Tetra Bio-Pharma Inc. Provides Corporate Update Ahead of Its Annual General Meeting
Momentum Public Relations
Press Release: June 13 2018
Tetra Bio-Pharma Inc.=(TBP:V) (OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, is pleased to provide a Corporate Update on its programs and upcoming milestones in the development of its bio-pharmaceutical and natural health products that address large markets with significant unmet medical needs.
- In Q3 of this year, TBP will file a request to commence a Phase 1 clinical trial for PPP004 our topical product indicated for General Neuropathic Pain, conservatively estimated as a billion-dollar market. Neuropathic pain can be caused by injury or disease and can be associated with such common conditions as shingles, diabetic neuropathy, multiple sclerosis, spinal stenosis and sciatica among other conditions.
- In Q3, we anticipate filing a request to commence a Phase 1 clinical trial for PPP003 an ocular treatment for eye pain and inflammation and dry eye. The company has identified one lead compound that is a non-scheduled 1 cannabinoid which would significantly reduce time to market as is it not considered a controlled substance. TBP is also exploring conducting a study focused on Dry-Eye, in the USA.
- Tetra-Bio-Pharma anticipates launching its Rx Oil capsules for the treatment of chronic pain and cancer pain in Q3 of this year. The company is presently conducting a Phase IV study expected to be completed in Q3 and we expect the launch to occur in Q3.
- We expect to complete our Phase III trial for PPP001 in Q4/2018, Q1/2019 and will file for approval in Q1 of 2019. Tetra will seek additional indications for this product and we will announce our intentions soon.
- In Q3, we expect to launch our bioavailability study for PPP0002, and if we prove equivalence to the referenced product, Tetra anticipates filing for approval under the 505 (B) 2 route in the USA in Q4 2018. In addition, Tetra expects to commence a Phase II study in chronic pain with PPP002 in Q3 of this year.
- Legalization of recreational cannabis is expected to take place in Q3/Q4 of this year following which Tetra Bio-Pharma will launch no fewer than 7 cannabinoid based Natural Health products in the Canadian market. We will also look to license these products worldwide.
“Tetra Bio-Pharma has come a long way in the last 12 months and the momentum is building as we advance our products through various phases of clinical development, thereby answering the need for rigorous scientific evidence. We believe our independently credentialed clinical development work, in combination with the launch of our natural health products will be instrumental in building shareholder value,” stated Guy Chamberland Interim CEO and CSO for Tetra Bio-Pharma.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a clinical program aimed at bringing novel drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries that are engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant-based elements. Tetra Bio-Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
For further information, please contact Tetra Bio-Pharma Inc.
Robert (Bob) Béchard
Executive Vice President, Corporate Development & Licensing
(514) 817-2514
For investors information, please contact:
investors@tetrabiopharma.com
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.
- Published in Tetra Bio Pharma
Tetra Bio-Pharma Signs Landmark Commercialization Term Sheet for its Lead Pharmaceutical Product, PPP001, in Israel
Momentum Public Relations
Press Release: April 24
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP) (OTCQB:TBPMF), announced today that the Company has signed a first binding term sheet for the marketing and distribution of PPP001 in Israel with Kamada Ltd., a leading pharmaceutical company. The signing of a Definitive Distribution Agreement is expected to follow shortly. PPP001 is being developed to be the first smokable cannabis product for advanced cancer pain available under prescription.
This first international market commercialization agreement represents a significant milestone and a validation of Tetra Bio-Pharma’s business model with a leading Israel-based pharmaceutical company. Israel, like Canada, is considered one of the world leaders in the production and development of cannabinoid-based products. Kamada is a company with two FDA-approved products and an Israeli-based distribution segment that has demonstrated continued growth. Tetra Bio-Pharma intends to work closely with Kamada as PPP001 advances towards regulatory approval and commercial launch in Israel.
Under the terms of the anticipated final agreement, Kamada will be responsible for registering the product, as well as all marketing and distribution, in Israel. Tetra will be eligible to receive certain milestone payments and an undisclosed percentage of the sales of PPP001 generated by Kamada in Israel.
About PPP001
On April 4, 2018, Tetra Bio-Pharma officially started the Phase 3 trial for PPP001 indicated for terminal stage cancer patients with a goal to improving the quality of life of these patients as well as minimizing their pain. PPP001 is being developed to be the first smokable cannabis product for advanced cancer pain available under prescription.
About Tetra Bio-Pharma: Tetra Bio-Pharma (TSX VENTURE:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products. Tetra Bio-Pharma is currently developing a pipeline of five cannabinoid-based products using different delivery systems such as smokable pellets, oral tablets, eye drops and topical ointments. More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Inc.
Robert (Bob) Béchard
Vice President Finance and Business Development
bob@tetrabiopharma.com
M: +1 514 817-2514
For media information, please contact:
Daniel Granger
Daniel.granger@acjcommunication.com
ACJ Communication
O: +1 514 840 7990
M: +1 514 232 1556
- Published in Tetra Bio Pharma
Tetra Bio-Pharma Clinical Study on Cannabis Oil Capsules for Patients Suffering from Chronic Pain should be completed by Fall 2018
Momentum Public Relations
Press Release: April 12 2018
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP) (OTCQB:TBPMF), provides a status report on its encapsulated cannabis oils (PPP005) clinical trials and that these cannabis products are ready to commercialize in the retail market post-legalization.
Natural health products and OTC medications
The authorization from the Office of Controlled Substances marks the initiation of the treatment phase of the Phase 2 clinical trial that will be used to support Product License Applications post legalization. Tetra is performing this clinical study to obtain safety and efficacy data to support modern claims for the use of encapsulated cannabis oils in the treatment of chronic pain. Tetra’s program is designed to build a leading position in the development and commercialization of cannabis-based natural health products. Tetra’s products are being developed to be compliant with standards expected for pharmaceutical products which will be supported by scientific and clinical evidence.
PPP005 Phase 1 Clinical trial
Phase 1 clinical trial to assess safety, tolerability and pharmacokinetics of single and multiple dose of encapsulated cannabis oil (10 mg THC with 10 mg CBD) will be completed soon. “This study will provide cardiovascular safety data to ensure that the oil formulations can be safely used by consumers. The pharmacokinetic data will provide the data required to define the frequency of dosing needed to avoid inappropriate use that could lead to accumulation of cannabinoids in the body,” said Dr. Guy Chamberland, M.Sc., Ph.D., interim CEO and Chief Scientific Officer.
PPP005 Phase 2 Clinical trial
On March 22, 2018, Santé Cannabis, the Montreal-based clinic that is conducting the Phase 2 clinical trial for Tetra, received authorization from the Office of Controlled Substances to use the cannabis oil capsules of PPP005 (controlled substance).
This authorization allowed the Principal Investigator of the trial, Dr. Antonio Vigano, to proceed with the clinical trial of PPP005 in chronic pain patients. This exemption allows Santé Cannabis to prescribe the blinded study medication and for Aphria Inc to ship blinded products to patient’s home under the jurisdiction of the ACMPR. The screening and enrolment is proceeding faster than expected and will allow Tetra to meet its corporate objectives.
“We are performing this Phase 2 clinical trial to obtain safety and efficacy data to help drive the sales of encapsulated cannabis oil products for the treatment of chronic pain,” added Dr. Guy Chamberland. “We expect chronic pain patients to use cannabis oils, but many of these patients will also be taking opioids or other prescription medications. The capability of different doses and ratios of medical cannabis oil to change the amount and type of concomitant medications, such as opioids, used for pain, and the need for rescue pain medication to control chronic non-cancer and cancer pain is evaluated. The use of measures that quantify different pain drug regimens used by the patients will help us understand the potential of cannabis oils to be used for opioid sparing. The trial should be completed by fall 2018.”
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products. Tetra Bio-Pharma is currently developing a pipeline of five cannabinoid-based products using different delivery systems such as smokable pellets, oral tablets, eye drops and topical ointments.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
anne-sophie.courtois@
(514) 360-8040 Ext. 210
For media information, please contact:
Daniel Granger
Daniel.granger@
ACJ Communication
O: 1 514 840 7990
M: 1 514 232 1556
- Published in Tetra Bio Pharma
Tetra Bio-Pharma Announces the appointment of Gregory Drohan to its board of directors
Momentum Public Relations
Press Release: April 10 2018
Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, announced today that it has appointed Gregory Drohan to its board of directors effective April 10, 2018.
The company will nominate Mr. Drohan for election at Tetra’s 2018 Annual Meeting of Shareholders.
Chairman André Rancourt welcomes Mr. Drohan to the board and comments, “We are pleased to welcome Greg as a new Independent director to the Tetra board. His extensive experience as a senior executive and marketer in the consumer products space will bring tremendous vision and skills to the execution and development of the Tetra Bio-Pharma growth strategy.”
“These are exciting times at Tetra and having Greg join us at this pivotal moment in the history of cannabis and its consumption is a tremendous win.” said Guy Chamberland, Interim CEO and CSO of Tetra Bio-Pharma.
“I am excited to be joining the board of Tetra and to be involved with a leading company in an industry that is shaping the future of health care. I can’t wait to put my experience to work alongside Guy and his team of professionals at Tetra,” added Greg Drohan.
Gregory Drohan’s committee appointments will be determined immediately following his election to the board at the 2018 Annual Meeting of Shareholders.
About Gregory Drohan
Until 2013, Greg Drohan was President of the board of Church and Dwight Canada Corp. While with Church and Dwight Canada, Drohan successfully merged the Church & Dwight and Carter-Horner businesses which lead to the doubling of sales revenue and achieved #1 market share on brands such as Trojans, Oxi Clean, First Response, Rub A535 and Arm & Hammer. Following his successful 40-year career in the consumer products sector Mr. Drohan has established a management consulting practice. His previous board experiences include President on the Board of Church and Dwight and director of the Ryerson University Alumni Relations Board. Drohan holds an MBA from York University and a BBM from Ryerson Polytechnical Institute.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
anne-sophie.courtois@
(514) 360-8040 Ext. 210
For media information, please contact:
Daniel Granger
Daniel.granger@
ACJ Communication
O: 1 514 840 7990
M: 1 514 232 1556
- Published in Tetra Bio Pharma
Tetra Bio-Pharma Initiates Enrolment of Patients in Phase 3 PPP001 Smokable Cannabis Pellet Study
Momentum Public Relations
Press Release: April 4 2018
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP) (OTCQB:TBPMF), today announced the initiation of screening and enrolment activities in the Phase 3 study of its PPP001 smokable cannabis pellet for advanced cancer patients with uncontrolled pain.
Tetra authorized the initiation of the patient enrolment activities at its main clinical site, Santé Cannabis, a private medical cannabis clinic in Montreal which is in compliance with Health Canada Division 5 regulations and the International Conference on Harmonization (ICH) Good Clinical Practices (GCP) (E6) R2.
PPP001 aims to be the first smokable cannabis for advanced cancer pain available under prescription. It is a dried cannabis pellet designed to be smoked in an inhalation device specifically developed for this product. PPP001 is a unique blend of 3 strains of standardized dried cannabis, creating a drug substance with 9.5% THC and 2.5% CBD.
“This is a significant milestone in the lead product of our strong pipeline of cannabinoid-based drugs targeting patients with advanced pain,” said Guy Chamberland, Tetra’s CEO and CSO. “The launch of the Phase 3 clinical trial will be used to support the marketing application of PPP001 smokable pellet that is followed by four other cannabinoid-based products that we are developing using different delivery systems such as oral tablets, eye drops, topical ointments and oral capsules of cannabis oil.”
On February 28th, 2018, Santé Cannabis received authorization from the Office of Controlled Substances to use PPP001 (controlled substance) for the Phase 3 clinical trial. This authorization granted the Principal Investigator of the Phase 3 trial, Dr. Antonio Vigano, exemption from the application of several provisions of the Controlled Drugs and Substances Act and the Narcotic Control Regulations thereby allowing the investigator to proceed with the clinical study of PPP001 in advanced cancer patients. In addition, the exemption allows Santé Cannabis to store and dispense the study medication directly to the patients, a process not permitted by Licensed Producers under the ACMPR.
“We are performing the first large study of the safety and efficacy of a dried cannabis smoked drug in advanced cancer patients,” added Guy Chamberland. “Over the next month Tetra will expand the trial by working with other clinics across Canada. Most importantly, we believe this multisite study has the potential to change the current vision of the use of smoked cannabis as an effective palliative care therapy of patients with advanced cancer.”
About PPP001:
PPP001 aims to be the first smokable marihuana for advanced cancer pain under prescription. It is a dried cannabis pellet designed to be smoked in an inhalation device specifically developed for this product. PPP001 is a unique blend of 3 strains of standardized dried cannabis, creating a drug substance with 9.5% THC and 2.5% CBD.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Corporation believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Corporation’s ability to control or predict, that may cause the actual results of the Corporation to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the failure to obtain sufficient financing to execute the Corporation’s business plan; the success of the Rx Princeps™product offering and inhalation device; guidance on expected sales volumes associated with the Rx Princeps™product offering and inhalation device; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Corporation’s public disclosure record on file with the relevant securities regulatory authorities. Although the Corporation has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Corporation does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(438) 899-7575
For media information, please contact:
Daniel Granger
Daniel.granger@acjcommunication.com
ACJ Communication
O: 1 514 840 7990
M: 1 514 232 1556
For investors information, please contact:
investors@tetrabiopharma.com
(438) 504-5784
- Published in Tetra Bio Pharma
Tetra Bio-Pharma Inc. Announces the Closing of $4,292,000 Non-Brokered Private Placement
Momentum Public Relations
Press Release: March 28 2018
Tetra Bio-Pharma Inc.(TBP:V), a global leader in cannabinoid-based drug development and discovery, is pleased to announce it has closed its non-brokered private placement of 4,292,000 units at a price of $1.00 per unit for aggregate gross proceeds of $4,292,000. Each unit consists of one common share and one non-transferable warrant, with a whole warrant entitling the holder to purchase one common share at a price of $1.30 per share for a period of thirty-six months expiring March 28th, 2021.
The Corporation intends to use the net proceeds of the Offering to advance its Phase 3 trial for PPP001 and other clinical trials, to effect the repayment of indebtedness, for the support of its commercial efforts and for general corporate and working capital purposes.
The securities issued pursuant to the private placement will be subject to a four-month hold period from the closing date. Completion of the private placement remains subject to the receipt of all necessary regulatory approvals, including the approval of the TSX Venture Exchange.
The securities described herein have not been, and will not be, registered under the U.S. Securities Act or any state securities laws, and accordingly, may not be offered or sold within the United States except in compliance with the registration requirements of the U.S. Securities Act and applicable state securities requirements or pursuant to exemptions therefrom. This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities in the United States, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
The Corporation paid commissions in association with the financing of an aggregate of $275,800 in cash and the issuance of 275,800 finders’ warrants to GMP Richardson and IA Securities, exercisable at a price of $1.00 for a period of 24 months from closing. Each finders’ warrant is exercisable into a common share and common share purchase warrant, which is exercisable at a price of $1.30 per common share purchase warrant for a period of 24 months from the closing of the financing.
The TSX Venture Exchange Inc. has not approved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
- Published in Tetra Bio Pharma
Tetra Bio-Pharma Receives Approval from Health Canada of its Phase 1 Clinical Trial with PPP005 (Cannabis Oil)
Momentum Public Relations
Press Release: January 16,2018
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery, is pleased to announce that it has received a No Objection Letter (NOL) from the Therapeutic Products Directorate (TPD), Health Canada to evaluate the safety, pharmacokinetics and pharmacodynamics of its cannabis oil PPP005.
According to Health Canada data1, the annual Canadian cannabis oil production for medical purposes was 22,766 kg between October 1st 2016 and September 30th 2017, and is growing continuously. In the third quarter of 2017, it grew 24% from Q2 (Apr-Jun) to Q3 (Jul-Sep)1. According to an Eight Capital analysis2, the cannabis oil market is expected to reach 1.5B$ in 2024.
The launch of this trial is the first step in Tetra’s plans to commercialize natural health products with its partners. The corporation will develop cannabis-based supplements for commercialization under the Natural Health Product regulations in Canada and in other countries where regulatory authorities have a recognized pathway for approval and commercialization of such products. The trial will eventually include formulations that will be registered as drugs under Health Canada’s TPD regulatory pathway. “Tetra Bio-Pharma Inc. seeks to become an important player in the retail market post legalization and this clinical trial is part of the sales and marketing strategy required to effectively penetrate the lucrative pharmacy and health stores retail markets,” states Bernard Fortier, CEO of Tetra.
Tetra’s vision is to develop an evidence-based approach, thereby allowing pharmacists to dispense these medicines to patients in need. Despite the growing popularity of cannabis oils, physicians and pharmacists across Canada are still hesitant to support the use of these products because of the lack of data supporting its medical use. Dr. Guy Chamberland, Chief Science Officer, commented: “This trial is part of Tetra’s corporate strategy to develop the science required to commercialize safe and efficacious cannabis oil products post-legalization and to create innovative oral drug formulations for the development of medicines in the management of pain, anxiety and the treatment of cancer.”
In that respect, Tetra’s scientific team is supporting the strategy by initiating a phase 1 clinical trial to characterize the safe use of these cannabis oil medicines in humans. Tetra has worked with Altasciences Clinical Research for the preparation of the Clinical Trial Application (CTA) for the conduct of a double-blind phase 1 study to assess safety, tolerability and pharmacokinetics of single and multiple daily doses of cannabis (Delta-9-tetrahydrocannabinol/Cannabidiol) oil capsules administered to healthy human volunteers. Health Canada issued a No Objection Letter for the conduct of the phase I clinical trial on January 12nd, 2018. Altasciences Clinical Research will be initiating the clinical trial activities in the coming weeks. The cannabis oil is manufactured by Tetra’s partner, Aphria Inc.
1: | Health Canada Market Data, [https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-use-marijuana/licensed-producers/market-data.html] |
2: | Cannabis Sector, Eight Capital Estimates, July 2017 |
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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.
Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Inc.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210
anne-sophie.courtois@tetrabiopharma.com
- Published in Medical Marijuana, Tetra Bio Pharma