- Lexaria Bioscience recently released its 2023 annual letter from CEO Chris Bunka, providing a strategic update to all stakeholders
- The letter highlights the key milestones achieved in calendar 2022, outlines expectations for calendar 2023, and indicates why Chris Bunka expects 2023 to be the company’s best year so far
- 1In calendar 2023, Lexaria expects to attain FDA registration for an investigational new drug (“IND”) program and commence Phase 1(b) clinical study evaluating the safety and tolerability of DehydraTECH(TM)-processed CBD as a treatment for hypertension
- The company will also be pursuing commercial relationships in 2023 even as its R&D continues to progress by engaging in discussions with potential collaborators who may license the patented DehydraTECH technology
Lexaria Bioscience (NASDAQ: LEXX) started calendar 2022 with optimism, which according to CEO Chris Bunka’s recently published annual letter to shareholders (https://nnw.fm/6iN2l), turned out to well founded. Now, as the company begins calendar 2023, “that optimism is, if anything, even stronger today.” Lexaria has reason to be optimistic about the current year, coming off a year that saw it successfully fulfill its primary objectives and tick most, if not all, of the boxes on its priority list.
At the start of calendar 2022, the company intended to introduce its patented DehydraTECH(TM) drug delivery technology to world-leading collaborators and to avoid raising additional funds through the capital markets. It also planned to develop its DehydraTECH-CBD hypertension program, explore whether DehydraTECH-nicotine pouches could replace nicotine administration via inhalation (smoking), and evaluate DehydraTECH-CBD as a therapeutic against other conditions such as epilepsy, dementia, and diabetes. Lexaria, through Chris Bunka’s letter, is pleased to report that these objectives were wholly completed in 2022 or are nearing completion in early 2023.
The completed objectives include the introduction of DehydraTECH to potential licensees via ongoing discussions as well as the completion of EPIL-A21-1 animal study evaluating DehydraTECH-CBD as an anti-seizure therapeutic and the HYPER-H21-4 human clinical study evaluating DehydraTECH-CBD as a potential treatment for hypertension.
The results affiliated with the primary objectives of the HYPER-H21-4 study, namely the blood pressure and pharmacokinetic performance, were positive, with no serious adverse events observed. It is, therefore, accurate to say that the study was a success, Bunka writes. Moreover, in the EPIL-A21-1 study, DehydraTECH-CBD demonstrated certain performance enhancements, namely more efficacy at lower doses and more rapid action, than Epidiolex, a leading CBD-based anti-seizure medication. Of note, and following the success of the EPIL-A21-1 seizure study, Bunka writes, Lexaria is rating its DehydraTECH-CBD for seizure investigation as one of its highest priorities along with the DehydraTECH-CBD for hypertension and DehydraTECH-nicotine.
In the Q1 of calendar 2023, the company expects to complete dosing in the human nicotine study NIC-H21-1, the animal diabetes study, and the animal dementia study, having initiated them in late 2022. The company is also evaluating a series of secondary objectives of HYPER-H21 4 study, with some of the findings and additional results expected within this period.
Remarkably, the company achieved these milestones and managed the growth while exercising excellent fiscal controls. In fact, and despite the inflationary pressures, Lexaria hit its annual 2022 budget, +/- about 2%, building on an accomplishment that began in 2021. This helped the company preserve its existing capital and stay true to its earlier commitment not to raise additional funds by issuing equity or taking on any debt. As a result, its cash in hand is enough to support operations through nearly all of 2023 without needing to raise additional capital if the company chooses to reduce its R&D spending.
“However, as we prefer to keep advancing our applied R&D at as rapid a pace as we can, we are also continuing to pursue capital-strengthening possibilities that do not involve the issuance of any equity,” Bunka writes.
According to the letter, the R&D programs and the capital-strengthening opportunities are interlinked. If successful, the DehydraTECH-CBD hypertension program, for example, is expected to help increase not only Lexaria’s corporate value but also the probability of reaching one or more commercial out-licensing agreements within the pharmaceutical industry. In addition, the success could also pave the way for more commercial pursuits of its DehydraTECH-CBD for therapeutic use. Similarly, if the nicotine study is successful, the company feels it will have inched closer to completing its scientific investigations, positioning it to market the technology to the global nicotine industry in pursuit of growing revenue streams.
“Each of these three areas of investigation [DehydraTECH-CBD as a hypertension therapeutics, DehydraTECH-CBD as an anti-seizure medication, and DehydraTECH-nicotine] has the potential to support important industry relationships that prove meaningful or even transformative for Lexaria. Because of the obvious medical and market needs in each of these three sectors, we will be pursuing commercial relationships in 2023 even as our R&D continues to progress,” the letter reads.
Accordingly, Lexaria’s CEO expects calendar 2023 will be the company’s “best year ever.” Among the key milestones the company intends to achieve is a Food and Drug Administration (“FDA”) registration for an Investigational New Drug (“IND”) program that will sanction the commencement of a Phase 1(b) FDA-registered clinical trial evaluating the safety and tolerability of DehydraTECH-CBD as a treatment for hypertension. The company expects this research program will dominate the second half of calendar 2023 and beyond.
In all, the registered clinical trials for DehydraTECH-CBD are expected to culminate in the filing of a new drug application (“NDA”) via the abbreviated 505(b)(2) pathway. To support this shortened route to commercial approval, Bunka says, Lexaria will leverage precedent safety data generated from the clinical study of FDA-approved Epidiolex. In its trials, for example, Epidiolex demonstrated the pharmaceutical’s safety and tolerability when administered chronically but at much higher doses than Lexaria’s intended dosing of DehydraTECH-CBD.
Still, the company maintains that DehydraTECH-CBD is not its only long-term plan for FDA registration. “Stakeholders can follow our progress in other areas of therapeutic interest through the results we receive in our applied R&D programs,” emphasizes Bunka.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://nnw.fm/LEXX
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