KELOWNA, BC / February 15, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, today announced that it has entered into definitive agreements for the purchase and sale of 1,558,443 shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $2.31 per share (or per common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 1,558,443 shares of common stock at an exercise price of $2.185 per share that will be immediately exercisable upon issuance and will expire five years following the date of issuance. The closing of the offering is expected to occur on or about February 16, 2024, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $3.6 million before deducting placement agent fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for research and development studies and the patent and legal costs associated thereto, and for general working capital purposes.

The common stock (or common stock equivalents) (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above are being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-262402) that was declared effective by the Securities and Exchange Commission (the "SEC") on February 4, 2022. The offering of the shares of common stock (or common stock equivalents) is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, New York 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 39 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the completion of the offering, the satisfaction of customary closing conditions related to the offering, the intended use of proceeds from the offering, and the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

Final results from a human pilot study show DehydraTECHTM-powered semaglutide outperforms Rybelsus®:

  • Sustained higher levels of semaglutide in blood;
  • Better blood glucose control;
  • Faster achievement of peak drug delivery; and
  • Reduced side effects.

KELONA, BC / January 4, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX & LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces positive final results from its recently completed human Pilot Study #1 (the "Study") evaluating DehydraTECHTM technology for the oral delivery of the glucagon-like peptide-1 ("GLP-1") drug semaglutide available commercially in the branded product Rybelsus®.

The Study was performed by a prominent university research center comparing a single 7 mg semaglutide dose of a Rybelsus® tablet ("Control") to a matching dose from Rybelsus that had been compound formulated in capsule form using DehydraTECH processing technology enhancements ("DehydraTECH GLP-1").

In general, the DehydraTECH processing enabled improvements in delivery of semaglutide to the bloodstream, and the improvements in controlling blood sugar were more pronounced in the final combined results of the Study than they were in the first half of the Study as reported in press releases issued November 27 and November 28, 2023.

Blood Levels of Semaglutide

The first post-baseline blood was sampled 20 minutes after oral administration and, at that point in time, the DehydraTECH GLP-1 blood semaglutide level was ~261% higher than that of the Control, demonstrating DehydraTECH's well-known ability to deliver drugs to the bloodstream faster. At each of the 19 blood sample time points, the DehydraTECH GLP-1 blood semaglutide levels were higher than the Control levels. The peak levels of semaglutide in blood were 43% higher in the DehydraTECH GLP-1 than in the Rybelsus® Control.

Blood Semaglutide Levels (mmol/L)

Rybelsus Control (blue) 7mg (n=7) DehydraTECH (orange) GLP-1 7mg (n=7)

24 hours after the ingestion of the single dose, the DehydraTECH GLP-1 blood semaglutide levels were approximately 44% higher than the Control levels (Note - only the first 10 hours post dosing is shown in the graph above).

Side Effects

The DehydraTECH GLP-1 processed semaglutide was generally better tolerated than the Rybelsus® tablets themselves. Only the Rybelsus® tablets resulted in instances of moderate nausea and moderate diarrhea, whereas no such instances were reported upon DehydraTECH-semaglutide dosing.

Blood Glucose Levels

It is accepted by the Food and Drug Administration ("FDA") that, "one role of GLP-1 is to prompt the body to produce more insulin, which reduces blood glucose (sugar)." Because blood glucose levels are a key consideration in control of diabetes and other health conditions, the Study measured blood glucose levels at each of the 19 sample time points.

Blood Glucose Levels (mmol/L)

Rybelsus Control (blue) 7mg (n=7) DehydraTECH (orange) GLP-1 7mg (n=7)

The Control group evidenced inconsistent blood glucose reduction that did not prevent blood glucose spikes after eating. DehydraTECH GLP-1 reduced blood glucose to lower levels and was much more effective at maintaining consistently reduced blood glucose levels even after eating a standardized meal at the 240-minute mark and a standardized snack at the 360-minute mark. Actual data levels for each hour after Rybelsus® (control) and DehydraTECH drug administration are shown below.

Blood Glucose Levels (mmol/L)

Minutes

Control Mean

Change from Time Zero

DehydraTECH Mean

Change from Time Zero

0

5.04

5.13

60

4.84

-3.97%

4.54

-11.42%

120

4.63

-8.22%

4.34

-15.32%

180

4.49

-11.05%

4.33

-15.60%

240

4.46

-11.61%

4.33

-15.60%

300

5.43

+7.65%

4.60

-10.31%

360

5.39

+6.80%

4.64

-9.47%

420

5.5

+9.07%

4.67

-8.91%

480

5.3

+5.10%

4.64

-9.47%

540

5.09

+0.85%

4.60

-10.31%

600

5.03

-0.28%

4.61

-10.03%

24-Hour

5.04

0.00%

4.87

-5.01%

Notably, even as long as 24 hours after dose administration, the blood glucose levels were reduced in the DehydraTECH GLP-1 group by 5.01% relative to baseline while the blood glucose levels evidenced in the Rybelsus® Control group were unchanged. Our current assumption is that the improved delivery of semaglutide using DehydraTECH is most likely responsible for the observed greater efficacy in achieving sustained blood glucose reduction, thereby helping to attenuate the postprandial spikes in blood glucose experienced in the Control group.

This Study is only meant to provide early-stage indicative information to Lexaria about the possibility of enhancing the pharmacokinetic and pharmacodynamic performance of orally delivered GLP-1 drugs to assist in guiding the Lexaria team in additional investigations. There was minor variability in the diets of the subjects at the 240-minute meal and 360-minute snack intervals noted above during the concentrated 10-hour post dosing monitoring period which could account for some of the differences in the test data, although meal and snack selection allowance was from a set of standardized choices.

Future Work

Due to the success of the Study, Lexaria is already preparing for other human and animal studies to continue the evaluation of DehydraTECH's effectiveness with GLP-1 drugs. This work will be conducted on an expedited basis given the urgent need for effective oral delivery of GLP-1 drugs and DehydraTECH's apparent ability to improve their performance. Lexaria will provide more details about its GLP-1 strategy in separate news.

About the Study

The Study was performed to provide an early-stage indication of whether DehydraTECH processing could improve oral drug delivery characteristics of the GLP-1 drug semaglutide sold as Rybelsus®. A single semaglutide dose of 7 mg of the Control was compared to the matching dose of the DehydraTECH GLP-1, swallowed by each subject after an overnight fasting period together with a 50 mL glass of water. The DehydraTECH GLP-1 formulation used in this Study was compound formulated strictly for research purposes. Seven healthy subjects were dosed with each test article following a cross over study design across two study visits.

About Semaglutide

Rybelsus® (semaglutide) is the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic® and Wegovy®, administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk®.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 38 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the Company relating to the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com