subscriptions are a "related party transaction." The Corporation is exempt from the formal valuation requirement of MI 61-101 in connection with the insider subscriptions in reliance on section 5.5(b) of MI 61-101, as no securities of the Corporation are listed or quoted for trading on the Toronto Stock Exchange, the New York Stock Exchange, the American Stock Exchange, the NASDAQ stock market or any other stock exchange outside of Canada or the United States. Additionally, the Corporation is exempt from obtaining minority shareholder approval in connection with the insider subscriptions in reliance on section 5.7(1)(a) of MI 61-101 as the aggregate value of the insider subscriptions does not exceed 25% of the market capitalization of the Corporation. Due to the limited time between the launch and the close of the Offering, there will be less than 21 days between the date the Corporation files its material change report in respect of the Offering and the completion date of the Offering.About Theralase® Technologies Inc.:Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, 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 StatementsThis 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 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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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.For More Information:1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/287848
Original: Theralase(R) Closes $1.1 M Non-Brokered Private Placement
CA Market News
3月前
Theralase(R) Demonstrates That X-Ray-Activated Rutherrin(R) Is Significantly More Effective than Radiation Alone in the Destruction of Muscle Invasive Bladder CancerMarch 9, 2026 7:00 AM
NewsfileToronto, Ontario--(Newsfile Corp. - March 9, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses, is pleased to present its latest preclinical data demonstrating that X-Ray-activated Rutherrin® is effective in the destruction of Muscle Invasive Bladder Cancer ("MIBC").In the MIBC preclinical models conducted by the Theralase® research team, Rutherrin® demonstrated an ability to significantly enhance the efficacy of radiation therapy in the destruction of MIBC, supporting its potential as an effective drug for this devastating condition.Approximately 25% of the 83,000+ new bladder cancer cases diagnosed annually in the United States and 13,300+ cases in Canada are MIBC. MIBC carries a significant risk of death that has not changed in decades.1,2The standard of care for MIBC is currently cisplatin-based neoadjuvant chemotherapy (pre-operative) followed by Radical Cystectomy ("RC") (bladder removal).1 In patients who undergo RC, systemic recurrence rates vary by stage, ranging from 20% to 70%.3 As a bladder-preservation option, Tri Modal Therapy ("TMT"), comprised of maximal trans-urethral resection of the bladder tumour, followed by radiation and chemotherapy, has become increasingly popular in recent years; however, patients must be appropriately selected.4,5Based on the latest preclinical data, Theralase® is planning to conduct a Phase 0/I/II adaptive clinical study with radiation-activated Rutherrin®, with or without chemotherapy and/or immunotherapy, subject to regulatory approval, for patients diagnosed with MIBC to provide an alternative treatment option versus RC or TMT.In vitro experiments using mouse MIBC cells ("MBT-2"), Rutherrin® combined with 2.5 Gray X-Ray radiation resulted in significantly greater cell death compared to radiation alone (Figure 1). These results indicate that Rutherrin® enhances radiation-induced cytotoxicity, supporting its potential as a radiosensitizer in the destruction of MIBC.Figure 1: In Vitro MBT-2 Cell Kill After Rutherrin® and 2.5 Gray X-Ray TreatmentTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/286595_17f6f13c641d1bf2_001full.jpgMBT-2 cells were used to establish an orthotopic MIBC model in mice, by surgically injecting the cells directly into the muscle layer of the mouse's bladder, leading to tumour growth and invasion of the muscle layer. In this model, the tumour grew into the bladder lumen, pushing against the inner urothelial layer, resulting in a reduction of the volume available for urine storage (Figure 2). If left untreated, the tumour would continue to grow until the bladder was completely blocked, rendering it inoperable and reaching the humane endpoint.Figure 2: Histological Analysis Confirmed Successful Establishment of a MIBC ModelTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/286595_17f6f13c641d1bf2_002full.jpgAfter systemic Rutherrin® was administered intravenously to mice with MBT-2 tumours, tissue analysis showed that tumour sites had approximately four times higher Rutherrin® levels than normal bladder, demonstrating tumour-selective uptake and a favourable therapeutic index (drug in cancer cells versus healthy cells). See Figure 3. Figure 3: Selective Tumour Uptake of Rutherrin®To view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/286595_17f6f13c641d1bf2_003full.jpgIn further research, Theralase® is conducting an ongoing in-vivo MIBC study assessing the use of repeatable, intravenous Rutherrin® administration, in combination with fractionated radiation therapy (total cumulative dose of 25 Gray). At day 35 in this study, all mice in the Rutherrin® + radiation group survived and showed complete tumour clearance; however, in the radiation alone group mice exhibited persistent and larger tumour volumes, with 50% of the mice reaching their humane endpoint post treatment, with the other 50% displaying steady growth in their tumours. (Figure 4 and 5). These results indicate that Rutherrin® significantly enhanced radiation efficacy and may improve tumour control even when lower doses of radiation are employed.Figure 4: Tumour Volume Analysis in MBT-2 Mouse Model Treated with 25 Gray Cumulative RadiationTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/286595_17f6f13c641d1bf2_004full.jpgFigure 5: Representative MRI Sections of the Mouse Bladder Before and After TreatmentsTo view an enhanced version of this graphic, please visit:
https://images.newsfilecorp.com/files/2786/286595_17f6f13c641d1bf2_005full.jpgMark Roufaiel, PhD, Research Scientist at Theralase®, commented, "These preclinical findings demonstrate that Rutherrin® selectively accumulates in MIBC tumours versus health bladder tissue and significantly enhanced the therapeutic effect of radiation. Most importantly, we observed complete tumour clearance in X-Ray-activated Rutherrin® treated animals even under low radiation dosing conditions. This supports the potential of Rutherrin® to improve radiation response and expand treatment options for patients with aggressive MIBC."Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer, Theralase®, stated, "Treatment options for MIBC patients are limited to cisplatin-based chemotherapy before RC or TMT. Preclinical data collected supports the clinical opportunity of employing X-Ray-Activated Rutherrin® in the treatment of difficult-to-treat cancers; such as, glioblastoma multiforme, non-small cell lung cancer, as previously reported, and now based on the recent data, MIBC. In preclinical studies, mice treated with radiation alone did not survive or continued to show detectable cancer with rapid tumour progression; whereas, mice treated with a combination of Rutherrin® and radiation therapy showed no detectable cancer. These results will hopefully lay the groundwork for new therapeutic approaches for patients faced with these challenging diseases."Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President, Chief Executive Officer and Chairman of the Board of Theralase®, added, "The combination of selective tumour uptake by Rutherrin®, demonstrated X-Ray enhancement in vitro, accelerated tumour regression and complete tumour destruction in vivo at low radiation doses collectively supports the executive decision by Theralase® to pursue clinical development of Rutherrin®, as a radiation sensitizer in patients diagnosed with GBM, NSCLC and MIBC, subject to regulatory approval."References:
1 Patel M et al. Bladder sparing management for muscle-invasive bladder cancer after a complete clinical response: ready for prime time? -a narrative review. Transl Cancer Res. 2024 Nov 30;13(11):6413-6429.
2 Kulkarni et al. 2025 Canadian Urological Association Guideline: Muscle-invasive bladder cancer. Can Urol Assoc J. 2025;19(I):E1-16.
3 Holzbeierlein J et al. Treatment of Non-Metastatic Muscle-Invasive Bladder Cancer: AUA/ASCO/SUO Guideline (2017; Amended 2020, 2024). Journal of Urology [Internet]. 2024 Jul 1. 212(1):3-10.
4 Su X et al. Oncological effectiveness of bladder-preserving trimodal therapy versus radical cystectomy for the treatment of muscle-invasive bladder cancer: a system review and meta-analysis. World J Surg Oncol. 2023 Aug 29;21(1):271.
5 Embracing Trimodal Therapy as a Viable Alternative to Radical Cystectomy. Uro Today. May 2024About Theralase® Technologies Inc.:
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, 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 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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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.For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/286595
Original: Theralase(R) Demonstrates That X-Ray-Activated Rutherrin(R) Is Significantly More Effective than Radiation Alone in the Destruction of Muscle Invasive Bladder Cancer
CA Market News
4月前
Correcting and Replacing: Theralase Bladder Cancer Clinical Data to be Presented at the 2026 European Association of Urology CongressFebruary 20, 2026 7:00 AM
NewsfileThis Press Release identifies that Dr. Kulkarni has participated in a medical advisory position for Theralase(R) in the past.Toronto, Ontario--(Newsfile Corp. - February 20, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses, is pleased to announce that its interim clinical data has been selected for presentation at the 2026 European Association of Urology Congress ("EAU26").The EAU has accepted Theralase®'s abstract titled, "Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ" for presentation at EAU26 to be held in London, United Kingdom, from March 13th to 16th, 2026.The interim clinical data from Theralase®'s international, multicenter Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") study ("Study II") will be presented by principal investigator Dr. Girish Kulkarni in an oral presentation. Enrollment has been completed in Study II and Theralase® expects to commence submission of the clinical data in a rolling review to Health Canada and the FDA in 3Q2026. Pending regulatory approval, expected in 2027, this innovative technology represents an opportunity for a significant advancement in bladder cancer therapy, providing a safe and effective treatment for patients, who have exhausted their standard of care therapeutic options and are facing radical cystectomy (bladder removal).The interim clinical data supports potential safety and efficacy of the treatment with 2 out of 3 patients obtaining a complete response and 2 out of 5 patients maintaining that complete response for 15 months or more. In post study analysis, 1 out of 5 patients have demonstrated a duration of response of 3 years or greater with a single treatment.These interim preliminary findings are encouraging in support of the use of light-activated Ruvidar® by the international urology community to safely and effectively treat patients afflicted with BCG-Unresponsive NMIBC CIS, helping to revolutionize the treatment landscape for bladder cancer.Girish Kulkarni, MD, PhD, FRCSC, a urologic surgeon in the Department of Surgical Oncology at the Princess Margaret Cancer Centre, University Health Network and Professor at the University of Toronto, Department of Surgery stated, "We are excited that our clinical study has been accepted for presentation at the EAU26 Conference. The early data is supportive of light-activated Ruvidar®, as a treatment modality for BCG-Unresponsive NMIBC CIS, thus having the potential to allow patients to preserve their bladders and maintain their quality of life." Dr. Kulkarni has participated in a medical advisory position for Theralase® in the past.Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer, Theralase® stated, "In the interim clinical data, we have observed a high efficacy and fovourable safety profile in bladder cancer patients treated at numerous clinical study sites across Canada and the US. The data supports the use of light-activated Ruvidar® in the treatment of patients with high-grade, high-risk NMIBC. In addition, the latest results demonstrate a long-lasting duration of complete response induced by this innovative technology, which is able to be completed within a few hours and is suitable for patients with CIS of the urinary bladder, who have not responded to previous therapies and who are currently facing a life-altering option, such as radical cystectomy."Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer, Theralase® stated, "The acceptance of the Theralase® abstract for presentation at the EAU26 Annual Conference is a testament to the importance and significant impact that this clinical research could have on the lives of bladder cancer patients. We look forward to the presentation and the continued development of Ruvidar® for bladder cancer patients. With patient enrollment completed, clinical data is expected to be submitted to Health Canada and the FDA in a rolling review commencing 3Q2026. Pending successful regulatory approval, expected in 2027, Theralase® plans to make this technology commercially available to the entire urological community, commencing with Canada and the United States."About EAU26:
EAU26 is Europe's largest urological event, with researchers and scientists from around the world presenting their latest research, which is critically examined and discussed by the field's leading experts. The EAU represents the leading authority within Europe on urological practice, research and education, with over 19,000 medical professionals.About Study II:
Study II utilizes the therapeutic dose of the patented drug, Ruvidar® (TLD-1433) activated by the patented study device, the TLC-3200 Medical Laser System. Study II has enrolled and treated 90 BCG-Unresponsive NMIBC CIS patients in 12 clinical study sites located in Canada and the United States. About NMIBC:
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.2 In the United States, bladder cancer is the sixth most common cancer,3 fourth among men4 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.4 Historically, 75% of bladder cancer presents as NMIBC.5 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.6 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network guidelines recommend cystectomy (complete removal of the bladder).7About Ruvidar®:
Ruvidar® is a small molecule activated by energy, intended for the safe and effective destruction of cancer, bacteria and viruses.About Theralase® Technologies Inc.:
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.Additional information is available at www.theralase.com and www.sedarplus.caReferences:Kamat AM et al. Definitions, End Points, and Clinical Trial Designs for Non-Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group. J Clin Oncol. 2016 Jun 1;34(16):1935-44.Urology Care Foundation. Non-muscle Invasive Bladder Cancer. https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed November 2025.National Cancer Institute. Cancer Statistics. https://www.cancer.gov/about-cancer/understanding/statistics. Accessed November 2025.American Cancer Society. Cancer Facts & Figures 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Accessed November 2025.Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022 Jan;81(1):75-94.Lidagoster S, et al. BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. Curr Oncol. 2024 Feb 16;31(2):1063-1078.National Comprehensive Cancer Network. Bladder Cancer (Version 2.2025). https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed November 2025.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 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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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 and 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.For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/284551
Original: Correcting and Replacing: Theralase Bladder Cancer Clinical Data to be Presented at the 2026 European Association of Urology Congress
CA Market News
4月前
Theralase Bladder Cancer Clinical Data to be Presented at the 2026 European Association of Urology CongressFebruary 17, 2026 7:00 AM
NewsfileToronto, Ontario--(Newsfile Corp. - February 17, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses, is pleased to announce that its interim clinical data has been selected for presentation at the 2026 European Association of Urology Congress ("EAU26").The EAU has accepted Theralase®'s abstract titled, "Interim Analysis of Light-Activated TLD-1433 in a Phase II Clinical Study of BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In-Situ" for presentation at EAU26 to be held in London, United Kingdom, from March 13th to 16th, 2026.The interim clinical data from Theralase®'s international, multicenter Phase II Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS") study ("Study II") will be presented by principal investigator Dr. Girish Kulkarni in an oral presentation. Enrollment has been completed in Study II and Theralase® expects to commence submission of the clinical data in a rolling review to Health Canada and the FDA in 3Q2026. Pending regulatory approval, expected in 2027, this innovative technology represents an opportunity for a significant advancement in bladder cancer therapy, providing a safe and effective treatment for patients, who have exhausted their standard of care therapeutic options and are facing radical cystectomy (bladder removal).The interim clinical data supports potential safety and efficacy of the treatment with 2 out of 3 patients obtaining a complete response and 2 out of 5 patients maintaining that complete response for 15 months or more. In post study analysis, 1 out of 5 patients have demonstrated a duration of response of 3 years or greater with a single treatment.These interim preliminary findings are encouraging in support of the use of light-activated Ruvidar® by the international urology community to safely and effectively treat patients afflicted with BCG-Unresponsive NMIBC CIS, helping to revolutionize the treatment landscape for bladder cancer.Girish Kulkarni, MD, PhD, FRCSC, a urologic surgeon in the Department of Surgical Oncology at the Princess Margaret Cancer Centre, University Health Network and Professor at the University of Toronto, Department of Surgery, stated, "We are excited that our clinical study has been accepted for presentation at the EAU26 Conference. The early data is supportive of light-activated Ruvidar®, as a treatment modality for BCG-Unresponsive NMIBC CIS, thus having the potential to allow patients to preserve their bladders and maintain their quality of life."Arkady Mandel, MD, PhD, DSc, Chief Scientific Officer, Theralase® stated, "In the interim clinical data, we have observed a high efficacy and fovourable safety profile in bladder cancer patients treated at numerous clinical study sites across Canada and the US. The data supports the use of light-activated Ruvidar® in the treatment of patients with high-grade, high-risk NMIBC. In addition, the latest results demonstrate a long-lasting duration of complete response induced by this innovative technology, which is able to be completed within a few hours and is suitable for patients with CIS of the urinary bladder, who have not responded to previous therapies and who are currently facing a life-altering option, such as radical cystectomy."Roger DuMoulin-White, BSc, P.Eng, Pro.Dir, President and Chief Executive Officer, Theralase®, stated, "The acceptance of the Theralase® abstract for presentation at the EAU26 Annual Conference is a testament to the importance and significant impact that this clinical research could have on the lives of bladder cancer patients. We look forward to the presentation and the continued development of Ruvidar® for bladder cancer patients. With patient enrollment completed, clinical data is expected to be submitted to Health Canada and the FDA in a rolling review commencing 3Q2026. Pending successful regulatory approval, expected in 2027, Theralase® plans to make this technology commercially available to the entire urological community, commencing with Canada and the United States."About EAU26:
EAU26 is Europe's largest urological event, with researchers and scientists from around the world presenting their latest research, which is critically examined and discussed by the field's leading experts. The EAU represents the leading authority within Europe on urological practice, research and education, with over 19,000 medical professionals.About Study II:
Study II utilizes the therapeutic dose of the patented drug, Ruvidar® (TLD-1433) activated by the patented study device, the TLC-3200 Medical Laser System. Study II has enrolled and treated 90 BCG-Unresponsive NMIBC CIS patients in 12 clinical study sites located in Canada and the United States. About NMIBC:
NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.2 In the United States, bladder cancer is the sixth most common cancer,3 fourth among men4 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.4 Historically, 75% of bladder cancer presents as NMIBC.5 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.6 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network guidelines recommend cystectomy (complete removal of the bladder).7About Ruvidar®:
Ruvidar® is a small molecule activated by energy, intended for the safe and effective destruction of cancer, bacteria and viruses.About Theralase® Technologies Inc.:
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.Additional information is available at www.theralase.com and www.sedarplus.ca.References:Kamat AM et al. Definitions, End Points, and Clinical Trial Designs for Non-Muscle-Invasive Bladder Cancer: Recommendations From the International Bladder Cancer Group. J Clin Oncol. 2016 Jun 1;34(16):1935-44.Urology Care Foundation. Non-muscle Invasive Bladder Cancer. https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed November 2025.National Cancer Institute. Cancer Statistics. https://www.cancer.gov/about-cancer/understanding/statistics. Accessed November 2025.American Cancer Society. Cancer Facts & Figures 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Accessed November 2025.Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022 Jan;81(1):75-94.Lidagoster S, et al. BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. Curr Oncol. 2024 Feb 16;31(2):1063-1078.National Comprehensive Cancer Network. Bladder Cancer (Version 2.2025). https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed November 2025.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 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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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 and 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.For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/284094
Original: Theralase Bladder Cancer Clinical Data to be Presented at the 2026 European Association of Urology Congress
CA Market News
4月前
Theralase(R) Provides Update on Bladder Cancer Clinical StudyFebruary 4, 2026 7:00 AM
NewsfileInterim clinical data has exceeded the recommended guidelines of the International Bladder Cancer Group for complete response and duration of complete responseToronto, Ontario--(Newsfile Corp. - February 4, 2026) - Theralase® Technologies Inc. (TSXV: TLT) (OTCQB: TLTFF) ("Theralase®" or the "Company"), a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses, is pleased to provide an update on the Phase II clinical study for bladder cancer. To date, 90 patients have been enrolled and treated with the Theralase® Study Procedure, achieving the patient enrollment specified by the statistical analysis plan.78 patients have completed the clinical study and were evaluated at all scheduled assessment visits or were prematurely removed by the principal investigator due to lack of response. There are 12 patients pending study completion.
Primary Endpoint Performance (CR at any Point in Time)#%Confidence Interval (95%)Complete Response ("CR")56/8764.4%[48.6, 80.2]Total Response (CR and IR)64/8773.6%[56.7, 90.5] Note: Indeterminate Response ("IR") is defined as negative cystoscopy (no evidence of Urothelial Cell Carcinoma ("UCC") in the bladder) and positive / suspicious urine cytology (detection of cancer in the urine, without a negative confirmatory bladder biopsy, suggesting UCC in the renal system other than the bladder).
Secondary Endpoint Performance (Duration of CR) (450 Days)
#%Confidence Interval (95%)Complete Response19/4740.4%[23.8, 57.1]Total Response20/4742.6%[26.6, 58.5]
Tertiary Endpoint Performance (Safety) (450 Days)
#%Safety78/78100.0% Note: Theralase® believes all Serious Adverse Events ("SAEs") reported to date are unrelated or unlikely related to the Study Drug or Study Device.These results exceed the International Bladder Cancer Group's recommended guidelines of "clinically meaningful initial complete response rates for carcinoma in situ of at least 50% at 6 months and 30% at 12 months."1Interim data from 47 patients indicates that complete response rates of 21.3% at both 2 and 3 years and 2.1% at 7 years were sustained.Theralase® will compile the clinical data in 2026 for presentation to Health Canada and FDA with an expected regulatory approval in 2027.About Phase II Clinical Study:
Primary Endpoint: Efficacy (complete response at any point in time)
Secondary Endpoint: Efficacy (duration of complete response of 12 months)
Tertiary Endpoint: Safety (serious adverse events directly related to the study drug or study device that do not resolve within 450 days)
Study Procedure: Light-activated Ruvidar®
Patient Population: Bacillus Calmette-Guérin ("BCG")-Unresponsive Non-Muscle Invasive Bladder Cancer ("NMIBC") Carcinoma In-Situ ("CIS"), who have failed standard-of-care therapy and are facing radical cystectomy (bladder removal) ("Study II").About NMIBC:NMIBC is a form of bladder cancer that is found in the inner layer cells of the bladder and does not invade into or beyond the muscle wall.2 In the United States, bladder cancer is the sixth most common cancer,3 fourth among men,4 and it is estimated that there will be approximately 84,870 new cases of bladder cancer in the U.S. in 2025.4 Historically, 75% of bladder cancer presents as NMIBC.5 In patients with high-risk NMIBC, intravesical BCG remains the first-line standard-of-care; however, approximately one third of patients with NMIBC will not respond to BCG therapy and 50% of those with an initial response will experience recurrence or progression of their disease.6 Current treatment options for BCG-unresponsive patients are very limited and National Comprehensive Cancer Network guidelines recommend cystectomy (partial or complete removal of the bladder).7About Ruvidar®:Ruvidar® is a small molecule activated by energy, intended for the safe and effective destruction of cancer, bacteria and viruses.About Theralase® Technologies Inc.:Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of energy-activated small molecules for the safe and effective destruction of cancer, bacteria and viruses.Additional information is available at www.theralase.com and www.sedarplus.ca.References:Rose KM et al., Systematic Review and Meta-Analysis of Response Rates in BCG-unresponsive Non-Muscle-Invasive Bladder Cancer: A Consensus Statement From the International Bladder Cancer Group. Société Internationale d'Urologie Journal. 2022; 3(5):333-339.Urology Care Foundation. Non-muscle Invasive Bladder Cancer. https://www.urologyhealth.org/urology-a-z/n/non-muscle-invasive-bladder-cancer. Accessed November 2025.National Cancer Institute. Cancer Statistics. https://www.cancer.gov/about-cancer/understanding/statistics. Accessed November 2025.American Cancer Society. Cancer Facts & Figures 2025. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2025/2025-cancer-facts-and-figures-acs.pdf. Accessed November 2025.Babjuk M, Burger M, Capoun O, et al. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer. Eur Urol. 2022 Jan;81(1):75-94.Lidagoster S, et al. BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. Curr Oncol. 2024 Feb 16;31(2):1063-1078.National Comprehensive Cancer Network. Bladder Cancer (Version 2.2025). https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed November 2025.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 StatementsThis 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 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; access to sufficient capital to fund the Company's operations is available on terms that are commercially favorable to the Company or at all; the Company's small molecule and formulations may not be effective against the diseases tested in its clinical studies; 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 and 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.For More Information:
1.866.THE.LASE (843.5273)
416.699.LASE (5273)
www.theralase.comKristina Hachey, CPA
Chief Financial Officer X 224
khachey@theralase.comTo view the source version of this press release, please visit https://www.newsfilecorp.com/release/282520
Original: Theralase(R) Provides Update on Bladder Cancer Clinical Study