Theralase(R) 1Q2025 Financial Statements
Theralase® will be hosting a conference call on Monday June 9 th, 2025 at 11:00 am ET, which will include a presentation of the financial and operational results for the fiscal quarter ending March 31 st, 2025.
Questions are welcome; however, to ensure we have time to review and properly address them during the call, please send them in advance to [email protected].
An archived version will be available on the website following the conference call.
Financial Summary:
For the three-month period ended March 31 st:
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1 Other represents foreign exchange, interest accretion on lease liabilities and / or interest income
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Financial Highlights
For the three-month period ended March 31, 2025:
Operational Highlights
Private Placements
The Company has raised approximately $CAN 6.3 million over the last 2 years through non-brokered private placements in support of its research and development programs. It is currently investigating the use of a full-service investment bank in the United States to advise on potential financings and US listing opportunities. Information on any future financings will be released once available in accordance with applicable securities laws.
Herpes Simplex Virus ('HSV') Treatment Program
Theralase® continues preclinical development of its HSV treatment using non-light activated and light-activated small molecules. The Company is actively working on in-vitro, and in the near future, in-vivo HSV preclinical models to finalize a formulation for optimal dermal penetration to increase patient safety and efficacy. Good Laboratory Practice ('GLP') toxicology studies will commence once a formulation has been finalized. Additional details will be announced as strategic objectives are achieved.
Phase II Bladder Cancer Study Update ('Study II')
Interim Clinical Results
For the primary endpoint of Study II (Complete Response ('CR') at any point in time) 62% of patients provided the Study Procedure (Study Drug activated by the Study Device) demonstrated a CR. Including patients, who demonstrated an Indeterminate Response ('IR') (negative cystoscopy and positive or suspicious urine cytology), the Total Response ('TR') increases to 70%.
This represents that approximately 2 out of 3 BCG-Unresponsive NMIBC CIS patients treated with Theralase®'s unique Study Procedure are demonstrating complete destruction of their bladder cancer.
For the secondary endpoint of Study II (duration of CR) 42% of treated patients who achieved a CR, maintained their CR response for at least 12 months (450 days from date of Study Procedure).
For the tertiary endpoint of Study II (safety of Study Procedure) 100% (69/69) experienced no Serious Adverse Events ('SAEs') directly related to the Study Drug or Study Device.
Outside of the defined endpoints of Study II, Theralase® has demonstrated a duration of CR at extended time points of 23% at 2 years, 21% at 3 years and 2% at 7 years.
Note: Not all patients have been assessed at these extended time points. As more clinical data is collected, the duration of CR at 2, 3 and 7 years may increase.
Theralase® is on track to complete enrollment in Study II by the summer of 2025.
This will allow the Company to report on 75 patients who have completed Study II in December 2025 and to report on all 90 patients by September 2026.
Upon follow-up of all patients, the Company plans to submit a New Drug Application ('NDA') to Health Canada and the FDA in 4Q2026, with a decision expected by the respective regulatory authorities on a marketing approval in 2027.
As Theralase® completes enrollment in Study II, it is actively searching for commercialization partners for international marketing and sales of Ruvidar®.
To this end, Theralase® is in various stages of initial and advanced discussions with international pharmaceutical companies for various geographical territories concerning:
In recent discussions with the FDA, the Company has decided that since Study II is 91% complete, the best course of action is not to pursue Break Through Designation, but to complete Study II and submit the clinical data to the FDA in a formal NDA. At the end of the meeting, the FDA made a comment that they were impressed that the interim clinical data obtained to date was able to be achieved with only one clinical treatment, in the majority of cases.
Ruvidar® has demonstrated 10 years of shelf life, strongly supporting the stability of the molecule and the ability of clinics to store the small molecule for extended periods of time.
Additional Oncology Targets
Theralase® has combined Ruvidar® with transferrin (human glycoprotein) to form Rutherrin®.
Rutherrin® is a strong candidate for the systemic treatment of recurrent, deep seated and/or progressive cancers.
Due to the limitations of using laser light to activate Rutherrin® in deep oncological targets, Theralase® plans to activate Rutherrin® with radiation therapy to increase the 'tumour's damage zone' and the effectiveness of Theralase®'s small molecule beyond the reach of light in the body.
Rutherrin®, if clinically proven, will be able to 'hunt' and 'localize' into cancer cells and when activated by radiation 'destroy' them; wherever, they may reside in the body.
The Company expects to complete Good Laboratory Practice toxicology analysis in 4Q2025 to allow commencement of a Phase 0/I/II adaptive clinical study in 1Q2026 for the following indications:
1) Glio Blastoma Multiforme ('GBM') Brain Cancer Treatment
2) Non-Small Cell Lung Cancer ('NSCLC') Treatment
3) Pancreatic Cancer
4) Colorectal Cancer
5) Muscle Invasive Bladder Cancer ('MIBC') Treatment
6) Herpes Simplex Virus ('HSV-1") Topical Treatment for Cold Sore Lesions
For additional information, please refer to the Company's Management's Discussion and Analysis ('MD&A') available at www.sedarplus.ca.
About Ruvidar®:
Ruvidar®(TLD-1433) is a small molecule, able to be activated by light, radiation, sound and/or other drugs, intended for the safe and effective destruction of various cancers, bacteria and viruses.
About Theralase® Technologies Inc.:
Theralase® is a clinical stage pharmaceutical company dedicated to the research and development of light, radiation, sound and/or drug-activated small molecule compounds, their associated drug formulations and the light systems that activate them, with a primary objective of efficacy and a secondary objective of safety in the destruction of various cancers, bacteria and viruses.
Additional information is available at www.theralase.com and www.sedarplus.ca
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-Looking Statements:
This news release contains Forward-Looking Statements ('FLS') within the meaning of applicable Canadian securities laws. Such statements include; but, are not limited to statements regarding the Company's proposed development plans with respect to small molecules and their drug formulations. FLS may be identified by the use of the words 'may, 'should', 'will', 'anticipates', 'believes', 'plans', 'expects', 'estimate', 'potential for' and similar expressions; including, statements related to the current expectations of the Company's management regarding future research, development and commercialization of the Company's small molecules; their drug formulations; preclinical research; clinical studies and regulatory approvals.
These statements involve significant risks, uncertainties and assumptions; including, the ability of the Company to fund and secure the regulatory approvals to successfully complete various clinical studies in a timely fashion and implement its development plans. Other risks include: the ability of the Company to successfully commercialize its small molecule and drug formulations; the risk that access to sufficient capital to fund the Company's operations may not be available on terms that are commercially favorable to the Company or at all; the risk that the Company's small molecule and drug formulations may not be effective against the diseases tested in its clinical studies; the risk that the Company fails to comply with the terms of license agreements with third parties and as a result loses the right to use key intellectual property in its business; the Company's ability to protect its intellectual property; the timing and success of submission, acceptance and approval of regulatory filings. Many of these factors that will determine actual results are beyond the Company's ability to control or predict.
Readers should not unduly rely on these FLS, which are not a guarantee of future performance. There can be no assurance that FLS will prove to be accurate as such FLS involve known and unknown risks, uncertainties and other factors which may cause actual results or future events to differ materially from the FLS.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 outInvestor Inquiries - Theralase Technologies.
For More Information:
1.866.THE.LASE (843-5273)
416.699.LASE (5273)
www.theralase.com
Kristina Hachey, CPA
Chief Financial Officer X 224
[email protected]
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/253913
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