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Tetra Bio-Pharma hopes $6M raise carries firm through to revenue stage
"“Right now, I should be in revenue mode,” Neron said this week. “Unfortunately, we’re still at the mercy of Health Canada.”"
https://obj.ca/index.php/article/techopia/tetra-bio-pharma-hopes-6m-raise-carries-firm-through-revenue-stage
Tetra Bio-Pharma hopes $6M raise carries firm through to revenue stage
Aug 31, 2022 3:20pm EDT
Cannabinoid stock image
An Orl?éans-based company that’s spent years developing drugs designed to mimic the pain-killing and anti-inflammatory benefits of cannabis without major side effects is hoping its latest fundraising effort will give it enough working capital to see its research efforts through to market.
Tetra Bio-Pharma, which trades on the Toronto Stock Exchange and the OCTQB exchange in the U.S., said last week it’s agreed to issue up to $6 million worth of unsecured debentures and stock purchase warrants to London-based investment firm Alpha Blue Ocean Group.
The offering is expected to occur in 15 tranches for total net proceeds of about $5.4 million.
Chief commercial officer Steeve Neron said the deal should provide enough cash to keep the company afloat for the next 14 to 15 months as it awaits the green light from Health Canada to sell one of its key products – a gel capsule used to treat chemotherapy-induced nausea and vomiting in cancer patients and weight loss and severe nausea in patients with HIV infections.
The drug’s active ingredient is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis. Tetra says the drug, branded REDUVO, “remains a top priority and the company is ready to launch manufacturing activities as soon as possible following regulatory approval.”
"Right now, I should be in revenue mode. Unfortunately, we’re still at the mercy of Health Canada."
Steeve Neron - chief commercial officer of Tetra Bio-Pharma
“Right now, I should be in revenue mode,” Neron said this week. “Unfortunately, we’re still at the mercy of Health Canada.”
In addition to developing REDUVO, Tetra’s scientists have been working on other products that provide the anti-inflammatory benefits of CBD, a therapeutic ingredient found in cannabis, but without some of the side effects that can include nausea, headaches and fatigue.
One of them, ARDS-003, is a cannabinoid-derived drug is designed to treat sepsis and acute respiratory distress syndrome, life-threatening conditions triggered when the body’s immune system “goes rogue” in response to an infection such as COVID-19 and begins attacking healthy cells as well as harmful bacteria and viruses.
The company says the drug effectively blunts the severity of the exaggerated immune response that often occurs in patients suffering from COVID-19, cancer and other diseases, thereby reducing the likelihood of deadly consequences such as sepsis and ARDS.
While the drug is currently administered via injection, Tetra is also working on an oral formulation designed for out-patient settings. Earlier this month, Tetra issued a news release saying preclinical trials have delivered positive results from live COVID-19 virus infection studies in animals as well as a septic lung model.
According to the release, ARDS-003 “produced a significant reduction of systemic cytokine/chemokine release” – the so-called “cytokine storm” that can cause organ failure and severe respiratory illness when a person’s immune system kicks into overdrive.
Meanwhile, Tetra is also developing an inhalable cannabinoid-based pain reliever for cancer patients. Dubbed QIXLEEF, the drug is currently undergoing clinical trials in the U.S.
Last month, Tetra announced a deal that will see British medical pot producer Akanda Corp. supply pharmaceutical-grade cannabis for the drug. Akanda has also agreed to manufacture the drug at a facility in Portugal, with Tetra pegging the total addressable market for QIXLEEF at nearly $1.7 billion by 2028.
Still, investors appear to be getting antsy.
Tetra believes its products have multibillion-dollar sales potential, but the drugs have yet to make it to pharmacy shelves – a situation that's reflected in the firm's share price.
Share price plummets
Tetra’s stock has plummeted by more than 80 per cent in the past 12 months, and now sits at just five and a half cents on the TSX as of Wednesday afternoon.
Tetra has slashed its workforce from 65 employees a few years ago to 32 today and trimmed expenses in other areas in an effort to rein in expenses. Neron says the firm has cut its burn rate from more than $420,000 per month to about $200,000 as it looks to extend its runway.
Now, he’s hoping good news on the regulatory front comes sooner than later.
“There seems to be a lack of confidence either in the board or in the management team,” he said. “We need significant and very material advances to get a spike in the share price, in my opinion.
“We hope that these (clinical) milestones will generate a growth in the share price and accordingly people will start exercising their warrants and we won’t have to do any more raises.”
Reduvo: dead, no approval for 20 months. Guy a liar or Canada Health a joke or one gas other ideas?
Reborn: intermediate results were planned for June. Trial has been running now for 15 months.
I believe the drug is working, no big doubts, but maybe FDA not interested. People make too much much money with Opiates. Delays might be wanted and more to come. To get participants fot the trial is another big issue.
In Germany doctors get paid when they prescribe Paxalovid; maybe BP pay also doctors for prescribing Opiates? Pharma Industry is a too crooked mafia business.
News!
https://ir.tetrabiopharma.com/newsroom/press-releases/news-details/2022/Tetra-Bio-Pharma-Announces-Positive-Preclinical-Results-of-ARDS-003-a-Novel-Therapeutic-for-Sepsis-and-Viral-Infections/default.aspx?fbclid=IwAR07sFrlsVu7-fAkuI-7MSGfBC24j2-Sj-zocvfGYGz2geRGxAi9_pfsuzw
Tetra Bio-Pharma Announces Positive Preclinical Results of ARDS-003, a Novel Therapeutic for Sepsis and Viral Infections
08/10/2022
ARDS-003 is a novel therapeutic for acute systemic inflammation and prevention of acute respiratory distress syndrome (ARDS).
ARDS-003 may offer steroid-sparing opportunities.
ARDS-003 has demonstrated antiviral properties.
ARDS-003 developed as an oral formulation for an immediate release administration.
OTTAWA, ON, Aug. 10, 2022 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development announced today new positive preclinical results from live SARS-CoV-2 virus infection studies as well as a septic lung model, carried out by independent researchers.
Tetra Bio-Pharma Logo (CNW Group/Tetra Bio-Pharma Inc.)
These studies explored the potential of ARDS-003 to increase survival metrics following SARS-CoV-2 infection in the humanized ACE2 mouse model. Secondary outcomes evaluated ARDS-003 against an antiviral drug, a clinical standard of care therapeutic used for patients with COVID, in SARS-CoV-2 infected animals. Results indicate that compared to placebo, ARDS-003 dose dependently reduced signs of morbidity and mortality, including respiratory distress. ARDS-003 also outperformed the antiviral drug in reducing multiple proinflammatory mediators (i.e., cytokines) involved in hyperinflammation and immune system dysfunction following viral infection.
Using a recent septic lung model, the administration of ARDS-003 produced a significant reduction of systemic cytokine/chemokine release. In addition, lung histology was improved, peripheral immune hyper activation was reduced, and there was an improvement in capillary perfusion in lung tissue compared to controls. An additional study evaluated in vitro viral infectivity and demonstrated dose dependent inhibition of viral replication.
Guy Chamberland, CEO and CRO at Tetra commented "ARDS-003 is a clinical stage asset that has a huge potential as it is focused on developing novel treatments for unmet medical needs, such as lung inflammation, viral encephalitis, and brain inflammation conditions."
ARDS-003 Oral Formulation
Further to the ARDS-003 injection formulation, Tetra's research team has developed an oral formulation using its proprietary technology for an immediate release administration that can be administered for longer term care in an outpatient setting. ARDS-003 has the potential to reduce the cytokine storm associated with CAR T immunotherapy complications and has been shown to have synergistic antiviral effects in several viral in vivo infection models.
Dr. Chamberland further commented "ARDS-003, for example, could be used as an adjunct to Paxlovid or other antivirals to help reduce the morbidities associated with prolonged infection by SARS-CoV-2 and other viruses. In the case of COVID, the treatment period with ARDS-003 could be extended to continue to improve clinical outcome and prevent the rebound effect observed in immunocompromised patients receiving existing antivirals."
About ARDS-003
ARDS-003 is a novel First in Human (FIH) drug product containing the active pharmaceutical agent, Onternabez, a potent and selective full agonist of the type 2 cannabinoid receptor (CB2R), an important immunomodulatory target. ARDS-003 is positioned to modulate acute systemic inflammation and prevent Sepsis, ARDS, and organ damage - ARDS represents the severe end of lung dysfunction resulting from systemic inflammation secondary to infectious or non-infectious clinical insult (McIntosh, 2020). While the clinical profile of ARDS arising from viral (COVID) or bacterial Sepsis can vary, hyperinflammation involving a dysfunctional immune response is a common mediator of lung damage. Tetra's preclinical studies have demonstrated that ARDS-003 decreases this hyperinflammatory response and slows disease progression.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX 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 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 and development strategies, including the success of this product or any other product, 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. 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.
Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/tetra-bio-pharma-announces-positive-preclinical-results-of-ards-003-a-novel-therapeutic-for-sepsis-and-viral-infections-301603075.html
SOURCE Tetra Bio-Pharma Inc.
20 months since company applied for DIN. That's the way how "health organisations" exhaust small Biotecs to death.
Reborn trial? Not a failure but the next never ending stories. Results were promised for June.
When and How do such stories end? When BP get them for less than a breakfast. Corruption, even Mafia was better.
https://spharm-inc.com/the-drug-review-and-approval-process-in-canada-an-eguide/
According to this information, Canada's regulatory approval process takes 0,5 to 2 years. How could Guy tell us the approval process for DIN would take us to the end of 2021?
The excellent message: Relax, only anymore 5 months until approval.
Maybe Health Canada comes up with other excuses? How about Monkeypox?
By the way, in this article it is written that Canada has by far the slowest process for approving; far behind FDA, MHRA, and EMA.
My bad - correct we are awaiting REBORN and PLENTITUDE
I’m not making any assumptions on things I don’t have knowledge of.
We are waiting for Reborn.
Reduvo is a side battlefield which would have given us some income, but after 19 months of waiting, I doubt it will ever come. Something went wrong.
First Reborn trial results were promised for June 22. Maybe also this is considerably delayed. They got problems with patient recruitment.
The CEO seems to have nothing under control.
TEVA reaches tentative 4.25 BILLION settlement over Opiods -
- yes there is a significant market for Opiod alternatives
AND
- a significant market financial incentive to replace Opiods.
REDUVO results - is it worth the wait ? …. Yes I would say it’s with Billions
… AND millions of lives …
I expected the approval of Reduvo by end of 2021. Some were saying it will come at the end of March 22. Canada Health are sleeping or we have an unreported problem with Reduvo. NOW soon 19 months gone since application.
I was hoping we get in June 22 some interim results about the Reborn trial. It seems that trial is delayed as well.
What is left? Hope! It dies as the last. Not a good strategy.
This cooperation is an indirect confirmation that trials are promising. Finally something with substance.
Good news. Thanks for sharing.
Akanda to Supply Tetra Bio-Pharma with Pharmaceutical-Grade Cannabis for FDA Trials of QIXLEEF™, a Potential Multimillion Dollar Prescription Drug
07/12/2022
Provides Tetra with stable supply of high-quality ingredients and regulatory-approved services to satisfy clinical trials and prescription products
Diversifies Akanda into cancer pain medical market as a specialized manufacturer of cannabis-based drugs for use in FDA clinical trials and pharmaceutical markets
LONDON and MONTREAL, July 12, 2022 /CNW/ - Akanda Corp. ("Akanda") (NASDAQ: AKAN) and Tetra Bio-Pharma ("Tetra") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), today jointly announced that Akanda will supply Tetra with pharmaceutical grade cannabis flower in a microdose cap form, for use in a Storz & Bickel Mighty Medic Vaporizer for global commercialization of Tetra's QIXLEEFTM and related products. In addition, Akanda will act as a Contract Development and Manufacturing Organization (CDMO) for Tetra's clinical drug and commercial supply programs. With this project, Akanda becomes a CDMO in addition to being an EU GMP cannabis manufacturer, marking Akanda's first entry into cannabinoid drug development, which is a new and growing market opportunity for the company, while Tetra secures a stable supply of high-quality ingredients and regulatory-approved services to satisfy clinical trials and commercialization.
QIXLEEF™ is a proprietary botanical inhaled investigational new drug currently being studied in two U.S. Food and Drug Administration (FDA) authorized clinical trials: 1) REBORN©1, a Phase 2 study authorized by the FDA to evaluate inhaled cannabinoids against a class of immediate-release oral opioids for the management of breakthrough cancer pain, and 2) PLENITUDE©, a Phase 2 multicenter clinical trial authorized by the FDA to evaluate the safety and efficacy of inhaled cannabinoids to relieve uncontrolled pain in patients with advanced cancer. The companies estimate the total addressable market (TAM) for QIXLEEF™ to be nearly $1.7 billion by 20281.
Under the multi-year agreement, Akanda will supply Tetra with high-quality, premium THC and CBD flower, and will provide regulatory, quality and pharmaceutical manufacturing services for the QIXLEEFTM clinical drug development and marketing authorization from its Portugal operations. The supply of the active pharmaceutical ingredient starts in [the third quarter of] 2022 and is anticipated to increase incrementally over the succeeding years based on growing demand and commercializing of Tetra's cannabinoid-derived medicines.
1
Source: Derived from DelveInsight data encompassing the seven major markets, or 7MM, including the United States, Germany, France, Italy, Spain, United Kingdom and Japan.
QIXLEEFTM product has been designed specifically for use in the Storz & Bickel Mighty Medic Vaporizer, the first medically approved portable cannabis vape, pictured here with dosing capsules filled at Holigen. (CNW Group/Tetra Bio-Pharma Inc.)
Akanda will provide Tetra with a range of services, including regulatory affairs, quality control and stability testing through Akanda's internal lab, as well as manufacturing capabilities. Upon FDA approval, the anticipated supply commitments could reach [over 10 metric tonnes] per year.
Tetra, a leader in drug discovery and development for cannabinoid-based medicines, is focusing on therapeutic areas of inflammation, pain, ophthalmology and oncology through a robust pipeline using multiple delivery systems.
"This supply agreement with Tetra is a major milestone in Akanda's journey in becoming a cannabis platform company serving all regulated markets in the EMEA region," commented Tej Virk, CEO of Akanda. "In supporting a terrific partner with a mission to improve patient health and quality of life though cannabinoid-derived medicine, we are demonstrating that cannabis can fit into the traditional public sector model, with the expectation of reimbursement. Simultaneously, we are productively utilizing our diverse capabilities to support clinical trials for pharma grade cannabinoids. If approved, we expect to provide flower for the authorized compound, potentially creating a significant, incremental revenue stream for Akanda. This opportunity could only have been possible with our state-of-the-art facilities that we gained through the acquisition of Holigen in May."
Product and services from Akanda's EU GMP Holigen facility will be utilized in this trial. (CNW Group/Tetra Bio-Pharma Inc.)
"This collaboration transitions our Sintra facility into a global CDMO for cannabinoid-based pharmaceuticals as we build up our internal laboratory capacity and manufacturing under EU GMP," commented Dr. Akkar-Schenkl, President of Akanda. "Together with Tetra we are aiming to become the ambassadors for cancer pain treatment. The pharmaceutical grade flower and the level of pharmaceutical excellence in manufacturing, quality operations and regulatory affairs we will be providing into these projects is our fundamental commitment to worldwide palliative care in pain treatment in the field of oncology. The bioburden quality of the flower we will be providing for this delicate patient population can only be managed under stringent manufacturing conditions, special regulatory and pharmaceutical know-how."
"Tetra has been looking for quite a while to find a Global strategic CDMO partner, and we believe that Akanda is a perfect fit from a vision standpoint. This partnership will allow Tetra to secure a robust and trustable source for its clinical drug supply and for QIXLEEF™ commercialization plans. Aside from quality, Akanda will rapidly automate our process and increase our capacity, resulting in a 67% reduction of our cost of goods sold (COGS)," commented Guy Chamberland, M.Sc., Ph.D., Chief Executive Officer and Chief Regulatory Officer at Tetra. "Establishing a defined source of high-quality ingredients is important for Tetra, and we are excited to advance a productive collaboration with Akanda as we advance target drugs through the regulatory process."
About Akanda Corp.
Akanda (NASDAQ: AKAN) is an international medical cannabis and wellness platform company seeking to help people lead better lives through improved access to high quality and affordable products. Akanda's portfolio includes Bophelo Bioscience & Wellness, a GACP qualified cultivation campus in the Kingdom of Lesotho in Southern Africa; Holigen, a Portugal-based cultivator, manufacturer and distributor with a prized EU GMP certified indoor grow facility; and CanMart, a UK-based fully licensed pharmaceutical importer and distributor which supplies pharmacies and clinics within the UK. The company's seed-to-patient supply chain also includes partnerships with Cellen Life Sciences' Leva Clinic, one of the first fully digital pain clinics in the UK, and Cantourage, which operates a platform for bringing medical cannabis to Europe.
Connect with Akanda: Email | Website | LinkedIn | Twitter | Instagram
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.
Connect with Tetra: Email | Website | LinkedIn | Twitter | Instagram
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 Akanda and/or Tetra 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 ability of either company to control or predict, that may cause the actual results of the companies 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 companies to obtain sufficient financing to execute their respective business plans; competition; regulation and anticipated and unanticipated costs and delays, the success of the companies' research and development strategies, including the success of this product or any other product, 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 Akanda's and Tetra's public disclosure record on file with the relevant securities regulatory authorities. Although Akanda and Tetra have 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 Akanda and Tetra do 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.
Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.
Tetra and Akanda Logos (CNW Group/Tetra Bio-Pharma Inc.)
Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/akanda-to-supply-tetra-bio-pharma-with-pharmaceutical-grade-cannabis-for-fda-trials-of-qixleef-a-potential-multimillion-dollar-prescription-drug-301584204.html
SOURCE Tetra Bio-Pharma Inc.
It is waiting for approval for 19 months. Is this alive?
Why do you say Reduvo is dead?
Reduvo is dead. What a scam.
Reborn was supposed to deliver results in June 22. Is it the next scam?
Fact is that Canada Health, FDA and EMA are protecting Big Pharma.
That's a good read. Anyone know what the next Phase entails after Phase 2 for QIXLEEF?
Covid, the perfect excuse for everyone. How comfortable to blame the virus for the own lack of capabilities.
Canada Health by the way is my opinion the same Mafia like FDA with the target help big pharma and kill small biotechs.
Who cares of pain? Who cares of people's health and lives? Not any of all these corrupted organisations. They keep us at bay until 2023 or even 2024. Until last shareholder left, then the patents become free lunch for Pfizer & Co. Always the same.
This excellent news. During the Annual meeting, Guy mentioned there were delays approving all non Covid drugs in Canada. It’ll happen. We just need patience.
TBPMF
What a joke! 18 months ago we applied for DIN, now we have discussions with authorities? 18 months and no DIN for Reduvo? After 12 months no results about Reborn? But, distracting activities and pr continue. Now new company in Australia. One company here, another one there. We covering Nord- and South America, we cover Europe, Asia and now Australia. But we have no drug for sale. Great!!!
https://ir.tetrabiopharma.com/newsroom/press-releases/news-details/2022/Tetra-Bio-Pharma-Opens-New-Subsidiary-in-Australia-and-Provides-Regulatory-Update/default.aspx
——
The Company is also pleased announce it has completed the Annual Licence Review process for our Health Canada Drug Establishment Licence (DEL) and meets the regulatory requirements of C.01A.009 of the Food and Drug Regulations to maintain our DEL for the distribution of pharmaceuticals, like REDUVO™, in Canada. Any company that intends to distribute pharmaceutical drugs in Canada must obtain a DEL as per Health Canada regulatory requirements.
On December 30, 2020, the Company submitted its first New Drug Submission (NDS) for REDUVO™ to Health Canada to obtain a Drug Identification Number (DIN) for the prescription drug. The Company is in discussions with Health Canada to address final commentary on the submission. REDUVO™ remains a top priority and the Company is ready to launch manufacturing activities as soon as possible following regulatory approval.
Thanks for letting me share
Here’s the audio replay
https://edge.media-server.com/mmc/p/xr7kexjv
I was on the road for work so I didn’t attend either.
I didn't have the number required to get in, any thing interesting happening there.
Gary
Tetra Bio-Pharma will host a live webcast of its 2022 Annual Meeting of Shareholders on Monday, May 30, 2022, at 2:00 PM EST. The meeting will be held in a virtual format only and can be accessed at https://meetnow.global/MLKPF2U.
The presentation slides will be available on Tetra’s website after the Meeting: www.tetrabiopharma.com.
I wish so also plus an update on reduvo
Good article. I just wished we had an update on Phase 2 results.
This study backs up everything tetra is doing.
https://www.jpost.com/health-and-wellness/article-707418
News!
https://ir.tetrabiopharma.com/newsroom/press-releases/news-details/2022/Tetra-Bio-Pharma-Announces-Closing-of-First-Tranche-with-Cannvalate/default.aspx
Tetra Bio-Pharma Announces Closing of First Tranche with Cannvalate
05/17/2022
OTTAWA, ON, May 17, 2022 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development, is pleased to announce the closing of the first tranche of the previously announced private placement with Cannvalate Pty Ltd ("Cannvalate"), resulting in the issuance of 8,236,681 common shares in the capital of the Company (the "Common Shares"), representing 1.95% of the issued and outstanding Common Shares, at a price of $0.06 per Common Share for proceeds to the Company of $0.5 million.
Tetra Bio-Pharma Inc. Logo (CNW Group/Tetra Bio-Pharma Inc.)
The subscription price per Common Share issuable under the first tranche was at a discount of 7% to the 5-day VWAP of the Common Shares on the Toronto Stock Exchange ("TSX") on May 4, 2022, the day of execution of the subscription agreement. This first tranche of seven (7) distinct tranches, which will result in aggregate proceeds of $7,500,000 to the Company, triggers the collaboration with iNGENu that will lead to the initiation of the REBORN©1 clinical trial in Australia.
Dr. Guy Chamberland, CEO and CRO of Tetra stated, "We are encouraged by the partnership with Cannvalate and iNGENu as it will allow the Company to further advance our QIXLEEF™ drug program, a promising alternative to opioids. Many investigational new drugs fail trying to carve a use in the management of severe pain. Our interim clinical data demonstrates that QIXLEEF™ has the potential to make a significant difference in patients. Our new partners join us in the race to bring alternatives to pain management."
Partnership with Cannvalate
As previously announced, Tetra has entered into a research agreement with Cannvalate for the performance of clinical trials of Tetra's drug candidates in Australia. Cannvalate is a medical cannabis company bringing in safe and effective cannabinoid-based products to the Australian market. Cannvalate's wholly owned entity, iNGENu, is one of the largest global CROs specializing in cannabinoid clinical trials. Conducting Tetra's clinical trial activities in Australia with iNGENu will allow the Company to benefit from a 43.5% tax credit on all money spent on clinical trials in Australia, and an increased access to patients seeking participation in trials where the pharmaceutical cannabis drug is provided at no cost. Through the Cannvalate partnership, Tetra aims to efficiently assess the clinical viability of its drug products, as well as any new products developed.
About QIXLEEF ™
QIXLEEF™ is the Company's proprietary investigational new drug currently being studied in two U.S Food and Drug Administration (FDA) authorized clinical trials. QIXLEEF™ is a botanical therapy with a fixed dosage of tetrahydrocannabinol (THC) and cannabidiol (CBD). The drug is inhaled using a medical vaporizer and manufactured in Canada in a licensed current good manufacturing practice (cGMP) facility authorized by Health Canada.
About REBORN©1 - Clinical Trial
REBORN©1 is a Phase 2 study authorized by the U.S. FDA to evaluate inhaled cannabinoids against a class of immediate-release oral opioids for the management of breakthrough cancer pain (BTcP). The study consists of a 10-week proof-of concept, open-label randomized study to evaluate the effect of inhaled QIXLEEF™ as compared to morphine sulfate or hydromorphone or oxycodone for the treatment of BTcP in 20 patients.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians, and insurance companies.
For more information: www.tetrabiopharma.com
Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.
Hard to say. There is no info, positive or negative.
Does anyone believe REDUVO will ever get an approval? CEO never tells us what is wrong.
Pretty much all OTC penny stocks have been doing badly for a very long time. Eventually, companies with real value like TBPMF will bounce back IMHO.
Good news. Thanks for sharing.
Tetra Bio-Pharma Announces Licensing Agreement with True North for Patented CBD Technology
Panag Pharma Inc (Panag), a subsidiary of Tetra Bio-Pharma, will collect royalties on sales on products produced with the technology True North has licensed from Panag.
Use of a highly innovative proprietary liposome encapsulated technology leads to a better CBD absorption.
This New True North Nectar product line in liquid and powder formats are expected to launch in select markets in Q4 2022.
OTTAWA, ON, May 10, 2022 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) a leader in cannabinoid-derived drug discovery and development in collaboration with Panag, a subsidiary of Tetra Bio-Pharma, and True North Cannabis Corp (True North), today announced it has entered into a technology licensing agreement allowing True North to use its highly innovative proprietary liposome encapsulated technology within formulations distributed under the True North brand.
Tetra Bio-Pharma Inc. logo (CNW Group/Tetra Bio-Pharma Inc.)
Tetra's patented technology leads to better absorption and aqueous emulsification of the CBD molecule in a variety of products. Panag will work with True North's product team to integrate this technology and develop a line of hemp-derived CBD formulations, for True North and its partners to commercialize through their existing distribution relationships in both the medical and recreational markets in Canada
About the Technology
In developing these products, the Panag team is using Tetra's liposome encapsulated technology, a patented process to encapsulate and protect the active molecules into a multi-layered sphere. Delivery of the formulation is greatly improved by enhancing the dispersion of loaded liposomal spheres within an aqueous (water-based) environment.
"This opportunity is the beginning of a great relationship between the two companies. Panag has enjoyed working closely with the True North team and we are very excited at the expansion of our pipeline with innovative wellness products that fit within their portfolio, in the competitive and growing CBD market," said Chris MacLean, COO of Panag Pharma.
"I am glad that this highly innovative and patented technology will benefit the wellness market. We are adapting our pharmaceutical technologies for the benefit of True North customers," said Steeve Néron, CCO of Tetra BioPharma.
"True North is pleased to have entered into a licensing agreement with Panag Pharma Inc. to exclusively incorporate their molecular technology into product formulations distributed under the True North brand. Panag's patented CBD encapsulation technology is expected to further differentiate True North's branded product offering in the highly competitive medical and recreational CBD product market. True North looks forward to bringing an exciting array of innovative products utilizing this technology to consumers across the country," said Brett Halvorson, President & CFO of True North.
About True North
True North Cannabis Corp. is a Canadian hemp-based CBD products company. True North and its partners supply value priced CBD bulk ingredients to licensed producers across Canada, and deliver a range of extracted and edible CBD products to patients and consumers alike through the True North brand. For more information, please visit www.truenorthcannabis.com.
About Panag Pharma
Panag Pharma Inc. is a Canadian based bio-tech company focused on the development of novel cannabinoid-based formulations for the treatment of pain and inflammation. Panag believes that pain relief should be safe, non-addictive and above all; effective. The Panag Pharma team of PhD scientists and medical doctors are among the world's leading researchers and clinicians in pain treatment and management. They bring a combined experience of over 100 years in research and clinical care of people dealing with chronic pain and inflammatory conditions. Panag's development pipeline of pain relief products include topical, oral, and ocular delivery solutions for challenging molecules.
What in the world is going on with this stock??!!!
News! Tetra Bio-Pharma and Cannvalate Enter Into Partnership
https://ir.tetrabiopharma.com/newsroom/press-releases/news-details/2022/Tetra-Bio-Pharma-and-Cannvalate-Enter-Into-Partnership/default.aspx
Tetra Bio-Pharma and Cannvalate Enter Into Partnership
05/05/2022
Cannvalate to invest CAD$7.5M in Tetra.
Cannvalate to launch and manage QIXLEEF™ and CAUMZ™ clinical trials in Australia.
The Company to benefit from a 43.5% tax credit on all money spent on clinical trials in Australia.
OTTAWA, ON, May 5, 2022 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) a leader in cannabinoid-derived drug discovery and development, today announced it has entered into a research and development agreement with Cannvalate Pty Ltd ("Cannvalate") for the initiation of the REBORN®, PLENITUDE® and CAUMZ® clinical trials in Australia, and a subscription agreement contemplating a private placement (the "Private Placement") of common shares in the capital of the Company (the "Common Shares") with Cannvalate for aggregate proceeds to the Company of up to CAD$7,500,000.
Tetra Bio-Pharma Logo (CNW Group/Tetra Bio-Pharma Inc.)
The Company has also appointed Dr. Sud Agarwal as a Special Advisor to the CEO and the board of directors with a mandate to advise on strategic aspects of the Company's activities and to aid in the advancement of our key programs: QIXLEEF™ and CAUMZ™.
Partnership with Cannvalate
Tetra has entered into a research agreement with Cannvalate for the performance of clinical trials of Tetra's drug candidates in Australia. Cannvalate is a medical cannabis company bringing in safe and effective cannabinoid-based products to the Australian market. Cannvalate's wholly owned entity, iNGENu, is one of the largest global CROs specializing in cannabinoid clinical trials. By conducting Tetra's clinical trial activities in Australia with iNGENu, it will allow the Company to benefit from a 43.5% tax credit on all money spent on clinical trials in Australia, and an increased access to patients seeking participation in trials where the pharmaceutical cannabis drug is provided at no cost. Through the Cannvalate partnership, Tetra aims to efficiently assess the clinical viability of its drug products, as well as any new products developed.
Dr. Guy Chamberland, CEO and CRO of Tetra stated, "We have been developing inhaled cannabinoid drugs since 2016 and have a wealth of data to support the potential development of a new generation of drugs to help patients suffering from chronic diseases. It takes years of research and development to have a drug in two Phase 2 trials designed to support drug approval in the USA and Europe. Finding ways to accelerate timelines while reducing the monthly burn is a continuous battle for all biotechnology companies. This partnership is intended to allow Tetra to achieve both goals."
Private Placement
Cannvalate also agreed to acquire Common Shares of Tetra on a private placement basis, through seven (7) distinct tranches, for aggregate proceeds of CAD$7,500,000. The first tranche providing for the issuance of Common Shares having an aggregate subscription price of CAD$500,000 was triggered by the signing of the subscription agreement, whereas the subsequent tranches of the Private Placement will be triggered by the completion of various operational events in connection with the REBORN®, PLENITUDE® and CAUMZ® clinical trials, such as the achievement of first patient enrolments in each such trial. The Company intends to use the proceeds of the Private Placement to fund its clinical trials and R&D activities in collaboration with Cannvalate and iNGENu.
The subscription price per Common Share issuable under the first tranche will be at a discount of 7% to the 5-day VWAP of the Common Shares on the Toronto Stock Exchange ("TSX") on the day of execution of the subscription agreement with respect to the Private Placement. Subject to compliance with the rules and regulations of the TSX, the subscription price per Common Share issuable under the second and third tranches will be at a discount of 7%, whereas the subscription price per Common Share issuable under the fourth to seventh tranches will be at a discount of 20%, in each case based on to the 5-day VWAP of the Common Shares on the TSX prior to the date of the issuance of the respective tranche. In accordance with the terms of the Private Placement, the subscription price per Common Share shall be adjusted upwards to ensure that Cannvalate and its affiliates shall not beneficially own, or have control or direction over, Common Shares in excess of 19.99% of the number of Common Shares issued and outstanding immediately after giving effect to the issuance of Common Shares issuable under the applicable tranche.
Upon completion of the fifth tranche of the Private Placement which will result in the Company having received aggregate proceeds of CAD$4,500,000, the Company will enter into a nomination right agreement with Cannvalate providing for the grant of a seat on Tetra's board of directors to Dr. Sud Agarwal for so long as Cannvalate owns or exercises control or direction, directly or indirectly, over 10% or more of the issued and outstanding Common Shares. Guy Chamberland, CEO and CRO of Tetra stated, "Dr. Agarwal will bring both inhalation clinical expertise and cannabinoid drug development experience to Tetra's board. His addition will further strengthen our board as we continue to evolve into a cannabinoid pharmaceutical company."
The securities issued pursuant to the Private Placement will be subject to a four-month hold period from the date of their respective issuance. Completion of the Private Placement remains subject to the receipt of all necessary regulatory approvals, including the approval of the TSX.
This news release does not constitute an offer to sell or a solicitation of an offer to sell any securities of the Company in the United States. The securities described in this news release have not been and will not be registered under the United States Securities Act of 1933, as amended ("U.S. Securities Act") or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.
About Dr. Sud Agarwal BSc, MB ChB, FANZCA
Dr. Sud Agarwal is the Co-Founder and CEO of Cannvalate and iNGENu, a globally renowned contract research organisation in the cannabinoid space. Dr. Agarwal is an internationally recognised key opinion leader in the clinical use of medicinal cannabis and is regularly invited as a keynote to key industry and pharmaceutical events. His research interests include synthetic cannabinoid drug development, novel inhalational cannabinoids drug-device combinations and cannabinomimetic analogues.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians, and insurance companies.
For more information visit: www.tetrabiopharma.com
Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.
Forward-looking statements
Some statements in this news 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 in the news release include, without limitation, statements with respect to clinical trials for the Company's drug candidates and expected timing thereof, the benefits expected to be derived by the Company from the partnership with Cannvalate, the expected closing of the tranches under the Private Placement and timing thereof, the expected aggregate proceeds to be received by the Company under the Private Placement, the receipt of regulatory approval with respect to the Private Placement, including the receipt of TSX approval, the expected use of the proceeds under the Private Placement and the appointment of Dr. Sud Agarwal to the board of directors of the Company. 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 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 and development strategies, including the success of this product or any other product, 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. 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.
Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/tetra-bio-pharma-and-cannvalate-enter-into-partnership-301540349.html
SOURCE Tetra Bio-Pharma Inc.
Reduvo is at least four months overdue with approval from Canada Health. I guess and hope now that we get an update about Reborn instead in the month of July.
Reborn is ten times more important and is the reason we are here.
Canada Health is another highly underperforming institution. If the FDA of the USA will play by exception fair with Tetra will be a different story as Woodcrook said in public that she doesn't like small pharma. She prefers Big Pharma with a lot of money. The FDA- system kills small pharma to enable Big Pharma to get the small companies on the silver plate.
Overall, maybe in July something positive. Until then try to survive.
Nevertheless, new drugs are approved later in Canada than in the U.S. and EU. Recently, Fraser Institute authors showed that, despite the time taken to review and approve new drugs in Canada being consistent with that in the U.S. and EU between 2012/2013 and 2018/2019, new medicines received approval in Canada a median of 289 days after approval in the U.S. and a median of 154 days after approval in the EU. In other words, later approval in Canada is now primarily due to applications being submitted later in Canada than in the U.S. and EU, not a longer review process at Health Canada.
Fully agreed.
Therefore, I remain fully invested and will buy another bigger amount of shares in addition if we break through the current resistance level.
Having an excellent drug is one thing, depending on corrupted instutions is a huge problem. Big Pharma controls to 100% FDA in USA. I dont know about Health Canada, but might be similar. Money talks.
Not the drug is the risk, but Health Canada and Big Pharma.
Covid is just a comfortable excuse for everything.
Current PPS matters little since this is a long term play. If TBP succeeds in bringing QIXLEEF into multi billion dollar pain killer market, PPS will reach dollars.
I checked once more the monthly chart. Only in 2016, we were at that low 0.055 as now. If it takes another few weeks or even months, we could see the next and last resistance level with 0.0125. On the daily chart for 6 and 9 months it looks like we are building a bottom, but if Health Canada doesn't come off their sleeping shelves, 0.0125 is in the cards.
Has anyone an idea if Health Canada is in operation or if all officers still in their Covid slee? They are taking already 15 months for a possible Reduvo approval. CEO can't complain in public, and therefore he doesn't say anything, otherwise these parasites would delay an approval even more. In fact, the approval can be delayed another 6 or 12 months. Nothing we can do about it and Covid is a comfortable excuse for everyone and everything.
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