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All I care about is CE removal. This should get us there.
Filings are showing up! Our patience will soon be rewarded! This is only the beginning. I expect huge revenue deals this year AIMHO.
I added more shares to celebrate. Lol
UNSS LONG & STRONG
YAHOOOO FINS!!!!!!!! $UNSS CE removal is next!!!!
Nope, he's actually outperforming our expectations. You do realize no one will be influence by your comments here, right? Longs are holding.
UNSS LONG & STRONG
ENTREX CARBON MARKET Legitimizing the Carbon Offset Marketplace
(Again, we are talking about $3+ Billion in revenue potential for a 53M share float ticker!!!)
Over the years, carbon emissions have immensely contributed to climate change and global warming. To reimburse its hazardous impacts, the concept of carbon offsetting was introduced to the market. The idea of carbon offsetting revolves around the balancing of mechanisms so as to compensate for the carbon footprints. It is regarded as a potential solution to the daily carbon emissions—such as the emissions generated by large industries or the ones caused due to forest fires—which are irreversible and unavoidable.
Through carbon offsetting, people can compensate for these emissions by funding projects that provide sustainable development to communities around the world. These projects offer equivalent reduction in emissions, either through counteracting or absorbing carbon dioxide and bringing balance to the environment. Carbon offsetting supports or executes projects that have a positive contribution to the environment.
In addition, the increased funding received by carbon offsetting projects can change lives—bringing economic, social and health improvements to whole communities. With a lot of carbon offsets available in the market, it is hard to choose one with promising policies and secure outcomes. Entrex Carbon Market was incorporated in the year 2019 to address the traditional environment underperformance. The company believes in the promising aspects of carbon offsets and the carbon neutrality it aims to deliver in the near future.
An Ingenious Mastermind
Entrex Carbon Market was founded by Stephen H. Watkins (CEO). It is a majority owned subsidiary of its parent company Entrex Inc., (OTC: UNSS) which was founded by Stephen more than 20 years ago with a mission to improve access to capital for entrepreneurial companies.
Talking about the company's inception, Stephen asserts, “We've successfully built two companies that grew to over one billion dollars in market cap and have brought similar leadership to Entrex Carbon Market.”
MM2021|02
Stephen H. Watkins
CEO
“‘Entrex Carbon Market is the first regulatory- compliant marketplace to buy, sell and retire carbon o?set securities and futures.”
Entrex has assembled an experienced and talented management team with a track record of building and leading world-class businesses in multiple dynamic industries. Stephen believes that it is his duty to decipher client demands and lead the technology team to create efficient solutions.
Holistic Services
Being the only regulatory-compliant trading market in the carbon offset industry, Entrex Carbon Market offers various potentials to verify and secure carbon offsetting. The company provides numerous benefits on buying, selling and retiring of carbon offset securities and securitized futures. It aims at building frictionless methods to supply registered offsets to the global market.
Furthermore, Entrex Carbon Market provides simple, safe and regulatory-compliant solutions. With these solutions, it ensures to help the new administration attain carbon neutrality, while maintaining its industry leading position. The company offers offsets which are registered under the United Nations and World Bank carbon offset processes. It believes that an idea as good and as promising as offsetting carbon emissions as part of the organization's carbon neutrality program deserves higher attention.
The First Regulatory-Compliant Carbon Offset Marketplace
The carbon marketplace had a maligned reputation during the early times. Numerous schemes were sold out with false promises of carbon emission reductions and enhancement of the green environment. Over the past few years, the carbon offset marketplace has undergone a drastic change. Government introduced scrutinized carbon offset policies and paved the way for carbon offset projects.
Entrex Carbon Market operates with the sole purpose of legitimizing the carbon trading market. The company is the first ever regulatory compliant marketplace where one can buy, sell and even retire carbon offset securities and futures. Entrex Carbon Market aims at addressing the traditional environmental underperformance and frauds that previously existed in the carbon offset industry. It focuses on offering schemes and policies which fall under the government's legitimized and verified regulations.
A One-stop Shop
The Entrex Carbon market has been built on the IBM nominated technology platform that can manage offset supply to worldwide carbon neutral buyers at scale. It has a
We believe an idea as good and as promising as o?setting carbon emissions as part of organization's carbon neutrality program deserves nothing less.
proprietary technology platform at the core which has been continuously developed and refined over time. The advanced technological platform was even featured in a case study authored by IBM on innovative applications of their Domino and Hyperledger technologies. The Entrex Carbon Market was first of its kind to be designed to comply with all applicable United States Securities and Exchange Commission rules for private transactions between regulated parties.
Entrex Carbon Market is consistent with its purpose of bringing clarity and visibility to the carbon offset marketplace. As a purpose-driven company, it is unique beyond its regulatory compliance. It offers a single-source solution for carbon offsets, securitized carbon offset futures, and carbon offset registration programs. Simultaneously, the company also acts on creating and maintaining predictable and credible supply and demand in a regulatory-compliant manner. In a nutshell, Entrex Carbon Market offers a one stop shop for global carbon neutral companies.
Evolution of Carbon Offset Marketplace
Over the years, the carbon market has transitioned into a legitimate and more secure version with the help of government assistance and fundings by large enterprises. Numerous organizations are switching to sustainable methods of business operations and functioning which are driven by climate change concerns. Likewise, the carbon market has evolved from speciality to mainstream corporate citizens following regulatory protocols. Entrex Carbon Market provides partnership benefits to both carbon offset producers or organizations seeking to purchase carbon offsets as part of their carbon reduction or neutrality initiatives. As such, one can imagine how the supply and demand requirements have changed significantly through that evolution.
03|MM2021
Very nice article on Entrex Carbon Market
"Jun 2021 Entrex Carbon Market highlighted in Mirror Review article"
Link: http://tigrcub.entrex.us/entrex/EntrexNewsFAQs.NSF/0/57B83935BE4B79B9852586F10048CC79/%24File/__Mirror%20Review%20-%20Entrex%20Carbon%20Market%20Article.pdf?Open
That's 6 PRS in June. Watkins has been busy insuring the future will be bright!
Filings any day/ LOA.
http://florida.entrex.market/news/
UNSS LONG & STRONG
Awesome! We are close.
UNSS about to take off!
"I think you are Watkins"
Oh man, thanks for the compliment! Watkins is a BOSS!!!
UNSS LONG & STRONG
I'm sorry to hear that. We will miss you
UNSS LONG & STRONG
Yeah, why else would they "get the lawyers involved". Exciting times indeed!!!!
BOOMAGE!!! Ask getting slapped hard! $WCSR
TWEET! "Update this week. Stay Tuned. Exciting Times."
Update this week. Stay Tuned. Exciting Times.
— Western Sierra Resource (@WSRCorp) June 28, 2021
Good TBPMF review. We should hear about QIXLEEF preliminary trial within the next week or two. Huge catalyst if results are positive as expected!
Amazing! Such a small float, too
Exactly. UNSS’s incredibly small and very locked zero dilution 53M shares float size, in addition to the fact Entrex has very real billion dollar opportunities with seasoned management, is what makes this a once in a lifetime opportunity. AIMHO
UNSS LONG & STRONG
So another ticker (HIRU) had its CE status removed within a few short days of providing Letter of Attorney and updated filings. Their updated Fins were submitted June 15 and LOA was submitted June 22.
Let's hope OTC will do the same and as quickly for $UNSS when updated filings/LOA are uploaded.
Let's go Paul!
UNSS LONG & STRONG
Yup, great time to add!
"This agreement starts the first of a series of strategic acquisition targets which will allow Entrex Carbon Market to scale beyond our leadership position in the sector into the dominant domestic regulatory- compliant market"
Very interesting, indeed. I reached out by email this morning but no response yet. I'm sure he's busy locking up new opportunities! :)
UNSS LONG & STRONG
Tweet!!! "IMPORTANT UPDATE SOMETIME NEXT WEEK - STAY TUNED"
IMPORTANT UPDATE SOMETIME NEXT WEEK - STAY TUNED
— Western Sierra Resource (@WSRCorp) June 25, 2021
Great tweet! The amount of opportunities Entrex is generating is staggering!!!
https://twitter.com/EntrexInc/status/1408438033158975490?s=20
Entrex executes purchase option agreement with Net Zero Analysis and Design
UNSS Long & Strong
BREAKOUT!!!
Yup there holding this back...but not for long!
"Broken record for months saying the same thing, any day now…."
At least you admit it. Good for you
Well said. Watkins said there were a few more minor details to provide LOA. We are close!!
UNSS Long and Strong
Let's go!!!!
"Sub penny then delisting coming fast…" I guess that comment was meant for $EVLI and not UNSS. Yikes that's gotta hurt!
Watkins feels very likely Letter of Attorney to be completed early this week based on what he's told by Paul. Sit tight!
UNSS Long & Strong
Nice news. Thanks for sharing. Good start to trading week!
Significant Discovery Reveals New Antiviral Properties of Tetra Bio-Pharma's Innovative Drug ARDS-003
Combining ARDS-003 with antiviral drugs significantly decreased viral replication compared to antiviral treatment alone.
OTTAWA, ON, June 21, 2021 /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 that its investigational new drug ARDS-003 has been studied in a viral infected organoid model as part of a research collaboration between Targeted Pharmaceuticals ("Targeted") and George Mason University. ARDS-003 is a new patent protected therapeutic developed to treat hyperinflammatory conditions, such as those seen in patients suffering from COVID-19 viral infections and sepsis.
Tetra Bio-Pharma Inc. Logo (CNW Group/Tetra Bio-Pharma Inc.)
On March 26, 2021, Tetra announced it had entered into an agreement with Targeted Pharmaceuticals to initiate additional studies on its leading drug candidate ARDS-003. As a result, a preliminary study on HIV using the HU-308 molecule, the Active Pharmaceutical Ingredient used in our Covid-19 therapeutic ARDS-003, determined that viral replication is significantly decreased when HU-308 is used in combination with a standard antiviral drug to treat HIV. In other words, it clears the virus significantly better than the standard antiviral drug alone. These results suggest that in addition to immunomodulator properties, ARDS-003 demonstrates strong antiviral effects in humans.
Extracellular vesicles (EVs) play a role in the immune response against viral pathogens and post-infection complications, such as neurodegeneration. They incorporate and spread both viral and host factors, thereby inducing or inhibiting immune responses towards the viruses via multiple mechanisms. Studies have shown that EVs are implicated in SARS-CoV-2 infected disease. EVs have been involved in the transfer of viral receptors to other cells making these cells more susceptible for SARS-CoV-2 infection. Further, according to the Sepsis Alliance (Viral Infections | Sepsis Alliance), viral infections are a frequent cause of sepsis.
"Understanding the affect of ARDS-003 on EVs in viral infections is important for guiding the long-term clinical development of Tetra's proprietary asset, particularly since this drug clearly has both anti-inflammatory and antiviral properties. The neuro-organoid spheres used in this study are like mini brains! They get infected with the virus thereby allowing us to study our drug without infecting live animals. This has transformed how we conduct research" stated Dr. Guy Chamberland, Chief Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma.
On June 16, 2021, Targeted stated in its news release "These studies are significant in that cannabinoids may provide a protective effect by alleviating the pathogenic effects of EVs in HIV-1 and CNS-related infections," commented Dr. Fatah Kashanchi, Professor and Director at the George Mason University's Laboratory of Molecular Virology Lab. "Our data suggests that certain cannabinoids, such as CBD and THC can act as viral transcription inhibitors, potentially through two independent mechanisms and provide significant reduction in EVs released from infected cells", stated Dr. Kashanchi. Tetra confirms that this research also included its proprietary investigational drug ARDS-003.
Dr. Guy Chamberland also stated, "Our partnership with Targeted is allowing us to learn more about the therapeutic potential of our proprietary drug ARDS-003. Sepsis is a major cause of death worldwide and viral infections contribute to this. These types of studies are a first of a kind using neuro-organoid spheres. We believe this partnership will lead to new market opportunities for both corporations as we leverage our cannabinoid inhalation intellectual property as well as that of the ARDS-003 drug."
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. Our evidence-based scientific approach has enabled us 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 we 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
About Targeted Pharmaceuticals LLC
Targeted Pharmaceuticals is a clinical-stage pharmaceutical company focused on treatments for oncology and central nervous system disorders.
Learn more at https://www.targetedpharma.com
About George Mason University
George Mason University is Virginia's largest public research university. Located near Washington, D.C., Mason enrolls more than 37,000 students from 130 countries and all 50 states. The National Center for Biodefense and Infectious Diseases (NCBID) at Mason focuses on host-pathogen interactions using proteomics and nanotechnology as they are applied to diagnostic, therapeutic, and vaccine development. NCBID manages The Biomedical Research Lab (BRL), one of thirteen Regional Biocontainment Laboratories in the U.S. constructed with funding support from the National Institute of Allergy and Infectious Diseases/National Institutes of Health (NIAID/NIH), performing pioneering research of infectious diseases, both emerging and potential bio threat agents.
Learn more at www.ncbid.gmu.edu
About the College of Science
The College of Science at Mason is a leader in scientific discovery creating innovative solutions for the rapidly changing needs of today's world. Mason's College of Science blends traditional science education with sought-after programs in disciplines as diverse as personalized medicine, infectious diseases, geoinformatics, climate dynamics, materials science, astronomy, forensic science, and applied mathematics. The College encourages meaningful education and research at all levels offering innovative undergraduate programs, minors, certificates, and graduate degree opportunities, as well as global, transfer-focused, and online, or hybrid, programs that allow professionals the opportunity to reskill or change careers.
Learn more at www.science.gmu.edu
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:http://www.prnewswire.com/news-releases/significant-discovery-reveals-new-antiviral-properties-of-tetra-bio-pharmas-innovative-drug-ards-003-301316069.html
SOURCE Tetra Bio-Pharma Inc.
Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2021/21/c0734.html
Don’t be so hard on yourself Lol
I think the penny market is a little weak like it is many summers. TBPMF has strong fundamentals and things will pick up eventually.
At this stage, it's mostly brokers outside the US. Not sure if any US platforms allows buying of CE status stocks.
Yup, those of us who spoke with Watkins are super confident about Fins progressing in the right direction. Never as fast as we want them too, but there are no longer any holdbacks (LOA is the last step). My best guess is anytime this week.
UNSS LONG AND STRONG
Doubt it. Overall penny market is bearish with typical much smaller volume during the summer (except for last year). I got in @0.147 and out @0.256. Was hoping for much bigger gains but volume just isn't there. GL
Yup, this should be flying high on the news.
He's not. Letter of Attorney is in the works so expects Fins any day this week.
Huge gap up!!
$BPSR HUGE NEWS!!!! Organicell Announces Positive Results Of Their Expanded Access Trial For The Treatment Of Mild To Moderate COVID-19 Using Zofin™
PRESS RELEASE
Miami, FL (June 15th, 2021) – Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced the outcome of their expanded access (EA) intermediate size patient population trial (NCT04657406) which:
Met endpoints for safety and efficacy in patients with mild to moderate COVID-19
Mitigated mild and moderate symptoms
Improved pulmonary opacities detected in chest X-rays
Improved inflammatory biomarkers
The trial was conducted at United Memorial Medical Center (UMMC) in Houston, TX. The administration of Zofin™ was well tolerated in all enrolled subjects, with no adverse events. Chest X-ray data demonstrated that 75% of subjects had bilateral opacities caused by COVID-19 infection at day 0 (baseline), prior to Zofin™ treatment. Thirty days after Zofin™ treatment, chest X-ray data showed 83% of treated subjects had normal lung imaging, indicating complete recovery. There was also a significant decrease in biomarker levels like CRP, IL-6, and TNF-a at day 14, 21, and 30 when compared to the respective control with p-values less than p < 0.05, p < 0.01 and p < 0.001, respectively. Organicell intends to submit results for scientific peer review and publication.
Organicell will immediately submit this data to the FDA for a requested amendment to their approved IND (NCT04384445) to perform a placebo-controlled Phase 2 clinical trial to confirm safety and efficacy in a randomized fashion.
“There are only a few evidence-based treatments for acute COVID-19 that are appropriate for use in the outpatient setting. We are extremely pleased by the outcome of this analysis, which provides strong evidence that Zofin™ may be an effective treatment for patients who are at high risk of progressing to severe COVID-19, hospitalization, or both if no treatment is given,” said Vincent Friedewald, MD, FACC, FACP, Primary Investigator at UMMC, Houston, TX.
“The study results mark an important step in our journey to bring forward a biological drug capable of helping end this devastating pandemic,” said Mari Mitrani, M.D. Ph.D., Chief Science Officer of Organicell.
ABOUT ZOFIN™
Zofin™ is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, and chemokines as well as extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin™F is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin™ for the treatment of moderate to SARS related to COVID-19 infection.
ABOUT ORGANICELL REGENERATIVE MEDICINE, INC.
Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR) is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases. The Company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring exosomes, hyaluronic acid, and proteins without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Mari Mitrani, Chief Scientific Officer. To learn more, please visit https://organicell.com/.
ABOUT UNITED MEMORIAL MEDICAL CENTER (UMMC)
UMMC Hospital was established to fill the need for quality emergency and surgical care in the community of Spring, Texas. We are a complete surgical facility with an Emergency Room to provide care for those unexpected medical emergency needs using innovative techniques and the latest methods of treatment. We operate by the Hippocratic Oath to the best of our ability. Our doctors remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon’s knife or the chemist’s drug. To learn more, please visit https://ummc.care
FORWARD-LOOKING STATEMENTS
Certain of the statements contained in this press release should be considered forward-looking statements within the meaning of the Securities Act of 1933, as amended (the “Securities Act”), the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are often identified by the use of forward-looking terminology such as “will,” “believes,” “expects,” “potential” or similar expressions, involving known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. We remind you that actual results could vary dramatically as a result of known and unknown risks and uncertainties, including but not limited to: potential issues related to our financial condition, competition, the ability to retain key personnel, product safety, efficacy and acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, our inability to expand sales and distribution channels, legislation or regulations affecting our operations including product pricing, reimbursement or access, the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties, including the risk factors discussed in the Company’s periodic reports that are filed with the SEC and available on the SEC’s website (http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these risk factors. Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press release.
Media Contact:
Jeanene Timberlake
Rooney Partners
646-770-8858jtimberlake@rooneyco.com
JUNE 15, 2021/BY ORGANICELL
https://organicell.com/2021/06/15/organicell-announces-positive-results-of-their-expanded-access-trial-for-the-treatment-of-mild-to-moderate-covid-19-using-zofin/
Huge news!!!
Tetra Bio-Pharma progressing fast as it advances coronavirus drug candidate ARDS-003 to human trials
Vial of COVID-19-positive blood on cannabis leaves
Derived from cannabinoids, ARDS-003 is designed to prevent and treat acute respiratory distress syndrome, a severe inflammatory response that could be life-threatening to coronavirus patients
Biopharmaceutical company with a pipeline of novel proprietary drugs
Partnership with medicinal chemistry biotech to ensure new proprietary molecules for long term success
Target markets: coronavirus and sepsis, acute and chronic pain, inflammatory diseases of the eye, and cancer
Five orphan drug designations from US FDA
What Tetra Bio-Pharma does:
Tetra Bio-Pharma (TSE:TBP) is a Canadian biotechnology company that is reimagining cannabinoid-based drug development.
The Ottawa-based firm has a pipeline of novel proprietary drugs targeted towards a multitude of conditions, but it is their potential coronavirus (COVID-19) treatment that is currently exciting investors.
Derived from cannabinoids, ARDS-003 is designed to prevent and treat acute respiratory distress syndrome (ARDS), a severe inflammatory response that could be life-threatening to patients with COVID-19 or sepsis.
Tetra is confident that ARDS-003 will be effective, given 12 years of preclinical efficacy research in sepsis and cytokine hyperinflammatory reactions. Potential revenues from royalties on net sales, milestone and upfront payments look to be over US$500 million by 2026, based on a conservative market penetration and patient-based model.
Outside of ARDS-003, the company is advancing a full pipeline of other drug candidates - CAUMZ is targeted towards uncontrolled pain and cancer; PPP-003 is a possible inflammatory eye treatment; HCC-011 is for chemotherapy-induced nausea; and QIXLEEF is being developed as a strong painkiller.
Led by CEO Guy Chamberland, Tetra’s executive team is comprised of drug development veterans and together, the firm has five orphan drug designations from the US Food and Drug Administration (FDA) and patents extending out to 2034.
How is it doing:
Tetra reached a key milestone in early December 2020 after it completed safety trials for ARDS-003.
In March 2021, the company then revealed that it had received positive feedback from Health Canada on its application for a clinical trial on ARDS-003. Tetra said that Health Canada had acknowledged that the preclinical safety data are “robust and sufficient” to file a clinical trial application designed to treat hospitalized COVID-19 patients, who are at risk of developing ARDS, or acute respiratory distress syndrome.
Tetra said its trial will be the first worldwide drug to involve the use of an injectable sterile synthetic cannabinoid in patients with COVID-19. The company is hoping to demonstrate the effectiveness of ARDS-003 in preventing acute respiratory distress in COVID patients.
Away from ARDS-003, in June 2021, Tetra announced that Health Canada had accepted its New Drug Submission (NDS) for REDUVA, the company’s soft gel capsule designed to treat chemotherapy-induced nausea and vomiting (CINV). The active pharmaceutical ingredient in REDUVO is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis.
The application entered the final phase of the review process and, If successful, REDUVO will be issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN), which permits Tetra to market the drug in Canada.
At the end of May, with regard to QIXLEEF, the company announced that the first patient was recently dosed in the REBORN1 trial of patients with cancer pain. In the REBORN1 study, the screening process requires eligible patients complete a questionnaire for seven continuous days to assess the intensity of their background chronic pain, the number of episodes of breakthrough cancer pain and opioid use.
The company also announced in May that it was speeding up its PLENITUDE clinical trial, a Phase 2 study of QIXLEEF’s safety and effectiveness in managing uncontrolled pain in patients with advanced cancer.
On the financial front, the company revealed in May that it had it generated more than C$47.5 million in revenue from a distribution deal with Danish biopharma DanCann Pharma for the exclusive distribution of Reduvo Adversa, QIXLEEF and ENJOUCA in Denmark, Norway, Sweden, Finland, and Germany.
Tetra also recently undertook financing, raising C$11.5 million in gross proceeds after underwriters exercised an overallotment option in May to a $10 million placing.
Inflection points:
ARDS-003 progressing through preclinical trials as a COVID-19 treatment
Health Canada review of REDUVA
Phase 2 trials of QIXLEEF in 2021, Phase 3 trial in early 2022
What the boss says:
"The severity of Sars-CoV-2 infection in a patient has significant impacts on our health care system,” Tetra CEO Guy Chamberland said in May.
“ARDS-003 can become a valuable therapeutic if clinical trials demonstrate a reduction in the severity of the infection. Tetra is also studying the benefits of ARDS-003 on the immune system response to establish advantages over the use of dexamethasone in Acute Respiratory Distress Syndrome or Sepsis patients. We believe a broad action immunomodulator that does not result in pronounced immune suppression will play a more significant role."
Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com
Follow him on Twitter @andrew_kessel
Phuket...I'm going to Thailand!!! :D