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TETRA BIO-PHARMA INC. MANAGEMENT’S DISCUSSION & ANALYSIS
For the nine months ended August 31, 2019 and up to October 17, 2019

Biopharmaceutical – Chronic Pain Segment:
PPP011 Caumz(TM) = in Serenity(c) and Reborn(c) Clinical Trials:
Targeting Intended Uses & Conditions

TETRA HAS BEEN [VERY BUSY] RAMPING UP ACTIVITIES FOR CAUMZ’S(TM) PHASE 3 CLINICAL TRIAL SERENITY(c). Over the last 4 months Tetra has been qualifying sites, applying to obtain scientific and ethics approval, and confirming or applying for eligibility to conduct the trial in accordance with the regulations of Drug Enforcement Agency and Health Canada’s new cannabis research license. The Company has already SECURED MORE THAN 20 CLINICAL SITES, with 10 BASED IN THE UNITED STATES, with the goal of obtaining FDA and Health Canada marketing approval by late 2020. In a phone call to Tetra investor relations, the company made clear that they are absolutely moving forward with all speed and diligence helping every new clinical trial site get all their necessary approvals, as stated above. To research cannabinoids is a milestone for these sites, a first in their history, and everybody is working together to complete all of these needs and compliances in order to begin their first clinical trial for Tetra's CAUMZ drug. The company is still keeping the sites close to the vest, due to MNDA non-disclosure agreements, but can be expected to announce more about these sites and their locations as that becomes public information and the trials are slated to begin. As the reader is probably well aware of, many places in the United States have wanted to conduct research on cannabinoids, and now, with the help and partnership of Tetra, they are doing this very thing, very long-awaited thing!

TETRA EXPECTS TO SUBMIT THE NECESSARY REGULATORY DOCUMENTS FOR ALL CLINICAL SITES BY THE END OF Q4 2019 TO HEALTH CANADA AND THE FDA.

VERY IMPORTANT TO NOTE:
Assuming successful outcome, Tetra will request conditional approval for the drug’s primary intended use and SUBSEQUENTLY SEEK COVERAGE FROM PUBLIC INSURERS. Also, be aware that not only will Tetra be seeking insurance coverage for the drug's intended use, but they will also apply for insurance coverage for treating secondary conditions such as chronic pain and breakthrough pain, which will increase the market size for CAUMZ considerably. As stated in a prior article, just for the advanced cancer pain market alone, the Big Pharma companies in negotiation with them have presented their research to Tetra that they expect CAUMZ would grow its sales over the next ten year to achieve $2 Billion USD in sales by 2029.

However, we would be remiss to stop there. Oh no. And in fact, Tetra noted this was only a figure given for just one of Caumz's intended conditions it will treat. Take a look at THIS: According to Transparency Market Research, the US market for Therapeutic Pain Management is currently about $40 Billion USD and growing at a 4% annual rate, so is 4-5 times the size of the advanced cancer pain market in the United States. These same large pharmaceutical companies predict Tetra's CAUMZ will likely gain 20-25% of the US market for advanced cancer pain (the $2 Billion annually by 2029), and that implies possible $10 Billion USD in annual revenue for Tetra Bio-Pharma from this additional pain market by 2029. You heard that right: While they are predicted to make $2 Billion a year through Caumz for advanced cancer pain in the USA, the Caumz revenue for therapeutic pain management is looking at $10 Billion USD annually for Tetra based on the same percentages of 20-25% market share. It is quite possible since it will be covered as an insurable drug, these figures can go higher due to opioid replacement strategies and the fondness of the general US population for treating conditions with cannabinoids through the human endocannabinoid system. The Therapeutic Pain Management market is growing globally at a 4% rate per annum and Tetra will definitely seek the same insurance coverage for CAUMZ for this condition as well. https://www.transparencymarketresearch.com/pain-management-t...

In parallel, the Company intends to resume Phase 2 trial called REBORN©, a head to head comparative study assessing Caumz(TM) as an alternative to OxyIR(c) (short-acting Oxycodone) for breakthrough pain in cancer patients. This is Tetra's Caumz versus Fentanyl study where Tetra is taking Fentanyl on in a head-to-head study as an opioid replacement to try to alleviate the great opioid crisis by putting a prescription drug, Caumz, into the arsenal of doctors and physicians, because of the vast array of scientific, clinical data amassed by Tetra in its many clinical trials to date focusing on what the medical community has been asking for. Physicians are demanding this safety and efficacy data derived from Health Canada and FDA clinical trials and that is exactly the path Tetra Bio-Pharma has chosen. The promise this pathway holds is becoming more evident every day that passes.

If approved by Canadian and American regulatory agencies, this would allow Tetra to tap into a large therapeutic market with unmet needs. Tetra is already involved in discussions with several potential commercialization partners from around the world, and this means we have to add further to our predictions for Tetra's revenue by 2029 quite substantially. The tally on the first two conditions above is $2 Billion and $10 Billion, or $12 Billion total annually for those two by 2029. Add in their share of global sales, not just USA sales, for these two Caumz-treatable conditions, you would add a possible 2/3rd more, since USA accounts for just under 60% of the market for these drugs and the rest of the world accounts for about 40% of the market. That would result in the $12 Billion in US sales annually plus another $8 billion from the global market all totaling together $20 Billion in worldwide sales annually for Tetra's CAUMZ. The Breakthrough Cancer Pain market is much smaller by comparison at a little over $4 Billion annual sales for the US, Europe and Japan combined in 2019. $20 Billion in annual sales globally is what Tetra Bio-Pharma is looking at in revenues by 2029. Aphria (NYQ:APHA) and Canopy Growth (NYQ:CGC) have their substantial stakes in Tetra Bio-Pharma, whose shares trade public in both the US and Canada. Tetra recently announced they intend to file for listing on the Nasdaq, which will likely happen as soon as their stock begins to rebound from severely undersold toward fair value, as word gets out and more news is released.

Note:
In 2017 and 2018, Tetra completed several clinical trials evaluating safety, efficacy and impact of smoked, and vaporized cannabis on the body.
TETRA SUCCESSFULLY BRIDGED INHALATION RESEARCH DATA FOR their 100%-owned subsidiary Phyto Pain Pharma's PPP001 DRUG TO CAUMZ(TM)(PPP011), thereby allowing Tetra to proceed with its new NEXT-GENERATION drug, Caumz(TM). Caumz(TM) is composed of pure synthetic THC and CBD and is an adjacent drug therapy alongside standard palliative care that is aimed at improving patients’ quality of life while helping reduce malignant cancer pain and other uncontrolled pain. A Class 2 Health Canada approved medical device, Mighty Medic vaporizer (Canopy Growth's medical device that Tetra got approved with regulators), is used in the clinical trials to inhale Caumz. Both the drug and the device will be covered by insurance upon regulatory approval of the Phase 3 clinical trial.
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