Dear Fellow Investors in, and Followers of, Sona Nanotech Inc. (the “Company”), we wanted to take the opportunity with the turning of the New Year to share some reflections on 2024 and thoughts on the year ahead. 2024 was a busy and exciting time for the Company during which it delivered strong preclinical efficacy study results for its cancer therapy and laid the groundwork for our advance into human clinical trials.
Sona’s THT-Immunotherapy
2024 will be remembered as a foundational year for the Company. Sona delivered two important preclinical studies through the Giacomantonio laboratory at Dalhousie University that demonstrated the ability of our Targeted Hyperthermia Therapy (“THT”) to both shrink tumors and trigger a strong immune response while not damaging healthy, noncancerous cells, as happens with chemotherapy, radiation, and surgery. Moreover, these studies showed how Sona’s THT therapy can cause the highly desired ‘abscopal effect’, where untreated, distant metastasizing tumors also responded to THT treatment applied only to the primary tumor. Needless to write but replicating these promising results in human clinical trials could have profound implications for patients suffering from a variety of cancers that are unresponsive to current therapies.
We are pleased to report that detailed analysis of findings from these two important preclinical studies, one in melanoma and one in triple negative breast cancer, and related follow-up analysis have now been published in the prestigious, peer reviewed journal, Frontiers In Immunology. “In the Life Sciences industry, it is one thing for a small company like Sona Nanotech to report positive preclinical trial results but quite another to have that data subjected to a robust peer review process and accepted for publishing in a leading Industry Scientific Journal”, says David Regan, CEO of Sona Nanotech Inc. We therefore anticipate heightened interest in our work with the publishing of this study.
The published findings from our paper, entitled, “Targeted Intra-tumoral Hyperthermia with Uniquely Biocompatible Gold Nanorods Induces a Strong Immunogenic Cell Death in Two Immunogenically ‘Cold’ Tumors”, highlight the rigorous scientific experiments and peer reviewed analysis of data demonstrating that the changes in tumors resulting from treatment with our THT protocol activated a strong immune response in tumors previously proven to be resistant to immunotherapy. To read the full, just published paper in Frontiers In Immunology, click here.
We were also very gratified by the response to our ‘family and friends’ financing campaign in September, which was oversubscribed, raising $3.1million in support of our efforts to develop our THT therapy and get it into the clinic. We did this with the issuance of 12.575 million common shares at $0.25 per share without a warrant attached.
Considering the question of whether Sona’s promising preclinical study results will translate to humans, based on our novel approach and mechanisms of activating immunity in cold tumors, we believe Sona’s THT therapy to be a logical and elegant approach to rescuing cancer patients whose tumors are not responding to current immunotherapies. Our local, intra-tumoral, treatment delivery strategy is at the leading edge of current research and medical thinking. What’s more, our treatment protocols require minimal clinical infrastructure and technical resources to be administered, making this technology ideally suitable for delivery in a community clinical setting. This would offer a compelling addition or alternative to the current standard ofc are for such patients.
“While we are still in the early stages, based on my 26 years of research in the field of cancer biology and immunology, observing what has, and what has not translated from preclinical studies to human clinical trials, I believe that the relevant dynamics of a cancerous tumor’s microenvironment (the target of our THT) is consistent across species which would make our THT
therapy ‘tumor agnostic’”, says our CMO, Dr. Carman Giacomantonio. Looking to the future, our priority is to expand our horizon and continue to build on our core technology. To this end, in 2024, in addition to receiving official patent protection for our uniquely biocompatible GNRs, we also filed provisional patents for a number of innovations that incorporate our GNR platform into novel, cutting edge cancer therapies.
Near Infrared Light Conversion to Heat Using Sona’s GNRs
2024 also saw Sona advancing the key elements of its two-device system used to provide THT: our laser light device and our GNRs. Our laser provides the non-thermal light energy at an 860-nanometer wavelength that passes harmlessly into tumors previously injected with our GNRs, where it is converted to heat. We are very pleased with both how this custom designed and built ‘beta model’ laser has performed and with how we have learned to optimize its use in the application of THT.
Higher Standards of GNR Production at Sona Nanotech
We have also made significant improvements to our GNR manufacturing process recently, having produced our largest batch ever, in record time. These improvements have benefited from advancements made in our Quality Management System. This improved, electronic quality system will enable us to get to market faster, reduce regulatory audit time requirements and provide the necessary quality framework to permit us to pursue ISO 13485 certification, a key milestone for Sona Nanotech Inc. that will eventually be required by regulators.
Thanks to Shareholders
Getting set up properly to maximize our chances for success in human clinical trials has taken time, and we appreciate shareholders for their patience as we follow this strategic approach to accelerate our way forward. Having taken the time to establish a solid foundation will benefit the business and should help us to garner wider recognition of our progress, and prospects, with industry players and investors alike.
While there is still much to be done, we are delighted with where the business currently stands and excited about the many tangible milestones that lie ahead of us in 2025. As of now, it is clear that our therapy can turn immunogenically ‘cold’ tumors into the ‘hot’ ones, potentially dramatically improving response rates in patients with cancers currently receiving immunotherapy, and importantly, presenting new opportunities for patients with cancers currently not offered immunotherapy. We look forward to demonstrating this potential advancement in cancer treatment soon and sharing that data with you.
Our goals and aspirations for 2025 are ambitious, however, we are confident that the platform we have put in place and the strategy we have set will allow us to realize on them.
Yours sincerely,
David Regan
Chief Executive Officer
Dr. Carman Giacomantonio
Chief Medical Officer
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This update does contain Forward-Looking Statements so please refer to the Company’s Cautionary Note appended below.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION:
Information set forth in this letter contains forward-looking statements that are based on assumptions as of the date of this letter. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. Words such as “expects”, “aims”, “anticipates”, “targets”, “goals”, “projects”, “intends”, “plans”, “believes”, “seeks”, “estimates”, “continues”, “may”, variations of such words, and similar expressions and references to future periods, are intended to identify such forward-looking statements. Sona Nanotech Inc. (“Sona” or the “Company”) cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond Sona’s control. These statements include those regarding the anticipated applications and potential opportunities of Targeted Hyperthermia Therapy, Sona’s preclinical and clinical study plans, Sona’s intention to submit preclinical study results for peer reviewed publication, Sona’s ability to secure a human trial, future patent filings and its product development plans. Forward-looking statements are necessarily based upon a number of assumptions or estimates that,while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, the risk that Sona’s intended publications may not be accepted by a leading scientific journal and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required bylaw. Except as required under applicable securities legislation, Sona undertakes no obligation to publicly update or revise forward-looking information. Sona does not intend, and does not assume any obligation, to update these forward-looking statements, except as required under applicable securities legislation. For more information on Sona, readers should refer to Sona’s website at www.sonanano.com.
Information set forth in this letter is intended to summarize or highlight the Company’s results for the previous year based upon previously disclosed results provided in the Company’s news releases and disclosures. Readers of this letter should refer to the Company’s news releases, available on the Company’s website or SEDAR.com, to obtain important additional technical information and disclosure.