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BetterLife Obtains Excellent Animal Cardiopulmonary Safety Data for Oral BETR-001

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BetterLife Pharma, an emerging biotech company, announced successful completion of its animal GLP cardiopulmonary safety study for BETR-001, a non-hallucinogenic derivative of LSD. The study showed no significant safety issues at doses over 100 times the projected starting dose for human trials. Key findings include no effects on ECG, respiratory parameters, body temperature, and activity levels. BETR-001's safety profile contrasts with LSD and psilocybin, known for cardiac toxicity due to 5-HT2B receptor agonism. BetterLife plans to file the BETR-001 IND by the end of 2024. Additionally, the company issued over 1 million common shares and warrants as part of a convertible debenture conversion totaling $103,534.20, with warrants exercisable at $0.10 per share until December 2025.

Positive
  • Successful completion of the animal GLP cardiopulmonary safety study for BETR-001.
  • No significant cardiopulmonary safety issues at doses over 100 times the projected human trial starting dose.
  • No BETR-001 related effects on ECG intervals, respiratory parameters, core body temperature, or activity levels in animal studies.
  • BETR-001 is a non-hallucinogenic derivative of LSD, potentially a safer alternative.
  • BETR-001 lacks agonist activity at the 5-HT2B receptor, reducing cardiac toxicity risks compared to LSD and psilocybin.
  • Plans to file the BETR-001 IND by the end of 2024.
Negative
  • Issuance of 1,035,342 common shares and 1,035,342 share purchase warrants could lead to shareholder dilution.
  • Share purchase warrants exercisable at $0.10 per warrant may affect stock price with potential influx of new shares.

VANCOUVER, British Columbia, May 14, 2024 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic derivative of lysergic acid diethylamide (“LSD”), announced it has completed its animal GLP cardiopulmonary safety study of BETR-001. The study demonstrated that oral BETR-001 at doses over 100-fold the projected starting dose in upcoming human trials did not show any significant cardiopulmonary pharmacological safety issues in animals.

Cardiopulmonary safety (also known as telemetry) studies investigate the effect of a drug in animals using surgically implanted transmitters to assess blood pressure, electrocardiography (ECG), lung respiration, body temperature, and general activity level. The BETR-001 cardiopulmonary study found no BETR-001 related effects on ECG intervals, respiratory parameters, core body temperature, or activity levels.

Dr. Ahmad Doroudian, CEO of BetterLife, commented, “We are very excited about these findings. BETR-001 is a unique non-hallucinogenic derivative of LSD with robust activity in animal depression and anxiety models without the burden of being hallucinogenic. Our previous in vitro neuroreceptor pharmacology studies (Cell Report 2023) had shown that BETR-001 is not an agonist at the 5-HT2B receptor. This is in marked contrast to LSD, psilocybin, and many other serotonergic psychedelics which are known to be agonists at the 5-HT2B receptor. Agonism at the 5-HT2B receptor is a known cause of cardiac toxicity (Pharmacol. Ther. 2011). The clean safety profile of BETR-001 in our completed cardiopulmonary study in animals further supports the claim that BETR-001 demonstrates much better cardiac safety profile compared to LSD, psilocybin and other serotonergic psychedelics with 5-HT2B activity.”

Dr. Doroudian added, “We are currently completing the remaining BETR-001 IND-enabling studies and project to file the BETR-001 IND by end of 2024.”

The Company also announces that it has issued 1,035,342 common shares and 1,035,342 share purchase warrants pursuant to the conversion of principal and accrued interest on convertible debentures totalling $103,534.20. Share purchase warrants are exercisable into common shares, on a one-for-one basis, at an exercise price of $0.10 per warrant and expires on December 31, 2025.

About BetterLife Pharma

BetterLife Pharma Inc. is an emerging biotechnology company primarily focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuro-psychiatric and neurological disorders.

BETR-001, which is in preclinical and IND-enabling studies, is a non-hallucinogenic and non- controlled LSD derivative in development and it is unique in that it is unregulated and therefore can be self-administered. BetterLife’s synthesis patent for BETR-001 eliminates regulatory hurdles and its pending patent, for composition and method of use, covers treatment of major depressive disorder, anxiety disorder and neuropathic pain and other neuro-psychiatric and neurological disorders.

BETR-002, which is in preclinical and IND-enabling studies, is based on honokiol, the active anxiolytic ingredient of magnolia bark. BetterLife’s pending method of use and formulations patent covers treatment of anxiety related disorders including benzodiazepine dependency.

BetterLife also owns a drug candidate for the treatment of viral infections and is in the process of seeking strategic alternatives for further development.

For further information, please visit BetterLife Pharma.

Contact

David Melles, Investor Relations Manager
Email: David.Melles@blifepharma.com
Phone: 1-778-887-1928

Cautionary Note Regarding Forward-Looking Statements

No securities exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.


FAQ

What is BETR-001?

BETR-001 is a non-hallucinogenic derivative of LSD developed by BetterLife Pharma.

What did the animal cardiopulmonary safety study of BETR-001 show?

The study found no significant cardiopulmonary safety issues at doses over 100 times the projected starting dose for human trials.

Did BETR-001 affect ECG or respiratory parameters in the study?

No, BETR-001 did not affect ECG intervals, respiratory parameters, core body temperature, or activity levels in animal studies.

How is BETR-001 different from LSD and psilocybin?

BETR-001 is non-hallucinogenic and does not act as an agonist at the 5-HT2B receptor, reducing cardiac toxicity risks.

When does BetterLife plan to file the BETR-001 IND?

BetterLife plans to file the BETR-001 IND by the end of 2024.

What is the significance of the convertible debenture conversion?

BetterLife issued 1,035,342 common shares and 1,035,342 share purchase warrants, potentially leading to shareholder dilution.

What is the exercise price of the issued share purchase warrants?

The share purchase warrants are exercisable at $0.10 per share until December 31, 2025.

BETTERLIFE PHARMA INC

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