Qixleef (inhaled medical cannabis) / Tetra Bio-Pharma - LARVOL DELTA

Efficacy of Apremilast for the Treatment of Japanese Patients With Palmoplantar Pustulosis: Results From a Phase 3, Randomized, Placebo-Controlled Study (EADV 2024) - "Introduction & Objectives: Palmoplantar pustulosis (PPP) is a chronic dermatitis associated with itching and pain, for which treatment options are limited. Clinical improvement in Japanese pts with moderate to severe PPP was observed with APR relative to PBO, regarding of baseline demographics and disease characteristics. Rapid onset of efficacy as early as week 2 was observed with APR. PPP-001 Ph 2 Exploratory Page 1** of 1**"

Clinical • P3 data • Dermatitis • Dermatology • Immunology • Pain • Pruritus • Psoriasis

Tetra Bio-Pharma’s QIXLEEF on Track After Type C Meeting with U.S. FDA (PRNewswire) - “Tetra Bio-Pharma Inc….received the response letter for a Type C meeting with the United States Food and Drug Administration (FDA) for its inhaled cannabinoid-based product, QIXLEEF™. The meeting was held to discuss the nonclinical safety requirements for the marketing approval.”

FDA event • Pain

"$tbp $tbpmf #QIXLEEF #REBORN #PLENTITUDE #alternativetoopioids @DancannPharma #inhaled #aerosol #prescription #cannabis @JazzPharma @Curaleaf_Inc" (@A_Rosenthal)

Tetra Bio-Pharma Receives Positive Opinion for Orphan Drug Designation for QIXLEEF from the European Medicines Agency (PRNewswire) - "Tetra Bio-Pharma Inc...today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the Company's application for Orphan Drug Designation (ODD) for its investigational medicine QIXLEEF™ as a potential treatment for Complex Regional Pain Syndrome (CRPS), a chronic neuropathic pain condition....The positive opinion issued by the COMP will be sent to the European Commission, which is expected to grant the orphan designation within 30 days....Since QIXLEEF™ will be intended to treat an orphan condition, clinical studies will be preformed with a significantly smaller number of patients and could be entitled to conditional approval through a decentralized procedure resulting in a single decision from the European Commission, valid in all EU Member States, which would shorten the time to market approval."

Orphan drug • CNS Disorders • Neuralgia • Pain

PLENITUDE: Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer (clinicaltrials.gov) - P2; N=78; Recruiting; Sponsor: Tetra Bio-Pharma; Trial completion date: Sep 2022 ➔ Apr 2023; Trial primary completion date: Sep 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Oncology • Pain

REBORN: Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Tetra Bio-Pharma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Pain

Tetra Bio-Pharma Accelerates PLENITUDE(C) Clinical Trial to Evaluate the Effect of Cannabis for Use in Managing Uncontrolled Cancer Pain (Issuer Direct) - “Tetra Bio-Pharma…announced today the acceleration of a revolutionary Phase 2 clinical trial, PLENITUDE, to evaluate the safety and efficacy of the investigational cannabis medicine, QIXLEEF, for use in managing uncontrolled pain in patients with advanced cancer."

Trial status • Oncology • Pain

DanCann Pharma A/S signs a Letter of Intent with Canadian Tetra Bio-Pharma Inc. for the exclusive distribution of Reduvo Adversa and Qixleef in Scandinavia and Germany (Cision) - “DanCann Pharma…announce the signing of a Letter of Intent with Canadian Tetra Bio-Pharma Inc. concerning the exclusive distribution of the cannabinoid-based medicines Reduvo Adversa and Qixleef in Denmark, Norway, Sweden, Finland, and Germany. Pursuant to registration with the European Medicines Agency (EMA), DanCann Pharma will handle the exclusive sales and distribution in the Nordics and Germany for the products, Reduvo Adversa and Qixleef. In addition, the agreement covers Tetra’s OTC product Enjouca.”

Licensing / partnership • Oncology

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

Head-to-Head

REBORN: Inhaled Cannabinoids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Tetra Bio-Pharma; N=60 ➔ 20; Trial primary completion date: Feb 2021 ➔ Mar 2022

Clinical • Enrollment change • Trial primary completion date • Oncology • Pain

"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" (@DrGChamberland)

Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Relief in Patients With Advanced Cancer (clinicaltrials.gov) - P2; N=78; Recruiting; Sponsor: Tetra Bio-Pharma; Not yet recruiting ➔ Recruiting; Trial completion date: Feb 2023 ➔ Sep 2022; Trial primary completion date: Feb 2021 ➔ Sep 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Oncology • Pain

Tetra Bio-Pharma Announces FDA Clearance on IND, allowing U.S. Reborn1(TM) Clinical Trial to Commence (BioSpace) - "Tetra Bio-Pharma...announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application, allowing Tetra to initiate its QIXLEEFTM Reborn1^TM clinical trial in cancer patients with breakthrough pain...We aim to initiate this proof-of-concept trial designed to demonstrate that QIXLEEF^TM can provide pain relief faster than an immediate-release oral morphine..."

IND • Pain

CORRECTION FROM SOURCE: Tetra Bio-Pharma Provides Update on QIXLEEF’s European Activities (Tetra Bio-Pharma Press Release) - "Tetra Bio-Pharma Inc....is pleased to announce that the Corporation is set to accelerate its European activities. The Corporation has received support from Malta Enterprise and will be creating a subsidiary in Europe to expand its clinical and regulatory activities as well as its future commercial operations for QIXLEEF™, in Europe....In Q4 2020, Tetra will open its European office in Malta....'It is anticipated that this support will allow Tetra to quickly and efficiently launch QIXLEEF™ in the five Major European Markets, notably Germany, France, Spain, Italy and the UK'....Tetra intends to submit the Plenitude© clinical trial as a Phase 3 study in Q4 2020 as the first step in initiating a clinical trial program in Malta."

Launch Europe • Trial initiation date • Pain

Tetra Bio-Pharma’s Management Provides Corporate Update on QIXLEEF & CAUMZ Drug Development Activities (Tetra Bio-Pharma Press Release) - "QIXLEEF™ CANNABINOID METABOLIC PROFILE STUDY IN HUMANS:...This study is advancing as planned and we expect to receive the first data by end of August, beginning of September. Tetra is on track to complete this study as promised in Q3 2020....CAUMZ™ UPDATE:...The Corporation expects to complete the manufacturing set-up and required GMP validations prior to the start of the ReBornã trial....'Once the USA and Canadian manufacturing facilities are fully operational and validated, Tetra will be able to accelerate the clinical development of the CAUMZ™ technology product line...'"

Clinical • Clinical data • Trial completion date • Pain

Tetra Bio-Pharma’s Management Provides Corporate Update on QIXLEEF & CAUMZ Drug Development Activities (Tetra Bio-Pharma Press Release) - "Tetra Bio-Pharma Inc....today announced that the long awaited resumption of its PLENITUDE© clinical trial is on time and set to commence in Q3 2020....QIXLEEF™ UPDATE: The Plenitude© trial, which will involve ten clinical sites across the United States, is set to begin site initiation study specific procedures in August 2020....Patient recruitment and enrollment will begin as soon as the sites receive the GMP grade cannabis drug product from Aphria. Plenitude© is on target to deliver the initial drug dose to patients in the clinical trial by September 2020."

Enrollment status • Trial status • Pain

Safety and Pharmacokinetics of Vaped Cannabis in Healthy Volunteers (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Tetra Bio-Pharma

Clinical • New P1 trial

Tetra Bio-Pharma’s pleased to announce advancement of Qixleef and Caumz clinical trials ahead of Annual General Meeting (Market Watch) - "Tetra Bio-Pharma Inc....today announced that the long awaited resumption of its PLENITUDE© clinical trial to bring QIXLEEF™ to market is set to commence in Q3 2020. In addition, the Company expects to resume the ReBorn© clinical trial to bring CAUMZ™ to the market as an alternative to opioids for breakthrough pain....Tetra is continuing to move full speed into the implementation of this commercial manufacturing technology and should be ready for commercial manufacturing in Q4 2020....Tetra is now planning to initiate ReBorn© in Q4 2020."

Trial initiation date • Trial status • CNS Disorders • Pain

[VIRTUAL] Cognitive Performance and Psychedelic Effects Following Single and Multiple Ascending Doses of a New Cannabis Formulation (PPP001) Administered by Smoking/Inhalation in Male and Female Volunteers (ASCP 2020) - "A marked increase when compared to placebo (maximum peak effect ranging from 32.8 to 58.6 for the active arm and ranging from 0 to 15.2 for placebo arm) for the “feeling high” item in Part A. No cumulative effect was observed upon QD, BID or TID regimen (4 hours apart) administered on a single day. No clear difference with placebo was observed for “feeling drowsy” item. An increase when compared to placebo was detected for the composite scores “internal perception” (7 items) and external perception (6 items)."

CNS Disorders • Pain

Tetra Bio-Pharma announces closing of public offering (Yahoo Finance) - "Tetra Bio-Pharma Inc....is pleased to announce it has closed its previously announced public overnight marketed offering of units...A total of 35,191,000 Units of the Corporation were sold at a price of $0.26 per Unit, for aggregate gross proceeds of $9,149,660...The Corporation intends to use the net proceeds of the Offering to continue the development of its clinical program, including Phase 2 and phase 3 clinical trials, toxicology, regulatory and manufacturing expenses related to QIXLEEF™ (PPP001)."

Financing • Pain

Tetra Bio-Pharma provides management update on COVID-19 (Yahoo Finance) - "During this crisis period...Tetra has prioritized obtaining critical clinical research data during this period that had previously been planned for late 2020. The clinical outcomes from these studies will provide important scientific and medical information on CAUMZ...This information is required for the marketing application for any new drug....Tetra has communicated with all of its drug suppliers, including those that produce THC, CBD, HU308 and PPP001. Current assessment by these firms is that the COVID-19 crisis will not significantly affect supply of the clinical research medications."

Clinical • Clinical data

Safety and Pharmacokinetics of Smoked Cannabis in Healthy Patients (clinicaltrials.gov) - P1; N=48; Completed; Sponsor: Tetra Bio-Pharma

Clinical • New P1 trial

Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Releif in Patients With Advanced Cancer (clinicaltrials.gov) - P2; N=78; Not yet recruiting; Sponsor: Tetra Bio-Pharma; Initiation date: Jan 2020 ➔ Jul 2020

Clinical • Trial initiation date

"#TetraBioPharma Receives Favorable Letter of Advice from USA #FDA for #QIXLEEF https://t.co/FZPuoXdd43 @biospace @TetraBioPharma" (@PlexusVentures)

Tetra Bio-Pharma receives favorable letter of advice from USA FDA for QIXLEEF (Yahoo Finance) - "Tetra Bio-Pharma...today announced that it has received a favorable Letter of Advice from the US Food and Drug Administration for QIXLEEF....This Letter of Advice clearly shows that QIXLEEF can be developed for chronic pain conditions beyond pain in patients with advanced cancer."

FDA event