Last week, Lexaria Bioscience Corp. (Nasdaq: LEXX) reported two major developments that our readers should be aware of.
The more significant announcement was Lexaria awarding a contract for clinical research organization (CRO) services to California-based InClin, Inc. The contract is for its upcoming Food and Drug Administration (FDA)-registered, U.S. Phase 1b Investigational New Drug (IND) hypertension study with its patented DehydraTECH-powered cannabidiol (DehydraTECH-CBD).
The clinical study will evaluate safety and tolerability of DehydraTECH-CBD as a potential treatment for hypertension and we expect positive data to serve as a major catalyst for the stock. The appointment of InClin should expedite the study by quickly commencing study start-up and preparatory activities.
By starting these activities, it will take less time for Lexaria to start patient dosing after the expected FDA IND filing and review is completed. The management team expects to file the IND this summer which should allow it to start dosing patients as early as October.
Based on the management team’s FDA pre-IND meeting in August 2022, we expect the company to hit these milestones. Lexaria has already started working with its regulatory and clinical advisors on the upcoming IND submission and we are favorable on this.
During the last year, Lexaria has been working tirelessly with its regulatory and clinical advisors on refining the study plan and preparing for the IND submission. The work the company has done was based on the pre-IND guidance it received from the FDA. Currently, Lexaria is working on one of the final requirements to submitting its formal IND application to the FDA and we are closely following this aspect of the business.
Further Strengthens Its IP Portfolio
A few days before Lexaria awarded its CRO contract, the company reported to have received notifications of four new patents either awarded or allowed. This development represents an important achievement for its intellectual property portfolio and we are favorable on the diversity of the patents.
The newly awarded or allowed patents were from Japan, Canada, Australia, and the US. These were not Lexaria’s first awarded or allowed patents in the countries. We believe the development further strengthened the company’s IP portfolio in these markets and consider this to be an underappreciated aspect of the story.
After the awarding of these patents, Lexaria’s total patent portfolio will have grown to 32 granted patents worldwide. We are bullish on the strength of the company’s IP portfolio and are favorable on how the management team continues to focus on this aspect of the business.
An Undervalued Growth Story
During the last month, Lexaria has come under pressure and we believe the weakness has created a great opportunity for investors. From advancing clinical trials to strengthening its IP portfolio, Lexaria has been nothing short of an execution story. We are favorable on how the management team has been executing and find the valuation to be attractive at current levels.
For biotech companies, valuations tend to surge higher when positive clinical trial data is reported. According to Bay Bridge Bio, typical company valuations at the start of Phase I are USD $88 million and USD $248 million at the start of Phase II. Based on these valuations, we believe Lexaria has substantial upside potential.
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This article contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, “believes”, “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, state, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal, state and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the impact of the Russia-Ukraine conflict on the global economy; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws
