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Detox with Indigenous wisdom

Universal Ibogaine and Osoyoos Indian Band sign MOU to battle opioid crisis

Universal Ibogaine (IBO) and Osoyoos Indian Band signed an agreement to develop a detox center that combines western science and Indigenous wisdom.

The center will use ibogaine treatments to ease opioid cravings and withdrawal symptoms, followed by Indigenous healing practices as aftercare to “rebuild people in a holistic manner.”

Their flagship detox center will be in Manitoba, Canada with the goal of working with other First Nations to expand across the country, and then globally. 

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Universal Ibogaine Commences Development Plan At Kelburn In Preparation For Ibogaine Treatments And Provides Update On Drug Supply

Universal Ibogaine Commences Development Plan At Kelburn In Preparation For Ibogaine Treatments And Provides Update On Drug Supply

CALGARY, AB, Feb. 2, 2022 /CNW/ – Universal Ibogaine Inc. (TSXV: IBO) (“UI” or the “Company“) a life sciences company with a mission to deliver medicalized ibogaine-centered addiction treatment, has initiated development plans at its Kelburn treatment facility in preparation for treatment protocol approval and commencement of ibogaine treatments.

What is Ibogaine?

Ibogaine is a plant derived neuroactive compound that appears to reset the brains of drug dependent individuals to a pre-addicted state.  Ibogaine has demonstrated particular effectiveness in treating opioid use disorder.  When applied according to a strict safety protocol, ibogaine appears to eliminate the most painful symptoms of opioid withdrawal and provides a several month window free of drug cravings.  Dr Alberto Sola, co-founder of Universal Ibogaine has administered more ibogaine treatments than any other doctor in the world. 

Kelburn Addiction Treatment Center

Universal Ibogaine acquired the licensed and operational Kelburn Mental Health and Addiction Treatment facility in October of 2021.  The facility sits on a destination 50 acre estate with a 9 hole golf course and currently operates as a traditional addiction treatment center. 

Universal Ibogaine has undertaken plans to expand the facility to include traditional drug detox and to begin to incorporate the best in nuovo treatment modalities including Ketamine, Psilocybin and MDMA assisted psychotherapies. 

Universal Ibogaine has commenced development plans to construct a stand alone ibogaine detox facility on the property in preparation for the completion of its proof of concept study with Health Canada.


Dr Ian Rabb – Chief Clinics Officer

Dr Ian Rabb of Universal Ibogaine stated: “In my 20 years of addiction treatment, I have not seen anything with the power and promise of ibogaine to break the cycle of addiction.  When paired with a long term support plan, which we provide through our Kelburn facility, we expect to completely disrupt the addiction treatment model.  Ibogaine is legal in Canada under the prescription drug list and requires a proof of safety trial through Health Canada.  We are sitting on the edge of being able to tackle the opioid crisis head on.”

Drug Supply Update

Universal Ibogaine would also like to provide an update regarding the drug supply agreement with Psygen. The agreement was announced prematurely and contained some minor errors regarding the synthesis of the compound.  As a result, the parties to the agreement have withdrawn.

UI is currently in negotiations with two alternative drug suppliers.


About Universal Ibogaine Inc.
UI is a life sciences company, with a mission to demonstrate the safety and efficacy of its ibogaine based drug detox protocol through a Canadian Clinical Trial, and ultimately to utilize that protocol around the globe through future licensing agreements. UI is concurrently developing a state of the art holistic addiction treatment protocol at its Kelburn Clinic that, when paired with the ibogaine detox protocol, is intended to
revolutionize the way we treat addiction and drastically improve the lives of individuals and families affected by addiction.

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS


‎This news release may contain forward-looking statements and information. Forward-looking information is frequently characterized by words such ‎as “plans”, “expect”, “project”, “intend”, “will”, “believe”, “anticipate”, “estimate”, “scheduled”, ‎‎”potential”, or other similar words, or statements that certain events or conditions “may”, “should” or ‎‎”could” occur. The forward-looking statements and information are based on certain key expectations ‎and assumptions made by UI. Although UI believes that the expectations
and assumptions on which the forward-‎looking statements are based are reasonable, undue reliance should not be placed on the forward-‎looking statements because UI can give no assurance that they will prove to be correct.


Since ‎forward-looking statements address future events and conditions, by their very nature they involve ‎inherent risks and uncertainties. Actual results could differ materially from those currently anticipated ‎due to a number of factors and risks, which include, but are not limited to, risks that required ‎regulatory approvals are not obtained. The reader is cautioned that assumptions used in the ‎preparation of such information, although considered reasonable by UI at the time of ‎preparation, may prove to be incorrect
and readers are cautioned not to place undue reliance on ‎forward-looking information, which speaks only to conditions as of the date hereof. UI does not ‎undertake any obligation to release publicly any revisions to forward-looking information contained ‎herein to reflect events or circumstances that occur after the date hereof or to reflect the occurrence ‎of unanticipated events, except as may be required under applicable securities laws. ‎


For further information:


Investor Relations: Dugan Selkirk, IR Manager
dugan.selkirk@universalibogaine.com


Media Contact: Cathy Fernandes, Director – Marketing & Communications
cathy.fernandes@universalibogaine.com

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Universal Ibogaine Enters Drug Supply Agreement

Universal Ibogaine Enters Drug Supply Agreement

Calgary, AB – January 26, 2022 – Universal Ibogaine Inc. (TSXV:IBO) (“UI” or the “Company”) a life sciences company with a mission to develop and deliver medicalized ibogaine-centered addiction care, is pleased to advise it has entered into an agreement (the “agreement”) with Psygen Labs Inc. (“Psygen”) to secure a supply of GMP ibogaine for use in its planned future clinical trial for opioid use disorder and ongoing ibogaine detox treatments at its clinics.


UI is in process of finalizing its pre-clinical trial (“pre-CTA”) submission to Health Canada, following which it intends to apply to undertake a clinical trial of ibogaine for use in treatment of opioid use disorder(s). The final approval by Health Canada will require UI to have an approved, secure supply of GMP certified ibogaine to use in the eventual clinical trial process. Psygen is a Canadian company based in Calgary and is a leader in the manufacture of a range of medical grade products being used in the emerging
psychedelics-based psycho-therapy field of treatment of anxiety, depression and other mental health issues.


Nick Karos – Universal Ibogaine CEO
Nick Karos noted “We are pleased to have secured a firm of Psygen’s caliber as one of our key partners.Ibogaine has been used in tribal ceremonies in Africa for centuries and has traditionally been sourced for medical use from the root bark of a shrub found in limited areas of the Congo basin in Africa. Psygen has developed a process to manufacture synthetic ibogaine, which will provide a more secure and sustainable source of supply for our trials and a scalable solution for our treatment protocol to help as many people as possible. We look forward to a long-term partnership with Psygen as part of our goal of having ibogaine
approved for wide-scale use in opioid detoxification and addiction treatments.”


About Universal Ibogaine Inc.
UI is a life sciences company, with a mission to demonstrate the safety and efficacy of its ibogaine based drug detox protocol through a Canadian Clinical Trial, and ultimately to utilize that protocol around the globe through future licensing agreements. UI is concurrently developing a state of the art holistic addiction treatment protocol at its Kelburn Clinic that, when paired with the ibogaine detox protocol, is intended to
revolutionize the way we treat addiction and drastically improve the lives of individuals and families affected by addiction.

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS


‎This news release may contain forward-looking statements and information. Forward-looking information is frequently characterized by words such ‎as “plans”, “expect”, “project”, “intend”, “will”, “believe”, “anticipate”, “estimate”, “scheduled”, ‎‎”potential”, or other similar words, or statements that certain events or conditions “may”, “should” or ‎‎”could” occur. The forward-looking statements and information are based on certain key expectations ‎and assumptions made by UI. Although UI believes that the expectations
and assumptions on which the forward-‎looking statements are based are reasonable, undue reliance should not be placed on the forward-‎looking statements because UI can give no assurance that they will prove to be correct.


Since ‎forward-looking statements address future events and conditions, by their very nature they involve ‎inherent risks and uncertainties. Actual results could differ materially from those currently anticipated ‎due to a number of factors and risks, which include, but are not limited to, risks that required ‎regulatory approvals are not obtained. The reader is cautioned that assumptions used in the ‎preparation of such information, although considered reasonable by UI at the time of ‎preparation, may prove to be incorrect
and readers are cautioned not to place undue reliance on ‎forward-looking information, which speaks only to conditions as of the date hereof. UI does not ‎undertake any obligation to release publicly any revisions to forward-looking information contained ‎herein to reflect events or circumstances that occur after the date hereof or to reflect the occurrence ‎of unanticipated events, except as may be required under applicable securities laws. ‎


For further information:

Investor Relations: Dugan Selkirk, IR Manager
dugan.selkirk@universalibogaine.com

Media Contact: Cathy Fernandes, Director – Marketing & Communications
cathy.fernandes@universalibogaine.com

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Universal Ibogaine Announces World-class Clinical Trial Partners In Advance Of Clinical Trial Application For Ibogaine In Opioid Use Disorder

Universal Ibogaine Announces World-class Clinical Trial Partners In Advance Of Clinical Trial Application For Ibogaine In Opioid Use Disorder

Calgary, AB – January 14, 2022 – Universal Ibogaine Inc. (TSXV:IBO) (“UI” or the “Company”) a life sciences company with a mission to develop and deliver medicalized ibogaine-centered addiction care, is pleased to introduce its contract research organization (“CRO”) partners who will enable UI’s planned clinical trial in Canada to be conducted, subject to the required approval by Health Canada. UI is currently working with its CRO partners to finalize UI’s study design in advance of an anticipated pre-clinical trial application meeting to soon be held with Health Canada.

UI has selected Intrinsik Corp. (“Intrinsik”), an internationally recognized regulatory affairs consulting firm, to provide regulatory strategy and support for the preparation and submission of UI’s Canadian Clinical Trial Application (“CTA”), as well as follow-up and monitoring if a No Objection Letter (“NOL”) is received from Health Canada. Intrinsik is comprised of an experienced team who have driven hundreds of successful clinical trials and investigational new drug applications and have collectively contributed to more than 20 new drug marketing applications. The group has over 25 regulatory affairs professionals based in its Canadian headquarters located in the greater Toronto area, and unparalleled expertise and experience related to Central Nervous System Disorders (CNS: the therapeutic area to which addiction and mental health disorders belong). 

Support for the development of the substance of the CTA package, as well as ultimately the operation of the clinical trial itself, is being provided by the world-class team at CATO Research Canada Inc.(“CATO SMS”). The CATO SMS team of experts have over 30-years’ experience optimizing the design and execution of clinical trials for life sciences companies such as UI. CATO SMS has successfully conducted over 500 clinical trials in over 25 countries and have enrolled more than 60,000 patients at over 5,500 sites. 

The CATO SMS engagement team, along with UI’s team, involves a variety of experts in Canada, the US and Europe, providing critical expertise ranging from clinical study designs to biostatistics to clinical operations (e.g., patient recruitment, study startup, budgeting, site management, data management, etc.). CATO SMS’ contributions will also include the analysis and synthesis of proprietary real-world data and evidence ( “RWD” and “RWE”, respectively) stemming from the application of ibogaine for the treatment of opioid use disorder in approximately 200 patients who have been treated in Cancun, Mexico by UI’s licensing partner – Clear Sky Recovery Cancun SA de CV.  UI believes that the presentation of RWD and RWE as part of the CTA package will strengthen the application, particularly the preliminary claim to safety, and is aligned with emerging guidance by regulators, such as the US Food and Drug Administration (“FDA”), to acknowledge and incorporate RWD and RWE in clinical development, and generally in evidence-based medicine.    

Finally, UI is lining up prominent academic and medical centres to support the CTA to Health Canada, as well as potentially serve as sites to undertake the ultimate clinical trial. Notably, UI has engaged the research office of a leading Canada-based academic and teaching institution in the therapeutic area of addiction to support the design of the study protocol and generate interest in trial site selection.

Nick Karos – Universal Ibogaine CEO

Nick Karos (CEO) noted “Our engagement with Health Canada to date has clearly highlighted the road UI must take to provide practitioners and patients access to authorized ibogaine in Canada to treat opioid use disorder. The conduct of clinical trials is a very precise business requiring solid partnerships with the right expertise and players, and Universal Ibogaine is pleased that we have now secured these partnerships. We are confident that that with our partners expertise, we will move towards our goal of conducting clinical trials with Health Canada.”

About Universal Ibogaine Inc.

UI is a life sciences company, with a mission to develop and acquire a network of addiction treatment clinics throughout Canada, and to eventually use ibogaine as a primary modality for the interruption and ideally cessation of addictions: primarily opioids such as oxycodone, heroin, fentanyl, as well as alcohol, cocaine, and other stimulants.  

As such, UI concurrently plans to clinically develop ibogaine, a plant derived substance, as an authorized addiction interruption medicine for the treatment of Opioid Use Disorder.  A Clinical Trial Application to Health Canada is being developed to undertake clinical trials in Canada, aimed at proving the safety and efficacy of the use of ibogaine for this purpose.  In the longer term, and once approved as planned, UI will introduce ibogaine into the addiction treatment protocols to be used in its future facilities.

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS 

‎This news release may contain forward-looking statements and information. Forward-looking information is frequently characterized by words such ‎as “plans”, “expect”, “project”, “intend”, “will”, “believe”, “anticipate”, “estimate”, “scheduled”, ‎‎”potential”, or other similar words, or statements that certain events or conditions “may”, “should” or ‎‎”could” occur.  The forward-looking statements and information are based on certain key expectations ‎and assumptions made by UI.  Although UI believes that the expectations and assumptions on which the forward-‎looking statements are based are reasonable, undue reliance should not be placed on the forward-‎looking statements because UI can give no assurance that they will prove to be correct. 

Since ‎forward-looking statements address future events and conditions, by their very nature they involve ‎inherent risks and uncertainties. Actual results could differ materially from those currently anticipated ‎due to a number of factors and risks, which include, but are not limited to, risks that required ‎regulatory approvals are not obtained. The reader is cautioned that assumptions used in the ‎preparation of such information, although considered reasonable by UI at the time of ‎preparation, may prove to be incorrect and readers are cautioned not to place undue reliance on ‎forward-looking information, which speaks only to conditions as of the date hereof.  UI does not ‎undertake any obligation to release publicly any revisions to forward-looking information contained ‎herein to reflect events or circumstances that occur after the date hereof or to reflect the occurrence ‎of unanticipated events, except as may be required under applicable securities laws. ‎

For further information: 

Investor Relations: Dugan Selkirk, IR Manager

dugan.selkirk@universalibogaine.com

Media Contact: Cathy Fernandes, Director – Marketing & Communications cathy.fernandes@universalibogaine.com 

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Universal Ibogaine Announces Change In Leadership

Universal Ibogaine Announces Change In Leadership

Calgary, AB – TheNewswire – January 10, 2022 – Universal Ibogaine Inc. (TSXV:IBO) (“UI” or the “Company”) announces that Rami Batal has been replaced as Chief Executive Officer (“CEO”) of the Company and its subsidiaries.  For the present time, the Company has appointed Nick Karos as CEO, effective immediately.  Mr. Karos had recently been appointed as a Capital Markets consultant to the Company.

“We are grateful for Rami’s leadership and many contributions,” said Chief Ian Campbell, Chair of the UI Board of Directors.  “We wish Rami all the best.”

Mr. Karos is based in Los Angeles, USA, and is a seasoned financier.  His career includes senior roles with US investment banks, including serving at Piper Jaffray as head of Nasdaq Trading and Agency Services, and most recently as CEO of Private Trading Group, which has provided business development and capital raising services for several successful start-up ventures.

Mr. Karos said “I’m very excited to work with the talented partners at UI to move towards our goal of conducting clinical trials with Health Canada.  Universal Ibogaine’s goal is to transform the addiction treatment model using ibogaine as the cornerstone of our new addiction treatment protocol.  Addiction is a disease that affects society like none other, and we believe our ground-breaking protocol will give patients and families a better path towards long-term recovery.”

The Board of Directors will immediately begin an executive search process for selecting a new CEO.  Mr. Karos remains a short list candidate for the long term position.

About Universal Ibogaine Inc.

UI is a life sciences company, with a goal to develop a platform of addiction treatment clinics, which may eventually use ibogaine as a primary modality for the interruption and ideally cessation of addictions to primarily opioids such as oxycodone, heroin, fentanyl, as well as alcohol, cocaine, and other stimulants.  

UI separately plans to clinically develop ibogaine, a natural plant substance, as an authorized addiction interruption medicine for the treatment of Opioid Use Disorder.  A Clinical Trial Application to Health Canada is being developed to undertake clinical trials in Canada, aimed at proving the safety and efficacy of the use of ibogaine for this purpose.  In the longer term, UI plans to introduce ibogaine into the addiction treatment protocols to be used in its’ future facilities.

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This news release may contain forward-looking statements and information. Forward-looking information is frequently characterized by words such ‎as “plans”, “expect”, “project”, “intend”, “will”, “believe”, “anticipate”, “estimate”, “scheduled”, ‎‎”potential”, or other similar words, or statements that certain events or conditions “may”, “should” or ‎‎”could” occur.  The forward-looking statements and information are based on certain key expectations ‎and assumptions made by UI.  Although UI believes that the expectations and assumptions on which the forward-‎looking statements are based are reasonable, undue reliance should not be placed on the forward-‎looking statements because UI can give no assurance that they will prove to be correct.

Since ‎forward-looking statements address future events and conditions, by their very nature they involve ‎inherent risks and uncertainties. Actual results could differ materially from those currently anticipated ‎due to a number of factors and risks, which include, but are not limited to, risks that required ‎regulatory approvals are not obtained. The reader is cautioned that assumptions used in the ‎preparation of such information, although considered reasonable by UI at the time of ‎preparation, may prove to be incorrect and readers are cautioned not to place undue reliance on ‎forward-looking information, which speaks only to conditions as of the date hereof.  UI does not ‎undertake any obligation to release publicly any revisions to forward-looking information contained ‎herein to reflect events or circumstances that occur after the date hereof or to reflect the occurrence ‎of unanticipated events, except as may be required under applicable securities laws. ‎

For further information:

Investor Relations: Dugan Selkirk – IR Manager

dugan.selkirk@universalibogaine.com

Media Contact: Cathy Fernandes – VP, Marketing & Communications cathy.fernandes@universalibogaine.com

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Universal Ibogaine Announces Expansion Of Executive Team And Grant Of Stock Options

Universal Ibogaine Announces Expansion Of Executive Team And Grant Of Stock Options

Calgary, AB – TheNewswire – December 2, 2021 – Universal Ibogaine Inc. (TSXV:IBO) (“ UI ” or the “ Company ”), a life sciences company with a mission to research and deliver medicalized ibogaine-centered addiction care, is pleased to announce an expansion of its’ Executive team, and welcomes Nick Karos as its new Director – Capital Markets.

Mr. Karos is based in Los Angeles, USA, and is a seasoned financier.  His career includes senior roles with US investment banks, including serving at Piper Jaffray as head of Nasdaq Trading and Agency Services, and most recently as CEO of Private Trading Group, which has provided business development and capital raising services for several successful start-up ventures.

Mr. Karos’ mandate will include expanding awareness of UI in the US-based investment community (including institutional investors, family offices, high net worth individuals and investment advisors), securing sources of expansion capital, as well as identifying business development opportunities in the addiction treatment industry.  UI is currently in the process of finalizing an application to be listed for trading in the USA on the OTC QB market.

UI also advises that it has granted incentive stock options (“ Options ”) to members of its recently expanded Executive team, as well as to several key, long-serving consultants to UI, and two new members of its’ Board of Directors who joined UI effective October 18, 2021, as follows:

Chief Clinics Officer (Ian Rabb, joined UI November 15)3,000,000
Chief Financial Officer (Greg Leavens)2,000,000
Director – Capital Markets (Nick Karos)2,000,000
Board members (David Danziger and Anthony DeCristofaro, joined UI October 18)400,000
Consultants1,450,000
8,850,000

The grants are made under the Company’s 20% Fixed Stock Option Plan, which based on the total shares outstanding as at the date of the Company’s Amalgamation on August 31, 2021, has a cap of 38.1 million shares issuable for the exercise of Options and Performance Shares.

None of the current grantees have previously been issued any UI Options, and each Option will entitle the holder to acquire one UI common share at an exercise price of $0.25 per share (which was the issue price of the August 31, 2021 go-public Offering).  Entitlement to exercise the Options will vest over a term of 3 years (1/3 per year) for 4,850,000 of the Options and 2,000,000 Options will vest over a term of 2 years. For Mr. Karos, the vesting period is one year, and 1,150,000 of his 2,000,000 Option grant (58% of his total) will only vest upon achieving performance-based milestones.  The term to expiry of the Options will be 5 years, except for 3,000,000 Options which will have a term of 10 years.

Dr. Rami Batal, UI’s CEO noted “As a life sciences company, we are an integral participant in the knowledge economy. While we have aimed to minimize cash compensation costs, the importance for UI of recruiting and retaining top talent is paramount, particularly in today’s competitive environment. Our team, including members of our Board of Directors who continue to provide both governance and operational guidance, are relentless in their quest to make UI successful. The recent addition of Anthony DeCristofaro and David Danziger enhanced our Board of Directors and strengthened our business and financial acumen. Dr. Ian Rabb, who joined us in mid-November, is making considerable strides in shaping our innovative addiction care model, which is to be piloted at the Kelburn Clinic in Winnipeg.  Mr. Nick Karos, our exciting new addition to the UI team, will augment our corporate finance and capital markets expertise and experience, and bolster our access and effectiveness in the ever-critical US market environment.”