Lexaria Bioscience Corp.’s (NASDAQ: LEXX) Drug Development Program and Recent FDA Confirmation Position It for Favorable Valuation

  • Lexaria is a global innovator of drug delivery platforms, including its patented DehydraTECH(TM) technology
  • The company recently released information that would help its stakeholders research and understand how biotech and pharmaceutical companies are valued
  • Based on some of the methodologies used in valuation, Lexaria is positioned favorably as its DehydraTECH-processed CBD for the treatment of hypertension has successfully reached the IND application stage, with the program recently receiving an additional boost
  • The FDA agreed with Lexaria’s proposal to pursue a 505(b)(2) new drug application (“NDA”) regulatory pathway, an abbreviated pathway, for its hypertension program

As a follow-up to recent coverage by Zacks Small-Cap Research, which valued the company at $15.00 (https://cnw.fm/obZ1e), global innovator Lexaria Bioscience (NASDAQ: LEXX) provided information to its stakeholders that would help them conveniently research and understand different non-affiliated third-party sources and their methodologies for valuing biotech and pharmaceutical companies.

“Valuation of equities is a complex task with innumerable risks and rewards that include far-reaching macro events as well as company-specific developments. It is nearly impossible to foresee all risks and rewards, but underlying logic-based evaluation is one way to provide a realistic framework of expectations that investors can use in their analysis,” the August 11 press release reads (https://cnw.fm/DGYh2).

One of the logic-based evaluations considers the stage at which a company’s drug development program has reached. According to the U.S. Food and Drug Administration (“FDA”), there are five steps to the drug development process: Discovery and Development, Preclinical Research, Clinical Research, FDA Drug Review, and, finally, FDA Post-Market Drug Safety Monitoring. However, not more than about 250 of 5,000-10,000 compounds tested during the Discovery stage successfully transition to the third step. Against this backdrop, Lexaria stands out, having completed the first two steps with its DehydraTECH-CBD for hypertension treatment, with favorable results to boot.

The company’s first advanced human clinical study (“HCS”) for hypertension, conducted in 2018, for example, showed that DehydraTECH drug delivery technology delivered 317% more CBD to the blood at 30 minutes. Later HCS’s evidenced rapid and sustained drop in blood pressure (HYPER-H21-1), up to a 23% average reduction in overnight blood pressure and reduced arterial stiffness (HYPER-H21-2), and a 41% overall reduction in pulmonary artery systolic pressure (“PASP”) in male subjects (HYPER-H21-3). Lexaria is set to announce results from its fourth HCS – HYPER-H21-4 – in Q4 2022 (https://cnw.fm/caWiK).

If the HYPER-H21-4 study were registered with the FDA, Lexaria notes, it would possibly be a Phase 1B or 2A study. This information lends color to the company’s valuation going by a guide prepared by Bay Bridge Bio, which notes that a company’s valuation increases as its drug development progresses from Phase 1 through Phase 3. For example, at the start of a Phase I trial, a biotech company’s valuation would be $88 million, a figure that would then rise to $248 million at the start of Phase 2 study, finally eclipsing the $1 billion mark to settle at $1.119 billion when the Phase III trial begins. The figures increase further following an FDA approval of the drug candidate.

Considering the FDA’s recent confirmation that it agreed with Lexaria’s proposal to pursue a 505(b)(2) new drug application (“NDA”) regulatory pathway, an abbreviated pathway, the company’s accelerated drug development program for hypertension therapeutics could wend way to a multi-billion-dollar valuation in due course. The pharmaceutical industry is rife with examples of such possibilities.

In March, for example, Pfizer Inc. (NYSE: PFE) completed the acquisition of clinical-stage company Arena Pharmaceuticals for a total consideration of $6.7 billion. At the time of the acquisition, Arena was expecting results for its Phase 3 trial undertaken to evaluate the safety and efficacy of the etrasimod drug candidate in patients with active ulcerative colitis (https://cnw.fm/LRYMc).

As a December 2021 report by accounting firm PwC notes, big pharma is set to spend anywhere between $5 billion and $15 billion and, in some cases, as much as $50 billion in 2022 to purchase promising biotech companies and their IP, as they seek to bring on board in new drugs that can become serious revenue generators (https://cnw.fm/3KBKG). Such acquisitions attest that biotech companies with little to no revenue can still be worth billions.

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://cnw.fm/LEXX

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