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Paul removed Watkins as CEO almost right away. I suspect he didn’t want Watkins to find out about some the skeletons UNSS had that prevented it from becoming current. Not becoming current is on Paul and remains so.
Not really. It’s a confirmation Entrex have moved on and will not merge with UNSS. The only small consolation we have is UNSS gets 2.5% of Entrex’s Carbon market revenue.
Other than that, we are stuck with Paul who can’t seem to deliver on anything.
Not sure if the 2.5% applies to this raise.
https://www.sec.gov/Archives/edgar/data/1960607/000196060723000001/ecmreg1a6.pdf
100% agree.
REDUVO™ Marketing Approval on the Right Path
12/22/2022
Second Clarifax received from Health Canada.
MONTREAL, Dec. 22, 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 providing its shareholders with another regulatory update on the REDUVO™ New Drug Submission (NDS). The last update was provided on November 18, 2022.
Tetra Bio-Pharma Logo (CNW Group/Tetra Bio-Pharma Inc.)
On December 21, 2022, the Company received a second Clarification Request (Clarifax) from Health Canada regarding the product's Risk Management Plan, which is not atypical for a controlled substance drug. The Company will be submitting the response to Health Canada within the allowed timeframe. The Company cannot comment on Health Canada's response timelines. Questions/feedback from Health Canada are received as the review of the dossier progresses through different review streams.
About REDUVO™
REDUVO™ is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV). It is also used to treat weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVO™ is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis. REDUVO™ 5-year cumulative gross sales expected to reach $121M.
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.
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/reduvo-marketing-approval-on-the-right-path-301709009.html
SOURCE Tetra Bio-Pharma Inc.
Let’s hope approval happens!
Exactly…Teslas are much safer than ICE cars.
I speak French
«Les circonstances sont toujours nébuleuses, est-ce qu’il s’agit d’un endormissement ou encore une distraction?’ Basically they don’t know if she fell asleep or was distracted.
Gas cars are 11 times more likely to catch fire and don’t have a crumple zone. The engine will crush you in big crashes. Tesla’s have the highest safety ratings and are far safer than ICE cars. Also, the low Center of gravity means they are much less likely to flip over. Need more reasons Lol
I don’t own Tesla shares so I’m unbiased. Tesla and SpaceX are industry disrupters in a major way. Twitter is the worst, and Elon made a huge mistake getting into social media - not his strength.
Thankfully Teslas are much safer than gas cars, so this doesn’t happen as often. They say she might have fallen asleep at the wheel possibly.
Good to see a few PRs.
Good stuff. Finally a sign of life.
Hi Garyst, long time no talk!
I hope you are well and had a restful summer.
I always respected your opinions because you are one of the few stand up traders I trust on this site. With this in mind, what is your take on state of the OTC market.
My observations is that there are very few big gainers per week, or even per month compared to what I noticed in most of the last 10 years. It's never been so dead. I've always thought OTC was somewhat oblivious to large swings in the higher tiered markets like DOW, Nasdaq etc. and that there were always penny stock opportunities even when those markets were crashing. My intention was to trade penny stock full time last year, but I'm so sure that's feasible anymore.
Do you think rule changes that prevented US citizens from buying CE status stocks and the creation of the Expert Market killed the OTC for good, or we are just in a bear penny stock market (or both Lol)?
I'm seeing you took a break from the market as well, for a while. I would truly appreciate your response.
Kind regards,
Bueller
First CE removal in quite a while:
CRVH
https://www.otcmarkets.com/market-activity/corporate-actions
I don’t you read my post right. Gas cars are 11 times more likely to catch fire…And gas cars can explode!
Would you rather light a match next to a battery or a gas canister? And that’s why EVs win.
Same and I'm happy to report the storm was a non-event in his area.
Tesla does not a chronic fire issue, gas cars do Lol…11 more times likely to catch fire then an EV!
People who lack imagination don’t get Tesla. It’s why they never believed they could produce even one EV or be profitable, or have a chance against legacy automakers. Oh boy, were they ever wrong!
I don’t believe FSD will be truly effective for another 7-10 years, but when it is, it will be largely thanks to Tesla.
I echo your frustration and emailed something similar to Paul earlier this week. At the end of the day, we are at his mercy. My only sliver of hope stems from the fact it is in his own interest to get UNSS issues resolved.
Hey, I don't have private messaging anymore. I found out Paul is still working with an accounting firm to get latest Fins completed. Seems there were issues to resolve before they can finally submit Q2. Hopefully he does so before OTC downgrades UNSS to Expert 'grey' Market which would make the hill even steeper to climb.
I’m giving it a one chance out of ten that it will based on my recent DD.
I believe it’s the same investor based on Level 2 activity. Whoever got shares at 0.0014 average lately might make 100 times their money if PPS goes back to 14 cents again, one day! Nice Risk vs. Reward ratio. Big IF, of course Lol. I don’t see the value in selling off at these prices.
IF the DIN is approved by Health Canada, PPS will go way higher than 5 cents. I now consider TBPMF a lotto play.
*removing the CE
At this stage, OTC won't even consider reming the CE removal until Paul issues the latest Fins AND the Letter of Attorney.
Something is holding back Paul to issue the letter until whatever internal issue is resolved. Your guess is as good as mine, as to what the issue is. My intel tells me he hasn't given up and is trying to come with a resolution. We can only hope he succeeds or we are all hooped!
Interesting article explaining PPS woes for many biotech companies like TBPMF:
Big Pharma Won't Bail Out Battered Biotech -- Heard on the Street -- WSJ
7:00 am ET June 30, 2022 (Dow Jones) Print
By David Wainer
The stock market might be in the doldrums, but the biotechnology index has fallen off a cliff. One measure says it all: Dozens of publicly traded biotechs have dropped so much that they are now valued below the amount of cash they have in the bank.
Some healthcare investors have been pointing to that trend as a sign things have started to bottom. The argument goes that biotech has become so cheap that big pharma -- staring down a patent cliff and armed with hundreds of billions of dollars of dry powder for acquisitions -- will come to the rescue. Indeed, a popular biotech exchange-traded fund, the SPDR S&P Biotech ETF, has rebounded by around 20% from its recent lows.
That analysis paints with too broad a brush. Many of the companies now trading below cash are likely to go out of business in a macroeconomic environment in which their key input cost -- money -- is rising. To an even greater degree than high-growth tech companies such as Shopify or Roblox, biotech struggles in a rising interest-rate environment because many companies don't have any real revenue streams and don't expect to have a product in the market for years. Sadly for both investors and patients, clinical trials move slowly.
That problem has been exacerbated by a biotech bubble in recent years as too many early-stage companies went public. In 2021, the peak bubble year, 111 biotechs had initial public offerings in the U.S., topping the previous peak of 91 in 2020. Some of those companies are still conducting preclinical trials, meaning they haven't even begun testing their therapies on humans.
Sio Gene Therapies, with its shares down 87% in the past year, is an example of a company trading at a negative enterprise value. Sio Gene's market capitalization is $27 million, even though it had $65 million in the bank as of the end of the first quarter.
But Sio Gene is anything but a bargain. The company has terminated its gene therapy licensing agreements with the University of Massachusetts, is quickly running out of cash, and has fired much of its staff. Because a company like Sio Gene is effectively locked out of the capital markets these days, it needs to find a buyer to bail it out. The company hired SVB Securities in late April to help it explore a sale. Whether it can survive in some form remains to be seen.
Sio Gene isn't alone. Fierce Biotech, a news outlet focused on the industry, started a layoff tracker this year, and it looks scary. In the first week of June, for instance, oncology biotech Atreca announced plans to cull a quarter of its workforce and stem-cell developer Athersys said it is cutting 70% of its staff. And the list goes on.
So when will the bleeding stop? For Les Funtleyder, a healthcare investor at E Squared Capital Management, the sector as a whole can't really begin to rebound until it is clear that the Federal Reserve is finished raising rates. As of now, traders are pricing in rate cuts later next year, so a recovery could start early next year, he says. Pharma companies, Mr. Funtleyder says, aren't particularly focused on valuations. What they are focused on is the science and whether the business is a strategic fit.
Of course the market rout leaves some solid biotech businesses trading at bargain prices. That means the deal pace will probably pick up this year, especially in the crowded oncology space. Ipsen has agreed to acquire Epizyme for $247 million, and Bristol-Myers Squibb said it would buy Turning Point Therapeutics for $4.1 billion. Both are cancer plays. While the Turning Point deal reflected a premium, the purchase price was still below last year's high. Much of the most recent strength in the biotechnology sector has been related to speculation that Merck & Co. might buy Seagen, a company that could fetch about $40 billion.
But pharma companies are looking for needles in the haystack, not the haystack itself. That means more pain could still be coming for biotech investors. Big pharma won't be there to help.
CFRA Research Disclosure
3rd Party Research Disclosure
This gives me more hope, not all is lost. Let’s go Health Canada!
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.”
Radio silence
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.
Come on Paul. Be the hero and get the damn AL and Fins out this month!
Correction: *I wouldn't say a lost cause* Lol
I would say a lost cause. It’s my understanding Paul is working on a resolution. How long will it take is the harder part to answer. Fins are still being submitted which costs money, so I would he still is hopeful he can clean this up and get UNSS moving. Frustratingly slow, but not a lost cause IMHO.
Good to hear from you, Eageleye. This is definitely the best iHub board I’ve been in.
Hopefully things progress with the CE removal process and you’ll want to increase your position at what will still be early stages.
Hope your enjoying your summer.
Bueller
It's up almost 50% today. I'm still very hopeful. Time will tell if Paul can deliver.
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.
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Forward-looking Statements
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Good signs, especially that he finally communicated. Thanks for sharing!
Fingers crossed once again Lol
There's definitely a value here for UNSS. You have a better on what that value is than I do. You would think this would be clear in the reports. Then again, clarity is what's been missing lately with no updates. I still believe Paul can get the ball rolling in the right direction, but have given up on guesstimating when that will be.
Those are insane numbers. I hope Paul is still working on resolving issues. Well worth for him, so I believe he is.