1/20 Long post WARNING. A history lesson in #QIXLEEF & #CAUMZ inhaled drugs that meet US cGMP reg. reqs. to treat pain in cancer patients. QIXLEEF is a botanical drug fixed ratio of THC & CBD while CAUMZ is synthetic version of QIXLEEF. @timseymour @BettingBruiser @todd_harrison

2/20 Current status: QIXLEFF 1) active Phase 2 PLENITUDE #clinicaltrial in the US and 2) QIXLEEF, @FDA clearance on IND, allowing Reborn1 trial to commence in the US.

3/20 Go back 5 years to 2016, $TBP obtained binding jurisdiction for a smokable #drug-device combination #cannabis drug product. Eventually medical device changed based on $TBP body of evidence – safety and cannabinoid composition inhaled. Many clinical advantages to this change.

4/20 In 2017, we had our 1st Type B meeting with @FDA to seek guidance on QIXLEEF as a smokable drug product. The FDA guidance gave TBP a clear path to progress from early to late phase clinical development.

5/20 In 2017, @GovCanHealth allowed Phase 1a & 1b randomized double-blind placebo-controlled trial with smoked QIXLEEF. The Phase 1 assessed safety, pharmacokinetic, and pharmacodynamic of the drug in single and multiple dose escalation in healthy volunteers.

6/20 In 2018, @FDA granted @Tetrabiopharma an Orphan Drug Designation for THC/CBD formulation in the treatment of complex regional pain syndrome, providing $TBP with many incentives.

7/20 2018, we demonstrated the superiority of QIXLEEF inhalation compared to oral THC & CBD. Max THC plasma up to 10-fold higher & within 5 min. Yes, really! The relative THC & CBD bioavailability is respectively 5X higher than #Marinol and 4X higher than #Epidiolex. @jazzpharma

8/20 In 2018, we launched a Phase 2/3 randomized double-blind placebo-controlled trial with smoked QIXLEEF in #Canada. The phase 2/3 trial assessed safety and efficacy of the drug in patients with advanced #cancer with #chronicpain. Stay with me.

9/20 This is where we introduced #vaporized QIXLEEF. We launched a Phase 1 randomized double-blind placebo-controlled trial with vaporized QIXLEEF in #Canada. The phase 1 assessed safety and pharmacokinetic of the drug in healthy volunteers.

10/20 2018 presents yet another very exciting moment for $TBP when our R&D discovered composition of matter #Intellectualproperty for inhaled #cannabinoids in smoked & vaporized QIXLEEF. @jazzpharma

11/20 Moving on to early 2019, big turning point for $TBP. Our pharma quality program reveals mycotoxin risks in botanical drug QIXLEEF. This hauled our clinical activities - we quickly pivoted & bridged QIXLEEF with our new #synthetic formulation, CAUMZ. We are #resilient.

12/20 End of 2019, $TBP successfully implemented a mycotoxin risk reduction quality program which results in the @FDA clearing #IND for Plenitude trial. The phase 2 blind placebo-controlled study assesses vaporized QIXLEEF efficacy in patients with advanced cancer with pain.

13/20 Another achievement in 2019 – the @FDA granted @Tetrabipharma an Orphan Drug Designation for THC in the treatment of hepatocellular #carcinoma.

14/20 Into 2020, we conducted a type B meeting with the @FDA and #Pre-CTA meeting with @GovCanHealth to seek guidance on our synthetic vaporized THC-CBD formulation, CAUMZ.

15/20 Also in 2020, we conducted a type B meeting with @FDA to seek guidance on our synthetic vaporized formulation containing only THC.

16/20 We characterized the profile of precursors & metabolites of THC & CBD in humans exposed to smoked & vaporized QIXLEEF: THCA, CBDA, CBGA, 11-OH-THC, 11-nor-9-carboxy-THC, CBC, CBG, CBN, 7-OH-CBD, 7-COOH-CBD.

17/20 In 2020, we also showed that #CBD in inhaled QIXLEEF results in less exposure to 7-OH-CBD (35X lower) and 7-COOH-CBD (16X lower) than oral CBD. Data in humans support the low by-pass #metabolism effect of QIXLEEF and its superior safety profile compared to oral CBD.

18/20 This brings us to 2021, noted in #2, @FDA cleared IND for Reborn1 trial. This is a crossover open-label study comparing safety & efficacy of QIXLEEF versus immediate release morphine in patients with breakthrough #pain. This could be a game changer in the #opioid crisis.

19/20 Finally, also noted in #2, Tetra initiated the in-life phase of the PLENITUDE trial to prove the efficacy and safety of QIXLEEF for the relief of pain in patients living with cancer.

20/20 Stay tuned for another lesson on #ARDS-003, @Tetrabiopharma synthetic #cannabinoid intravenous drug for the prevention/treatment of #COVID19 and #sepsis. Exciting things happening at $TBP!