Caumz (cannabidiol/delta 9 tetrahydrocannabinol) / Tetra Bio-Pharma, Alternavida - LARVOL DELTA

Marijuana use is on the rise, including older adults. Data presented at 2023 AHA (cardiology) meeting suggests that marijuana user have higher risk of MI & CVA; & daily marijuana users were 34% more likely to develop heart failure (in hospitalized adults) https://cnn.it/3FLOF11

Tetra Bio-Pharma and Cannvalate Enter Into Partnership (Yahoo News) - "Tetra Bio-Pharma Inc...today announced it has entered into a research and development agreement with Cannvalate Pty Ltd ('Cannvalate') for the initiation of the...CAUMZ® clinical trials in Australia...Cannvalate also agreed to acquire Common Shares of Tetra on a private placement basis, through seven (7) distinct tranches, for aggregate proceeds of CAD$7,500,000. The first tranche providing for the issuance of Common Shares having an aggregate subscription price of CAD$500,000 was triggered by the signing of the subscription agreement, whereas the subsequent tranches of the Private Placement will be triggered by the completion of various operational events in connection with the...CAUMZ® clinical trials, such as the achievement of first patient enrolments in each such trial. The Company intends to use the proceeds of the Private Placement to fund its clinical trials and R&D activities in collaboration with Cannvalate and iNGENū."

Financing • Licensing / partnership • Cachexia • CNS Disorders • Fibromyalgia • Pain

Serenity: Safety and Efficacy of Inhaled Synthetic THC/CBD for Improving Physical Functioning and for Modulating Cachexia Progression in Patients With Advanced Cancer and Associated Cachexia (clinicaltrials.gov) - P3; N=334; Suspended; Sponsor: Tetra Bio-Pharma; Trial completion date: Oct 2021 ➔ Dec 2023; Not yet recruiting ➔ Suspended; Trial primary completion date: Dec 2020 ➔ Jul 2023

Clinical • Trial completion date • Trial primary completion date • Trial suspension • Cachexia • Oncology

Tetra Bio-Pharma (TBP) Acquires Dronabinol Soft Gel Capsules Exclusive Canadian Distribution Rights to Establish a Strong Commercial Presence in Canada and Accelerate its Profitability (Yahoo Finance) - "Tetra Bio-Pharma Inc....announced today that it has entered into a definitive agreement with a USA strategic partner to acquire the Canadian exclusive rights for Dronabinol Soft Gel capsules....The experience gained with Dronabinol will help to pave the way for the introduction of CAUMZ^TM to the marketplace. The addressable market is estimated to be $80M CDN by 2022. Tetra's intention is to gain experience with a cannabinoid derived medicine in the Canadian market in order to acquire strategic insight so that this will strengthen our discussion at the Global level with our partners."

Commercial • Licensing / partnership • CNS Disorders • 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 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

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

Inhaled Synthetic Cannabioids Versus Immediate-release Oral Opioids for the Management of Breakthrough Cancer Pain (clinicaltrials.gov) - P2; N=60; Suspended; Sponsor: Tetra Bio-Pharma; Trial completion date: Jun 2019 ➔ Apr 2022; Not yet recruiting ➔ Suspended; Trial primary completion date: Jun 2019 ➔ Feb 2021

Clinical • Trial completion date • Trial primary completion date • Trial suspension

Serenity: Safety and Efficacy of Inhaled Synthetic THC/CBD for Improving Physical Functioning and for Modulating Chachexia Progression in Patients With Advanced Cancer and Associated Cachexia (clinicaltrials.gov) - P3; N=334; Not yet recruiting; Sponsor: Tetra Bio-Pharma; Trial completion date: Nov 2022 ➔ Oct 2021; Initiation date: Sep 2019 ➔ Jul 2020

Clinical • Trial completion date • Trial initiation date

Tetra Bio-Pharma enters into manufacturing agreement with Vitiprints LLC for Caumz and HCC011 (GlobeNewswire) - "Tetra Bio Pharma...today announced it has signed a definitive manufacturing agreement with Vitiprints LLC, for the commercial scale production of CAUMZ™ and HCC011. This agreement will further protect CAUMZ™ and HCC011 with four additional patents on manufacturing know-how."

Licensing / partnership

Tetra Bio-Pharma receives favorable response following type B meeting with USA FDA for CAUMZ (Canada Newswire) - "Tetra Bio-Pharma Inc...is pleased to announce that it has received a favorable letter from the United States Food and Drug Administration...with respect to CAUMZ™. This follows the Company's previously announced Type B meeting with the FDA for CAUMZ™. The Company will be issuing a news release on Monday, February 3rd, explaining the decisions."

FDA event

Tetra Bio-Pharma provides update on U.S. and Canadian regulatory activities (GlobeNewswire) - "Tetra Bio-Pharma Inc....today provided an update on its ongoing regulatory activities with both the U.S. Food and Drug Administration (FDA) and Health Canada....The data demonstrate that a surrogate endpoint could be used to support drug approval under the Accelerated Approval pathway, potentially expediting patients’ access to important treatments for serious conditions....On the company’s two OTC DIN applications submitted to Health Canada in November...Both applications are continuing through the review process and the company continues to anticipate commercial launch in Canada in pharmacy retail outlets in early 2020."

Canadian regulatory • Launch Canada • Regulatory

Tetra Bio-Pharma Signs Definitive Commercialization Agreement for CAUMZ™ in Portugal With Azevedos Indústria Farmacêutica, S.A (GlobeNewswire, Tetra Bio-Pharma) - "Tetra Bio-Pharma...today announced the signing of a definitive agreement with Azevedos Indústria Farmacêutica, S.A. (Azevedos) for the marketing and distribution of CAUMZTM (PPP011) in Portugal. Under the terms of the agreement, Tetra will receive milestone payments and profit sharing on all sales of CAUMZ^TM in Portugal."

Commercial

Tetra Bio-Pharma Signs Definitive Commercialization Agreement for CAUMZ™ in Mexico With Alternavida S.A. (GlobeNewswire, Tetra Bio-Pharma) - "Tetra Bio-Pharma Inc...today announced that it has signed a definitive co-development and commercialization agreement ('Agreement') with Alternavida S.A. de C.V. ('Alternavida') for the clinical development, marketing and distribution of CAUMZ^TM (PPP011) in Mexico....Under terms of the agreement, Alternavida will...fully fund two clinical trial sites in Mexico for the Serenity and fibromyalgia trials, and will be responsible for registering and commercializing CAUMZ^TM in Mexico. The clinical trial sites...are expected to be up and running in early 2020....Alternavida has been granted a Right of First Refusal to commercialize CAUMZ^TM in eight additional countries including Colombia, Ecuador, Chile, Panama, Costa Rica, Honduras, Peru and the Dominican Republic."

Commercial • Launch non-US • Licensing / partnership • Non-US regulatory

Tetra Bio-Pharma receives FDA Orphan Drug Designation for hepatocellular carcinoma (GlobeNewswire) - "Tetra Bio-Pharma Inc...announced it has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for delta-9-tetrahydrocannabinol (THC) in the treatment of hepatocellular carcinoma....Tetra will leverage the pharmacokinetic and safety data from its Caumz™ Phase 1 clinical trials to support its Phase 2 trial of a modified formulation Caumz™ in patients with advanced hepatocellular carcinoma. Tetra intends to initiate this new trial in the first quarter of 2020."

New P2 trial • Orphan drug • P1 data

FDA approves advancement of PPP001 clinical trial previously discontinued (GlobeNewswire) - "Tetra Bio-Pharma Inc....today announced that the U.S. Food and Drug Administration (FDA) has authorized the advancement of Plenitude, the company’s clinical trial for its investigational therapeutic QIXLEEF™ (PPP001), for the treatment of uncontrolled pain in advanced cancer patients....Tetra has begun activities to resume this clinical trial program and plans to initiate enrollment as quickly as possible."

Enrollment status • FDA event • Trial status

Tetra Bio-Pharma confirms regulatory strategy of lead product Caumz and strengthens management team (GlobeNewswire) - "Tetra Bio-Pharma Inc....today confirmed its regulatory strategy of its CAUMZ^TM (PPP011) inhalation drug product and provided additional updates on its progress with U.S. Food and Drug Administration (FDA) for an expedited review. Additionally, the company provided updates on its plans and preparations for commercial launch of CAUMZ^TM, which include the appointments of key strategic personnel....Tetra is currently in the process of formalizing its strategy on manufacturing CAUMZTM for the global market."

Commercial • Regulatory

Tetra Bio Pharma Inc updates on inhalation drug Caumz (MMJ Observer) - "Earlier this month, the US FDA approved evaluation of Caumz®-kit as a combination drug and device product, offering clarity on regulatory permit pathway. This development marked as the first step in the company’s plan to launch this drug in the market with more FDA guidance expected by close of 2019. The pre-commercialization developments bring additional development challenges and requirements for a company in 2020."

Launch US

Tetra Bio-Pharma provides management update on commercializing its inhalation drug Caumz (GlobeNewswire) - "Tetra Bio-Pharma Inc....today provides an update on its initiatives to bring its Caumz® (PPP011) inhalation drug product to the market."

Commercial

Safety and Efficacy of Smoked Cannabis for Improving Quality of Life in Advanced Cancer Patients (clinicaltrials.gov) - P3; N=8; Terminated; Sponsor: Tetra Bio-Pharma; N=946 ➔ 8; Recruiting ➔ Terminated; Trial primary completion date: Sep 2018 ➔ Dec 2018; Mycotoxin potential contamination of one lot of study drug

Clinical • Enrollment change • HEOR • Trial primary completion date • Trial termination

Safety and Efficacy of Inhaled Cannabis For the Uncontrolled Pain Releif in Patients With Advanced Cancer (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Tetra Bio-Pharma; N=78 ➔ 0; Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal

NICE draft guidance and NHS England review highlight need for more research on cannabis-based medicinal products (NICE) - "The committee were unable to make a recommendation about the use of cannabis-based medicines for severe treatment-resistant epilepsy because there was a lack of clear evidence that these treatments provide any benefits....The draft guidance does not recommend Sativex for treating spasticity in people with multiple sclerosis..."

NICE