FILAMENT HEALTH ANNOUNCES AUTHORIZATION OF PHASE 2 CLINICAL TRIAL FOR PEX010 IN THE TREATMENT OF METHAMPHETAMINE USE DISORDER

FILAMENT HEALTH ANNOUNCES AUTHORIZATION OF PHASE 2 CLINICAL TRIAL FOR PEX010 IN THE TREATMENT OF METHAMPHETAMINE USE DISORDER

Company study investigating PEX010, Filament's botanical psilocybin drug candidate, has been
authorized by both FDA and Health Canada

FILAMENT HEALTH CORP. (OTCQB: FLHLF) (Cboe CA: FH) (FSE:7QS) (" Filament " or the " Company "), a clinical‐stage natural psychedelic drug development company, today announced Health Canada and the United States Food and Drug Administration (" FDA ") authorization for a Phase 2 clinical trial of PEX010, Filament's botanical psilocybin drug candidate, for the treatment of methamphetamine use disorder (" MAUD "). This will be the first ever clinical trial to study the safety and efficacy of botanical psilocybin in a MAUD patient population.

Filament Health Corp. logo (CNW Group/Filament Health Corp.)

There is a critical need for new interventions to support people with MAUD as there are no FDA-approved pharmacotherapies for the treatment of the condition and effective options are extremely limited. It has been suggested that the complexities of MAUD call for a comprehensive approach to treatment that reduces stimulant overdose and relapse. This may not be achievable with solely pharmacological interventions and research has demonstrated that psychedelic-assisted psychotherapy may be a promising approach.

"The prevalence of methamphetamine use disorder has rapidly increased worldwide over the last decade, with the highest rate of use in North America ," said Dr. Christian Schütz, Professor of Psychiatry at the University of British Columbia (" UBC ") and Principal Investigator for the trial. "Existing clinical data indicates that psilocybin shows promise for the treatment of MAUD. Our aim with this trial is to assess the safety and efficacy of PEX010 in the treatment of MAUD, and to evaluate changes in participants' substance use, cravings, motivation, and recovery capital. We are grateful to Filament Health for funding and facilitating this much-needed research."

"These authorizations are a significant milestone in Filament's mission to support the treatment of substance use disorders with naturally-derived psychedelics," said Benjamin Lightburn , Chief Executive Officer and Co-Founder of Filament Health. "As a Vancouver -based company, the challenges faced by those in our community who are suffering from MAUD and the toxic drug crisis are close at hand. We are proud to sponsor this crucial research, and to partner with Dr. Schütz and his team."

The randomized, double-blinded, placebo-controlled clinical trial will evaluate approximately 90 patients with amphetamine-type stimulant use disorder. The primary efficacy endpoint is the change in the overall response rate based on clinically assessed criteria over the 3-month treatment period. Additional endpoints will assess safety and tolerability, changes in methamphetamine use and both clinician and patient reported outcomes across a variety of objective and subjective analyses. Patients assigned to the PEX010 arm will be treated with a single dose of PEX010 25mg in addition to psychotherapy. The Company expects to initiate dosing at UBC in the second half of 2024.

This is the second major regulatory milestone relating to Filament's investigation of PEX010 for substance use disorders (" SUD "). Earlier this year, the Company announced that the FDA accepted an Investigational New Drug (" IND ") application for PEX010 for SUD with an initial study in opioid use disorder (" OUD ").

PEX010 is authorized for investigation in 36 clinical trials worldwide for 14 mental health indications. PEX010 has also been studied extensively in compassionate use cases for major depressive disorder and end-of-life distress.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (CBOE CA:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with what we believe to be the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health   and on Twitter , Instagram , and LinkedIn .

SOURCE FILAMENT HEALTH CORP.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2024/03/c6587.html

News Provided by Canada Newswire via QuoteMedia

FH:AQL
The Conversation (0)
FILAMENT HEALTH ANNOUNCES WARRANT EXERCISE AND NOTE CONVERSION BY NEGEV CAPITAL AND CONCURRENT PRIVATE PLACEMENT OF COMMON SHARES TO BENJAMIN LIGHTBURN, CHIEF EXECUTIVE OFFICER

FILAMENT HEALTH ANNOUNCES WARRANT EXERCISE AND NOTE CONVERSION BY NEGEV CAPITAL AND CONCURRENT PRIVATE PLACEMENT OF COMMON SHARES TO BENJAMIN LIGHTBURN, CHIEF EXECUTIVE OFFICER

FILAMENT HEALTH CORP. (OTCQB: FLHLF) (Cboe CA: FH) (FSE: 7QS) (" Filament " or the " Company "), a clinical‐stage natural psychedelic drug development company, today announced that it has entered into agreements with Negev Capital Fund One, LP (" Negev "), a leading psychedelic drug development venture fund and existing investor in the Company, and Benjamin Lightburn the Chief Executive Officer and Co-Founder of the Company, to complete a C$1.0 million bridge financing (the " Financing ").

Filament Health Corp. logo (CNW Group/Filament Health Corp.)

Pursuant to the Financing, Negev will exercise its outstanding warrants (the " Warrants ") to purchase an aggregate of 17,284,443 common shares in the capital of the Company (" Common Shares ") and will convert its outstanding C$1.25 million convertible note, due July 13, 2024 (the " Note "), into 25,000,000 Common Shares. In consideration for the immediate exercise of the Warrants for cash, Filament has agreed to reduce the exercise price of such Warrants to C$0.05 per share, which is equal to the 15-day volume-weighted average closing price of the Common Shares on the Cboe Canada Canada Inc. (" Cboe Canada ") prior to entry into the agreement to complete the Financing. In connection with the conversion of the Note, Filament also agreed to reduce the conversion price to C$0.05 per share concurrent with the exercise of the Warrants. The Company also agreed to extend the expiration date of remaining warrants held by Negev's affiliates by twelve months. The gross proceeds to the Company from the exercise of the Warrants by Negev are C$0.9 million .

Additionally, as part of the Financing, Benjamin Lightburn , Chief Executive Officer of the Company, will purchase 2,700,000 Common Shares, also at a price of C$0.05 per share for gross proceeds to the Company of C$0.1 million . The Common Shares issued to Benjamin Lightburn will be subject to a four month and one day hold period in accordance with applicable securities laws.

Filament intends to complete the Financing, subject to regulatory approval, including the approval of Cboe Canada, on or about June 10, 2024.

"We are pleased to reinforce our continued commitment to Filament Health," said Ken Belotsky , Partner at Negev Capital. "Filament is strategically positioned to combat substance use disorders, leveraging its groundbreaking botanical drug development platform and an industry-leading intellectual property portfolio."

"We are thrilled that Negev, a strategic investor with strong industry expertise, has reaffirmed their commitment to Filament Health," said Benjamin Lightburn , Chief Executive Officer and Co‐Founder at Filament. "We believe that the Financing is in the best interest of our shareholders and is necessary for the continued advancement of our clinical development programs."

As a result of the exercise of Warrants and the conversion of the Note, Negev will become a holder of greater than 20% of the issued and outstanding Common Shares. The terms of the Financing and associated contractual amendments are exempt from shareholder approval pursuant to Section 10.10(2) of the Cboe Canada Listing Manual due to the current financial difficulties of the Company and the related risk of its ability to continue as a going concern as previously disclosed in Filament's financial statements. Additionally, the independent directors of the Company's board of directors have determined that the completion of the Financing, including the amendments to the exercise price of the Warrants and the conversion price of the Note, is in the best interests of the Company and is reasonable in the current circumstances and market conditions. It would also not be feasible to obtain shareholder approval or to complete an offering to existing shareholders on the same terms.

As Benjamin Lightburn , Chief Executive Officer and a Director of the Company (the " Related Party ") is participating in the Financing, the Financing is considered to be a "related party transaction" under Multilateral Instrument 61-101 - Protection of Minority Security Holders in Special Transactions (" MI 61-101 "). All of the independent directors of the Company, acting in good faith, have considered the Financing and have determined that the fair market value of the Common Shares being issued to the Related Party and the consideration being paid is reasonable. The Company has relied on the exemptions from the valuation and minority shareholder approval requirements of MI 61-101 contained in sections 5.5(b) and 5.7(a) of MI 61-101.

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (CBOE CA:FH) (FSE:7QS)
Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter , Instagram , and LinkedIn .

FORWARD LOOKING INFORMATION
Certain statements and information contained herein may constitute "forward‐looking statements" and "forward‐looking information," respectively, under Canadian securities legislation. Generally, forward‐looking information can be identified by the use of forward‐looking terminology such as, "expect", "anticipate", "continue", "estimate", "may", "will", "should", "believe", "intends", "forecast", "plans", "guidance" and similar expressions are intended to identify forward‐looking statements or information. The forward‐looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward‐looking statements. Forward‐looking statements regarding the Company are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward‐looking statements or forward‐looking information. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward‐ looking statements and forward‐looking information. Filament will not update any forward‐ looking statements or forward‐looking information that are incorporated by reference herein, except as required by applicable securities laws.

SOURCE FILAMENT HEALTH CORP.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2024/03/c0096.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
FILAMENT HEALTH ANNOUNCES FIRST QUARTER 2024 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

FILAMENT HEALTH ANNOUNCES FIRST QUARTER 2024 FINANCIAL RESULTS AND OPERATIONAL HIGHLIGHTS

FILAMENT HEALTH CORP. (OTCQB: FLHLF) (Cboe CA: FH) (FSE: 7QS) ("Filament" or the "Company"), a clinical-stage natural psychedelic drug development company, released its first quarter financial results and operational highlights for the period ended March 31, 2024 .

Filament Health Corp. logo (CNW Group/Filament Health Corp.)

"This quarter we have continued to advance Filament's drug development efforts in substance use disorders, as evidenced by the opening of our first IND with FDA in the United States . " said Benjamin Lightburn , Chief Executive Officer and Co-Founder at Filament Health. "We expanded our network of licensing partners to new jurisdictions around the globe and our botanical psilocybin drug candidate, PEX010, is now authorized for investigation in 31 clinical trials worldwide for 13 mental health indications.."

Q1 2024 Financial Highlights:

  • Cash and cash equivalents of $872,048 and a working capital of $359,664 as of March 31, 2024 ;
  • Cash used in operating activities of $949,606 and total revenues of $297,932 .

Q1 2024 Operational Highlights:

  • On January 31, 2024 , the Company announced that the U.S. Food and Drug Administration ("FDA") has accepted the Investigational New Drug application for PEX010 for treatment of substance use disorders.
  • On March 19, 2024 , the Company announced that it had completed exports of PEX010, the Company's botanical psilocybin drug candidate, to five research institutions in Canada , the United States , Belgium , and Israel for use in clinical trials studying mental health indications such as cannabis use disorder, depression, anxiety, and alcohol use disorder.
  • On February 15, 2024 , the Company announced that it had completed an export of PEX010 to Israel , which is believed to be the first botanical psilocybin exported to Israel .
  • On January 17, 2024 , the Company announced that it had completed an export of PEX010 to Perth , Western Australia , which is believed to be the first botanical psilocybin to be exported to Australia to its licensing partner, Reset Pharmaceuticals Inc. ("Reset").
ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (CBOE CA:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter , Instagram and LinkedIn .

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute "forward-looking statements" and "forward-looking information," respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, "expect", "anticipate", "continue", "estimate", "may", "will", "should", "believe", "intends", "forecast", "plans", "guidance" and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning the impact of the patent on the Company's business and the ability of the Company to secure future patents. Forward-looking statements regarding the Company are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including status of patent applications and the ability to secure patents. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

SOURCE FILAMENT HEALTH CORP.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2024/14/c2780.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
FILAMENT HEALTH ANNOUNCES CHANGE TO BOARD OF DIRECTORS

FILAMENT HEALTH ANNOUNCES CHANGE TO BOARD OF DIRECTORS

FILAMENT HEALTH CORP. (OTCQB: FLHLF) (Cboe CA: FH) (FSE: 7QS) (" Filament " or the " Company "), a clinical-stage natural psychedelic drug development company, today announced that Chris Wagner has stepped down from his position as Director on the Company's board of directors due to the requirements of a new role, effective April 30, 2024 .

Filament Health Corp. logo (CNW Group/Filament Health Corp.)

Wagner commented: "I have been part of Filament's leadership team since the Company was founded, and I firmly believe in its differentiated competitive position and prospects. I wish Filament nothing but success going forward."

The Board of Directors and the Company's management team would like to thank Chris for his valuable contributions. Filament CEO Benjamin Lightburn , Dr. Konstantin Adamsky , Jonathan Conlin , and Michael Messinger continue to serve on the Company's board.

ABOUT FILAMENT HEALTH   (OTCQB:FLHLF) (CBOE CA:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament's platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter , Instagram and LinkedIn .

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute "forward-looking statements" and "forward-looking information," respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, "expect", "anticipate", "continue", "estimate", "may", "will", "should", "believe", "intends", "forecast", "plans", "guidance" and similar expressions are intended to identify forward-looking statements or information. Forward-looking statements herein include, but are not limited to, statements regarding the resignation of Greg Mills from the board of directors and the composition of the audit committee. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. Forward-looking statements regarding the Company are based on the Company's estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

SOURCE FILAMENT HEALTH CORP.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/May2024/03/c5962.html

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×